Approved Clinical Trials This page provides a searchable list of all clinical trial research protocols that have been reviewed and approved by the Uganda National Council for Science and Technology (UNCST).
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Name Title Study Sites Nationality Approval Date Expiry Date Sample Size Target Population Sponsors Field of Science/Classification Trial Type Research Type  
SABRINA KITAKA BAKEERA
ID: UNCST-2020-R014290
 SEARCH2: A Randomized Control Trial of Telephonic Reminders for HPV Vaccination among Adolescent Girls in Kampala, Uganda
REFNo: HS3929ES


General Objective
To conduct a randomized control trial to assess the impact of text message and automated phone reminders on HPV vaccination.

Specific Objectives:
1.To assess the impact of text message and automated phone reminders on HPV vaccination.
Sub-objectives include:
1) To assess if text message and automated phone reminders were equally effective
2) To examine subgroup effects (girl: age, site, school status [in or out of school], grade, relationship with caregiver; caregiver: age, education, employment, income, marital status, distance to health facility, language), when possible depending on the degree of variability observed
3) to assess for possible additive or subtractive effects of receiving two series of message for families of girls who may have been in the intervention for both initiation and completion

Kampala, Adolescent Clinic
Kampala, Kawala HC 3
Kampala, Kiswa HC 3
Kampala, Kisenyi HC 3
 Uganda 2024-07-02 12:45:18 2027-07-02 296 Target population: Families of adolescent girls in Uganda Study population: Families of adolescent girls who visited any of the following health centers: Kisenyi HC IV, Kiswa HC III, or Kawaala HC III or Makerere/Mulago/Columbia Adolescent Health Clinic at Mulago National Referral Hospital Accessible population: Families of adolescent girls who visited any of the following health centers: Kisenyi HC IV, Kiswa HC III, or Kawaala HC III or Makerere/Mulago/Columbia Adolescent Health Clinic at Mulago National Referral Hospital who meet the following selection criteria. National Institutes of Health USA Medical and Health Sciences Clinical Trial Non-degree Award
Elizabeth namukwaya namukwaya
ID: UNCST-2021-R013177
 PARASTOP-Paracetamol with strong opioids
REFNo: HS4423ES

To explore whether placebo with strong opioids compared to paracetamol with strong opioids changes pain intenisty for different doses of opioids, different cancers and quality of lifeintensity,To establish whether placebo with strong opioids compared to paracetamol with strong opioids changes opioid related side-effects,changes in opioid requirements and global rating of improvement,To establish whether placebo with strong opioids compared to paracetamol together with strong opioids provides non-inferior analgesia for cancer related pain,To establish whether the analgesic efficacy of strong opioids after withdrawal of paracetamol is non-inferior compared the analgesic efficacy of strong opioids used together with paracetamol for cancer-related pain.,
 Kampala, Mulago
Kampala, makinndye
 Uganda 2024-07-02 12:41:56 2027-07-02 25 cases and 25 controls Participants are eligible to be included in the study only if all of the following criteria apply: 1. Participant must be ≥ 18 years of age inclusive, at the time of signing the informed consent. 2. ≥50 kg study dose of paracetamol favours that weight 3. Participants who are under palliative care or oncology service review 4. Diagnosis of metastatic cancer. This includes all incurable solid malignancy in an advanced stage, either locally advanced or metastatic. This also includes malignant lymphoma in the palliative setting and multiple myeloma with bone disease. 5. Clinician-predicted life expectancy >2 months 6. Receiving daily regular strong opioids for cancer pain 7. Receiving stable scheduled opioid dose last 48 hours* 8. Receiving paracetamol 1 gram x three or four times a day for at least five days 9. Average pain intensity past 24 hours ≥ 2 and ≤ 7 (NRS 0-10)* 10. Able to take study drug/placebo as tablets 11. Able to comply with all study procedures 12. Capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol * It is allowed to repeat procedure within the screening period without considering the participant being a rescreen 5.2. Exclusion Criteria Participants are excluded from the study if any of the following criteria apply: 1. History of allergy or hypersensitivity to any of the active substances or excipients in the study drug 2. Known severe liver or renal failure equivalent with CTCAE Grade 3 or 4* precluding continuation of paracetamol. (*Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0) 3. Participants receiving subcutaneous, intravenous, intrathecal, or epidural opioid therapy 4. Participants receiving systemic anticancer treatment during the intervention period if they are anticipated to have increasing pain or other symptoms related to the treatment 5. Co-enrolment in other drug trials. Participants will not be enrolled in any other on-going interventional clinical trial. Study participants may be enrolled in non-interventional research (e.g. questionnaire, tissue collection studies) 6. Previously enrolled in this study 7. Pregnant or lactating women SouthEastern Norway Regional Health Authority Medical and Health Sciences Clinical Trial Non-degree Award
DAVID KITYA
ID: UNCST-2022-R009620
 Assessment of Accuracy, Precision, and Feasibility of a Handheld Near-Infrared Light Device (InfraScanner 2500™) in Detecting Intracranial Hemorrhage in Patients Admitted to Mbarara Regional Referral Hospital
REFNo: HS4141ES

Use these findings to evaluate the InfraScanner 2500™\'s ability to accurately detect intracranial hemorrhages in darker-skinned populations within LMICs. ,Determine whether the InfraScanner 2500™ detects intracranial hemorrhage (ICH) with adequate precision relative to CT scans to be used as an effective triage tool to prioritize imaging and need for level of clinical monitoring in an African, LMIC population.,To demonstrate that the InfraScanner 2500™ is capable of detecting and ruling out intracranial hematomas at rates similar to CT scan in patients hospitalized at Mbarara Regional Referral Hospital who have sustained or are suspected to have sustained head trauma.,
 Mbarara, Kamukuzi
 Uganda 2024-06-24 0:30:16 2027-06-24 180 12 years and above Duke Global Neurology Neurosurgery Medical and Health Sciences Clinical Trial Non-degree Award
Hannah Kibuuka
ID: UNCST-2020-R014355
 PROTECT-APT 1 _ Master Protocol for Early Treatment and Post-Exposure Prophylaxis of COVID-19 Adaptive Platform Trial V3.0 dated 02 June 2023 and Appendix C entitled “A phase 2 safety and efficacy study of upamostat for early outpatient treatment of COVID-19” V3.0 dated 01 June, 2023
REFNo: HS3116ES

To determine if early treatment with upamostat can shorten time to sustained symptom alleviation or resolution in participants infected with SARS-CoV-2.
Kabarole, Baza
 Uganda 2024-06-24 0:12:16 2027-06-24 40 Adult male and female participants aged 18 years and above FHI Clinical Medical and Health Sciences Clinical Trial Non-degree Award
Jonathan Izudi
ID: UNCST-2019-R000469
 Integrating Tuberculosis Treatment into Community Pharmacies to improve TB/HIV outcomes in Uganda: the Community Pharmacy Tuberculosis Treatment (COPHAT) study
REFNo: HS4397ES

To evaluate the implementation and preliminary effectiveness of integrating TB treatment into community pharmacies among people with TB/HIV.,To adapt a person-centered strategy for integrating TB treatment into community pharmacies using a human-centered design methodology.,To explore the barriers and facilitators to integrating TB treatment into community pharmacies among people with TB/HIV.,The main objective of this Community Pharmacy Tuberculosis Treatment (COPHAT) study is to develop and pilot an implementation strategy focused on integrating TB treatment into community pharmacies among people with TB/HIV in Kampala, Uganda. ,
 Kampala, Kisugu
Kampala, Kisenyi
Kampala, Kaawala
Kampala, Kitebi
Kampala, Komamboga
Kampala, Kiswa
 Uganda 2024-06-21 17:46:35 2027-06-21 126 People with TB/HIV, ART focal persons, TB focal persons, MoH officials, and Community Pharmacy health workers, aged 18 years and over, irrespective of tribe. National Institutes of Health Medical and Health Sciences Clinical Trial Non-degree Award
Cissy  Kityo
ID: UNCST-2021-R013663
 A Phase 2a/2b Study Evaluating Safety, Immunogenicity, and Therapeutic Efficacy of ID93 + GLA-SE Vaccination in Participants with Rifampicin-Susceptible Pulmonary TB
REFNo: HS3834ES

1.2 Secondary Objectives 1.2.1 Phase 2a and 2b: To evaluate the proportion of participants with a quantifiable RS ratio after therapeutic vaccination with ID93 + GLA-SE compared to placebo. 1.2.2 Phase 2a: To evaluate the kinetics of cellular immunogenicity of ID93 + GLA-SE through 12 months post second dose of study product. 1.2.3 Phase 2a: To evaluate the kinetics of humoral immunogenicity of ID93 + GLA-SE through 12 months post second dose of study product. 1.2.4 Phase 2a: To evaluate innate immune changes in response to ID93 + GLA-SE through 2 weeks post second dose of study product. 1.2.5 Phase 2b: To compare therapeutic vaccination with ID93 + GLA-SE, to placebo, with respect to the proportion of participants with TB-related unfavorable outcomes at 540 days after study entry, which is approximately 18 months after start of TB treatment, in subgroups defined by: Hard-to-treat phenotype and not hard-to-treat phenotype, where hard-to-treat phenotype is defined as smear Grade ≥3 and cavitary disease on chest radiograph at TB diagnosis.1.3 Exploratory Objectives 1.3.1 Phase 2a: To compare therapeutic vaccination with ID93 + GLA-SE to placebo, with respect to: • The safety and immunogenicity of ID93 + GLA-SE in participants living with and without HIV. • The quantitative RS ratio at time points relative to vaccination and TB treatment as indicated in the Schedule of Evaluations (SOE). • The magnitude and quality of immune responses with respect to the composition of the intestinal microbiota. 1.3.2 Phase 2b: To compare therapeutic vaccination with ID93 + GLA-SE to placebo, with respect to the proportion of participants with TB-related unfavorable outcomes at 540 days after study entry, which is approximately 18 months after start of TB treatment, adjusted for • Pharmacokinetics (PK) assessments of first-line TB drugs (exposure) during TB treatment as per the SOE. • Levels of participant adherence to standard of care (SOC) TB treatment measured using self-reporting and urine acetyl-isoniazid (AcINH) from start to end of TB treatment. 1.3.3 Phase 2b: To compare therapeutic vaccination with ID93 + GLA-SE to placebo, with respect to the proportion of participants with TB-related unfavorable outcomes at 540 days after study entry, which is approximately 18 months after start of TB treatment, stratified by bacterial burden at start of TB treatment. 1.3.4 Phase 2a and 2b: To develop the composite predictive model of TB drug response by using measures of adherence, drug exposure (PK), immune response, gut microbiota, and participant phenotype. 1.3.5 Phase 2a and 2b: To compare therapeutic vaccination with ID93 + GLA-SE to placebo, with respect to proportion of participants with sputum culture conversion at baseline at time of randomization and at Step 2, Days 30, 120, and 150, which are approximately 2, 5, and 6 months after start of TB treatment. 1.3.6 Phase 2a and 2b: To compare therapeutic vaccination with ID93 + GLA-SE to placebo, with respect to cumulative relapse from end of TB treatment up to end of study follow-up, that is, Step 2, Days 420, 450, 480, and 510, for Groups 1, 2, 3 (&5), and 4 (&5), respectively. 1.3.7 Phase 2a and 2b: To compare therapeutic vaccination with ID93 + GLA-SE to placebo, with respect to lung function and health-related quality of life, as measured by spirometry and the St. George’s Respiratory Questionnaire. 1.3.8 Phase 2a and 2b: To compare the within-person change in lung function tests over time from the first dose of therapeutic vaccination with ID93 + GLA-SE to placebo. 1.3.9 Phase 2a and 2b: To compare therapeutic vaccination with ID93 + GLA-SE to placebo, with respect to resolution of transcriptomic biomarkers of TB disease. 1.3.10 Phase 2b: To identify correlates of protection for unfavorable TB outcomes. 1.3.11 Phase 2b: To estimate the effect of the vaccine on the proportion of participants with TB-related unfavorable outcomes among participants living with and without HIV. 1.3.12 Phase 2a and 2b: To conduct analyses related to furthering the understanding of TB, HIV, immunology, vaccines, and clinical trial conduct.,1.1 Primary Objectives 1.1.1 Phase 2a and 2b: To evaluate safety of a two-dose ID93 + GLA-SE vaccine regimen administered 60 days apart on Step 2, Days 0 and 60, with TB treatment administered, at approximately: 1.1.1.1 Months 4 and 6 after start of TB treatment (Group 1) 1.1.1.2 Months 3 and 5 after start of TB treatment (Group 2) 1.1.1.3 Months 2 and 4 after start of TB treatment (Group 3 and Group 5, if this vaccination schedule is adopted for Group 5) 1.1.1.4 Months 1 and 3 after start of TB treatment (Group 4 and Group 5, if this vaccination schedule is adopted for Group 5) 1.1.2 Phase 2a and 2b: To determine if therapeutic vaccination with ID93 + GLA-SE will increase the magnitude of vaccine-specific cellular responses compared to placebo at 2 weeks post second dose of study product. 1.1.3 Phase 2b: To estimate the effect of the vaccine on the proportion of participants with TB-related unfavorable outcomes (treatment failure, TB recurrence, or death due to TB) at Day 540 after study entry, which is approximately 18 months after start of TB treatment (Group 5 combined with either Group 3 or Group 4, depending on which vaccination schedule is selected for Group 5).,
 Kampala,
Uganda 2024-06-05 17:42:17 2027-06-05 100 Individuals with or without HIV, 18 years or older male or female (any tribe) with bacteriologically confirmed rifampicin-susceptible pulmonary TB receiving locally provided SOC TB treatment. Enrollment of participants living with HIV will be capped at 20% in each group. National Institute of Allergy and Infectious Diseases Medical and Health Sciences Clinical Trial Non-degree Award
ERIC WOBUDEYA
ID: UNCST-2019-R001047
 Shortened RegiMen for Drug-susceptIbLE TB in Children
REFNo: HS4030ES

Primary
1. To determine if an 8-week HPZM regimen in children with presumed drug-susceptible TB disease has non-inferior efficacy to 8-weeks of HRZ(E) plus 8- or 16-weeks of HR(E) for achieving treatment success.
2. To evaluate the safety of the 8-week HPZM regimen in comparison to the 16- or 24- week HRZ(E) regimen among children with and without HIV.
Secondary
1. To evaluate the tolerability of the 8-week HPZM regimen in comparison to the 16- or 24- week HRZ(E) regimen among children with and without HIV.
2. To determine the weight-banded dosing of rifapentine and moxifloxacin taken as part of the HPZM regimen.
3. To evaluate the palatability and acceptability of the 8-week HPZM regimen in comparison to the 16- or 24-week HRZ(E) regimen among children with and without HIV.
4. To evaluate adherence to the 8-week HPZM regimen in comparison to the 16- or 24- week HRZ(E) regimen among children with and without HIV.
5. To evaluate clinical and laboratory characteristics and drug exposures associated with unsuccessful treatment outcomes (treatment failure or death).
6. To evaluate the cost and cost-effectiveness of the 8-week HPZM regimen relative to the 16- or 24-week HRZ(E) standard of care regimen, using a societal approach.
Exploratory
1. To characterize rifapentine and moxifloxacin PK parameters in malnourished children.
2. To evaluate the effect of rifapentine or rifampin, taken as part of the HPZM or HRZ(E) regimen, on the PK of dolutegravir.
3. To evaluate virologic control (less than 200 copies/mL) at 24- and 48-weeks among children with HIV taking a dolutegravir-based ARV treatment regimen co-administered with either HPZM or HRZ(E).
4. To collect and store biospecimens from consented participants for the purpose of future TB research.

 Kampala, mulago
 Uganda 2024-05-31 18:02:19 2027-05-31 150 Children less than 10 years of age Johns Hopkins University Medical and Health Sciences Clinical Trial Non-degree Award
Adoke Yeka
ID: UNCST-2021-R004300
 A randomized, open-label, multicenter study to compare efficacy, safety and tolerability of KLU156 with Coartem® in the treatment of uncomplicated Plasmodium falciparum malaria in adults and children ≥ 5 kg body weight followed by an Extension phase with repeated KLU156 treatment.
REFNo: HS3732ES

This study aims to confirm the efficacy, safety and tolerability of KLU156, a fixed dose combination of ganaplacide (KAF156) and a solid dispersion formulation of lumefantrine (lumefantrine-SDF), when administered once daily for three days in adults and children ≥ 5 kg body weight and ≥ 2 months of age suffering from uncomplicated P.Falciparum malaria (with or without other plasmodium spp. co-infection). In the Extension phase, the safety, tolerability and efficacy of repeated treatment with KLU156 will be assessed for a maximum of two years in patients who did not experience early treatment failure(ETF), who did not experience any study treatment-related SAE (Serious Adverse Event) previously and who gave informed consent to participate in the Extension phase.
 Tororo, Tororo
 Uganda 2024-05-29 9:37:35 2027-05-29 1500 male and female patients’ ≥ 5 kg body weight and ≥ 2 months of age will be randomized in the study Novartis Medical and Health Sciences Clinical Trial Non-degree Award
Jane Achan Edwin
ID: UNCST-2023-R005498
 Evaluation of the protective efficacy of a spatial repellent to reduce malaria prevalence in Uganda: Study protocol for a cluster-randomized double-blinded control trial: The Mossie-GO trial
REFNo: HS4196ES

The study’s primary objective is to demonstrate and quantify the protective efficacy (PE) of Mossie-GO, an active spatial repellent system disseminating transfluthrin, in reducing the prevalence of malaria infection in children ≤ 5 years of age.

The study’s secondary objective is to measure the impact of the intervention on entomological correlates of transmission including vector densities and host seeking behaviour. Insecticide resistance in the local mosquito population will also be explored.

