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  
Etheldreda Nakimuli-Mpungu
ID: UNCST-2020-R014808
Tele-Psychotherapy for Youth using Mobile Phones during Covid-19 Pandemic
REFNo: HS2106ES

1. We aim to conduct online and community-based participatory qualitative research to obtain information on the potential usefulness of individual tele-support psychotherapy in addressing depression during the Covid-19 pandemic.
2. We will compare the effectiveness of individual tele-support psychotherapy (TSP) delivered by trained lay counsellors in combination with standard mental health services (SMHS) for depression with use of SMHS alone.
3. We aim to compare the effects of TSP combined with SMHS and SMHS alone on other psychosocial variables including self-esteem, anxiety, alcohol and substance use, social support, stigma, number of disability days, asset possession, poverty indices, and cost-effectiveness measures.
4. To conduct a process evaluation of trial activities informed by Linnan and Steckler’s process evaluation frameworks to specifically determine indicators of feasibility, acceptability, fidelity, and to explore causal mediating processes and contextual influences
5. We will also explore whether or not the effects of TSP and SMHS are moderated by alcohol and drug use.
6. We shall explore whether the strength of a therapeutic relationship will mediate the effects of TSP and SMHS on depression
Kampala, Makerere
Kampala, Kamwokya Parish
Kampala, Naguru Ii Parish or Go down
Uganda 2022-04-21 2025-04-21 300 To be eligible for the study, each participant must be 15-30 years old, diagnosed with significant depression symptoms assessed with the self reporting questionnaire, residing in Naguru Go-down and Kamwokya slums, or Makerere University campus. USAID (DIV) Medical and Health Sciences Clinical Trial Non-degree Award
Nahwera Loyce
ID:
EFFECTS OF 12-WEEKS AEROBIC DANCE ON BLOOD PRESSURE, PERCENT BODY FAT AND hs-CRP IN HYPERTENSIVE PATIENTS ATTENDING KYAMBOGO MEDICAL CENTRE, UGANDA
REFNo: HS2202ES

1. To establish the baseline systolic and diastolic blood pressure, percent body fat and hs-CRP levels in stage 1 hypertensive patients attending Kyambogo University Medical Centre in Kampala, Uganda.
2. To determine the effect of a 12-week aerobics dance programme on Systolic Blood Pressure (SBP) levels in stage 1 hypertensive patients attending Kyambogo University Medical Centre in Kampala, Uganda.
3. To determine the effect of a 12-week aerobics dance programme on Diastolic Blood Pressure (DBP) levels in stage 1 hypertensive patients attending Kyambogo University Medical Centre in Kampala, Uganda.
4. To establish the effect of a 12-week aerobics dance programme on percent body fat in stage 1 hypertensive patients attending Kyambogo University Medical Centre in Kampala, Uganda.
5. To determine the effect of a 12-week aerobics dance programme on hs-CRP levels in stage 1 hypertensive patients attending Kyambogo University Medical Centre in Kampala, Uganda.

Kampala, Kyambogo
Uganda 2022-04-19 2025-04-19 76 participants ( 34 in both experimental and control group) The target population will be stage 1 hypertensive patients attending KUMC. The study focuses on age group 30-55 years. Regional Universities Forum for Capacity Building in Agriculture Medical and Health Sciences Clinical Trial Degree Award
Haruna Muwonge
ID: UNCST-2019-R000128
A Randomized, Double-Blinded, Placebo-Controlled, Phase III, Clinical Trial of SARS-CoV-2 Vaccine, Inactivated (Vero Cell) in Adults Aged 18 Years and Above
REFNo: HS2185ES

