Maxensia owor
ID: UNCST-2021-R014003
|
IMPAACT 2036: Phase I/II Study of the Safety, Tolerability, Acceptability, and Pharmacokinetics of Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in Virologically Suppressed Children Living with HIV-1, Two to Less Than 12 Years of Age. Version 1.0, 22 September 2022. DAIDS study protocol ID: 38932
REFNo: HS2599ES
iii. Cohort 2: To describe the maintenance of viral suppression and immunologic activity of 48 weeks of CAB + RPV (oral and injectable) or 44 weeks of CAB LA + RPV LA (injectable only),iv. Cohort 2: To describe HIV-1 genotypes and phenotypes for children who experience virologic failure during 48 weeks of CAB + RPV (oral and injectable) or during 44 weeks of CAB LA + RPV LA (injectable only),ii. Cohort Cohort 2: To describe the safety and repeat-dose pharmacokinetics of 48 weeks of CAB + RPV (oral and injectable) or 44 weeks of CAB LA + RPV LA (injectable only),i. Cohort 2: To describe tolerability and acceptability of 48 weeks of CAB + RPV (oral and injectable) and 44 weeks of CAB LA + RPV LA (injectable only),ii Cohort 1: To assess the safety of the oral lead-in of CAB + RPV, and the safety of CAB + RPV (oral and injectable) through Week 24,i.Cohort 1: To describe the repeat-dose pharmacokinetics of CAB + RPV (oral and injectable) through Week 24,
|
Kampala, all parishes
Wakiso, all parishes
|
Uganda |
2023-02-13 11:10:13 |
2026-02-13 |
90 children and 90 parents/ caregivers worldwide but MUJHU plans to enroll 5 -15 children and 5-15 parents/ caregivers. |
Children living with HIV-1, two years to less than 12 years of age
and weighing ≥10 kg and <40 kg, who are virologically suppressed on
stable antiretroviral therapy and their parents/caregivers.
|
DAIDS/NIH |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Winnie Muyindike R
ID: UNCST-2021-R013558
|
A Randomized Clinical Trial to Evaluate Solutions for the Management of Virologic Failure for Individuals on TLD in Sub-Saharan Africa.(RESOLVE)
REFNo: HS2620ES
Aim 2: Use simulation modeling to examine the clinical impact, costs, and cost-effectiveness of strategies to improve viral suppression after virologic failure on TLD. We will populate the previously validated Cost-Effectiveness of Preventing AIDS Complications-International (CEPAC-I) model with the novel clinical trial data from Aim 1 to project long-term clinical outcomes and cumulative lifetime costs. We will then compare the cost-effectiveness of the three strategies evaluated in Aim 1 for addressing virologic failure among people treated with first-line TLD in Uganda or South Africa. ,Aim 1: Conduct a randomized clinical trial to determine the optimal strategy for management of virologic failure on first-line TLD in SSA. We will recruit 648 adolescents and adults with two viral loads >1,000 copies/mL while on first-line TLD for at least 12 months, who are in care at one of six public-sector HIV clinics in Uganda or South Africa. We will randomize participants to one of the following strategies, stratified by clinic and prior NNRTI-exposure: a) Maintenance on TLD with switch to protease inhibitor (PI)-based second-line ART if virologic failure persists past six months; b) Individualized Care, with regimen choice based on results of genotypic resistance tests and urine tenofovir assays; or c) Immediate Switch to PI-based second-line ART. The primary outcome will be viral suppression (<50 copies/mL) at 48 weeks post-enrollment using the FDA snapshot definition. We hypothesize that rates of viral suppression at 48 weeks will be higher in the Individualized Care arm than in the Maintenance on TLD and Immediate Switch arms.,
|
Mbarara, Kamukuzi
Mbarara, Kakoba
|
Uganda |
2023-02-09 11:06:56 |
2026-02-09 |
324 |
15 years and above, female and male wo are on TLD irrespective of tribe |
National Institutes of Health |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Afiz Kibuuka Kibuuka
ID: UNCST-2021-R012755
|
A Phase 3, multicenter, randomized, double-blind, 24-week study of the clinical and
antiviral effect of S-217622 compared with placebo in non-hospitalized participants with
COVID-19
REFNo: HS2642ES
The main intent of the study is to evaluate the efficacy of S-217622 vs. placebo. The study will be conducted in the setting of the locally available standard-of-care COVID-19 treatment. High-risk and low-risk participants will be analyzed together for the primary analysis and separately for secondary analyses. The following primary, secondary, and exploratory objectives will be addressed in the modified intent-to-treat (mITT) population, except for the safety analyses, which will be analyzed in the Safety population, and pharmacokinetic (PK) analyses, which will be analyzed in the PK population.
