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  
Henry Mugerwa
ID: UNCST-2019-R000420
 A phase III, Multicenter, Randomized, Placebo Controlled, Double-blind Study to Assess Efficacy and Safety of Crizanlizumab (5 mg/kg) versus placebo, with or without Hydroxyurea/Hydroxycarbamide Therapy, in Adolescent and Adult Sickle Cell Disease Patients with Frequent Vaso-Occlusive Crises
REFNo: HS5274ES

Primary Objective: To compare the efficacy of 5 mg/kg of crizanlizumab versus placebo, with or without hydroxyurea/hydroxycarbamide, on the annualized rate of VOCs* that are HCPmanaged (including VOCs leading to
management at a health care facility or those managed via remote consultation) over the planned 52-week treatment period in SCD
patients aged 12 years and older with a history of frequent VOCs (4-12 events in 12 months prior to the screening visit).

Secondary Objective: Key secondary objective:

To compare the efficacy of 5 mg/kg of
crizanlizumab versus placebo, with or without
hydroxyurea/hydroxycarbamide, on the
annualized rate of all VOCs including VOCs that are HCP-managed (including VOCs leading to
management at a health care facility or those managed via remote consultation) and VOCs that are self-managed without recommendations from HCP during the event over the planned 52-week treatment period in SCD patients aged 12 years and older with a history of frequent VOCs (4-12 events in the 12 months prior to the screening visit).

To evaluate the annualized rate of VOCs by type of management between treatment arms over the planned 52-week treatment period:
VOCs that are HCP-managed at a health
care facility
• VOCs that are HCP-managed via remote
consultation
• VOCs that are self-managed without
recommendations from HCP during the
event
• VOCs that are HCP-managed via remote
consultation or self-managed without
recommendations from HCP during the
event

• To evaluate the time to first VOC that is HCPmanaged (including VOCs leading to
management at a health care facility or those managed via remote consultation) between treatment arms over the planned 52-week treatment period.

To evaluate the proportion of participants free from VOCs that are HCP-managed (including VOCs leading to management at a health care facility or those managed via remote consultation) between treatment arms over the planned 52-week treatment period.

To evaluate the duration of VOCs that are HCP-managed (including VOCs leading to management at a health care facility or those managed via remote consultation) between treatment arms over the planned 52-week treatment period.

To evaluate the safety and immunogenicity of crizanlizumab 5 mg/kg over the 2-year study
period.

To explore the efficacy of crizanlizumab 5 mg/kg over the 2-year study period.

To explore the proportion of VOCs that are selfmanaged without recommendations from HCP during the event, versus VOCs that are HCP-managed (including VOCs leading to
management at a health care facility or those managed via remote consultation) between treatment arms over the planned treatment period of 52 weeks.

To explore the proportion of VOCs that are HCP-managed via remote consultation versus VOCs that are HCP-managed at a healthcare facility between treatment arms over the planned 52-week treatment period.

To explore the incidence rates of all VOCs,
VOCs that are HCP-managed at a healthcare
facility, VOCs that are HCP-managed via remote consultation, VOCs that are HCP-managed,VOCs that are self-managed without
recommendations from HCP during the event,
VOCs that are HCP-managed via remote
consultation or self-managed without
recommendations from HCP during the event, by treatment arm.

To explore quality of life in each treatment arm (ASCQ-Me Short Forms: emotional impact, sleep impact, and joint stiffness).

To explore healthcare facility resource utilization (inpatient hospital admission, emergency room visit, urgent care/clinic visit, infusion center visit)between treatment arms over
the planned 52-week treatment period.

To explore the pharmacokinetics (PK) profile of crizanlizumab at 5 mg/kg.

To explore the pharmacodynamics (PD) (Pselectin inhibition) of crizanlizumab at 5 mg/kg.

To explore biomarkers [p-selectin (free and
total)] and CRP].

