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  
Angelina Kakooza-Mwesige
ID: UNCST-2020-R014529
 Epilepsy in Uganda: Clinical characterization and co-morbidities, their relation to stigma among adolescents and impact of a community-based engagement program. (AWE Change project) REF: TASO-2022-102
REFNo: HS2421ES

1.TO CLINICALLY CHARACTERIZE EPILEPSY AND ITS IMPACTS AMONG CHILDREN AND ADULT CASES IN UGANDA. 2.DESCRIBE THE MAGNITUDE, DRIVERS, AND IMPACT OF EPILEPSY-RELATED STIGMA ON ADOLESCENTS IN UGANDA. 3.TO CO-CREATE AND EVALUATE THE IMPACT OF A COMMUNITY-BASED ENGAGEMENT PROGRAM TO REDUCE STIGMA ON EPILEPSY AMONG ADOLESCENTS IN UGANDA.
 Central Region,
Eastern Region,
Northern Region,
Western Region,
Butambala,
Bukomansimbi,
Buikwe,
Buvuma,
Gomba,
Kalangala,
Kayunga,
Kampala,
Kyankwanzi,
Kyotera,
Kalungu,
Luweero,
Lwengo,
Masaka,
Mpigi,
Mityana,
Mubende,
Mukono,
Nakasongola,
Nakaseke,
Rakai,
Sembabule,
Lyantonde,
Wakiso,
Amuria,
Bududa,
Bugiri,
Bukedea,
Bududa,
Bududa,
Bulambuli,
Busia,
Butaleja,
Bukwa,
Buyende,
Iganga,
Jinja,
Kaberamaido,
Kaliro,
Katakwi,
Kamuli,
Kibuku,
Kumi,
Luuka,
Manafwa,
Mayuge,
Mbale,
Namayingo,
Namutumba,
Ngora,
Pallisa,
Serere,
Sironko,
Soroti,
Tororo,
Abim,
Adjumani,
Agago,
Amuru,
Apac,
Arua,
Dokolo,
Kaabong,
Kitgum,
Koboko,
Kole,
Kotido,
Lamwo,
Lira,
Maracha,
Moroto,
Moyo,
Nebbi,
Nwoya,
Otuke,
Oyam,
Pader,
Yumbe,
Zombo,
Buhweju,
Buliisa,
Bundibugyo,
Hoima,
Ibanda,
Isingiro,
Kabale,
Kabarole,
Kamwenge,
Kanungu,
Kasese,
Kibaale,
Kiruhura,
Kiryandongo,
Kisoro,
Kyegegwa,
Kyenjojo,
Masindi,
Mbarara,
Mitooma,
Ntungamo,
Rubirizi,
Rukungiri,
Sheema,
Uganda 2022-10-25 14:54:28 2025-10-25 490 All ages across the life span, of every gender and tribe National Institutes of Health Medical and Health Sciences Clinical Trial Non-degree Award
Fredrick Kabi
ID:
EVALUATION OF THE SAFETY, EFFICACY AND EFFECTIVENESS OF THE SUBOLESIN BASED ANTI-TICK VACCINE: A RANDOMISED DOUBLE BLINDED MULTI-SITE CONFINED FIELD TRIAL
REFNo: A191ES

OVERALL OBJECTIVE
Evaluation of the Safety, Efficacy and Effectiveness of Subolesin based Anti-tick Vaccine for control of ticks naturally infesting different cattle breeds under confined field conditions in Uganda.

SPECIFIC OBJECTIVES
I. To determine the safety of the injectable Subolesin based Anti-tick vaccine for control of tick infestations under natural confined field conditions.
II. To determine the efficacy of the injectable Subolesin based Anti-tick vaccine for control of tick infestations under natural confined field conditions.
III. To determine the effectiveness of the injectable Subolesin based Anti-tick vaccine for control of tick infestations under natural confined field conditions.

 Apac,
Mbarara,
Ibanda,
Mbarara,
Masindi,
Wakiso,
Uganda 2022-10-21 12:58:12 2025-10-21 360 1. Species: Bos indicus (Indicine) and Bos taurus (Taurine) cattle 2. Breed: All cattle breeds in the trial site 3. Ownership: Owned by NARO and UPS 4. Number: Each trial site will provide 72 head of cattle. Total number of experimental cattle will b Government of Uganda (GoU) Agricultural Sciences Clinical Trial Non-degree Award
Eugene Ruzagira
ID: UNCST-2023-R008282
 A Phase Ib trial to evaluate the safety and immunogenicity of R21/Matrix-MTM in African children living with HIV.
REFNo: HS2496ES