|
Tororo, All Parishes
|
Uganda |
2023-02-06 17:17:04 |
2026-02-06 |
Each site in Uganda will (through competitive enrolment) enroll at least 8 participants making a total of 32 participants for all Uganda sites. |
Outpatient adults (≥18 years) with: a) documented positive
SARS-CoV-2 nucleic acid or antigen test from a sample
collected ≤120 hours (5 days) prior to randomization, b) onset
of symptoms of COVID-19 ≤5 days prior to randomization,
c) presence of 1 or more select COVID-19 symptoms within
24 hours prior to randomization. Participants will be eligible
regardless of vaccination status and will be classified as either
high risk or low risk.
High-risk participants: defined as aged ≥65 years or those with
presence of high-risk conditions.
|
National Institute of Allergy and Infectious Diseases (NIH), Division of AIDS (DAIDS) |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Noella Okalany Akwi Regina
ID: UNCST-2022-R011085
|
Congenital Cytomegalovirus Infection in Eastern Uganda
REFNo: HS2668ES
To determine the short-term neurodevelopmental outcomes and hearing impairment associated with congenital cytomegalovirus among infants in Eastern Uganda.,To determine the incidence of, and risk factors for postnatally acquired cytomegalovirus among infants in Eastern Uganda.,To describe the factors associated with congenital cytomegalovirus infection in neonates in Eastern Uganda.,To determine the prevalence of congenital cytomegalovirus infection among neonates in Eastern Uganda,To investigate the burden of congenital cytomegalovirus and its outcomes among infants in Eastern Uganda.,
|
Mbale, Mbale
Budaka, Budaka
|
Uganda |
2023-02-06 16:21:08 |
2026-02-06 |
2000 |
0 - 6 months of age |
University of Liverpool |
Medical and Health Sciences |
Clinical Trial |
Degree Award |
|
Kathy Burgoine
ID: UNCST-2022-R011521
|
Impact of prophylactic Continuous Positive Airway Pressure in the Delivery Room (DR-CPAP) on neonates <1500g in a low-resource setting: A feasibility trial
REFNo: HS2605ES
- To determine the acceptability of DR-CPAP to healthcare workers in a low-resource setting
- To determine the post-intervention acceptability of using a two-stage consent process in neonatal emergencies in the delivery room in this setting
- To evaluate the feasibility of a third-party allocation process for randomisation by determining the time to randomization
- To evaluate feasibility of initiating DR-CPAP in a low-resource setting in infants with birthweight 800-1500g within 15 minutes of delivery
- To determine the safety of initiating DR-CPAP in a low-resource setting
- To estimate the sample size to be used for future evaluation in the full trial
- To assess the feasibility of secondary outcome measures to be used in the full trial
|
Mbale,
|
UK |
2023-02-02 12:18:23 |
2026-02-02 |
100 |
The study population will be inborn preterm infants with a birthweight of 800g to less than 1500g who are spontaneously breathing at 5 minutes of life. They will be recruited within 15 minutes of birth and followed up until death or 28 days. Both male and female infants will be included. |
Mbale Clinical Research Institute (MCRI) |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Yerusa Kiirya
ID:
|
Acceptability, Feasibility and Effectiveness of a WhatsApp peer support group as a strategy to improve antiretroviral therapy adherence among youth in Kampala District
REFNo: SIR170ES
To determine the effectiveness of a WhatsApp peer support group combined with the standard of care in improving ART adherence among YLHIVA aged 15-24 years in Kampala district.,To determine the effect of a WhatsApp peer support group combined with the standard of care on psychosocial barriers to ART adherence and retention in care among YLHIVA aged 15-24 years in Kampala district.,To assess the feasibility of using a WhatsApp peer support group combined with the standard of care as an ART adherence and retention in care strategy among YLHIVA aged 15-24 years, To asses the acceptability of a WhatsApp peer support group combined with the standard of care as an ART adherence and retention in care strategy among YLHIVA aged 15-24 in Kampala district.,To assess the acceptability, feasibility and effectiveness of a WhatsApp peer support group combined with current standard care as a strategy to improve ART adherence among YLHIVA in Kampala.,
