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  
Achilles Katamba
ID: UNCST-2019-R000540
 Peer-led Implementation of TB-HIV Education and Adherence Counselling in Uganda
REFNo: HS4801ES

To evaluate the implementation fidelity and context of a peer-navigation strategy for TB-EC to improve TB treatment and ART outcomes, To determine the feasibility, acceptability, and appropriateness of a peer-navigation strategy for TB-EC and explore the social-behavioral mechanisms for improving adherence and clinical outcomes. ,To evaluate the implementation of a peer-navigation strategy for TB-EC to improve TB treatment completion and ART retention. , To evaluate the effectiveness and implementation of a novel, peer-led TB education and counseling strategy to improve outcomes among persons with tuberculosis (TB) with and without HIV/AIDS and assess the social-behavioral mechanisms underlying the observed treatment effects. ,
 Kampala,
Kampala,
Kampala,
Kampala,
Jinja, Wanyange
Jinja,
Buikwe,
Iganga,
Kiboga,
Mityana,
Butambala,
Wakiso,
Wakiso,
Kayunga,
Kampala,
Kamuli,
Luweero,
Lyantonde,
Mukono,
Uganda 2024-09-10 10:03:57 2027-09-10 1920 index cases Study population in Aim 1: Our target population is adults (age ≥18) starting treatment for TB/TB-HIV in public, private, and private not-for-profit primary care clinics in Uganda. Targeting this population will allow us to assess the impact of the TB-EC on TB and ART treatment adherence and outcomes across a diverse population. Study population Aim 2: For the pilot study to test Aim 2 instruments, we will enroll adults (age ≥18) undergoing evaluation for TB and on TB treatment in primary care clinics. All participants in Aim 1 of the study will participate in the Aim 2 of the study. We administer social and behavioral scales through the surveys that will be conducted in Aim 2. Study population in Aim 3: Aim 3 participants will include a subgroup of individuals enrolled in the Aim 1 trial, their peer navigators, and healthcare workers at study sites. National Institute of health Medical and Health Sciences Clinical Trial Non-degree Award
Milton Musaba Wamboko
ID: UNCST-2019-R000825
 Effectiveness and Safety Dosing of Sodium Bicarbonate in Women with Obstructed Labor in Eastern Uganda: A Phase III Randomized placebo-controlled Trial (SoBicOL- II Study)
REFNo: HS3885ES

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

 Mbale, Kawempe
 Uganda 2024-08-29 18:40:41 2027-08-29 280 Obstructed labour will be diagnosed by either an obstetrician or medical officer using a definition of the American Association of Obstetricians and Gynaecologists (ACOG). In the first stage of labour, the participant should have cervical dilatation >6 cm with ruptured membranes, adequate contractions lasting >4 hours with no change in cervical dilatation or delay in the second active stage of labour (nullipara >2 hours, multipara >1 hour) with adequate uterine contractions. In addition, any two of: the obvious signs of severe obstruction such as caput formation, severe moulding, Bandl’s ring, subconjunctival haemorrhages or an oedematous vulva. Busitema University Medical and Health Sciences Clinical Trial Non-degree Award
GUMA  ASHIRAF
ID:
PREVALENCE, PATTERNS AND CORRELATES OF GENERAL JOINT PAIN AMONG PATIENTS WITH DIABETES MELLITUS ATTENDING DIABETIC CLINIC AT MBARARA REGIONAL REFFERRAL HOSPITAL
REFNo: HS3963ES

To determine the prevalence of general joint pain among patients with DM attending diabetes clinic at MRRH.To determine the patterns of joint pain among patients with DM attending diabetes clinic at MRRH.To determine the associated factors to general joint pain among patients with DM attending diabetes clinic at MRRH.
 Mbarara, Rwebikona
 Uganda 2024-08-29 10:59:36 2027-08-29 242 The study population will be patients with DM attending diabetes clinic at MRRH. The diabetes clinic has a patient census of approximately 1500 patients of which about 80 patients attend every week. The study population is between the age of 18 years to 90 years. Most of the study population are Banyankole, Bakiga and Bahima. The study population is made of both males and females. Guma Ashiraf, Jemba Jovane, Mwesigwa Emma, Bananuka Bernard Medical and Health Sciences Clinical Trial Degree Award
Ruth Namazzi
ID: UNCST-2020-R014305
 Zinc for Infection Prevention in Sickle cell anemia ZIPS-2
REFNo: HS4824ES