Buikwe, N/A
Jinja, N/A
 Uganda 2024-05-23 14:23:11 2027-05-23 5600 The population will include children less than 5 years of age living in selected households in the selected villages. We will include children of both sexes and of all tribes in the selected villages. AFRICA POWER Medical and Health Sciences Clinical Trial Non-degree Award
Josephine Najjuma Nambi
ID: UNCST-2021-R013717
 Developing and testing a simulation-based intervention to improve stroke nursing care in Mbarara Regional Referral Hospital
REFNo: HS3535ES

6. Pilot test the simulation-based nursing intervention for feasibility, acceptability, functionality, quality of life, and preliminary health outcomes among stroke patients at MRRH. ,5. Develop a simulation-based stroke training packet/intervention for nurses to improve stroke care and management at Mbarara Regional Referral Hospital,4. Explore the barriers and facilitators for stroke management, and training among health care professionals at Mbarara Regional Referral Hospital ,The general objective of the study is to develop and pilot a simulation-based stroke intervention to improve stroke management at MRRH ,
 Mbarara, Kyamugorani
 Uganda 2024-05-07 13:49:58 2027-05-07 168 Age 18-100, Both male and Female and all tribes Self-sponsored Medical and Health Sciences Clinical Trial Degree Award
Jenny Löfgren
ID: UNCST-2024-R005428
 Simulation-based training for mesh inguinal hernia repair under local anaesthesia - a randomized trial
REFNo: HS4058ES

Assess the learning curve of mesh inguinal hernia repair for novice learners and how it is affected by simulation based training prior to supervised surgery on patients.
Soroti,
Mubende,
Iganga,
Sweden 2024-05-02 12:38:06 2027-05-02 440 Trainees: intern doctors with an interest in surgery and who are not already routinely performing inguinal hernia mesh repair Patients: Adult (18 years and above), otherwise healthy (ASA 1-2) men with primary, reducible, groin hernia Karolinska Institutet Medical and Health Sciences Clinical Trial Degree Award
Christopher Turyatunga Bernard
ID: UNCST-2023-R006842
 Drivers, profiling and drugs resistance effects, outcomes and cost-effectiveness of diagnostic and Syndromic interventions among urogenital discharging patients in southwestern Uganda
REFNo: HS3796ES

Establish the aetiology and sensitivity profile of urogenital discharges among patients in south western Uganda. ,5. Evaluate the Comparative cost effectiveness of diagnostic and Syndromic approaches in the management of patients with urogenital discharges in south western Uganda.,4. Compare the treatment outcomes between syndromic and diagnostic approaches in the management of patients with urogenital discharges in south western Uganda.,3. Determine the drivers of drugs resistance among patients with urogenital discharges in south western Uganda. ,2. Determine the effect of drugs’ resistance on the management of patients with urogenital discharges in south western Uganda.,This study is aimed at establishing the drivers, profiling and effect of drugs resistance, comparative treatment outcomes and cost-effectiveness of diagnostic and Syndromic interventions on patients with urogenital discharges in southwestern Uganda, and it is a parallel randomized intervention at STI clinics of Kabale and Mbarara Regional Referral Hospitals and Kisiizi Mission Hospital.,
 Uganda 2024-04-26 9:21:22 2027-04-26 476 Females and males Participants aged 15 to 60 years, with urethral and abnormal vaginal discharges void of HIV/AIDS, Diabetes Mellitus and pregnancy who have sought treatment more than once in the previous three months. MUST and STUDY Participants Medical and Health Sciences Clinical Trial Degree Award
Fred Ssewamala
ID: UNCST-2020-R014060
 Bridges2Scale: Testing Implementation Strategies for an intervention among young people affected by AIDS
REFNo: SS2488ES

Bridges2Scale will use a two-arm Hybrid III effectiveness-implementation cluster randomized clinical trial, where we will compare two multifaceted strategies (standard vs. enhanced) for scaling the Bridges interventions (consisting of financial literacy training, peer mentorship, family income-generating , and youth development accounts). The standard implementation strategy has been applied in our prior and ongoing studies and involves educational meetings that prepare staff members to deliver Bridges with minimal disruption to site workflow. This will be compared to an enhanced strategy that will be developed using Implementation Mapping, a systematic protocol for developing implementation strategies using theory, evidence, and stakeholder input. Aim 1: Compare the implementation effectiveness of the standard implementation strategy vs. an enhanced implementation strategy. Aim 2: Determine the clinical effectiveness of Bridges implemented via a standard vs. enhanced implementation strategy. Aim 3: Explore implementation processes, mechanisms, and determinants. Aim 4: Compare the cost and cost-effectiveness of the two implementation strategies.
 Masaka, Kimaanya
Rakai, Kakuuto
Kyotera, Kyotera TC
Lwengo, Lwengo
Kalungu, Kasaali
Sembabule, Parish ward
Bukomansimbi, Mbiriizi
 Uganda 2024-04-19 18:42:54 2027-04-19 1440 Inclusion and Exclusion Criteria: Adolescent Inclusion Criteria: (1) ages 13-17 years; (2) a student at one of the 48 public primary schools included in the study; (3) living within a family and not an institution/orphanage. Caregiver Inclusion Criteria: A caregiver would be eligible if they are (1) self-identified and confirmed by the AY as primary caregiver of the AY; and (2) capable of providing informed consent. Schools’ inclusion criteria: The 48 public (government) primary schools would be eligible if they are (1) located in one of the seven districts in the greater Masaka region – on secondment from the Ministry of Education or local government representative (District Education Officer [DEO]), and (2) willing and able to participate in study implementation. Youth-serving NGOs will be invited if they are: (1) registered with the government of Uganda; (2) willing to work with the study team; and (3) have a history of implementing micro-finance EE interventions. Exclusion criteria: Adolescents will be ineligible if: 1) they are unable to understand study procedures and participant rights as assessed during informed consent/assent process with the adolescent and parent. 2) If the adolescent or adult caregiver presents with emergency needs (e.g., hospitalization), needed care will be secured, rather than study participation. Facilitator Recruitment. The leaders of public schools and youth-serving NGOs will help us select the facilitators based on their interest in the intervention and willingness to work with study participants. Standard Implementation Strategy (SIS) condition. we will meet with both NGO and school staff to gauge their interest in partnering on study implementation and describe roles and responsibilities. Enhanced Implementation Strategy (EIS) condition. The headmaster of each school in the EIS will identify at least 2 teachers per school to be enrolled in the study and deliver the intervention—as implementation champions. We expect to recruit at least 48 teachers in EIS (2 teachers/school x 24 schools). Similar procedures will be followed for NGO staff. Specifically, we will recruit at least 8 facilitators from NGOs and 8 facilitators from community (including PTA members) to serve as trainers for implementation champions. Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Social Science and Humanities Clinical Trial Non-degree Award
Patricia NAHIRYA Ntege Nahirya
ID: UNCST-2019-R001117
 Long-Term Follow-Up of CAB LA for Participants in HPTN 083 and HPTN 084 CAB PrEP Studies at Risk of HIV Acquisition.
REFNo: HS3876ES

Primary Objective
• To describe new HIV infections in adult and adolescent participants at risk of HIV acquisition included in the HPTN 084 studies and their associated sub-studies.

Secondary Objective
• To describe any serious adverse events (SAEs), Grade 3 and Grade 4 ISRs, and AEs leading to withdrawal in adult and adolescent participants included in the HPTN 084 studies and their associated sub-studies.


 Kampala, Mulago
 Uganda 2024-04-04 8:20:33 2027-04-04 146 Participants must be currently enrolled and ongoing in one of the following studies: • HPTN 083 • HPTN 084 • HPTN 083 and HPTN 084 adolescent and pregnancy sub-studies Participants who have permanently withdrawn from prior CAB PrEP studies cannot enroll into this study. 2. Evidence of continued benefit (HIV negative and at risk) from CAB LA during participation in the parent study/sub-study. 3. Participants must have a nonreactive HIV test at Screening (rapid test, antigen/antibody test and HIV-1 RNA from the parent study/sub-study) and Day 1 (a rapid test and HIV Immunoassay [Antigen/Antibody test]) Males and Females: All participants who are engaging in sexual activity should be counselled on safer sexual practices including the use and benefit/risk of effective barrier methods (e.g., male condom) and on the risk of acquiring HIV and other STIs. Females: Cisgender female participants who are of childbearing potential and who are engaging in sexual activity that could lead to pregnancy, must talk to the investigator about recommended contraception options (Section 11.1). Contraception will be optional in this study. Condoms are recommended in addition, because their appropriate use is the only contraception method effective for preventing HIV-1 transmission. Pregnant participants from the HPTN 084 study are eligible to enroll into this study f they meet all eligibility criteria ViiV Healthcare UK Limited Medical and Health Sciences Clinical Trial Non-degree Award
KANIKA  Jean-Claude MASSAMBA
ID:
effectiveness of vaginal misoprostol versus vaginal dinoprostone among pregnant women undergoing labor induction at Jinja regional Referral Hospital. (REC Approval: BSU-REC-2023-244)
REFNo: HS4007ES

To assess the Peripartum fetal complications as well as the maternal obstetrics outcomes in vaginal misoprostol group versus vaginal dinoprostone group at Jinja Referral Regional Teaching-Hospital maternity ward. ,The main goal of this study is to compare the effectiveness of vaginal misoprostol to vaginal dinoprostone and identify the feto-maternal complications in women undergoing labor induction at Jinja Referral Regional Teaching-maternity Hospital\'s unit.,
 Jinja, Jinja
 Democratic Republic of Congo 2024-03-28 18:36:47 2027-03-28 136 Pregnant women between 37 weeks + 0 day to 41 weeks + 6 days of gestation attending antenatal clinic at Jinja RRH and who have indications of labor induction and consent to participate in the study. Principal Investigator Medical and Health Sciences Clinical Trial Degree Award
Jonathan Izudi
ID: UNCST-2019-R000469
 Effectiveness of Multi-Month Dispensing of Anti-Tuberculosis Drugs (MULTI-DAT) Versus Standard of Care on Treatment Success Rate Among People with Drug Susceptible Tuberculosis in Rural Eastern Uganda
REFNo: HS3953ES

To evaluate the effectiveness of MULTI-DAT on cure and treatment success rates at 6 months of treatment compared to the standard of care (SOC) using an open-label, individually randomized controlled trial or RCT (Aim 2). ,To explore stakeholder perceptions regarding the relevance and appropriateness of MULTI-DAT, including the delivery of MULTI-DAT among people with drug-susceptible PTB aged ≥15 years using a qualitative study (Aim 1).,Overall, the MORAD study will focus on the practicability and effectiveness of MULTI-DAT among people with drug-susceptible pulmonary TB (PTB) aged ≥15 years on the standard 6-month anti-TB treatment regimen in eastern Uganda,
 Soroti, Soroti
Kumi, Kumi
Serere, Serere
Not Applicable (N/A), Soroti
 Uganda 2024-03-27 18:52:57 2027-03-27 66 stakeholders (Aim 1); 260 participants in a 1:1 ratio (Aim 2) Aim 1: i) TB focal persons with ≥1 year of work experience; other stakeholders with ≥3 years of work experience in TB; ii) People with TB on treatment for ≥4 months including the respective treatment supporters. Aim 2: People with drug-susceptible PTB ≥15 years. UC Berkeley Medical and Health Sciences Clinical Trial Non-degree Award
Ahmed Ddungu
ID: UNCST-2019-R000944
 CHARACTERIZATION OF TUBERCULOSIS ASSOCIATED LUNG FIBROSIS AND RESPIRATORY IMPAIRMENT, AND PREVENTION USING DOXYCYCLINE IN A DOUBLE BLIND RANDOMISED CONTROLLED TRIAL
REFNo: HS3385ES

To characterise/describe TB associated lung fibrosis and TB associated chronic respiratory impairment (where appropriate: burden and severity, radiological phenotype based on high resolution CT, clinical phenotype based on symptoms and lung function status, and predictors/ associations (including with selected biomarkers)); and to assess the efficacy of doxycycline as an adjuvant therapy to prevent TALF amongst patients with advanced TB
 Kampala, Mulago
 Uganda 2024-03-20 15:59:56 2027-03-20 0200 - Age of 18 – 65 years - sex : Male and Female - Tribe (Non discriminatory of tribe) - Index PTB episode (sputum smear positive or GeneXpert positive with rifampicin susceptibility) - Baseline Chest X-ray showing infiltrates in at least 2 lung zones (≥30% lung involvement) meeting criteria for moderate/advanced PTB - HIV uninfected (clinical trial ) - Subjects willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. - Able to give written informed consent. Makerere University Research and innovation Fund and Makerere University Lung Institute through the MAKNCD PROGRAM Medical and Health Sciences Clinical Trial Degree Award
Pontiano  Kaleebu
ID: UNCST-2020-R019901
 Field Performance Evaluation of the TrinScreen™ HIV rapid test kit
REFNo: HS3878ES

1. To describe the performance (sensitivity and specificity) of the TrinScreen™ rapid test, when compared to the national testing algorithm.

2. To describe the performance (sensitivity and specificity) of the TrinScreen™ rapid test compared to the reference testing (Genscreen ULTRA HIV1/2 Ag/Ab EIA followed by the Murex diasorin HIV1/2 Ag/Ab combination).


3. Estimate the proportion of inconclusive test results by Trinscreen™

Kampala, Naguru
Wakiso, kigongo
Gomba, mpigi
Kayunga, Kawolo
Mukono, Mukono
Mpigi, Nkozi
Wakiso, Mityana
Wakiso, wagagai
Kayunga, Kayunga
 Uganda 2024-03-14 12:38:09 2027-03-14 1550 - Adults above 18 years of age - Willing to have an HIV test. - Eligible for testing as per the National HIV testing service eligibility screening tool - Documented co Trinity Biotech Manufacturing Ltd Medical and Health Sciences Clinical Trial Non-degree Award
Kamoga Ronald
ID: UNCST-2019-R001524
 VAGUS NERVE STIMULATION IN A RAT MODEL OF ALZHEIMER’S DISEASE-LIKE SYMPTOMS: MORPHOLOGICAL, IMMUNOHISTOCHEMICAL, MOLECULAR AND BEHAVIORAL CHANGES
REFNo: HS3781ES

1. To conduct a scoping review of literature on vagus nerve stimulation in Alzheimer's-disease and related dementias.
2. To determine behavioral changes associated with vagus nerve stimulation in a rat model of Alzheimer-like symptoms.
3. To evaluate the morphological, Immunohistochemical and molecular changes in the Hippocampus, prefrontal cortex and medial temporal cortex associated with chronic stimulation of the vagus nerve in a rat model of Alzheimer’s-like disease.

 Mbarara, Medical cell
 Uganda 2024-02-26 13:43:22 2027-02-26 42 Wistar rats Wistar rats bewteen 3 months and 7 months old Self sponsorship Medical and Health Sciences Clinical Trial Degree Award
Sarah Lofgren
ID: UNCST-2019-R001647
 Supervised Treadmill intervention to Reduce Inflammation and Depression through Exercise in HIV: The STRIDE Pilot Study
REFNo: HS3358ES

The objective of this study is to determine the feasibility and acceptability of an aerobic intervention via a treadmill among individuals with HIV and depression in Uganda.
3.1 Primary Endpoint: Feasibility and acceptability of Exercise as a treatment for depression in Ugandans with HIV. This will be measured by:
-Percent completion of the prescribed aerobic exercise intervention, as assessed by research staff logging participation.

3.2 Secondary Endpoint(s)/ Outcome(s):
- acceptability of the intervention assessed via a post intervention survey
-feasibility and acceptability of using a wearable exercise tracker to assess the volume of exercise, based on calories burned and steps achieved, during the intervention period among Ugandans with HIV and depression.
- measure the mean and standard deviation of baseline and 8-week serum BDNF and IL-6 level to estimate an effect size and power a future study.
- measure the mean and standard deviation of baseline and 8-week depression score via PHQ-9 to estimate an effect size and power a future study.
- measure the mean and standard deviation in aerobic fitness baseline and at 8 weeks measured via METS/watts achieved and total time/distance to estimate the effect size for a future intervention.
Wakiso, Lweeza
 USA 2024-02-26 13:41:23 2027-02-26 24 • Enrolled in Mildmay HIV clinic • Adults 18-45 years old • HIV positive • Receiving HIV therapy • HIV viral suppression (<400 copies/mL) per chart review • Mild to Moderate (PHQ9 score >5 but >20) • Not currently engaged in a formal exercise program or manual labor such as construction or delivery requiring a manual bike or walking • Able to walk/run on a treadmill • Informed consent University of Minnesota, Makerere University Medical and Health Sciences Clinical Trial Non-degree Award
Julian Adong
ID: UNCST-2021-R013487
 Retention through mHealth for adolescents and young adults with HIV in care
REFNo: HS3722ES

Test the acceptability, feasibility, and preliminary impact of the developed adolescent-tailored mHealth intervention for retention in care of AYWH who are new to or newly re-engaging in care,Iteratively develop a social media-based adolescent-tailored mHealth intervention to improve retention in care for AYWH who are new or newly re-engaging in care,Define the cognitive, environmental, and behavioural challenges and their impact on behavioural intention for AYWH who are new or newly re-engaging in HIV care,To develop and test an mHealth intervention for retention in care for adolescents and young adults with HIV,
 Mbarara, kamukuzi
Mbarara, kamukuzi
 Uganda 2024-02-26 13:34:00 2027-02-26 105 We will enroll male and female adolescents and young adult participants with HIV aged 15-24. and health care workers aged 18 and above. National Institutes of Health/Fogarty International Center Medical and Health Sciences Clinical Trial Non-degree Award
Bruce Kirenga J
ID: UNCST-2019-R001460
 SOLIDARITY TRIAL-A phase I/II Randomized Placebo controlled trial to evaluate the Safety and Immunogenicity of Sudan Ebolavirus in Uganda
REFNo: HS3190ES

Phase I (rVSV-SUDV)
1. To determine the safety of rVSV-SUDV candidate SUDV vaccine among adult healthy volunteers in Uganda.
2. To determine the immunogenicity of rVSV-SUDV candidate SUDV vaccine.

Phase II (ChAdox1, CAd3 and rVSV-SUDV)
Primary objectives
1. To determine the safety of ChAdox1, CAd3 and rVSV-SUDV candidate SUDV vaccines among healthy volunteers and persons with stable comorbidities.
2. To determine the immunogenicity of ChAdox1, CAd3 and rVSV-SUDV candidate SUDV vaccines.
Secondary objectives
1. To determine the durability of SUDV-specific induced immune responses following vaccination.
2. To determine the factors associated with optimal vaccine-induced immune responses.
3. To determine the putative cross reactivity by the SUDV vaccine candidates against other ebolaviruses (e.g. Bundibugyo ebolavirus (BUDV) and EBOV).

Exploratory objectives
1. To determine the effect of SUDV vaccines on host gene expression.
2. To determine the T and B cell specific responses and immune profiling in response to vaccination.
3. To determine the effect of SUDV vaccines on the host metabolome.
4. To determine the effect of SUDV vaccines on host innate immune responses.

