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  
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
Joseph Ngonzi
ID: UNCST-2019-R001579
 Automated visual evaluation and geospatial mapping for cervical cancer screening optimization in sub-Saharan Africa (AVE-Map)
REFNo: HS2069ES

3. To use AVE and geospatial analysis to scale up cervical cancer screening in Uganda ,2. To determine access to cervical cancer screening and referral pathways in Uganda ,1. To validate and expand use of AVE for cervical cancer screening in SSA ,We aim to leverage and develop data science expertise at our sites to first optimize and then combine AVE-based screening by health workers at peripheral health facilities with geospatial-analysis and needs-driven assessment to inform scale-up of cervical cancer screening in Uganda ,
 ,
Mbarara, Kakoba
 Uganda 2022-02-28 2025-02-28 2000 Females aged 25 years and above NATIONAL INSTITUTE OF HEALTH Medical and Health Sciences Clinical Trial Non-degree Award
Musa Sekikubo
ID: UNCST-2021-R014010
 A placebo controlled clinical trial investigating the safety and immunogenicity of GBS6 in pregnant women with and without human immunodeficiency virus (HIV) infection and their infants
REFNo: HS1991ES

1. To describe the safety and tolerability of GBS6 when administered at ? 27 0/7 to ? 35 6/7 weeks’ gestation to pregnant women, with and without HIV, aged ? 18 to ? 40 years of age and their infants..
2. To assess the safety of GBS6 in infants born to HIV positive and negative women who were vaccinated during pregnancy.

 Kampala, Kawempe
Kampala, Kisenyi
Uganda 2022-02-11 2025-02-11 300 pregnant women aged 18 to 40 years at gestation age of ? 27 0/7 to ?35 6/7 weeks. St George’s, University of London Cranmer Terrace SW17 0RE Medical and Health Sciences Clinical Trial Non-degree Award
Aisha Nanyiti
ID: UNCST-2021-R013489
 A Randomized Control Trial (RCT) on the Adoption of Liquefied Petroleum Gas (LPG) Cooking Technology among Fast Food (Chapati) Vendors in Uganda
REFNo: SS1017ES

This study seeks to establish the impact of hire purchase schemes and health and safety information on adoption of LPG cookstoves by chapati vendors.

This study will achieve the following specific objectives:
1) The impact of learning from LPG use in grace period before purchase armotisation on adoption of LPG cookstoves by chapati vendors for their businesses and households.
2) The impact of hire purchase on adoption of LPG cookstoves by chapati vendors for their businesses and households.
3) The impact of information on safety and health benefits of LPG on adoption of LPG cookstoves by chapati vendors for their businesses and households.
4) The impact of peer learning from other vendors using LPG cookstoves on adoption of LPG cookstoves by chapati vendors for their businesses and households.
 Kampala,
Uganda 2022-02-10 2025-02-10 210 chapatti vendors; they are mainly males of age range in 18-45 years from all districts of Uganda. Environment for Development Initiative Social Science and Humanities Clinical Trial Non-degree Award
Robert Kalyesubula
ID:
Effectiveness of a community health worker delivered care intervention for hypertension control in Uganda: a stepped wedge, cluster randomized control trial.
REFNo: HS1917ES

To assess the effectiveness of a CHW-delivered intervention for hypertension control in Uganda.,
 Nakaseke, Kigegge, Bulwadda, Mifunya, Kyamutakasa, Kasambya, Kasagga, North Ward. East Ward. Namilali, Kivule Central Ward
 Uganda 2022-02-10 2025-02-10 900 Hypertensive patients, 18 years and above, attending Nakaseke hospital or Life Care NCD clinics, and residing either in Nakaseke town council, Nakaseke Subcounty or Kasangombe. Else Kroner Fresenius Stiftung Medical and Health Sciences Clinical Trial Non-degree Award
Fred Ssewamala
ID: UNCST-2020-R014060
 M-Suubi: A Multi-Level Integrated Intervention to Reduce the Impact of HIV Stigma on HIV Treatment Outcomes among Adolescents Living with HIV in Uganda
REFNo: SS1166ES

Aim 1: Examine the impact of M-Suubi on HIV viral suppression (primary outcome); and adherence to HIV treatment (keeping appointments, pharmacy refills, pill counts), and retention in care (secondary outcome).

Aim 2: Examine the effect of M-Suubi on Stigma (internalized anticipated, and enacted), with secondary analyses to explore hypothesized mechanisms of change (e.g. depression) and intervention mediation.

Aim 3: Assess the cost and cost-effectiveness of each intervention condition.

Aim 4: Qualitatively examine: a) participants’ experiences with HIV stigma, HIV treatment adherence, and the intervention; and 2) educators’ attitudes towards ALHIV and experiences with GED-HIVSR, and program/policy implementation post-training.

Aim 5: Conduct formative work (focus group discussions) to understand the needs of depressed ALHIV.

 Masaka, Kimaanya
Kalungu, Bukulula
Rakai, Kakuuto TC
Lyantonde, Lyantonde TC
Bukomansimbi, Butenga
Lwengo, Lwengo
 Uganda 2022-02-04 2025-02-04 840 dyads The target populations for this study will be ALHIV, their caregivers (N=840 child-caregiver dyads), and administrators attending 42 boarding schools in the greater Masaka region. Participants will be included in the study if they meet the following inclu National Institute of Mental Health (NIMH) Social Science and Humanities Clinical Trial Non-degree Award
Emmy Okello
ID: UNCST-2020-R009792
 Remote Ischaemic Conditioning in STEMI patients in sub-Saharan AFRICA: The RIC-AFRICA trial
REFNo: HS1865ES

RIC will reduce the rates of all-cause death and early post-myocardial heart failure by approximately 25% when compared to sham control.,The RIC-AFRICA trial will investigate the effect of RIC in STEMI patients on the rates of all-cause death and early post-MI heart failure (pre-discharge HF and hospitalisation for HF at 30 days post-MI,) when compared to sham control,
 ,
Kampala, MULAGO
 Uganda 2022-02-01 2025-02-01 1500 Participants will be recruited from the Uganda Heart Institute and other nearby state and private hospitals with STEMI care with in Uganda and other collaborating sites in Sub-Saharan countries Mancherje-Potash Foundation, USA Medical and Health Sciences Clinical Trial Non-degree Award
Jackson Mukonzo
ID: UNCST-2021-R013916
 Safety and Efficacy of COVIDEX™ Therapy in Management of adult Covid-19 Patients in Uganda: A randomized double-blind placebo controlled adaptive phase 2 B clinical trial.
REFNo: HS2041ES

3. To determine the plasma concentration of berberine in COVID-19 patients receiving COVIDEX. ,2. To determine the efficacy of COVIDEXTm for treatment of COVID-19 among adults in Uganda.,To determine the efficacy of COVIDEXTm for treatment of COVID-19 among adults in Uganda.,To validate the safety and determine the efficacy of COVIDEXTm therapy for treatment of COVID-19 in adult Ugandans. ,
 Mbarara, kakoba
Kampala, mulago 1
 Uganda 2022-01-25 2025-01-25 584 Participants who are categorized as mild score 2 (limitation of activities), moderately ill COVID-19 patients score 3 (Hospitalized with no oxygen therapy), score 4(Hospitalized with oxygen by mask or nasal prongs) and hospitalized severe disease score 5 JENA HERBALS LTD, MINISTRY OF HEALTH UGANDA Medical and Health Sciences Clinical Trial Non-degree Award
Susanne Guidetti Gittel Eleonora
ID: UNCST-2021-R012422
 Participation in everyday life - A randomized controlled trial of mobile phone-supported and family-centred rehabilitation after stroke in Uganda
REFNo: HS1528ES

General objective (Overall aim)
To implement and evaluate the effects a mobile phone supported and family-centred rehabilitation intervention F@ce 2.0 aiming to enable performance in daily activities and participation in everyday life among persons who have had a stroke and their family members both in urban (Kampala and its surroundings) and rural (Greater Masaka) areas.

Specific objectives
• To describe the perceived impact of stroke and perceived participation in everyday life in a sample of people with stroke in rural Uganda. (Study 1)
• To evaluate the effects of F@ce in comparison with ordinary rehabilitation among persons with stroke in urban and rural Uganda regarding a) self-efficacy b) perceived performance and participation in everyday activities c) independence in ADL, d) healthcare utilization and e)their families´ perceived participation in everyday activities.(Study 2)
• To explore and describe the experiences of people with stroke and family members of participating in the F@ce (Study 3)
• To evaluate the implementation process of F@ce and to gain knowledge on the mechanisms of impact as well as the contextual factors that might influence the implementation process and its outcome. (Study 4)
• To determine the cost of delivering the F@ce intervention in comparison with the usual rehabilitation (Study 5)

 Kampala,
Masaka,
Iganga,
Sweden 2022-01-19 2025-01-19 174 The sample size will accommodate for an attrition rate of 10%, based on our pilot study in Uganda, therefore will require the inclusion of a total of 174 participants with stroke, 15 health professionals and 15 caregivers (family members). The study will The Swedish Research Council Medical and Health Sciences Clinical Trial Non-degree Award
Maria NAKACHWA
ID:
Mobile Telephone Communication and Utilization of Antenatal Care Services During Pregnancy. A Case Study of Kyotera and Rakai Districts- Uganda
REFNo: HS1957ES

d. To develop a model for the prediction of ANC uptake when mobile telephone communication is used.,c. To evaluate effects of patient factors in the utilization of antenatal care services among expectant mothers in Kyotera and Rakai Districts , Uganda.,b. To assess patient factors influencing mobile telephone communication among expectant mothers in Kyotera and Rakai Districts, Uganda.,a. To examine effects of mobile telephone communication on the utilization of antenatal care services among expectant mothers in Kyotera and Rakai Districts, Uganda.,
 Rakai, Kitente
 Uganda 2022-01-12 2025-01-12 2214 THE STUDY POPULATION CONSTITUTES OF EXPECTANT MOTHERS AGED 15 TO 49 YEARS RESIDING IN KYOTERA AND RAKAI DISTRICTS FROM ALL THE TRIBES IN THESE COMMUNITIES. SELF SPONDORED Medical and Health Sciences Clinical Trial Degree Award
David Lubogo
ID: UNCST-2020-R014473
 Metabolic Syndrome among Females of Reproductive age in Wakiso district, Central Uganda: Risk factors and Effectiveness of a Community based Nutrition Education Intervention
REFNo: HS1281ES

General objective: To investigate the prevalence of, and factors associated with metabolic syndrome (MetS) and evaluate the effect of a community based nutrition education intervention among females of reproductive age with MetS in Wakiso district, Central Uganda in order to contribute information for the design of interventions for MetS.
Specific objectives
1. To determine the prevalence of, and factors associated with Metabolic Syndrome.
2. To determine optimal WC cut off points for MetS.
3. To determine the effectiveness of a 12 -week community-based nutrition education and counseling intervention for metabolic syndrome on selected cardiovascular outcomes (BP), biochemical outcomes (HDL, TGS, blood sugar), anthropometric measures (WC, weight), behavioral outcomes (dietary intake, physical activity), and on knowledge as an outcome.
4. To explore the female and health care provider perceptions/perspectives towards the nutrition promotion intervention on MetS among female of reproductive age in South Central Uganda.