|
Kampala, Kiswa
Kampala, Komambogo
Kampala, Kawala
|
Uganda |
2023-01-20 14:23:51 |
2026-01-20 |
488 |
This study will be conducted among YLHIVA aged 15-24 years currently receiving ART services at
Kiswa, Komambogo and Kawala HCIII with an
ART adherence score of less than 95% within the past 12 months |
Strengthening behavioral and social science research capacity to address evolving challenges in HIV care and prevention in Uganda. |
Engineering and Technology |
Clinical Trial |
Degree Award |
|
Winnie Muyindike R
ID: UNCST-2021-R013558
|
Gabapentin to Reduce Alcohol and Improve Viral Load Suppression (GRAIL) – “Promoting Treatment as Prevention”
REFNo: HS2622ES
2. To assess the impact of gabapentin compared to placebo on: a) alcohol consumption; b) pain severity; c) ART adherence; and d) engagement in HIV care, in order to explore potential mechanisms by which gabapentin may lead to HVL suppression.,1. To test the efficacy of gabapentin versus placebo to achieve undetectable HVL (Primary Outcome at 3 months; Secondary Outcome at 6 & 12 months),
|
Mbarara, Kamukuzi
Mbarara, Kakoba
|
Uganda |
2023-01-18 18:33:54 |
2026-01-18 |
300 |
18 years and above, female and male, irrespective of tribe, who are on antiretroviral therapy with detectable viral load and are unhealthy alcohol consumers. |
National Institute of Health |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Isaac Ssewanyana
ID: UNCST-2020-R014336
|
Evaluation of the performance of novel molecular point of care diagnostics for SARS-CoV-2
REFNo: HS2588ES
To assess the ease of use of the molecular POC devices being evaluated using a System Usability Scale (SUS) questionnaire administered to platform’s operators (minimum 3, where possible)., To evaluate the diagnostic accuracy of such platforms in detecting SARS-CoV-2 on respiratory specimens, compared with reference standard RTPCR in specific subgroups defined based on disease stage (days since symptoms onset), RTPCR Ct values (as surrogate for viral load). Participant’s vaccination status, previous COVID-19 infection(s) and SARS-CoV-2 genetic variant causing participant’s infection, determined by sequencing of the viral genome, may also be considered as subgroups. , To evaluate the diagnostic accuracy of molecular POC devices in detecting SARS-CoV-2 on respiratory specimens, compared with reference standard RT-PCR (WHO EUL or FDA EUA approved), among COVID-19 symptomatic individuals,
|
Kampala, Mulago
Kampala, Kiruddu
Kampala, Kawempe
Kampala, Butabika
|
Uganda |
2023-01-18 18:21:06 |
2026-01-18 |
200 |
The study will focus on adults with symptoms compatible with COVID-19 (and/or specimens collected from them) attending healthcare facilities in Uganda.
If a participant is screened and enrolled but is not able to provide the specimens required for the study, this participant will be withdrawn. |
FIND GENEVA |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Raymond Tweheyo
ID: UNCST-2020-R014507
|
Evaluating the pilot of the Community Health Extension Worker (CHEW) strategy in Uganda: assessing feasibility, and effectiveness for improving Village Health Team (VHT) supervision and reporting
REFNo: HS2545ES
General Objective
To explore the acceptability, document the implementation process and evaluate the effectiveness of the Community Health Extension Worker strategy in two districts of Uganda to guide improving the community health system
Specific Objectives
1) To assess the acceptability of introducing a Community Health Extension Worker (CHEW) strategy in a district health system.