The primary objective of the study is to determine if zinc supplementation at 20mg daily is safe and efficacious at reducing all-cause infection in Ugandan children 1.00-4.99 years of age with SCA.Secondary objectives 1. To determine the incidence of adverse events requiring discontinuation of study drug in children ages 1-4.99 supplemented with 20mg of daily zinc vs placebo 2. To determine the incidence of stroke or death in children ages 1-4.99 supplemented with 20mg of daily zinc vs placebo 3. To determine the incidence of infections requiring hospitalization in children ages 1-4.99 supplemented with 20mg of daily zinc vs placebo 4. To determine the incidence of vaso-occlusive crises in children ages 1-4.99 supplemented with 20mg of daily zinc vs placebo 5. To determine the change in transcranial Doppler (TCD) velocity from enrollment to 6-month study endpoint in children ages 1-4.99 supplemented with 20mg of daily zinc vs placebo 6. To determine change in serum zinc deficiency status from enrollment to 6-month study endpoint in children ages 1-4.99 supplemented with 20mg of daily zinc vs placebo 7. To determine the incidence of serious adverse events in children ages 1-4.99 supplemented with 20mg of daily zinc vs placebo 8. To determine the incidence of adverse events in children ages 1-4.99 supplemented with 20mg of daily zinc vs placebo
Jinja, Kakindu
 Uganda 2024-08-28 17:29:12 2027-08-28 100 Children with confirmed SCA between 1.00 and 4.99 years of age, living in the malaria endemic area of mid-eastern Uganda, who attend the Nalufenya Sickle Cell Clinic, Jinja Regional Referral Hospital whose caretakers’ consent to study participation CURES WITHIN REACH, INDIANA UNIVERSITY Medical and Health Sciences Clinical Trial Non-degree Award
Herbert Ainamani Elvis
ID: UNCST-2020-R014674
 The Impact of Self Help Plus and Climate Smart Agriculture on Mental Health and Food Security in the Rhino and Nakivale Refugee Settlements of Uganda
REFNo: HS4691ES

To compare the uptake of HGI between the mothers in the combined intervention group (HGI & SH+) with those in the HGI group living in Nakivale refugee settlement,To assess the effect of SH+ on the development of children aged 3-6 years belonging to participating mothers living in Rhino and Nakivale refugee settlements,To assess the effect of SH+ on the mental health of mothers with children aged 3-6 years living in Rhino and Nakivale refugee settlements ,To assess the perceptions and attitudes towards a home gardening intervention (HGI) among participating mothers living in Nakivale refugee settlement,To assess the effectiveness of Self Help Plus (SH+) and home gardening on maternal mental health, food security and child development in the Rhino and Nakivale refugee settlements of Uganda,
 Uganda 2024-08-26 14:58:27 2027-08-26 900 The target population of the proposed research project consists of refugee mothers (age 18+) with children aged 3-6 years, living in the Nakivale and Rhino refugee camps in Uganda. In Nakivale, the study will recruit 900 mother-child dyads across 30 villages, while in Rhino, 720 dyads from 24 villages will participate. Participating mothers in randomly selected intervention villages will be the recipients of the mental health and/or smart farming intervention. Outcomes will be measured at the level of the mother, the child, and the household. Uppsala University Medical and Health Sciences Clinical Trial Non-degree Award
Monicah Agaba
ID: UNCST-2024-R004221
 The Health-Beauty Paradox among Women in Mbarara City Uganda
REFNo: HS4708ES

iii. To characterise the cardio-metabolic profile of WRA.,ii. To document the risk behaviours and their factors related to these societal beauty perceptions.,i. To document societal beauty perceptions and their determinants.,To understand what, why and how the health-beauty paradox is so deeply entrenched in the culture.,
 Mbarara, Sampled
 Uganda 2024-08-26 10:18:37 2027-08-26 300 For the qualitative study, we target both women and men aged 15 up to 65 years who are residents of Mbarara City. For the quantitative study, we target only women of reproductive age (15 to 49 years) who are residents of Mbarara City. For both studies, their ethnicity is not a key inclusion or exclusion criterion. Global Minds Scholarship and Healthy Diets for Africa project Medical and Health Sciences Clinical Trial Degree Award
Rebecca Nuwematsiko
ID: UNCST-2022-R010501
 Effect and implementation factors of a contextually adapted short message service or phone call intervention to reduce loss to follow-up among presumptive TB patients in North Central Uganda
REFNo: HS3000ES