 Kabarole, Fort portal
Kampala, Mulago I
Kayunga, Kayunga
Mbarara, Rubindi
Wakiso, Nkumba
Mubende, Kikanddwa
Masaka, Kabonera
 Uganda 2024-02-26 13:31:25 2027-02-26 2121 participants will be recruited in phase II and phase I will recruit 250 participants healthy volunteers both male and females will be recruited in the study regardless of the ethnic group they belong to. The participants will recruit people aged 6-65 in to phase I and phase to World Health Organization and Ministry of Health Uganda Medical and Health Sciences Clinical Trial Non-degree Award
Betty Mwesigwa
ID: UNCST-2020-R014667
 Sabin 003: A Phase 2, Randomized, Double-blind, Placebo-Controlled Trial to Evaluate Safety, Tolerability, and Immune Responses of an Investigational Monovalent Chimpanzee Adenoviral-Vectored Sudan Ebolavirus Vaccine in Healthy Adults
REFNo: HS3628ES

To evaluate the safety and tolerability of cAd3-EBO S vaccine
 Kampala, Central
Kampala, Central
Kampala, Central
 Uganda 2024-02-13 17:35:43 2027-02-13 125 participants 18 to 70-year old healthy adults Sabin Vaccine Institute Medical and Health Sciences Clinical Trial Non-degree Award
Juliet Babirye Ndimwibo
ID:
TREAT INTERACT: Implementing a user involved education- and health system interactive task-shifting approach for child mental health promotion in Uganda
REFNo: HS3144ES

Based on findings from objectives 1-2, develop implementation advice to guide policymakers in school-based child and adolescent mental health (CAMH) management, integration with the health system, and how to implement and sustain large-scale evidence-informed CAMH interventions to contribute towards achieving universal mental health coverage. ,Develop, implement and evaluate an intersectoral supervision, referral and communication model between the health and education sector.,Implement the adapted module-based TREATment mhGAP school program and investigate effective implementation strategies and client outcomes.,Intervention mapping to adapt the mhGAP-IG to a primary school setting, and implementation mapping to develop implementation strategies with user involvement,The main objective of the TREAT INTERACT study is to adapt, implement and evaluate the impact of an adapted school version of the mhGAP-IG that aims to prevent, identify, refer and treat mental health problems in children and adolescents in Uganda through a user involved task-shifting implementation of the mhGAP-IG among primary school staff. This work is divided into 4 work Packages (WPs); each of the specific objectives below represents a single work package.,
 Mbale, Primary schools
 Uganda 2024-02-02 12:05:35 2027-02-02 612 teachers Teachers and pupils at primary schools Norwegian research Council Medical and Health Sciences Clinical Trial Non-degree Award
Harriet Ajilong
ID: UNCST-2022-R005889
 Assessing Vitamin D serum levels in HIV-positive adolescents 10-19 years with depression in Northern Uganda
REFNo: HS3454ES

To determine the burden of depression in HIV-positive adolescents at Gulu RRH,To assess for serum Vitamin D levels in HIV Positive adolescents 10-19 years with depressive symptoms in Gulu Regional Referral Hospital Methods,
 Gulu, Laroo
 Uganda 2024-01-24 22:30:43 2027-01-24 380 participants HIV Positive adolescents at Gulu Regional Referral Hospital Child Global Research Fellowship Medical and Health Sciences Clinical Trial Non-degree Award
Zubair Lukyamuzi
ID: UNCST-2021-R013107
 Feasibility and Acceptability of a Barbershop Based HIV Prevention Initiative Among Heterosexual Men in Kalangala Islands, Uganda: A Cluster Randomized Trial
REFNo: HS3430ES

1. To compare completion of self-initiated HIV testing between intervention and control groups
2. To evaluate the preliminary effectiveness of the intervention on change in behaviors associated with HIV acquisition
3. To compare interest in or use of HIV prevention services between intervention and control groups
4. To evaluate the preliminary effectiveness of the intervention on incident STIs
Kalangala, Bugala Island
 Uganda 2024-01-08 13:20:21 2027-01-08 up 250 the study population will be men aged at least 16 at risk of HIV in Kalangala Division of AIDS (DAIDS), United States (US) National Institute of Allergy and Infectious Diseases (NIAID), US National Institutes of Health (NIH) Medical and Health Sciences Clinical Trial Non-degree Award
Timothy  Muwonge Ronald
ID: UNCST-2020-R014680
 Achieving HIV viral suppression in refugee settlements in Uganda with Head StART: a cluster randomized trial evaluating the effectiveness of community ART delivery for people newly diagnosed with HIV
REFNo: HS2935ES

To estimate the programmatic cost and budget impact of implementing the Head StART intervention in refugee settlements in Uganda. ,To assess Head StART implementation across refugee settlement sites to understand the impact of contextual factors on study outcomes. ,To evaluate the effectiveness of “Head StART,” the expansion of community ART delivery to people newly diagnosed with HIV, in achieving HIV viral suppression in refugee settlements in Uganda. ,The primary objective of this research is to evaluate the effectiveness of expanding community ART delivery to clients newly diagnosed with HIV.,
 Uganda 2024-01-05 9:11:58 2027-01-05 1200 We will recruit adult persons living with HIV aged 18 and above and accessing care from health care centers in refugee camps in Uganda. National Institute of Health Medical and Health Sciences Clinical Trial Non-degree Award
PATRICK MUSINGUZI
ID: UNCST-2023-R007731
 UTILITY, ACCEPTABILITY AND APPLICABILITY OF A NUCLEIC ACID AMPLIFICATION TEST (NAAT) IN COMPARISON WITH SYNDROMIC APPROACH IN THE MANAGEMENT OF SEXUALLY TRANSMITTED DISEASES AT MULAGO NATIONAL REFERRAL HOSPITAL IN UGANDA.
REFNo: HS3100ES

To estimate the actual relative prevalence of causative agents of STDs in our study setting.,To evaluate the acceptability of the NAAT.,To assess the degree of concordance between actual pathogens diagnosed through the molecular test and the presumed pathogens indicated by the syndromic approach.,To evaluate whether the use of NAAT for the management of STDs improves clinical outcome and microbiological cure compared with the syndromic approach.,To evaluate whether microbiological diagnosis using NAAT improves appropriateness of therapy of STDs (as a measure of clinical usefulness) in comparison with the syndromic approach without or with limited laboratory tests currently in use.,
 Uganda 2024-01-05 9:01:56 2027-01-05 240 Adults aged 18 years and above presenting with signs and symptoms of STDs at the Mulago Hospital STDs clinic during the study period, who provide written consent to the participation to the study and are diagnosed with UDS, AVD and GUD. Italian Society of Infectious and Tropical Diseases (SIMIT) Medical and Health Sciences Clinical Trial Non-degree Award
Harriet Mayanja-Kizza
ID: UNCST-2021-R013074
 Six weeks of daily Rifapentine vs. a comparator arm of 12-16 week Rifamycin-based treatment of latent M. tuberculosis infection: Assessment of safety, tolerability, and effectiveness
REFNo: HS3492ES

The main objective of this trial is to compare the safety and effectiveness of a six-week regimen of daily Rifapentine to that of a standard arm of 12weeks of HP or 12 weeks of H or 16 weeks of R for the treatment of LTBI
 Kampala, Mulago
 Uganda 2023-12-21 20:31:51 2026-12-21 The target total enrollment is 3400 participants from all participating sites and approximately 250 participants will be enrolled from the Ugandan site The target study population will include male and female (except pregnant or breast-feeding) participants aged 12 years or older with LTBI who do not have evidence of active disease and are at increased risk of progression to active TB. U.S. Centers for Disease Control and Prevention Medical and Health Sciences Clinical Trial Non-degree Award
Dennis Ssesanga Ernest
ID: UNCST-2023-R008022
 EFFECT OF MHEALTH COMMUNICATION ON STIGMA AND RETENTION IN CARE AMONG YOUTH LIVING WITH HIV AND LINKED TO CARE IN UGANDA.
REFNo: SS2215ES

1. To explore the effect of mhealth communication on stigma among youth living with HIV and linked to care in Uganda.
2. To systematically develop and evaluate an mHealth intervention on stigma and retention in care among youth living with HIV and linked to care in Uganda.
3. To investigate the determinants of stigma and retention in care among youth living with HIV and linked to care in Uganda.
4. To determine the effect of mhealth communication on retention in care among youth living with HIV and linked to care in Uganda.
 Kampala, Nsambya
Kampala, Mulago
Jinja,
Jinja,
Uganda 2023-12-19 11:26:33 2026-12-19 142 Participants will include voluntary consented and assented HIV-positive patients aged 15-24 years, who communicate in English, Lusoga or Luganda. Clinical Uganda Virus Research Institute Social Science and Humanities Clinical Trial Degree Award
Cissy  Kityo
ID: UNCST-2021-R013663
 Platform Assessing Regimens And Durations In a Global Multisite consortium for TB. A Seamless Phase 2B/2C Platform Trial to Evaluate Multiple Regimens and Durations of Treatment in Pulmonary Tuberculosis
REFNo: HS3044ES

Phase 2C: Amongst regimens selected for progression from phase 2B, to further evaluate the safety profile and to identify the optimal treatment duration (between 8 and 16 weeks) based on unfavourable outcome to support advancement to future Phase 3 trials.,Phase 2B: To identify regimens with acceptable safety profile that have the greatest potential, based on assessment of quantitative sputum liquid culture and treatment failure/relapse to progress to investigation of optimal treatment duration in Phase 2C.,To identify novel drug regimen(s) with acceptable safety profile, non-inferior efficacy and shortened treatment duration compared to the standard-of-care 24-week HRZE regimen that could be used to treat people with rifampicin susceptible and rifampicin resistant TB.,
 Kampala, Kampala
Wakiso, Kampala
Mukono, Kampala
Mpigi, Mpigi
 Uganda 2023-12-01 17:56:07 2026-12-01 Up to 2500 overall will be enrolled, 700 in phase 2B and 1800 in phase 2C. An estimate of 165 patients in total for Uganda sites (60 in phase 2B and 105 in phase 2C) and about 30 patients for JCRC Lubowa in phase 2B and 55 patients in phase 2C. Adults ≥18 years with newly diagnosed pulmonary TB will be enrolled University College London Medical and Health Sciences Clinical Trial Non-degree Award
Jude Byansi Zziwa
ID:
DEVELOPING A FRAMEWORK FOR PROVIDING SUSTAINABLE SANITATION SERVICES IN URBAN SCHOOLS IN LOW- AND MIDDLE-INCOME COUNTRIES: A CASE OF TWO CITIES IN UGANDA
REFNo: SIR254ES

(iv) To establish the effect of the school centered sanitation service framework on human faecal exposure pathways in urban schools of LMICs.,To ascertain how the key factors in objective (ii) above, interact to provide sustainable sanitation services in city schools,To establish factors sustaining sanitation service provision in city schools,To determine the status of sanitation service provision in city schools ,The general objective of this study is to develop a sanitation management framework that will contribute to sustainable service provision in urban schools of Low- and Middle Income Countries (LMICs).,
 Arua, Pajuni, Adumi, Oluko, Todamu, Aroi, Manibe and Ayivuni
Arua, Arua Hill, River Oli
Arua, Pajuni, Adumi, Oluko, Todamu, Aroi, Manibe and Ayivuni
Arua, Arua Hill, River Oli
 Uganda 2023-11-20 15:27:51 2026-11-20 2,434 participants The pupil population from age 9 to 25 years, Teacher population from age 23 to 60 years, Other stakeholders will be adults. Male and female participants will be balanced. Citywide Inclusive sanitation Program Engineering and Technology Clinical Trial Degree Award
sunday anziku oyeeson
ID:
Exploring the Teachers’ Feedback Practices and its Influence on Students’ Learning in CBC: A case of a selected secondary school in Central Division, Arua City.
REFNo: SS2007ES

To explore how teachers’ feedback influences students' learning in CBC in lower secondary schools in Arua City.
To find out how students perceive the influence of feedback on their own learning in CBC.
To examine the strategies used by teachers to administer feedback to students in CBC in lower secondary schools in Arua City.
To find out the challenges faced by teachers in administering feedback to students in CBC in lower secondary schools in Arua City.

 Uganda 2023-11-16 13:34:21 2026-11-16 2 school administrators (Headteacher and Deputy), 3 Teachers of lower secondary or CBC classes (S.1, S.2, and S.3) and 9 Students in CBC classes (considering 3 students from each class) The study will be conducted in a secondary school involving CBC class students, teachers and the school administrators Self-Sponsored Social Science and Humanities Clinical Trial Degree Award
Esther Atukunda Cathyln
ID: UNCST-2019-R001701
 Integration of a patient-centered mobile health intervention (Support-Moms) into routine antenatal care to improve maternal health in Uganda.
REFNo: HS3366ES

Evaluate the cost and cost-effectiveness of implementing Support-Moms intervention into routine care and implications for sustainability,Evaluate intervention implementation using the Proctor framework and plan for future scale-up per the Consolidated Framework for Implementation Research ,Test the effectiveness of the Support-Moms intervention in a randomized controlled trial,
 Uganda 2023-11-13 12:57:49 2026-11-13 824 We will include individuals who: 1) are in the first trimester of pregnancy who have not yet presented for ANC, 2) reside in the catchment area of a study HC, 3) are emancipated minors and adults aged ≥ 18 years, 4) report access to a cell phone with reception in their home, 5) are able to identify at least two social supporters living within the study districts, and 6) are able to provide consent. National Institutes of Health Medical and Health Sciences Clinical Trial Non-degree Award
JOSAPHAT KAYOGOZA BYAMUGISHA
ID: UNCST-2019-R001680
 A phase II/III, open-label, randomized clinical trial to evaluate the efficacy and safety of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) in life-threatening postpartum haemorrhage (PPH) in reducing adverse maternal outcome compared to standard of care in Uganda.
REFNo: HS3240ES

To assess the time to insert the REBOA.,To assess if the proportion of participants with either maternal death and/or emergency hysterectomy is lower in the intervention arm when excluding ‘inevitable’ hysterectomies due to either an irreparable uterine rupture, a pathological placenta growing into the uterus (placenta accreta, increta or percreta) or a pathological uterus, such as a bicorne uterus or one with very large fibroids.,To assess if post-partum haemoglobin concentration is higher in in the intervention arm compared to the comparator arm,To assess if the number of blood transfusion units is lower in the intervention arm compared to the comparator arm.,To assess if the number of participants with acute kidney injury is lower in the intervention arm compared to the comparator arm,To assess if the proportion of participants with maternal deaths is lower in the intervention arm compared to the comparator arm.,To assess if the proportion of participants with emergency hysterectomy, is lower in the intervention arm compared to the comparator arm., To assess the safety of REBOA in a national referral hospital in a low-income country like Uganda.,To assess if the proportion of participants with either maternal death and/or emergency hysterectomy, can be decreased from 50 % in the comparator arm (using standard of care alone) to 30 % or less in the intervention arm (using REBOA). ,
 Kampala, Kawempe
 Uganda 2023-11-13 12:15:41 2026-11-13 10 women in phase IIb and 212 women in Phase III (222 IN TOTAL) Women aged 18 and above years and emancipated minors with life-threatening PPH and a systolic blood pressure equal to or less than 80 mmHg will be recruited Centre For International Health Medical and Health Sciences Clinical Trial Non-degree Award
Stephen Okoboi
ID: UNCST-2019-R001356
 Peer Delivered HIV/Syphilis Self-Testing with Assisted Partner Notification Services for Men who Have Sex with Men (MSM) in Uganda
REFNo: HS3021ES

Estimate the cost-effectiveness of peer-delivered HIV/syphilis self-tests and partner services compared to facility-based testing.,Conduct a pilot randomized trial to pilot test the preliminary effectiveness of peer delivered HIV/syphilis self-tests and partner services versus facility-based testing., Conduct formative research to inform implementation of peer delivered self-tests for HIV and syphilis with partner services for Ugandan MSM. ,
 Uganda 2023-10-31 19:59:00 2026-10-31 200 Inclusion criteria: In both arms, peers will recruit network members who are 1) aged 18 years and older, 2) Self-report of anal sexual intercourse at least once in the prior quarter 3) self-identify as MSM, 4) not tested in past 3 months or never tested for HIV or syphilis before; 5) willing to provide informed consent; 6) willing to undergo study procedures National Institute of health Medical and Health Sciences Clinical Trial Non-degree Award
Prudence Beinamaryo
ID: UNCST-2023-R007239
 Efficacy of the combination ivermectin and albendazole vs albendazole alone in school-aged children infected with Trichuris trichiura: a randomized controlled trial
REFNo: HS3160ES

To evaluate the safety and tolerability of the ,To determine the CRs and ERRs of the study drugs (i.e. albendazole alone, albendazole-ivermectin) against Ascaris lumbricoides and hookworm in co-infected participants.,To determine the egg reduction rates (ERRs) of ivermectin/albendazole combination therapy compared to albendazole monotherapy against T. trichiura,To demonstrate that co-administered ivermectin (200 µg/kg) plus albendazole (400 mg) is superior to albendazole (400 mg) monotherapy in terms of CRs against T. trichiura infections assessed by Kato-Katz at 14-21 days post-treatment in individuals aged 6-12 years.,
 Kabale, Rukore
Kabale, Rukore
 Uganda 2023-10-04 13:42:09 2026-10-04 750 School age children of from Age 6-12 both males and female of any tribe residing in area. Prof. Dr. Jennifer Keiser Medical and Health Sciences Clinical Trial Non-degree Award
Andrew Odur
ID: UNCST-2022-R009128
 A RANDOMIZED CONTROL TRIAL TO DETERMINE THE EFFICACY OF MACHINE LEARNING MODELS TO PREDICT POSTPARTUM HEMORRHAGE
REFNo: HS3132ES

Determine whether earlier knowledge of the high-risk patient likelihood of morbidity can change clinical management to better outcomes,Demonstrate the efficacy of a mobile app prediction-based platform in informing clinical judgment,Determine the suitability of mobile app-based platform integration into the clinical workflow of African obstetricians,Determine the efficacy of ML models to predict the likelihood of pregnancy complications among African mothers,We aim to conduct a randomized control trial to determine the efficacy of machine learning models to predict postpartum hemorrhage to potentially establish a new gold standard way of screening patients in low-resource settings,
 Lira, Cathedral
 Uganda 2023-10-02 15:32:14 2026-10-02 RCT sample size will be 200 The study will enroll pregnant women 18 years and older attending ANC at Lira Regional Referral Hospital intending to deliver from the same facility residing within 10 km distance from the hospital. INFIUSS Health, Inc Medical and Health Sciences Clinical Trial Non-degree Award
Conrad Muzoora Kihembe
ID: UNCST-2019-R001432
 REDUCING MORTALITY IN ADULTS WITH ADVANCED HIV DISEASE (REVIVE)
REFNo: HS2892ES

To determine whether azithromycin is effective in reducing the incidence of new infection compared to placebo in adults with advanced HIV (CD4 ≤ 100 cells/mm3).,To determine whether azithromycin is effective in reducing mortality and hospitalisation at early and late timepoints (4weeks and 24weeks) compared to placebo in adults with advanced HIV (CD4 ≤ 100 cells/mm3).,To determine whether azithromycin is an effective and safe intervention to reduce excess mortality in adults with advanced HIV (CD4 ≤ 100 cells/mm3). ,
 All Districts, Not applicable
 Uganda 2023-09-27 17:43:49 2026-09-27 8000 18 years and above, all sexes and all tribes Population Health Research Institute (PHRI) Canada Medical and Health Sciences Clinical Trial Non-degree Award
Adoke Yeka
ID: UNCST-2021-R004300
 PLATINUM: A multi-part, multi-center PLATform study to assess the efficacy, safety, tolerability and pharmacokinetics of anti-malarial agents administered as monotherapy at multiple dose levels and/or combination therapy IN patients with Uncomplicated Plasmodium falciparum Malaria.
REFNo: HS2817ES

Part A: To assess the parasite clearance time (PCT) of oral doses of an anti- malarial agent administered as monotherapy in patients with uncomplicated
P. falciparum malaria
Part B: To assess the effect on adjusted 28-day cure rate of an anti-malarial agent administered orally as combination therapy versus the standard of care (SoC) in patients with uncomplicated P. falciparum malaria.
Part A: To assess the effect on adjusted 28-day cure rate of an anti-malarial agent administered orally as monotherapy in patients with uncomplicated
P. falciparum malaria
Part B: To assess the parasite clearance time (PCT) of oral combinations of anti-malarial agents versus SoC in patients with uncomplicated P. falciparum malaria
All parts:
To characterize PK of each anti-malarial agent administered orally as monotherapy [Part A] and/or as combination therapy [Part B] in patients with uncomplicated P. falciparum malaria
To assess the safety and tolerability of each anti-malarial agent administered orally as monotherapy [Part A] and/or as combination therapy versus SoC [Part B] in patients with uncomplicated P. falciparum malaria