Primary objective a) To assess the safety and reactogenicity profile of the malaria vaccine candidate R21/Matrix-MTM in 5-36-month-old African children living with HIV Secondary objectives a) To assess the humoral immunogenicity of R21/Matrix- MTM in 5-36-month-old African children, comparing children living with HIV with HIV negative children b) To assess the impact of vaccination on HIV reservoir c) To assess whether increasing age and nadir CD4 count are associated with immunogenicity of R21/Matrix-MTM in 5-36- month-old African children living with HIV Tertiary objectives a) To assess the immunogenicity profile of R21/Matrix-MTM in 5- 36-month-old African children, comparing children living with HIV with HIV negative children
 Wakiso, Central
 Uganda 2022-10-20 18:13:49 2025-10-20 120 120 Children aged 5-36 months will be recruited to the trial. HIV positive children will be recruited from Pediatric HIV care centers within Kampala and Wakiso districts while HIV negative children will be recruited from Entebbe hospital and primary health care centers that provide immunisation and growth monitoring services within Kampala and Wakiso districts. 100 children with confirmed HIV infection will be recruited to group 1 and 20 children without HIV will be recruited to group 2. The Serum Institute of India Pvt Ltd Medical and Health Sciences Clinical Trial Non-degree Award
Robert Kalyesubula
ID:
Human-centered design to adapt and inform an integrated chronic disease management program in Uganda using mobile payment services. (Acronym: IMPEDE CVD)
REFNo: HS2445ES

1)To understand patient and provider perspectives on the potential and acceptability of financing schemes and mHealth interventions aimed at strengthening behavior in relation to ideal drug availability and uptake among NCD patients (Work Package (WP) 1a).
2)To develop together with end-users a prototype for a mobile phone-based solution (including mobile-based nudges) to increase the availability and uptake of NCD drugs (WPs 1b, and 2).
3)To test the prototype, establishing proof of concept, and to assess end-users’ experiences interacting with two versions of the prototype (comparing two saving models), including how users make and evaluate payment management decisions, in preparation for a subsequent study (WP 3).
 Nakaseke, Semuto
Uganda 2022-10-20 18:01:35 2025-10-20 For the quantitative Studies, interview will be conducted until saturation; For the quantitative study (Trial), 380 participants will be included in the study The respondent groups for this study include medical health care providers (CHWs, medical doctors, clinic staff throughout all work packages), community members and key stakeholders (religious and local leaders, members of pooled financing schemes, academics (WP1 and 2)), clients (adults aged 18 years or older who regularly seek care in the study facility for diagnosed hypertension and diabetes (WP1-3), and decision makers (policymakers, MoH representatives, Health insurance (WP1)), as their attitudes, experiences, knowledge, and behaviors are explicitly within the target of the research question. For WP3, we also include study team members involved in intervention design, implementation, and evaluation processes as respondents. This study is funded through the German Alliance of Global Health Research. Medical and Health Sciences Clinical Trial Non-degree Award
Francis Kiweewa
ID: UNCST-2020-R014929
 A Global Multi-Center, Randomized, Blinded, Placebo-Controlled Phase 3 Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (LVRNA009) for the Prevention of COVID-19 in Participants Aged 18 Years and Older
REFNo: HS2476ES

The objective of this study is to evaluate the effectiveness, safety, and the ability of the study vaccine to provoke an immune response in your body against COVID-19. This study is necessary because the COVID-19 epidemic poses a significant global health challenge, and a large number of effective vaccines are still needed for the future. A total of approximately 34,000 participants like you from around the world, such as Africa and Asia will participate in this study. The entire study will last approximately 20 months, and your participation will last approximately at least 17 months. (The exact duration of your participation in the study may depend on the specific situation of the study. Please consult your study doctor at that time.)
 Wakiso,
Kampala,
Lira,
Tororo,
Uganda 2022-09-28 14:10:52 2025-09-28 234 Adults aged 18 years and older of all sexes. AIM Vaccine Co., Ltd, AIM Innovation Biotechnology (Shanghai) Co., Ltd, LiveRNA Therapeutics Inc. & Ningbo Rongan Biological Pharmaceutical Co., Ltd Medical and Health Sciences Clinical Trial Non-degree Award
Byamah Mutamba Brian
ID: UNCST-2022-R011124
 Strengthening Care in collaborAtion with People with lived Experience of psychosis in Uganda (SCAPE-U
REFNo: HS2327ES