1.To determine the proportion of pre-diagnosis LTFU among presumptive TB patients and influencing factors in North Central Uganda (Sub-study 1). 2.To explore stakeholder’s perceptions on use of an SMS or phone call intervention to reduce LTFU among presumptive TB patients in health care facilities in North Central Uganda and contextually adapt the interventions (Sub-study 2). 3.To assess the effect of a contextually adapted SMS or phone call intervention to reduce LTFU among presumptive TB patients in health care facilities in North Central Uganda (Sub-study 3). 4.To explore factors that influence implementation of a locally adapted SMS or phone call intervention to reduce LTFU among presumptive TB patients in North Central Uganda (Sub-study 3). 5.To synthesize evidence on effectiveness of mHealth interventions to reduce LTFU in the TB presumption phase in LMICs (Sub-study 4)
Mukono, Mukono
Buikwe, Kawolo
Mityana, Mityana
 Uganda 2024-08-22 13:00:28 2027-08-22 1410 This will include presumptive TB patients aged 18 years and above who present to the study facilities during the study period and do not complete diagnosis on the same day of the hospital visit. Inclusion criteria A presumptive TB patient who is;  Aged 18 years and above  Current resident in the study district  Willing to sign informed consent  Owning a personal mobile phone (The patient should be in possession of the phone at the time of screening)  Being able to read  Those sent for GeneXpert testing  Presumed for TB within 12 hours  Patient has not completed TB diagnosis on the same day  Speaks or reads English or Luganda MILEAGE4TB project hosted at Makerere University School of Public Health Medical and Health Sciences Clinical Trial Degree Award
Grace Kisitu Paul
ID: UNCST-2024-R004102
 Universal2: Pharmacokinetics, safety and acceptability of a solid paediatric fixed-dose combination of darunavir/ritonavir (DRV/r) 120/20mg for children living with HIV
REFNo: HS4762ES

To evaluate the pharmacokinetics and safety of DRV/r 120/20 mg tablets in children greater than or equal to 3 years of age and weighing 10 to less than 25 kg

To evaluate the pharmacokinetics and safety of DRV/r 120/20 mg tablets in children greater than or equal to 3 years of age and weighing 10 to Less than 25 kg

To evaluate the acceptability of DRV/r tablets in children greater than or equal to 3 years of age and weighing 10 to less than 25 kg

To evaluate the short-term efficacy of the DRV/r 120/20 mg tablets in children greater than or equal to 3 years of age and weighing 10 to less than 25 kg

To describe RTV PK parameters as well as darunavir unbound plasma concentrations.

 Uganda 2024-08-22 11:45:22 2027-08-22 50 Children with HIV, from 3 years of age, requiring DRV/r: • weighing 10 to less than 25 kg with 1 or 2 DRV resistance-associated mutations (RAM) * Or • weighing 10 to less than 20 kg requiring DRV/r, with no DRV RAM* *DRV RAMs: V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V Fondazione Penta ETS 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
Proscovia Nabunya
ID: UNCST-2019-R000970
 Testing the Feasibility and Acceptability of a Combination Intervention to Address Mental Health among Refugee Youth in Uganda
REFNo: SS2834ES

This proposed two-year study will be conducted in two phases. The first phase seeks to understand whether the COVID-19 pandemic had differential impact on refugee youth living in different settings. The second phase will test the feasibility and acceptability of an innovative combination intervention that has not been previously tested among refugee youth to address psychological problems that have increased since the onset of the COVID-19 pandemic. Aim 1. To examine the mental health impact of COVID-19 on refugee youth living in Bidibidi refugee settlement compared to refugee youth living in urban centers (Arua town) in northern Uganda. Aim 2. To test the feasibility, acceptability and preliminary short-term impact of an innovative intervention combining the youth readiness intervention (YRI) with youth development accounts and financial literacy training (YDA-FLT) to address the mental health impact of COVID-19 among refugee youth living in Bidibidi refugee settlement in northern Uganda.
Uganda 2024-08-19 11:03:04 2027-08-19 200 The total sample size needed for the Refugee Youth COVID-19 study is 200 refugee youth, 15 to 24 years of age. Specifically, we will recruit 100 refugee youth from the five zones within Bidibidi Refugee settlement and another 100 youth among refugee youth living in Arua town (urban center). Youth will be recruited from centrally located ration distribution centers in the settlement, through churches, and youth advocacy groups led by refugee youth in Arua town that we will partner with. For the pilot RCT component, we will only include the 100 participants in Bidibidi refugee settlement with 50 randomized to the treatment group and the other 50 randomized to usual care group. Washington University in St. Louis Social Science and Humanities Clinical Trial Non-degree Award
Peter Olupot-Olupot Olupot
ID: UNCST-2020-R014798
 SMAART-MAP trial Severe Malaria A Research and Trials consortium - Multisite Adaptive Platform trial
REFNo: HS4547ES

