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  
Maxensia owor
ID: UNCST-2021-R014003
 An open-label randomised controlled trial comparing novel combination and currently used antibiotic regimens for the empiric treatment of neonatal sepsis with a run-in confirmatory pharmacokinetic phase: NeoSep1
REFNo: HS5639ES

In Part 2, a secondary objective is to provide a ranking of clinically relevant antibiotic regimens based on other efficacy and safety secondary outcomes, as well as on health economic measures and the potential selection of resistance. The trial data will provide data to inform the balance between efficacy, safety, costs (and cost-effectiveness and equity, using health economic analysis) and propensity for resistance selection (based on microbiology tests) that will influence facility-level and national decision-making about adoption of studied regimens, and potential future inclusion in WHO guidelines.,In Part 2, the primary objective is to provide a ranking of eight different clinically relevant antibiotic regimens for first-line empiric and second-line (after lack of response/deterioration) treatment in terms of 28-day mortality as the primary outcome measure. It will flexibly compare these multiple different relevant treatment regimens to enable the trial to be run in sites worldwide with very different background rates of different pathogens, of resistance and patterns of routine clinical care by randomising each participant to locally relevant antibiotic regimens agreed prior to site initiation. The trial will ensure generalisability by focusing inclusion based on clinical symptoms associated with high mortality risk in the NeoOBS study, which have been developed into a novel neonatal sepsis severity score – the NeoSep Severity Score.,
 Kampala, Kawempe
Kampala, Mulago
 Uganda 2025-04-02 9:04:16 2028-04-02 400 for the MU-JHU site.Approximately 3000 participants across all participating sites. Neonates≤28 days of age hospitalised with clinical signs of neonatal sepsis. Global Antibiotic Research & Development Partnership (GARDP) Medical and Health Sciences Clinical Trial Non-degree Award
Sylvia Kusemererwa
ID: UNCST-2019-R001717
 A phase III, multi-center, randomized, placebo-controlled, double-blind study to assess efficacy and safety of crizanlizumab (5 mg/kg) versus placebo, with or without hydroxyurea/hydroxycarbamide therapy, in adolescent and adult Sickle Cell Disease patients with frequent vaso-occlusive crises
REFNo: HS5607ES

To assess the efficacy and safety of crizanlizumab (5 mg/kg) versus placebo, with or without
hydroxyurea (HU)/hydroxycarbamide (HC) , on VOC rate in Sickle Cell Disease (SCD) patients aged 12 years and older who experience frequent vaso-occlusive crises (VOCs)
Primary Objective
1. To compare the efficacy of 5 mg/kg of crizanlizumab versus placebo, with or without hydroxyurea/hydroxycarbamide, on the annualized rate of VOCs* that are HCP managed (including VOCs leading to management at a health care facility or those via remote consultation) over the planned 52-week treatment period in SCD patients aged 12 years and older with a history of frequent VOCs (4-12 events in 12 months prior to the screening visit).
Secondary Objectives
1. To compare the efficacy of 5 mg/kg of crizanlizumab versus placebo, with or without
hydroxyurea/hydroxycarbamide, on the annualized rate of all VOCs including VOCs that are HCP-managed (including VOCs leading to management at a health care facility or those managed via remote consultation) and VOCs that are self-managed without recommendations from HCP during the event over the planned 52-week treatment period in SCD patients aged 12 years and older with a history of frequent VOCs (4-12 events in the 12 months prior to the screening visit).
2. To evaluate the annualized rate of VOCs by type of management between treatment arms over the planned 52-week treatment period:
 VOCs that are HCP-managed at a health care facility
 VOCs that are HCP-managed via remote consultation
Page 4 of 18
 VOCs that are self-managed without recommendations from HCP during the event
 VOCs that are HCP-managed via remote consultation or self-managed without recommendations from HCP during the event
 Masaka, Masaka
 Uganda 2025-04-02 8:58:47 2028-04-02 20 A total of 10-20 participants will be recruited at the MRC/UVRI and LSHTM Uganda Research Unit site. Recruitment will be competitive across sites and countries. Participants will be recruited through referrals from the sickle cell clinic at the Masaka Regional Referral Hospital. The clinic has a total of about 600 patients. The site will recruit participants according to the main study protocol using the inclusion and exclusion criteria stated. They will collect detailed locator information including addresses, telephone contact, and next of kin to facilitate phone and/or physical tracing during the follow-up phase of the study. LSHTM Medical and Health Sciences Clinical Trial Non-degree Award
Henry Mugerwa
ID: UNCST-2019-R000420
 A phase III, Multicenter, Randomized, Placebo Controlled, Double-blind Study to Assess Efficacy and Safety of Crizanlizumab (5 mg/kg) versus placebo, with or without Hydroxyurea/Hydroxycarbamide Therapy, in Adolescent and Adult Sickle Cell Disease Patients with Frequent Vaso-Occlusive Crises
REFNo: HS5274ES

