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  
Nanyonga Elizabeth Monica
ID: UNCST-2025-R018232
 srd
REFNo: SIR516ES

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 Uganda 2025-05-27 9:30:38 2028-05-27 AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA Engineering and Technology Clinical Trial Non-degree Award
Fred  Bulamba
ID: UNCST-2020-R014888
 Rule of THUMB: A multi-centre cluster trial evaluating the implementation of a perioperative care complex intervention to improve outcomes from haemorrhage during and after caesarean section in African hospitals
REFNo: HS5855ES

To evaluate the effect of the trial intervention on patient outcomes relevant to future trials.,To evaluate whether implementation of the ‘Rule of THUMB’ perioperative complex intervention increases risk assessment and improves diagnosis and compliance with proven interventions for haemorrhage during and after caesarean section.,
 Mbale, Hospital Cell
Uganda 2025-05-14 9:24:07 2028-05-14 600 Any patient who requires a caesarean section Department of Anaesthesia and Perioperative Medicine Medical and Health Sciences Clinical Trial Non-degree Award
Mohamed Farah Mohamud
ID: UNCST-2025-R016841
 EFFECTIVENESS OF INTRAVENOUS PETHIDINE VERSUS INTRAVENOUS TRAMADOL FOR PERIOPERATIVE ANALGESIA IN UTERINE EVACUATION PROCEDURES AT JINJA REGIONAL REFERRAL HOSPITAL
REFNo: HS5960ES

1. To assess the effectiveness of intravenous pethidine versus intravenous tramadol for perioperative analgesia in uterine evacuation procedure at Jinja Regional Referral Hospital
2. To compare the secondary outcomes encountered among women administered with intravenous pethidine versus those with Intravenous Tramadol for perioperative analgesia in uterine evacuation procedures at Jinja Regional Referral Hospital
3. To compare the level of patient satisfaction with intravenous pethidine versus Intravenous tramadol in uterine evacuation procedures at Jinja Regional Referral Hospital

 Jinja, rippon
 Somalia 2025-04-30 7:27:21 2028-04-30 170 t All adult women with an indication for uterine evacuation admitted on gynecology ward of Jinja Regional Referral Hospital selfsponser Medical and Health Sciences Clinical Trial Degree Award
Flavia Matovu Kiweewa
ID: UNCST-2021-R013337
 An Open-label, Single-arm Study to Provide Continued Access to Study Drug to Participants Who Have Completed Pediatric Clinical Studies Involving Gilead HIV Treatments.
REFNo: HS5804ES

The primary objective of this trial is to provide continued access to the study medication received in the parent protocol or switch to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF; coformulated; Biktarvy®) for participants who completed a Gilead parent study evaluating medications for HIV treatment.
Kampala, kampala
 Uganda 2025-04-11 16:20:58 2028-04-11 This study is not formally powered. The purpose of this study is to provide continued access to the study medication received in the parent study or to provide B/F/TAF to applicable participants who have completed a relevant parent study. Therefore, all participants who are on parent study medication and have completed a Gilead parent study evaluating medications for HIV treatment may be enrolled in this study dependent on eligibility. Participants who have completed a parent study and meet all eligibility criteria will be offered the opportunity to roll over to this study and receive the same regimen as in the parent study. Participants will also be allowed to switch to B/F/TAF when they enroll in this study if they meet the additional eligibility criteria. Gilead sciences Inc Medical and Health Sciences Clinical Trial Non-degree Award
Janet Nakigudde
ID: UNCST-2019-R000444
 TESTING MULTI-LEVEL SCALE-UP STRATEGIES TO IMPLEMENT A SCHOOL-BASED POPULATION APPROACH OF MENTAL HEALTH PREVENTIVE INTERVENTION: UGANDA
REFNo: HS5647ES

