Eugene Ruzagira
ID: UNCST-2023-R008282
|
A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to
Evaluate the Efficacy and Safety of MK-8527 Oral Once-Monthly as HIV-1 Preexposure
Prophylaxis in Women
REFNo: HS6565ES
To evaluate the efficacy of MK-8527 qm
compared to FTC/TDF qd for the
prevention of HIV-1 infection as assessed
by the incidence rate per year of adjudicated
HIV-1 infections
To evaluate the safety and tolerability of
MK-8527 qm compared to FTC/TDF qd.
|
Masaka, Masaka
|
Uganda |
2025-11-21 11:18:30 |
2028-11-21 |
150 |
This study includes participants of varying age, race, ethnicity, and sex, female at birth, Aged from 16 years to 30 years of age inclusive, at the time of providing the informed consent or assent and Is confirmed HIV-uninfected based on negative HIV-1/HIV-2 test results during
screening.
|
Merck Sharp & Dohme LLC |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
ERIC WOBUDEYA
ID: UNCST-2019-R001047
|
Shortened RegiMen for Drug-susceptIbLE TB in Children
REFNo: HS4030ES
Primary
1. To determine if an 8-week HPZM regimen in children with presumed drug-susceptible TB disease has non-inferior efficacy to 8-weeks of HRZ(E) plus 8- or 16-weeks of HR(E) for achieving treatment success.
2. To evaluate the safety of the 8-week HPZM regimen in comparison to the 16- or 24- week HRZ(E) regimen among children with and without HIV.
Secondary
1. To evaluate the tolerability of the 8-week HPZM regimen in comparison to the 16- or 24- week HRZ(E) regimen among children with and without HIV.
2. To determine the weight-banded dosing of rifapentine and moxifloxacin taken as part of the HPZM regimen.
3. To evaluate the palatability and acceptability of the 8-week HPZM regimen in comparison to the 16- or 24-week HRZ(E) regimen among children with and without HIV.
4. To evaluate adherence to the 8-week HPZM regimen in comparison to the 16- or 24- week HRZ(E) regimen among children with and without HIV.
5. To evaluate clinical and laboratory characteristics and drug exposures associated with unsuccessful treatment outcomes (treatment failure or death).
6. To evaluate the cost and cost-effectiveness of the 8-week HPZM regimen relative to the 16- or 24-week HRZ(E) standard of care regimen, using a societal approach.
Exploratory
1. To characterize rifapentine and moxifloxacin PK parameters in malnourished children.
2. To evaluate the effect of rifapentine or rifampin, taken as part of the HPZM or HRZ(E) regimen, on the PK of dolutegravir.
3. To evaluate virologic control (less than 200 copies/mL) at 24- and 48-weeks among children with HIV taking a dolutegravir-based ARV treatment regimen co-administered with either HPZM or HRZ(E).
4. To collect and store biospecimens from consented participants for the purpose of future TB research.
|
Kampala, mulago
|
Uganda |
2024-05-31 18:02:19 |
2027-05-31 |
150 |
Children less than 10 years of age |
Johns Hopkins University |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
ERIC WOBUDEYA
ID: UNCST-2019-R001047
|
Phase I/II Dose Finding, Safety and Tolerability Study of Daily Rifapentine Combined with Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age with and without HIV
REFNo: HS6555ES
Primary Objectives
Cohort 1 and Cohort 2
• To determine the weight-band dosing of RPT taken as part of the 1HP regimen by evaluating:
⎯ PK RPT exposures among children with and without HIV
⎯ Safety and tolerability of the 1HP regimen among children with HIV while receiving twice-daily DTG and children without HIV through 28 days of dosing
Cohort 2
• To evaluate the effect of RPT taken as part of the 1HP regimen on the PK of DTG
Secondary Objectives
Cohort 1 and Cohort 2
• To evaluate the effect of covariates including age, weight, sex, ethnicity, nutritional status, and HIV-1 status on the PK of RPT taken as part of the 1HP regimen
• To evaluate the safety of the 1HP regimen through 24 weeks of follow-up
• To evaluate the palatability and acceptability of the 1HP regimen
• To evaluate adherence to the 1HP regimen
Cohort 2
• To evaluate the safety and tolerability of twice-daily DTG through 42 days among children with HIV who are receiving 1HP
• To evaluate virologic control (less than 200 copies/mL) at Day 42 among children taking a DTG-based ARV treatment regimen co-administered with 1HP
|
Kampala, mulago
|
Uganda |
2025-11-04 12:59:17 |
2028-11-04 |
40 |
children living without HIV (Cohort 1) and children living with HIV (Cohort 2) at risk of TB disease who are less than 13 years of age. |
National Institute of Allergy and Infectious Diseases Eunice Kennedy Shriver National Institute of Child Health and Human Development National Institute of Mental Health |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Ezekiel Mupere
ID: UNCST-2023-R008637
|
Earlier prime-BOOST schedule to improve MEasles protection in high burden settings (BoostME)
REFNo: HS2883ES
Safety Objectives
1.To assess the safety and reactogenicity profile of the vaccine when given at different ages
2.To assess the number of measles infections throughout the study.