2)To document the process of setting up and implementing a Community Health Extension
Worker (CHEW) strategy within a district health system.
3) To estimate the program costs and duration for setting up a government-led Community Health Extension Worker (CHEW) strategy within a district health system.
4) To determine the effectiveness of the CHEW strategy for improving the quality of Village Health Team (VHT) member’s supervision and reporting in a district health system.
5) To assess the effect of the CHEW strategy on community-level indicators: completion of four antenatal care visits, skilled delivery attendance, fully immunized under-fives, and U5 sick children seen by VHTs and treated within 24 hours.
|
Mayuge, all parishes
Lira, all parishes
Kabarole, all parishes
Kyotera, all parishes
|
UK |
2023-01-03 13:08:01 |
2026-01-03 |
3,016 women of reproductive age |
1) Household members: Adult women of reproductive age 18 to 49 years.
2) Community health workers - 18 years and above
3) Health facility workers - 18 years and above
4) District technical and political leaders - 18 years and above
5) Community Health Implementing partners - adults, 18 years and above |
USAID/ Uganda Health Systems Strengthening Activity (UHSS) |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Pontiano Kaleebu
ID: UNCST-2020-R019901
|
Performance evaluation of the Determine™ HIV Early Detect 4th Generation HIV Rapid Diagnostic test
REFNo: HS2603ES
Primary Objectives:
1. To evaluate the Laboratory performance (Sensitivity and specificity) of the Determine™ HIV Early Detect
2. To assess the field performance of the Determine™ HIV Early Detect in parallel with the Determine™ HIV-1/2 test
Secondary Objective:
1. To assess the effectiveness of the Determine Early Detect to identify acute HIV infection among newly infected individuals
|
Buikwe, kawolo
Kampala, Kisenyi
Kampala, Naguru
Mityana, Mityana
Mukono, Mukono hospital
Wakiso, Wagagai
Wakiso, UVRI
Kayunga, Kayunga hospital
Kalungu, Nkozi hospital
Gomba, Gombe hospital
|
Uganda |
2022-12-23 18:06:59 |
2025-12-23 |
10,000 |
The study will enroll;
- Adults above 18 years of age
- Willing to have an HIV test.
- Eligible for testing as per the National HTS eligibility screening tool
- Documented
|
- Abott Diagnostics |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Lawrence Okello Rafaih
ID:
|
Evaluation practices and strategy performance of local NGOs in Uganda
REFNo: SS1561ES
4. To determine the relationship between organizational evaluation steering process and strategy performance of NGOs in Uganda,3. To establish the relationship between organizational evaluation technical expertise and strategy performance of NGOs in Uganda,2. To determine the relationship between evaluation planning process and strategy performance of NGOs in Uganda,1. To validate the contextual relevance of organizational effectiveness competency model for strategy evaluation of NGOs in Uganda.,The purpose of this study is to validate the extent to which evaluation practices influence strategy performance of national NGOs in Uganda.,
|
Moroto, Moroto
Gulu, Gulu
Kampala, Kampala
Mbarara, Mbarara
Moroto, Moroto
Gulu, Gulu
Kampala, Kampala
Mbarara, Mbarara
Lira, Lira
|
Uganda |
2022-12-19 12:19:45 |
2025-12-19 |
379 |
In short study targets adult population ( aged between 18-70 years)population from local NGOs who are members of the national NGO forums spread across the country. A total of 40 cluster NGO forums will be engaged to reach our to gather a proportionate sample of about 80 respondents per region. Similarly, Only adult respondents will be included for key informant interviews |
Lawrence Rafaih Okello |
Social Science and Humanities |
Clinical Trial |
Degree Award |
|
Daniella Ferguson
ID:
|
A Retrospective Analysis of Suramin Treatment forStage 1 Trypanosoma Brucei Rhodesiense Human African Trypanosomiasis (S1 TBR HAT) in Uganda and Malawi
REFNo: HS2582ES
Primary objectives
The primary objective is to determine whether standard of care treatment with suramin, as currently practiced in Uganda and Malawi, leads to better health outcomes in patients with S1 TBR HAT than observed in an untreated natural history cohort with source data from a published epidemiologic study.
