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  
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
Margaret Nagawa
ID: UNCST-2022-R009705
 EARLY NUTRITIONAL INTERVENTION FOR NUTRITIONALLY AT-RISK INFANTS UNDER 6 MONTHS OF AGE TO REDUCE MALNUTRITION IN THE FIRST YEAR OF LIFE
REFNo: HS3503ES

5. To assess the maternal and health worker perceptions on the integrated intervention package.,4. To assess the effect of an early integrated family intervention program for LBW and undernourished children u6m on growth in the first year of life.,3. To understand the barriers and facilitators to the integration of maternal mental health care and community-based management of malnutrition in infants u6m of age.,2. To assess the prevalence of maternal mental health among caregivers of u6m infants.,1. To determine the factors associated with malnutrition among infants u6m of age and challenges caregivers of LBW and undernourished infants face. ,2. To assess the prevalence of malnutrition among infants u6m and their associations, To assess the effect of an early integrated nutrition intervention for nutritionally at-risk infants u6m of age in reducing malnutrition in the first year of life. ,
 Adjumani, Adjumani
 Uganda 2025-03-14 16:37:34 2028-03-14 300 mother baby pairs Infants under 6 months of age. and caregivers of infants under six months of age. sex: males and females Tribe: refugees and host communities self funded Medical and Health Sciences Clinical Trial 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
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
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
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
GUMA  ASHIRAF
ID:
PREVALENCE, PATTERNS AND CORRELATES OF GENERAL JOINT PAIN AMONG PATIENTS WITH DIABETES MELLITUS ATTENDING DIABETIC CLINIC AT MBARARA REGIONAL REFFERRAL HOSPITAL
REFNo: HS3963ES

To determine the prevalence of general joint pain among patients with DM attending diabetes clinic at MRRH.To determine the patterns of joint pain among patients with DM attending diabetes clinic at MRRH.To determine the associated factors to general joint pain among patients with DM attending diabetes clinic at MRRH.
 Mbarara, Rwebikona
 Uganda 2024-08-29 10:59:36 2027-08-29 242 The study population will be patients with DM attending diabetes clinic at MRRH. The diabetes clinic has a patient census of approximately 1500 patients of which about 80 patients attend every week. The study population is between the age of 18 years to 90 years. Most of the study population are Banyankole, Bakiga and Bahima. The study population is made of both males and females. Guma Ashiraf, Jemba Jovane, Mwesigwa Emma, Bananuka Bernard Medical and Health Sciences Clinical Trial 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
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
Peter Olupot-Olupot Olupot
ID: UNCST-2020-R014798
 SMAART-MAP trial Severe Malaria A Research and Trials consortium - Multisite Adaptive Platform trial
REFNo: HS4547ES

OBJECTIVES
The objective of the SMAART-MAP trial is to identify promising adjunctive therapies to take forward into a large Phase III trial in severe malaria with a mortality endpoint. The adaptive platform design enables additional domains to be added so a range of adjunctive therapies can be tested, across multiple clinical presentations of severe malaria, in a timely manner.

PRIMARY OBJECTIVE(S)
To explore within each domain the therapeutic efficacy of the intervention using an early indicator such as a biomarker or clinical assessment at 24-72 hours.

SECONDARY OBJECTIVE(S)
? To assess the impact of the interventions on clinical outcomes (readmission and
mortality) on all children 28 days and 90 days after randomization
? To assess the impact of the interventions on Grade 3 or 4 adverse events, and adverse
events of any grade related to the interventions or comparators.
? To assess the impact of proposed definitions for severe malaria based on platelet counts
?150,000/µL and plasma pfHRP2 concentrations ?800 ng/mL on differences between
randomized groups
? In a sub study, to determine the performance characteristics of a POC pfHRP2 test
compared with quantitative plasma pfHRP2 concentrations determined from plasma.