Primary Objectives
1.To compare protective measles antibody concentrations at 2.5 years of age in infants receiving an early (6 months) compared to standard (9 month) dose of MCV, and a booster dose at 18 months of age.
2.To compare protective measles antibody concentrations one month after a second dose of MCV given at 12 months (early) compared to standard (18 months), in those who received an early (6 months) first dose.
Secondary Objectives
•To describe the measles antibody concentrations one month after first dose in infants receiving an early (6 months) compared to standard (9 month) dose of MCV.
•To describe the effect of maternal antibodies on infant humoral and cellular immune response to first and second doses in children vaccinated under different schedules.
•To describe the effect of maternal HIV infection on infant antibody responses post MCV1 and MCV2 given at different schedules
•To describe the impact of different vaccination schedules on responses to the rubella component of the vaccine.
Community Objectives
To assess the effect of a measles vaccination clinical trial on public perceptions of measles immunisation
|
Kampala, Kawaala
Kampala, Kisenyi
Kampala, Komamboga
Kampala, Mulago
|
Uganda |
2023-06-23 7:46:04 |
2026-06-23 |
450 infants |
Any infant aged 6 months (23-28 weeks) at screening visit and has
not received prior vaccination against measles |
University of Oxford Research Governance, Ethics and Assurance Joint Research Office Boundary Brook House Churchill Drive Headington Oxford OX3 7GB United Kingdom, and funded by Bill and Melinda Gates Foundation. |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Fred Bulamba
ID: UNCST-2020-R014888
|
PErioperative respiratory care and outcomes for patieNts Undergoing hIgh risk abdomiNal surgery
REFNo: HS2178ES
To explore the cost-effectiveness of the different treatment combinations in reducing pneumonia and SSI at pre-selected centres.,To assess the impact of both interventions on postoperative mortality at 30-days, and the effect of 80-100% FiO2 only on the re-operation rate at 30 days after surgery.,To assess whether (1) preoperative 0.2% chlorhexidine mouthwash reduces the rate of postoperative pneumonia at 30-days compared to no mouthwash, and (2) 80-100% FiO2 used during surgery reduces the rate of postoperative SSI at 30-days compared to 21-35% FiO2, amongst patients aged 10 years or over undergoing elective or emergency midline laparotomy, with an anticipated abdominal incision of ≥5cm, for any indication except caesarean section.,
|
Mbale, Hospital cell
|
Uganda |
2025-08-28 10:15:49 |
2028-08-28 |
1000 (for Uganda only) |
Patients above 10 years undergoing abdominal surgery |
Dr Birgit Whitman |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Fred Bulamba
ID: UNCST-2020-R014888
|
Rule of THUMB: A multi-centre cluster trial evaluating the implementation of a perioperative care complex intervention to improve outcomes from haemorrhage during and after caesarean section in African hospitals
REFNo: HS5855ES
To evaluate the effect of the trial intervention on patient outcomes relevant to future trials.,To evaluate whether implementation of the ‘Rule of THUMB’ perioperative complex intervention increases risk assessment and improves diagnosis and compliance with proven interventions for haemorrhage during and after caesarean section.,
|
Mbale, Hospital Cell
|
Uganda |
2025-05-14 9:24:07 |
2028-05-14 |
600 |
Any patient who requires a caesarean section |
Department of Anaesthesia and Perioperative Medicine |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Felix Magala
ID: UNCST-2024-R016043
|
Incidence of Post-Operative Sore Throat Among Patients Undergoing Open Abdominal Surgery: A Randomized Control Trial Comparing Video and Direct Laryngoscopy
REFNo: HS5685ES
To compare the incidence of POST, and recovery from POST following intubation using Video laryngoscopy or Direct laryngoscopy during general anaesthesia among general surgery patients undergoing laparotomy at MRRH
1. To determine the incidence of POST in the first 24 hours following intubation with either Video-laryngoscopy or Direct-laryngoscopy for patients undergoing open abdominal surgery at MRRH
2. To determine the recovery time from POST among patients intubated with Video laryngoscopy compared to Direct-laryngoscopy.