General Objective
The overall goal of this study is to address vertical and horizontal scale-up implementation framework gaps in Uganda. This study will test new recommended vertical scale-up and sustainability implementation strategies and study impact and underlying mechanisms when the new scale-up model is applied.
This research will guide the development of evidence-informed theoretical frameworks and processes to effectively institutionalize EBIs in LMICs such as Uganda. To achieve this goal, we will carry out 4 sequential steps (4 aims).
Specific Objectives
1.
To establish a cross-level partnership and strengthen stakeholders/leaders’ advocacy capacity to make evidence-based informed children’s mental health policy and practice decisions and to facilitate the EBI institutionalization through the educations system illustrated in figure 1.
2.
To develop implementation Protocols in collaboration with cross level partners (established in Aim 1) based on a new multilevel train-the-trainer scale-up framework to support the EBI/PD scale-up.
10
3.
Implement the new Protocols for scale-up and test the relative value of additional implementation supports intended to sustain teacher EBI practices through a Hybrid III cRCT.
4.
To explore underlying scale-up and sustainability implementation mechanisms.
 Arua, Lodonga, Arua Hill
Mityana, Busubizi, Kyanja
Gomba, Kabulasoke, Nakato
Masaka, Ndegeya, Kyanamukaka
Buikwe, Nkokonjeru, Kasenge
Kabale, Bukinda, Nyaruzinga
Bushenyi, Nyakabirizi
Sheema, Nyabubare
Western Region, Burahya
Iganga, Lwawu
Soroti, Kolojjo
Gulu, Awach
 Uganda 2025-04-11 16:03:54 2028-04-11 The study population and sample will consist of approximately 1,594 participants.46 Advocacy Leaders and Education System Leaders, including 10 from the Ministry of Education (MOE)/Ministry of Health (MOH), 12 from Teacher Training Colleges (TTCs), 12 from District Education Offices, and 12 head teachers (one from each school district/region). Additionally, 12 TTCs will be selected based on MOE prioritization and needs, with 96 tutors trained in Evidence-Based Intervention (EBI) implementation (8 per TTC). The study will also include 120 schools that are stratified and randomized, with approximately 1,200 teachers (10-15 per school) and 240 Peer Teacher Trainers (PTTs) selected and trained. The study population will consist of participants from diverse backgrounds. The age group of the participants will vary, with Advocacy Leaders and Education System Leaders typically being adults in their 30s and 40s, while teachers, tutors, and Peer Teacher Trainers (PTTs) will range from 20 to 50 years of age. The study will aim for gender balance, with an equal representation of male and female participants. Participants will be drawn from various ethnic groups across Uganda, including, but not limited to, Baganda, Basoga, Banyankole, Bakiga, and other tribal groups, ensuring inclusivity and representation from all regions of Uganda. The study will also reflect the diversity of the Ugandan educational system, capturing perspectives from urban and rural settings, as well as from different educational leadership and teaching roles. 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
FRED TWINOMUGISHA
ID: UNCST-2024-R003414
 THE ROLE OF INVOLVING PATIENTS IN PROMOTING HAND HYGIENE PRACTICES AMONG HEALTHCARE WORKERS IN MUKONO AND KAGADI DISTRICTS: A MIXED METHODS STUDY
REFNo: HS5449ES

1)To determine the level of knowledge and practice on hand hygiene among patients and health workers in selected healthcare facilities in Mukono and Kagadi districts, Uganda.
2)To explore the barriers and facilitators of involving patients in promoting hand hygiene practices among healthcare workers in selected healthcare facilities in Mukono and Kagadi districts, Uganda.
3)To explore the perceptions of healthcare workers on involving of patients in promoting hand hygiene practices in selected healthcare facilities in Mukono and Kagadi districts, Uganda.
4)To design and evaluate an intervention to improve hand hygiene among health workers.