 Wakiso,
Wakiso,
Uganda 2021-12-28 2024-12-28 840 Females aged 15- 49 years in Wakiso district. Strengthening Education and Training Capacity in Sexual and Reproductive Health and Rights in Uganda (SET-SRHR) and the Government of Uganda Medical and Health Sciences Clinical Trial Degree Award
JIM ARINAITWE
ID: UNCST-2021-R012572
 Quit4Life: Adapting and Evaluating a Phone-Based Tobacco Uses Cessation Program for People Living with HIV in Uganda and Zambia.
REFNo: HS1762ES

The goal of the study is to adapt and evaluate the efficacy of a phone-based tobacco cessation intervention for PLWH in Uganda and Zambia in five years. The primary objective of the study is to promote smoking cessation among HIV infected persons. Specifically, 1) adapt a standard short message service (SMS) for tobacco cessation program, 2) Nicotine Replacement Therapy, 3) compare the efficacy of our SMS-based program tailored to meet the needs of PLWH (Quit4Life+) to the current standard of care.
Arua, Adumi HCIV, Omugo HCIV and River Oli HCIV
Moroto, Loputuk HCIII, Nadunget HCIII and Tapac HCIII
 Uganda 2021-12-28 2024-12-28 Total Sample size is 800 with 400 from Uganda and 400 from Zambia The study will include males and females of consenting age attending HIV services at Health III, IV, District/Regional Referral Hospitals National Institute of Health Medical and Health Sciences Clinical Trial Non-degree Award
JULIET MWANGA-AMUMPAIRE
ID: UNCST-2022-R009420
 An open-label, multicentre, randomized, adaptive platform trial of the safety and efficacy of several therapies, including antiviral therapies, versus control in mild/moderate cases of COVID-19
REFNo: HS1789ES

Primary objective: to compare the efficacy of alternative treatment strategies versus control on the risk of progression to severe respiratory disease
The secondary objectives are:
 To compare the safety of each study arm to control, up to Day 21 of follow-up
 To compare the rate of hospitalizations due to COVID-19 in each study arm versus control
 To compare the time to hospitalization due to COVID-19 in each study arm versus control
 To compare the rate of hospitalizations for other reason than Covid-19 in each study arm versus control
 To compare the disease-free rate in each study arm versus control
 To compare the death rate in each study arm versus control
 To compare time to worsening of SpO2 < 93in each study arm versus control
 To compare the capacity to prevent severe progression between study arms
 To identify risk factors for severe progression
 To assess efficacy in sub-groups of patients e.g. with pre-existing conditions/co-morbidities, by age group, sex, BMI, timeframe between onset of symptoms and randomization.

 Mbarara, Mbarara Medical Cell
 Uganda 2021-12-07 2024-12-07 175 1. Male or female patients, 2. Adult’s  18 years of age at the time of screening. Children > 12 years of age may be included if recommended by the DSMB after the first analysis. 3. COVID-19 confirmed by molecular biology or validated antigenic test Drugs for Neglected Diseases Initiative (DNDi) Medical and Health Sciences Clinical Trial Non-degree Award
Flavia Matovu Kiweewa
ID: UNCST-2021-R013337
 PURPOSE 1: GS-US-412-5624/ A Phase 3, Double-Blinded, Multicenter, Randomized Study to Evaluate Safety and Efficacy of Twice Yearly Long-Acting Subcutaneous Lenacapavir, and Daily Oral Emtricitabine/Tenofovir Alafenamide for Pre-Exposure Prophylaxis in Adolescent Girls and Young Women at Risk of HIV Infection. Version 2.0, dated 10 March 2021.
REFNo: HS1920ES

1. Primary Objectives i) To evaluate the efficacy of LEN for HIV PrEP in AGYW at risk of HIV infection. ii) To evaluate the efficacy of F/TAF for HIV PrEP in AGYW at risk of HIV infection. 2. Secondary Objectives/ end points i) To compare the efficacy of LEN with F/TDF for HIV PrEP in AGYW at risk of HIV infection. ii) To evaluate the efficacy of LEN for HIV PrEP in AGYW at risk of HIV infection in participants adherent to LEN. iii) To evaluate the efficacy of F/TAF for HIV PrEP in AGYW at risk of HIV infection in participants adherent to F/TAF. iv) To compare the efficacy of F/TAF with F/TDF for HIV PrEP in AGYW at risk of HIV infection. v) To evaluate the safety and tolerability of LEN, F/TAF, and F/TDF for HIV PrEP in AGYW at risk of HIV infection. vi) To evaluate the safety and tolerability of LEN and F/TAF for HIV PrEP in AGYW ≥ 16 to < 18 years of age who have sex with male partners and are at risk for HIV infection. 3. Exploratory objectives i) To assess the adherence rate to LEN as assessed by on-time LEN injection ii) To assess LEN plasma levels iii) To assess the adherence rate to F/TAF and F/TDF using intracellular TFV-DP levels in DBS. iv) To evaluate the acceptability of a once every 26 weeks LEN injection for HIV PrEP in AGYW at risk of HIV infection. v) To assess LEN plasma levels during pregnancy. vi) To explore concentrations of hormonal contraceptives in LEN participants.
Mityana, Mityana
Hoima, Hoima county
Masaka, Masaka
Kalangala, Kalangala
 Uganda 2021-11-25 2024-11-25 The study will be conducted in 2 parts: a cross-sectional study (Incidence Phase) and a randomized blinded study (Randomized Phase). The Incidence Phase of the study will remain open until the backg Cisgender AGYW who have sex with male partners, at risk for HIV infection ≥ 16 to ≤ 25 years of age. Gilead Sciences Inc. Medical and Health Sciences Clinical Trial Non-degree Award
Kamya Moses
ID: UNCST-2020-R014203
 Enhancing immunity to malaria in young children with effective chemoprevention
REFNo: HS1763ES

To compare the incidence of malaria from 4 weeks to 4 years of age among children born to mothers randomized to receive intermittent preventative therapy in pregnancy (IPTp) with monthly sulfadoxine pyrimethamine (SP) alone, monthly DP alone, or both monthly SP+DP.

To compare the incidence of malaria from 2-4 years of age among children randomized to receive IPT in childhood (IPTc) with monthly DP from 8 weeks to 1 year of age vs. monthly DP from 8 weeks to 2 year of age vs. no IPTc.

To compare innate and adaptive effector and regulatory responses between children randomized to different IPT arms.

Busia, Masafu
 Uganda 2021-11-24 2024-11-24 924 HIV-uninfected infants Children both male and female, 4 weeks to 4 years of age, resident of Busia District Division of Microbiology and Infectious Diseases (DMID) Medical and Health Sciences Clinical Trial Non-degree Award
Cissy  Kityo
ID: UNCST-2021-R013663
 ACTIV-2/A5401: Adaptive Platform Treatment Trial for Outpatients with COVID-19 (Adapt Out COVID)
REFNo: HS1813ES

1.1 Co-Primary Objectives 1.1.1 Phases II and III: To evaluate safety of the investigational agent. 1.1.2 Phase II: To determine efficacy of the investigational agent to reduce the duration of COVID-19 symptoms through study day 28. 1.1.3 Phase II: To determine the efficacy of the investigational agent to increase the proportion of participants with nasopharyngeal (NP) SARS-CoV-2 RNA below the lower limit of quantification (LLoQ) at study days 3, 7, and 14. 1.1.4 Phase III: To determine if the investigational agent will prevent the composite endpoint of hospitalization due to any cause or death due to any cause through study day 28. Hospitalization is defined as ≥24 hours of acute care, in a hospital or similar acute care facility, including Emergency Rooms or temporary facilities instituted to address medical needs of those with severe COVID-19 during the COVID-19 pandemic. 1.2 Secondary Objectives 1.2.1 Phases II and III: To determine whether the investigational agent reduces a COVID-19 Severity Ranking scale based on COVID-19-associated symptom burden (severity and duration), hospitalization, and death, through study day 28. 1.2.2 Phase II and III: To determine whether the investigational agent reduces the progression of COVID-19-associated symptoms. 1.2.3 Phase II and III: To determine if the investigational agent reduces levels of SARS-CoV-2 RNA in NP swabs. 1.2.4 Phase III: To determine the efficacy of the investigational agent to increase the proportion of participants with NP SARS-CoV-2 RNA below the LLoQ at study day 3. 1.2.5 Phase II: To determine the pharmacokinetics of the investigational agent. 1.2.6 Phase II: To determine efficacy of the investigational agent to obtain pulse oximetry measurement of ≥96% through day 28. 1.2.7 Phase III: To determine if the investigational agent will prevent the composite endpoint of hospitalization due to any cause or death due to any cause through study week 72. 1.2.8 Phase III: To evaluate if the investigational agent reduces the time to sustained symptom resolution through study day 28.
Wakiso,
Mpigi,
Mukono,
Uganda 2021-11-22 2024-11-22 The phase II evaluation will enroll approximately 110 participants per investigational agent (and 110 on placebo) (this includes all participants enrolled under previous protocol versions, irrespectiv Outpatient adults (≥18 years) with a documented positive SARS-CoV-2 molecular (nucleic acid) or antigen test from a sample collected ≤240 hours (10 days) prior to study entry and with ≤7 days of symptoms of COVID-19 at study entry, plus the presence The National Institute of Allergy and Infectious Diseases, Division of AIDS/NIAID/NIH/DHHS, Rockville, Maryland 20892 USA Medical and Health Sciences Clinical Trial Non-degree Award
Francis Ssali
ID: UNCST-2021-R012134
 A Phase 2, Open-label, Single-arm, Multicentre Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Efficacy of Switching to RPV Plus Other ARVs in HIV-1-infected Children (Aged 2 to less than 12 years) who are Virologically Suppressed (TMC278HTX2002)
REFNo: HS1815ES


Primary Endpoints
• Area under the plasma concentration-time curve from the time of administration up to 24 hours post-dose of RPV, as derived from the intensive PK assessments.
• Incidence of grade 3/4 AEs, SAEs, HIV-related events (including acquired immune deficiency syndrome [AIDS]-defining illnesses and Stage-3-defining Opportunistic Illnesses in HIV Infection), and AEs leading to discontinuation of study intervention through 24 weeks of study treatment.

Secondary Endpoint
• Incidence and severity of AEs/HIV-related events and their relatedness to RPV through 24 and 48 weeks of study treatment.
• Change from baseline Movement.
• Viral genotype at the time of virologic failure through 24 and 48 weeks of study treatment.
• Treatment adherence, as assessed by the Pediatric European Network for the Treatment of AIDS (PENTA) adherence questionnaire and by study intervention accountability, through 24 and 48 weeks of study treatment.

 Wakiso, Makindye
,
Uganda 2021-11-22 2024-11-22 lower limit is 3 and Upper limit is 10 Participants (boys and girls) aged ≥2 to <12 years with a bodyweight of at least 11 kg Janssen Sciences Ireland Unlimited Company Medical and Health Sciences Clinical Trial Non-degree Award
Jerome  Kabakyenga Kahuma
ID: UNCST-2021-R013729
 The A-Lite vein locator: “a non-invasive assistive medical device designed to improve vein visibility among patients requiring intravenous therapy.”
REFNo: HS1547ES

Main Objective
1. To assess the efficacy, safety and impact of using an assistive medical device to aid vein visibility among patients requiring intravenous therapy.

Specific Objectives
1. To assess the safety and efficacy of the A-Lite vein locator among 10 adults in Uganda.

2. To investigate non-inferiority by assessing the performance of the A-Lite vein locator with respect to the existing standard of care among 48 adolescents in Uganda.

