Abel Kakuru
ID: UNCST-2022-R009193
|
Dihydroartemisinin-piperaquine plus sulfadoxine-pyrimethamine versus sulfadoxine-pyrimethamine alone for the prevention of febrile illnesses in children with sickle cell anemia: a double-blind randomized controlled trial
REFNo: HS6294ES
1.
To compare the incidence of all-cause febrile illness among children with sickle cell anemia randomized to receive monthly SP vs. monthly DP+SP.
2.
To compare the incidence of adverse events among children with sickle cell anemia randomised to receive monthly SP vs. monthly DP+SP.
3.
To compare the prevalence of markers of antimalarial resistance, including those associated with SP and DP resistance, among parasitemic children with sickle cell anemia randomized to receive monthly SP vs. monthly DP+SP.
|
Busia, Selected parishes
|
Uganda |
2025-10-29 15:55:44 |
2028-10-29 |
232 children with sickle cell anemia |
Aged 2-10 years children with sickle cell anemia |
Thrasher Research Fund |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Susan Adakun
ID:
|
Comparing adherence to MDR-TB treatment among patients on self-administered therapy and those on Directly Observed Therapy: Non Inferiority Randomized Controlled Trial
REFNo: HS1796ES
Primary Objectives
1. To determine if adherence to MDR-TB treatment among patients on self-administered therapy (measured by Medication Events Monitoring System (MEMS) technology) is non-inferior to that among patients on Directly Observed Therapy (DOT)
Secondary objectives
1. To determine the correlation between serum MDR-TB drug concentrations and adherence as measured by MEMS technology
2. To compare treatment outcomes between MDR-TB patients on self-administered therapy and DOT
|
Kampala, Mulago
Lira,
Mbarara,
|
Uganda |
2021-10-20 |
2024-10-20 |
164 |
Age of study Population: 8 years and above
Gender of study population: Both male and female
Persons of any and all tribes are eligible for study participation as long as they fit the eligibility criteria |
Janssen Global Public Health, a division of Janssen Pharmaceutica NV, under grant number 1550786 |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Daniel Atwine
ID: UNCST-2019-R012948
|
SAFETY AND EFFICACY OF THE PHOTO-KABADA DEVICE AS COMPARED TO DEVICES IN ROUTINE USE IN ADMINISTERING PHOTOTHERAPY FOR BABIES WITH NEONATAL JAUNDICE: AN OPEN-LABEL, RANDOMIZED CONTROLLED CLINICAL TRIAL (MUST-2024-1404).
REFNo: HS5411ES
5) Secondary: To describe the experiences of health workers using the test (Photo-Kabada) and control PT devices and caretakers of children treated with these devices.,4) Secondary: To compare the other safety and efficacy outcomes when babies are treated with Photo-Kabada compared to available phototherapy devices on the neonatal unit of MRRH. ,3) Secondary: To compare the reduction in bilirubin levels per unit time when babies are treated with Photo-Kabada compared to available phototherapy devices on the neonatal unit of MRRH. ,2) Primary: To compare the efficacy of Photo-Kabada phototherapy machine with existing phototherapy machine at selected hospitals in treating neonates with jaundice.,1) Primary: To compare the safety of Photo-Kabada phototherapy machine with existing phototherapy machine at selected hospitals in treating neonates with jaundice.,
|
Mbarara, Nyamitanga
|
Uganda |
2025-07-10 11:09:52 |
2028-07-10 |
30 |
neonates less than 28 days old. Both male and female. |
Villgro Africa |
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 |
|
Agaba Katureebe Ishmael
ID: UNCST-2024-R004089
|
Getting a GRIP on Hypertension in Uganda: Giving Repetitive Isometric Exercise for Blood Pressure Control (GRIP in Uganda)
REFNo: HS4712ES
To assess knowledge, attitudes, and practices (KAP) about HTN and experience with IHT (if applicable) ,To measure HTN medication adherence for those prescribed HTN medication during their follow-up, which will be measured through pill counting (counting the remaining amount of pills for prescribed medication).,To assess the need for HTN medication at endline, as per clinical and MOH guidelines, which will be measured through changes in BP levels at week 12,To evaluate the effects of Isometric Hand Training (IHT) on resting diastolic Blood Pressure when compared to standard care after 12 weeks ,To evaluate the effects of Isometric Hand Training (IHT) on resting Systolic Blood Pressure when compared to standard care after 12 weeks ,To determine the efficacy of Isometric Hand Training (IHT) in a population of Hypertension (HTN) patients compared to standard care after 12 weeks of care,
|
Jinja, Ivunamba
|
Uganda |
2024-08-22 11:38:26 |
2027-08-22 |
250 adult participants |
We intend to enroll 250 adult participants men and women aged 18 years and above. Participants will be persons who seek care at the Soft Power Mukagwa Allan Stone community clinic in Kyabirwa jinja. These come from Jinja and the neighboring districts of Iganga, Luuka, Kamuli and Mayuge in East Central sub-region. The area is predominantly inhabited by Basoga and then minority Baganda, Bagisu, Banyole etc.
