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  
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
Herbert Kayiga Kayiga
ID:
EFFECTIVENESS, ACCEPTABILITY AND UPTAKE OF EARLY VERSUS STANDARD INTRAUTERINE CONTRACEPTION FOLLOWING PROVISION OF FIRST TRIMESTER MEDICAL POST ABORTION CARE IN CENTRAL UGANDA
REFNo: HS2111ES

1. To determine the proportion of women who take up IUC after mPAC for 1st trimester incomplete abortion. 2. To compare the expulsion rates at six months between early versus standard IUC insertions post mPAC treatment for first trimester incomplete abortion. 3. To compare the IUC continuation rates at six months between early versus standard IUC insertion post mPAC treatment for first trimester incomplete abortion. 4. To explore the women and their spouses' perception on Long Acting Reversible Contraceptives (LARC) and IUC following mPAC treatment. 5. To explore the Healthcare providers' perception on LARC and IUC following mPAC treatment.
Wakiso, Kasangati
Kampala, Namirembe
Buikwe, Kawolo
Mpigi, Mpigi
Luweero, Luweero
Mukono, Kawolo
Masaka, Masaka
Mityana,
Kayunga,
Gomba,
Uganda 2022-05-10 9:21:09 2025-05-10 2076 Women with first trimester incomplete abortion irrespective of tribe and nationality undergoing medical management will receive written and oral information about the study from the attending physician according to the principles of the Helsinki Declarati Prof Kristrina Gemzell Medical and Health Sciences Clinical Trial Degree Award
ANTHONY NUWA
ID: UNCST-2022-R011102
A hybrid effectiveness-implementation study to assess the effectiveness and chemoprevention efficacy of implementing seasonal malaria chemoprevention in five districts in Karamoja region, Uganda
REFNo: HS2212ES

5) To monitor the safety and torelabilty of DP as compared to SPAQ among children 6-59 months in Karamoja when used in SMC,4) To understand the SMC implementation model, determining process, costing and acceptability outcomes for the intervention,3) To investigate the presence and change of SPAQ and DP resistance markers over time as a result of SMC implementation ,2) To determine chemoprevention efficacy of SPAQ and DP when used for SMC in Karamoja region, Uganda, and the extent to which efficacy is impacted by drug resistance and/or drug concentrations. ,1) To determine the effectiveness of SMC with DP and SPAQ in terms of its reduction in incidence of malaria infection among children aged 3–59 months,Phase 2 of this study aims to test the feasibility, effectiveness and chemoprevention efficacy of SMC with SPAQ and DP in Karamoja region in Uganda, where malaria transmission is highly seasonal, and inform malaria policy in Uganda. Accelerated adoption and scale-up of SMC will support efforts to accelerate progress in malaria control in high-burden countries.,
Amudat, All
Nakapiripirit, All
Kotido,
Moroto, All
Uganda 2022-05-05 11:23:22 2025-05-05 5550 3-59 months Bill and Melinda Gates Foundation Medical and Health Sciences Clinical Trial Non-degree Award
Isaac Ssewanyana
ID: UNCST-2020-R014336
Performance evaluation of an improved point-of-care test (dual target) SAMBA HIV-1 qualitative test for early infant diagnosis of HIV-1 infection in resource-poor healthcare settings
REFNo: HS2219ES

To verify the field performance (sensitivity and specificity) of the improved, dual-target SAMBA II HIV-1 Qual Test against routine Cobas Ampliprep/Taqman HIV-1 Qualitative Test Version 2.0 (DBS)- for early diagnosis of HIV-1 in exposed infants and adults. In addition, discrepant results will be analysed using Cepheid Xpert HIV-1 Qual ,
Uganda 2022-05-04 11:32:24 2025-05-04 0 Infants and Adults, between 1.5 months of age and all adults of all tribes Diagnostics for Real World (DRW) Medical and Health Sciences Clinical Trial Non-degree Award
Dennis Muhanguzi
ID: UNCST-2019-R001101
Evaluation of the Safety , Efficacy and Stability of Sangatraz®-125 & Sangatraz®-250: A Randomised Single-Blinded Positive Controlled Multi-Site Acaricides Field Trial
REFNo: A186ES