3. To determine the effectiveness of using the A-Lite vein locator for improving vein visibility among 156 children requiring intravenous cannulation in Uganda.
 Kalungu, Bugonzi
Lira, Junior Quarters
Mbarara, Rwebishekye
Isingiro, Kashojwa
 Uganda 2021-11-19 2024-11-19 214 Ages eligible for the study: 1 up to 30 years Sexes eligible for the study: All International Development Research Centre (IDRC) – Canada and the Government of Uganda Medical and Health Sciences Clinical Trial Non-degree Award
ANGELLA MUSIIMENTA
ID: UNCST-2021-R013297
 My Mobile Wallet: An Intervention to Support Access to Tuberculosis Care and medication Adherence in Rural Uganda
REFNo: HS1688ES

Assess the refined My Mobile Wallet intervention for larger scale feasibility, acceptability, and impact on TB treatment adherence and clinical outcomes. We will randomize 162 newly diagnosed TB patients (1:1:1) to SMS texts + incentives Arm A, SMS texts only B, and control Arm C (standard clinic-based TB care); follow-up will be the 6 month-treatment period. Feasibility and acceptability will be assessed per above. Impact will be based on electronically monitored medication adherence (primary), as well as treatment completion, clinic attendance, cure, and mortality (secondary).,Refine the My Mobile Wallet intervention. We will adapt the intervention to address any feasibility and accessibility issues raised in R21 findings. We will then pilot test the refined version of the intervention in 10 TB patients over two months of treatment to ensure optimal functionality. ,Assess the initial feasibility and acceptability of My Mobile Wallet. Forty patients with newly diagnosed TB will use My Mobile Wallet over their 6-month course of treatment. Feasibility will be assessed by appropriate receipt of the cash transfers and SMS texts, and intervention functionality. Acceptability will be assessed using System Usability Scale [53] and interviews based on the Unified Theory of Acceptance and Use of Technology [54].,Determine the optimal design and develop My Mobile Wallet as an intervention to support TB medication adherence. Through client-centered approaches, we will iteratively conduct focus group discussions with up to 30 TB patients to develop an optimal My Mobile Wallet intervention.,
 Mbarara, Kamukuzi
Mbarara,
Uganda 2021-11-19 2024-11-19 242 TB patients (18 and above years old) living not beyond 60 Kilometers from MRRH who are willing to participate in the study US National Institute of Health (Eunice Kennedy Shriver National Institute Of Child Health & Human Development of the National Institutes of Health) Medical and Health Sciences Clinical Trial Non-degree Award
Adeodata Rukyalekere Kekitiinwa
ID: UNCST-2019-R000799
 BREATHER Plus: A randomized open-label 2-arm, 96-week trial evaluating the efficacy, safety and acceptability of short cycle (five days on, two days off) dolutegravir/tenofovir-based triple antiretroviral therapy (ART) compared to daily dolutegravir/tenofovir- based triple ART in virologically suppressed HIV-infected adolescents aged 12 to 19 years of age in sub-Saharan Africa, Version 2.0, Dated 18-Mar-2020; ISRCTN #: 85058577
REFNo: HS1822ES

Major Objective: A randomized open-label 2-arm, 96-week trial evaluating the efficacy, safety and acceptability of short cycle (five days on, two days off) dolutegravir/tenofovir-based triple antiretroviral therapy (ART) compared to daily dolutegravir/tenofovir-based triple ART in virologically suppressed HIV-infected adolescents aged 12 to 19 years of age in sub- Saharan Africa
Specific Objectives
To evaluate an innovative and contemporary ART strategy in HIV-infected adolescents to provide choice for young people facing life-long treatment. Output from this RCT will provide evidence on efficacy, safety and acceptability of a novel treatment approach in HIV-infected adolescents in sub-Saharan Africa
To evaluate the virological efficacy, safety, acceptability and Quality of Life of DTG-based Short-cycle Therapy with weekends off compared with Continuous Therapy with a DTG- based ART regimen
To optimize treatment for HIV-infected adolescents in sub-Saharan Africa

 Kampala, Mulago
Wakiso, Seguku
 Uganda 2021-11-15 2024-11-15 460 HIV-infected, non-pregnant, non-breastfeeding adolescents aged 12 to 19 years of age, virologically-suppressed for at least one year, without any history of treatment failure, on 3-drug combination antiretroviral (ART) consisting of dolutegravir with a 2- University College London (UCL), UK and funded by the European and Developing Countries Clinical Trials Partnership [RIA2017MC- 2005] Medical and Health Sciences Clinical Trial Non-degree Award
Namulema Edith
ID:
Effectiveness of the ‘LeVe CPAP’ against the standard AIRVO CPAP among Covid-19 patients with Acute Hypoxemic Respiratory Failure at Mengo Hospital Kampala Uganda: A Cross-Over Randomised Trial.
REFNo: HS1647ES

The main objective of the trial is to compare the clinical effectiveness of the LeVe CPAP device to the standard AIRVO CPAP in the delivery and maintaining continuous positive airway pressures among patients diagnosed with AHRF at Mengo Hospital Uganda.
 Kampala, mengo
 Uganda 2021-10-28 2024-10-28 40 Male and Female Adult patients with evidence of acute hypoxaemic respiratory failure admitted at the CTU. Any Tribe. Leeds Teaching Hospital National Health Service Trust in the UK Medical and Health Sciences Clinical Trial Non-degree Award
Khamisi Musanje
ID: UNCST-2021-R012863
 Acceptability, Feasibility and Effectiveness of a Mindfulness based Intervention to Promote Adherence to Antiretroviral Therapy among Adolescents in Kampala.
REFNo: HS1656ES

1. To adapt and explore acceptability of ACT-DNA-v among users (ALWHA) and providers (HCPs).
2. To measure feasibility of the adapted ACT-DNA-v for use with ALWHA.
3. To examine the impact of ACT-DNA-v on reducing proximal psychosocial barriers to medication adherence (depression, anxiety and stigma) among ALWHA.
4. To measure effectiveness of a mindfulness based intervention (ACT-DNA-v) on self-reported adherence among ALWHA in Kampala, and ascertain its impact on viral load reduction via analysis of data from medical records

Kampala, Mutundwe
Kampala, Central
Uganda 2021-10-20 2024-10-20 116 Study will be conducted among older adolescents 14-19 years living with HIV attending care at either Kisenyi or Kitebi health centers. Both male and female will be considered. Behavioral social science research grant Medical and Health Sciences Clinical Trial Degree Award
Damalie Nalwanga
ID: UNCST-2021-R013217
 SEVERE PNEUMONIA IN CHILDREN: THE ABILITY OF BODY COMPOSITION TO PREDICT SURVIVAL, AND THE EFFECT OF NUTRITIONAL SUPPLEMENTATION ON OUTCOMES
REFNo: HS1719ES

4. To determine the effect of a nutritional intervention (RUTF) on clinical outcomes (post discharge mortality, re-admission, and occurrence of severe acute malnutrition) of children hospitalized for severe pneumonia.,3. To determine the effect of a nutritional intervention (RUTF) on fat and muscle mass in children hospitalised for severe pneumonia.,2. To compare the ability of various muscle and fat mass indices to predict survival in children hospitalised for severe pneumonia.,1. To describe the role of nutritional status on outcomes following hospitalization for severe pneumonia among children.,To describe the relationship between muscle and fat mass and survival, and determine the role of nutritional supplementation on fat and muscle mass, and on treatment outcomes of children hospitalized for severe pneumonia,
 ,
Jinja,
Mbale,
Soroti,
Uganda 2021-10-20 2024-10-20 450 Children aged 6 months to 12 years hospitalized for severe pneumonia. Self Sponsored Medical and Health Sciences Clinical Trial Degree Award
Susan Adakun
ID:
Comparing adherence to MDR-TB treatment among patients on self-administered therapy and those on Directly Observed Therapy: Non Inferiority Randomized Controlled Trial
REFNo: HS1796ES

Primary Objectives
1. To determine if adherence to MDR-TB treatment among patients on self-administered therapy (measured by Medication Events Monitoring System (MEMS) technology) is non-inferior to that among patients on Directly Observed Therapy (DOT)
Secondary objectives

1. To determine the correlation between serum MDR-TB drug concentrations and adherence as measured by MEMS technology


2. To compare treatment outcomes between MDR-TB patients on self-administered therapy and DOT

 Kampala, Mulago
Lira,
Mbarara,
Uganda 2021-10-20 2024-10-20 164 Age of study Population: 8 years and above Gender of study population: Both male and female Persons of any and all tribes are eligible for study participation as long as they fit the eligibility criteria Janssen Global Public Health, a division of Janssen Pharmaceutica NV, under grant number 1550786 Medical and Health Sciences Clinical Trial Non-degree Award
Eleanor Namusoke Magongo
ID: UNCST-2021-R013199
 Uganda Paediatric and Adolescent HIV Cohort on Antiretroviral Therapy: Study Protocol (UP-ART)
REFNo: HS1699ES

The objectives of this study are to:
1) Describe the characteristics of children and adolescents living with HIV receiving paediatric care in the participating centres and coverage of ART
2) Describe the uptake of new antiretroviral drugs such as DTG across age groups and regions
3) Assess the effectiveness and safety of new antiretroviral drugs such as DTG, including viral suppression, incidence of adverse events, serious adverse events and discontinuation of drug
4) Assess broader clinical outcomes including retention in care, mortality, disease progression, immune response, viral suppression, overall and by age and treatment regimen/treatment history
5) Assess (i) the prevalence of HIV drug resistance among children/adolescents start of treatment and the impact on treatment response, and (ii) among those who experiencing virological failure on DTG to describe the risk of accumulation of drug resistance (see sub-study Section 4).

Hoima, Kahora Division
Lira, Lira
Wakiso, Wakiso
 Uganda 2021-10-14 2024-10-14 3000 All children/adolescents attending HIV care at the participating clinics will be invited to join the study the International AIDS Society, the World Health Organisation, University College London capacity strengthening grant and UNICEF (grant and in-kind support). Medical and Health Sciences Clinical Trial Non-degree Award
Fred Ssewamala
ID: UNCST-2020-R014060
 Youth Health SMS: Using mobile technology to prevent HIV and related Youth Health problems: Sexual health, Mental health, and Substance use in southwest Uganda
REFNo: SS969ES

This study will result in the development of one of the first mobile phone-based interventions for Adolescents and Young Adults (AYA) in East Africa that begins to address the co-morbid HIV risk factors of sexual health, mental health, and alcohol use. AYA is a developmental period associated with the increased importance of peers, increased technology use, increased mobility, initiation of sex, emergence of mental health disorders (if at risk), and initiation of alcohol use. Consequently, AYA is a critical time for preventive interventions. Poor mental health and alcohol abuse are associated with increased risk for HIV infection. Thus, the proposed research will attempt to address these areas concurrently.

The proposed research will evaluate if adapting and updating the existing free and nationally available text message and interactive voice recognition (IVR) service included in *161 that was initially developed by FHI 360. Our work will test and tailor messages for AYA to disseminate pre-exposure prophylaxis (PrEP) information and pilot specific mental health and hazardous alcohol use screens. Symptomatic AYA will be referred to behavioral health counselors for further assessment and treatment as needed. AYA today rely heavily on mobile phones for information and services, thus we believe the proposed intervention could be applied and adapted across the region, and potentially in other under-resourced settings.

We will conduct formative research to evaluate and adapt an existing text-message and interactive voice recognition (IVR) platform. We will then pilot the new menus and examine if using this platform promotes HIV prevention (pre-exposure prophylaxis (PrEP), HIV testing, safer sexual behaviors) and increases mental health and alcohol use screening and linkage to counselors as needed for adolescents and young adults (AYA) in a rural Ugandan region with high HIV seroprevalence and limited resources.

2. State the study objective(s) and research question(s)
Aim 1: To adapt an evidence-based mobile phone-delivered sexual health program, to include PrEP information and deliver mental health and alcohol use assessments with the goal of increasing screening and referral, as well as linkage to counselors for AYA at HIV risk.

Aim 2: Evaluate through a pilot RCT (N=126 AYA, 15-19 years) intervention (a) acceptability and feasibility, and (b) impact on uptake of HIV prevention strategies, as well as screening and linkage to mental health and alcohol use school-based counselors.