Eligibility criteria
Inclusion criteria are: 1) diagnosis of stage 1 HTN (BP >140-159/90-99 mmHg ), which is based on the clinic and MOH definitions , 2) not currently taking HTN medication, 3) not having been on HTN medication in the past 3 months, and 4) age > 18 years and older.
Exclusion criteria are: 1) diagnosis of stage 1 HTN and currently taking HTN medication, 2) diagnosis of stage 2 HTN, 3) diabetes, 4) history of recent myocardial infarction (in the past year), 5) congestive heart failure, 6) complete heart block, 7) unstable angina, 8) Glomerular Filtration rate of 90 or lower, 9) any pregnancy associated HTN, 10) any limitation (e.g., limited hand mobility) preventing proper performance of IHT exercise, and 11) any other condition that alters autonomic nervous system function.
|
Canadian Institutes of Health Research (CIHR) |
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 |
|
Adeodata Rukyalekere Kekitiinwa
ID: UNCST-2019-R000799
|
BREATHER Plus: A randomized open-label 2-arm, 96-week trial evaluating the efficacy, safety and acceptability of short cycle (five days on, two days off) dolutegravir/tenofovir-based triple antiretroviral therapy (ART) compared to daily dolutegravir/tenofovir- based triple ART in virologically suppressed HIV-infected adolescents aged 12 to 19 years of age in sub-Saharan Africa, Version 2.0, Dated 18-Mar-2020; ISRCTN #: 85058577
REFNo: HS1822ES
Major Objective: A randomized open-label 2-arm, 96-week trial evaluating the efficacy, safety and acceptability of short cycle (five days on, two days off) dolutegravir/tenofovir-based triple antiretroviral therapy (ART) compared to daily dolutegravir/tenofovir-based triple ART in virologically suppressed HIV-infected adolescents aged 12 to 19 years of age in sub- Saharan Africa
Specific Objectives
To evaluate an innovative and contemporary ART strategy in HIV-infected adolescents to provide choice for young people facing life-long treatment. Output from this RCT will provide evidence on efficacy, safety and acceptability of a novel treatment approach in HIV-infected adolescents in sub-Saharan Africa
To evaluate the virological efficacy, safety, acceptability and Quality of Life of DTG-based Short-cycle Therapy with weekends off compared with Continuous Therapy with a DTG- based ART regimen
To optimize treatment for HIV-infected adolescents in sub-Saharan Africa
|
Kampala, Mulago
Wakiso, Seguku
|
Uganda |
2021-11-15 |
2024-11-15 |
460 |
HIV-infected, non-pregnant, non-breastfeeding adolescents aged 12 to 19 years of age, virologically-suppressed for at least one year, without any history of treatment failure, on 3-drug combination antiretroviral (ART) consisting of dolutegravir with a 2- |
University College London (UCL), UK and funded by the European and Developing Countries Clinical Trials Partnership [RIA2017MC- 2005] |
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 |
|
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 |
|
Afiz Kibuuka Kibuuka
ID: UNCST-2021-R012755
|
A phase III, Multicenter, Randomized, Placebo Controlled, Double blind Study to Assess Efficacy and Safety of Crizanlizumab (5 mg/kg) versus placebo, with or without Hydroxyurea/Hydroxycarbamide Therapy, in Adolescent and Adult Sickle Cell Disease Patients with Frequent Vaso-Occlusive Crises
REFNo: HS5365ES
To compare the efficacy of 5 mg/kg of crizanlizumab versus placebo, with or without hydroxyurea/hydroxycarbamide, on the annualized rate of VOCs* that are healthcare professional (HCP)-managed (including VOCs leading to management at a health care facility or those managed via remote consultation) over the planned 52-week treatment period in SCD patients aged 12 years and older with a history of frequent VOCs (4-12 events in 12 months prior to the screening visit).