To explore exposure-response relationship.
 Wakiso, Lubowa
 Uganda 2025-04-02 8:43:56 2028-04-02 10-15 SCD participants aged 12 years and older who experienced at 4-12 VOCs that are HCP-managed (including VOCs leading to management at a health care facility or those managed via remote consultation) in the 12 months prior to screening visit. Participants who have been taking HU/HC for at least 6 months at a stable dose for at least 3 months and plan to continue taking at the same dose and schedule until the participant has reached 52 weeks of study treatment will be permitted. Participants who have not been receiving HU/HC, and/or erythropoietin stimulating agent must not have received it for at least 6 months prior to the screening visit. Novartis Medical and Health Sciences Clinical Trial Non-degree Award
Ronald Moses Galiwango
ID: UNCST-2024-R015239
 INTEGRATED FEMALE SEXUALLY TRANSMITTED INFECTION TESTING FOR HIV EPIDEMIC CONTROL THROUGH PREP (IN-STEP)
REFNo: HS5715ES

a) To conduct an individually randomized effectiveness implementation trial of SRST plus cSTI testing to increase PrEP use among African women at high HIV risk.
b) To perform a mixed-methods, implementation science evaluation of female cSTI testing for improving PrEP use for HIV prevention.
c) To determine the most efficient, population-level female cSTI testing strategies to reduce HIV incidence in African settings.

Rakai, All parishes in the mentioned subcounty
Kyotera, All parishes in the mentioned subcounty
Lyantonde, All parishes in the mentioned subcounty
 Uganda 2025-03-25 11:13:20 2028-03-25 5000 The targeted population is adolescent girls and women aged 15 - 39 years of age National Institute of Allergy and Infectious Diseases, R01AI177132 (Financial support); Abbott Laboratories (Material support) Medical and Health Sciences Clinical Trial Non-degree Award
Bruce Kirenga J
ID: UNCST-2019-R001460
 SURVEY, SAFETY AND EFFICACY OF HERBAL PRODUCTS USED FOR MALARIA PROPHYLAXIS AND TREATMENT IN UGANDA.
REFNo: HS5468ES

To conduct a survey of herbal medicinal products used for malaria prophylaxis and treatment, evaluate their safety and prophylactic efficacy among school-age children (8-15yrs) in Kibuku district, Uganda.
1. To identify herbal medicinal products used by communities for malaria prophylaxis and treatment in Uganda.
2. To evaluate the artemisinin content of herbal medicinal products used by communities for malaria prophylaxis and treatment in Uganda.
3. To determine the antiplasmodial activity (IC50) of herbal medicinal products used for malaria prophylaxis and treatment in Uganda.
4. To evaluate the safety of herbal medicinal products used for malaria prophylaxis among school age children (8-15 years) in Kibuku district in eastern Uganda.
5. To determine malaria incidence among school age children (8-15 years) receiving selected herbal medicinal products for malaria prophylaxis compared to monthly Dihydroartemisinin-Piperaquine (DP) in Kibuku district in eastern Uganda.
6. To determine prevalence of parasitaemia among school age children (8-15 years) receiving selected herbal medicinal products for malaria prophylaxis compared to monthly Dihydroartemisinin-Piperaquine (DP) in Kibuku in eastern Uganda.

 All Districts, NA
Kibuku,
Uganda 2025-03-14 19:08:33 2028-03-14 222 participants for the trial (111 per study arm) 8 to 15 years of age, both male and female, all tribes accessible. The Government of Uganda through the Science, Technology, and Innovation Secretariat - Office of the President (STI-OP) Medical and Health Sciences Clinical Trial Non-degree Award
Victor Musiime -
ID: UNCST-2021-R013794
 A global phase 3, randomised, double-blind and placebo-controlled study evaluating the efficacy and safety of etavopivat in adolescents and adults with sickle cell disease
REFNo: HS5637ES

1. To demonstrate superiority of
treatment with etavopivat
versus placebo in adolescents
and adults with SCD.
2. To evaluate clinical efficacy
measures of etavopivat treatment
versus placebo in adolescents
and adults with SCD
3. To assess clinically meaningful
improvement in fatigue and
functional exercise capacity
and QOL measures of
adolescents and adults with
SCD taking etavopivat
treatment compared to placebo
 Wakiso, Sabagabo
Kampala, Mulago
Jinja, Jinja
 Uganda 2025-03-14 17:26:26 2028-03-14 408 12-17, 18 and above, male female all tribes Novo Nordisk A/S Medical and Health Sciences Clinical Trial Non-degree Award
Margaret Nagawa
ID: UNCST-2022-R009705
 EARLY NUTRITIONAL INTERVENTION FOR NUTRITIONALLY AT-RISK INFANTS UNDER 6 MONTHS OF AGE TO REDUCE MALNUTRITION IN THE FIRST YEAR OF LIFE
REFNo: HS3503ES