 Tororo, Tororo
Tororo, Tororo
 Uganda 2023-09-26 11:55:15 2026-09-26 Part A 12,pART b18 The study population will consist of male and female patients aged ≥18 years for Part A and aged ≥12 years for Part B. Novartis Medical and Health Sciences Clinical Trial Non-degree Award
Dennis Buwembo Rogers
ID: UNCST-2021-R011765
 QUALITY OF SELF-CARE FOR OLDER (AGED 60 YEARS AND ABOVE) PEOPLE WITH DEMENTIA IN WAKISO DISTRICT, UGANDA. CAREGIVER PERCEPTIONS, AND EFFECTS OF A PSYCHOEDUCATION INTERVENTION ON QUALITY OF SELF-CARE.
REFNo: HS2958ES

To determine the effect of a remotely delivered psychoeducation intervention for caregivers of older people with dementia on the quality of self-care.,To explore the perception, caregivers of older people with dementia have towards quality of self-care.,To measure the quality of self-care for older people with dementia in Wakiso district, Uganda.,To Improve quality of self-care provided to older people with dementia through use of a remotely delivered psychoeducation intervention of caregivers of older people with dementia in Wakiso, district Uganda.,
 Wakiso, Kiwenda
 Uganda 2023-09-19 7:51:22 2026-09-19 71 Caregivers of older people diagnosed with dementia, 18-70 years, both female and males, all tribes as applicable Brain Health Training Program Medical and Health Sciences Clinical Trial Degree Award
Edrisa Mutebi Ibrahim
ID:
Safety of JNK61 in Healthy Human Volunteers.
REFNo: HS2474ES

To determine the effect of JNK61 on the blood sugar levels in healthy human volunteers.,To determine the safety of JNK61 in healthy human volunteers,
 Kampala, Makerere University
 Uganda 2023-08-30 16:05:54 2026-08-30 50 Male and female adults of any tribe Government of Uganda through Makerere University Research and Innovations Fund Medical and Health Sciences Clinical Trial Non-degree Award
Joseph  Matovu KB
ID: UNCST-2020-R014654
 Enhancing communication on relationship preservation, safer conception, and pre-exposure prophylaxis (PrEP) to promote HIV testing
REFNo: HS3025ES

Conduct a pilot trial of “PrEPing Healthy Families” with intervention sites implementing the novel communication,Conduct formative research to expand a communication strategy focused on relationship preservation and safer conception into a multi-component intervention with broader reach,To leverage the growing availability of PrEP to determine if and how a communication strategy focused on relationship preservation and safer conception can increase testing and entry into treatment (ART) or prevention (PrEP) among couples in Uganda,
 Mukono, Ntaawo ward
Mityana, Central ward
Butambala, Gombe ward
 Uganda 2023-08-25 8:26:15 2026-08-25 267 The proposed study will recruit up to 267 total participants. These participants include project advisory board members (up to 25) clients in assisted partner notification (APN) or antenatal care (ANC) programs (up to 36 for in-depth interviews [IDIs], up to 150 for exit surveys), their partners (up to 36 for IDIs), and ANC/APN providers at the intervention site (up to 20). Participants will all be aged 18 years and above and all sexes. Glenn Wagner Medical and Health Sciences Clinical Trial Non-degree Award
Mark Kaddumukasa
ID: UNCST-2020-R001798
 SELF MANAGEMENT INTERVENTION FOR REDUCING EPILEPSY BURDEN AMONG UGANDANS WITH EPILEPSY
REFNo: HS2944ES

1. To assess the efficacy of SMART- U vs. eTAU via an RCT.
H1: Individuals randomized to SMART-U will have significantly improved QOL and fewer seizures compared to eTAU.
H2: Individuals randomized to SMART-U will have greater improvement in depression and functional status compared to eTAU.
2. To use short message service (SMS) delivered via mobile phone text to validate patient self-reported seizure occurrence and push epilepsy self-management messaging in a practical/accessible format.
3. To obtain input from stakeholders (patients, family and clinicians) guided by an Integrated Promotion Action on Research Implementation in Health Services (i-PARIHS) framework to help establish sustainable infrastructure that will facilitate future scale up of SMART in Uganda with epilepsy partners

 Kampala, Mulago
Mbarara, Mbarara
 Uganda 2023-08-25 8:11:10 2026-08-25 188 Target population: all adult patients attending the neurology clinic at Mulago and Mbarara hospitals. Accessible population: All adult patients with epilepsy on treatment attending the clinic during the study period. Study population: All adult patients with epilepsy on treatment who will meet the inclusion criteria from all tribes attuning the study clinics. All consecutive adult patients who came either for follow up or as new referrals with confirmed diagnosis of epilepsy were screened for the inclusion into the study. NIH/ USA Medical and Health Sciences Clinical Trial Non-degree Award
Sharon Pang Sze Lu
ID:
Transform Randomised Controlled Trial in Uganda
REFNo: SS1823ES

To evaluate the impact of the Transform program on the key indicators in values, health and livelihood in Uganda
 Hong Kong 2023-08-25 8:07:30 2026-08-25 4800 The study population will include participants aged 18 to 90 years old. Both male and female participants are included in the study. ICM will first choose communities and identify 30 ultra-poor households for its Transform program (administered across control and treatment groups). Eligibility for Transform is determined using poverty assessment via an asset-based scoring and self-reported household income. Historically, there have been an average of 30 households per community. With a target sample size of 160 communities, we will have approximately 4,800 households in the study. ICM targets communities to receive a Transform program based on the proportion of community members living in ultra-poverty (less than USD $0.50/person/day).Participants who are above the threshold using the poverty assessment will be excluded from the study. Households also cannot participate in the study if they have previously received the Transform program, unless the implementation team overrides the score due to specific circumstances that only affect a minority of participants. International Care Ministries Social Science and Humanities Clinical Trial Non-degree Award
Adoke Yeka
ID: UNCST-2021-R004300
 An adaptive, randomized, active-controlled, open-label, sequential cohort, multicenter study to evaluate the efficacy, safety, tolerability and pharmacokinetics of intravenous cipargamin (KAE609) in adult and pediatric participants with severe Plasmodium falciparum malaria (KARISMA – KAE609’s Role In Severe Malaria)
REFNo: HS1980ES

Primary objective
To assess the efficacy of different doses of
intravenous cipargamin vs artesunate by evaluating the proportion of
participants with ? 90% reduction of parasitemia at 12 hours post
administration of the first dose.

Secondary Objectives
1. To assess the presence/absence of severe malaria related individual
signs over time
2. To evaluate parasite clearance dynamics and proportion of participants
with recrudescence and reinfection
3. To assess recovery of participants as measured by time (days and hours)
to discharge from hospital or recovery from prostration
4. To evaluate the safety and tolerability of IV cipargamin
5. To assess the risk of long term neurological sequelae for participants at
Day 29
6. The assess the risk of hemolysis (early and delayed) during the study
duration
7. To characterize the plasma pharmacokinetics of IV cipargamin

 Tororo, Masafu
 Uganda 2023-08-18 9:05:14 2026-08-18 200 patients for AL treatment arm and 100 patients for the other treatment arms per site. At least two drugs will be studied per site The study population will consist of male and female participants, including pediatric participants aged ? 6 months or older. Approximately 252 participants (60 participants of ? 12 years and 192 participants < 12 years) will be randomized Novartis Medical and Health Sciences Clinical Trial Non-degree Award
Henry Mugerwa
ID: UNCST-2019-R000420
 PLATINUM: A multi-part, multi-center PLATform study to assess the efficacy, safety, tolerability and pharmacokinetics of anti-malarial agents administered as monotherapy at multiple dose levels and/or combination therapy IN patients with Uncomplicated Plasmodium falciparum Malaria
REFNo: HS2748ES

Main Objectives:
1. Part A: To assess the parasite clearance time (PCT) of oral doses of an anti- malarial agent administered as monotherapy in patients with uncomplicated P. falciparum malaria
2. Part B: To assess the effect on adjusted 28-day cure rate of an anti-malarial agent administered orally as combination therapy versus the standard of care (SoC) in patients with uncomplicated P. falciparum malaria

Secondary Objectives
1. Part A: To assess the effect on adjusted 28-day cure rate of an anti-malarial agent administered orally as monotherapy in patients with uncomplicated P. falciparum malaria
2. Part B: To assess the parasite clearance time (PCT) of oral combinations of anti-malarial agents versus SoC in patients with uncomplicated P. falciparum malaria
3. To characterize PK of each anti-malarial agent administered orally as monotherapy [Part A] and/or as combination therapy [Part B] in patients with uncomplicated P. falciparum malaria
4. To assess the safety and tolerability of each anti-malarial agent administered orally as monotherapy [Part A] and/or as combination therapy versus SoC [Part B] in patients with uncomplicated P. falciparum malaria
 Uganda 2023-08-10 13:49:44 2026-08-10 14 The study population will consist of male and female patients aged ≥18 years for Part A and aged ≥12 years for Part B. Novartis Medical and Health Sciences Clinical Trial Non-degree Award
Bernard Kikaire
ID:
Effect of an interactive SMS system in improving the reporting of adverse drug reactions among people living with HIV in Tanzania and Uganda: a randomized controlled trial: The REMIND ADR TRIAL
REFNo: HS2922ES


To investigate the effectiveness of SMS reminders on improving ADR reporting compared to no SMS among people living with HIV in Tanzania and Kampala Uganda.
To describe the most commonly reported ADR profiles among people living with HIV in Tanzania and Uganda.
To determine the most common routes/ methods of reporting ADR used by PLHIV.
To explore the causal relationship between the commonly reported ADRs and ART.
To improve treatment options for participants who reported ADR.
To explore the technical feasibility and acceptability of the intervention in reporting ADR among PLHIV.

 Kampala, mulago
 Uganda 2023-08-08 12:42:32 2026-08-08 114 Age between 18 and 65 confirmed and documented HIV infection Being on ART treatment for less than one year Able to read and understand SMS Able to understand and willing to sign the informed consent document Able to read and write a text message Have a mobile phone The study is funded by Eastern Africa Consortium for Clinical Research (EACCR3) which is a network of excellence under EDCTP Medical and Health Sciences Clinical Trial Non-degree Award
Joseph Lutaakome
ID: UNCST-2020-R008323
 Strategies and Treatments for Respiratory Infections & Viral Emergencies (STRIVE)
REFNo: HS2703ES

Strategies and Treatments for Respiratory Infections & Viral Emergencies (STRIVE) is a master protocol being conducted in many countries around the world, and funded by the National Institutes of Health, USA. STRIVE will evaluate the safety and effectiveness of unlicensed and licensed treatments and different combinations of treatments, to improve the health outcomes of adults
hospitalised with acute respiratory infections, like COVID-19 or influenza.
 Kampala, Kampala
Masaka, Masaka
Gulu, Gulu
Lira, Lira
 Uganda 2023-08-08 12:39:21 2026-08-08 1,500 The participant population are non-pregnant or breast-feeding adults aged ≥ 18 years; with confirmed COVID-19 for <14 days, and requiring inpatient hospital acute medical care and with evidence of a COVID-19 lower respiratory tract infection. National Institutes of Health Medical and Health Sciences Clinical Trial Non-degree Award
Harriet Mayanja-Kizza
ID: UNCST-2021-R013074
 A phase 2, partially-blinded, randomised trial assessing the safety and efficacy of TBAJ876 or bedaquiline, in combination with pretomanid and linezolid in adult participants with newly diagnosed, drug-sensitive, smear-positive pulmonary tuberculosis
REFNo: HS2928ES

The objectives of the trial are to evaluate the efficacy, safety, and tolerability of TBAJ876 (3 doses) or bedaquiline in combination with pretomanid and linezolid in adult participants with newly diagnosed, smear-positive pulmonary DS-TB in comparison to the SOC
 Kampala, Mulago
Kampala, Lubowa
 Uganda 2023-08-07 15:20:08 2026-08-07 The trial is planned to randomise at least 60 participants per treatment arm, for a total of at least 300 participants randomised. Study population should have the following characteristics: 1. Signed written informed consent prior to undertaking any trial-related procedures. 2. Participants aged 18 to 65 years, inclusive. 3. Body weight (in light clothing and no shoes) ≥35 kg. 4. Sputum positive for tubercle bacilli (at least 1+ on the IUATLD/WHO scale on smear microscopy) at the trial laboratory. 5. DS-TB participants defined as the following: a. Sensitive to rifampicin and isoniazid by rapid sputum-based test (see trial Mycobacteriology Laboratory Manual) AND b. Either newly diagnosed for TB or have a history of being untreated for at least 3 years after cure from a previous episode of TB. 6. A chest x-ray during the screening period or within 14 days of screening which in the opinion of the investigator is compatible with pulmonary TB. 7. Be of non-childbearing potential OR using effective methods of birth control as defined below: Non-childbearing Potential a. Participant is not heterosexually active or practices sexual abstinence OR b. Female participant or male participant’s female sexual partner: bilateral oophorectomy, bilateral tubal ligation, and/or hysterectomy or has been postmenopausal with a history of no menses for at least 12 consecutive months OR c. Male participant or female participant’s male sexual partner: vasectomized or has had a bilateral orchidectomy at least 3 months prior to screening Effective method of birth control is defined as 1 of the following: a. Double-barrier method which can include a combination of male condom, diaphragm, cervical cap, or female condom. Note: Female and male condom should not be used together. b. Combination of a barrier method with hormone-based contraceptives or an intrauterine device. Both male and female participants must be willing to continue practicing birth control methods and not be planning to conceive throughout treatment and for 6 months after the last dose of IMP. References to male or female mean “assigned male or female at birth,” respectively. TB Alliance Medical and Health Sciences Clinical Trial Non-degree Award
Proscovia Nabunya
ID: UNCST-2019-R000970
 Say No to Stigma-Round 2: Pilot testing the impact of visuals designed to reduce mental health stigma among primary school students in Uganda
REFNo: SS1818ES

Examine the acceptability and preliminary impact of the Say No to Stigma visual solutions on children’s mental health awareness and stigma in schools.
 Uganda 2023-07-27 20:55:02 2026-07-27 100 One hundred (100) students in total will be recruited for this study. Inclusion Criteria: Children: 1) ages between 8 to 13 (primary 2 to 7) enrolled in the selected school. Exclusion Criteria: 1) inability to comprehend study procedures or participant rights as assessed by trained staff during the informed consent process; or 2) they are unwilling or unable to commit to completing the study. Washington University in St. Louis Social Science and Humanities Clinical Trial Non-degree Award
Grace Mirembe
ID: UNCST-2022-R008850
 RV 591 entitled “A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of an Ad26.Mos4.HIV and CH505 TF chTrimer (Env) Combination to Mimic Acute HIV Viral Replication Kinetics in Healthy Adults”
REFNo: HS2891ES

To assess the safety, reactogenicity and tolerability of two vaccination regimens: rapid dose-escalation of CH505 TF chTrimer+ALFQ and Ad26.Mos4.HIV or co-administration of CH505 TF chTrimer+ALFQ and Ad26.Mos4.HIV
 Kampala, Central
 Uganda 2023-07-14 9:49:16 2026-07-14 50 Healthy male and female participants, aged 18 to 50 years The Surgeon General, Department of the Army Medical and Health Sciences Clinical Trial Non-degree Award
Joy Gumikiriza- Onoria Louise
ID:
Development of a Caregiver Centered Psychotherapy (CCPT) in addressing patient care for older persons with Alzheimer’s Disease and Related Dementias (ADRD) in Uganda.
REFNo: HS2909ES

1. To explore ways in which older people in the community of Wakiso district conceptualize ADRD and what informs their opinions. 2. To assess caregiver distress, non-professional techniques of patient care, quality of life and the associated factors among family caregivers of persons with ADRD in Wakiso district.To adapt and pre-test the WHO-iSupport for family caregivers of persons with ADRD in Wakiso, Uganda4. To determine the effectiveness of A-iSupport in the alleviation of distress among family caregivers of persons with ADRD in Wakiso, Uganda
 Wakiso, Busukuma
Wakiso, Nansana
 Uganda 2023-07-14 9:40:03 2026-07-14 180 All residents of Wakiso district aged 60 years and older, includidng caregivers of persons with ADRD BRAIN health Medical and Health Sciences Clinical Trial Degree Award
Nixon Niyonzima
ID: UNCST-2020-R014577
 A PHASE III, RANDOMIZED, OPEN-LABEL STUDY EVALUATING THE EFFICACY AND SAFETY OF GIREDESTRANT IN COMBINATION WITH PHESGO VERSUS PHESGO AFTER INDUCTION THERAPY WITH PHESGO-TAXANE IN PATIENTS WITH PREVIOUSLY UNTREATED HER2-POSITIVE, ESTROGEN RECEPTOR-POSITIVE LOCALLY-ADVANCED OR METASTATIC BREAST CANCER (HeredERA)
REFNo: HS2968ES

To identify and/or evaluate biomarkers that are predictive of response to Phesgo and giredestrant (i.e., predictive biomarkers), are early surrogates of efficacy, are associated with progression to a more severe disease state (i.e., prognostic biomarkers), are associated with acquired resistance to Phesgo and giredestrant, are associated with susceptibility to developing adverse events or can lead to improved adverse event monitoring or investigation (i.e., safety biomarkers), can provide evidence of Phesgo and giredestrant activity (i.e., pharmacodynamic biomarkers), or can increase the knowledge and understanding of disease biology and drug safety,To evaluate potential effects of ADAs,To evaluate the immune response to pertuzumab, trastuzumab, and rHuPH20,To evaluate the potential relationships between Phesgo and giredestrant exposure and the safety, efficacy, immunogenicity, or biomarker endpoints.,To characterize the giredestrant, pertuzumab, and trastuzumab PK profile when given in combination,To evaluate the safety of Phesgo plus giredestrant compared with Phesgo from the participant's perspective,To evaluate health utility of participants treated with Phesgo plus giredestrant compared with Phesgo to generate utility scores for use in economic models,To evaluate effects of Phesgo plus giredestrant compared with Phesgo on work productivity and activity,To evaluate the safety of Phesgo plus giredestrant compared with Phesgo,To evaluate the efficacy of Phesgo plus giredestrant compared with Phesgo,
 Kampala, Mulago
 Uganda 2023-07-14 12:43:26 2026-07-14 20 This study will enrol patients with locally advanced or metastatic receptor positive breast cancer above 18 years of age La Roche Hoffman Medical and Health Sciences Clinical Trial Non-degree Award
Angella Natukunda
ID:
DETERMINANTS OF NUTRITION STATUS AMONG ADOLESCENTS IN SELECTED SECONDARY SCHOOLS OF KANUNGU DISTRICT SOUTH WEST REGION UGANDA
REFNo: SS1812ES