 Masaka, Kimaanya
Kalungu, Kabukunge
 Uganda 2021-10-12 2024-10-12 164 There will be two phases to the study. The first will be approximately three months and include 24 male and female AYA (15-19) years. The second phase will include 140 male and female (15-19 years). National Institute of Mental Health (NIMH) Social Science and Humanities Clinical Trial Non-degree Award
Christine  Wiltshire Sekaggya
ID: UNCST-2019-R000578
 Clinical Predictors of 3-Months Isoniazid Rifapentine (3HP)- Related Adverse Drug Reactions (ADR) During Tuberculosis Preventive Therapy (PAnDoRA-3HP study)
REFNo: HS1582ES

Primary Objectives
1.To describe the safety profile of 3HP among people receiving tuberculosis preventive therapy.
2.To describe the effect of adverse drug reactions on tuberculosis preventive therapy completion rates
Secondary Objective
1.To describe the pharmacokinetic and pharmacogenomic determinants of ADRs among people receiving tuberculosis preventive therapy in Uganda
2.To determine the efficacy of 3HP when used for tuberculosis preventive therapy.

 Kampala, Mulago III
Kampala, Kisenyi
Kampala, Kasubi
Kampala, Nakawa I
Jinja, Magwa
Mubende, Mubende Town Council
 Uganda 2021-10-04 2024-10-04 614 Patients will be included in the study if they meet the following inclusion criteria: 1. Individuals of any age who have been initiated on TPT using the isoniazid/rifapentine regimen according to standard of care 2. Both PLWHIV and HIV-uninfected indivi National Institution of Health Medical and Health Sciences Clinical Trial Non-degree Award
Joseph Lutaakome
ID: UNCST-2020-R008323
 An International Multicenter, Randomized, Double-Blind, PlaceboControlled Trial of the Safety and Efficacy of Anti-Coronavirus Hyperimmune Intravenous Immunoglobulin for the Treatment of Adult Outpatients in Early Stages of COVID-19
REFNo: HS1715ES

Primary Objective
Primary objective: Among outpatients with recently diagnosed SARS-CoV-2 infection to compare the safety and efficacy of a single infusion of hIVIG (pooled for the 2 hIVIG

products) versus placebo, each given with SOC, on clinical status after seven days. Two hypotheses will be tested to address this primary objective, which compares the primary endpoint among two study populations: 1) participants where neutralizing MAb was not specified as part of SOC treatment (stratum 1, see Section 6.1 Overall Study Design); and 2) all randomized participants (stratum 1 and stratum 2 combined). hIVIG will be considered superior to placebo if either of the two hypotheses are rejected.
Secondary Objectives and Endpoints
Secondary objectives, including subgroup analyses and safety outcomes, will be addressed for all randomized participants and for those in stratum 1 and 2 separately.
Secondary Endpoints
The clinical status as classified on the ordinal outcome scale will be assessed with a number of additional analyses comparing hIVIG (pooled for the 2 hIVIG products) with placebo, among the overall study population as well as for the key subgroup of those not receiving anti-SARS-CoV-2 monoclonal antibodies as part of SOC (stratum 1), including:
1. All-cause hospitalization or death through 28 days.
2. All-cause mortality through 28 days.
3. Significant disease progression through 28 days, using a time to event analysis with outcome defined by fulfilling criteria for category 4 or 5 on the ordinal scale.
4. Distribution of ordinal scale outcome at Day 4, 14, and 28.
5. The proportion of participants with any disease progression at Day 7, using a sliding dichotomous scale progression defined by a categorization on the ordinal scale that is worse than the status at entry

 Uganda 2021-10-04 2024-10-04 A sample size for this phase 3 trial of 820 participants is planned, which would consist of at least 656 participants in stratum 1. In order to be eligible to participate in this study, a patient must meet all of the following inclusion criteria prior to randomization: i. Clinical risk based on age ≥ 55 years or an adult (age ≥ 18 years) with an ii. immunosuppressed condition. The study is funded by the National Institute of Allergy and Infectious Diseases, National Institutes of Health, through their contract organization Leidos. There is a subcontract between the University of Minnesota (the Sponsor) and the MRC CTU at UCL. Medical and Health Sciences Clinical Trial Non-degree Award
Lukia Namaganda Hamid
ID:
Malnutrition as a probable predictor of mortality in cerebral palsy (CP), and the effect of positive deviance and parent facilitator training strategies to malnutrition and caregiving among children and adolescents with CP in the Iganga, Mayuge and Bugweri rural districts of eastern Uganda
REFNo: HS1427ES

Specific Objectives:
1. To assess mortality and whether malnutrition is one of the predictors among a population based sample of children and adolescents with cerebral palsy the Iganga Mayuge-Health and Demographic Surveillance Site (IM-HDSS), Uganda
2. To assess the difference in the change in nutritional status in 2015 and 2019 among children with CP compared to their age and sex matched controls without CP at the IM-HDSS, Uganda.
3. To explore positive and negative nutrition practices among caregivers of well-nourished and under-nourished children with cerebral palsy respectively at the IM-HDSS, Uganda.
4. To determine the difference in the effectiveness of the positive deviance strategy and parent facilitator trainings on CP child and adolescent malnutrition and caregiving within the Iganga, Mayuge and Bugweri districts, Uganda.

 Iganga,
Mayuge,
Uganda 2021-09-29 2024-09-29 126 for the RCT Caregivers of children and adolscents with Cerebral aged 2-21 years old Cerebral Palsy in Uganda Project (CURIE), Makerere University School of Public Health, Department of Epidemiology and Biostatistics Medical and Health Sciences Clinical Trial Degree Award
Isaac Ssewanyana
ID: UNCST-2020-R014336
 Evaluation of the performance of the Salmonella Biolineâ„¢ typhi IgG/IgM Fast test in a near-patient testing environment, including evaluation of usability
REFNo: HS1700ES

To evaluate the usability of the Biolineâ„¢ Salmonella typhi IgG/IgM Fast test in the near-patient environment using a questionnaire based survey. ,To establish the performance of the Biolineâ„¢ Salmonella typhi IgG/IgM Fast test in a near-patient setting compared to the performance in a professional lab (i.e. Central Public Health Laboratory) using venous whole blood samples. ,
 pakwach,
Kampala, Kiruddu
Kampala, kisenyi
 Uganda 2021-09-29 2024-09-29 80 • Male and female patients above 18 years seeking treatment from selected health units who are able to give consent to the study meeting the selection criteria. ABBOTT KOREA Medical and Health Sciences Clinical Trial Non-degree Award
Isaac Ssewanyana
ID: UNCST-2020-R014336
 COMPARISON OF PERFORMANCE OF CAPILLARY BLOOD VS VENOUS BLOOD ON SYPHILIS ULTRA TEST DEVICE/ TEST REF: ISY-U402 AND CAPILLARY BLOOD VS VENOUS BLOOD ON SYPHILIS ULTRA RAPID TEST STRIP) REF: ISY-U401 USING SD BIOLINE VERSION 3.0 AS A REFERENCE
REFNo: HS1643ES

The objective of this evaluation is to demonstrate the equivalence of capillary (fingerprick) whole blood and venous whole blood on the Syphilis Ultra test device/ Test strip (Whole Blood/Serum/ Plasma) and strip.
2.4 Exploratory Objectives
• To determine the diagnostic accuracy of the Syphilis Ultra test device/ Test (Whole Blood/Serum/ Plasma) and strip.

 Kampala, Naguru
 Uganda 2021-09-23 2024-09-23 100 3.1 Subject Population Patients attending the Sexually Transmitted Diseases clinic (STD) at China Friendship Regional referral Hospital Uganda will be enrolled for the study. Patients attending this clinic are referrals from other units presenting with s Ministry of Health Medical and Health Sciences Clinical Trial Non-degree Award
Eleanor Namusoke Magongo
ID: UNCST-2021-R013199
 Transitioning children to Optimal Regimens of Paediatric Dolutegravir (TORPEDO) in Uganda
REFNo: HS1596ES

the primary objective for the study is to assess patients’/ caregivers’ preference for a paediatric DTG regimen over their previous regimen, when transitioned from another regimen.

 Hoima, Kahora Division
Wakiso, Wkiso
Lira, Lira city
Buikwe, Buikwe
Mayuge, Mayuge
Kampala, Kampala
 Uganda 2021-09-22 2024-09-22 approximately 4,000 children and adolescents 0-19 years Clinton Health Access Initiative Medical and Health Sciences Clinical Trial Non-degree Award
ELIZABETH NALINTYA
ID: UNCST-2021-R012882
 Long title: A community-based Phase III, cluster randomized trial of point-of-care CD4 testing and enhanced screening and prophylaxis in advanced HIV disease Short title: An enhanced package of care to reduce mortality in advanced HIV disease
REFNo: HS1605ES

Primary Objectives:
1. To assess 24-week survival with retention in care in persons with advanced HIV disease (CD4<200 cells/µL) with point-of-care CD4 testing compared to standard flow cytometry
2. To assess 24-week survival with retention in care with an enhanced diagnostic OI screening and prophylaxis strategy compared to standard WHO package of care in persons with advanced HIV disease
Secondary Objectives:
1. To determine incidence of OIs
2. To measure adverse events with enhanced prophylaxis regimens
3. To assess tolerability and adherence of enhanced prophylaxis regimens
4. To determine incidence and cause of hospitalization for persons with advanced HIV disease
5. To determine cause of death for persons with advanced HIV disease
6. To determine HIV outcomes of viral suppression in persons with advanced HIV disease.
7. Measure cost, cost-effectiveness, and budgetary impact of the CD4 testing strategies, and OI screening and prophylaxis strategies.

 Kampala,
Wakiso,
Uganda 2021-09-21 2024-09-21 2400 • Age >18 years • CD4<200 cells/µL • Ability and willingness to give informed consent for the enhanced package of care arm. INFECTIOUS DISEASES INSTITUTE Medical and Health Sciences Clinical Trial Non-degree Award
Achilles Katamba
ID: UNCST-2019-R000540
 Human-Centred Design and Communities of Practice to Improve Delivery of Home based Tuberculosis Contact Investigation in Uganda
REFNo: HS1720ES

General Objective: The study aims to assess the effectiveness of an enhanced intervention strategy for implementing TB contact investigation relative to usual care. Specific Objectives: 1.To compare the implementation, effectiveness, and public health impact of TB contact investigation delivered via an enhanced intervention strategy vs. the usual care strategy in a stepped-wedge, cluster-randomized implementation trial. 2.To identify implementation processes and contextual factors that influence the effectiveness of the intervention strategy for TB contact investigation. 3.To compare the costs and epidemiological impact of the intervention and usual care strategies for TB contact investigation.
Masaka, Ndejje
Masaka, Masaka
Butambala, Goombe
Wakiso, Wakiso
Wakiso, Ndejje
Kiboga, Kiboga
Mubende, Kasambya
Mubende, Mubende
Mityana, Mityana
Iganga, Iganga
Bugiri, Bugiri
Jinja, Jinja
Wakiso, Entebbe
Wakiso, Kasangati
Kayunga, Kayunga
Kayunga, Nagalama
 Uganda 2021-09-17 2024-09-17 1764 household and close contacts within approximately 2304 eligible index patient clusters over a 16-month period. Household and close contacts of index patients with active pulmonary TB National Institute of Allergy and Infectious Diseases (NIAID) Medical and Health Sciences Clinical Trial Non-degree Award
Martha Musyoka Mbenia
ID:
PREDICTORS OF ADVERSE FETO-MATERNAL OUTCOMES AMONG MOTHERS ADMITTED WITH ANTEPARTUM HEMORRHAGE AT MBARARA REGIONAL REFERRAL HOSPITAL
REFNo: HS1450ES