Secondary objectives
The secondary objective is to evaluatethe safety and tolerability of suramin.
|
Kaberamaido, Lwala
|
South Africa |
2022-12-19 12:17:26 |
2025-12-19 |
150 -200 patients |
The study will include TBR HAT patients treated with suramin between 2000 and 2020 in Uganda and Malawi. The study will include all of the approximately 150 - 250 patients evaluated through chart review who are deemed eligible and have sufficient data. A natural history cohort composed of source data from approximately 200 patients from a published epidemiological study will be used as a comparator. |
PaxMedica, Inc. 303 South Broadway Suite 125 Tarrytown, NY |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
KENNETH MUGABE
ID: UNCST-2022-R010732
|
Using lactate testing to improve maternal sepsis identification: a multi-country test accuracy study: LACTate in mATernal sEpsis
REFNo: HS2589ES
VI. Conduct a validation study of an alternative reference standard in which the SOFA score is modified to incorporate maternity specific ranges for creatinine and platelet concentration.,V. Exploratory analysis will examine the effect of adjusting the threshold values for both vital sign and lactate assessment on the sensitivity and specificity of the index tests.,IV. To explore if the test accuracy of lactate in addition to maternal vital sign monitoring alone varies by the pre-specified subgroups of pregnancy status (pregnant or post-delivery (including abortion or miscarriage)) and recruitment country.,III. To explore if baseline venous lactate, in addition to vital sign measurements, improves prediction of severe morbidity and mortality from infection.,II. To assess short-term predictive value of lactate testing, by comparing the baseline index test with 24-hour reference standard, in those without sepsis at baseline.,I. Immediate diagnostic value of lactate testing by comparing the baseline index test with baseline reference standard.,Determine the diagnostic accuracy of maternal venous lactate measurement in addition to maternal vital sign thresholds, in maternal sepsis in low-resource health facility settings in Malawi, Uganda and Pakistan.,
|
|
Uganda |
2022-12-12 15:55:39 |
2025-12-12 |
500 (150 in Uganda) |
Women, 16years or greater, with suspected infections, who are pregnant or recently pregnant(up to 42 days) |
University of Liverpool |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Bruce Kirenga J
ID: UNCST-2019-R001460
|
SAFETY, PHARMACOKINETICS AND PRELIMINARY EFFICACY OF HERBAL PRODUCTS FOR THE TREATMENT OF ACUTE RESPIRATORY VIRAL INFECTIONS INCLUDING SARS-COV2 IN UGANDA; PHASE 2A OPEN LABEL CLINICAL TRIAL
REFNo: HS2548ES
The general objective is to assess the safety, pharmacokinetics and preliminary efficacy of TazCoV and Vidicine for the treatment of acute respiratory viral infections (SARS-CoV2, RSV and Influenza A/B) in Uganda.