Broad obective To investigate the determinants of nutrition status among adolescents in selected secondary schools in Kanungu District South West Uganda. Specific objectives To assess the nutrition status of adolescents in the selected secondary schools of Kanungu District South West Region Uganda. To determine the social demographic and economic factors influencing nutrition status of adolescents in the selected secondary schools of Kanungu District South West Region Uganda. To determine the diet-related factors influencing nutrition status of adolescents in the selected secondary schools of Kanungu District South West Region Uganda. To determine the level of adolescent nutrition knowledge associated with nutrition status among adolescents in the selected secondary schools of Kanungu District South West Region Uganda.
Uganda 2023-07-14 12:34:44 2026-07-14 370 The study population will constitute of adolescents both male and female studying in secondary schools of Kanungu district 12 to 19 years. Natukunda Angella Social Science and Humanities Clinical Trial Degree Award
Rhoda Wanyenze
ID: UNCST-2021-R013352
 A Hybrid Implementation-Effectiveness Trial of Game Changers for Cervical Cancer Prevention (GC-CCP) in Uganda
REFNo: SS1873ES

1. Conduct a multisite RCT of the GC-CCP network-based advocacy strategy to evaluate effects on CC screening uptake, access to early-stage treatment and prevention of advanced disease among unscreened alters across urban/rural and public/private clinics,4. Evaluate the cost-effectiveness of Implementing GC-CCP to increase CC screening and low cost, early-stage treatment, and prevent advanced disease, compared to enhanced usual care.,3. Examine mediators and moderators (among index, alter and network characteristics) of intervention effects on (a) alter CC screening; and (b) engagement in CC prevention advocacy of index and alter (1st and 2nd degree) to better understand its multiplier effect on diffusion of advocacy throughout a network.,2. Use a mixed methods approach (semi-structured interviews and administrative clinic data) to examine clinic-, provider-, and client-level barriers and facilitators of GC-CCP Implementation and Sustainment.,
 Kampala, Nsambya
Kampala, Kawempe
Buikwe, Buikwe
Kayunga, Kayunga
 Uganda 2023-07-13 11:13:19 2026-07-13 1400 women Women recently screened for Cancer of the Cervix and aged 25 years and above will be enrolled as index participants, Women who have not screened for Cancer of the Cervix but are network members of index participants will be enrolled as alter participants, Clinic leadership and providers of Cervical Cancer services will participate in qualitative interviews. National Institute of Mental Health Social Science and Humanities Clinical Trial Non-degree Award
Nixon Niyonzima
ID: UNCST-2020-R014577
 A Phase III, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared with Physician’s Choice of Adjuvant Endocrine Monotherapy in Patients with Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer (Lidera)
REFNo: HS2193ES

Main Objective

1. To demonstrate superiority of giredestrant over the control treatment.
Specific Objectives

1. To evaluate the efficacy of giredestrant compared with Therapy of Physician's Choice
2. To evaluate the safety of giredestrant compared with Therapy of Physician's Choice
3. To characterize giredestrant Pharmacokinetics
4. To evaluate health status utility scores of participants treated with giredestrant compared with Therapy of Physician's Choice
5. To evaluate the tolerability of giredestrant compared with Therapy of Physician's Choice
6. To identify and/or evaluate biomarkers that are predictive of response to giredestrant (i.e., predictive biomarkers), are early surrogates of efficacy, are associated with progression to a more severe disease state (i.e., prognostic biomarkers), are associated with acquired resistance to giredestrant, are associated with susceptibility to developing adverse events or can lead to improved adverse event monitoring or investigation (i.e., safety biomarkers), can provide evidence of giredestrant activity (i.e., pharmacodynamic biomarkers), or can increase the knowledge and understanding of disease biology and drug safety
 Kampala, Mulago
Uganda 2023-07-13 10:07:44 2026-07-13 18 women aged 18 years of age and over with histologically confirmed breast cancer Hoffman La Roche Medical and Health Sciences Clinical Trial Non-degree Award
Flavia Matovu Kiweewa
ID: UNCST-2021-R013337
 A Phase 2/3, Open-Label Study of the Pharmacokinetics, Safety, and Antiviral Activity of the GS-9883/Emtricitabine/Tenofovir Alafenamide (GS9883/F/TAF) Fixed Dose Combination (FDC) in HIV-1 Infected Adolescents and Children.
REFNo: HS2931ES

The primary objective of this study is to confirm the dose of B/F/TAF FDC in HIV-1 infected pediatric participants, to confirm the dose of B/F/TAF TOS in HIV-1 infected pediatric participants and to evaluate the safety and tolerability these medications.
Kampala,
Uganda 2023-07-06 17:23:47 2026-07-06 5 Adolescents and children Gilead Sciences Medical and Health Sciences Clinical Trial Non-degree Award
Thomas McHale
ID: UNCST-2022-R008812
 Optimizing the Dose of Flucytosine for Cryptococcal Meningitis
REFNo: HS2940ES

Determine if 50 mg/kg/day of 5-FC has a similar mortality benefit compared to 100 mg/kg/day,Reduce the cost and supply burden of treating an individual with cryptococcal meningitis,Determine if 50 mg/kg/day of 5-FC is a safer dosage compared to 100 mg/kg/day of 5-FC,Determine if 50 mg/kg/day of 5-FC is has a similar rate of cryptococcal clearance from CSF compared to 100 mg/kg/day,Determine the optimal dose of 5-FC for for management of induction phase of therapy for cryptococcal meningitis,
 Kampala,
Mbarara,
USA 2023-07-05 11:41:24 2026-07-05 The target sample size is 50 participants The study will enroll adults with HIV who are over 18 years old and sick with cryptococcal meningitis. National Institute of Health, United States Medical and Health Sciences Clinical Trial Degree Award
Daniella Akellot
ID:
EVALUATION OF THE EFFECTIVENESS OF CLORPACTIN IN COMPARISON WITH OTHER WOUND DRESSING AGENTS USED AT SIGN SUPPORTED HOSPITALS IN UGANDA
REFNo: HS2769ES

To determine the effectiveness of Clorpactin in wound dressing at Kumi Orthopaedic Center and St. Mary’s hospital, Lacor.,
 Kumi, Booma South
Gulu, ForGod
 Uganda 2023-07-03 13:32:54 2026-07-03 546 patients Patients admitted at Kumi Orthopaedic Center and St. Mary’s hospital, Lacor with surgical wound sepsis, infected open fractures, diabetic wounds, chronic osteomyelitis. SIGN Fracture Care International Medical and Health Sciences Clinical Trial Non-degree Award
Ezekiel Mupere
ID: UNCST-2023-R008637
 Earlier prime-BOOST schedule to improve MEasles protection in high burden settings (BoostME)
REFNo: HS2883ES

Safety Objectives 1.To assess the safety and reactogenicity profile of the vaccine when given at different ages 2.To assess the number of measles infections throughout the study. Primary Objectives 1.To compare protective measles antibody concentrations at 2.5 years of age in infants receiving an early (6 months) compared to standard (9 month) dose of MCV, and a booster dose at 18 months of age. 2.To compare protective measles antibody concentrations one month after a second dose of MCV given at 12 months (early) compared to standard (18 months), in those who received an early (6 months) first dose. Secondary Objectives •To describe the measles antibody concentrations one month after first dose in infants receiving an early (6 months) compared to standard (9 month) dose of MCV. •To describe the effect of maternal antibodies on infant humoral and cellular immune response to first and second doses in children vaccinated under different schedules. •To describe the effect of maternal HIV infection on infant antibody responses post MCV1 and MCV2 given at different schedules •To describe the impact of different vaccination schedules on responses to the rubella component of the vaccine. Community Objectives To assess the effect of a measles vaccination clinical trial on public perceptions of measles immunisation
 Kampala, Kawaala
Kampala, Kisenyi
Kampala, Komamboga
Kampala, Mulago
 Uganda 2023-06-23 7:46:04 2026-06-23 450 infants Any infant aged 6 months (23-28 weeks) at screening visit and has not received prior vaccination against measles University of Oxford Research Governance, Ethics and Assurance Joint Research Office Boundary Brook House Churchill Drive Headington Oxford OX3 7GB United Kingdom, and funded by Bill and Melinda Gates Foundation. Medical and Health Sciences Clinical Trial Non-degree Award
Tonny Kiyimba
ID:
Efficacy of polyphenols from Tamarindus indica fruit juice on cardiometabolic health of patients living with HIV and elevated triglycerides: A study protocol
REFNo: HS2923ES

3. To establish dose response dynamics of long-term intake of T. indica fruit juice polyphenols on selected cardiometabolic risk markers of PLWH.,2. To assess the effect of an acute, single-dose intake of T. indica fruit juice on vascular function, lipid profile and plasma levels of procyanidin metabolites.,1. To produce and evaluate the sensory acceptability of T. indica fruit juice.,To determine the efficacy of T. indica fruit juice on selected cardiometabolic risk markers of PLWH in HIV community care model in Wakiso district, Uganda.,
 Wakiso, Kajjansi
Wakiso, Kajjansi
 Uganda 2023-06-20 11:05:36 2026-06-20 240 Participants will be adult(30-50 years) male and female patients living with HIV (PLWH) managed under the community-based model (Community Drug Distribution Points-CDDPs) in Wakiso district, central Uganda. The district encircles Kampala, Uganda's capital city with an estimated population of over 2.9 million people. The district has the highest prevalence (10%) of HIV in Uganda. Over 3,801 PLWH are currently receiving the HIV care from CDDPs in Wakiso District. The study inclusion and exclusion criteria are presented in Table 1. VLIROUS Medical and Health Sciences Clinical Trial Degree Award
Betty Mwesigwa
ID: UNCST-2020-R014667
 SABIN-002: A Phase 2, Randomized, Double-blind, Placebo-Controlled Trial to Evaluate Safety, Tolerability, and Immune Responses of an Investigational Monovalent Chimpanzee Adenoviral-Vectored Marburg Virus Vaccine in Healthy Adults
REFNo: HS2838ES

To evaluate the safety and tolerability of
cAd3-Marburg vaccine
 Kampala, Nakasero
 Uganda 2023-06-14 11:06:46 2026-06-14 80 Male and female adults, 18-70 Years Sabin Vaccine Institute Medical and Health Sciences Clinical Trial Non-degree Award
NANKWASA SAILAS
ID:
RANDOMIZED CONTROLLED FOR NON USE OF ANTIBIOTIC AFTER UNCOMPLICATED VAGINAL BIRTH AND POST-PARTUM ENDOMETRITIS AT ST FRANCIS HOSPITAL NSAMBYA
REFNo: HS2768ES

3. To determine the factors that may predict the likelihood of infection after uncomplicated vaginal birth at St. Francis Nsambya Hospital,2. To determine the incidence of perineal tear/episiotomy wound breakdown among women who received antibiotic and those who do not at St. Francis Nsambya Hospital,1. To determine the incidence of post-partum endometritis after uncomplicated vaginal birth in women who receive antibiotic compared to those who do not at St. Francis Nsambya Hospital,To determine whether not providing an antibiotic after uncomplicated vaginal birth is associated with increased incidence of post-partum endometritis at St. Francis Nsambya Hospital,
 Kamuli, Nsambya
Uganda 2023-06-06 7:53:44 2026-06-06 260 participants adult post delivery mothers with uncomplicated vaginal birth NANKWASA SAILAS Medical and Health Sciences Clinical Trial Degree Award
RICHARD MPANGO STEPHEN
ID:
Adaptation and Evaluation of the New Forest Parenting Program (NFPP) in the management of ADHD among Children and Adolescents infected with HIV (CA-HIV) in Uganda (Formative phase)
REFNo: SS1721ES

i) To adapt and evaluate the effectiveness of the NFPP in the management of ADHD among Children and adolescents infected with HIV (CA-HIV).
ii) To evaluate the acceptability and feasibility of NFPP in the management of ADHD among CA-HIV.
 Masaka, NOT APPLICABLE
Kampala, NOT APPLICABLE
 Uganda 2023-05-29 20:36:58 2026-05-29 44 Twenty-two (22) participants; ten (10) Child and adolescent mental health specialists’ and HIV clinicians (representing a range of professional disciplines including psychiatrists, psychologists, psychiatric clinical officers, psychiatric nurses, experienced HIV counsellors and HIV clinicians); ten (10) parents / grandparents / teachers /day-mothers / guardians / caregivers; two (2) facilitators CHILD Global Research Social Science and Humanities Clinical Trial Degree Award
Richard Idro
ID: UNCST-2021-R013599
 Dihydroartemisinin-piperaquine and azithromycin for the post-discharge management of children with severe anaemia in Malawi, Kenya and Uganda; A, multicentre, parallel-group, two-arm, randomised, double-blind superiority trial.
REFNo: HS2815ES

To determine if PDMC with four courses of monthly AZ treatment in combination with four months of weekly DP is superior to PDMC with weekly DP-alone in reducing non-malaria SCCV by six months post-discharge in children aged <5 years admitted with severe anaemia (Hb<5g/dl) who are ready to be discharged and are clinically stable and able to switch to oral medication,
 Jinja, Jinja City
Kitgum, Municipality
 Uganda 2023-05-25 12:04:54 2026-05-25 958 Children aged less than 5 years, with severe anemia. Training and Research Unit of Excellence, Blantyre, Malawi Medical and Health Sciences Clinical Trial Non-degree Award
David Meya Bisagaya
ID: UNCST-2019-R000837
 Platform Trial For Cryptococcal Meningitis - PLATFORM-CM
REFNo: HS2649ES

The purpose of this study is to know whether this oral form of amphotericin (MAT2203) is safe and effective in the treatment of people sick with cryptococcal meningitis.
 Mbarara, Mbarara
Masaka, Masaka
Kampala, Kampala
 Uganda 2023-05-25 12:01:51 2026-05-25 270 Adult (18 years and above) males and females HIV-infected persons with cryptococcal meningitis. Matinas BioPharma Nanotechnologies, Inc. Medical and Health Sciences Clinical Trial Non-degree Award
Dominik Biesalski
ID:
The Drivers, Effects and Measurement of Time Use Among the Urban Poor: Evidence from Uganda
REFNo: SS1674ES

Get insights into the time use patterns of urban workers and understand their effects on productivity and well-being.
 Kampala, Kampala
 Germany 2023-05-11 14:41:00 2026-05-11 200 Workers who are older than 18 years old, both men and women of all tribes Private Enterprise Development in Low-Income Countries (PEDL) Social Science and Humanities Clinical Trial Degree Award
James Davis KATUMBA
ID:
Uncontrolled asthma among adolescents in selected secondary schools in Kampala City: Prevalence, associated factors, in-school needs, pathways to care and effectiveness of an mHealth Self-management app
REFNo: HS2791ES

To determine the effectiveness, acceptability and feasibility of the KmAsthma self-management app in improving the control of asthma among day scholar secondary school adolescents 12-19 years old in Kampala City Uganda.,To examine pathways to asthma care and their influence on asthma control among secondary school adolescents with asthma in Kampala City Uganda ,To establish the in-school needs associated with asthma control among adolescents in selected secondary schools in Kampala City Uganda ,To determine the prevalence of and factors associated with uncontrolled asthma among adolescents in selected secondary schools in Kampala City Uganda ,To establish the prevalence of and factors associated with uncontrolled asthma, in-school needs, pathways to asthma care, and effectiveness of KmAsthma Self-management app intervention to control asthma among adolescents in selected secondary schools in Kampala City Uganda,
 Kampala, Kawempe, Rubaga, Makindye, Kampala Central, Nakawa
 Uganda 2023-05-02 22:22:49 2026-05-02 323 Secondary school adolescents in Kampala City Uganda who will provide written informed consent (or assent plus consent from parents in case of minors) during the time of the study. Self Sponsored Medical and Health Sciences Clinical Trial Degree Award
John Kellett Gale
ID:
Can continuous non-invasive monitoring of movement predict and detect clinical deterioration of hospital patients earlier and more efficiently than traditional intermittent observations?
REFNo: HS2765ES

To determine if continuously collected accelerometer data can indicate and identify clinical deterioration of acutely ill hospitalised patients before intermittently collected vital signs.
 Masaka, Ssenyange
 Ireland 2023-05-02 22:11:25 2026-05-02 1100 All non-pregnant patients aged 18 years or over admitted to the medical ward for any medical condition who are competent to provide consent to participate in the study or have a surrogate decision maker who can consent on their behalf. Patients may decide to participate or withdraw from the study at any time during their hospitalization. Dr John Kellett Medical and Health Sciences Clinical Trial Non-degree Award
Grace Ndeezi
ID: UNCST-2019-R001802
 Nutritional management of growth faltering in infants aged under six months. Study protocol for an individually randomised trial
REFNo: HS2766ES

To determine the effect of nutritional supplementation plus intensive breastfeeding support compared with intensive breastfeeding support alone on mortality, morbidity and growth in infants aged 0-6 months with growth faltering in low resource settings in South Asia and Sub-Saharan Africa.
Iganga,
Iganga,
Iganga,
Iganga,
Iganga,
Mayuge,
Mayuge,
Uganda 2023-04-26 11:15:23 2026-04-26 900 infants Pregnant women (and adolescents) aged 15 to 45 years. Their babies will be enrolled at birth for a nutritional intervention. Both female and male babies will be enrolled. There will be no exclusion based on tribe as long as they comprehend English and Lusoga. World Health Organisation Medical and Health Sciences Clinical Trial Non-degree Award
ELIZABETH ASIGE
ID:
THE IMPACT AND COST-EFFECTIVENESS OF A COMMUNITY-BASED PROGRAM FOR CHILDREN WITH CEREBRAL PALSY AND THEIR CAREGIVERS AND THE STAKEHOLDERS IN UGANDA.
REFNo: HS1979ES

1. To examine the impact of a community-based program on children with CP reported frequency of participation in the home, school, and community activities. 2. To assess the impact of a community-based training program on improving caregiver knowledge regarding CP and reducing caregiver stress. 3. To determine the impact of a communication and advocacy program in broadening stakeholders’ knowledge, attitude and practices regarding childhood disability and inclusion. 4. To determine the cost-effectiveness of a community-based program on children with CP, their caregivers, and the stakeholders in relation to costs and benefits.
Iganga, Iganga
Mayuge, Mayuge
 Uganda 2023-04-20 21:15:22 2026-04-20 100 participants- 50 in the study group and 50 in the control group The study population will comprise children and youth with cerebral palsy aged 2-22 years, both male and female, and their primary caregivers of any tribe living in the study communities plus the community stakeholders Prof. Hans Forssberg -Karolinska Institutet Astrid Lindgren Children’s Hospital 17176, Stockholm Sweden Medical and Health Sciences Clinical Trial Degree Award
Beatrice  Onyango Ekesa
ID:
Bio-efficacy of Pro-Vitamin A-rich banana to improve vitamin A status among children in Uganda living in an area with a high burden of inflammation
REFNo: HS2721ES

3. Establish the stability of retinol isotopes on DSS at room temperature in the determination of TBS of vitamin A.,2. Assess the effect of inflammation and nutritional status on vitamin A absorption and TBS assessment among school-aged Ugandan children.,1. Determine the bio-efficacy of carotenoids in Pro-Vitamin A rich bananas in improving TBS in children aged 6-14years.,This study will determine the bio-efficacy of carotenoids in Pro-Vitamin A-rich banana-based diets and their potential in improving the vitamin A body stores by the RID technique among school-going children aged 6-14years living in Tororo district, an area with a high burden of inflammation.,
 Tororo, Aturukuk
 Kenya 2023-04-19 12:44:24 2026-04-19 110 The study will be conducted among school going children aged 6-14 years because the school setting facilitates the feeding trial and monitoring, and the age group forms the youngest group available in an organised setting that can easily be engaged for a long period. In addition, this age group is not involved in the current national vitamin A supplementation programs. International Atomic Energy Agency (IAEA) Medical and Health Sciences Clinical Trial Non-degree Award
Pontiano  Kaleebu
ID: UNCST-2020-R019901
 Field Evaluation of National HIV Testing Services Algorithm
REFNo: HS2701ES

Main Objective
To determine the appropriate HIV rapid test algorithm to be used in Uganda considering the new kits on the market.