To describe adverse outcomes and determine predictors of adverse feto-maternal outcomes in mothers with antepartum hemorrhage at Mbarara Regional Referral Hospital
 Mbarara, Mbarara
 Kenya 2021-09-09 2024-09-09 107 All women of childbearing age presenting with antepartum hemorrhage at Mbarara Regional Referral Hospital Self. No conflict of interest anticipated Medical and Health Sciences Clinical Trial Degree Award
Isaac Ssewanyana
ID: UNCST-2020-R014336
 PERFORMANCE EVALUATION OF COVID-19 ANTIGEN RAPID DIAGNOSTIC TESTS
REFNo: HS1690ES

To determine the association of positive index test results with disease stage (days since symptom onset, e.g. acute, early, late), symptom severity and symptom severity.,To determine the diagnostic accuracy of SARS-CoV-2 Ag RDTs on a respiratory specimen (NP swab, OP swab, nasal swab, saliva), vs Cobas SARS-CoV-2 assay as performed in patients presenting with influenza-like illness.,
 pakwach,
Kampala, Mulag0
Kampala, Kiruddu
Masaka, Masaka
Mbarara, Mbarara
 Uganda 2021-09-08 2024-09-08 5000 • Suspected COVID-19 cases ≥ 18 years of age presenting with symptoms at selected reginal and national referral hospitals in Uganda, will be enrolled for the study. These sites were chosen because they are the regional referral hospitals and register FIND, the global alliance for diagnostics Medical and Health Sciences Clinical Trial Non-degree Award
Pontiano Kaleebu
ID: UNCST-2021-R013577
 A clinical trial to assess the safety and immunogenicity of LNP-nCOV saRNA-02, a self-amplifying ribonucleic acid (saRNA) vaccine encoding the S glycoprotein of SARS-CoV-2, the causative agent of COVID-19, in SARS-CoV-2 seronegative and seropositive Uganda population
REFNo: HS1641ES

Primary Objective:

• To compare the safety and immune responses for SARS-CoV-2 seronegative and seropositive individuals from two immunisations with LNP-nCOV saRNA-02 administered IM 4 weeks apart at one dose level in 42 participants age 18-45 years.

Exploratory Objectives:
• To characterise the humoral and cellular immune responses to LNP-nCOV saRNA-02 administered at one dose given at 0 weeks and 4 weeks for individuals seronegative and seropositive for SARS-CoV-2 antibodies
• To characterise the profile of class and sub-class of antibody responses
• To characterize infection induced immune responses in participants with naturally acquired infection who are also exposed to the vaccine

 Masaka, Butego
 Uganda 2021-09-08 2024-09-08 42 The study will be conducted in healthy young adults as these individuals generate the most robust responses (18-45 years). Both male and female participants will be included and the trial site will attempt to keep an equal proportion, although the priorit The study is sponsored by Imperial College London, funded by the United Kingdom Engineering and Physical Sciences Research Council. Medical and Health Sciences Clinical Trial Non-degree Award
Pontiano Kaleebu
ID: UNCST-2021-R013577
 A behavioural Science Research to Determine Factors that Facilitate Future Uptake of HIV Prevention Products and Multi-Purpose Prevention Technologies to Prevent HIV and Unwanted Pregnancy in Sub-Saharan Africa Universally Accessible HIV Prevention Technologies for African Girls and Young Women through Knowledge Applied from Behavioural Economics (UPTAKE)
REFNo: HS1540ES

Multi-purpose Prevention Technologies (MPTs) to prevent HIV and unwanted pregnancy in Sub-Saharan Africa

i. To understand facilitators of and barriers to uptake and retention of injectable and implantable long acting pre-exposure prophylaxis (LA-PrEP) and MPT to inform product development, using formative behavioural research methods
ii. To design interventions to impact the uptake of new biomedical HIV prevention products, as part of a suite of self-care and self-screening products for sexual and reproductive health, using quantitative behavioural research methods
iii. To test the effectiveness of the alternate design/interventions and strategies, using marketed LA contraceptive products as proxies for LA HIV prevention products in development
iv. To estimate the cost of retention interventions and the cost effectiveness of products and delivery methods among adolescent girls and young women (AGYW) and female sex workers (FSWs) for prevention of pregnancy and/or HIV, using modelling

 Kampala, NOT APPLICABLE
 Uganda 2021-08-31 2024-08-31 1190 Adolescent Girls and Young Women (AGYW) aged 15 to 24 years and Female Sex Workers (FSW) aged 15 to 45 years, Health Care Providers (HCP), and Policy Makers (PM) in Kampala, Uganda and Nairobi, Kenya. Study Size and duration: Stage 1: 30 AGYW, 30 FSW, 10 International AIDS Vaccine Initiative, The Address, 11th Floor, Muthangari Drive, Nairobi, Kenya; T:+254.719.043.000 Medical and Health Sciences Clinical Trial Non-degree Award
BRENDA GATI MIREMBE
ID: UNCST-2021-R013390
 A Phase 3, Randomized, Active Controlled, Double-blind Clinical Study to Evaluate the Efficacy and Safety of Oral Islatravir Once Monthly as Pre-Exposure Prophylaxis in Cisgender Women at High Risk for HIV 1 Infection.
REFNo: HS1631ES

Primary Objectives:
1. To evaluate the efficacy of oral ISL QM compared to FTC/TDF QD for the
prevention of HIV-1 infection as assessed by the incidence rate per year of confirmed
HIV-1 infection.

2. To evaluate the safety and tolerability of oral ISL QM compared to oral FTC/TDF QD as assessed by review of the accumulated safety data

Secondary Objective
1. To evaluate the efficacy of oral ISL QM in reducing the incidence per year of HIV-1
infection relative to the background rate.

 Kampala,
Wakiso,
Mukono,
Mpigi,
Nakaseke,
Luweero,
Buikwe,
Jinja,
Gomba,
Butambala,
Kayunga,
Uganda 2021-08-27 2024-08-27 Approximately 4,500 participants will be randomized (stratified by site and age) in a 1:1 ratio to receive either ISL or FTC/TDF for the duration of the study. Approximately 50% of the global study po Cisgender female participants aged 16 to 45 years of age who are at high risk of acquiring HIV-1 infection. Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Medical and Health Sciences Clinical Trial Non-degree Award
Jayne Ellis
ID: UNCST-2021-R013987
 “Integrated management of cryptococcal and opportunistic infections to improve outcomes in advanced HIV disease (IMPROVE study)”
REFNo: HS1607ES

1) To generate evidence on the safety (adverse events) and feasibility (adherence and tolerability) of 1HP (one month of isoniazid and rifapentine) for TB preventative therapy (TPT) amongst adults with HIV-associated cryptococcal meningitis.
2) To generate preliminary data on potential secondary benefits (reduced loss to follow-up, reduced active TB disease, reduced mortality due to TB) of early (inpatient initiation) 1HP TPT as compared to standard (outpatient initiation) 1HP TPT amongst adults with HIV-associated cryptococcal meningitis.

Kampala, Salaama
Mbarara, Mbarara
 UK 2021-08-25 2024-08-25 205 Adults (>18 years) with HIV-associated cryptococcal meningitis London School Hygiene and Tropical Medicine Medical and Health Sciences Clinical Trial Degree Award
Peter Elyanu James
ID: UNCST-2021-R013210
 CoVPN 3008- UBUNTU Multi-Center, Randomized, Efficacy Study of COVID-19 mRNA Vaccine in Regions with SARS-CoV-2 Variants of Concern. Version 1.0, dated 16 May 2021. DAIDS Document ID # 38838.
REFNo: HS1642ES

Primary Objectives
The primary objectives of this study are to determine the following:
1. To assess vaccine efficacy (VE) of COVID-19 mRNA vaccine to prevent virologically-confirmed symptomatic COVID-19 starting 14 days after dose 2 in adults who are at risk of severe COVID-19
2. To assess vaccine efficacy (VE) of COVID-19 mRNA vaccine to prevent severe COVID-19 starting 14 days after dose 2 in adults who are at risk for severe COVID-19
3. To assess safety and tolerability of COVID-19 mRNA vaccine in adults who are at risk of severe COVID-19

Secondary Objectives
The secondary objectives of this study are to evaluate the following:
1. Durability of VE of COVID-19 mRNA vaccine against COVID-19 and against severe COVID-19 through the final study visit (Month 12 post-dose 1) in volunteers with no previous COVID-19
2. VE of COVID-19 mRNA vaccine against COVID-19 and against severe COVID-19 by neutralization phenotype and Spike sequence features of acquired SARS-CoV-2 viruses (sieve analysis), including VE against the B.1.351/501Y.V2 variant and VE against all other variants combined in volunteers with no previous COVID-19
3. VE of COVID-19 mRNA vaccine against SARS-CoV-2 infection defined by nucleocapsid protein seroconversion regardless of symptomology in volunteers with no previous COVID-19
4. VE of COVID-19 mRNA vaccine against asymptomatic SARS-CoV-2 infection defined by nucleocapsid protein seroconversion without prior occurrence of the symptomatic COVID-19 primary endpoint in volunteers with no previous COVID-19
5. Post -vaccination immune response markers as correlates of risk of COVID-19 and as correlates protection against COVID-19
6. VE of COVID-19 mRNA vaccine against COVID-19 and severe COVID-19 in all participants regardless of baseline SARS-CoV-2 status

Exploratory Objectives
The exploratory objectives of this study are to evaluate the following:
1. VE of COVID-19 mRNA vaccine against COVID-19 and severe COVID-19 by baseline HIV infection status in volunteers with no previous COVID-19 and in all volunteers regardless of previous COVID-19 status
2. VE of COVID-19 mRNA vaccine against COVID-19 and against severe COVID-19 by neutralization phenotype and Spike sequence features of acquired SARS-CoV-2 viruses (sieve analysis), including VE against the B.1.351/501Y.V2 variant and VE against all other variants combined in volunteers with no previous COVID-19 and in all volunteers regardless previous COVID-19 status
3. VE of COVID-19 mRNA vaccine against COVID-19 and severe COVID-19 in volunteers with previous COVID-19
4. Relative rate of COVID-19 and severe COVID-19 in placebo recipients with previous COVID-19 compared to vaccine recipients with no previous COVID-19
5. Assess T-cell responses in placebo recipients who develop COVID-19 compared to vaccine recipients who develop symptomatic COVID-19
6. Assess incidence of adverse birth outcomes among pregnant persons enrolled in the trial

 Kampala, Mulago
Kampala, Kawaala
Kampala, Wankuluku
Kampala, Kisenyi
Kampala, Kisugu
Kampala, Kisugu
 Uganda 2021-08-24 2024-08-24 125 This study will be conducted in regions and populations where new more resistant variants of SARS-CoV-2 are highly prevalent. Prevalence of the new variants is known to result in reinfections, suggesting that a prior infection with the SARS-CoV-2 ancestra The study is sponsored by the South African Medical Research Council (SAMRC) and funded by the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institute of Health (NlH) of the United States of America. Medical and Health Sciences Clinical Trial Non-degree Award
Ronald Kiguba
ID: UNCST-2019-R000844
 Two-way risk communication mobile application use versus traditional methods of adverse drug reaction reporting in Uganda: a cluster-randomized controlled trial
REFNo: HS1366ES