General objective
To assess the impact of SCAPE-U on individual, family members’ and health system outcomes, and evaluate trial procedures to determine the optimal design for a future fully-powered cluster randomised controlled trial (RCT).
Specific objectives
1. To assess the feasibility and acceptability of SCAPE-U from the perspective of people with lived experience of psychosis, their family members and primary and community care providers.
2. To demonstrate proof-of-concept for the benefit of SCAPE-U for service users (i.e., patients with psychosis receiving primary care services) and their families, including changes in psychosis symptoms, quality of life, frequency of hospitalization and the potential impacts on family members.
3. To determine changes in health systems outcomes in terms of primary care provider knowledge, attitudes, competency in psychosis diagnosis and management, as well as accuracy of diagnosis and fidelity to treatment guidelines in actual care settings.
4. To evaluate trial procedures, including costing, recruitment and retention, and data collection protocols, to determine the optimal design for a future fully-powered cluster RCT

 Kampala, All parishes
Wakiso, All parishes
 Uganda 2022-09-21 21:32:50 2025-09-21 120 persons diagnosed with Psychosis There will be five categories of participants in this study: Persons with lived experience of psychosis (SCAPE-U facilitators) – Approximately 10-20 people with lived experience of psychosis will be recruited from prior YouBelong Uganda programs to be trained in PhotoVoice as SCAPE-U facilitators in the SCAPE-U arm. These people with lived experience of psychosis will require a diagnosis of a psychotic disorder confirmed by a mental health professional (psychiatric clinical officer or psychiatrist). Mental health professionals will be required to evaluate PLWP for any health or functional impairment that could jeopardize their safe participation as well as seek their consent. Currently participating in treatment (taking antipsychotics, receiving psychosocial support, or both) is not an exclusion criterion. We plan to draw SCAPE-U facilitators from YouBelongHome beneficiaries. The YBH intervention comprises two unique phases: 1) a pre-discharge assessment which provides a detailed description of an individual’s general health and mental health history; individual goals and aspirations; a social demography of the individual and his/her family with particular emphasis on potential barriers to and supports for individual and family well-being; and the education and awareness level of the local community in mental health; this first phase is completed in a 2 to 3 weeks and 2) the second phase is the post-discharge community-based strengthening, informed by the pre-discharge assessment, that focuses on both empowering the family as an active agent in the returned person’s recovery and connecting the person with SMI and family to the support of friends, extended family, community, and work. This phase includes both face to face and phone engagements over a 12-week period. In response to the COVID-19 pandemic, YBU has modified the pre and post discharge process from a 16 week to a 5-week intervention, to allow for a higher rate of return and resettlement of patients, while ensuring that those patients in need of complex mental health and psychosocial care still receive the unmodified YBH pre and post discharge version of care. They will meet the following selection criteria: a) completion of the YBH program, b) confirmed diagnosis of a primary psychotic disorder (e.g., schizophrenia) by a psychiatrist or PCO, c) provision of informed consent, d) fluency in the local language (Luganda), e) good functioning with respect to performance of daily chores, engagement with family members, comprehension and community participation as assessed by the YBH team, and f) a supportive family member. We will also maintain professional conduct guidelines to monitor experience of clients during home visits and other interactions. Primary care providers – Primary care providers who have been selected by the in-charge of the health facility to participate in the study, will be trained in mental health service delivery with the mhGAP-IG. Two providers will be selected per facility and there are no exclusion criteria, for an estimated 70 primary care providers per arm. At the primary care provider level, all primary care providers being trained in mental health services will be eligible for participation. Community health workers – Five community health workers (VHTs) who are affiliated to the health facilities where PHWs receive training in mhGAP and have been selected by the in-charge of the health facility to participate in the study. Service users (main intended beneficiaries) – The primary intended beneficiaries of study interventions are patients receiving treatment for psychoses. At the patient level, any patient presenting to HC-II, III, or IV receiving a diagnosis of psychosis from primary care providers will be eligible for participation in this study. The goal is to have 60 patients per arm for the two arms (120 patients total). At the patient level, any patient presenting to HC-II, III, or IV receiving a diagnosis of psychosis from primary care providers will be eligible for participation in this study. Service user inclusion criteria: 1. Persons diagnosed with psychosis at a primary health care facility in Kampala/Wakiso District; 2. Ability of the patient or responsible surrogate to consent to study enrolment and procedures; 3. Persons eligible for outpatient management of psychosis. Exclusion criteria will be 1. Persons diagnosed with psychosis requiring inpatient management/services; and 2. Persons for whom consent for participation in the study cannot be obtained. Family members of service users – At least one primary carer to a participating service user will be identified in order to collect outcome data from the carer Wellcome Trust, UK Medical and Health Sciences Clinical Trial Non-degree Award
Henry Ssenyondo
ID:
Maternal Antibody in Milk After Group B Streptococcus Vaccination in Uganda: MAMA study
REFNo: HS1986ES