Specific objectives
1. To assess specificity, sensitivity, negative predictive value (NPV), positive predictive value (PPV) of the rapid HIV tests on the market in Uganda and come up with best RDT algorithm.
2. To identify an algorithm that will best identify acute HIV infections
3. To determine the inter-observer and inter-lab agreement in HIV diagnosis using evaluated RDTs.

 Gulu, Lacor hospital
Mbarara, Mbarara hospital
Tororo, AIC and TASO
Central Region, UVRI CLINIC
 Uganda 2023-04-12 15:44:58 2026-04-12 3500 Adults aged 18 years and above who would have come for an HIV test The Global Fund Medical and Health Sciences Clinical Trial Non-degree Award
Francis Ssali
ID: UNCST-2021-R012134
 Protocol A5394: “Safety, Tolerability, and Impact of Oral TLR8 Agonist Selgantolimod on HBsAg in Participants with both Chronic Hepatitis B and HIV” Version 1.0, May 27, 2022
REFNo: HS2647ES

1.2 Primary Objectives

1.2.1 To assess the safety and tolerability of treatment with SLGN administered once weekly by mouth for 24 weeks.

1.2.2 To determine the proportion of participants with ≥1 log10 IU/mL decline in quantitative HBsAg (qHBsAg) after SLGN treatment at Week 24.

1.3 Secondary Objectives

1.3.1 To determine the proportion of participants with ≥1 log10 IU/mL decline in qHBsAg at any time during the study after SLGN treatment initiation.

1.3.2 To determine the proportion of participants with ≥0.5 log10 IU/mL decline in qHBsAg after SLGN treatment at Week 24.

1.3.3 To determine the proportion of participants with ≥0.5 log10 IU/mL decline in qHBsAg at any time during the study after SLGN treatment initiation.

1.3.4 To evaluate the proportion of participants who achieve HBsAg loss after SLGN initiation and who sustain HBsAg loss during follow-up.

1.3.5 To evaluate changes in qHBsAg levels at Weeks 4, 12, 24, 36, and 48 after SLGN initiation and, separately, among the placebo recipients.

1.3.6 To determine the proportion of HBeAg positive participants at baseline who lose HBeAg at any time during the study, by study arm.

1.3.7 To determine the proportion of anti-HBe negative participants at baseline who develop anti-HBe at any time during the study, by study arm.

1.3.8 To determine the proportion of hepatitis B surface antibody (anti-HBs) negative participants at baseline who develop anti-HBs at any time during the study, by study arm.
1.3.9 To evaluate levels of circulating cytokines, including IFN-gamma, IL-12p40, IL-1RA, and CD163 at entry, 24 hours post-first study drug dose, Weeks 4, 12, 24, 36, and 48, by study arm.

1.3.10 To determine whether administration of SLGN will perturb HIV latency as measured by an increase in HIV transcription.

1.3.11 To determine whether administration of SLGN will decrease the size of the latent reservoir, as measured by the change in amount of cell-associated unspliced HIV RNA, HIV DNA, replication-competent and/or intact virus at Weeks 2, 4, 24, and 48.

1.4 Exploratory Objectives

1.4.1 To define the pharmacokinetic (PK) profile and PK-pharmacodynamic (PD) associations of SLGN in people with both HIV and CHB taking suppressive antiviral therapy for both viruses.

1.4.2 To explore if SLGN and antiretroviral (ARV) PK are altered when administered together.

1.4.3 To evaluate participants’ adherence by using several tools, including self-report, directly observed therapy (DOT), and drug concentrations.

1.4.4 To compare quantitative changes in experimental measures of HBV antiviral efficacy (including HBV RNA, hepatitis B core related antigen [HBcrAg], qHBeAg, and low positive HBsAg measured with a high sensitivity qHBsAg assay [LLOQ of 0.05 IU/mL]) and measure changes in large, medium, and small HBsAg isoforms from baseline during and after treatment.

1.4.5 To determine the immunological effects of SLGN on circulating immune signaling by performing single cell RNA sequencing using peripheral blood mononuclear cells (PBMCs) and evaluating HIV-specific T-cell responses.

1.4.6 To determine the effects on circulating immune cells, including cellular phenotypes and T and B-cell responses.

1.4.7 To determine whether administration of SLGN will affect levels of circulating cytokines, including TNF-alpha, IL-12, IL18, IP-10, ISG15, IL-21, Fas Ligand, and TRAIL.

 Kampala, Seguku
 Uganda 2023-04-12 14:38:49 2026-04-12 The total sample size will be 48 participants (36 active and 12 placebo). Up to 6 additional participants may be enrolled if replacements are needed for key analyses. Participants with both (1) HIV and chronic hepatitis B (CHB) on suppressive effective antiviral therapy for HIV (ART) and HBV for ≥5 years immediately prior to study entry and (2) screening quantitative hepatitis B surface antigen (qHBsAg) >1000 IU/mL, and without evidence of advanced liver fibrosis or cirrhosis. Enrollment of women (female sex assigned at birth) is encouraged, and the study will set an enrollment goal of at least 14 women. The study is expected to enroll participants in North America, South America, Africa, and Asia. For the first 9 months, enrollment will be capped at 24 participants at US sites and 24 participants at non-US sites. After 9 months, enrollment will be open to all sites without regional caps The total sample size will be 48 participants (36 active and 12 placebo). Up to 6 additional participants may be enrolled if r eplacements are needed for key analyses. There are no Uganda specific differences. National Institute of Allergy and Infectious Diseases, Gilead Sciences, Inc. Medical and Health Sciences Clinical Trial Non-degree Award
Bruce Kirenga J
ID: UNCST-2019-R001460
 A multiple arm, multiple stage (MAMS), phase 2B/C, open label, randomized, controlled platform trial to evaluate experimental arms including an increased dose of rifampicin, an optimized dose of pyrazinamide, moxifloxacin and sutezolid, in adult subjects with newly diagnosed, smear-positive pulmonary tuberculosis
REFNo: HS2644ES

Primary Efficacy Objective:
Rifampicin- containing experimental arms (arms 1,2)
To evaluate whether one or more of two experimental regimens based on
optimized dose rifampicin, optimized dose of pyrazinamide, and moxifloxacin
given for 12, respectively 17 weeks, are superior to standard treatment given for
26 weeks, as assessed by time to sputum culture conversion to negative in liquid
media.
Sutezolid-containing experimental arm (arm 4)
 To evaluate whether the efficacy of an experimental regimen composed of
sutezolid, delamanid, bedaquiline, and moxifloxacin given for 17 weeks is
superior to standard treatment given for 26 weeks, as assessed by time to
sputum culture conversion to negative in liquid media.
Secondary Objectives This study’s secondary objectives are:
Efficacy
 To assess treatment efficacy based on proportion of patients with relapse
free outcome at 12 months after randomization.
 To assess treatment efficacy based on the rate of decline of bacterial load
measured by the Molecular Bacterial Load Assay
 To rank the relative efficacy of the experimental four-drug combinations
for the treatment of pulmonary tuberculosis within the first twelve weeks
of treatment, and select the most efficient experimental treatment
regimen or regimens for further development.
Safety and Tolerability
To assess the frequency, severity, and type of adverse events (AEs), and AErelated
treatment discontinuations.
Pharmacokinetics
To describe the pharmacokinetics of the drugs and doses used, and to assess
possible relationships between pharmacokinetic parameters of the various drugs and between pharmacokinetic parameters and participant characteristics.
Pharmacodynamics To describe relationships between pharmacokinetic parameters on the one hand and efficacy and safety endpoints on the other hand.
 Kampala, Kawempe
 Uganda 2023-04-11 15:27:11 2026-04-11 360 Adults A total of up to 360 adult (≥ 18 years of age) participants will be enrolled. In case of a high number of dropouts or non‐evaluable participants, it may be necessary to recruit more participants into the study. Also, if the stage 2 starts later than stage 1, it will be necessary to increase the number of control arm participants to achieve a 1:1 ratio of concomitantly recruited control and arm 4 participants (see sample size considerations). Both males and females regardless of tribe as long as an ICF of that particular language spoken by the participant is available, will be enrolled. LMU Klinikum Marchioninistr. 15, 81377 Munich Germany Medical and Health Sciences Clinical Trial Non-degree Award
Brenda Kakayi Catherine
ID: UNCST-2022-R008787
 Insulin-like Growth Factor/Growth Hormone Levels and Stunting in HIV Exposed Uninfected Children from the 1077BF/P1084s study (CHASE: Changes in IGF/Hormone Axis and Stunting in HIV-Exposed uninfected children.
REFNo: HS2686ES

1. To investigate IGF-1, IGFBP-1, and IGFBP-3 as predictors of growth faltering/stunting in the first 2 years of life in HEU children

2. To describe the concentrations of hormonal growth factors in infants in relation to infant growth percentile at birth, 26 weeks, and 74 weeks of age.

Uganda 2023-04-03 20:41:44 2026-04-03 Samples from approximately 154 participants from the P1084s study Samples of approximately 154 P1084s HEU children with serum specimens available at birth, week 26, and week 74 will have assays done on stored specimens for IGF-1, IGFBP-1, and IGFBP-3 at these time points. The 154 participants will be randomly selected from the 268 participants from Uganda, Malawi and South Africa that were enrolled in the study. The samples for use will be from both male and female participants. DAIDS-IMPAACT Network Medical and Health Sciences Clinical Trial Non-degree Award
JOSELYN RWEBEMBERA
ID: UNCST-2021-R013915
 Intramuscular vs. Enteral Penicillin Prophylaxis to Prevent Progression of Latent Rheumatic Heart Disease: A non-inferiority randomized trial. (GOALIE)
REFNo: HS2659ES

Primary Objective:
To compare the proportion of children aged 5-17 years with latent RHD receiving oral penicillin prophylaxis who progress to worse valvular disease at 2-years compared to children who receive IM penicillin prophylaxis.

 Lira, Adyel
 Uganda 2023-03-24 2:23:26 2026-03-24 1004 Age group = 5-17 Sex not specified. Tribe not specified. National Institute of Health Medical and Health Sciences Clinical Trial Non-degree Award
Adeodata Rukyalekere Kekitiinwa
ID: UNCST-2019-R000799
 Long-Acting Treatment in Adolescents (LATA); A randomized open-label 2-arm 96-week trial in virologically suppressed HIV-1-positive adolescents aged 12-19 years of age in Sub-Saharan Africa version 1.0 dated 01 December 2021.
REFNo: HS2515ES

• To evaluate an innovative and contemporary ART strategy in HIV- positive adolescents to provide choice for young people facing life-long treatment.
• To evaluate the virological efficacy, safety, acceptability, and quality-of-life of the dual long-acting injectable combination, cabotegravir and rilpivirine, antiretroviral therapy compared to continuous daily oral therapy with triple oral ART consisting of DTG with a backbone of tenofovir either as the TAF or TDF formulations, combined with either 3TC or FTC regimen, to optimize treatment for HIV-positive adolescents in sub-Saharan Africa.

 Kampala, Mulago
 Uganda 2023-03-16 13:14:16 2026-03-16 170 Adolescents aged 12 to 19 years of age living with HIV-1 who are not pregnant or breastfeeding, and are virologically-suppressed (HIV-1 RNA <50 copies/mL) for at least one year, without any known history of treatment failure, on a 3-drug combination ART consisting of an anchor drug with a 2-drug nucleos(t)ide reverse transcriptase inhibitor (NRTI) backbone. There will be no exceptions to eligibility requirements at the time of randomisation. Questions about eligibility criteria should be addressed prior to attempting to randomise the participant. The eligibility criteria are the standards used to ensure that only medically appropriate patients are considered for this study. Patients not meeting the criteria should not join the study. For the safety of the patients, as well as to ensure that the results of this study can be useful for making treatment decisions regarding other patients with similar diseases, it is important that no exceptions be made to these criteria for admission to the trial. Participants will be considered eligible for enrolment in this trial if they fulfil all the inclusion criteria and none of the exclusion criteria as defined below. INCLUSION CRITERIA 1. HIV-1-positive 2. Aged 12-19 years 3. Aware of HIV status 4. Body weight ≥35Kg 5. On ART consisting of 2NRTI and a third agent 6. On ART for ≥1 year with no previous regimen change for treatment failure* 7. Virologically suppressed with all HIV-1 RNA viral loads <50copies/mL¥ in the last 12 months up to and including screening. Additionally, there must be one result <50copies/mL¥ at least 12 months prior to screening and the viral load at trial screening must be <50 copies/mL 8. Written informed consent provided by participant (if aged 18 to 19 years) and/or carer/legal guardian (if participant aged 12 to 17 years) as appropriate 9. Written informed assent in participants aged 12 to 17 years 10. Females who are sexually active must be willing to adhere to highly effective methods of contraception⌂ EXCLUSION CRITERIA 1. Known HIV-2 positive 2. Females who are pregnant or breastfeeding 3. Females who plan to become pregnant during the trial follow-up or are sexually active and are unwilling to avoid pregnancy for the duration of the trial 4. Moderate or high-risk score on the Columbia-Suicide Severity Rating Scale 5. Hepatitis B SAg positive 6. ALT ≥3 x upper limit of normal 7. On treatment for active TB 8. Known contraindication to receipt of dolutegravir, cabotegravir, rilpivirine, emtricitabine/ lamivudine and any formulation of tenofovir 9. Participants determined by the investigator to have a high risk of seizure, including those with unstable or poorly controlled seizure disorder 10. Unwilling or contraindication to receiving injections 11. Contraindication to receiving injectable agents in the buttock area 12. Underlying medical condition (e.g. bleeding disorder; use of warfarin) that in the opinion of the investigator precludes participation 13. Previous randomisation in the BREATHER Plus trial University College London (UCL), UK and funded by the European and Developing Countries Clinical Trials Partnership Medical and Health Sciences Clinical Trial Non-degree Award
Victoria Ndyanabangi
ID: UNCST-2021-R012645
 IMPAACT 2036: Phase I/II Study of the Safety, Tolerability,Acceptability, and Pharmacokinetics of Oral and Long-ActingInjectable Cabotegravir and Rilpivirine in Virologically SuppressedChildren Living with HIV-1, Two to Less Than 12 Years of Age, DAIDSStudy ID #38932 IND # 138754
REFNo: HS2688ES

To propose the weight band dosing of oral cabotegravir (CAB) + oral rilpivirine (RPV)followed by long-acting injectable CAB (CAB LA) + long-acting injectable RPV (RPV LA)in children living with HIV-1, and to describe participant choice and experience with theregimen with or without an oral lead-in period.
To describe the repeat-dose pharmacokinetics of CAB + RPV (oral and injectable)through Week 24
To assess the safety of the oral lead-in of CAB + RPV, and the safety of CAB + RPV (oraland injectable) through Week 24
To assess the safety of CAB + RPV (oral and injectable) through Weeks 48 and 72
To describe the repeat-dose pharmacokinetics of injectable CAB LA + RPV LA throughWeeks 48 and 72
To assess the maintenance of viral suppression of CAB + RPV (oral and injectable)through Weeks 24, 48, and 72
To evaluate the tolerability and acceptability of injectable CAB LA + RPV LA throughWeeks 24, 48, and 72
To describe HIV-1 genotypes and phenotypes for children who experience virologicfailure during study treatment
To assess immunologic activity of CAB + RPV (oral and injectable) through Weeks 24,48, and 72
To describe tolerability and acceptability of 48 weeks of CAB + RPV (oral and injectable)and 44 weeks of CAB LA + RPV LA (injectable only)
To describe the safety and repeat-dose pharmacokinetics of 48 weeks of CAB + RPV(oral and injectable) or 44 weeks of CAB LA + RPV LA (injectable only)
To describe the maintenance of viral suppression and immunologic activity of 48 weeks ofCAB + RPV (oral and injectable) or 44 weeks of CAB LA + RPV LA (injectable only)
To describe HIV-1 genotypes and phenotypes for children who experience virologicfailure during 48 weeks of CAB + RPV (oral and injectable) or during 44 weeks of CABLA + RPV LA (injectable only)
To characterize long-term safety and washout PK through 48 weeks after permanentdiscontinuation of injectable CAB LA + RPV LAV LA
To characterize PK of CAB + RPV oral formulations when dispersed in liquid vs. directly ingested (Weight Bands 3, 4 and 5)
 Kampala, Mulago
 Uganda 2023-03-16 12:55:20 2026-03-16 35 Children living with HIV-1, two years to less than 12 years of age and weighing ≥10 kg and <40 kg, who are Virologically suppressed on stable antiretroviral therapy and their parents/caregivers. Proposed the weight band dosing of oral cabotegravir (CAB) + oral rilpivirine (RPV) followed by long-acting injectable CAB (CAB LA) + long-acting injectable RPV (RPV LA) in children living with HIV-1, and to describe participant choice and experience with the regimen with or without an oral lead-in period. National Institute of Allergy and Infectious Diseases (NIAID) Medical and Health Sciences Clinical Trial Non-degree Award
Peter Elyanu James
ID: UNCST-2021-R013210
 GS-US-380-1474: A Phase 2/3, Open-Label Study of the Pharmacokinetics, Safety, and Antiviral Activity of the GS-9883/Emtricitabine/Tenofovir Alafenamide (GS-9883/F/TAF) Fixed Dose Combination (FDC) in HIV-1 Infected Adolescents and Children
REFNo: HS2708ES

This is a multisite, multi-cohort study that aims to recruit subjects in four weight-based cohorts (i.e. Cohort 1, 2, 3 and 4), with each cohort having specific objectives aligned with it. Baylor Uganda site will recruit subjects in cohort 4 with is further subdivided in 4 weight-based sub-groups. The study objectives in relation to the Cohort 4 are as follows;
Cohort 4
Group 1:
The primary objective of this study is:
• To evaluate the safety and tolerability of B/F/TAF 30/120/15 mg (administration of 2 B/F/TAF 15/60/7.5 mg FDC TOS) once daily through Week 24 in HIV-1 infected, virologically suppressed children ≥ 2 years of age weighing ≥ 14 to < 25 kg who are unable to swallow tablets
The secondary objectives of this study are:
• To evaluate the safety and tolerability of B/F/TAF 30/120/15 mg (administration of 2 B/F/TAF 15/60/7.5 mg FDC TOS) once daily through Week 48 in HIV-1 infected, virologically suppressed children ≥ 2 years of age weighing ≥ 14 to < 25 kg who are unable to swallow tablets