 Mbale, North central
Soroti, Pioneer Ward
Agago, Oreet
 Uganda 2024-08-16 11:01:14 2027-08-16 150 per domain Hospitalized children with severe malaria Imperial College London Medical and Health Sciences Clinical Trial Non-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
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
Isaac Ssinabulya
ID: UNCST-2021-R004352
 ImpleMEntation of a Digital-first care deLiverY model for heart failure in Uganda (MEDLY Uganda)
REFNo: HS4581ES

In this study, we will implement a digital-first, multi-component strategy for HF (Medly Uganda) and evaluate both implementation and clinical outcomes. The primary objective is to assess the implementation and clinical effectiveness of a digital-first implementation strategy to improve HF self-care in Uganda. We will conduct a stepped-wedge, cluster randomized trial in outpatient departments at 6 Ugandan RRH. The co-primary outcomes will be the Self-Care of HF Index (implementation) and the composite of mortality and HF hospitalization (clinical effectiveness). The secondary objectives will include the following. Conduct a mixed method process evaluation to inform iterative adjustments to the implementation process. We will use a community-engaged approach to systematically collect qualitative and quantitative process data at pre-determined time points based on the Learn-As-You-Go design and make contextually appropriate implementation adaptations. Prior to recruitment, we will also explore patients’ journeys to heart failure diagnosis in Uganda through a qualitative component by conducting in-depth interviews. The aims of this work will be to explore factors associated with patient’s journeys to heart failure diagnosis, including descriptions of initial symptoms, progression, health care referral journey, barriers and facilitators to care, and role of health education and self-care awareness. We will assess the implementation fidelity and sustainability of Medly Uganda with a focus on reach, adoption, and maintenance. Using Medly Uganda meta data from patients (app) and providers (dashboard), we will identify patterns and predictors of usage. We will interview patients and providers to explore these findings, and ensure implementation fidelity. We will also explore patient and provider perspectives on the sustainability of Medly Uganda, using semi-structured interviews to explore patient and provider barriers and facilitators of long-term use, to surface strategies that would optimize Medly Uganda implementation over time. We shall explore cost, cost effectiveness, and sustainability factors for Medly Uganda. We will collect and examine cost data from patients and facilities examining the unit cost (cost per HF patient treated and per HF patient controlled) of control and Medly Uganda scenarios both from a financial and societal perspective. Primary outcomes for cost effectiveness analysis will be the Incremental Cost-Effectiveness Ratio per patient treated and per death averted.
Arua,
Lira,
Mbale,
Masaka,
Mbarara,
Kabarole,
Uganda 2024-11-18 22:56:37 2027-11-18 576 We will consecutively recruit patients 18 years or older presenting for HF care at the medical outpatient NCD and/or cardiac clinics at the 6 participating sites, each a Ugandan public sector Regional Referral Hospital (RRH) located in Arua, Fort Portal, , Lira, Masaka, Mbale and Mbarara. For the secondary objectives 1 and 2 of this study, we will recruit patients, implementers and administrators to participate in the process evaluation, and in reflections on implementation and sustainability. We expect to recruit 12 implementers (2/site at minimum), 22 administrators (2/site, 6 regional representatives, and 4 MoH) as well as 72 patients (8-12 at minimum/site) for qualitative assessment over the course of the study. Our qualitative component will recruit patients 18 years or older with recently diagnosed HF (within past three months), presenting for care at Uganda Heart Institute, or Arua, Masaka, and/ Mbale RRH. National Institutes of Health Medical and Health Sciences 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
Milton Musaba Wamboko
ID: UNCST-2019-R000825
 Effectiveness and Safety Dosing of Sodium Bicarbonate in Women with Obstructed Labor in Eastern Uganda: A Phase III Randomized placebo-controlled Trial (SoBicOL- II Study)
REFNo: HS3885ES

General objective
To determine the efficacy and safety of a preoperative infusion of sodium bicarbonate on pH and lactate levels (metabolic acidosis) among women with obstructed labour.
Specific objectives
1. To determine the efficacy of a preoperative infusion of sodium bicarbonate on acidosis, compared with placebo among women with obstructed labour (OL).
2. To determine the safety of a preoperative infusion of sodium bicarbonate compared with placebo among women with obstructed labour (OL).

