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  
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
ELIZABETH ASIGE
ID:
THE IMPACT AND COST-EFFECTIVENESS OF A COMMUNITY-BASED PROGRAM FOR CHILDREN WITH CEREBRAL PALSY AND THEIR CAREGIVERS AND THE STAKEHOLDERS IN UGANDA.
REFNo: HS1979ES

1. To examine the impact of a community-based program on children with CP reported frequency of participation in the home, school, and community activities. 2. To assess the impact of a community-based training program on improving caregiver knowledge regarding CP and reducing caregiver stress. 3. To determine the impact of a communication and advocacy program in broadening stakeholders’ knowledge, attitude and practices regarding childhood disability and inclusion. 4. To determine the cost-effectiveness of a community-based program on children with CP, their caregivers, and the stakeholders in relation to costs and benefits.
Iganga, Iganga
Mayuge, Mayuge
Uganda 2023-04-20 21:15:22 2026-04-20 100 participants- 50 in the study group and 50 in the control group The study population will comprise children and youth with cerebral palsy aged 2-22 years, both male and female, and their primary caregivers of any tribe living in the study communities plus the community stakeholders Prof. Hans Forssberg -Karolinska Institutet Astrid Lindgren Children’s Hospital 17176, Stockholm Sweden Medical and Health Sciences Clinical Trial 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
Adoke Yeka
ID: UNCST-2021-R004300
An adaptive, randomized, active-controlled, open-label, sequential cohort, multicenter study to evaluate the efficacy, safety, tolerability and pharmacokinetics of intravenous cipargamin (KAE609) in adult and pediatric participants with severe Plasmodium falciparum malaria (KARISMA – KAE609’s Role In Severe Malaria)
REFNo: HS1980ES

Primary objective
To assess the efficacy of different doses of
intravenous cipargamin vs artesunate by evaluating the proportion of
participants with ? 90% reduction of parasitemia at 12 hours post
administration of the first dose.

Secondary Objectives
1. To assess the presence/absence of severe malaria related individual
signs over time
2. To evaluate parasite clearance dynamics and proportion of participants
with recrudescence and reinfection
3. To assess recovery of participants as measured by time (days and hours)
to discharge from hospital or recovery from prostration
4. To evaluate the safety and tolerability of IV cipargamin
5. To assess the risk of long term neurological sequelae for participants at
Day 29
6. The assess the risk of hemolysis (early and delayed) during the study
duration
7. To characterize the plasma pharmacokinetics of IV cipargamin

Tororo, Masafu
Uganda 2023-08-18 9:05:14 2026-08-18 200 patients for AL treatment arm and 100 patients for the other treatment arms per site. At least two drugs will be studied per site The study population will consist of male and female participants, including pediatric participants aged ? 6 months or older. Approximately 252 participants (60 participants of ? 12 years and 192 participants < 12 years) will be randomized Novartis Medical and Health Sciences Clinical Trial Non-degree Award
Henry Ssenyondo
ID:
Maternal Antibody in Milk After Group B Streptococcus Vaccination in Uganda: MAMA study
REFNo: HS1986ES

General Objective • To determine the concentration of antibody transferred in breastmilk following vaccination with Group B Streptococcal vaccine Specific Objectives • To determine the anti-GBS (anti-Alp1N, Alp2N, AlpCN and RibN) Immunoglobulin A (IgA) concentrations in the colostrum of women following vaccination with a GBS-containing vaccine or placebo in pregnancy.
• To determine the total IgA and Immunoglobulin G (IgG) concentrations in the colostrum and breastmilk of women at less than 48 hours, 28 (+/-4 days) and 56 (+/- 6 days) days after delivery following vaccination with a GBS-containing vaccine or placebo in pregnancy.
• To determine the anti-GBS (antiAlp1N, Alp2N, AlpCN and RibN) IgA concentrations in the breastmilk of women at 28 (+/-4 days) and 56 (+/- 6 days) days after delivery following vaccination with a GBS-containing vaccine in pregnancy.
• To determine the anti-GBS (antiAlp1N, Alp2N, AlpCN and RibN) IgG concentrations in the colostrum and breastmilk of women at less than 48 hours, 28 (+/-4 days) and 56 (+/- 6 days) days after delivery following vaccination with a GBS-containing vaccine in pregnancy.
Kampala, Kawempe Central
Uganda 2022-09-21 21:13:49 2025-09-21 50 Women 18 to 40 years All tribes Makerere University Medical and Health Sciences Clinical Trial 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
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
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
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
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
Jackson Mukonzo
ID: UNCST-2021-R013916
Ivermectin-artemisinin Combination Therapy for Eradication of Malaria
REFNo: HS2081ES