To compare the efficacy of 5 mg/kg of crizanlizumab versus placebo, with or without hydroxyurea/hydroxycarbamide, on the annualized rate of all VOCs including VOCs that are HCP-managed (including VOCs leading to management at a health care facility or those managed via remote consultation) and VOCs that are self-managed without recommendations from HCP during the event over the planned 52 week treatment period in SCD patients aged 12 years and older with a history of frequent VOCs (4-12 events in the 12 months prior to the Screeening visit
To evaluate the annualized rate of VOCs by type of management between treatment arms over the planned 52-week treatment period: • VOCs that are HCP-managed at a health care facility • VOCs that are HCP-managed via remote consultation • VOCs that are self-managed without recommendations from HCP during the event • VOCs that are HCP-managed via remote consultation or self-managed without recommendations from HCP during the event
To evaluate the time to first VOC that is HCP managed (including VOCs leading to management at a health care facility or those managed via remote consultation) between treatment arms over the planned 52-week treatment period.
To evaluate the proportion of participants free from VOCs that are HCP-managed (including VOCs leading to management at a health care facility or those managed via remote consultation) between treatment arms over the planned 52-week treatment period.
|
Eastern Region, All parishes
|
Uganda |
2024-12-23 11:34:49 |
2027-12-23 |
315 |
Participants must be aged 12 years and older on the day of signing informed consent.
Adolescents include participants aged 12 to <18 years old and adults include participants
aged 18 years and older. |
Novartis |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
alfred bulamu
ID: UNCST-2023-R008638
|
Uganda Translational Breast Cancer Screening Research Center with Innovations in MRI and Genetic Testing.
REFNo: HS4689ES
Implementation of breast MRI with genetic testing as BC screening method for women at high risk of BC by July 2029 (Phase 6) , Continuous Trainings for radiologists, radiographers and laboratory staffs on the modern technologies of MRI and Genetic testing (phase 3 to phase 6) ,Evaluating the feasibility of screening BC using MRI and genetic testing for high risk women by December 2028 (phase 5),Large scale education of the community about BC by July 2028 (phase 3 and phase 4).,Large scale determination of the utility of genetic testing as a screening modality for BC in Uganda by perform mutational genetic analysis for women at high-risk aged19 years to 80 years by July 2028 (phase 3 and phase 4) , Large scale determination of the utility of quantitative breast MRI for screening women at high risk BC aged 19 years to 80 years by July 2028 (phase 3 and phase 4) ,Training of the users on equipment i.e. Radiologists, Radiographers and laboratory staffs by 2025 (phase 2) ,Securing and installation of lab equipment for genetic testing by 2025 (Phase 2,Securing and installation of MRI with Breast coils by July 2025 (Phase 2),To build capacity for 20 laboratory health care workers in genetic testing technologies by December 2023 (phase 1).,To build capacity for 30 radiology health professionals in modern breast Imaging with MRI by December 2023 (Phase 1),To determine the utility of quantitative breast MRI for screening women at high risk breast cancer aged 19 years to 80 years by July 2024 (phase 1),To determine the utility of genetic testing as a screening modality for BC in Uganda by perform mutational genetic analysis for women at high-risk of BC aged 19 years to 80 years, by July 2024 (phase1),To build a long-lasting infrastructure for research, clinical screening in Uganda and training using modern technologies. ,To offer improved access to Breast Cancer screening in Uganda through quantitative MRI and genetic testing research center,
|
All Districts, All parishes
|
Uganda |
2024-08-06 17:27:31 |
2027-08-06 |
100 participants |
All women at the risk of breast Cancer between the Ge of 19 year to 80years of all the tribes in the different regions |
Kiphart Foundation |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
alice namatovu
ID: UNCST-2025-R017415
|
EVALUATION OF THE EFFECTIVENESS OF BACTERIOPHAGE COCKTAILS AGAINST MULTI-DRUG-RESISTANT BACTERIA ON PATIENTS WITH DIABETIC FOOT ULCERS ATTENDING SELECTED REFERRAL HOSPITALS IN UGANDA
REFNo: HS5652ES
Main objective:
To assess the efficacy of bacteriophages in the management of diabetic foot wounds/ulcers in animal models and among patients attending the selected referral hospitals in Uganda.