5. To assess the maternal and health worker perceptions on the integrated intervention package.,4. To assess the effect of an early integrated family intervention program for LBW and undernourished children u6m on growth in the first year of life.,3. To understand the barriers and facilitators to the integration of maternal mental health care and community-based management of malnutrition in infants u6m of age.,2. To assess the prevalence of maternal mental health among caregivers of u6m infants.,1. To determine the factors associated with malnutrition among infants u6m of age and challenges caregivers of LBW and undernourished infants face. ,2. To assess the prevalence of malnutrition among infants u6m and their associations, To assess the effect of an early integrated nutrition intervention for nutritionally at-risk infants u6m of age in reducing malnutrition in the first year of life. ,
 Adjumani, Adjumani
 Uganda 2025-03-14 16:37:34 2028-03-14 300 mother baby pairs Infants under 6 months of age. and caregivers of infants under six months of age. sex: males and females Tribe: refugees and host communities self funded Medical and Health Sciences Clinical Trial Degree Award
Schola  Matovu Nakachwa
ID: UNCST-2022-R011040
 Development and Testing of BAJJAJJA: An Intervention to Promote Economic Empowerment and Health of Grandmothers who Provide Primary Care for Grandchildren in Uganda
REFNo: SS3611ES

Main Objective
The study’s objective is to refine and test the feasibility and acceptability of my innovative intervention, BAJJAJJA: Building A Joint Action for JaJJAs which couples an income- generating activity (IGA) with nurse-facilitated group health coaching. This objective is informed by the NIH Stage Model of behavioral intervention development.

Specific Objectives
Aim 1: To refine and adapt the BAJJAJJA intervention through a collaborative and iterative feedback process with a diverse community group of 18 members. In a series of sessions, I will iteratively engage diverse community groups (nurses, local officials, IGA experts, and GMCs) and use cognitive interviewing to gain feedback on the appropriateness of study measures, content, delivery, and intervention format.
Aim 2: To test the feasibility, acceptability, and preliminary efficacy of the BAJJAJJA intervention in improving economic and health outcomes among 24 Ugandan GMCs. Over a 12-month period and at three time points of assessment, I will use a mixed methodology with a quasi-experimental design to collect data that will be examined to assess the feasibility, acceptability, and preliminary efficacy of the intervention on participants’ household income and health outcomes.
Aim 3: To explore the barriers and facilitators to (3a) maintenance of the BAJJAJJA individual intervention benefits (e.g., physical activity level and frequency) and (3b) sustainability of the IGA activities (e.g., grandmothers’ accessing external supports such as community resources) at 6 months post-intervention. Following a mixed methods approach, the 24 GMCs from Aim 2 will be interviewed to further evaluate the long-term maintenance and sustainability of the intervention. Health assessments, interviews, and IGA site visits will be used to explore the intervention outcomes and benefits at 6 months post-intervention.

Buikwe, Kiteza
 USA 2025-03-10 12:23:29 2028-03-10 24 Grandmother Caregivers 1. Grandmothers: Ugandan GMCs who are (a) > 50 years (considering the average reproductive age range in Uganda of 15-49 years), (b) Luganda-speaking (commonly spoken language), (c) primary caregivers for at least one minor grandchild (< 18 years) for > 6 months, and (d) able to perform activities of daily living (e.g., cooking, bathing) without assistance. 2.Community Advisory Board: 10 key informants: Local elected community leaders ( LCs), healthcare professionals, nurses from local health centers and a village health team member, IGA experts, and grandmothers. Participants will be identified by LC leaders or referred by other participants using a snowball sampling technique. Participants are female (grandmother caregivers) with no tribal restrictions as long as she can speak luganda NIH JOHN E FORGATY International Center Social Science and Humanities Clinical Trial Non-degree Award
Pauline Byakika-Kibwika
ID: UNCST-2019-R001206
 Randomized trial to evaluate the efficacy and safety of select therapeutic agents in the treatment of Ebola Disease (TOKOMEZA - Ebola Disease Therapeutics)
REFNo: HS5686ES