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

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

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

 Mbale, North central
Soroti, Pioneer Ward
Agago, Oreet
 Uganda 2024-08-16 11:01:14 2027-08-16 150 per domain Hospitalized children with severe malaria Imperial College London Medical and Health Sciences Clinical Trial Non-degree Award
VINCENT MUBANGIZI
ID: UNCST-2024-R004232
 Opti-MaP (Optimising Implementation of Maternal and Perinatal Death Surveillance and Response to prevent avoidable future deaths in Uganda
REFNo: HS4630ES

To review existing tools, develop and adapt a harmonised toolbox of resources to optimise MPDSR implementationTo co-design customised an "intervention package" using the toolboxTo evaluate effectiveness and cost-effectiveness of the "customised intervention package" to reduce perinatal and maternal mortalityTo develop and adapt a harmonised toolbox of resources to optimise MPDSR implementation
 Kamwenge, All parishes
Kyenjojo, All parishes
Lyantonde, All parishes
 Uganda 2024-08-06 18:02:24 2027-08-06 For work packages 2-7, the sample size will be determined when the interviewers reach a point of saturation. For the intervention phase (work package 8), the estimated sample size is 4032. Adult males and females plus emancipated minors in the study area regardless of their tribe will be involved in the study. We will also interview key stake holders in the central ministries and bodies. We will interview persons who have lost a women due to pregnancy related causes or had a still birth or a baby died within 28 days of birth Merlin L Willcox Medical and Health Sciences Clinical Trial Non-degree Award
Cissy  Kityo
ID: UNCST-2021-R013663
 A Phase 4, Open-Label, Rollover Study to Provide Continued Access to Cabotegravir Long-acting Injection and Rilpivirine Long-acting Injection to Participants Living with Human Immunodeficiency Virus Type 1 (HIV-1) Infection Who Participated in Long-Acting Combination Therapy Studies.
REFNo: HS4452ES

The secondary objective is to assess the long-term safety and tolerability of CAB LA + RPV LA by evaluating the incidence of serious adverse events (SAEs), pregnancies, adverse events (AEs) leading to discontinuation of CABLA +RPV LA, and AEs considered to be related to the study intervention.,The primary objective of the study is to provide continued CAB LA + RPV LA access to participants who were enrolled and treated with CAB LA + RPV LA in the parent studies, and who, at the time of roll-over, experience and are expected to continue to experience clinical benefit from this treatment.,
 Wakiso, Katabi
Wakiso, Lubowa
Kampala, Mulago
Kabarole, Buyinga
Uganda 2024-08-06 17:32:50 2027-08-06 710 in Uganda Virologically suppressed adults who have had a detectable HIV viral load in prior 2 years of taking first-line ART or who have disengaged from HIV care. Janssen-Cilag International NV 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
Moses Oketch
ID: UNCST-2024-R004313
 Long-Term Impacts of Improved Childhood Literacy
REFNo: SS2796ES

Economic situation,
 Amolatar,
Dokolo,
UK 2024-08-05 14:01:33 2027-08-05 6581 Former participants of a study on the impact of an early-grade literacy intervention. The study was implemented from 2009 to 2011. The respondents are aged between 19 and 24 years old, with an average age of 21 years. Center for Global Development Social Science and Humanities Clinical Trial Non-degree Award
Jenny Löfgren
ID: UNCST-2024-R005428
 Outcomes of paediatric inguinal hernia repair performed by surgeons versus medical officers
REFNo: HS4508ES