Specific Objectives
i) To determine the biological and genotypic characteristics of lytic bacteriophages against the MDR- bacteria isolated from diabetic wounds of patients.
ii) To determine the virulence genes of the bacteria isolated from DFU patients and those genes associated with antimicrobial resistance.
iii) Determine the phage receptor genes on the MDR bacteria isolated from DFU patients.
iv). To evaluate the effectiveness of the identified Bacteriophage preparation/cocktail in the healing of induced diabetic wounds in mice.
v). To evaluate the effectiveness of the identified bacteriophage preparation/cocktail in the healing of diabetic foot wounds on patients in selected referral hospitals in Uganda.
|
Kampala, Namirembe
Kampala, Nsambya
|
Uganda |
2025-09-12 16:14:57 |
2028-09-12 |
138 human participants |
The study will be conducted on patients attending the selected regional referral hospitals in Uganda diagnosed with diabetes including those having diabetic foot ulcer/wounds that are not responding to antibiotic therapy, those with diabetes and not having diabetic foot and those without diabetes but having chronic wounds.
Inclusion and exclusion criteria: All Patients of 18 years and above, male or female diagnosed with diabetes and willing to participate in the study will be included. Diabetic type will be determined clinically based on the diabetes control strategy used. Those depending on insulin for diabetes control since the time of diagnosis will be classified as having T1DM while those who had been controlled on oral anti-diabetic drugs with or without insulin will be categories as T2DM. One hundred and thirty-eight patients expected to participate in the study as cases are expected to have non traumatic DFU while the control group will include diabetic patients without DFU and non-diabetic patients with chronic foot wounds. The different groups will be matched for age and gender. The exclusion criteria will include pregnant women, patients with other diabetes other than types 1 and 2, and those with wounds limited to above the ankle joints.
|
Makerere Research and innovation Fund by the Ugandan Government |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Bonny Aloka
ID: UNCST-2022-R010624
|
Development and Evaluation of Nutrient-Dense Composite from Local Food Materials to Manage Moderate Acute Malnutrition (MAM) and Nodding Syndrome in northern Uganda
REFNo: A234ES
3. To investigate the stakeholder perception regarding the nutrient dense composites developed to manage MAM and NS in Acholi and Lango sub-regions,To evaluate the efficacy of the recipes in improving the conditions of clients with MAM and nodding syndrome in Acholi and Lango sub-regions,To test the level of acceptability of the developed composites by the selected mothers/care takers and their children in Acholi and Lango sub-regions,To develop a nutrient dense composites from local food materials to manage MAM and nodding syndrome in Lango and Acholi sub-regions,To develop a nutrient dense composite from local food materials to manage moderate acute malnutrition (MAM) and nodding syndrome in Lango and Acholi sub-regions in northern Uganda.,
|
Lira, Ayami Parish
Alebtong, Ayami Parish
Kole, Akwirididi Parish
Oyam, Atura Parish
Gulu, Pawel Parish
Nwoya, Kalatocon Parish
Pader, Kalawinya Parish
Kitgum, Pajimu Parish
|
Uganda |
2022-11-28 11:12:34 |
2025-11-28 |
387 |
The study population will be children between 6-23 months (MAM), Children aged 3-28 years (nodding syndrome) and adults aged 18-80 years of age (sensory evaluation). |
European Union |
Agricultural Sciences |
Clinical Trial |
Non-degree Award |
|
Andrew Mujugira
ID: UNCST-2019-R000871
|
CHOICE-BASED PrEP DELIVERY FOR TRANSGENDER PEOPLE IN UGANDA
REFNo: HS2316ES
Aim 1: Identify PRECEDE factors that influence PrEP implementation for transgender people in Uganda.
Guided by the PRECEDE-PROCEED model, which is widely used for public health interventions, we will analyze previously collected qualitative data from four TGP studies and also conduct two new focus groups with TGP and providers to identify predisposing, reinforcing, and enabling factors that may impact implementation of choice-based PrEP. A stakeholder workshop anchored in good participatory practice will discuss results of the qualitative research and guide design of the optimal choice-based PrEP delivery model for Aim 2.
Aim 2: Offer PrEP choice to transgender people in a DSD model and evaluate implementation and effect on PrEP use (PROCEED).
We will offer choice of CAB-LA or oral PrEP, and choice of facility or community delivery (with option to switch), to 300 HIV-negative TGP with follow-up for 24 months. Adverse events, product switching, and trajectories of choice over time will be monitored and documented. Persistence on CAB LA and oral PrEP will be compared during the choice period, and with a historical cohort without PrEP choice (ClinicalTrials.gov, NCT04491422). Primary outcomes are choice of PrEP option & delivery model, adherence, and persistence.