Specific objectives
1. To determine the safety and pharmacokinetics of TAZCOV and Vidicine herbal products among adult patients with acute respiratory infections due to laboratory-confirmed SARS-CoV2, RSV and Influenza A/B
2. To determine the extent of SARS-CoV2, RSV and Influenza A/B viral clearance among adult patients with acute viral respiratory infection treated using TAZCOV and Vidicine
3. To establish time-to-remission of symptoms among patients with acute respiratory infections due to laboratory-confirmed SARS-CoV2, RSV and Influenza treated with TAZCOV or Vidicine
4. To evaluate disease progression among patients with acute respiratory infections due to laboratory-confirmed SARS-CoV2, RSV and Influenza treated with TAZCOV or Vidicine
|
Kampala, Mulago
|
Uganda |
2022-11-29 12:38:24 |
2025-11-29 |
510 |
The maximum individual participant trial duration will be 90. The actual time the trial will last will depend on the rate of enrollment. It is estimated that the trial will take 18 months. days. |
The Government of Uganda through the Ministry of Science, Technology and Innovation-Office of the President (STI-OP) |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
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|
Bonny Aloka
ID: UNCST-2022-R010624
|
Development and Evaluation of Nutrient-Dense Composite from Local Food Materials to Manage Moderate Acute Malnutrition (MAM) and Nodding Syndrome in northern Uganda
REFNo: A234ES
3. To investigate the stakeholder perception regarding the nutrient dense composites developed to manage MAM and NS in Acholi and Lango sub-regions,To evaluate the efficacy of the recipes in improving the conditions of clients with MAM and nodding syndrome in Acholi and Lango sub-regions,To test the level of acceptability of the developed composites by the selected mothers/care takers and their children in Acholi and Lango sub-regions,To develop a nutrient dense composites from local food materials to manage MAM and nodding syndrome in Lango and Acholi sub-regions,To develop a nutrient dense composite from local food materials to manage moderate acute malnutrition (MAM) and nodding syndrome in Lango and Acholi sub-regions in northern Uganda.,
|
Lira, Ayami Parish
Alebtong, Ayami Parish
Kole, Akwirididi Parish
Oyam, Atura Parish
Gulu, Pawel Parish
Nwoya, Kalatocon Parish
Pader, Kalawinya Parish
Kitgum, Pajimu Parish
|
Uganda |
2022-11-28 11:12:34 |
2025-11-28 |
387 |
The study population will be children between 6-23 months (MAM), Children aged 3-28 years (nodding syndrome) and adults aged 18-80 years of age (sensory evaluation). |
European Union |
Agricultural Sciences |
Clinical Trial |
Non-degree Award |
|
Bruce Kirenga J
ID: UNCST-2019-R001460
|
Ring vaccination trial to evaluate the efficacy and safety of Sudan ebolavirus vaccines in Uganda
REFNo: HS2574ES
Probable SUVD and death from confirmed SUVD ,main secondary objective is to assess the safety of the vaccine by monitoring weekly for 21 days any adverse reactions to vaccination and any other serious adverse events,The primary analysis will be of laboratory-confirmed SUVD (from samples taken either while living, or within 48 hours of death),
|
|
Uganda |
2022-11-23 15:04:05 |
2025-11-23 |
N/A |
All active contacts of Ebola viral disease,
Participants aged 6 years and above, all tribes, all genders |
World Health Organisation and the Ministry of Health Uganda |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Haruna Muwonge
ID: UNCST-2019-R000128
|
EFFICACY AND SAFETY OF DIHYDROARTEMISININ-PIPERAQUINE (EURARTESIM) FOR TREATMENT OF UNCOMPLICATED P. FALCIPARUM MALARIA IN ADULT PATIENTS WITH COVID-19 CO-INFECTION: AN OPEN LABEL RANDOMISED PILOT CLINICAL TRIAL (EMCOS CLINICAL TRIAL)
REFNo: HS2563ES
To evaluate the incidence of adverse events in adult participants with uncomplicated P. falciparum malaria and COVID-19 coinfection receiving DHA/PPQ treatment or Artemether – lumefantrine treatment. ,To determine the efficacy of DHA-PPQ in treatment of adult patients suffering from uncomplicated P. falciparum malaria with COVID-19 coinfection.,To assess the therapeutic efficacy and safety of DHA-PPQ for the treatment of uncomplicated P. falciparum malaria- COVID-19 co-infection.
|
Kampala, all parishes
Wakiso, all parishes
|
Uganda |
2022-11-17 18:12:26 |
2025-11-17 |
80 |
Adults of 18 years and above diagnosed with COVID-19 RT-PCR of SARS-CoV-2 plus a positive P. falciparum malaria parasite blood slide at Mulago National Referral Hospital, Kiruddu Hospital, and Entebbe regional referral Hospital. The study will include participants who are 18 years or more living around the areas of Kampala City, Wakiso District and Mukono District and who consent in writing to participate in the study. |
Alfasigma S.p.A. (Makerere University Lung Institute is CRO) |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Proscovia Nabunya
ID: UNCST-2019-R000970
|
Suubi-Mhealth: A mobile health intervention to address depression and improve ART adherence among Youth living with HIV (YLHIV) in Uganda
REFNo: SS1442ES
The overall goal of this proposal is to develop a mobile health intervention (hereafter “Suubi-Mhealth”) for use among Ugandan youth with comorbid HIV and depression, taking into account their unique contextual, cultural, and developmental needs. This digital therapy intervention (mobile app) will apply user-centered design methodologies and will be based on the cognitive-behavioral therapy (CBT) tenets found to improve depression among individuals with HIV.