General Objective • To determine the concentration of antibody transferred in breastmilk following vaccination with Group B Streptococcal vaccine Specific Objectives • To determine the anti-GBS (anti-Alp1N, Alp2N, AlpCN and RibN) Immunoglobulin A (IgA) concentrations in the colostrum of women following vaccination with a GBS-containing vaccine or placebo in pregnancy.
• To determine the total IgA and Immunoglobulin G (IgG) concentrations in the colostrum and breastmilk of women at less than 48 hours, 28 (+/-4 days) and 56 (+/- 6 days) days after delivery following vaccination with a GBS-containing vaccine or placebo in pregnancy.
• To determine the anti-GBS (antiAlp1N, Alp2N, AlpCN and RibN) IgA concentrations in the breastmilk of women at 28 (+/-4 days) and 56 (+/- 6 days) days after delivery following vaccination with a GBS-containing vaccine in pregnancy.
• To determine the anti-GBS (antiAlp1N, Alp2N, AlpCN and RibN) IgG concentrations in the colostrum and breastmilk of women at less than 48 hours, 28 (+/-4 days) and 56 (+/- 6 days) days after delivery following vaccination with a GBS-containing vaccine in pregnancy.
 Kampala, Kawempe Central
 Uganda 2022-09-21 21:13:49 2025-09-21 50 Women 18 to 40 years All tribes Makerere University Medical and Health Sciences Clinical Trial Degree Award
Eugene Ruzagira
ID: UNCST-2023-R008282
 A phase Ib study to assess the safety and immunogenicity of a recombinant adenovirus-based vaccine against plague in Uganda
REFNo: HS2387ES

Primary To investigate safety and tolerability of 5 x 1010 VP of the proposed ChAdOx1 Plague vaccine in healthy African adults aged 18 to 49 residing in Uganda, when given as one or two dose(s) intramuscularly with different prime-boost intervals Secondary To determine the immunogenicity of 5 x 1010 VP of the proposed ChAdOx1 Plague vaccine, in healthy African adults aged 18 to 49 years residing in Uganda when given as one or two dose(s) intramuscularly with different prime-boost intervals. Tertiary Exploratory immunogenicity assays to determine the immunogenicity of 5 x 1010 VP of the proposed ChAdOx1 Plague vaccine, in healthy African adults aged 18 to 49 years residing in Uganda when given as one or two dose(s) intramuscularly with different prime-boost intervals.
Masaka, KATWE
 Uganda 2022-09-12 18:28:42 2025-09-12 36 Healthy male or female African adults aged 18-49 years, inclusive. Inclusion and exclusion criteria are as follows: Inclusion Criteria • Willing and able to give informed consent for participation in the trial. • Male or female aged between 18-49 years inclusive at enrolment (first vaccination visit, V1) • In good health as determined by o Medical history (as determined by verbal medical history) o Physical examination o Clinical judgment of the investigators • Female participants of childbearing potential must be willing to ensure that they use effective contraception during the trial and for 3 months after the last vaccination. • Female participants of childbearing potential must have a negative pregnancy test on the day(s) of screening and vaccination. • Able to attend the scheduled visits and to comply with all study procedures • Agrees to refrain from donating blood for the duration of the trial • Clinically acceptable baseline screening results (includes vital signs, physical examination, urinalysis, and laboratory results) • In the Investigator’s opinion, is able and willing to comply with all trial requirements. Exclusion Criteria The participant may not be enrolled in the study if any of the following apply: • Female participant who is pregnant, lactating or planning pregnancy during the course of the trial. • History of significant organ/system disease that could interfere with trial conduct or completion. This includes a known history of significant disease in the following: o Cardiovascular disease including congenital heart disease, previous myocardial infarction, valvular heart disease (or history of rheumatic fever), previous bacterial endocarditis, history of cardiac surgery (including pacemaker insertion), personal or family history of cardiomyopathy or sudden adult death o Respiratory disease such as uncontrolled asthma and chronic obstructive pulmonary disease o Endocrine disorders such as diabetes mellitus and Addison’s disease o Significant renal or bladder disease o Biliary tract disease o Gastro-intestinal disease such as inflammatory bowel disease, major abdominal surgery within the last two years, coeliac disease and liver disease (including hepatitis B or C infection) o Neurological disease such as seizures and myasthenia gravis o Haematological problems such as coagulation problems or anaemia (haemoglobin < 12.5g/dL for females and < 13.5 g/dL and for males) o Metabolic disease such as glucose-6-phosphate dehydrogenase deficiency o Psychiatric illness requiring hospitalisation or depression if severity is deemed clinically significant by the study Investigators o Known or suspected drug and/or alcohol misuse o Non-benign cancer, except squamous cell or basal cell carcinoma of the skin and cervical carcinoma in situ • Any other significant disease or disorder which, in the opinion of the Investigator, could: o Put the participant at risk because of participation in the trial o Influence the result of the trial o Impair the participant’s ability to participate in the trial • History of allergy to a vaccine or any component of the vaccines used in this study • History of anaphylaxis • Have any known or suspected impairment or alteration of immune function, resulting from, for example: o Congenital or acquired immunodeficiency o Human Immunodeficiency Virus infection or symptoms/signs suggestive of an HIV-associated condition o Autoimmune disease o Receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 12 months or long-term systemic corticosteroid therapy (including for more than 7 days consecutively within the previous 3 months). • Receipt of immunoglobulins or any blood product transfusion within 3 months prior to enrolment • Scheduled elective surgery or other procedures requiring general anaesthesia during the trial • Weight <50kg or a body mass index (BMI) greater than 35kg/m2. • Known history of previous occurrence of disease caused by Y. pestis or receipt of a vaccine against plague • Current active participation in another research study involving an investigational product (including receipt of an IMP within last 30 days) or where involvement in this study could impact the results • It is not in the best interest of the volunteer to participate in the trial, in the opinion of the Investigator. University of Oxford Medical and Health Sciences Clinical Trial Non-degree Award
Gorretti Nassali
ID:
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
REFNo: HS2133ES