Aim 3: Use mixed methods to evaluate how choice influences PrEP use among TGP (PROCEED).
Inductive and deductive analyses based on in-depth interviews with purposively sampled PrEP users (n=50) and providers (n=10) will be used to explain “how” and “why” choice did or did not work and interpret implementation data from Aim 2. Choice preferences will be assessed via structured questionnaires.
Aim 4: Estimate cost implications associated with integrating CAB LA into HIV programs.
We will conduct health system versus client cost analyses to inform budgeting. Costs incurred and averted will be estimated using activity-based micro-costing, study budget, and the literature. Costs and modeled outcomes will be combined to estimate budget impact with PrEP persistence at 6 and 12 months.
|
Wakiso, Kasangati
|
Uganda |
2022-06-28 16:44:09 |
2025-06-28 |
420 |
Population: Trans women and men (up to 300 participants)
Eligibility Eligible TGP must be aged ≥18, weigh ≥35kg, be interested in taking PrEP, at high risk for sexually acquiring HIV (i.e., any self-report of condomless sex, multiple partners, stimulant drug use or STIs) in the prior six months, and eligible for PrEP in accordance with Uganda National PrEP Guidelines
|
United States National Institute of Mental Health (R01 MH130208) |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
ANGELLA MUSIIMENTA
ID: UNCST-2021-R013297
|
My Mobile Wallet: An Intervention to Support Access to Tuberculosis Care and medication Adherence in Rural Uganda
REFNo: HS1688ES
Assess the refined My Mobile Wallet intervention for larger scale feasibility, acceptability, and impact on TB treatment adherence and clinical outcomes. We will randomize 162 newly diagnosed TB patients (1:1:1) to SMS texts + incentives Arm A, SMS texts only B, and control Arm C (standard clinic-based TB care); follow-up will be the 6 month-treatment period. Feasibility and acceptability will be assessed per above. Impact will be based on electronically monitored medication adherence (primary), as well as treatment completion, clinic attendance, cure, and mortality (secondary).,Refine the My Mobile Wallet intervention. We will adapt the intervention to address any feasibility and accessibility issues raised in R21 findings. We will then pilot test the refined version of the intervention in 10 TB patients over two months of treatment to ensure optimal functionality. ,Assess the initial feasibility and acceptability of My Mobile Wallet. Forty patients with newly diagnosed TB will use My Mobile Wallet over their 6-month course of treatment. Feasibility will be assessed by appropriate receipt of the cash transfers and SMS texts, and intervention functionality. Acceptability will be assessed using System Usability Scale [53] and interviews based on the Unified Theory of Acceptance and Use of Technology [54].,Determine the optimal design and develop My Mobile Wallet as an intervention to support TB medication adherence. Through client-centered approaches, we will iteratively conduct focus group discussions with up to 30 TB patients to develop an optimal My Mobile Wallet intervention.,
|
Mbarara, Kamukuzi
Mbarara,
|
Uganda |
2021-11-19 |
2024-11-19 |
242 |
TB patients (18 and above years old) living not beyond 60 Kilometers from MRRH who are willing to participate in the study |
US National Institute of Health (Eunice Kennedy Shriver National Institute Of Child Health & Human Development of the National Institutes of Health) |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Annet Nanvubya
ID: UNCST-2025-R015525
|
Randomized, Efficacy Study of COVID-19 mRNA Vaccine in Regions with SARS-CoV-2 Variants of Concern version 1.0 16-05-2021.