Primary Objective: To compare the efficacy of 5 mg/kg of crizanlizumab versus placebo, with or without hydroxyurea/hydroxycarbamide, on the annualized rate of VOCs* that are HCPmanaged (including VOCs leading to
management at a health care facility or those managed via remote consultation) over the planned 52-week treatment period in SCD
patients aged 12 years and older with a history of frequent VOCs (4-12 events in 12 months prior to the screening visit).

Secondary Objective: Key secondary objective:

To compare the efficacy of 5 mg/kg of
crizanlizumab versus placebo, with or without
hydroxyurea/hydroxycarbamide, on the
annualized rate of all VOCs including VOCs that are HCP-managed (including VOCs leading to
management at a health care facility or those managed via remote consultation) and VOCs that are self-managed without recommendations from HCP during the event over the planned 52-week treatment period in SCD patients aged 12 years and older with a history of frequent VOCs (4-12 events in the 12 months prior to the screening visit).

To evaluate the annualized rate of VOCs by type of management between treatment arms over the planned 52-week treatment period:
VOCs that are HCP-managed at a health
care facility
• VOCs that are HCP-managed via remote
consultation
• VOCs that are self-managed without
recommendations from HCP during the
event
• VOCs that are HCP-managed via remote
consultation or self-managed without
recommendations from HCP during the
event

• To evaluate the time to first VOC that is HCPmanaged (including VOCs leading to
management at a health care facility or those managed via remote consultation) between treatment arms over the planned 52-week treatment period.

To evaluate the proportion of participants free from VOCs that are HCP-managed (including VOCs leading to management at a health care facility or those managed via remote consultation) between treatment arms over the planned 52-week treatment period.

To evaluate the duration of VOCs that are HCP-managed (including VOCs leading to management at a health care facility or those managed via remote consultation) between treatment arms over the planned 52-week treatment period.

To evaluate the safety and immunogenicity of crizanlizumab 5 mg/kg over the 2-year study
period.

To explore the efficacy of crizanlizumab 5 mg/kg over the 2-year study period.

To explore the proportion of VOCs that are selfmanaged without recommendations from HCP during the event, versus VOCs that are HCP-managed (including VOCs leading to
management at a health care facility or those managed via remote consultation) between treatment arms over the planned treatment period of 52 weeks.

To explore the proportion of VOCs that are HCP-managed via remote consultation versus VOCs that are HCP-managed at a healthcare facility between treatment arms over the planned 52-week treatment period.

To explore the incidence rates of all VOCs,
VOCs that are HCP-managed at a healthcare
facility, VOCs that are HCP-managed via remote consultation, VOCs that are HCP-managed,VOCs that are self-managed without
recommendations from HCP during the event,
VOCs that are HCP-managed via remote
consultation or self-managed without
recommendations from HCP during the event, by treatment arm.

To explore quality of life in each treatment arm (ASCQ-Me Short Forms: emotional impact, sleep impact, and joint stiffness).

To explore healthcare facility resource utilization (inpatient hospital admission, emergency room visit, urgent care/clinic visit, infusion center visit)between treatment arms over
the planned 52-week treatment period.