Primary objective:
To demonstrate superiority of giredestrant over the control treatment
Secondary objectives:
1. To evaluate the efficacy of giredestrant compared with TPC
2. To evaluate the safety of giredestrant compared with TPC
3. To characterize giredestrant pharrmacokinetics (PK)
4. To evaluate health status utility scores of participants treated with giredestrant compared with TPC
5. To evaluate the efficacy of giredestrant compared with TPC
6. To evaluate the tolerability of giredestrant compared with TPC
7. To identify and/or evaluate biomarkers that are predictive of response to giredestrant
Kampala, mulago
 Uganda 2022-09-06 14:14:37 2025-09-06 Approximately 4700 participants will be screened to achieve random assignment in 1:1 ratio to study treatment of 4100 randomized participants for an estimated total of 2050 randomized participants per Approximately 4100 participants with medium- and high-risk Stage I?III histologically confirmed ER? and HER2? EBC will be enrolled during the global enrollment phase of this study. After completion of the global enrollment phase, additional participants F. Hoffmann-La Roche Ltd Grenzacherstrasse 124 4070 Basel, Switzerland Medical and Health Sciences Clinical Trial Non-degree Award
Isaac Ssewanyana
ID: UNCST-2020-R014336
 ASSESSMENT OF USABILITY OF THE WONDFO HIV SELF-TEST ONE STEP HIV 1/2 WHOLE BLOOD/SERUM/PLASMA TEST BY UNTRAINED USERS
REFNo: HS1878ES

To evaluate the ability to correctly comprehend key messaging from device packaging and labelling, including the Instructions for Use.,The evaluation of untrained users’ and their interaction with the device in terms of effectiveness and efficiency, i.e. successful / unsuccessful completion and difficulty of the critical steps as per the Instructions for Use,To evaluate the ability of untrained users to obtain an accurate HIV test result using the Wondfo HIV Self-Test.,
 Buhweju, Nsika
Wakiso, Central
Bulambuli, Bulambuli Town Council
Mbale, Mbale City
 Uganda 2022-08-30 10:24:48 2025-08-30 100 All participants will be > 18 years old of all Sex from the bamasaba region Central Public Health Laboratories Medical and Health Sciences Clinical Trial Non-degree Award
Prudence Atukunda Friberg
ID: UNCST-2023-R006221
 The NutriMind Trial: A low-cost randomized trial combining a healthy diet and psychotherapy to treat depressive symptoms among university students – The case of Uganda
REFNo: HS2146ES

The primary outcome is a mean reduction of 6 scores on the CES-D scale
• Biomarkers of metabolism (i.e. lipids, carbohydrates and hormones) will be measured in samples from blood, urine or saliva as appropriate and using standard methods.
• Biomarkers of inflammation (e.g. CRP, interleukins) and antioxidants will be measured in blood, urine or saliva as appropriate and using e.g. multiplex-techniques, immunolabelling methods and metabolomics.
• Microbiome will be analysed in samples from the oral cavity and from feces using established techniques (16S rRNA amplicon sequencing and reduced metagenome sequencing).