General objectives To determine the efficacy, safety and stability of Sangatraz®-125 & Sangatraz®-250(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 to determine; i.efficacy of Sangatraz®-125 & Sangatraz®-250 when applied onto cattle by hand spraying and plunge dipping for tick control. ii.safety of Sangatraz®-125 & Sangatraz®-250 when applied onto cattle by hand spraying and plunge dipping for tick control. iii.Stability of Sangatraz®-125 & Sangatraz®-250 when applied onto cattle by plunge dipping for tick control.
Mayuge, Musoli
Mayuge, Wabulungu ward
Mayuge, Katonte
Mayuge, Nkombe
Gomba, Madu Parish
Gomba, Kyayi Parish
,
Uganda 2022-04-25 2025-04-25 n= 1,579 Cattle on 10 farms [5 farms in Gomba District and the other 5 from Mayuge District]. These will be both female and males above 2 months of age. All cattle breeds will be recruited Sanga Vet. Chem. Ltd P.O Box 75164 | Plot 1144, Kampala Industrial Business Park | Kampala-Uganda Tel: 02008000100 | Web: https://www.sangavetchem.com/ Agricultural Sciences Clinical Trial Non-degree Award
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
Pontiano  Kaleebu
ID: UNCST-2020-R019901
Performance evaluation of the CheckNOW™ HIV Self-Test study
REFNo: HS2170ES

1. To evaluate the performance (Sensitivity and specificity) of the CheckNOW™ HIV SELF TEST when compared to the Genscreen ULTRA HIV1/2 Ag/Ab EIA followed by the Murex diasorin HIV1/2 Ag/Ab combination (reference testing) in the laboratory and the national testing algorithm.

2. To describe the clinical performance (sensitivity and specificity) of the CheckNOW™ HIV SELF TEST, as obtained by the professional users, when compared to the reference testing and the national testing algorithm.

3. To describe the clinical performance (sensitivity and specificity) of the CheckNOW™ HIV SELF TEST, as obtained by the lay users, when compared to the reference testing and the national testing algorithm.

4. To assess the accuracy of the lay user interpretation of the HIVST result. This will be compared with the interpretation by the RA.
5. To assess the usability of the CheckNOW™ HIV SELF TEST. The usability of the test will be evaluated by questionnaires completed by the study staff observers and by the lay users.



Kampala, Kampala
Kalungu, Kalungu
Kayunga, Kayunga
Mukono, Mukono
Uganda 2022-04-01 2025-04-01 1000 Adults aged 18 years and above who are willing to have an HIV test. - Abott Diagnostics Medical and Health Sciences Clinical Trial Non-degree Award
Fred Ssewamala
ID: UNCST-2020-R014060
Suubi4Stronger Families: Addressing Child Behavioral Health by Strengthening Financial Stability and Parenting among Families in Uganda
REFNo: SS1205ES

The study examines the mechanisms by which economic empowerment (EE) and family strengthening (FS) interventions targeting social, familial and context-specific drivers affect childhood behavioral health.

Specific aims of the study are:

Aim 1: Examine the impact of EE only, MFG-based FS only, and combined EE+MFG-based FS on children’s DBD symptoms and behavioral functioning.

Aim 2: Test the influence of EE only, MFG-based FS only, and combined EE+MFG-based FS on family financial stability (e.g., food and housing stability, material assets, savings), parenting and protective family
processes (e.g., family organization, caregiver/child interaction, cohesion, support) and perceptions related to
help seeking (e.g., stigma) on CBH and functioning; and assess whether these change mechanism mediate intervention effects on DBD symptoms and behavioral functioning, and explore moderation by context specific moderators of intervention effects.

Aim 3: Qualitatively examine participants’ experiences with each intervention arm.
Masaka, Kimaanya
Rakai, Kakuuto
Kyotera, Kyotera TC
Lwengo, Lwengo
Kalungu, Bukulula
Uganda 2022-03-30 2025-03-30 900 A total of 900 primary-school-going children (ages 10-14 at enrollment) in upper primary (the last 3 year of primary school: P5-P7), both male and female will be enrolled and followed for three school-academic terms(12 months). To avoid stigma that surro National Institute of Mental Health (NIMH) Social Science and Humanities Clinical Trial Non-degree Award
SIMON ARUNGA
ID: UNCST-2021-R013498
Cluster randomised controlled trial of a complex intervention package to reduce blindness from severe microbial keratitis in Uganda.
REFNo: HS1814ES