3. To describe the symptoms associated with POST amongst patients intubated for open abdominal surgery
|
Mbarara, Mbarara
|
Uganda |
2025-07-11 18:00:56 |
2028-07-11 |
148 |
Study population
We will recruit surgical patients scheduled for laparotomy (open abdominal surgery, requiring an incision of at least 5cm) at the surgical and emergency ward of MRRH.
Eligibility criteria
We shall include;
• General surgery patients scheduled for laparotomy under general anaesthesia.
• Aged 18 years and above.
• ASA class I to III.
• Mallampati class I to II.
We shall exclude:
• Have had an upper respiratory tract infection or have had an endoscopy or bronchoscopy procedure in the past 2 weeks.
• Have had any ENT, neck or thoracic surgery in past 3 months.
• Those who have symptoms of gastroesophageal reflux disease (GERD).
• And those with history of smoking.
• Those with anatomical abnormality in the neck, head, face.
• Edentulous patient.
• Patients with suspected difficult airway as assessed by the principal investigator.
|
self sponsored |
Medical and Health Sciences |
Clinical Trial |
Degree Award |
|
Francis Kiweewa
ID: UNCST-2020-R014929
|
A Global Multi-Center, Randomized, Blinded, Placebo-Controlled Phase 3 Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (LVRNA009) for the Prevention of COVID-19 in Participants Aged 18 Years and Older
REFNo: HS2476ES
The objective of this study is to evaluate the effectiveness, safety, and the ability of the study vaccine to provoke an immune response in your body against COVID-19. This study is necessary because the COVID-19 epidemic poses a significant global health challenge, and a large number of effective vaccines are still needed for the future.
A total of approximately 34,000 participants like you from around the world, such as Africa and Asia will participate in this study. The entire study will last approximately 20 months, and your participation will last approximately at least 17 months. (The exact duration of your participation in the study may depend on the specific situation of the study. Please consult your study doctor at that time.)
|
Wakiso,
Kampala,
Lira,
Tororo,
|
Uganda |
2022-09-28 14:10:52 |
2025-09-28 |
234 |
Adults aged 18 years and older of all sexes.
|
AIM Vaccine Co., Ltd, AIM Innovation Biotechnology (Shanghai) Co., Ltd, LiveRNA Therapeutics Inc. & Ningbo Rongan Biological Pharmaceutical Co., Ltd |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
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|
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 |
|
Flavia Matovu Kiweewa
ID: UNCST-2021-R013337
|
A Phase 2/3, Multicenter, Open-label, Multicohort Study Evaluating Pharmacokinetics (PK), Safety, and Efficacy of Cobicistat-boosted Atazanavir (ATV/co) or Cobicistat-boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in HIV-1 Infected, Virologically Suppressed Pediatric Participants.
REFNo: HS2646ES
The primary objective of this study is to confirm the dose of ATV/co or DRV/co in HIV-1 infected pediatric participants, to confirm the dose of F/TAF in HIV-1 infected pediatric participants and to evaluate the safety and tolerability these medications.
|
Mityana, Mityana
Mubende, Mubende
Masaka, Masaka
Rakai, Kalisizo
Kampala, Kampala
Wakiso, Entebbe
|
Uganda |
2023-03-09 23:33:04 |
2026-03-09 |
15 |
The study will be conducted in young children and adolescents aged 3 to < 18 years; HIV-1 infected on a stable antiretroviral regimen for a minimum of 3 months. In Uganda, the study will be conducted by researchers from the coordinating site, MU-JHU Research Collaboration, MU-JHU CARE – Kampala, Uganda, in collaboration with Africa Medical and Behavioral Sciences Organization (AMBSO) – Kampala and SICRA-TASO MULAGO National Referral Hospital, Masaka, Uganda. |
Gilead Sciences Inc |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Flavia Matovu Kiweewa
ID: UNCST-2021-R013337
|
A Phase 2/3, Open-Label Study of the Pharmacokinetics, Safety, and Antiviral Activity of the GS-9883/Emtricitabine/Tenofovir Alafenamide (GS9883/F/TAF) Fixed Dose Combination (FDC) in HIV-1 Infected Adolescents and Children.