This study will: i) assess the feasibility of implementing a mobile app for the reporting of ADRs associated with DTG and IPT at selected ART-sites in Uganda; ii) describe the characteristics (causality, seriousness, completeness, unexpectedness, severity, outcome) of the DTG- and IPT-linked ADR-reports submitted to NPC using the mobile app; and, iii) determine if use of the mobile app versus existing methods of ADR-reporting (paper-form and web-form) increases by 25% the number of reported ADRs linked to DTG and IPT use during 2.5 years of follow-up, iv) determine the cost and cost-effectiveness of using the mobile app versus existing methods of ADR-reporting.
 Wakiso, Seguku
 Uganda 2021-08-20 2024-08-20 382 Antiretroviral Sites across Uganda The mobile app will be introduced nationwide at 382 high-volume accredited antiretroviral therapy (ART)-sites where MoH implemented the scale up of IPT. These pre-selected ART-sites hold 80% of the patients on ART in Uganda. All HCPs at the pre-selected A Makerere University Research & Innovations Fund Medical and Health Sciences Clinical Trial Non-degree Award
Cissy  Kityo
ID: UNCST-2021-R013663
 Multi-Center, Randomized, Efficacy Study of COVID-19 mRNA Vaccine in Regions with SARS-CoV-2 Variants of Concern.
REFNo: HS1669ES

-To assess vaccine efficacy (VE) of COVID-19 mRNA vaccine to prevent
virologically-confirmed symptomatic COVID-19 starting 14 days after dose 2 in
adults who are at risk of severe COVID-19 -2. To assess vaccine efficacy (VE) of COVID-19 mRNA vaccine to prevent severe COVID-19 starting 14 days after dose 2 in adults who are at risk for severe COVID-19 -3. To assess safety and tolerability of COVID-19 mRNA vaccine in adults who are at risk of severe COVID-19
Wakiso, Ssabagabo
 Uganda 2021-08-20 2024-08-20 14,000 age ≥ 40 and at least one comorbidity known to be associated with severe COVID-19, 2) age ≥ 18 and pregnant, 3) age ≥ 18 and HIV-infected. South African Medical Research Council (SAMRC) Cape Town, South Africa. Medical and Health Sciences Clinical Trial Non-degree Award
Philippa Musoke
ID: UNCST-2021-R013523
 ViiV 205858: Open-label access to dolutegravir for HIV-1 infected children and adolescents completing IMPAACT Studies P1093 and P2019 Version 4.0 dated 10 Dec 2020
REFNo: HS1453ES

Primary
• To provide access to age appropriate formulations of dolutegravir (DTG), either as single entity DTG or as fixed dose combination (FDC) abacavir/dolutegravir/lamivudine (ABC/DTG/3TC), in an open-label protocol to eligible participant s who have completed the P1093 or P2019 parent studies.

Secondary

To assess any serious adverse events (SAEs) and any clinical or laboratory adverse events that lead to the discontinuation of IP (DTG or ABC/DTG/3TC FDC).
 Kampala, Mulago
 Uganda 2021-08-20 2024-08-20 3 participants previously enrolled in P1093 at the MU-JHU Site Children aged 0-18 years who are formeerly participants in P1093 study at MU-JHU Site, both male and female and of any tribe as long as their caretakers/parents understand the language of consent. ViiV Health care Company Medical and Health Sciences Clinical Trial Non-degree Award
Deo Wabwire Ogema
ID: UNCST-2021-R013932
 COVPN 3008: Multi-Center, Randomized, Efficacy Study of COVID-19 mRNA Vaccine in Regions with SARS-CoV-2 Variants of Concern. Version 1.0 16 May 2021
REFNo: HS1659ES

The primary objectives are:
•To assess vaccine efficacy (VE) of COVID-19 mRNA vaccine to prevent virologically-confirmed symptomatic COVID-19 starting 14 days after dose 2 in adults who are at risk of severe COVID-19
•To assess vaccine efficacy (VE) of COVID-19 mRNA vaccine to prevent severe COVID-19 starting 14 days after dose 2 in adults who are at risk for severe COVID-19
•To assess safety and tolerability of COVID-19 mRNA vaccine in adults who are at risk of severe COVID-19

Secondary objectives are to evaluate the following:
•Durability of VE of COVID-19 mRNA vaccine against COVID-19 and against severe COVID-19 through the final study visit (Month 12 post-dose 1) in volunteers with no previous COVID-19
•VE of COVID-19 mRNA vaccine against COVID-19 and against severe COVID-19 by neutralization phenotype and Spike sequence features of acquired SARS-CoV-2 viruses (sieve analysis), including VE against the B.1.351/501Y.V2 variant and VE against all other variants combined in volunteers with no previous COVID-19
•VE of COVID-19 mRNA vaccine against SARS-CoV-2 infection defined by nucleocapsid protein seroconversion regardless of symptomology in volunteers with no previous COVID-19
•VE of COVID-19 mRNA vaccine against asymptomatic SARS-CoV-2 infection defined by nucleocapsid protein seroconversion without prior occurrence of the symptomatic COVID-19 primary endpoint in volunteers with no previous COVID-19
•Post -vaccination immune response markers as correlates of risk of COVID-19 and as correlates protection against COVID-19
•VE of COVID-19 mRNA vaccine against COVID-19 and severe COVID-19 in all participants regardless of baseline SARS-CoV-2 status
gestational age)
The exploratory objectives are to evaluate:
•VE of COVID-19 mRNA vaccine against COVID-19 and severe COVID-19 by baseline HIV infection status in volunteers with no previous COVID-19 and in all volunteers regardless of previous COVID-19 status
•VE of COVID-19 mRNA vaccine against COVID-19 and against severe COVID-19 by neutralization phenotype and Spike sequence features of acquired SARS-CoV-2 viruses (sieve analysis), including VE against the B.1.351/501Y.V2 variant and VE against all other variants combined in volunteers with no previous COVID-19 and in all volunteers regardless previous COVID-19 status
•VE of COVID-19 mRNA vaccine against COVID-19 and severe COVID-19 in volunteers with previous COVID-19
•Relative rate of COVID-19 and severe COVID-19 in placebo recipients with previous COVID-19 compared to vaccine recipients with no previous COVID-19
•Assess T-cell responses in placebo recipients who develop COVID-19 compared to vaccine recipients who develop symptomatic COVID-19
•Assess incidence of adverse birth outcomes among pregnant persons enrolled in the trial

 Kampala, Mulago 1
 Uganda 2021-08-20 2024-08-20 14,000 across all sites, about 500 from Uganda The study population will include 1.Adults aged 40 years or more with at least one co-morbid factor associated with severe COVID 19 2.People living with HIV who are 18 years and above Pregnant women aged 18 years and above South African Medical Research Council (SAMRC) Medical and Health Sciences Clinical Trial Non-degree Award
Annet Nanvubya
ID: UNCST-2025-R015525
 Randomized, Efficacy Study of COVID-19 mRNA Vaccine in Regions with SARS-CoV-2 Variants of Concern version 1.0 16-05-2021.
REFNo: HS1677ES

Primary Objectives
The primary objectives of this study are to determine the following:
• To assess vaccine efficacy (VE) of COVID-19 mRNA vaccine to prevent virologically-confirmed symptomatic COVID-19 starting 14 days after dose 2 in adults who are at risk of severe COVID-19
• To assess vaccine efficacy (VE) of COVID-19 mRNA vaccine to prevent severe COVID-19 starting 14 days after dose 2 in adults who are at risk for severe COVID-19
• To assess safety and tolerability of COVID-19 mRNA vaccine in adults who are at risk of severe COVID-19

Secondary Objectives

The secondary objectives of this study are to evaluate the following:
• Durability of VE of COVID-19 mRNA vaccine against COVID-19 and against severe COVID-19 through the final study visit (Month 12 post-dose 1) in volunteers with no previous COVID-19
• VE of COVID-19 mRNA vaccine against COVID-19 and against severe COVID-19 by neutralization phenotype and Spike sequence features of acquired SARS-CoV-2 viruses (sieve analysis), including VE against the B.1.351/501Y.V2 variant and VE against all other variants combined in volunteers with no previous COVID-19
• VE of COVID-19 mRNA vaccine against SARS-CoV-2 infection defined by nucleocapsid protein seroconversion regardless of symptomology in volunteers with no previous COVID-19
• VE of COVID-19 mRNA vaccine against asymptomatic SARS-CoV-2 infection defined by nucleocapsid protein seroconversion without prior occurrence of the symptomatic COVID-19 primary endpoint in volunteers with no previous COVID-19
• Post -vaccination immune response markers as correlates of risk of COVID-19 and as correlates protection against COVID-19
• VE of COVID-19 mRNA vaccine against COVID-19 and severe COVID-19 in all participants regardless of baseline SARS-CoV-2 status
gestational age)

Exploratory Objectives
The exploratory objectives of this study are to:
• VE of COVID-19 mRNA vaccine against COVID-19 and severe COVID-19 by baseline HIV infection status in volunteers with no previous COVID-19 and in all volunteers regardless of previous COVID-19 status
• VE of COVID-19 mRNA vaccine against COVID-19 and against severe COVID-19 by neutralization phenotype and Spike sequence features of acquired SARS-CoV-2 viruses (sieve analysis), including VE against the B.1.351/501Y.V2 variant and VE against all other variants combined in volunteers with no previous COVID-19 and in all volunteers regardless previous COVID-19 status
• VE of COVID-19 mRNA vaccine against COVID-19 and severe COVID-19 in volunteers with previous COVID-19
• Relative rate of COVID-19 and severe COVID-19 in placebo recipients with previous COVID-19 compared to vaccine recipients with no previous COVID-19
• Assess T-cell responses in placebo recipients who develop COVID-19 compared to vaccine recipients who develop symptomatic COVID-19
• Assess incidence of adverse birth outcomes among pregnant persons enrolled in the trial


 Wakiso, Division A and B
 Uganda 2021-08-20 2024-08-20 14,000 This study will enroll participants who meet one or more of the following criteria: 1) Age > 40, who have at least one comorbidity known to be associated with severe COVID-19, 2) women age 18 years or older who are pregnant, and 3) HIV-1-infected indiv South African Medical Research Council(SAMRC) Cape Town, South Africa Medical and Health Sciences Clinical Trial Non-degree Award
Eun Seok Kim
ID:
Cross-sectional prevalence study of schistosomiasis and soil-transmitted helminthiasis with nested open-label randomised controlled study of evaluating the impact of fatty meal co-administration and double-dosing on albendazole effectiveness against hookworm infection among school-aged children in Mayuge district: Implications for Mayuge NTDs Elimination (MANE) Project
REFNo: HS1411ES

Objective 1: To determine the effect of albendazole administration with a fatty meal such as avocado, versus albendazole administration without a fatty meal, on hookworm cure rate and egg reduction rate.

Objective 2: To determine the effectiveness of dual-dose (400mg/day, two consecutive days) versus single-dose (400mg) albendazole treatment regimens on hookworm cure rate and egg reduction rate.

Objective 3: To identify and evaluate environmental, social and cultural variables affecting hookworm infection, and cure rate and egg reduction rate of albendazole against hookworm.