This is an open-label, adaptive, randomised platform clinical trial to evaluate the impact of 278 potential treatments on mortality in patients with Ebola Disease
 All Districts, Not specific
 Uganda 2025-03-07 18:39:19 2028-03-07 180 All age groups, sex, and tribes that are eligible for recruitment. Ministry of Health of Uganda and World Health Organization Medical and Health Sciences Clinical Trial Non-degree Award
Nixon Niyonzima
ID: UNCST-2020-R014577
 A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY AND SAFETY OF INAVOLISIB IN COMBINATION WITH PHESGO? VERSUS PLACEBO IN COMBINATION WITH PHESGO? AS MAINTENANCE THERAPY AFTER FIRST LINE INDUCTION THERAPY IN PARTICIPANTS WITH PIK3CA?MUTATED HER2?POSITIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER (INAVO122)
REFNo: HS5649ES

This study will enrol particpants
Kampala, Mulago
Uganda 2025-03-07 18:26:49 2028-03-07 20 Adult females above 18 years of age with breast cancer F.Hoffman La Roche Medical and Health Sciences Clinical Trial Non-degree Award
Angelina Kakooza-Mwesige
ID: UNCST-2020-R014529
 EVALUATION OF THE IMPACT OF THE THREE TIER INTERVENTIONS FOR DISABILITY IN EARLY CHILDHOOD (IDEC) PROGRAMME IN UGANDA
REFNo: HS5596ES

GENERAL OBJECTIVE

The overall aim of this study is to evaluate the impact of the three-tier IDEC model piloted in the two districts of Mubende and Kassanda in Uganda, with a twofold purpose: (1) to improve intervention design and management and (2) to inform decisions about future investment and scale-up by establishing evidence and impact.

SPECIFIC OBJECTIVES.

Primary objectives
1. To determine the coverage of vision screening at 0-3 months and developmental screening at 9 and 18 months in the study sites.
2. To determine the change in functional abilities in children receiving the Tier 2 intervention.
3. To evaluate effects of the individualised (Tier 3) program at regular intervals (at least every 3 months) on child and family functioning, well-being and participation.
Secondary objectives
1. To determine the change in knowledge and skills in parental/caretaker after the Tier 2 interventions.
2. To determine the change in parental/caretaker level of stress after Tier 2 interventions.
3. To determine the change in parental/caretaker level of stress after Tier 3 interventions.

4. To establish the extent to which children with developmental delay and disability Tier 1 are included in ECD programmes
5. To establish the extent to which children with developmental delay and disability tier 2 are included in ECD programmes. (This could be a compliance or fidelity issue
6. To determine how well (fidelity) the health workers provided the Tier 2 and 3 interventions.
7. To determine compliance with Tier 2 and Tier 3 interventions by the caregivers.
8. To determine family satisfaction with all three tiers of the program, including both children that failed and children who passed the screening assessment (Tier I).
9. To determine the costs and cost-effectiveness of the entire program.
10. To assess the likelihood of continuation
Mubende, Kiyuni
Mubende, Kiyuni
 Uganda 2025-03-04 13:40:10 2028-03-04 296 Children aged 0-3 months, Children aged 6-36 months,Children with developmental delay, at risk of Celebral Palsy and Austism UNICEF Medical and Health Sciences Clinical Trial Non-degree Award
ISMAHIL ADENIYI ADEKUNLE
ID: UNCST-2024-R002602
 EFFECTS OF ETHYL-ACETATE FRACTION OF Bidens pilosa LEAVES ON TESTES AND PITUITARY GLAND OF MALE MICE EXPOSED TO BISPHENOL A
REFNo: HS5372ES