REFNo: HS1677ES
Primary Objectives
The primary objectives of this study are to determine the following:
• To assess vaccine efficacy (VE) of COVID-19 mRNA vaccine to prevent virologically-confirmed symptomatic COVID-19 starting 14 days after dose 2 in adults who are at risk of severe COVID-19
• To assess vaccine efficacy (VE) of COVID-19 mRNA vaccine to prevent severe COVID-19 starting 14 days after dose 2 in adults who are at risk for severe COVID-19
• To assess safety and tolerability of COVID-19 mRNA vaccine in adults who are at risk of severe COVID-19
Secondary Objectives
The secondary objectives of this study are to evaluate the following:
• Durability of VE of COVID-19 mRNA vaccine against COVID-19 and against severe COVID-19 through the final study visit (Month 12 post-dose 1) in volunteers with no previous COVID-19
• VE of COVID-19 mRNA vaccine against COVID-19 and against severe COVID-19 by neutralization phenotype and Spike sequence features of acquired SARS-CoV-2 viruses (sieve analysis), including VE against the B.1.351/501Y.V2 variant and VE against all other variants combined in volunteers with no previous COVID-19
• VE of COVID-19 mRNA vaccine against SARS-CoV-2 infection defined by nucleocapsid protein seroconversion regardless of symptomology in volunteers with no previous COVID-19
• VE of COVID-19 mRNA vaccine against asymptomatic SARS-CoV-2 infection defined by nucleocapsid protein seroconversion without prior occurrence of the symptomatic COVID-19 primary endpoint in volunteers with no previous COVID-19
• Post -vaccination immune response markers as correlates of risk of COVID-19 and as correlates protection against COVID-19
• VE of COVID-19 mRNA vaccine against COVID-19 and severe COVID-19 in all participants regardless of baseline SARS-CoV-2 status
gestational age)
Exploratory Objectives
The exploratory objectives of this study are to:
• VE of COVID-19 mRNA vaccine against COVID-19 and severe COVID-19 by baseline HIV infection status in volunteers with no previous COVID-19 and in all volunteers regardless of previous COVID-19 status
• VE of COVID-19 mRNA vaccine against COVID-19 and against severe COVID-19 by neutralization phenotype and Spike sequence features of acquired SARS-CoV-2 viruses (sieve analysis), including VE against the B.1.351/501Y.V2 variant and VE against all other variants combined in volunteers with no previous COVID-19 and in all volunteers regardless previous COVID-19 status
• VE of COVID-19 mRNA vaccine against COVID-19 and severe COVID-19 in volunteers with previous COVID-19
• Relative rate of COVID-19 and severe COVID-19 in placebo recipients with previous COVID-19 compared to vaccine recipients with no previous COVID-19
• Assess T-cell responses in placebo recipients who develop COVID-19 compared to vaccine recipients who develop symptomatic COVID-19
• Assess incidence of adverse birth outcomes among pregnant persons enrolled in the trial
|
Wakiso, Division A and B
|
Uganda |
2021-08-20 |
2024-08-20 |
14,000 |
This study will enroll participants who meet one or more of the following criteria:
1) Age > 40, who have at least one comorbidity known to be associated with severe COVID-19,
2) women age 18 years or older who are pregnant, and
3) HIV-1-infected indiv |
South African Medical Research Council(SAMRC) Cape Town, South Africa |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Aisha Nanyiti
ID: UNCST-2021-R013489
|
A Randomized Control Trial (RCT) on the Adoption of Liquefied Petroleum Gas (LPG) Cooking Technology among Fast Food (Chapati) Vendors in Uganda
REFNo: SS1017ES
This study seeks to establish the impact of hire purchase schemes and health and safety information on adoption of LPG cookstoves by chapati vendors.
This study will achieve the following specific objectives:
1) The impact of learning from LPG use in grace period before purchase armotisation on adoption of LPG cookstoves by chapati vendors for their businesses and households.
2) The impact of hire purchase on adoption of LPG cookstoves by chapati vendors for their businesses and households.
3) The impact of information on safety and health benefits of LPG on adoption of LPG cookstoves by chapati vendors for their businesses and households.
4) The impact of peer learning from other vendors using LPG cookstoves on adoption of LPG cookstoves by chapati vendors for their businesses and households.
|
Kampala,
|
Uganda |
2022-02-10 |
2025-02-10 |
210 |
chapatti vendors; they are mainly males of age range in 18-45 years from all districts of Uganda. |
Environment for Development Initiative |
Social Science and Humanities |
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 |
|
Angelina Kakooza-Mwesige
ID: UNCST-2020-R014529
|
Epilepsy in Uganda: Clinical characterization and co-morbidities, their relation to stigma among adolescents and impact of a community-based engagement program. (AWE Change project)
REF: TASO-2022-102
REFNo: HS2421ES
1.TO CLINICALLY CHARACTERIZE EPILEPSY AND ITS IMPACTS AMONG CHILDREN AND ADULT CASES IN UGANDA.
2.DESCRIBE THE MAGNITUDE, DRIVERS, AND IMPACT OF EPILEPSY-RELATED STIGMA ON ADOLESCENTS IN UGANDA.