Safety: To evaluate adverse events from the first dose and the booster dose to Day 28 after the whole-course immunization and serious adverse events from the first dose and the booster dose to at least 12 months after the whole-course immunization,Efficacy: To evaluate the efficacy of the SARS-CoV-2 Vaccine, Inactivated (Vero Cell) for symptomatic and laboratory-confirmed (RT-PCR method) COVID-19 cases caused by different SARS-CoV-2 variants,Immunogenicity: To evaluate the immune persistence of the investigational vaccine,Immunogenicity: To demonstrate the consistency of 3 lots of investigational vaccine in terms of GMT 14 days after the whole-course immunization,Immunogenicity: To evaluate the levels of neutralizing antibody and IgG antibody against SARS-CoV-2 14 days after the whole-course and after the booster immunization,Efficacy: To evaluate the efficacy of the SARS?CoV?2 Vaccine, Inactivated (Vero Cell) against symptomatic and laboratory-confirmed (RT?PCR method) severe COVID-19 disease,Efficacy: To evaluate the efficacy of the SARS?CoV?2 Vaccine, Inactivated (Vero Cell) after at least one dose, 2 doses, and after the booster dose of immunization,To evaluate the efficacy, safety and immunogenicity of the SARS?CoV?2 Vaccine, Inactivated (Vero Cell) in adults aged 18 years and above after a 2-dose schedule, and after booster vaccination,
Kayunga, Ntenjeru
Jinja, Nakasero
Mityana, Central Ward
Mubende, Kyaterekera
Gulu, Agwee
Wakiso, Central Ward
Mukono, Ggulu Ward
Kampala, Mulago I
Uganda 2022-04-07 2025-04-07 5000 Adults 18years and above, male and female, all tribes that fulfill the study inclusion criteria Institute of Medical Biology Chinese Academy of Medical Sciences Medical and Health Sciences Clinical Trial Non-degree Award
Miriam Nakalembe
ID: UNCST-2021-R014040
Simplified Treatment for Eclampsia Prevention using Magnesium sulfate: A phase III, randomized, open label, active controlled, multicountry, multicentre, non-inferiority trial of simplified magnesium sulfate regimen for eclampsia prophylaxis (The STEP-Mag Trial).
REFNo: HS2076ES

The primary objective of this trial is to evaluate non-inferiority of magnesium sulfate 10g IM administered 12 hourly x 2 doses compared with a standard IV (Zuspan) or IM (Pritchard) magnesium sulfate regimen1 in the prevention of maternal eclamptic seizure.

The secondary objective of this trial is to evaluate superiority of magnesium sulfate 10g IM administered 12 hourly x 2 doses compared with a standard IV (Zuspan) or IM (Pritchard) magnesium sulfate regimen in the proportion of women experiencing adverse events indicative of magnesium toxicity.
Kampala, Kawempe
Uganda 2022-04-02 2025-04-02 1500 Uganda The target trial population are women admitted to participating hospitals with pre-eclampsia during pregnancy, labour or within 24 hours of childbirth, whether it involves a single or multiple gestation. World Health Organisation Medical and Health Sciences Clinical Trial Non-degree Award
Thereza Piloya Were
ID: UNCST-2019-R000491
Diabetes in African Youth: Improving Glucose Time-In-Range (DAY Time) Randomized Clinical Trial.
REFNo: HS2129ES

Primary Study Objectives
1. To determine if patient ability to continuously observe plasma glucose levels for 6 months using a flash intermittently scanned CGM improves glucose TIR compared to baseline. The change in glucose TIR while wearing the unblinded CGM will be compared to change in TIR in patients performing 3x/day SMBG (wearing a blinded CGM for endpoint measurement).
2. To perform a cost analysis on flash glucose monitoring compared to 3x/day SMBG, to determine whether this technology is cost effective in the setting of a low-resource nation.
Secondary Objectives: To assess the change-from-baseline impact of unblinded CGM on:
1. Percent time-in-range at 12 months
2. Percent time with glucose 180-250, >250, <70, and <54 mg/dl at 6 and 12 months
3. HbA1c at 6 and 12 months
4. Patient satisfaction and quality of life at 6 and 12 months
5. Glucose variability (coefficient of variation, CV) at 6 and 12 months

Kampala, Mulago
Kampala, Nsambya
Uganda 2022-04-01 2025-04-01 180 randomized in 2 groups : - 90 per group Inclusion Criteria ? Children and youth in Uganda, age 4-26 years at baseline ? T1D of at least 12 months duration at baseline ? Receiving insulin therapy ? Access to a cell phone (nearly ubiquitous in Uganda, even in remote areas) ? Participant/pare United States of America, National Institute of Health Medical and Health Sciences Clinical Trial Non-degree Award
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