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  
Joseph  Matovu KB
ID: UNCST-2020-R014654
Reducing hazardous alcohol use and optimizing treatment as prevention among men living with HIV in risk environments
REFNo: HS5558ES

Understand barriers and facilitators in the inner and outer context for implementing the components of Kisoboka within the routine clinical setting to inform future widespread implementation guided by the Exploration, Preparation, Implementation and Sustainment (EPIS) framework and documentation of intervention and implementation costs. ,Assess the impact of the Kisoboka intervention and its components on measures of psychological, physical, and socioeconomic well-being that capture frequent comorbidities of people living with HIV and are associated with achieving successful treatment as prevention,Determine the efficacy of the Kisoboka intervention and its components on alcohol and HIV outcomes among hazardously drinking men living with HIV in Uganda in a 2x2 factorial RCT. ,Assess the efficacy of Kisoboka and its components (BE & MI) to gain insight into Kisoboka’s potential effect, determine if BE and MI interact and examine barriers and facilitators for implementing Kisoboka within routine clinical settings to inform future widespread implementation.,
Buikwe, Kawolo
Buikwe, Buikwe Mbiko
Buikwe, Nyenga
Buikwe, Ngogwe
Buikwe, Buikwe Ssi
Buikwe, Makonge
Buikwe, Buikwe Njeru
Nakasongola, Nakasongola Town
Nakasongola, Lwampanga
Nakasongola, Kalungi
Nakasongola, Nabiswera
Nakasongola, Nakayonza
Uganda 2025-02-14 15:19:41 2028-02-14 820 Eligibility is men aged ≥18, living with HIV, residing in a fishing community (on most days/nights), AUDIT-C positive (≥4) indicating potential hazardous alcohol drinking and >6 months since initial ART initiation, last VL was detectable or missing, not planning to move from the area within the next 6 months and have their own mobile phone and can be reached via phone. National Institute of Health (NIH) Medical and Health Sciences Clinical Trial Non-degree Award
David Mukunya
ID: UNCST-2022-R010707
A phase III, randomized, open-label, clinical trial to evaluate the safety and efficacy of emollient therapy for very low birthweight infants (<1500g) in Uganda in promoting survival, health, growth and development compared to no emollient treatment
REFNo: HS5338ES

To evaluate the efficacy of emollient therapy with SSO – compared to standard care without use of emollients – among hospitalised very low birth weight (VLBW, <1500g) infants in Uganda on: the rate of in-hospital mortality, serious infections, hypothermia, growth, intraventricular haemorrhage, and skin condition; maternal depression and anxiety; maternal and neonatal interaction; infant growth and neurodevelopment at 12 month corrected age (chronological age reduced by the number of weeks born before 40 weeks of gestation); and infant mortality.
Mbale, Hospital Cell
Uganda 2025-01-31 7:21:53 2028-01-31 1242 Preterm infants who are admitted to MRRH-NNU. Inclusion criteria: • Admission weight 800g to <1500g • Admission age < 24 hours • Mother +/- father who can understand English, Luganda, Lugwere, Ateso or Lumasaba • Mother +/- father who are willing and able to give verbal consent for participation of their infant in the study. • Mother aged 15 years or above Exclusion criteria: • Mother or father are not willing or are unable to give written, informed consent for participation of their infant in the study within 48 hours of admission to the NNU • Second or later birth order or a multiple pregnancy, when the first or an earlier birth order infant is eligible for participation • Infants with major congenital abnormality e.g. gastroschisis, cyanotic heart disease, upper airways abnormality • Critically ill infants at time of enrollment: Babies with apnoeas requiring frequent stimulation or bag mask ventilation; shock (heart rate >200 beats per minute and/or Mean Arterial Pressure <Gestational Age); Severe respiratory distress (Downs Score ≥8); Respiratory Failure (Oxygen saturation <90% on oxygen therapy/bCPAP) • Infants with generalized skin disease or a structural defect involving >5% body surface area likely to produce a defect in epidermal barrier function. • Mother and father unwilling to come back to Mbale RRH for follow-up Mbale Clinical Research Institute Medical and Health Sciences Clinical Trial Non-degree Award
JUDITH NASSAAZI
ID: UNCST-2023-R007664
Comparing in-person versus virtual postoperative review appointments for children following guided growth surgery at CORSU Hospital, Uganda
REFNo: HS5268ES