• To evaluate the antiviral activity of B/F/TAF 30/120/15 mg (administration of 2 B/F/TAF 15/60/7.5 mg FDC TOS) once daily through Weeks 24 and 48 in HIV-1 infected, virologically suppressed children ≥ 2 years of age weighing ≥ 14 to < 25 kg who are unable to swallow tablets
Group 2:
The primary objectives of this study are:
• To evaluate the steady state PK of BIC and TAF and confirm the dose of B/F/TAF 7.5/30/3.75 mg (administration of 2 B/F/TAF 3.75/15/1.88 mg FDC TOS) twice daily in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 10 to < 14 kg

• To evaluate the safety and tolerability of B/F/TAF 7.5/30/3.75 mg (administration of 2 B/F/TAF 3.75/15/1.88 mg FDC TOS) twice daily through Week 24 in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 10 to < 14 kg
The secondary objectives of this study are:
• To evaluate the safety and tolerability of B/F/TAF 7.5/30/3.75 mg (administration of 2 B/F/TAF 3.75/15/1.88 mg FDC TOS) twice daily through Week 48 in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 10 to < 14 kg

• To evaluate the antiviral activity of B/F/TAF 7.5/30/3.75 mg (administration of 2 B/F/TAF 3.75/15/1.88 mg FDC TOS) twice daily through Weeks 24 and 48 in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 10 to < 14 kg.
Group 3:
The primary objectives of this study are:
• To evaluate the steady state PK of BIC and TAF and confirm the dose of B/F/TAF 3.75/15/1.88 mg (administration of 1 B/F/TAF 3.75/15/1.88 mg FDC TOS) twice daily in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 6 to < 10 kg

• To evaluate the safety and tolerability of B/F/TAF 3.75/15/1.88 mg (administration of 1 B/F/TAF 3.75/15/1.88 mg FDC TOS) twice daily through Week 24 in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 6 to < 10 kg.
The secondary objectives of this study are:
• To evaluate the safety and tolerability of B/F/TAF 3.75/15/1.88 mg (administration of 1 B/F/TAF 3.75/15/1.88 mg FDC TOS) twice daily through Week 48 in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 6 to < 10 kg

• To evaluate the antiviral activity of B/F/TAF 3.75/15/1.88 mg (administration of 1 × B/F/TAF 3.75/15/1.88 mg FDC TOS) twice daily through Weeks 24 and 48 in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 6 to < 10 kg.
Group 4:
The primary objectives of this study are:
• To evaluate the steady state PK of BIC and TAF and confirm the dose of B/F/TAF 1.88/7.5/0.94 mg (administration of 1 B/F/TAF 1.88/7.5/0.94 mg FDC TOS) twice daily in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 3 to < 6 kg.

• To evaluate the safety and tolerability of B/F/TAF 1.88/7.5/0.94 mg (administration of 1 B/F/TAF 1.88/7.5/0.94 mg FDC TOS) twice daily through Week 24 in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 3 to < 6 kg
The secondary objectives of this study are:
• To evaluate the safety and tolerability of B/F/TAF 1.88/7.5/0.94 mg (administration of 1 B/F/TAF 1.88/7.5/0.94 mg FDC TOS) twice daily through Week 48 in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 3 to < 6 kg

• To evaluate the antiviral activity of B/F/TAF 1.88/7.5/0.94 mg (administration of 1 B/F/TAF 1.88/7.5/0.94 mg FDC TOS) twice daily through Weeks 24 and 48 in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 3 to < 6 kg

 Kampala, Mulago
 Uganda 2023-03-16 12:47:17 2026-03-16 10 4.1 Selection of the Study Population Approximately 170 pediatric subjects ≥ 1 month to < 18 years of age are planned to be enrolled into the entire study. However, 50 child subjects shall be recruited as follows for Cohort 4 across all participating sites; at least 8 evaluable subjects ≥ 2 years of age weighing ≥ 14 to < 25 kg and at least 42 evaluable subjects ≥ 1 month of age weighing ≥ 3 to < 14 kg are planned to be enrolled. Baylor Uganda site however, plans to recruit a total of 10 children in cohort 4 (i.e. 3 children in each of the groups 1, 2 and 3 and 1 child in group 1). In addition, replacement subjects may be enrolled for subjects whose Intensive PK data are not evaluable or who do not complete all Intensive PK procedures in Groups 2, 3, and 4 of Cohort 4. 4.2 Inclusion Criteria Subjects must meet all of the following inclusion criteria to be eligible for participation in this study. a) Age ≥ 1 month to < 18 years (according to requirements of enrolling Cohort) b) Parent or legal guardian able to provide written informed consent prior to any screening evaluations and willing to comply with study requirements. c) Body weight at screening for Cohort 4: • Group 1: ≥ 14 to < 25 kg (≥ 31 to < 55 lbs) • Group 2: ≥ 10 to < 14 kg (≥ 22 to < 31 lbs) • Group 3: ≥ 6 to < 10 kg (≥ 13 to < 22 lbs) • Group 4: ≥ 3 to < 6 kg (≥ 6.6 to < 13 lbs) d) Confirmed HIV infection if < 18 months of age (positive nucleic acid-based test result to be provided). e) Adequate renal function: • Estimated Glomerular Filtration Rate (eGFR) ≥ 90 mL/min/1.73 m2 (≥ 1.5 mL/sec/1.73 m2) for children ≥ 1 year of age using the Schwartz Formula. • Adequate renal function: eGFR ≥ the minimum normal values for age for children < 1 year of age using the Schwartz Formula. o Schwartz formula (mL/min/1.73 m2) = k × L/SCr where k is a proportionality constant, L is height in centimetres (cm) and SCr is serum creatinine (mg/dL). The value of k is 0.45 for children < 1 year old, 0.55 for children ≥ 1 to < 12 years old and adolescent girls ≥ 12 years old and 0.70 for adolescent boys (≥ 12 years old). f) Stable ARV regimen: • Stable ARV regimen of 2 NRTIs in combination with a third agent for a minimum of 6 months prior to the screening visit. Subjects undergoing dose modifications to their ARV regimen for growth or who are switching medication formulation(s) are considered to be on a stable ARV regimen (Cohort 4 Group 1). • Stable ARV treatment of 2 NRTIs in combination with a third agent for a minimum of 1 month prior to the screening visit or treatment naive (Cohort 4 Groups 2, 3, and 4 only) (patient is considered treatment naive if ARVs were given for prevention of mother-to-child transmission only and not for HIV treatment) g) Plasma HIV-1 RNA: < 50 copies/mL at the screening visit (Cohort 4 Group 1). No threshold for HIV RNA levels for Cohort 4 Groups 2, 3, and 4. h) Life expectancy ≥ 1 year. i) Have no documented or suspected resistance to FTC, TFV, or INSTIs including, but not limited to, the reverse transcriptase resistance mutation K65R. Subjects with M184V/I AND HIV-1 RNA < 50 copies/mL may be enrolled in Cohort 4. Subjects in Cohort 4 with HIV-1 RNA > 50 copies/mL shall have documentation of no FTC, TFV, or INSTI resistance by plasma testing at screening (> 200 copies/mL) or historical genotype (if > 50 copies/mL but < 200 copies/mL). j) Care taker(s) must be willing and able to comply with all study requirements. 4.3 Exclusion Criteria Subjects who meet any of the following exclusion criteria are not to be enrolled in this study. a) Cohort 4 Group 1: CD4 cell count < 200 cells/ mm3. Cohort 4 Groups 2, 3, and 4: CD4 cell count < 750 cells/mm3 for ≥1 to <12 months of age and < 500 cells/mm3 for ≥12 to <24 months of age. b) An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior to screening. c) An ongoing serious infection requiring systemic antibiotic therapy at the time of screening d) Evidence of active pulmonary or extra-pulmonary tuberculosis within 3 months e) Acute hepatitis in the 30 days prior to study entry f) Hepatitis B virus (HBV) surface antigen (HBsAg) positive g) Hepatitis C virus (HCV) antibody positive with detectable HCV RNA. Children < 18 months of age born to an HCV positive mother and/or HCV antibody positive will need to have 2 negative HCV RNA tests 6 months apart with the first test occurring no earlier than 2 months of age. In this situation, the earliest such a patient can be screened for study eligibility is at 8 months of age. h) Have any serious or active medical or psychiatric illness which, in the opinion of the Investigator, would interfere with subject treatment, assessment, or compliance with the protocol. This would include uncontrolled renal, cardiac, haematological, hepatic, pulmonary (including chronic asthma), endocrine (e.g., diabetes), central nervous, gastrointestinal (including an ulcer), vascular, metabolic (thyroid disorders, adrenal disease), immunodeficiency disorders, active infection, or malignancy that are clinically significant or requiring treatment within 30 days prior to Day 1. i) Subjects experiencing decompensated cirrhosis (eg, ascites, encephalopathy) j) A history of or ongoing malignancy other than cutaneous Kaposi’s sarcoma (KS), basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma. Subjects with biopsy-confirmed cutaneous KS are eligible, but must not have received any systemic therapy for KS within 30 days of Day 1 and are not anticipated to require systemic therapy during the study. k) ≤ 2 months of age and gestational age (GA) ≤ 37 weeks (Cohort 4 Groups 2, 3, and 4) l) Current alcohol or substance abuse (by parent/caretaker) judged by the Investigator to potentially interfere with subject compliance m) Have history of significant drug sensitivity or drug allergy n) Known hypersensitivity to the IMP, the metabolites, or formulation excipients. o) Participation in any other clinical trial, including observational studies without prior approval from sponsor is prohibited while participating in this trial. p) Cohort 4 Groups 2, 3, and 4: Last dose of nevirapine (NVP) or efavirenz (EFV), if applicable, ≥ 14 days prior to enrolment q) Subjects receiving ongoing therapy with any medication that is not to be taken with the study drug. Administration of any of the following medications must be discontinued at least 30 days prior to the Day 1 visit and for the duration of the study, with the exception of the subject’s prior ARV treatment regimen, which must be continued until their scheduled Day 1 visit Gilead Sciences, Inc. 333 Lakeside Drive Foster City, CA 94404 Medical and Health Sciences Clinical Trial Non-degree Award
Adoke Yeka
ID: UNCST-2021-R004300
 Phase IIa Proof of Concept, Multicenter, Randomized, Open-label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of the Combination M5717 plus Pyronaridine Administered once Daily for 1 or 2 Days to Adults and Adolescents with Acute Uncomplicated Plasmodium falciparum Malaria
REFNo: HS2736ES

To evaluate the safety and
tolerability of the M5717-
pyronaridine combination in
adult participants with acute
uncomplicated malaria due to
P. falciparum.
Secondary.
o describe the clinical efficacy
of the M5717-pyronaridine
combination in adult participants
with acute uncomplicated
malaria due to P. falciparum
 Tororo, Central
 Uganda 2023-03-16 12:35:56 2026-03-16 200 Participants Are ≥ 12 and ≤ 55 years of age (≥ 18 and ≤ 55 years of age for Part A) at the time of signing the informed consent. Type of Participant and Disease Characteristics: 2. Microscopic confirmation of acute uncomplicated P. falciparum using Giemsa-stained thick and thin film. 3. P. falciparum parasitemia of ≥ 1,000 to ≤ 50,000 asexual parasites/µL of blood in Part A and P. falciparum parasitemia of > 1,000 to ≤ 150,000 asexual parasites/µL of blood in Part B. 4. Axillary temperature ≥ 37.5ºC or tympanic temperature ≥ 38.0ºC (use as per COVID-19 protocols at the site [only at Screening]), or history of fever during the previous 24 hours (at least documented verbally). Weight: 5. Have a body weight ≥ 24 kg Merck Healthcare KGaA, Darmstadt, Germany an affiliate of Merck KGaA, Darmstadt, Germany Frankfurter Str. 250 64293, Darmstadt, Germany Medical and Health Sciences Clinical Trial Non-degree Award
Flavia Matovu Kiweewa
ID: UNCST-2021-R013337
 A Phase 2/3, Multicenter, Open-label, Multicohort Study Evaluating Pharmacokinetics (PK), Safety, and Efficacy of Cobicistat-boosted Atazanavir (ATV/co) or Cobicistat-boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in HIV-1 Infected, Virologically Suppressed Pediatric Participants.
REFNo: HS2646ES

The primary objective of this study is to confirm the dose of ATV/co or DRV/co in HIV-1 infected pediatric participants, to confirm the dose of F/TAF in HIV-1 infected pediatric participants and to evaluate the safety and tolerability these medications.
 Mityana, Mityana
Mubende, Mubende
Masaka, Masaka
Rakai, Kalisizo
Kampala, Kampala
Wakiso, Entebbe
 Uganda 2023-03-09 23:33:04 2026-03-09 15 The study will be conducted in young children and adolescents aged 3 to < 18 years; HIV-1 infected on a stable antiretroviral regimen for a minimum of 3 months. In Uganda, the study will be conducted by researchers from the coordinating site, MU-JHU Research Collaboration, MU-JHU CARE – Kampala, Uganda, in collaboration with Africa Medical and Behavioral Sciences Organization (AMBSO) – Kampala and SICRA-TASO MULAGO National Referral Hospital, Masaka, Uganda. Gilead Sciences Inc Medical and Health Sciences Clinical Trial Non-degree Award
Raymond Tweheyo
ID: UNCST-2020-R014507
 Understanding the effect of varied financial compensation structure for improving the performance, motivation and retention of Community Health Workers in Uganda - a quasi experiment
REFNo: HS2689ES

General objective: To understand the effect of varied financial compensation structure for improving the performance, motivation and retention of Community Health Workers in Uganda.

Specific objectives:
1. To determine the optimal performance based financial incentive incentive's structure required for improving the performance, motivation and retention of CHWs.

2. To explore the acceptability and perceptions of potential sustainability of CHWs financial compensation structure to various stakeholders, including the CHWs, and the CHW supervisors at the district and Ministry of Health.

3. To explore the perceived value and impact of financial incentives on CHW's job satisfaction, personal income and livelihood.
 Wakiso, all parishes
Mpigi, all parishes
Mbale, all parishes
Jinja, all parishes
 UK 2023-03-07 10:40:31 2026-03-07 3,215 children under five, 720 Community Health Workers, 32 Key Informants 1. Women of reproductive age (18 to 49 years) who have a child under five years of age. 2. Community Health Workers (18 years and above) 3. Adult Key Informants - district, Ministry of Health and Implementing Partner officials USAID/ Living Goods Medical and Health Sciences Clinical Trial Non-degree Award
Rachel Brathwaite
ID:
Assessing the Feasibility of Economic Approaches to Prevention of Substance Abuse among Adolescents
REFNo: HS2683ES

Aim 1. Examine the prevalence and consequences of ADU in a cohort of 200 AYLHIV (ages 18-24) seen at six (6) HIV clinics in southwestern Uganda.
Aim 2. Using a mixed methods approach, identify the multi-level (individual, interpersonal, community and structural) factors associated with ADU among AYLHIV.
Aim 3. Using a subset of the sample, explore the feasibility and short-term effects of a family-based economic empowerment intervention on ADU among AYLHIV.

 Masaka,
Trinidad and Tobago 2023-03-02 15:32:31 2026-03-02 230 220 Adolescents and youths living with HIV aged 18-24 years. 10 healthcare providers aged >18 years. National Institute on Alcohol Abuse and Alcoholism Medical and Health Sciences Clinical Trial Non-degree Award
Harriet Mayanja-Kizza
ID: UNCST-2021-R013074
 PHASE 2C CLINICAL TRIAL OF NOVEL, SHORT-COURSE REGIMENS FOR THE TREATMENT OF PULMONARY TUBERCULOSIS: CRUSH-TB (Combination Regimens for Shortening TB Treatment)
REFNo: HS2650ES

Primary objective
(1) To compare the efficacy of each experimental regimen to the efficacy of standard treatment, using the intermediate endpoint of time to culture negative in liquid media.