The study will be conducted in two phases (R21 and R33) as specified below
Phase 1. R21 Aim 1: Develop and iteratively refine an intervention protocol for Suubi-Mhealth based on formative work to understand the needs of depressed YLHIV, ages 14-17. We will conduct four focus groups, each with 6-8 depressed YLHIV and two focus groups with health care providers, recruited from clinics across the greater Masaka region of Uganda for feedback on proposed intervention content and methods to increase participation and retention.
R21 Aim 2: Based on the results of Aim #1, we will explore the feasibility and acceptability of Suubi- Mhealth for use with depressed YLHIV on a small scale (N= 30) to inform subsequent refinement for the larger phase of this project (R33 phase).
Phase 2. R33 Aim 1: Pilot test the preliminary impact of Suubi-Mhealth versus a waitlist control group (to receive the intervention after the active treatment condition), on reducing depression (primary outcome) and improving ART adherence, mental health functioning, quality of life, and lowering HIV stigma (secondary outcomes).
R33 Aim 2: Qualitatively examine barriers and facilitators for integrating Suubi-Mhealth into health care settings for depressed YLHIV.
|
|
Uganda |
2022-11-15 3:42:47 |
2025-11-15 |
262 |
The target population for this study is YLHIV enrolled in care at a health clinic that has partnered with ICHAD and RTY in the study region. We will recruit depressed YLHIV between ages 14-17, and health providers who agree to participate in the study at the participating clinics. We will enroll youth who are at least 14 so that our entire sample “should” be at a developmentally similar stage and because at age 14, adolescents begin to exhibit symptoms of depression that become more prevalent by age.
Youth inclusion criteria: 1) Ages 14-17 years with the cognitive ability to understand and comprehend the assenting process, 2) HIV positive and aware of their status i.e., disclosed to, 3) receiving ART and care from one of the participating clinics, 4) and living within a family, including with extended family members (not in institutions). We will identify youth with depression symptoms by administering the Patient Health Questionnaire (PHQ-9), which has been validated in rural settings in Uganda. Youth will be enrolled in the study after ascertaining their score on the PHQ-9.
Exclusion criteria: Youth will be ineligible if: 1) they do not meet the inclusion criteria; 2) they are unable to understand the study procedures and or participant rights during the informed consent process or they are unwilling or unable to commit to completing the study. If the youth or adult caregivers presents with emergency needs (e.g., hospitalization), needed care will be secured, rather than study participation.
Inclusion criteria for health care providers. Providers will be identified and recruited from collaborating clinics if they are working directly with YLHIV and agree to participate in the study.
Inclusion criteria for clinics. Clinics registered and supported by the Government of Uganda to provide ART to adolescents and YLHIV in the greater Masaka region, and have adolescent-friendly services e.g., adolescent clinic days.
|
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 |
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Namulema Edith
ID:
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Feasibility of using Continuous Positive Airway Pressure via the ‘LeVe CPAP System’ among Children with Acute Hypoxemic Respiratory Failure at Mengo Hospital Kampala Uganda: A mixed methods study
REFNo: HS2478ES
1) To assess the acceptability of the LeVe CPAP system to deliver continuous positive airway pressure among children with acute hypoxemic respiratory failure at Mengo Hospital Uganda.
2) To assess the safety of LeVe CPAP system among children with acute hypoxemic respiratory failure at Mengo Hospital Uganda.
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Kampala, 1
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Uganda |
2022-11-09 13:49:10 |
2025-11-09 |
40 |
Paediatric patients of Age > 1 month with hypoxemic respiratory failure and caretakers admitted at the paediatric ward. |
Leeds University |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
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