To explore the pharmacokinetics (PK) profile of crizanlizumab at 5 mg/kg.

To explore the pharmacodynamics (PD) (Pselectin inhibition) of crizanlizumab at 5 mg/kg.

To explore biomarkers [p-selectin (free and
total)] and CRP].

To explore exposure-response relationship.
 Wakiso, Lubowa
 Uganda 2025-04-02 8:43:56 2028-04-02 10-15 SCD participants aged 12 years and older who experienced at 4-12 VOCs that are HCP-managed (including VOCs leading to management at a health care facility or those managed via remote consultation) in the 12 months prior to screening visit. Participants who have been taking HU/HC for at least 6 months at a stable dose for at least 3 months and plan to continue taking at the same dose and schedule until the participant has reached 52 weeks of study treatment will be permitted. Participants who have not been receiving HU/HC, and/or erythropoietin stimulating agent must not have received it for at least 6 months prior to the screening visit. Novartis Medical and Health Sciences Clinical Trial Non-degree Award
Ronald Moses Galiwango
ID: UNCST-2024-R015239
 INTEGRATED FEMALE SEXUALLY TRANSMITTED INFECTION TESTING FOR HIV EPIDEMIC CONTROL THROUGH PREP (IN-STEP)
REFNo: HS5715ES

a) To conduct an individually randomized effectiveness implementation trial of SRST plus cSTI testing to increase PrEP use among African women at high HIV risk.
b) To perform a mixed-methods, implementation science evaluation of female cSTI testing for improving PrEP use for HIV prevention.
c) To determine the most efficient, population-level female cSTI testing strategies to reduce HIV incidence in African settings.

Rakai, All parishes in the mentioned subcounty
Kyotera, All parishes in the mentioned subcounty
Lyantonde, All parishes in the mentioned subcounty
 Uganda 2025-03-25 11:13:20 2028-03-25 5000 The targeted population is adolescent girls and women aged 15 - 39 years of age National Institute of Allergy and Infectious Diseases, R01AI177132 (Financial support); Abbott Laboratories (Material support) Medical and Health Sciences Clinical Trial Non-degree Award
Bruce Kirenga J
ID: UNCST-2019-R001460
 SURVEY, SAFETY AND EFFICACY OF HERBAL PRODUCTS USED FOR MALARIA PROPHYLAXIS AND TREATMENT IN UGANDA.
REFNo: HS5468ES

To conduct a survey of herbal medicinal products used for malaria prophylaxis and treatment, evaluate their safety and prophylactic efficacy among school-age children (8-15yrs) in Kibuku district, Uganda.
1. To identify herbal medicinal products used by communities for malaria prophylaxis and treatment in Uganda.
2. To evaluate the artemisinin content of herbal medicinal products used by communities for malaria prophylaxis and treatment in Uganda.
3. To determine the antiplasmodial activity (IC50) of herbal medicinal products used for malaria prophylaxis and treatment in Uganda.
4. To evaluate the safety of herbal medicinal products used for malaria prophylaxis among school age children (8-15 years) in Kibuku district in eastern Uganda.
5. To determine malaria incidence among school age children (8-15 years) receiving selected herbal medicinal products for malaria prophylaxis compared to monthly Dihydroartemisinin-Piperaquine (DP) in Kibuku district in eastern Uganda.
6. To determine prevalence of parasitaemia among school age children (8-15 years) receiving selected herbal medicinal products for malaria prophylaxis compared to monthly Dihydroartemisinin-Piperaquine (DP) in Kibuku in eastern Uganda.

 All Districts, NA
Kibuku,
Uganda 2025-03-14 19:08:33 2028-03-14 222 participants for the trial (111 per study arm) 8 to 15 years of age, both male and female, all tribes accessible. The Government of Uganda through the Science, Technology, and Innovation Secretariat - Office of the President (STI-OP) Medical and Health Sciences Clinical Trial Non-degree Award
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