The combined intervention arm with MBCT and Diet will reduce depressive symptoms more than the control arm
Biomarkers of metabolism ( lipids, carbohydrates and hormones) measured in samples from blood, urine or saliva as appropriate and using standard methods
Biomarkers of inflammation ( CRP, interleukins) and antioxidants measured in blood, urine or saliva as appropriate and using multiples-techniques, immunolabelling methods and metabolomics
Microbiome will be analysed in samples from the oral cavity and from feces using established techniques ( 16rRNA amplicon sequencing and reduced metagenome sequencing)
 Kampala, Makerere
 Uganda 2022-08-03 11:19:53 2025-08-03 200 The study population is university students with self reported depression symptoms as determined by Beck depression Inventory validated assessment tool. The partcipants will be aged range 19 and above both female and males will be included from all the tr University of Oslo Medical and Health Sciences Clinical Trial Non-degree Award
Atupele Mlangwa Subira
ID:
PREVALENCE AND FACTORS ASSOCIATED WITH PROLONGED HOSPITAL STAY FOLLOWING CAESEREAN DELIVERY AT MBARARA REGIONAL REFERRAL HOSPITAL
REFNo: NS383ES

2. To determine the factors associated with prolonged hospital stay following caesarean delivery at MRRH,1. To determine the prevalence of prolonged hospital, stay following caesarean delivery at MRRH,To determine the prevalence and factors associated with prolonged hospital stay following caesarean delivery at MRRH,
 Mbarara, Medical Cell
 Tanzania 2022-07-26 11:29:37 2025-07-26 427 Adult women delivered by caesarian section at Mbarara Regional Referral Hospital Atupele Subira Mlangwa Natural Sciences Clinical Trial Degree Award
Nixon Niyonzima
ID: UNCST-2020-R014577
 A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED CLINICAL TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF ADJUVANT ATEZOLIZUMAB OR PLACEBO AND TRASTUZUMAB EMTANSINE FOR HER2-POSITIVE BREAST CANCER AT HIGH RISK OF RECURRENCE FOLLOWING PREOPERATIVE THERAPY
REFNo: HS2173ES

8. To validate the ability of fertility biomarkers to diagnose and predict permanent loss of ovarian function, and to determine the impact of anti-cancer therapy on hormone levels,7. To evaluate health status utility scores of patients treated with atezolizumab when given in combination with trastuzumab emtansine compared with placebo and trastuzumab emtansine,6. To identify and/or evaluate biomarkers that are predictive of response to atezolizumab and trastuzumab emtansine (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 atezolizumab and trastuzumab emtansine, 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 atezolizumab and trastuzumab emtansine activity (i.e., pharmacodynamic biomarkers), or can increase the knowledge and understanding of disease biology and drug safety,5. To evaluate the immune response to atezolizumab and trastuzumab emtansine,4. To characterize the PK profiles of atezolizumab and trastuzumab emtansine when given in combination,3. To evaluate the safety of atezolizumab when given in combination with trastuzumab emtansine compared with placebo and trastuzumab emtansine,2. To evaluate the efficacy of atezolizumab when given in combination with trastuzumab emtansine compared with placebo and trastuzumab emtansine in the PRO-evaluable analysis set,1. The secondary efficacy objective for this study is to evaluate the efficacy of atezolizumab when given in combination with trastuzumab emtansine compared with placebo and trastuzumab emtansine in both the ITT population and PD-L1-positive population,The primary objective for this study is to evaluate the efficacy of atezolizumab when given in combination with trastuzumab emtansine compared with placebo and trastuzumab emtansine in both the ITT population (all comers) and the PD-L1-positive population (defined as all patients from the ITT population with a centrally assessed PD-L1-positive status [i.e., PD-L1 status of IC1/2/3] at randomization),
 Kampala, Mulago
Uganda 2022-07-21 11:00:02 2025-07-21 30 This study will enrolling women with a primary diagnosis of HER2-positive primary breast cancer who have received preoperative chemotherapy and HER2-directed therapy, including trastuzumab followed by surgery, with a finding of residual invasive disease i Nixon Niyonzima Medical and Health Sciences Clinical Trial Non-degree Award
Moffat  Nyirenda Joha
ID: UNCST-2020-R019333
 Development and Evaluation of an Integrated Community-based Management Model for HIV, Diabetes, and Hypertension in Tanzania and Uganda (The INTE-COMM study)
REFNo: HS2278ES