 Mayuge, All parish
,
South Korea 2021-08-16 2024-08-16 1650 Age: P4 and P5 grade students (approximately 9-10 years old) Sex: an approximately equal number of both male and female Korea International Cooperation Agency (KOICA) Medical and Health Sciences Clinical Trial Degree Award
Violet Korutaro
ID: UNCST-2019-R000618
 IMPAACT 2017: Phase I/II Study of the Safety, Acceptability, Tolerability, and Pharmacokinetics of Oral and Long-Acting Injectable Cabotegravir and Long-Acting Injectable Rilpivirine in Virologically Suppressed HIV-Infected Children and Adolescents. Short title: ‘MOCHA’ (More Options for Children and Adolescents), DAIDS # 30070, IND # 138,754
REFNo: HS1512ES

To assess the safety of CAB LA + RPV LA through Week 24 in HIV-infected, virologically suppressed adolescents,To confirm the doses for oral CAB followed by injectable CAB LA in HIV-infected, virologically suppressed adolescents by evaluating: Safety and multiple dose PK of oral CAB through Week 4, Safety and multiple dose PK of CAB LA through Week 16, and to confirm doses for injectable RPV LA in HIV-infected, virologically suppressed adolescents by evaluating safety and multiple dose PK of RPV LA through Week 16,To confirm the dose and evaluate the safety, tolerability, acceptability, and pharmacokinetics (PK) of oral cabotegravir (CAB), long-acting injectable cabotegravir (CAB LA), and long-acting injectable rilpivirine (RPV LA) in virologically suppressed HIV‐1 infected children and adolescents aged 12 to <18 years.,
 Kampala, Kisenyi
Kampala, Mulago
Kampala, Kawaala
Kampala, Naguru
Kampala, Kitebi
 Uganda 2021-08-16 2024-08-16 155 This study will be conducted in Kampala among HIV‐1 infected children and adolescents, 12 to <18 years of age, who are virologically suppressed on stable cART consisting of 2 or more drugs from 2 or more classes of antiretroviral. These potential partic National Institute of Allergy and Infectious Diseases Medical and Health Sciences Clinical Trial Non-degree Award
Jonathan Kayondo
ID: UNCST-2021-R008325
 Multi-Centre, Prospective, Evaluation for Matrix equivalence of capillary whole blood finger-stick and fresh and frozen venous whole blood with the NxTekâ„¢ Malaria Pf Plus Rapid Test Device and NxTekâ„¢ Malaria Pf/Pv Plus Rapid Test Device for the Detection of Plasmodium Infections in Patients with Symptoms Suggestive of Malaria within the Lab and its intended use environment for CE IVDR.
REFNo: HS1587ES

This trial is part of the R&D Verification and Validation studies, to provide clinical matrix equivalence evaluation to support the conformity assessment procedure for the use of fingerstick and venous whole blood samples with Abbott’s NxTek™ Malaria Pf Plus and NxTek™ Malaria Pf/Pv Plus Rapid Test Devices, as performed by professional users, in accordance with WHO PQ TSS-3, WHO PQ Dossier, EU 2017/7461.

Primary Objective: Matrix Equivalence
To assess the matrix equivalence of:
a. Fresh CWBFS and Fresh VWB
b. Frozen VWB and Fresh VWB
when used with the NxTekâ„¢ Malaria Pf/Pv Plus and NxTekâ„¢ Malaria Pf Plus by laboratory professionals (from hereon referred to as Lab operators) in a laboratory environment to support CE IVDR certification.

The test results of the NxTekâ„¢ Malaria Pf Plus and NxTekâ„¢ Malaria Pf/Pv Plus Rapid Test using a VWB sample, will be evaluated against the NxTekâ„¢ Malaria Pf Plus and NxTekâ„¢ Malaria Pf/Pv Plus Rapid Test using CWBFS sample from the same participant. In summary: Fresh CWBFS vs. Fresh VWB*. Likewise, the test results of the NxTekâ„¢ Malaria Pf Plus and NxTekâ„¢ Malaria Pf/Pv Plus Rapid Test using VWB samples that have been exposed to 1x Freeze/Thaw cycle will be evaluated against the NxTekâ„¢ Malaria Pf Plus and NxTekâ„¢ Malaria Pf/Pv Plus Rapid Test using fresh VWB samples from the same participant. In summary: Frozen VWB vs. Fresh VWB*

*indicates: Where Fresh VWB will be the comparator sample type.

The data obtained will be used in the application for CE IVDR certification and WHO PQ. Paired CWBFS and VWB samples will be taken from the same individuals for testing on both NxTekâ„¢ Malaria Pf/Pv Plus and NxTekâ„¢ Malaria Pf Plus RDTs.

Secondary Objective: Intended Users within the Intended Use Environment
Malaria RDTs are used outside of the laboratory for near patient testing (NPT)* by non laboratory healthcare workers with limited training. Thus the secondary objective of this study is to assess the perfromance of the NxTekâ„¢ Malaria Pf/Pv Plus and NxTekâ„¢ Malaria Pf Plus results when used in its intended environment (NPT setting) by intended users (non laboratory healthcare workers with limited training) using CWBFS as the sample type.*see NPT definition Section 4.2-4.3 of protocol (or below sections on trial operator types and trial envitronment types).

 Kanungu, Market Cell
Wakiso, Maganjo
Wakiso, Central Ward
 Uganda 2021-08-16 2024-08-16 Section 5.2 of Protocol: Two arms- each kit minimum 90 Pf Positives, 26 Pv Positives, 116 Negatives All comers, febrile symptomatic patients of both sexes aged 15 years and above suspected of having malaria and seeking standard medical care at the sites. Abbott Diagnostics Korea Inc. Medical and Health Sciences Clinical Trial Non-degree Award
Rhoda Wanyenze
ID: UNCST-2021-R013352
 PILOT OF A NETWORK-DRIVEN, ADVOCACY INTERVENTION TO PROMOTE CERVICAL CANCER SCREENING IN UGANDA (PHASE 3)
REFNo: HS1633ES

The proposed intervention development study seeks to improve cervical cancer screening in Uganda by engaging and training local public health researchers and program implementers, and empowering women living with cervical cancer risk (WLCCR), defined as women who have ever received CC screening procedures, to advocate for CC screening and early treatment among women in their social networks.
 Namayingo, Buyinja
 Uganda 2021-08-16 2024-08-16 40 index participants; 120 social network members This study represents phase 3 of the study that was earlier registered with UNCST. During this phase, we will aim to enroll women living with cervical cancer risk (hereafter referred to as the 'index participants'), defined as women who have ever been scr Glenn Wagner (RAND Corporation, USA) Medical and Health Sciences Clinical Trial Non-degree Award
Maxensia owor
ID: UNCST-2021-R014003
 IMPAACT 2017: Phase I/II Study of the Safety, Acceptability, Tolerability, and Pharmacokinetics of Oral and Long-Acting Injectable Cabotegravir and Long-Acting Injectable Rilpivirine in Virologically Suppressed HIV-Infected Children and Adolescents. Version 3.0, dated 13 August 2020
REFNo: HS1356ES

Primary Objectives:
Cohort 1
1.To confirm the doses for oral CAB followed by injectable CAB LA in HIV-infected, virologically suppressed adolescents
2.To confirm doses for injectable RPV LA in HIV-infected, virologically suppressed adolescents by evaluating safety and multiple dose PK of RPV LA through Week 16
Cohort 2:
1.To assess the safety of CAB LA + RPV LA through Week 24 in HIV-infected, virologically suppressed adolescents
Secondary Objectives: Cohort 1
• To monitor maintenance of viral suppression through Week 16 in HIV-infected, virologically suppressed adolescents
• To evaluate the tolerability and acceptability of CAB LA through Week 16 in HIV-infected,virologically suppressed adolescents
• To evaluate the tolerability and acceptability of RPV LA through Week 16 in HIV-infected,virologically suppressed adolescents
Secondary Objectives: Cohort 2
• To assess safety of oral CAB + oral RPV followed by CAB LA + RPV LA through Week 48 in HIVinfected, virologically suppressed adolescents
• To evaluate repeat-dose pharmacokinetics of CAB LA + RPV LA through Week 24, and through
Week 48 in HIV-infected, virologically suppressed adolescents.
• To assess antiviral activity of CAB LA + RPV
 Kampala, Mulago
Kampala, Mulago 1
 Uganda 2021-08-11 2024-08-11 155 participants overall but MUJHU plans to enroll 18-25 participants HIV‐1 infected children and adolescents, 12 to <18 years of age, who are virologically suppressed on stable cART consisting of 2 or more drugs from 2 or more classes of antiretroviral drugs, National Institutes Of Health Medical and Health Sciences Clinical Trial Non-degree Award
Pontiano  Kaleebu
ID: UNCST-2020-R019901
 Field Performance Evaluation of the m-PIMAâ„¢ HIV-1/2 VL plasma assay in Uganda
REFNo: HS1606ES

Main objective
To evaluate the field performance of the m-PIMATM HIV-1/2 VL plasma VL in identifying virological failure (VF) in adults on ART. The performance will be compared to standard PCR assays used at UNHLs and UVRI.
2.3.2 Primary objectives
I). To evaluate the diagnostic accuracy using the sensitivity, specificity, NPV, PPV, FPR and FNR of the m-PIMAâ„¢ HIV-1/2 VL plasma assay in comparison to a reference assay of HIV-1 RNA PCR in identifying HIV-VF at the WHO recommended threshold of 1000 copies/ml for HIV-1 infected.
II). To determine the operational characteristics of the m-PIMAâ„¢ HIV-1/2 VL plasma assay, such as ease of-use of the assay using the standardized system usability scale (SUS) by laboratory and no laboratory personnel
III). To determine changes in turn-around time and ease of clinic workflow integration.
IV).To determine acceptability of the m-PIMAâ„¢ HIV-1/2 VL plasma assay by the study participants

 Kampala, Kampala
Buikwe, Buikwe
Kayunga, Kayunga
Mpigi, Mpigi Town Council
 Uganda 2021-08-11 2024-08-11 403 participants -Adult ART patients who are ≥18 years old on ART for ≥ 6 months will be approached for study participation. Historical controls will be used to compare the time to initiation of intensive adherence counselling (IAC) between the m-PIMA and the standard - Abott Diagnostics Medical and Health Sciences Clinical Trial Non-degree Award
Hannah Kibuuka
ID: UNCST-2020-R014355
 A parallel-group, Phase III, multi-stage, modified double-blind, multi-armed study to assess the efficacy, safety, and immunogenicity of two SARS-CoV-2 Adjuvanted Recombinant Protein Vaccines (monovalent and bivalent) for prevention against COVID-19 in adults 18 years of age and older
REFNo: HS1638ES

1. To assess, in participants who are SARS-CoV-2 naïve, the
clinical efficacy of the CoV2 preS dTM-AS03 vaccines for
the prevention of symptomatic COVID-19 occurring ≥ 14
days after the second injection.

2. To assess the safety of the CoV2 preS dTM-AS03 vaccines
compared to placebo throughout the study.
 Kampala,
Wakiso,
Mukono,
Uganda 2021-08-10 2024-08-10 800 Adults 18 years of age and older Sanofi Pasteur Inc. Medical and Health Sciences Clinical Trial Non-degree Award
Pontiano Kaleebu
ID: UNCST-2021-R013577
 An open label, Phase 2 study to evaluate the safety and immunogenicity of an Ad26.ZEBOV booster dose in Human Immunodeficiency Virus Positive (HIV+) adults previously vaccinated with the Ad26.ZEBOV, MVA-BN-Filo vaccine regimen
REFNo: HS1350ES

• To assess the safety and tolerability of a Ad26.ZEBOV booster dose in HIV positive adults previously vaccinated with the Ad26.ZEBOV, MVA-BN-Filo vaccine regimen.

• To assess humoral responses induced by the booster dose against EBOV glycoprotein (GP), as measured by Filovirus Animal Non-Clinical Group (FANG) Enzyme-Linked Immunosorbent Assay (ELISA) at 7 and 21 days.