 Mbale, Kawempe
 Uganda 2024-08-29 18:40:41 2027-08-29 280 Obstructed labour will be diagnosed by either an obstetrician or medical officer using a definition of the American Association of Obstetricians and Gynaecologists (ACOG). In the first stage of labour, the participant should have cervical dilatation >6 cm with ruptured membranes, adequate contractions lasting >4 hours with no change in cervical dilatation or delay in the second active stage of labour (nullipara >2 hours, multipara >1 hour) with adequate uterine contractions. In addition, any two of: the obvious signs of severe obstruction such as caput formation, severe moulding, Bandl’s ring, subconjunctival haemorrhages or an oedematous vulva. Busitema University Medical and Health Sciences Clinical Trial Non-degree Award
Jackson Orem
ID: UNCST-2021-R012016
 A Phase III, Randomized, Open-Label, Non-Inferiority Study of Paclitaxel and Pegylated Liposomal Doxorubicin for Treatment of HIV-related Kaposi Sarcoma in Resource-Limited Settings
REFNo: HS4073ES

To describe the incremental cost-effectiveness ratio per QALY gained (as assessed by PROPr) between PLD and PTX,To assess quality of life across PROMIS domains (i.e., cognitive function, physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) with the PROPr tool at start of therapy, mid-treatment, and after treatment with PLD and PTX ,To describe the cost of therapy across AMC sites in sub-Saharan Africa to deliver both PLD and PTX by micro-costing analysis for goods and time-in-motion analysis for services. ,To estimate the objective response rate (defined as the sum of complete and partial responses) for AIDS-KS, response duration and overall survival in each treatment arm. ,To evaluate whether there is sufficient evidence to conclude that PLD is non-inferior to PTX in people with severe AIDS-associated KS receiving concomitant ART in resource-limited settings. ,
 Kampala, Mulago
Uganda 2024-12-10 14:39:24 2027-12-10 130 participants overall and up to 40 participants in Uganda This study will be done in adults above 18 years, both male and female of all tribes, and will recruit participants with HIV-associated Kaposi Sarcoma in Uganda. AIDS Malignancy Consortium 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
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
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
Francis Ssali
ID: UNCST-2021-R012134
 A5409: A Phase 2 Randomized, Adaptive, Dose-Ranging, Open-Label Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis (RAD-TB)
REFNo: HS4036ES

1.2 Primary Objectives

1.2.1 To compare MGIT liquid culture TTP slope over the first 6 weeks of treatment for each experimental treatment arm to the SOC arm.

1.2.2 To compare new Grade 3 or higher adverse events (AEs) (safety) over the first 8 weeks of treatment for each experimental treatment arm to the SOC arm.

1.3 Secondary Objectives

1.3.1 To compare time to stable culture conversion by MGIT liquid culture by week 8 for each experimental treatment arm to the SOC arm.

1.3.2 To compare MGIT liquid culture TTP slope over the first 8 weeks of treatment for each experimental treatment arm to the SOC arm.

1.3.3 To compare new Grade 3 or higher AEs (safety) over 26 weeks of treatment for each experimental treatment arm to the SOC arm.

1.3.4 To compare discontinuations of anti-TB drugs for any reason prior to 8 and 26 weeks of treatment for each experimental treatment arm to the SOC arm.

1.3.5 To determine the dose- and exposure-response relationships between experimental drug estimated pharmacokinetic (PK) parameters with safety and efficacy.

1.3.6 To compare a composite of efficacy and safety outcomes using a risk-benefit approach for each experimental treatment arm to the SOC arm.

1.3.7 To compare MGIT liquid culture TTP slope over the first 6 weeks of treatment for Arms 3A-3B and Arms 4A-4B compared to Arm 2.

1.3.8 To compare durable cure by 52 weeks after treatment initiation in each experimental treatment arm to the SOC arm.


 Kampala, Kampala
Wakiso, Wakiso
 Uganda 2024-12-23 12:34:14 2027-12-23 45 participants in each experimental treatment arm and at least 90 participants in the SOC arm. The JCRC site plans to recruit at least 50 participants Participants with Xpert MTB/RIF positive drug-susceptible pulmonary TB, living with and without HIV, aged ≥18 years. National Institute of Allergy and Infectious Diseases (NIAIDS) Medical and Health Sciences Clinical Trial Non-degree Award
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