REFNo: HS2931ES
The primary objective of this study is to confirm the dose of B/F/TAF FDC in HIV-1 infected pediatric participants, to confirm the dose of B/F/TAF TOS in HIV-1 infected pediatric participants and to evaluate the safety and tolerability these medications.
|
Kampala,
|
Uganda |
2023-07-06 17:23:47 |
2026-07-06 |
5 |
Adolescents and children |
Gilead Sciences |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Flavia Matovu Kiweewa
ID: UNCST-2021-R013337
|
An Open-label, Single-arm Study to Provide Continued Access to Study Drug to Participants Who Have Completed Pediatric Clinical Studies Involving Gilead HIV Treatments.
REFNo: HS5804ES
The primary objective of this trial is to provide continued access to the study medication received in the parent protocol or switch to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF; coformulated; Biktarvy®) for participants who completed a Gilead parent study evaluating medications for HIV treatment.
|
Kampala, kampala
|
Uganda |
2025-04-11 16:20:58 |
2028-04-11 |
This study is not formally powered. The purpose of this study is to provide continued access to the study medication received in the parent study or to provide B/F/TAF to applicable participants who have completed a relevant parent study. Therefore, all participants who are on parent study medication and have completed a Gilead parent study evaluating medications for HIV treatment may be enrolled in this study dependent on eligibility. |
Participants who have completed a parent study and meet all eligibility criteria will be offered the opportunity to roll over to this study and receive the same regimen as in the parent study. Participants will also be allowed to switch to B/F/TAF when they enroll in this study if they meet the additional
eligibility criteria. |
Gilead sciences Inc |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Flavia Matovu Kiweewa
ID: UNCST-2021-R013337
|
A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy and Safety of MK-8527 Oral Once-Monthly as HIV-1 Preexposure
Prophylaxis in Women
REFNo: HS6666ES
To evaluate the efficacy of MK-8527 qm
compared to FTC/TDF qd for the
prevention of HIV-1 infection as assessed
by the incidence rate per year of adjudicated
HIV-1 infections.
Hypothesis: MK-8527 qm is superior to
FTC/TDF qd with respect to the hazard
ratio for HIV-1 infecti
|
Mityana,
Kalangala,
Kampala,
Masaka,
Wakiso,
|
Uganda |
2025-10-16 17:51:09 |
2028-10-16 |
Approximately 4580 participants |
16 to 30 years of age |
Merck Sharp & Dohme LLC |
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 |
|
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 |
|
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 |
|
Fred Ssewamala
ID: UNCST-2020-R014060
|
Suubi+Adherence4Youth: Optimizing the Suubi Intervention for Adherence to HIV Treatment for Youth Living with HIV in Uganda
REFNo: SS1449ES
The proposed Suubi+Adherence4Youth study seeks to unpack the Suubi intervention to identify the most impactful and sustainable components: economic vs. psychosocial components, for adolescents living with HIV (ALHIV) across the HIV care continuum. The Suubi intervention was tested as a package of four components: 1) Financial Literacy Training (FLT); 2) Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs); 3) a manualized and visual-based intervention for ART adherence and stigma reduction; and 4) Engagement with HIV treatment-experienced role models. We propose a factorial experiment to unpack and optimize the Suubi intervention to enhance scale up in health systems using the multi-phase optimization strategy (MOST) -an engineering-inspired intervention framework. Our ultimate goal is to build Suubi version 2.0 that meaningfully improves viral suppression while performing efficiently, affordably, and at scale for a sustained impact.
Aim 1. Conduct a factorial experiment (optimization trial) to test the main effects of each of the four Suubi intervention components and combinations of components (interactions) on viral suppression (primary outcome).
Aim 2. Test mediators and explore moderators that explain and modify the relationship between each of the four Suubi intervention components and viral suppression.