Mukono, All
Kibaale, All
 Uganda 2025-04-11 14:30:15 2028-04-11 OBJECTIVE 1, 1292 This study will be conducted within the two districts of Mukono and Kagadi local governments. Study population: Patients admitted in Medical, Marternal and surgical wards aged 18 years and above. Tribes, all tribes both male and female. PROMISE CONSORTIUM PROJECT IN MAKERERE UNIVERSITY SCHOOL OF PUBLIC HEALTH Medical and Health Sciences Clinical Trial Degree Award
Ouma Simple
ID: UNCST-2021-R012820
 Harnessing Parental Social Networks to Increase HIV Testing Uptake Among Children of At-Risk Parents in Uganda: A Parallel-Group, Two-Arm Quasi-Experimental Implementation Science Protocol
REFNo: HS5741ES

Objectives:

Main Objective

To Adapt, implement and evaluate maternal SNS to improve access to HIV testing services among children of FSW.

Specific Objectives

1. To adapt SNS that harnesses maternal SN for HIV testing in children of female sex workers
2. To implement the adapted HASHTAG intervention targeting CARP in Gulu City
3. To evaluate the effectiveness and implementation science outcomes of the HASHTAG project
 Gulu, All Parishes
 Uganda 2025-04-11 14:13:08 2028-04-11 300 The target group for Intervention: We shall invite FSW with at least one child aged 0-17 years. For mothers to be categorized as FSW, each must have received money or goods in exchange for sexual services and consciously defined their activities as income-generating. In addition, we shall enrol active FSW who have been conducting sex work during the one year before setting up the cohort. Thus, maternal sex work status will be ascertained using three questions as follows: 1) Have you ever received money or goods in exchange for sexual services? 2) If yes, have you received money or goods in exchange for sexual services in the last year? 3) If yes, do you consider your receipt of money or goods for sexual services as income-generating? Mothers who answered "yes" to all three questions will be considered FSW. Conversely, mothers who answer "no" to either questions 2 or 3 will be considered non-FSW and be eligible to participate if they have been living in the same neighbourhood as the FSW in the past year before setting up the cohort (Attachment 1). We shall enrol only FSW who do not plan to move outside the greater Gulu in the one year following recruitment into the cohort. The comparator cohort: The comparative cohort will be matched 1:1 and will comprise non-sex working mothers matched on the neighbourhood, maternal age, child age, and child sex. The comparators must have lived in the same neighbourhood as FSW for at least the year before enrolment. Likewise, we shall enrol only non-FSWs who do not plan to move outside the greater Gulu in the one year following recruitment into the cohort. The children: Much as children of FSW are the direct target of the intervention, we shall not directly involve them as active participants in the cohort. Children of FSW will be randomly selected from both sexes and without stratification. Meanwhile, children of non-FSW will be matched to children on FSW in the neighbourhood, maternal age, child age, and child sex. IPHASA Medical and Health Sciences Clinical Trial Non-degree Award
Maxensia owor
ID: UNCST-2021-R014003
 An open-label randomised controlled trial comparing novel combination and currently used antibiotic regimens for the empiric treatment of neonatal sepsis with a run-in confirmatory pharmacokinetic phase: NeoSep1
REFNo: HS5639ES

In Part 2, a secondary objective is to provide a ranking of clinically relevant antibiotic regimens based on other efficacy and safety secondary outcomes, as well as on health economic measures and the potential selection of resistance. The trial data will provide data to inform the balance between efficacy, safety, costs (and cost-effectiveness and equity, using health economic analysis) and propensity for resistance selection (based on microbiology tests) that will influence facility-level and national decision-making about adoption of studied regimens, and potential future inclusion in WHO guidelines.,In Part 2, the primary objective is to provide a ranking of eight different clinically relevant antibiotic regimens for first-line empiric and second-line (after lack of response/deterioration) treatment in terms of 28-day mortality as the primary outcome measure. It will flexibly compare these multiple different relevant treatment regimens to enable the trial to be run in sites worldwide with very different background rates of different pathogens, of resistance and patterns of routine clinical care by randomising each participant to locally relevant antibiotic regimens agreed prior to site initiation. The trial will ensure generalisability by focusing inclusion based on clinical symptoms associated with high mortality risk in the NeoOBS study, which have been developed into a novel neonatal sepsis severity score – the NeoSep Severity Score.,
 Kampala, Kawempe
Kampala, Mulago
 Uganda 2025-04-02 9:04:16 2028-04-02 400 for the MU-JHU site.Approximately 3000 participants across all participating sites. Neonates≤28 days of age hospitalised with clinical signs of neonatal sepsis. Global Antibiotic Research & Development Partnership (GARDP) Medical and Health Sciences Clinical Trial Non-degree Award
Sylvia Kusemererwa
ID: UNCST-2019-R001717
 A phase III, multi-center, 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: HS5607ES