 Masaka, NOT APPLICABLE
Lwengo, NOT APPLICABLE
Bukomansimbi, NOT APPLICABLE
Kalungu, NOT APPLICABLE
 Uganda 2021-08-04 2024-08-04 50 participants Participants must be healthy (based on physical examination, medical history, and clinical judgment) HIV positive adults who received the Ad26.ZEBOV and MVA-BN-Filo vaccine regimen in the VAC52150EBL2002 trial and were aged ≥18 to ≤50 years at the tim London School of Hygiene & Tropical Medicine Medical and Health Sciences Clinical Trial Non-degree Award
Conrad Muzoora Kihembe
ID: UNCST-2019-R001432
 Determination of Adequate TUberculosis Regimen in Adults and adolescents hospitalised with HIV-associated severe immune suppression (Acronym: DATURA).
REFNo: HS1487ES

Primary objective: To estimate the impact of an intensified initial phase of tuberculosis (TB) treatment on mortality at 48 weeks among HIV-infected adults and adolescents hospitalised for TB with CD4 ≤ 100 cells/μL in comparison with the standard TB regimen. Secondary objectives: To estimate the impact of an intensified initial phase of TB treatment, in comparison with the standard TB regimen, on: ¥ Mortality at weeks 8 and 24 ¥ Adverse events, including: - All grade 3-4 events - Selected grade 2 events of interest - Drug-related adverse events - AIDS defining illnesses - Paradoxical TB-associated immune reconstitution inflammatory syndrome (IRIS) ¥ TB treatment success ¥ TB recurrence ¥ Antiretroviral treatment (ART) response in terms of virological success and immunological response ¥ Adherence to TB treatment and ART ¥ Peak plasma concentrations of rifampicin and isoniazid (and its N-acetyl-metabolite) at day 3, day 7 and week. ¥ Plasma concentrations of efavirenz and dolutegravir at week 4 (i.e. 2 weeks after the onset of ART)
Mbarara, Mbarara
 Uganda 2021-07-16 2024-07-16 1330 15-85years, All sexes, all tribes, ethnicities and religions Inserm-ANRS French National Institute for Health and Medical Research (Inserm) ANRS Infectious Emerging Diseases – Autonomous Agency of Inserm (ANRS) Medical and Health Sciences Clinical Trial Non-degree Award
Catriona  Waitt John
ID: UNCST-2019-R001068
 Implementation of a "bundle of care" to improve anticoagulation control in patients receiving warfarin in Uganda and South Africa
REFNo: HS1422ES

Primary objective is to evaluate whether implementation of warfarin bundle improves time in therapeutic range

Secondary objectives are:
-To evaluate whether implementation of the warfarin bundle improves time to achieving a therapeutic INR
-Whether implementation of the warfarin bundle affects the occurrence of adverse events(death, bleeding and thrombotic events)
-whether staff find the interventions contained in the bundle acceptable
-To explore patients' experiences and acceptability of the package of care, and
-Whether the bundle represents good value for money
 Kampala, Salaama
Kampala, Mulago
 UK 2021-07-09 2024-07-09 444 Adult patients (18 years or older),male or female newly initiated on warfarin for the first time University of Liverpool Medical and Health Sciences Clinical Trial Non-degree Award
Deborah  Ojiambo
ID:
Efficacy of Group Activity Adherence Counselling (GAAC) for Adolescents with Unsuppressed HIV viral load at three large HIV clinics in Uganda: Randomized controlled trial
REFNo: SS805ES

1.To examine the barriers such as behavior problems and mental health problems to adherence experienced by adolescents living with HIV.
2.To evaluate the efficacy of GAAC in addressing barriers to adherence among adolescents living with HIV.

3.To assess whether GAAC is associated with viral load suppression, among adolescents living with HIV compared to Standard Service Provision (SSP)
 Kampala, Mulago 1
Wakiso, Entebbe
 Uganda 2021-07-07 2024-07-07 300 The population for this study is school-going adolescents living with HIV (12-18 years) who received ART for at least 6 or more months at Mulago ISS, TASO Mulago, TASO Entebbe HIV clinics Makerere University Research and Innovation Fund (RIF) funded by Uganda government Social Science and Humanities Clinical Trial Non-degree Award
Susan  Nabadda
ID: UNCST-2020-R014331
 Diabetes Mellitus Tuberculosis and HIV multimorbidities among adult patients attending Kiruddu National Referral Hospital, Uganda Version 2 7/26/2020.
REFNo: HS1386ES

General Objective
The overall objective of this project is to determine the prevalence of DM among patients with either TB, HIV, and TB-HIV co morbidity. This will help to assess the prevalence of silent DM in these categories of patients.
Specific objectives

1. To describe the prevalence of DM among either TB patients or HIV patients or patients with both TB and HIV co morbidity attending the Kiruddu hospital outpatient clinics
2. To determine the factors associated with DM in patients with HIV alone, TB alone and HIV – TB co-infection.

 Kampala, Buziga
 Uganda 2021-06-29 2024-06-29 1000 Adults of 18 years and above, HIV-infected patients or TB patients receiving care at Kiruddu National Referral Hospital (patients with both TB and HIV will also be included) However, patients who will be critically ill and in need of emergency clinical c Beckton Dickinson and the United States Centers for Disease Control and Prevention (CDC), Uganda. Medical and Health Sciences Clinical Trial Non-degree Award
JUSTUS BARAGEINE KAFUNJO
ID: UNCST-2020-R014150
 COMPREHENSIVE REINTEGRATION ASSISTANCE FOR WOMEN WITH FEMALE GENITAL FISTULA: INTERVENTION PILOTING
REFNo: SS890ES

Aim 1: To understand the feasibility and acceptability of a pilot reintegration program for female genital fistula. Aim 2. To assess the acceptability of the pilot reintegration intervention to patients, intervention implementors. Aim 3. To assess the preliminary effectiveness of the pilot reintegration intervention.
 Kampala, MULAGO
,
Uganda 2021-06-24 2024-06-24 40 (30 women to participate in the intervention and indepth interview plus 10 stake holders Women aged 18 years and above or considered emancipated minors under Ugandan law who are undergoing genital fistula surgery. U.S. Eunice Shriver Kennedy National Institute of Child Health and Development. Social Science and Humanities Clinical Trial Non-degree Award
Mohammed Lamorde
ID: UNCST-2019-R001293
 Drug Interactions between Dolutegravir (DTG) and escalating-doses of Rifampicin (RIF) Study
REFNo: HS1376ES

The secondary objectives of the trial are to determine the safety and tolerability of the DTG/RIF combination, the PK of RIF, induction of PgP and CYP3A4 and effect of DTG on appetite,Primary Objective The primary objective of the study is to determine changes to the PK parameters of DTG when administered with standard, medium and high doses of RIF in HIV-negative, TB-monoinfected participants coming to the end of continuation TB therapy with standard doses of RIF and INH over a 10 week period,
 Kampala, Mulago 1
 Nigeria 2021-06-23 2024-06-23 18 Inclusion Criteria • Ability to give informed consent prior to participation • Willing and able to comply with all study requirements • Receiving standard doses of RIF and INH • HIV antibody negative • Male or non-pregnant, non-breastfeedin University of Liverpool Medical and Health Sciences Clinical Trial Non-degree Award
Irene Andia Biraro Rebecca
ID: UNCST-2019-R001475
 A Randomized Double Blind Placebo Controlled Trial of Rifapentine and Isoniazid for Prevention of Tuberculosis in People with Diabetes.
REFNo: HS1112ES

Primary objective:
To assess the efficacy of preventive therapy with a 12-week course of rifapentine and isoniazid (3HP) against the development of probable or definite TB disease over 24 months in people with Diabetes Mellitus (DM) who are latent TB infection (LTBI) test positive.
Secondary objectives:
• To assess the efficacy of 3HP against the development of possible, probable or definite TB disease over 24-40 months in people with DM who are latent tuberculosis infection test positive
• To compare the proportions who complete treatment between arms
• To compare the occurrence of adverse events between arms
• To compare the rate of TB or death between arms
• To compare the overall mortality rate between arms
• To explore the efficacy of 3HP against development of probable or definite TB in those who are LTBI test positive, across the following sub-groups, separately: study site (n=3); age groups; duration of DM; level of glycaemic control (baseline HbA1C) and body mass index (BMI).
• To assess the efficacy of 3HP against development of probable or definite TB, in two restricted analyses: TST positive and IGRA positive participants.
• To carry out sub-studies including i) an economic modelling and cost effectiveness study, ii) a cohort study of those who are IGRA and TST negative a baseline, iii) a cross-sectional study of HIV and TB prevalence and DM phenotype, (iv) evaluation of point-of care (POC) testing for LTBI, and computer-assisted X-ray, (v) a public health study of patient management, and v) future genetic studies.

Kampala, Munyonyo
Wakiso, Kasangati
Kampala, Rubaga
 Uganda 2021-06-18 2024-06-18 1500 Inclusion criteria I. Enrolled in diabetes care with a history of DM and current use of anti-diabetic medication (‘known DM’); OR in the absence of anti-diabetic medication an HbA1c of ≥6.5% (48 mmol/mol) or a fasting venous plasma glucose of ≥7. National Institute for Medical Research, Mbeya Tanzania Medical and Health Sciences Clinical Trial Non-degree Award
Julius Okuni Boniface
ID: UNCST-2019-R000963
 A MULTI-COUNTRY, SINGLE-BLINDED, PHASE 2 STUDY TO EVALUATE RAPID DETECTION SYSTEMS OF SARS-COV-2
REFNo: HS1425ES

1. To determine the clinical sensitivity of the test assays compared to the real-time RT-PCR-based method.
2. To determine the specificity of the test assays compared to the real-time RT-PCR-based method.

 Kampala, Mulago
 Uganda 2021-06-16 2024-06-16 500 The age group will be adults from 18 years and above. The samples will be collected from archives at the Biorepository in the Department of Immunology and Molecular Biology, Makerere University. The samples will be from people from patients that had compl EDCTP Medical and Health Sciences Clinical Trial Non-degree Award
Musa Sekikubo
ID: UNCST-2021-R014010
 A multi-Centre, randomised, placebo controlled, double-blind, parallel group study to evaluate the safety, tolerability and immunogenicity of two doses of Group B Streptococcus vaccine (GBS-NN/NN2) in women who are pregnant and living with HIV and women who are pregnant and do not have HIV
REFNo: HS1390ES

Objectives
Primary Objectives:
Safety:
To evaluate the safety and tolerability of the GBS-NN/NN2 vaccine in women living with HIV and women without HIV and their newborn babies from vaccination up to delivery/birth.
Immunological:
To compare the transfer rate of vaccine- specific immunoglobulin G (IgG) antibody concentrations from the mother to the baby at birth in women living with HIV with the transfer rate in women without HIV. This endpoint will be used to determine the sample size calculation.
Secondary Objectives
Safety: The safety and tolerability of the GBS-NN/NN2 vaccine in the mother and baby over the first 6 months post-partum, as assessed at 6 months of age.
Immunological: The secondary immunological objectives are:
• To compare IgG antibody responses, specific to the GBS-NN/NN2 vaccine, induced by the first and second vaccine doses over time in pregnant women living with HIV and pregnant women without HIV.
• To evaluate the concentration of IgG antibodies specific for the GBS-NN/NN2 vaccine up to 6 months post-delivery in the mother and baby in women with and without HIV.
• To determine the concentrations of vaccine specific IgG to GBS-NN/NN2 in cord blood at delivery in babies born to women with and without HIV.
Exploratory Objectives
• To compare between groups the isotype composition of the vaccine specific antibodies; in particular IgG and IgA as well as their subclasses, i.e. IgG1-4, IgA1 and IgA2 in maternal and cord blood.
• To compare between groups the vaccine specific IgG antibodies to Rib, Alp1, Alp2 and AlpC, GBS-NN and GBS-NN2 in maternal and cord blood.
• To compare between groups the functional activity of vaccine specific antibodies from cord blood in an opsonophagocytic killing assay (OPkA) and other in vitro assays in selected samples.

 Kampala, Kawempe
 Uganda 2021-06-08 2024-06-08 50 HIV negative and HIV positive pregnant women aged 18 to 40 years attending Kawempe national referral Hospital MINERVAX AS Medical and Health Sciences Clinical Trial Non-degree Award
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