Aim 3. Compare the cost and cost-effectiveness of each of the four Suubi intervention components and every combination of components.
|
Masaka, Kimaanya
Rakai, Kakuuto
Kyotera, Kyotera TC
Lwengo, Lwengo
Kalungu, Bukulula
|
Uganda |
2022-11-11 17:11:59 |
2025-11-11 |
576 |
We will recruit 576 ALHIV between ages 11-17, from 48 healthcare clinics associated with ICHAD and Masaka Catholic Diocese.
Inclusion and Exclusion Criteria: 1) An adolescent living with HIV (confirmed by medical report and aware of status); 2) living within a family; 3) being 11–17 years of age (at enrollment); 4) Prescribed ART; and 5) enrolled in ART care at one of the 48 health clinics in the study districts.
Exclusion criteria: Adolescents will be ineligible if: 1) they are unable to understand study procedures and participant rights as assessed during informed consent/assent process with the adolescent parent. 2) If the adolescent or adult caregiver presents with emergency needs (e.g., hospitalization), needed care will be secured, rather than study participation |
National Institute of Mental Health (NIMH) |
Social Science and Humanities |
Clinical Trial |
Non-degree Award |
|
Fred Ssewamala
ID: UNCST-2020-R014060
|
Bridges2Scale: Testing Implementation Strategies for an intervention among young people affected by AIDS
REFNo: SS2488ES
Bridges2Scale will use a two-arm Hybrid III effectiveness-implementation cluster randomized clinical trial, where we will compare two multifaceted strategies (standard vs. enhanced) for scaling the Bridges interventions (consisting of financial literacy training, peer mentorship, family income-generating , and youth development accounts). The standard implementation strategy has been applied in our prior and ongoing studies and involves educational meetings that prepare staff members to deliver Bridges with minimal disruption to site workflow. This will be compared to an enhanced strategy that will be developed using Implementation Mapping, a systematic protocol for developing implementation strategies using theory, evidence, and stakeholder input.
Aim 1: Compare the implementation effectiveness of the standard implementation strategy vs. an enhanced implementation strategy.
Aim 2: Determine the clinical effectiveness of Bridges implemented via a standard vs. enhanced implementation strategy.
Aim 3: Explore implementation processes, mechanisms, and determinants.
Aim 4: Compare the cost and cost-effectiveness of the two implementation strategies.
|
Masaka, Kimaanya
Rakai, Kakuuto
Kyotera, Kyotera TC
Lwengo, Lwengo
Kalungu, Kasaali
Sembabule, Parish ward
Bukomansimbi, Mbiriizi
|
Uganda |
2024-04-19 18:42:54 |
2027-04-19 |
1440 |
Inclusion and Exclusion Criteria:
Adolescent Inclusion Criteria: (1) ages 13-17 years; (2) a student at one of the 48 public primary schools included in the study; (3) living within a family and not an institution/orphanage.
Caregiver Inclusion Criteria: A caregiver would be eligible if they are (1) self-identified and confirmed by the AY as primary caregiver of the AY; and (2) capable of providing informed consent.
Schools’ inclusion criteria: The 48 public (government) primary schools would be eligible if they are (1) located in one of the seven districts in the greater Masaka region – on secondment from the Ministry of Education or local government representative (District Education Officer [DEO]), and (2) willing and able to participate in study implementation.
Youth-serving NGOs will be invited if they are: (1) registered with the government of Uganda; (2) willing to work with the study team; and (3) have a history of implementing micro-finance EE interventions.
Exclusion criteria: Adolescents will be ineligible if: 1) they are unable to understand study procedures and participant rights as assessed during informed consent/assent process with the adolescent and parent. 2) If the adolescent or adult caregiver presents with emergency needs (e.g., hospitalization), needed care will be secured, rather than study participation.
Facilitator Recruitment. The leaders of public schools and youth-serving NGOs will help us select the facilitators based on their interest in the intervention and willingness to work with study participants.
Standard Implementation Strategy (SIS) condition. we will meet with both NGO and school staff to gauge their interest in partnering on study implementation and describe roles and responsibilities.
Enhanced Implementation Strategy (EIS) condition. The headmaster of each school in the EIS will identify at least 2 teachers per school to be enrolled in the study and deliver the intervention—as implementation champions. We expect to recruit at least 48 teachers in EIS (2 teachers/school x 24 schools). Similar procedures will be followed for NGO staff. Specifically, we will recruit at least 8 facilitators from NGOs and 8 facilitators from community (including PTA members) to serve as trainers for implementation champions.