To assess the efficacy and safety of crizanlizumab (5 mg/kg) versus placebo, with or without
hydroxyurea (HU)/hydroxycarbamide (HC) , on VOC rate in Sickle Cell Disease (SCD) patients aged 12 years and older who experience frequent vaso-occlusive crises (VOCs)
Primary Objective
1. 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 HCP managed (including VOCs leading to management at a health care facility or those 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).
Secondary Objectives
1. 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 screening visit).
2. 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
Page 4 of 18
 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
 Masaka, Masaka
 Uganda 2025-04-02 8:58:47 2028-04-02 20 A total of 10-20 participants will be recruited at the MRC/UVRI and LSHTM Uganda Research Unit site. Recruitment will be competitive across sites and countries. Participants will be recruited through referrals from the sickle cell clinic at the Masaka Regional Referral Hospital. The clinic has a total of about 600 patients. The site will recruit participants according to the main study protocol using the inclusion and exclusion criteria stated. They will collect detailed locator information including addresses, telephone contact, and next of kin to facilitate phone and/or physical tracing during the follow-up phase of the study. LSHTM Medical and Health Sciences Clinical Trial Non-degree Award
Henry Mugerwa
ID: UNCST-2019-R000420
 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: HS5274ES

Primary Objective: 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 HCPmanaged (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).

Secondary Objective: Key secondary objective:

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 screening 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 HCPmanaged (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.

To evaluate the duration of 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.

To evaluate the safety and immunogenicity of crizanlizumab 5 mg/kg over the 2-year study
period.

To explore the efficacy of crizanlizumab 5 mg/kg over the 2-year study period.

To explore the proportion of VOCs that are selfmanaged without recommendations from HCP during the event, versus 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 treatment period of 52 weeks.

To explore the proportion of VOCs that are HCP-managed via remote consultation versus VOCs that are HCP-managed at a healthcare facility between treatment arms over the planned 52-week treatment period.

To explore the incidence rates of all VOCs,
VOCs that are HCP-managed at a healthcare
facility, VOCs that are HCP-managed via remote consultation, VOCs that are HCP-managed,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, by treatment arm.

To explore quality of life in each treatment arm (ASCQ-Me Short Forms: emotional impact, sleep impact, and joint stiffness).

To explore healthcare facility resource utilization (inpatient hospital admission, emergency room visit, urgent care/clinic visit, infusion center visit)between treatment arms over
the planned 52-week treatment period.

To explore the pharmacokinetics (PK) profile of crizanlizumab at 5 mg/kg.

To explore the pharmacodynamics (PD) (Pselectin inhibition) of crizanlizumab at 5 mg/kg.

To explore biomarkers [p-selectin (free and
total)] and CRP].