To determine the effectiveness of community-based integrated management of HIV, diabetes, and hypertension in comparison to clinic-based integrated management of these conditions in terms of patient outcomes, acceptability, and potential cost-effectiveness.
 Kampala, N/A
Wakiso, N/A
Mpigi, N/A
Lwengo, N/A
 Malawi 2022-07-13 16:33:33 2025-07-13 1,736 participants Assuming an intra-class coefficient, rho of 0.02, we need to form 116 groups, each comprising 12 persons (8 with diabetes or hypertension and 4 with HIV). This will provide over 80% power to detect an absolute difference in risk of diabetes and hypertension control of 10% (i.e. 50% versus 60% achieving good control in the 2 arms would be statistically significant at the 5% two-sided significance level). Power will be very high for differences larger than this. For the HIV viral suppression endpoint, we assume that viral suppression is close to 90% and that the primary aim is to show non-inferiority with the community-care arm (and secondary analyses will compare superiority). The trial will have over 80% power to show non-inferiority with a margin of delta= 8.5%, 7.5%, and 5.5% assuming viral suppression is 85%, 90% and 95% respectively. To allow for losses to follow-up, our target for enrolment is 124 groups each comprising 14 participants (i.e. a total of 1,736 participants). National Institute of Health Research (NIHR) Medical and Health Sciences Clinical Trial Non-degree Award
Jackson Mukonzo
ID: UNCST-2021-R013916
 Ivermectin-artemisinin Combination Therapy for Eradication of Malaria
REFNo: HS2081ES

Main Objective: 1. To investigate the effect of ivermectin adjunct therapy on household transmissibility of malaria from malaria-infected patients receiving artemether /lumefantrine Specific objectives 1. To determine the household malaria transmissibility within one month of IVN and artemether / lumefantrine therapy. 2. To determine the structural similarity of the nanopore plasmodium sequences between infecting plasmodium species isolated from the index patient and other household malaria positive patients. 3. To assess the safety of ivermectin-artemether/lumefantrine in malaria-infected patients.
 Kasese, NA
 Uganda 2022-07-13 16:29:55 2025-07-13 110 Participants Adults aged 18 to 65 years of age, both males and females. No specific tribe in our inclusion criteria but most of the study participants are expected to be Bakonzo given that the study site is Kasese. MAKERERE UNIVERSITY RESEARCH AND INNOVATION FUND Medical and Health Sciences Clinical Trial Non-degree Award
Andrew Mujugira
ID: UNCST-2019-R000871
 CHOICE-BASED PrEP DELIVERY FOR TRANSGENDER PEOPLE IN UGANDA
REFNo: HS2316ES

Aim 1: Identify PRECEDE factors that influence PrEP implementation for transgender people in Uganda.

Guided by the PRECEDE-PROCEED model, which is widely used for public health interventions, we will analyze previously collected qualitative data from four TGP studies and also conduct two new focus groups with TGP and providers to identify predisposing, reinforcing, and enabling factors that may impact implementation of choice-based PrEP. A stakeholder workshop anchored in good participatory practice will discuss results of the qualitative research and guide design of the optimal choice-based PrEP delivery model for Aim 2.

Aim 2: Offer PrEP choice to transgender people in a DSD model and evaluate implementation and effect on PrEP use (PROCEED).

We will offer choice of CAB-LA or oral PrEP, and choice of facility or community delivery (with option to switch), to 300 HIV-negative TGP with follow-up for 24 months. Adverse events, product switching, and trajectories of choice over time will be monitored and documented. Persistence on CAB LA and oral PrEP will be compared during the choice period, and with a historical cohort without PrEP choice (ClinicalTrials.gov, NCT04491422). Primary outcomes are choice of PrEP option & delivery model, adherence, and persistence.

Aim 3: Use mixed methods to evaluate how choice influences PrEP use among TGP (PROCEED).
Inductive and deductive analyses based on in-depth interviews with purposively sampled PrEP users (n=50) and providers (n=10) will be used to explain “how” and “why” choice did or did not work and interpret implementation data from Aim 2. Choice preferences will be assessed via structured questionnaires.

Aim 4: Estimate cost implications associated with integrating CAB LA into HIV programs.
We will conduct health system versus client cost analyses to inform budgeting. Costs incurred and averted will be estimated using activity-based micro-costing, study budget, and the literature. Costs and modeled outcomes will be combined to estimate budget impact with PrEP persistence at 6 and 12 months.