Study Objectives
Primary objectives
To compare the show-rates of in-person versus virtual/telehealth post-operative review appointments for children following guided growth surgery at CoRSU Hospital

Secondary objectives.
1.To compare parental satisfaction of in-person versus virtual appointments
2.To determine the factors that facilitate in-person and virtual appointments following guided growth surgery.
3.To compare the rate of post-operative complications following in-person follow-up versus virtual follow-up
Wakiso, KISUBI
Uganda 2025-01-22 10:12:27 2028-01-22 82 FROM AGE 3 TO 12 IN GIRLS AND 3 TO 16 IN BOYS ALL TRIBES AND BOTH MALES AND FEMALES ARE INCLUDED IN THE STUDY SELF SPONSORED AND PARTIAL FUNDING BY UNIVERSITY OF CARLIFORNIA SANFRANCISCO Medical and Health Sciences Clinical Trial Non-degree Award
Justine Namuli Diana
ID: UNCST-2021-R011844
ENHANCING COMPREHENSION OF INFORMED CONSENT IN RESEARCH INVOLVING PATIENTS WITH PSYCHOTIC DISORDERS USING AUDIO-VISUAL AIDS
REFNo: HS5358ES

To evaluate the comprehension of informed consent, identify key factors that are associated with comprehension of consent, determine the feasibility, acceptability, and preliminary effectiveness of audio-visual aids on enhancing the comprehension of consent information during the consenting process in research involving individuals with psychotic disorders
Kampala, Butabika
Uganda 2025-01-10 12:00:57 2028-01-10 study 1=418, study 2,8 participants, study 3,60 participants,study 4 not less than 18 Ugandans aged 18 years and above, all gender Makerere University international bioethics research training PhD program (GRANT NUMBER D43TW010892) Medical and Health Sciences Clinical Trial Degree Award
Francis Ssali
ID: UNCST-2021-R012134
A5409: A Phase 2 Randomized, Adaptive, Dose-Ranging, Open-Label Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis (RAD-TB)
REFNo: HS4036ES

1.2 Primary Objectives

1.2.1 To compare MGIT liquid culture TTP slope over the first 6 weeks of treatment for each experimental treatment arm to the SOC arm.

1.2.2 To compare new Grade 3 or higher adverse events (AEs) (safety) over the first 8 weeks of treatment for each experimental treatment arm to the SOC arm.

1.3 Secondary Objectives

1.3.1 To compare time to stable culture conversion by MGIT liquid culture by week 8 for each experimental treatment arm to the SOC arm.

1.3.2 To compare MGIT liquid culture TTP slope over the first 8 weeks of treatment for each experimental treatment arm to the SOC arm.

1.3.3 To compare new Grade 3 or higher AEs (safety) over 26 weeks of treatment for each experimental treatment arm to the SOC arm.

1.3.4 To compare discontinuations of anti-TB drugs for any reason prior to 8 and 26 weeks of treatment for each experimental treatment arm to the SOC arm.

1.3.5 To determine the dose- and exposure-response relationships between experimental drug estimated pharmacokinetic (PK) parameters with safety and efficacy.

1.3.6 To compare a composite of efficacy and safety outcomes using a risk-benefit approach for each experimental treatment arm to the SOC arm.

1.3.7 To compare MGIT liquid culture TTP slope over the first 6 weeks of treatment for Arms 3A-3B and Arms 4A-4B compared to Arm 2.

1.3.8 To compare durable cure by 52 weeks after treatment initiation in each experimental treatment arm to the SOC arm.


Kampala, Kampala
Wakiso, Wakiso
Uganda 2024-12-23 12:34:14 2027-12-23 45 participants in each experimental treatment arm and at least 90 participants in the SOC arm. The JCRC site plans to recruit at least 50 participants Participants with Xpert MTB/RIF positive drug-susceptible pulmonary TB, living with and without HIV, aged ≥18 years. National Institute of Allergy and Infectious Diseases (NIAIDS) Medical and Health Sciences Clinical Trial Non-degree Award
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