To explore exposure-response relationship.
 Wakiso, Lubowa
 Uganda 2025-04-02 8:43:56 2028-04-02 10-15 SCD participants aged 12 years and older who experienced at 4-12 VOCs that are HCP-managed (including VOCs leading to management at a health care facility or those managed via remote consultation) in the 12 months prior to screening visit. Participants who have been taking HU/HC for at least 6 months at a stable dose for at least 3 months and plan to continue taking at the same dose and schedule until the participant has reached 52 weeks of study treatment will be permitted. Participants who have not been receiving HU/HC, and/or erythropoietin stimulating agent must not have received it for at least 6 months prior to the screening visit. Novartis Medical and Health Sciences Clinical Trial Non-degree Award
Ronald Moses Galiwango
ID: UNCST-2024-R015239
 INTEGRATED FEMALE SEXUALLY TRANSMITTED INFECTION TESTING FOR HIV EPIDEMIC CONTROL THROUGH PREP (IN-STEP)
REFNo: HS5715ES

a) To conduct an individually randomized effectiveness implementation trial of SRST plus cSTI testing to increase PrEP use among African women at high HIV risk.
b) To perform a mixed-methods, implementation science evaluation of female cSTI testing for improving PrEP use for HIV prevention.
c) To determine the most efficient, population-level female cSTI testing strategies to reduce HIV incidence in African settings.

Rakai, All parishes in the mentioned subcounty
Kyotera, All parishes in the mentioned subcounty
Lyantonde, All parishes in the mentioned subcounty
 Uganda 2025-03-25 11:13:20 2028-03-25 5000 The targeted population is adolescent girls and women aged 15 - 39 years of age National Institute of Allergy and Infectious Diseases, R01AI177132 (Financial support); Abbott Laboratories (Material support) Medical and Health Sciences Clinical Trial Non-degree Award
Bruce Kirenga J
ID: UNCST-2019-R001460
 SURVEY, SAFETY AND EFFICACY OF HERBAL PRODUCTS USED FOR MALARIA PROPHYLAXIS AND TREATMENT IN UGANDA.
REFNo: HS5468ES

To conduct a survey of herbal medicinal products used for malaria prophylaxis and treatment, evaluate their safety and prophylactic efficacy among school-age children (8-15yrs) in Kibuku district, Uganda.
1. To identify herbal medicinal products used by communities for malaria prophylaxis and treatment in Uganda.
2. To evaluate the artemisinin content of herbal medicinal products used by communities for malaria prophylaxis and treatment in Uganda.
3. To determine the antiplasmodial activity (IC50) of herbal medicinal products used for malaria prophylaxis and treatment in Uganda.
4. To evaluate the safety of herbal medicinal products used for malaria prophylaxis among school age children (8-15 years) in Kibuku district in eastern Uganda.
5. To determine malaria incidence among school age children (8-15 years) receiving selected herbal medicinal products for malaria prophylaxis compared to monthly Dihydroartemisinin-Piperaquine (DP) in Kibuku district in eastern Uganda.
6. To determine prevalence of parasitaemia among school age children (8-15 years) receiving selected herbal medicinal products for malaria prophylaxis compared to monthly Dihydroartemisinin-Piperaquine (DP) in Kibuku in eastern Uganda.

 All Districts, NA
Kibuku,
Uganda 2025-03-14 19:08:33 2028-03-14 222 participants for the trial (111 per study arm) 8 to 15 years of age, both male and female, all tribes accessible. The Government of Uganda through the Science, Technology, and Innovation Secretariat - Office of the President (STI-OP) Medical and Health Sciences Clinical Trial Non-degree Award
Victor Musiime
ID: UNCST-2021-R013794
 A global phase 3, randomised, double-blind and placebo-controlled study evaluating the efficacy and safety of etavopivat in adolescents and adults with sickle cell disease
REFNo: HS5637ES

1. To demonstrate superiority of
treatment with etavopivat
versus placebo in adolescents
and adults with SCD.
2. To evaluate clinical efficacy
measures of etavopivat treatment
versus placebo in adolescents
and adults with SCD
3. To assess clinically meaningful
improvement in fatigue and
functional exercise capacity
and QOL measures of
adolescents and adults with
SCD taking etavopivat
treatment compared to placebo
 Wakiso, Sabagabo
Kampala, Mulago
Jinja, Jinja
 Uganda 2025-03-14 17:26:26 2028-03-14 408 12-17, 18 and above, male female all tribes Novo Nordisk A/S 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
Schola  Matovu Nakachwa
ID: UNCST-2022-R011040
 Development and Testing of BAJJAJJA: An Intervention to Promote Economic Empowerment and Health of Grandmothers who Provide Primary Care for Grandchildren in Uganda
REFNo: SS3611ES

Main Objective
The study’s objective is to refine and test the feasibility and acceptability of my innovative intervention, BAJJAJJA: Building A Joint Action for JaJJAs which couples an income- generating activity (IGA) with nurse-facilitated group health coaching. This objective is informed by the NIH Stage Model of behavioral intervention development.