The purpose of this study is to evaluate the impact of B. pilosa on testicular integrity and the pituitary gland of male mice exposed to BPA.
1.3.1 Specific Objectives
i. To assess the effect of B. Pilosa on spermatogenic metrics of the testes such as sperm motility, sperm count, morphology, agglutination, and vitality using routine and extended semen analysis.
ii. To determine the impact of B. pilosa on serum concentration of follicle-stimulating hormone, testosterone, and luteinizing hormone using enzyme-linked immunosorbent assay (ELISA) following BPA exposure.
iii. To assess the changes in testicular oxidative stress biomarkers (such as CAT, SOD, and GSH) and lipid peroxidation using MDA.
iv. To assess the histology, histochemical, and immunohistochemical changes in the testes and pituitary gland following treatment with B. pilosa in BPA exposure using Masson Trichrome, Periodic Acid Schiff (PAS), Hematoxylin and Eosin (H&E), Caspase 3, antiproliferating cell nuclear antigen (PCNA), Bcl-2, alpha-smooth muscle actin (?-SMA), and Bax.

 Bushenyi, Kampala International University, Western Campus
 Nigeria 2025-03-03 11:40:21 2028-03-03 30 animals Animals will be divided into five groups, with six animals in each group (n=6). Group 1 is the control, 2 ml/kg bw of distilled water. Group 2—100 mg/kg/day of BPA Group 3—100 mg/kg/day of BPA + low dose of B. pilosa (250 mg/kg). Group 4—100 mg/kg/day of BPA + medium dose of B. pilosa (500 mg/kg). Group 5: 100 mg/kg/day of BPA + high dose of B. pilosa (1000 mg/kg) All administration will be done via oral administration for 5 weeks (35 days) because sperm maturation in mice takes about 35 days; B. pilosa will be administered after 1 hour of treatment with BPA. At the conclusion of the administration period on the 35th day, as per the approved protocol, animals from all groups will be euthanized after receiving ketamine. Blood samples will be collected from the animals via cardiac puncture and transferred to a plain sample bottle to allow coagulation of the cellular components of the blood. The blood sample is then centrifuged for the collection of serum. The collected serum will be used for hormonal assay (testosterone, LH, and FSH) and determination of oxidative stress biomarkers (CAT, SOD, and GSH). Adeniyi A. Ismahil (self sponsored) Medical and Health Sciences Clinical Trial Degree Award
Nazarius Tumwesigye Mbona
ID: UNCST-2019-R000664
 COBIHA- A COMMUNITY BASED INTERVENTION AGAINST HARMFUL USE OF ALCOHOL IN A RURAL SETTING: A pilot study around lake Bunyonyi in Kigezi, Uganda
REFNo: HS5521ES

2.To explore reasons for harmful use of alcohol, and perceptions on effective and acceptable ways of reducing this.,1.To conduct a pilot survey to establish the level of harmful use of alcohol and factors associated with the behaviour , to fill the evidence gap on effective community interventions, the current burden of harmful use of alcohol, and community perceptions of the burden of harmful alcohol use in rural Uganda,
 Kabale, Mwendo
Kabale, Bwama
Rubanda, Kagarama
Rubanda, Butobole
Rubanda, Kabere
 Uganda 2025-02-20 18:51:21 2028-02-20 0 All adults aged 18 and above with alcohol harmful use National Institute for Health and Care Research Medical and Health Sciences Clinical Trial Non-degree Award
Christine  Muhumuza
ID: UNCST-2023-R008646
 Improving Family Wellness for Couples in Central Uganda 2024-2029
REFNo: HS5523ES

The study aims are to:

(1) In a cluster randomised trial, compare the efficacy of the FH=FW intervention vs. a time/attention matched comparator intervention at increasing modern contraceptive use and reducing unintended pregnancy among couples with an unmet need for family planning through 24-months, and identify potential mediators of the intervention effect.

(2) Determine the intervention’s effect on, and determinants of, contraceptive continuation.