Secondary objectives
(1) To compare the proportion of participants with a grade 3 or higher adverse event in each experimental arm with the control arm
(2) To describe the proportion of participants experiencing lack of sustained cure during treatment or follow-up to 52 weeks in each experimental arm as compared to control and make predictions as to how these regimens would perform in future phase III trials.
(3) To compare the efficacy of each experimental regimen to the efficacy of standard treatment, using the intermediate endpoint of time to culture negative in solid media
(4) To compare the proportion of participants in each arm who convert liquid and solid sputum cultures to negative by (a) 8 weeks of treatment and (b) 12 weeks of treatment
(5) To describe the rate of all-cause study drug discontinuation in each arm
(6) To compare time to sputum culture positivity curves through 17 weeks in the Mycobacterial Growth Indicator Tube (Bactec MGIT960) across arms
(7) To describe the proportion of participants experiencing lack of sustained cure during treatment or follow-up up to 78 weeks in each experimental arm as compared to control and make predictions as to how these regimens would perform in future phase III trials.
(8) To describe the population PK of bedaquiline and its M2 metabolite, with or without rifabutin co-administration (PK#1)
(9) To conduct pharmacokinetic/pharmacodynamics study of the test drugs to determine relationships between pharmacokinetic parameters (AUC, Cmax) and outcome measures (time to culture negativity or rate of change in TTP) using non-linear mixed effects models, adjusting for key covariates that may affect outcomes (e.g. companion drugs, HIV status, cavitary disease) (PK#2)

 Kampala, Mulago
 Uganda 2023-02-21 13:13:53 2026-02-21 288 overall, 100 in Uganda This will be a multisite international study. Male and female participants who are age 12 or older and have suspected or proven pulmonary tuberculosis will be enrolled into the study. Enrollment will be open to all TBTC sites willing to participate and who have completed trial start-up requirements. Target enrollment is at least 288 participants (96 participants per arm). Pregnant or breast-feeding individuals will be excluded from the study because of uncertainties about the safety of bedaquiline, delamanid, and moxifloxacin in these groups. The sex, ethnicity, and socioeconomic background of study participants are expected to mirror those of the populations served by local tuberculosis clinics and the populations most affected by tuberculosis worldwide. Co-enrollment in other therapeutic clinical trials is not allowed. U.S. Centers for Disease Control and Prevention Medical and Health Sciences Clinical Trial Non-degree Award
Wietse Tol
ID: UNCST-2021-R013085
 AlCohol use in HumanitariAN settings: a programme of work to address alcohol use disorders and associated adversities among conflict-affected populations in UGanda and UkrainE (CHANGE)
REFNo: SS1596ES

• To identify strategies and techniques from evidence-based alcohol use therapies which can be integrated into PM+, and to develop a new intervention called PM+A (Problem Management Plus Alcohol)
• To adapt PM+A to local circumstances, and to examine the feasibility, acceptability, perceived effectiveness, and preliminary impact of PM+A
• To evaluate effectiveness and cost-effectiveness of PM+A through two single-blind randomised controlled trials in Uganda and Ukraine
• To explore the process of implementation, and to identify, characterise and explain mechanisms that promote or inhibit the delivery and take-up of PM+A in both settings
• To examine the potential for scaling-up PM+A in Uganda and Ukraine

 Arua, Ofua zone Rhino Camp
 Netherlands 2023-02-17 12:18:30 2026-02-17 60 Adult South Sudanese men (>18 years) who meet all the following criteria.; Alcohol Use Disorder Identification Test (AUDIT) score 8-19 (Saunders et al., 1993) 2) Elevated levels of psychological distress (Kessler Psychological Distress Scale (ten item version) (K10 >6) (Kessler et al., 2002) Wellcome Trust and the Department of Health and Social Care, through the National Institute for Health Research Social Science and Humanities Clinical Trial Non-degree Award
Maxensia owor
ID: UNCST-2021-R014003
 IMPAACT 2036: Phase I/II Study of the Safety, Tolerability, Acceptability, and Pharmacokinetics of Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in Virologically Suppressed Children Living with HIV-1, Two to Less Than 12 Years of Age. Version 1.0, 22 September 2022. DAIDS study protocol ID: 38932
REFNo: HS2599ES

iii. Cohort 2: To describe the maintenance of viral suppression and immunologic activity of 48 weeks of CAB + RPV (oral and injectable) or 44 weeks of CAB LA + RPV LA (injectable only),iv. Cohort 2: To describe HIV-1 genotypes and phenotypes for children who experience virologic failure during 48 weeks of CAB + RPV (oral and injectable) or during 44 weeks of CAB LA + RPV LA (injectable only),ii. Cohort Cohort 2: To describe the safety and repeat-dose pharmacokinetics of 48 weeks of CAB + RPV (oral and injectable) or 44 weeks of CAB LA + RPV LA (injectable only),i. Cohort 2: To describe tolerability and acceptability of 48 weeks of CAB + RPV (oral and injectable) and 44 weeks of CAB LA + RPV LA (injectable only),ii Cohort 1: To assess the safety of the oral lead-in of CAB + RPV, and the safety of CAB + RPV (oral and injectable) through Week 24,i.Cohort 1: To describe the repeat-dose pharmacokinetics of CAB + RPV (oral and injectable) through Week 24,
 Kampala, all parishes
Wakiso, all parishes
 Uganda 2023-02-13 11:10:13 2026-02-13 90 children and 90 parents/ caregivers worldwide but MUJHU plans to enroll 5 -15 children and 5-15 parents/ caregivers. Children living with HIV-1, two years to less than 12 years of age and weighing ≥10 kg and <40 kg, who are virologically suppressed on stable antiretroviral therapy and their parents/caregivers. DAIDS/NIH Medical and Health Sciences Clinical Trial Non-degree Award
Winnie  Muyindike R
ID: UNCST-2021-R013558
 A Randomized Clinical Trial to Evaluate Solutions for the Management of Virologic Failure for Individuals on TLD in Sub-Saharan Africa.(RESOLVE)
REFNo: HS2620ES

Aim 2: Use simulation modeling to examine the clinical impact, costs, and cost-effectiveness of strategies to improve viral suppression after virologic failure on TLD. We will populate the previously validated Cost-Effectiveness of Preventing AIDS Complications-International (CEPAC-I) model with the novel clinical trial data from Aim 1 to project long-term clinical outcomes and cumulative lifetime costs. We will then compare the cost-effectiveness of the three strategies evaluated in Aim 1 for addressing virologic failure among people treated with first-line TLD in Uganda or South Africa. ,Aim 1: Conduct a randomized clinical trial to determine the optimal strategy for management of virologic failure on first-line TLD in SSA. We will recruit 648 adolescents and adults with two viral loads >1,000 copies/mL while on first-line TLD for at least 12 months, who are in care at one of six public-sector HIV clinics in Uganda or South Africa. We will randomize participants to one of the following strategies, stratified by clinic and prior NNRTI-exposure: a) Maintenance on TLD with switch to protease inhibitor (PI)-based second-line ART if virologic failure persists past six months; b) Individualized Care, with regimen choice based on results of genotypic resistance tests and urine tenofovir assays; or c) Immediate Switch to PI-based second-line ART. The primary outcome will be viral suppression (<50 copies/mL) at 48 weeks post-enrollment using the FDA snapshot definition. We hypothesize that rates of viral suppression at 48 weeks will be higher in the Individualized Care arm than in the Maintenance on TLD and Immediate Switch arms.,
 Mbarara, Kamukuzi
Mbarara, Kakoba
 Uganda 2023-02-09 11:06:56 2026-02-09 324 15 years and above, female and male wo are on TLD irrespective of tribe National Institutes of Health Medical and Health Sciences Clinical Trial Non-degree Award
Afiz Kibuuka Kibuuka
ID: UNCST-2021-R012755
 A Phase 3, multicenter, randomized, double-blind, 24-week study of the clinical and antiviral effect of S-217622 compared with placebo in non-hospitalized participants with COVID-19
REFNo: HS2642ES

The main intent of the study is to evaluate the efficacy of S-217622 vs. placebo. The study will be conducted in the setting of the locally available standard-of-care COVID-19 treatment. High-risk and low-risk participants will be analyzed together for the primary analysis and separately for secondary analyses. The following primary, secondary, and exploratory objectives will be addressed in the modified intent-to-treat (mITT) population, except for the safety analyses, which will be analyzed in the Safety population, and pharmacokinetic (PK) analyses, which will be analyzed in the PK population.
 Tororo, All Parishes
 Uganda 2023-02-06 17:17:04 2026-02-06 Each site in Uganda will (through competitive enrolment) enroll at least 8 participants making a total of 32 participants for all Uganda sites. Outpatient adults (≥18 years) with: a) documented positive SARS-CoV-2 nucleic acid or antigen test from a sample collected ≤120 hours (5 days) prior to randomization, b) onset of symptoms of COVID-19 ≤5 days prior to randomization, c) presence of 1 or more select COVID-19 symptoms within 24 hours prior to randomization. Participants will be eligible regardless of vaccination status and will be classified as either high risk or low risk. High-risk participants: defined as aged ≥65 years or those with presence of high-risk conditions. National Institute of Allergy and Infectious Diseases (NIH), Division of AIDS (DAIDS) Medical and Health Sciences Clinical Trial Non-degree Award
Noella Okalany Akwi Regina
ID: UNCST-2022-R011085
 Congenital Cytomegalovirus Infection in Eastern Uganda
REFNo: HS2668ES

To determine the short-term neurodevelopmental outcomes and hearing impairment associated with congenital cytomegalovirus among infants in Eastern Uganda.,To determine the incidence of, and risk factors for postnatally acquired cytomegalovirus among infants in Eastern Uganda.,To describe the factors associated with congenital cytomegalovirus infection in neonates in Eastern Uganda.,To determine the prevalence of congenital cytomegalovirus infection among neonates in Eastern Uganda,To investigate the burden of congenital cytomegalovirus and its outcomes among infants in Eastern Uganda.,
 Mbale, Mbale
Budaka, Budaka
 Uganda 2023-02-06 16:21:08 2026-02-06 2000 0 - 6 months of age University of Liverpool Medical and Health Sciences Clinical Trial Degree Award
Kathy Burgoine
ID: UNCST-2022-R011521
 Impact of prophylactic Continuous Positive Airway Pressure in the Delivery Room (DR-CPAP) on neonates <1500g in a low-resource setting: A feasibility trial
REFNo: HS2605ES

- To determine the acceptability of DR-CPAP to healthcare workers in a low-resource setting - To determine the post-intervention acceptability of using a two-stage consent process in neonatal emergencies in the delivery room in this setting - To evaluate the feasibility of a third-party allocation process for randomisation by determining the time to randomization - To evaluate feasibility of initiating DR-CPAP in a low-resource setting in infants with birthweight 800-1500g within 15 minutes of delivery - To determine the safety of initiating DR-CPAP in a low-resource setting - To estimate the sample size to be used for future evaluation in the full trial - To assess the feasibility of secondary outcome measures to be used in the full trial
Mbale,
UK 2023-02-02 12:18:23 2026-02-02 100 The study population will be inborn preterm infants with a birthweight of 800g to less than 1500g who are spontaneously breathing at 5 minutes of life. They will be recruited within 15 minutes of birth and followed up until death or 28 days. Both male and female infants will be included. Mbale Clinical Research Institute (MCRI) Medical and Health Sciences Clinical Trial Non-degree Award
Yerusa   Kiirya
ID:
Acceptability, Feasibility and Effectiveness of a WhatsApp peer support group as a strategy to improve antiretroviral therapy adherence among youth in Kampala District
REFNo: SIR170ES

To determine the effectiveness of a WhatsApp peer support group combined with the standard of care in improving ART adherence among YLHIVA aged 15-24 years in Kampala district.,To determine the effect of a WhatsApp peer support group combined with the standard of care on psychosocial barriers to ART adherence and retention in care among YLHIVA aged 15-24 years in Kampala district.,To assess the feasibility of using a WhatsApp peer support group combined with the standard of care as an ART adherence and retention in care strategy among YLHIVA aged 15-24 years, To asses the acceptability of a WhatsApp peer support group combined with the standard of care as an ART adherence and retention in care strategy among YLHIVA aged 15-24 in Kampala district.,To assess the acceptability, feasibility and effectiveness of a WhatsApp peer support group combined with current standard care as a strategy to improve ART adherence among YLHIVA in Kampala.,
 Kampala, Kiswa
Kampala, Komambogo
Kampala, Kawala
 Uganda 2023-01-20 14:23:51 2026-01-20 488 This study will be conducted among YLHIVA aged 15-24 years currently receiving ART services at Kiswa, Komambogo and Kawala HCIII with an ART adherence score of less than 95% within the past 12 months Strengthening behavioral and social science research capacity to address evolving challenges in HIV care and prevention in Uganda. Engineering and Technology Clinical Trial Degree Award
Winnie  Muyindike R
ID: UNCST-2021-R013558
 Gabapentin to Reduce Alcohol and Improve Viral Load Suppression (GRAIL) – “Promoting Treatment as Prevention”
REFNo: HS2622ES

2. To assess the impact of gabapentin compared to placebo on: a) alcohol consumption; b) pain severity; c) ART adherence; and d) engagement in HIV care, in order to explore potential mechanisms by which gabapentin may lead to HVL suppression.,1. To test the efficacy of gabapentin versus placebo to achieve undetectable HVL (Primary Outcome at 3 months; Secondary Outcome at 6 & 12 months),
 Mbarara, Kamukuzi
Mbarara, Kakoba
 Uganda 2023-01-18 18:33:54 2026-01-18 300 18 years and above, female and male, irrespective of tribe, who are on antiretroviral therapy with detectable viral load and are unhealthy alcohol consumers. National Institute of Health Medical and Health Sciences Clinical Trial Non-degree Award
Isaac Ssewanyana
ID: UNCST-2020-R014336
 Evaluation of the performance of novel molecular point of care diagnostics for SARS-CoV-2
REFNo: HS2588ES

To assess the ease of use of the molecular POC devices being evaluated using a System Usability Scale (SUS) questionnaire administered to platform’s operators (minimum 3, where possible)., To evaluate the diagnostic accuracy of such platforms in detecting SARS-CoV-2 on respiratory specimens, compared with reference standard RTPCR in specific subgroups defined based on disease stage (days since symptoms onset), RTPCR Ct values (as surrogate for viral load). Participant’s vaccination status, previous COVID-19 infection(s) and SARS-CoV-2 genetic variant causing participant’s infection, determined by sequencing of the viral genome, may also be considered as subgroups. , To evaluate the diagnostic accuracy of molecular POC devices in detecting SARS-CoV-2 on respiratory specimens, compared with reference standard RT-PCR (WHO EUL or FDA EUA approved), among COVID-19 symptomatic individuals,
 Kampala, Mulago
Kampala, Kiruddu
Kampala, Kawempe
Kampala, Butabika
 Uganda 2023-01-18 18:21:06 2026-01-18 200 The study will focus on adults with symptoms compatible with COVID-19 (and/or specimens collected from them) attending healthcare facilities in Uganda. If a participant is screened and enrolled but is not able to provide the specimens required for the study, this participant will be withdrawn. FIND GENEVA Medical and Health Sciences Clinical Trial Non-degree Award
Raymond Tweheyo
ID: UNCST-2020-R014507
 Evaluating the pilot of the Community Health Extension Worker (CHEW) strategy in Uganda: assessing feasibility, and effectiveness for improving Village Health Team (VHT) supervision and reporting
REFNo: HS2545ES

General Objective
To explore the acceptability, document the implementation process and evaluate the effectiveness of the Community Health Extension Worker strategy in two districts of Uganda to guide improving the community health system

Specific Objectives
1) To assess the acceptability of introducing a Community Health Extension Worker (CHEW) strategy in a district health system.

2)To document the process of setting up and implementing a Community Health Extension
Worker (CHEW) strategy within a district health system.

3) To estimate the program costs and duration for setting up a government-led Community Health Extension Worker (CHEW) strategy within a district health system.

4) To determine the effectiveness of the CHEW strategy for improving the quality of Village Health Team (VHT) member’s supervision and reporting in a district health system.

5) To assess the effect of the CHEW strategy on community-level indicators: completion of four antenatal care visits, skilled delivery attendance, fully immunized under-fives, and U5 sick children seen by VHTs and treated within 24 hours.

Mayuge, all parishes
Lira, all parishes
Kabarole, all parishes
Kyotera, all parishes
 UK 2023-01-03 13:08:01 2026-01-03 3,016 women of reproductive age 1) Household members: Adult women of reproductive age 18 to 49 years. 2) Community health workers - 18 years and above 3) Health facility workers - 18 years and above 4) District technical and political leaders - 18 years and above 5) Community Health Implementing partners - adults, 18 years and above USAID/ Uganda Health Systems Strengthening Activity (UHSS) Medical and Health Sciences Clinical Trial Non-degree Award
Pontiano  Kaleebu
ID: UNCST-2020-R019901
 Performance evaluation of the Determine™ HIV Early Detect 4th Generation HIV Rapid Diagnostic test
REFNo: HS2603ES

Primary Objectives:
1. To evaluate the Laboratory performance (Sensitivity and specificity) of the Determine™ HIV Early Detect
2. To assess the field performance of the Determine™ HIV Early Detect in parallel with the Determine™ HIV-1/2 test
Secondary Objective:
1. To assess the effectiveness of the Determine Early Detect to identify acute HIV infection among newly infected individuals

 Buikwe, kawolo
Kampala, Kisenyi
Kampala, Naguru
Mityana, Mityana
Mukono, Mukono hospital
Wakiso, Wagagai
Wakiso, UVRI
Kayunga, Kayunga hospital
Kalungu, Nkozi hospital
Gomba, Gombe hospital
 Uganda 2022-12-23 18:06:59 2025-12-23 10,000 The study will enroll; - Adults above 18 years of age - Willing to have an HIV test. - Eligible for testing as per the National HTS eligibility screening tool - Documented - Abott Diagnostics Medical and Health Sciences Clinical Trial Non-degree Award
Lawrence Okello Rafaih
ID:
Evaluation practices and strategy performance of local NGOs in Uganda
REFNo: SS1561ES

4. To determine the relationship between organizational evaluation steering process and strategy performance of NGOs in Uganda,3. To establish the relationship between organizational evaluation technical expertise and strategy performance of NGOs in Uganda,2. To determine the relationship between evaluation planning process and strategy performance of NGOs in Uganda,1. To validate the contextual relevance of organizational effectiveness competency model for strategy evaluation of NGOs in Uganda.,The purpose of this study is to validate the extent to which evaluation practices influence strategy performance of national NGOs in Uganda.,
 Moroto, Moroto
Gulu, Gulu
Kampala, Kampala
Mbarara, Mbarara
Moroto, Moroto
Gulu, Gulu
Kampala, Kampala
Mbarara, Mbarara
Lira, Lira
 Uganda 2022-12-19 12:19:45 2025-12-19 379 In short study targets adult population ( aged between 18-70 years)population from local NGOs who are members of the national NGO forums spread across the country. A total of 40 cluster NGO forums will be engaged to reach our to gather a proportionate sample of about 80 respondents per region. Similarly, Only adult respondents will be included for key informant interviews Lawrence Rafaih Okello Social Science and Humanities Clinical Trial Degree Award
Daniella Ferguson
ID:
A Retrospective Analysis of Suramin Treatment forStage 1 Trypanosoma Brucei Rhodesiense Human African Trypanosomiasis (S1 TBR HAT) in Uganda and Malawi
REFNo: HS2582ES

Primary objectives
The primary objective is to determine whether standard of care treatment with suramin, as currently practiced in Uganda and Malawi, leads to better health outcomes in patients with S1 TBR HAT than observed in an untreated natural history cohort with source data from a published epidemiologic study.

Secondary objectives
The secondary objective is to evaluatethe safety and tolerability of suramin.

 Kaberamaido, Lwala
 South Africa 2022-12-19 12:17:26 2025-12-19 150 -200 patients The study will include TBR HAT patients treated with suramin between 2000 and 2020 in Uganda and Malawi. The study will include all of the approximately 150 - 250 patients evaluated through chart review who are deemed eligible and have sufficient data. A natural history cohort composed of source data from approximately 200 patients from a published epidemiological study will be used as a comparator. PaxMedica, Inc. 303 South Broadway Suite 125 Tarrytown, NY Medical and Health Sciences Clinical Trial Non-degree Award
KENNETH MUGABE
ID: UNCST-2022-R010732
 Using lactate testing to improve maternal sepsis identification: a multi-country test accuracy study: LACTate in mATernal sEpsis
REFNo: HS2589ES

VI. Conduct a validation study of an alternative reference standard in which the SOFA score is modified to incorporate maternity specific ranges for creatinine and platelet concentration.,V. Exploratory analysis will examine the effect of adjusting the threshold values for both vital sign and lactate assessment on the sensitivity and specificity of the index tests.,IV. To explore if the test accuracy of lactate in addition to maternal vital sign monitoring alone varies by the pre-specified subgroups of pregnancy status (pregnant or post-delivery (including abortion or miscarriage)) and recruitment country.,III. To explore if baseline venous lactate, in addition to vital sign measurements, improves prediction of severe morbidity and mortality from infection.,II. To assess short-term predictive value of lactate testing, by comparing the baseline index test with 24-hour reference standard, in those without sepsis at baseline.,I. Immediate diagnostic value of lactate testing by comparing the baseline index test with baseline reference standard.,Determine the diagnostic accuracy of maternal venous lactate measurement in addition to maternal vital sign thresholds, in maternal sepsis in low-resource health facility settings in Malawi, Uganda and Pakistan.,
 Uganda 2022-12-12 15:55:39 2025-12-12 500 (150 in Uganda) Women, 16years or greater, with suspected infections, who are pregnant or recently pregnant(up to 42 days) University of Liverpool Medical and Health Sciences Clinical Trial Non-degree Award
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