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
EVALUATION OF THE IMPACT OF THE THREE TIER INTERVENTIONS FOR DISABILITY IN EARLY CHILDHOOD (IDEC) PROGRAMME IN UGANDA
REFNo: HS5596ES

GENERAL OBJECTIVE

The overall aim of this study is to evaluate the impact of the three-tier IDEC model piloted in the two districts of Mubende and Kassanda in Uganda, with a twofold purpose: (1) to improve intervention design and management and (2) to inform decisions about future investment and scale-up by establishing evidence and impact.

SPECIFIC OBJECTIVES.

Primary objectives
1. To determine the coverage of vision screening at 0-3 months and developmental screening at 9 and 18 months in the study sites.
2. To determine the change in functional abilities in children receiving the Tier 2 intervention.
3. To evaluate effects of the individualised (Tier 3) program at regular intervals (at least every 3 months) on child and family functioning, well-being and participation.
Secondary objectives
1. To determine the change in knowledge and skills in parental/caretaker after the Tier 2 interventions.
2. To determine the change in parental/caretaker level of stress after Tier 2 interventions.
3. To determine the change in parental/caretaker level of stress after Tier 3 interventions.

4. To establish the extent to which children with developmental delay and disability Tier 1 are included in ECD programmes
5. To establish the extent to which children with developmental delay and disability tier 2 are included in ECD programmes. (This could be a compliance or fidelity issue
6. To determine how well (fidelity) the health workers provided the Tier 2 and 3 interventions.
7. To determine compliance with Tier 2 and Tier 3 interventions by the caregivers.
8. To determine family satisfaction with all three tiers of the program, including both children that failed and children who passed the screening assessment (Tier I).
9. To determine the costs and cost-effectiveness of the entire program.
10. To assess the likelihood of continuation
Mubende, Kiyuni
Mubende, Kiyuni
Uganda 2025-03-04 13:40:10 2028-03-04 296 Children aged 0-3 months, Children aged 6-36 months,Children with developmental delay, at risk of Celebral Palsy and Austism UNICEF Medical and Health Sciences Clinical Trial Non-degree Award
ISMAHIL ADENIYI ADEKUNLE
ID: UNCST-2024-R002602
EFFECTS OF ETHYL-ACETATE FRACTION OF Bidens pilosa LEAVES ON TESTES AND PITUITARY GLAND OF MALE MICE EXPOSED TO BISPHENOL A
REFNo: HS5372ES

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

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

2.To explore reasons for harmful use of alcohol, and perceptions on effective and acceptable ways of reducing this.,1.To conduct a pilot survey to establish the level of harmful use of alcohol and factors associated with the behaviour , to fill the evidence gap on effective community interventions, the current burden of harmful use of alcohol, and community perceptions of the burden of harmful alcohol use in rural Uganda,
Kabale, Mwendo
Kabale, Bwama
Rubanda, Kagarama
Rubanda, Butobole
Rubanda, Kabere
Uganda 2025-02-20 18:51:21 2028-02-20 0 All adults aged 18 and above with alcohol harmful use National Institute for Health and Care Research Medical and Health Sciences Clinical Trial Non-degree Award
Christine  Muhumuza
ID: UNCST-2023-R008646
Improving Family Wellness for Couples in Central Uganda 2024-2029
REFNo: HS5523ES

The study aims are to:

(1) In a cluster randomised trial, compare the efficacy of the FH=FW intervention vs. a time/attention matched comparator intervention at increasing modern contraceptive use and reducing unintended pregnancy among couples with an unmet need for family planning through 24-months, and identify potential mediators of the intervention effect.

(2) Determine the intervention’s effect on, and determinants of, contraceptive continuation.

(3) Through a mixed-methods process evaluation, explore factors affecting the implementation of the intervention in order to improve feasibility, acceptability, and the likelihood of future adoption and sustainment
Kalungu, Kalungu
Gomba, Kinoni
Mpigi, Bulunda A
Kalungu, Lukaya
Gomba, Kisozi
Mpigi, Muduma
Kalungu, Kabungo
Kalungu, Bbaala
Kalungu, Kabale
Kalungu, Kalungi
Kalungu, Kasambya
Kalungu, Kabungo
Gomba, Bulwadda
Gomba, Kasaka
Gomba, Kyayi
Gomba, Bukalagi
Gomba, Mpenja
Gomba, Ngomanene
Mpigi, Bunjako
Mpigi, Mitala-Maria
Mpigi, Butoolo
Mpigi, Kampiringisa
Mpigi, Katende
Mpigi, Sekiwunga
Mpigi, Kitakyusa
Mpigi, Nsamu/Kyali
Mpigi, Bujuuko/Bulamu
Mpigi, Nindye
Uganda 2025-02-20 17:09:28 2028-02-20 We will sample 4 health centers (clusters) in each of the 3 districts. We expect that the 12 clusters will yield ~1704 participants (852 couples) across the two study arms. Married men and women (couples) aged 18-49 of any tribe in the selected districts. National Institute of Child Health and Development (NICHD), grant number: R01HD113806 Medical and Health Sciences Clinical Trial Non-degree Award
Dennis Muhanguzi
ID: UNCST-2019-R001101
Evaluation of the Safety, Efficacy and Stability of SangaSupa®-30% Emulsifiable Concentrate [EC]: A Randomised Single-Blinded Positive Controlled Multi-Site Acaricide Field Trial
REFNo: NS910ES

General objectives
To determine the efficacy, safety, and stability of SangaSupa® (Sanga Vet. Chem. Ltd, Kampala Industrial Park, Namanve ) when applied onto cattle by hand spraying and plunge dipping for tick control.
Specific objectives
The specific objectives of this acaricide field trial will to determine;-
i. efficacy of SangaSupa® when applied onto cattle by hand spraying and plunge dipping for tick control.
ii. safety of Sangasupa® when applied onto cattle by hand spraying and plunge dipping for tick control.
iii. Stability of Sangasupa® when applied onto cattle by plunge dipping for tick control.
Kyenjojo, Ntuutu
Kyenjojo, Ruhoko
Kyenjojo, Hima
Serere, Bugondo
Serere, Okidi
Kumi, Kachaboi
Uganda 2025-02-14 15:53:01 2028-02-14 n = 797 cattle above three months. For details please refer to the protocol Cattle above 3 months , both male and female. All cattle breeds will be eligible for recruitment. The detailed inclusion and exclusion criteria are described in the main protocol. The Government of Uganda Natural Sciences Clinical Trial Non-degree Award
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