To determine if a complex intervention package delivered at the Primary Health Centres (PHCs) including early recognition, prompt chlorhexidine 0.2% treatment and rapid referral can result in reduced rates of blindness from severe MK at three months
Ntungamo, All parishes
Isingiro, All parishes
Uganda 2022-03-21 2025-03-21 Participants Individuals with corneal abrasions and corneal infection (microbial keratitis) presenting at the cluster primary health centres in these two districts in South Western Uganda will be elig All individuals aged 18 and above, of all sexes in the two districts London School of Hygiene and Tropical Medicine Medical and Health Sciences Clinical Trial Non-degree Award
Johanna  Blomgren
ID: UNCST-2021-R012309
MIDWIZE - Strengthening midwives to implement and sustain quality improvements to optimise maternity care: A longitudinal observational study in Uganda
REFNo: HS1885ES

This PhD project aims to explore how midwives can take the lead in implementing or enhancing QI components within maternal health care in Uganda. The overall goal of this project is to improve the health of women and newborns. The way to achieve this is through enhancing the quality of care by capacitating midwives. Sub-study 1 - Co-creating and developing the intervention and the implementation Specific objectives: To explore multisectoral stakeholders' perspectives and ideas on how to strengthen midwives' capacity to implement QI components. To explore which QI components the midwives will implement or enhance. Sub-study 2 - Implementation and evaluating the sustainability of the implementation Specific objectives: -To measure the uptake of evidence-based QI components when midwives lead, organise and provide enhanced intra- and postpartum care. -To measure the long-term sustainability of the midwives' QI projects. Sub-study 3 – Process evaluation Specific objective: To evaluate the process of strengthening midwives' capacity to implement QIs in maternal care.
Kampala,
Sweden 2022-03-21 2025-03-21 668 Study 1 Midwives at Naguru hospital, women and their relatives, other professionals and managers, multisectoral stakeholders (professional association, education, policymakers) Study 2 Pregnant women above 18 years in the uptake area. However, dependin Karolinska Institutet Medical and Health Sciences Clinical Trial Degree Award
Pontiano Kaleebu
ID: UNCST-2021-R013577
A Randomized, Observer-Blind, Phase 2 Clinical Trial of COVAC-2 in Generally Healthy Adults
REFNo: HS2124ES

Primary Objective:
• To evaluate the safety and tolerability of the COVAC-2 vaccine (25 ?g dosing of S1 antigen) in generally healthy adults ages 18+.
Secondary Objectives:
• To determine spike-binding and pseudovirus neutralizing antibody responses against the Wuhan strain of SARS-CoV-2 induced by COVAC-2; and
• To determine a cellular immune response induced by COVAC-2.
Exploratory Objectives:
• To determine Receptor-Binding Domain (RBD)-binding antibody responses induced by COVAC-2; and
• To determine the neutralizing antibody response induced by COVAC-2 against one or more Variant(s) of Concern (VOC) and/or Variant(s) of Interest (VOI).


Wakiso, NOT APPLICABLE
Mbarara, NOT APPLICABLE
Masaka, NOT APPLICABLE
Uganda 2022-03-21 2025-03-21 300 The target population for this Phase 2 study is generally healthy adults of diverse gender ? 18 years of age. The target indication for the candidate COVAC-2 vaccine is adults because they are a population that experiences significant age-related COVID-19 The study is funded by the Government of Canada through the University of Saskatchewan’s Vaccine and Infectious Disease Organization (VIDO). Medical and Health Sciences Clinical Trial Non-degree Award
Pauline Byakika-Kibwika
ID: UNCST-2019-R001206
Exposure-Response Evaluation of IV Artesunate in Children with Severe Malaria
REFNo: HS2027ES

Primary:
• To determine the relationship between dihydroartemisinin (DHA) exposures following intravenous dosing and markers of physiologic dysfunction associated with severe malaria
Secondary:
• To determine the relationship between DHA exposures and time to hospital discharge
• To determine the relationship between DHA exposures and parasite clearance associated with treatment of severe malaria.
Exploratory:
• To determine the relationship between DHA exposures and neurodevelopmental outcomes associated with treatment of severe malaria outcomes and explore predictors that may affect this relationship
• To evaluate the role of parasite clearance as a mediator of the relationship between DHA exposures and markers of physiologic dysfunction associated with severe malaria
• To develop a score comprised of markers of physiologic dysfunction and describe its relationship to clinical outcomes
• To assess P. falciparum infections for artemisinin resistance

Tororo, central division
Uganda 2022-03-14 2025-03-14 100 Children with severe malaria who are 6 months to 14 years of age living in or near Tororo District, Uganda VTEU Contract HHSN2722013000221 Medical and Health Sciences Clinical Trial Non-degree Award
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