3.TO CO-CREATE AND EVALUATE THE IMPACT OF A COMMUNITY-BASED ENGAGEMENT PROGRAM TO REDUCE STIGMA ON EPILEPSY AMONG ADOLESCENTS IN UGANDA.
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Central Region,
Eastern Region,
Northern Region,
Western Region,
Butambala,
Bukomansimbi,
Buikwe,
Buvuma,
Gomba,
Kalangala,
Kayunga,
Kampala,
Kyankwanzi,
Kyotera,
Kalungu,
Luweero,
Lwengo,
Masaka,
Mpigi,
Mityana,
Mubende,
Mukono,
Nakasongola,
Nakaseke,
Rakai,
Sembabule,
Lyantonde,
Wakiso,
Amuria,
Bududa,
Bugiri,
Bukedea,
Bududa,
Bududa,
Bulambuli,
Busia,
Butaleja,
Bukwa,
Buyende,
Iganga,
Jinja,
Kaberamaido,
Kaliro,
Katakwi,
Kamuli,
Kibuku,
Kumi,
Luuka,
Manafwa,
Mayuge,
Mbale,
Namayingo,
Namutumba,
Ngora,
Pallisa,
Serere,
Sironko,
Soroti,
Tororo,
Abim,
Adjumani,
Agago,
Amuru,
Apac,
Arua,
Dokolo,
Kaabong,
Kitgum,
Koboko,
Kole,
Kotido,
Lamwo,
Lira,
Maracha,
Moroto,
Moyo,
Nebbi,
Nwoya,
Otuke,
Oyam,
Pader,
Yumbe,
Zombo,
Buhweju,
Buliisa,
Bundibugyo,
Hoima,
Ibanda,
Isingiro,
Kabale,
Kabarole,
Kamwenge,
Kanungu,
Kasese,
Kibaale,
Kiruhura,
Kiryandongo,
Kisoro,
Kyegegwa,
Kyenjojo,
Masindi,
Mbarara,
Mitooma,
Ntungamo,
Rubirizi,
Rukungiri,
Sheema,
|
Uganda |
2022-10-25 14:54:28 |
2025-10-25 |
490 |
All ages across the life span, of every gender and tribe |
National Institutes of Health |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Angelina Kakooza-Mwesige
ID: UNCST-2020-R014529
|
EVALUATION OF THE IMPACT OF THE THREE TIER INTERVENTIONS FOR DISABILITY IN EARLY CHILDHOOD (IDEC) PROGRAMME
IN UGANDA
REFNo: HS5596ES
GENERAL OBJECTIVE
The overall aim of this study is to evaluate the impact of the three-tier IDEC model piloted in the two districts of Mubende and Kassanda in Uganda, with a twofold purpose: (1) to improve intervention design and management and (2) to inform decisions about future investment and scale-up by establishing evidence and impact.
SPECIFIC OBJECTIVES.
Primary objectives
1. To determine the coverage of vision screening at 0-3 months and developmental screening at 9 and 18 months in the study sites.
2. To determine the change in functional abilities in children receiving the Tier 2 intervention.
3. To evaluate effects of the individualised (Tier 3) program at regular intervals (at least every 3 months) on child and family functioning, well-being and participation.
Secondary objectives
1. To determine the change in knowledge and skills in parental/caretaker after the Tier 2 interventions.
2. To determine the change in parental/caretaker level of stress after Tier 2 interventions.
3. To determine the change in parental/caretaker level of stress after Tier 3 interventions.
4. To establish the extent to which children with developmental delay and disability Tier 1 are included in ECD programmes
5. To establish the extent to which children with developmental delay and disability tier 2 are included in ECD programmes. (This could be a compliance or fidelity issue
6. To determine how well (fidelity) the health workers provided the Tier 2 and 3 interventions.
7. To determine compliance with Tier 2 and Tier 3 interventions by the caregivers.
8. To determine family satisfaction with all three tiers of the program, including both children that failed and children who passed the screening assessment (Tier I).
9. To determine the costs and cost-effectiveness of the entire program.
10. To assess the likelihood of continuation
|
Mubende, Kiyuni
Mubende, Kiyuni
|
Uganda |
2025-03-04 13:40:10 |
2028-03-04 |
296 |
Children aged 0-3 months, Children aged 6-36 months,Children with developmental delay, at risk of Celebral Palsy and Austism |
UNICEF |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
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