Main Objective: 1. To investigate the effect of ivermectin adjunct therapy on household transmissibility of malaria from malaria-infected patients receiving artemether /lumefantrine Specific objectives 1. To determine the household malaria transmissibility within one month of IVN and artemether / lumefantrine therapy. 2. To determine the structural similarity of the nanopore plasmodium sequences between infecting plasmodium species isolated from the index patient and other household malaria positive patients. 3. To assess the safety of ivermectin-artemether/lumefantrine in malaria-infected patients.
Kasese, NA
Uganda 2022-07-13 16:29:55 2025-07-13 110 Participants Adults aged 18 to 65 years of age, both males and females. No specific tribe in our inclusion criteria but most of the study participants are expected to be Bakonzo given that the study site is Kasese. MAKERERE UNIVERSITY RESEARCH AND INNOVATION FUND Medical and Health Sciences Clinical Trial Non-degree Award
Agnes Nyabigambo
ID:
Effectiveness of clinic-based patient-led HPV DNA self-sampling among HIV-infected women in Uganda.
REFNo: HS2084ES

1. To assess the difference and associated factors of uptake of clinic-based compared to home-based HPV self-sampling approach among HIV infected women in rural Uganda. 2. To identify factors associated with the prevalence of HPV among HIV-infected women in rural Uganda. 3. To determine factors influencing sample viability HPV self-collected samples in clinic arm compared with home -based arm. 4. To explore the facilitators and barriers of clinic-based compared to home-based HPV self-sampling approaches among HIV-infected women in rural Uganda. 5. To estimate the cost-effectiveness of the clinic-based approach compared to the home-based HPV-DNA self-sampling among HIV-infected women in rural Uganda.
Luweero, Kasana
Uganda 2022-06-08 15:13:10 2025-06-08 382 Women living with HIV aged 25-49 years. HEARD PhD Scholarship Medical and Health Sciences Clinical Trial Degree Award
Miriam Nakalembe
ID: UNCST-2021-R014040
Simplified Treatment for Eclampsia Prevention using Magnesium sulfate: A phase III, randomized, open label, active controlled, multicountry, multicentre, non-inferiority trial of simplified magnesium sulfate regimen for eclampsia prophylaxis (The STEP-Mag Trial).
REFNo: HS2076ES

The primary objective of this trial is to evaluate non-inferiority of magnesium sulfate 10g IM administered 12 hourly x 2 doses compared with a standard IV (Zuspan) or IM (Pritchard) magnesium sulfate regimen1 in the prevention of maternal eclamptic seizure.

The secondary objective of this trial is to evaluate superiority of magnesium sulfate 10g IM administered 12 hourly x 2 doses compared with a standard IV (Zuspan) or IM (Pritchard) magnesium sulfate regimen in the proportion of women experiencing adverse events indicative of magnesium toxicity.
Kampala, Kawempe
Uganda 2022-04-02 2025-04-02 1500 Uganda The target trial population are women admitted to participating hospitals with pre-eclampsia during pregnancy, labour or within 24 hours of childbirth, whether it involves a single or multiple gestation. World Health Organisation Medical and Health Sciences Clinical Trial Non-degree Award
Etheldreda Nakimuli-Mpungu
ID: UNCST-2020-R014808
Tele-Psychotherapy for Youth using Mobile Phones during Covid-19 Pandemic
REFNo: HS2106ES

1. We aim to conduct online and community-based participatory qualitative research to obtain information on the potential usefulness of individual tele-support psychotherapy in addressing depression during the Covid-19 pandemic.
2. We will compare the effectiveness of individual tele-support psychotherapy (TSP) delivered by trained lay counsellors in combination with standard mental health services (SMHS) for depression with use of SMHS alone.
3. We aim to compare the effects of TSP combined with SMHS and SMHS alone on other psychosocial variables including self-esteem, anxiety, alcohol and substance use, social support, stigma, number of disability days, asset possession, poverty indices, and cost-effectiveness measures.
4. To conduct a process evaluation of trial activities informed by Linnan and Steckler’s process evaluation frameworks to specifically determine indicators of feasibility, acceptability, fidelity, and to explore causal mediating processes and contextual influences
5. We will also explore whether or not the effects of TSP and SMHS are moderated by alcohol and drug use.
6. We shall explore whether the strength of a therapeutic relationship will mediate the effects of TSP and SMHS on depression
Kampala, Makerere
Kampala, Kamwokya Parish
Kampala, Naguru Ii Parish or Go down
Uganda 2022-04-21 2025-04-21 300 To be eligible for the study, each participant must be 15-30 years old, diagnosed with significant depression symptoms assessed with the self reporting questionnaire, residing in Naguru Go-down and Kamwokya slums, or Makerere University campus. USAID (DIV) Medical and Health Sciences Clinical Trial Non-degree Award
Dennis Muhanguzi
ID: UNCST-2019-R001101
Evaluation of the Safety , Efficacy and Stability of Sangatraz®-125 & Sangatraz®-250: A Randomised Single-Blinded Positive Controlled Multi-Site Acaricides Field Trial
REFNo: A186ES