(3) Through a mixed-methods process evaluation, explore factors affecting the implementation of the intervention in order to improve feasibility, acceptability, and the likelihood of future adoption and sustainment
 Kalungu, Kalungu
Gomba, Kinoni
Mpigi, Bulunda A
Kalungu, Lukaya
Gomba, Kisozi
Mpigi, Muduma
Kalungu, Kabungo
Kalungu, Bbaala
Kalungu, Kabale
Kalungu, Kalungi
Kalungu, Kasambya
Kalungu, Kabungo
Gomba, Bulwadda
Gomba, Kasaka
Gomba, Kyayi
Gomba, Bukalagi
Gomba, Mpenja
Gomba, Ngomanene
Mpigi, Bunjako
Mpigi, Mitala-Maria
Mpigi, Butoolo
Mpigi, Kampiringisa
Mpigi, Katende
Mpigi, Sekiwunga
Mpigi, Kitakyusa
Mpigi, Nsamu/Kyali
Mpigi, Bujuuko/Bulamu
Mpigi, Nindye
 Uganda 2025-02-20 17:09:28 2028-02-20 We will sample 4 health centers (clusters) in each of the 3 districts. We expect that the 12 clusters will yield ~1704 participants (852 couples) across the two study arms. Married men and women (couples) aged 18-49 of any tribe in the selected districts. National Institute of Child Health and Development (NICHD), grant number: R01HD113806 Medical and Health Sciences Clinical Trial Non-degree Award
Dennis Muhanguzi
ID: UNCST-2019-R001101
 Evaluation of the Safety, Efficacy and Stability of SangaSupa®-30% Emulsifiable Concentrate [EC]: A Randomised Single-Blinded Positive Controlled Multi-Site Acaricide Field Trial
REFNo: NS910ES

General objectives
To determine the efficacy, safety, and stability of SangaSupa® (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 determine;-
i. efficacy of SangaSupa® when applied onto cattle by hand spraying and plunge dipping for tick control.
ii. safety of Sangasupa® when applied onto cattle by hand spraying and plunge dipping for tick control.
iii. Stability of Sangasupa® when applied onto cattle by plunge dipping for tick control.
Kyenjojo, Ntuutu
Kyenjojo, Ruhoko
Kyenjojo, Hima
Serere, Bugondo
Serere, Okidi
Kumi, Kachaboi
 Uganda 2025-02-14 15:53:01 2028-02-14 n = 797 cattle above three months. For details please refer to the protocol Cattle above 3 months , both male and female. All cattle breeds will be eligible for recruitment. The detailed inclusion and exclusion criteria are described in the main protocol. The Government of Uganda Natural Sciences Clinical Trial Non-degree Award
Joseph  Matovu KB
ID: UNCST-2020-R014654
 Reducing hazardous alcohol use and optimizing treatment as prevention among men living with HIV in risk environments
REFNo: HS5558ES

Understand barriers and facilitators in the inner and outer context for implementing the components of Kisoboka within the routine clinical setting to inform future widespread implementation guided by the Exploration, Preparation, Implementation and Sustainment (EPIS) framework and documentation of intervention and implementation costs. ,Assess the impact of the Kisoboka intervention and its components on measures of psychological, physical, and socioeconomic well-being that capture frequent comorbidities of people living with HIV and are associated with achieving successful treatment as prevention,Determine the efficacy of the Kisoboka intervention and its components on alcohol and HIV outcomes among hazardously drinking men living with HIV in Uganda in a 2x2 factorial RCT. ,Assess the efficacy of Kisoboka and its components (BE & MI) to gain insight into Kisoboka’s potential effect, determine if BE and MI interact and examine barriers and facilitators for implementing Kisoboka within routine clinical settings to inform future widespread implementation.,
 Buikwe, Kawolo
Buikwe, Buikwe Mbiko
Buikwe, Nyenga
Buikwe, Ngogwe
Buikwe, Buikwe Ssi
Buikwe, Makonge
Buikwe, Buikwe Njeru
Nakasongola, Nakasongola Town
Nakasongola, Lwampanga
Nakasongola, Kalungi
Nakasongola, Nabiswera
Nakasongola, Nakayonza
 Uganda 2025-02-14 15:19:41 2028-02-14 820 Eligibility is men aged ≥18, living with HIV, residing in a fishing community (on most days/nights), AUDIT-C positive (≥4) indicating potential hazardous alcohol drinking and >6 months since initial ART initiation, last VL was detectable or missing, not planning to move from the area within the next 6 months and have their own mobile phone and can be reached via phone. National Institute of Health (NIH) Medical and Health Sciences Clinical Trial Non-degree Award
David Mukunya
ID: UNCST-2022-R010707
 A phase III, randomized, open-label, clinical trial to evaluate the safety and efficacy of emollient therapy for very low birthweight infants (<1500g) in Uganda in promoting survival, health, growth and development compared to no emollient treatment
REFNo: HS5338ES