Calculate and compare costs and cost-effectiveness between the two groups. ,Compare patient related outcomes between the group that has been operated on by medical officers versus those who were operated by general surgeons. ,The general objective of the proposed study is to investigate the possibility of task sharing between general surgeons and medical officers in inguinal hernia repair in children in Uganda. ,
 Soroti,
Mubende,
Iganga,
Sweden 2024-07-23 15:30:50 2027-07-23 341 Children, both girls and boys, 1-12 years old. Swedish Research Council Medical and Health Sciences Clinical Trial Degree Award
Nura Izath
ID: UNCST-2022-R009201
 Autothermo-a wearable continuous temperature measuring bracelet with a central display screen.
REFNo: HS3034ES

To assess the performance of Autothermo- a wearable continuous temperature measuring bracelet and a central display screen in comparison to the standard thermometer.,To assess the feasibility and acceptability of Autothermo among health workers and parents/caregivers of admitted neonates at Mbarara Regional Referral Hospital(MRRH).,
 Mbarara, Kamukuzi
 Uganda 2024-07-22 16:57:35 2027-07-22 The sample size of the health workers: Convenient sample of 4 out of 6 health workers engaged in the management and care of newborns admitted at Neonatal Intensive Care Unit-MRRH will be enrolled in the study. These study participants who will be nurses on duty will observe the use of Autothermo, ask a few questions and document findings at the end of each shift. The remaining two nurses will be recruited as study research nurses who will enroll and use Autothermo to monitor temperatures of the admitted newborns during the study period. The sample size for parents or caregivers will be calculated basing on the Kish and Leslie where P (0.5) will be the probability of parents or caregivers who will express willingness to have their newborns’ temperatures monitored with Autothermo and q (1-p) will be the probability of those who will not express willingness to use Autothermo. The study will use a precision of 0.126 and a Z of 1.96 giving a total of 60 parents or caregivers to be recruited into the study. Taking Feasibility and Acceptability of Autothermo: The study will include health workers and parents or primary caregivers of newborn. Parents and caregivers who are 18 years and above will be recruited and all health workers in the Neonatal Intensive Care Unit. The parents or caregivers will be informed that the Autothermo bracelet will be removed at any time at their request. Autothermo Performance Assessment: All neonates (0 to 28 days) admitted to the neonatal unit of MRRH during the study period will be screened for inclusion into the study. Ministry of ICT and National Guidance Medical and Health Sciences Clinical Trial Non-degree Award
Grace Kisitu Paul
ID: UNCST-2024-R004102
 UNIVERSAL1: Pharmacokinetic study of an optimized dose ratio of dolutegravir/emtricitabine/tenofovir alafenamide fumarate: expediting a UNIVERSAL first line regimen for all children living with HIV in Africa
REFNo: HS4280ES

Primary objective:
To evaluate the pharmacokinetics and short-term safety of DTG and FTC/TAF administered to children living with HIV using a novel dose ratio

Secondary objective:
To evaluate the short-term efficacy of DTG and FTC/TAF
formulations in children using a novel dose ratio

 Uganda 2024-07-19 3:45:20 2027-07-19 50 Children aged between 28 days and ≤10 years old weighing ≥3 to <25kg diagnosed with HIV. Fondazione Penta ETS Medical and Health Sciences Clinical Trial Non-degree Award
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
Cissy  Kityo
ID: UNCST-2021-R013663
 A Phase 2a/2b Study Evaluating Safety, Immunogenicity, and Therapeutic Efficacy of ID93 + GLA-SE Vaccination in Participants with Rifampicin-Susceptible Pulmonary TB
REFNo: HS3834ES

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

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

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

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

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

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

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

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

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

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

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

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

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


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

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

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

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

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

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


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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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


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

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

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

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

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

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

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

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

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

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

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

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


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

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

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

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

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

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

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

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

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

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

Main Objective

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

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

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

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

To determine the effectiveness of Clorpactin in wound dressing at Kumi Orthopaedic Center and St. Mary’s hospital, Lacor.,
 Kumi, Booma South
Gulu, ForGod
 Uganda 2023-07-03 13:32:54 2026-07-03 546 patients Patients admitted at Kumi Orthopaedic Center and St. Mary’s hospital, Lacor with surgical wound sepsis, infected open fractures, diabetic wounds, chronic osteomyelitis. SIGN Fracture Care International Medical and Health Sciences Clinical Trial Non-degree Award
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