Specific Objectives
Aim 1: To refine and adapt the BAJJAJJA intervention through a collaborative and iterative feedback process with a diverse community group of 18 members. In a series of sessions, I will iteratively engage diverse community groups (nurses, local officials, IGA experts, and GMCs) and use cognitive interviewing to gain feedback on the appropriateness of study measures, content, delivery, and intervention format.
Aim 2: To test the feasibility, acceptability, and preliminary efficacy of the BAJJAJJA intervention in improving economic and health outcomes among 24 Ugandan GMCs. Over a 12-month period and at three time points of assessment, I will use a mixed methodology with a quasi-experimental design to collect data that will be examined to assess the feasibility, acceptability, and preliminary efficacy of the intervention on participants’ household income and health outcomes.
Aim 3: To explore the barriers and facilitators to (3a) maintenance of the BAJJAJJA individual intervention benefits (e.g., physical activity level and frequency) and (3b) sustainability of the IGA activities (e.g., grandmothers’ accessing external supports such as community resources) at 6 months post-intervention. Following a mixed methods approach, the 24 GMCs from Aim 2 will be interviewed to further evaluate the long-term maintenance and sustainability of the intervention. Health assessments, interviews, and IGA site visits will be used to explore the intervention outcomes and benefits at 6 months post-intervention.

Buikwe, Kiteza
 USA 2025-03-10 12:23:29 2028-03-10 24 Grandmother Caregivers 1. Grandmothers: Ugandan GMCs who are (a) > 50 years (considering the average reproductive age range in Uganda of 15-49 years), (b) Luganda-speaking (commonly spoken language), (c) primary caregivers for at least one minor grandchild (< 18 years) for > 6 months, and (d) able to perform activities of daily living (e.g., cooking, bathing) without assistance. 2.Community Advisory Board: 10 key informants: Local elected community leaders ( LCs), healthcare professionals, nurses from local health centers and a village health team member, IGA experts, and grandmothers. Participants will be identified by LC leaders or referred by other participants using a snowball sampling technique. Participants are female (grandmother caregivers) with no tribal restrictions as long as she can speak luganda NIH JOHN E FORGATY International Center Social Science and Humanities Clinical Trial Non-degree Award
Pauline Byakika-Kibwika
ID: UNCST-2019-R001206
 Randomized trial to evaluate the efficacy and safety of select therapeutic agents in the treatment of Ebola Disease (TOKOMEZA - Ebola Disease Therapeutics)
REFNo: HS5686ES

This is an open-label, adaptive, randomised platform clinical trial to evaluate the impact of 278 potential treatments on mortality in patients with Ebola Disease
 All Districts, Not specific
 Uganda 2025-03-07 18:39:19 2028-03-07 180 All age groups, sex, and tribes that are eligible for recruitment. Ministry of Health of Uganda and World Health Organization Medical and Health Sciences Clinical Trial Non-degree Award
Nixon Niyonzima
ID: UNCST-2020-R014577
 A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY AND SAFETY OF INAVOLISIB IN COMBINATION WITH PHESGO→ VERSUS PLACEBO IN COMBINATION WITH PHESGO→ AS MAINTENANCE THERAPY AFTER FIRST LINE INDUCTION THERAPY IN PARTICIPANTS WITH PIK3CA‑MUTATED HER2‑POSITIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER (INAVO122)
REFNo: HS5649ES