To evaluate the efficacy of emollient therapy with SSO – compared to standard care without use of emollients – among hospitalised very low birth weight (VLBW, <1500g) infants in Uganda on: the rate of in-hospital mortality, serious infections, hypothermia, growth, intraventricular haemorrhage, and skin condition; maternal depression and anxiety; maternal and neonatal interaction; infant growth and neurodevelopment at 12 month corrected age (chronological age reduced by the number of weeks born before 40 weeks of gestation); and infant mortality.
Mbale, Hospital Cell
 Uganda 2025-01-31 7:21:53 2028-01-31 1242 Preterm infants who are admitted to MRRH-NNU. Inclusion criteria: • Admission weight 800g to <1500g • Admission age < 24 hours • Mother +/- father who can understand English, Luganda, Lugwere, Ateso or Lumasaba • Mother +/- father who are willing and able to give verbal consent for participation of their infant in the study. • Mother aged 15 years or above Exclusion criteria: • Mother or father are not willing or are unable to give written, informed consent for participation of their infant in the study within 48 hours of admission to the NNU • Second or later birth order or a multiple pregnancy, when the first or an earlier birth order infant is eligible for participation • Infants with major congenital abnormality e.g. gastroschisis, cyanotic heart disease, upper airways abnormality • Critically ill infants at time of enrollment: Babies with apnoeas requiring frequent stimulation or bag mask ventilation; shock (heart rate >200 beats per minute and/or Mean Arterial Pressure <Gestational Age); Severe respiratory distress (Downs Score ≥8); Respiratory Failure (Oxygen saturation <90% on oxygen therapy/bCPAP) • Infants with generalized skin disease or a structural defect involving >5% body surface area likely to produce a defect in epidermal barrier function. • Mother and father unwilling to come back to Mbale RRH for follow-up Mbale Clinical Research Institute Medical and Health Sciences Clinical Trial Non-degree Award
JUDITH NASSAAZI
ID: UNCST-2023-R007664
 Comparing in-person versus virtual postoperative review appointments for children following guided growth surgery at CORSU Hospital, Uganda
REFNo: HS5268ES

Study Objectives
Primary objectives
To compare the show-rates of in-person versus virtual/telehealth post-operative review appointments for children following guided growth surgery at CoRSU Hospital

Secondary objectives.
1.To compare parental satisfaction of in-person versus virtual appointments
2.To determine the factors that facilitate in-person and virtual appointments following guided growth surgery.
3.To compare the rate of post-operative complications following in-person follow-up versus virtual follow-up
 Wakiso, KISUBI
 Uganda 2025-01-22 10:12:27 2028-01-22 82 FROM AGE 3 TO 12 IN GIRLS AND 3 TO 16 IN BOYS ALL TRIBES AND BOTH MALES AND FEMALES ARE INCLUDED IN THE STUDY SELF SPONSORED AND PARTIAL FUNDING BY UNIVERSITY OF CARLIFORNIA SANFRANCISCO Medical and Health Sciences Clinical Trial Non-degree Award
Justine Namuli Diana
ID: UNCST-2021-R011844
 ENHANCING COMPREHENSION OF INFORMED CONSENT IN RESEARCH INVOLVING PATIENTS WITH PSYCHOTIC DISORDERS USING AUDIO-VISUAL AIDS
REFNo: HS5358ES