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
Social Science and Humanities |
Clinical Trial |
Non-degree Award |
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Fred Ssewamala
ID: UNCST-2020-R014060
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Suubi4PrEP: Improving PrEP Access and Adherence Among Adolescent Girls and Young Women in Uganda
REFNo: SS3990ES
Suubi4PrEP will examine the effect of a multilevel intervention, combining HIV risk reduction that incorporates sessions on PrEP, peer supporters with lived experiences to facilitate linkage to and continued care, and economic empowerment components targeting financial barriers associated with PrEP access, PrEP initiation, uptake and adherence among AGYW in Uganda. Study aims are:
Aim 1: Examine the impact of Suubi4PrEP on PrEP initiation (primary outcome); and PrEP adherence (secondary outcome).
Aim 2: Examine the effect of Suubi4PrEP on hypothesized mechanisms of change (financial stability, PrEP stigma, self-efficacy, depressive symptoms, and social support) and intervention mediation.
Aim 3: Use mixed methods to explore multi-level factors that influence PrEP initiation and adherence.
Aim 4: Assess the cost and cost-effectiveness of the interventions.
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Masaka, Nyendo
Lwengo, Kinoni
Kyotera, Kakuuto
Kalungu, Bukulula
Rakai, Kakuuto
Sembabule, Sembabule TC
Bukomansimbi, Mbiriizi
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Uganda |
2025-06-20 7:41:25 |
2028-06-20 |
600 |
The target study population for the proposed Suubi4PrEP study is AGYW (15-24 years) living in HIV hotspots in the greater Masaka region of Uganda.
Emancipated minors (below 18 years) will not need parental/caregiver consent. In Uganda, the National Guidelines for Research Involving Humans as Research Participants (NGHRP) define a child as any person below the age of 18. On the other hand, an emancipated minor is defined as an individual below the age of 18 who are pregnant, married, have a child, or are self-sufficient.
Inclusion Criteria. Female between 15-24 years. AGYW will be screened for HIV risk as determined by the national risk screening tool developed by the Uganda National AIDS Control Program, in alignment with national PrEP guidelines. AGYW will be deemed to be at substantial risk, and eligible to participate in the study, if they report at least one of the seven high-risk sexual behaviors on the risk assessment tool.
Exclusion criteria. A participant will be excluded if they are: 1) HIV Positive, 2) unable to understand the study procedures and/or participant rights during the informed consent process, or 3) they are unwilling or unable to commit to completing the study. If the potential participant has emergency needs (e.g., hospitalization), they will be referred for care instead.
Peer Supporters. These will be women who are HIV negative, enrolled and adhering to PrEP. We expect to recruit at least four peer supporters at each of the 20 sites receiving the PS intervention component.
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National Institute for Mental Health |
Social Science and Humanities |
Clinical Trial |
Non-degree Award |
|
Fredrick Kabi
ID:
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EVALUATION OF THE SAFETY, EFFICACY AND EFFECTIVENESS OF THE SUBOLESIN BASED ANTI-TICK VACCINE: A RANDOMISED DOUBLE BLINDED MULTI-SITE CONFINED FIELD TRIAL
REFNo: A191ES
OVERALL OBJECTIVE
Evaluation of the Safety, Efficacy and Effectiveness of Subolesin based Anti-tick Vaccine for control of ticks naturally infesting different cattle breeds under confined field conditions in Uganda.
SPECIFIC OBJECTIVES
I. To determine the safety of the injectable Subolesin based Anti-tick vaccine for control of tick infestations under natural confined field conditions.
II. To determine the efficacy of the injectable Subolesin based Anti-tick vaccine for control of tick infestations under natural confined field conditions.
III. To determine the effectiveness of the injectable Subolesin based Anti-tick vaccine for control of tick infestations under natural confined field conditions.
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Apac,
Mbarara,
Ibanda,
Mbarara,
Masindi,
Wakiso,
|
Uganda |
2022-10-21 12:58:12 |
2025-10-21 |
360 |
1. Species: Bos indicus (Indicine) and Bos taurus (Taurine) cattle
2. Breed: All cattle breeds in the trial site
3. Ownership: Owned by NARO and UPS
4. Number: Each trial site will provide 72 head of cattle. Total number of experimental cattle will b |
Government of Uganda (GoU) |
Agricultural Sciences |
Clinical Trial |
Non-degree Award |
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