Janet Nakigudde
ID: UNCST-2019-R000444
|
PROMOTING MENTAL HEALTH OF TEACHERS AND CAREGIVERS USING A PERSONALIZED MHEALTH TOOLKIT IN UGANDA
REFNo: HS4431ES
3. To examine feasibility of mWEL-T and mWEL-P with parents and teachers from urban and rural regions (including examining feasibility of the implementation procedures and intervention efficacy) (n=160, 80 parents and 80 teachers from urban and rural regions).,To conduct a user-centered testing study to optimize usability of the Teacher and Parent versions of mWEL- mWEL-T and mWEL-P,1. To build a school system capacity (by establishing a cross-discipline digital health leadership & learning collaborative (n=10) and training a group of peer-community health workers (P-CHW) (n=30; 15 peer teachers and 15 peer parents) to implement the mWEL that is developed,The aim of the study is to test mWEL a newly developed mobile app and user-engagement strategies for mental health management and promotion targeting teachers and parents,
|
Kampala, kibuli
Nakaseke, Nakaseke
|
Uganda |
2024-07-17 14:03:01 |
2027-07-17 |
For the proposal sample size N=160 for the full sample |
The study will enroll parent, teachers and caregivers of children.
We shall consider parents who are at least 18 years old, and have a child aged 6-14 years in the enrolled school |
This study is sponsor by the United States National Institute of Mental Health through a collaboration with New York University, Department of Population Health, New York School of Medicine and Makerere University College of Health Sciences, Department of Psychiatry |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Eugene Ruzagira
ID: UNCST-2023-R008282
|
Implementing oral (event-driven and daily) and long-acting Pre-exposure
prophylaxis (PrEP) in mobile men in Sub-Saharan Africa: a phase 3b, open-label, hybrid type 2 implementation and effectiveness trial (MOBILE MEN)
REFNo: HS4366ES
Overall Objective
To assess effectiveness and implementation of long-acting cabotegravir (CAB-LA) and oral Truvada (both daily and event driven) through comparison of uptake, retention in care, coital coverage, and participant choice.
|
Masaka, Masaka
|
Uganda |
2024-07-02 15:08:06 |
2027-07-02 |
400 mobile men. |
HIV negative men aged 18+ years in South
Africa and Uganda. Men who are mobile for work, and in the past 6-months have travelled for work or to find work and spent at least one night away from home for work-related purposes. Men male at birth, able and willing to provide informed consent and willing to have an HIV test. |
MRC/UVRI &LSHTM Uganda Research Unit |
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 |
|
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 |
.jpg)
|
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 |
|
| View |
|
Sort By: |
|
|
|
| |
|