General objectives To determine the efficacy, safety and stability of Sangatraz®-125 & Sangatraz®-250(Sanga Vet. Chem. Ltd, Kampala Industrial Park, Namanve ) when applied onto cattle by hand spraying and plunge dipping for tick control. Specific objectives The specific objectives of this acaricide field trial will to to determine; i.efficacy of Sangatraz®-125 & Sangatraz®-250 when applied onto cattle by hand spraying and plunge dipping for tick control. ii.safety of Sangatraz®-125 & Sangatraz®-250 when applied onto cattle by hand spraying and plunge dipping for tick control. iii.Stability of Sangatraz®-125 & Sangatraz®-250 when applied onto cattle by plunge dipping for tick control.
Mayuge, Musoli
Mayuge, Wabulungu ward
Mayuge, Katonte
Mayuge, Nkombe
Gomba, Madu Parish
Gomba, Kyayi Parish
,
Uganda 2022-04-25 2025-04-25 n= 1,579 Cattle on 10 farms [5 farms in Gomba District and the other 5 from Mayuge District]. These will be both female and males above 2 months of age. All cattle breeds will be recruited Sanga Vet. Chem. Ltd P.O Box 75164 | Plot 1144, Kampala Industrial Business Park | Kampala-Uganda Tel: 02008000100 | Web: https://www.sangavetchem.com/ Agricultural Sciences Clinical Trial Non-degree Award
Herbert Kayiga Kayiga
ID:
EFFECTIVENESS, ACCEPTABILITY AND UPTAKE OF EARLY VERSUS STANDARD INTRAUTERINE CONTRACEPTION FOLLOWING PROVISION OF FIRST TRIMESTER MEDICAL POST ABORTION CARE IN CENTRAL UGANDA
REFNo: HS2111ES

1. To determine the proportion of women who take up IUC after mPAC for 1st trimester incomplete abortion. 2. To compare the expulsion rates at six months between early versus standard IUC insertions post mPAC treatment for first trimester incomplete abortion. 3. To compare the IUC continuation rates at six months between early versus standard IUC insertion post mPAC treatment for first trimester incomplete abortion. 4. To explore the women and their spouses' perception on Long Acting Reversible Contraceptives (LARC) and IUC following mPAC treatment. 5. To explore the Healthcare providers' perception on LARC and IUC following mPAC treatment.
Wakiso, Kasangati
Kampala, Namirembe
Buikwe, Kawolo
Mpigi, Mpigi
Luweero, Luweero
Mukono, Kawolo
Masaka, Masaka
Mityana,
Kayunga,
Gomba,
Uganda 2022-05-10 9:21:09 2025-05-10 2076 Women with first trimester incomplete abortion irrespective of tribe and nationality undergoing medical management will receive written and oral information about the study from the attending physician according to the principles of the Helsinki Declarati Prof Kristrina Gemzell Medical and Health Sciences Clinical Trial Degree Award
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-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
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
Gorretti Nassali
ID:
A PHASE III, RANDOMIZED, OPEN-LABEL, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF ADJUVANT GIREDESTRANT COMPARED WITH PHYSICIAN'S CHOICE OF ADJUVANT ENDOCRINE MONOTHERAPY IN PATIENTS WITH ESTROGEN RECEPTOR?POSITIVE, HER2 NEGATIVE EARLY BREAST CANCER
REFNo: HS2133ES

Primary objective:
To demonstrate superiority of giredestrant over the control treatment
Secondary objectives:
1. To evaluate the efficacy of giredestrant compared with TPC
2. To evaluate the safety of giredestrant compared with TPC
3. To characterize giredestrant pharrmacokinetics (PK)
4. To evaluate health status utility scores of participants treated with giredestrant compared with TPC
5. To evaluate the efficacy of giredestrant compared with TPC
6. To evaluate the tolerability of giredestrant compared with TPC
7. To identify and/or evaluate biomarkers that are predictive of response to giredestrant
Kampala, mulago
Uganda 2022-09-06 14:14:37 2025-09-06 Approximately 4700 participants will be screened to achieve random assignment in 1:1 ratio to study treatment of 4100 randomized participants for an estimated total of 2050 randomized participants per Approximately 4100 participants with medium- and high-risk Stage I?III histologically confirmed ER? and HER2? EBC will be enrolled during the global enrollment phase of this study. After completion of the global enrollment phase, additional participants F. Hoffmann-La Roche Ltd Grenzacherstrasse 124 4070 Basel, Switzerland Medical and Health Sciences Clinical Trial Non-degree Award
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