This study will enrol particpants
Kampala, Mulago
Uganda 2025-03-07 18:26:49 2028-03-07 20 Adult females above 18 years of age with breast cancer F.Hoffman La Roche 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
ISMAHIL ADENIYI ADEKUNLE
ID: UNCST-2024-R002602
 EFFECTS OF ETHYL-ACETATE FRACTION OF Bidens pilosa LEAVES ON TESTES AND PITUITARY GLAND OF MALE MICE EXPOSED TO BISPHENOL A
REFNo: HS5372ES

The purpose of this study is to evaluate the impact of B. pilosa on testicular integrity and the pituitary gland of male mice exposed to BPA.
1.3.1 Specific Objectives
i. To assess the effect of B. Pilosa on spermatogenic metrics of the testes such as sperm motility, sperm count, morphology, agglutination, and vitality using routine and extended semen analysis.
ii. To determine the impact of B. pilosa on serum concentration of follicle-stimulating hormone, testosterone, and luteinizing hormone using enzyme-linked immunosorbent assay (ELISA) following BPA exposure.
iii. To assess the changes in testicular oxidative stress biomarkers (such as CAT, SOD, and GSH) and lipid peroxidation using MDA.
iv. To assess the histology, histochemical, and immunohistochemical changes in the testes and pituitary gland following treatment with B. pilosa in BPA exposure using Masson Trichrome, Periodic Acid Schiff (PAS), Hematoxylin and Eosin (H&E), Caspase 3, antiproliferating cell nuclear antigen (PCNA), Bcl-2, alpha-smooth muscle actin (α-SMA), and Bax.

 Bushenyi, Kampala International University, Western Campus
 Nigeria 2025-03-03 11:40:21 2028-03-03 30 animals Animals will be divided into five groups, with six animals in each group (n=6). Group 1 is the control, 2 ml/kg bw of distilled water. Group 2—100 mg/kg/day of BPA Group 3—100 mg/kg/day of BPA + low dose of B. pilosa (250 mg/kg). Group 4—100 mg/kg/day of BPA + medium dose of B. pilosa (500 mg/kg). Group 5: 100 mg/kg/day of BPA + high dose of B. pilosa (1000 mg/kg) All administration will be done via oral administration for 5 weeks (35 days) because sperm maturation in mice takes about 35 days; B. pilosa will be administered after 1 hour of treatment with BPA. At the conclusion of the administration period on the 35th day, as per the approved protocol, animals from all groups will be euthanized after receiving ketamine. Blood samples will be collected from the animals via cardiac puncture and transferred to a plain sample bottle to allow coagulation of the cellular components of the blood. The blood sample is then centrifuged for the collection of serum. The collected serum will be used for hormonal assay (testosterone, LH, and FSH) and determination of oxidative stress biomarkers (CAT, SOD, and GSH). Adeniyi A. Ismahil (self sponsored) Medical and Health Sciences Clinical Trial Degree Award
Nazarius Tumwesigye Mbona
ID: UNCST-2019-R000664
 COBIHA- A COMMUNITY BASED INTERVENTION AGAINST HARMFUL USE OF ALCOHOL IN A RURAL SETTING: A pilot study around lake Bunyonyi in Kigezi, Uganda
REFNo: HS5521ES

2.To explore reasons for harmful use of alcohol, and perceptions on effective and acceptable ways of reducing this.,1.To conduct a pilot survey to establish the level of harmful use of alcohol and factors associated with the behaviour , to fill the evidence gap on effective community interventions, the current burden of harmful use of alcohol, and community perceptions of the burden of harmful alcohol use in rural Uganda,
 Kabale, Mwendo
Kabale, Bwama
Rubanda, Kagarama
Rubanda, Butobole
Rubanda, Kabere
 Uganda 2025-02-20 18:51:21 2028-02-20 0 All adults aged 18 and above with alcohol harmful use National Institute for Health and Care Research Medical and Health Sciences Clinical Trial Non-degree Award
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