 Wakiso, Kasangati
 Uganda 2022-06-28 16:44:09 2025-06-28 420 Population: Trans women and men (up to 300 participants) Eligibility Eligible TGP must be aged ≥18, weigh ≥35kg, be interested in taking PrEP, at high risk for sexually acquiring HIV (i.e., any self-report of condomless sex, multiple partners, stimulant drug use or STIs) in the prior six months, and eligible for PrEP in accordance with Uganda National PrEP Guidelines United States National Institute of Mental Health (R01 MH130208) Medical and Health Sciences Clinical Trial Non-degree Award
Agnes Nyabigambo
ID:
Effectiveness of clinic-based patient-led HPV DNA self-sampling among HIV-infected women in Uganda.
REFNo: HS2084ES

1. To assess the difference and associated factors of uptake of clinic-based compared to home-based HPV self-sampling approach among HIV infected women in rural Uganda. 2. To identify factors associated with the prevalence of HPV among HIV-infected women in rural Uganda. 3. To determine factors influencing sample viability HPV self-collected samples in clinic arm compared with home -based arm. 4. To explore the facilitators and barriers of clinic-based compared to home-based HPV self-sampling approaches among HIV-infected women in rural Uganda. 5. To estimate the cost-effectiveness of the clinic-based approach compared to the home-based HPV-DNA self-sampling among HIV-infected women in rural Uganda.
Luweero, Kasana
 Uganda 2022-06-08 15:13:10 2025-06-08 382 Women living with HIV aged 25-49 years. HEARD PhD Scholarship Medical and Health Sciences Clinical Trial Degree Award
Joshua Muhumuza
ID:
Effect of chewing gum on duration of postoperative ileus following laparotomy for gastroduodenal perforations; a multi centre study.
REFNo: HS1665ES

i. To compare the time taken for post-operative ileus to resolve in the two groups. ii. To compare the duration of hospital stay in the two groups. iii. To determine other factors associated with the duration of post-operative ileus in the study population.
 Kabarole, Central Division
Bushenyi, Central Division
Hoima, Central Division
 Uganda 2022-05-30 17:10:09 2025-05-30 52 participants All adult patients 18 years and above, male and female admitted to the surgical wards of study centre hospitals irrespective of tribe with gastric or duodenal perforations during the study period at will be the study population self sponsored Medical and Health Sciences Clinical Trial Degree Award
Lisa Hartwig
ID:
The effectiveness of a behavioral science and design intervention for family savings on increased use of maternal health services and male involvement: a randomized controlled trial
REFNo: HS2194ES

To assess the effectiveness of a behavioral intervention designed to encourage financial savings for healthcare costs and birth preparedness among pregnant women and their partners in Uganda. To examine whether increased earmarked financial savings for healthcare costs leads to increased utilization of maternal health services and male involvement in maternal healthcare.
 Kyotera, All
 USA 2022-05-23 9:28:49 2025-05-23 700 To be eligible for joining the study, the participants must fulfill the following eligibility criteria: (1) 18-49 years old, (2) Between 12-32 gestational weeks (pregnant female) OR partner of someone who is (male), (3) Own a mobile phone, (4) Has a regis The University of Tokyo Medical and Health Sciences Clinical Trial Degree Award
Achilles Katamba
ID: UNCST-2019-R000540
 Clinic versus Hotspot Active Case Finding and Linkage to TB Preventive Therapy (ACF/TPT) Strategy Evaluation for Tuberculosis
REFNo: HS2166ES

3. To estimate (using simulation) the impact of each intervention on diagnostic delays and TB prevalence.,2. To measure the implementation of hotspot-based and facility-based ACF + TPT, including the reach (number of individuals willing to be screened), implementation (measured via cascades of care), and maintenance (of effectiveness over time).,1. To compare the effectiveness of hotspot-focused versus facility-based ACF + linkage to TPT in terms of the number of individuals started on treatment for microbiologically confirmed TB in each community (i.e., reduction in undiagnosed TB prevalence, primary outcome) ,
 Lwengo,
Masaka, Kalisizo
Mpigi, Nkozi
Mityana, Mityana
Bugiri, Bugiri
Butambala, Gombe
Iganga, Iganga
Kiboga, Kiboga
Lyantonde, Lyantonde
Mukono, Mukono
Kayunga, Kayunga
Luweero, Luwero
Mubende, Kassanda
Jinja, Kawoolo
Buikwe, Kawolo
Nakaseke, Nakaseke
 Uganda 2022-05-18 9:43:01 2025-05-18 80000 All willing participants 15 years and above of any sex and tribe residing with the study area National Institutes of Health Medical and Health Sciences Clinical Trial Non-degree Award
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