To evaluate the comprehension of informed consent, identify key factors that are associated with comprehension of consent, determine the feasibility, acceptability, and preliminary effectiveness of audio-visual aids on enhancing the comprehension of consent information during the consenting process in research involving individuals with psychotic disorders
 Kampala, Butabika
 Uganda 2025-01-10 12:00:57 2028-01-10 study 1=418, study 2,8 participants, study 3,60 participants,study 4 not less than 18 Ugandans aged 18 years and above, all gender Makerere University international bioethics research training PhD program (GRANT NUMBER D43TW010892) Medical and Health Sciences Clinical Trial Degree Award
Francis Ssali
ID: UNCST-2021-R012134
 A5409: A Phase 2 Randomized, Adaptive, Dose-Ranging, Open-Label Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis (RAD-TB)
REFNo: HS4036ES

1.2 Primary Objectives

1.2.1 To compare MGIT liquid culture TTP slope over the first 6 weeks of treatment for each experimental treatment arm to the SOC arm.

1.2.2 To compare new Grade 3 or higher adverse events (AEs) (safety) over the first 8 weeks of treatment for each experimental treatment arm to the SOC arm.

1.3 Secondary Objectives

1.3.1 To compare time to stable culture conversion by MGIT liquid culture by week 8 for each experimental treatment arm to the SOC arm.

1.3.2 To compare MGIT liquid culture TTP slope over the first 8 weeks of treatment for each experimental treatment arm to the SOC arm.

1.3.3 To compare new Grade 3 or higher AEs (safety) over 26 weeks of treatment for each experimental treatment arm to the SOC arm.

1.3.4 To compare discontinuations of anti-TB drugs for any reason prior to 8 and 26 weeks of treatment for each experimental treatment arm to the SOC arm.

1.3.5 To determine the dose- and exposure-response relationships between experimental drug estimated pharmacokinetic (PK) parameters with safety and efficacy.

1.3.6 To compare a composite of efficacy and safety outcomes using a risk-benefit approach for each experimental treatment arm to the SOC arm.

1.3.7 To compare MGIT liquid culture TTP slope over the first 6 weeks of treatment for Arms 3A-3B and Arms 4A-4B compared to Arm 2.

1.3.8 To compare durable cure by 52 weeks after treatment initiation in each experimental treatment arm to the SOC arm.


 Kampala, Kampala
Wakiso, Wakiso
 Uganda 2024-12-23 12:34:14 2027-12-23 45 participants in each experimental treatment arm and at least 90 participants in the SOC arm. The JCRC site plans to recruit at least 50 participants Participants with Xpert MTB/RIF positive drug-susceptible pulmonary TB, living with and without HIV, aged ≥18 years. National Institute of Allergy and Infectious Diseases (NIAIDS) Medical and Health Sciences Clinical Trial Non-degree Award
Henry Mugerwa
ID: UNCST-2019-R000420
 A Phase 1b, Age De-Escalation/Dose Escalation Trial to Evaluate Safety, Tolerability, and Pharmacokinetics of MAM01 in an African Population of Adults and Children in a Setting of Perennial Malaria Transmission
REFNo: HS5298ES

Primary Objective. To assess the safety and tolerability of MAM01. Secondary Objectives. To assess the safety of MAM01. To characterize the PK of MAM01 following SC, IV, and IM administration of MAM01. To assess the formation of anti-drug antibodies (ADAs) to MAM01. Exploratory Objectives. To assess the protective efficacy of a single dose of MAM01 over 182 days against Pf infection, as detected by blood smear microscopy compared to a placebo. To assess the protective efficacy of a single dose of MAM01 over 182 days against Pf infection, as detected by blood smear microscopy compared to placebo. To assess the protection of MAM01 against events of malaria illness (first/only and all episodes). To correlate MAM01 concentration with Pf infection risk. To assess the complexity of Pf infection following administration of MAM01 or placebo.
Tororo, Osukuru
Tororo, Kayoro
Tororo, Magola
Kampala, Lubowa
 Uganda 2024-12-23 12:23:27 2027-12-23 139 Adults and children, male and female Bill & Melinda Gates Medical Research Institute (Gates MRI) Medical and Health Sciences Clinical Trial Non-degree Award
Afiz Kibuuka Kibuuka
ID: UNCST-2021-R012755
 A phase III, Multicenter, Randomized, Placebo Controlled, Double blind Study to Assess Efficacy and Safety of Crizanlizumab (5 mg/kg) versus placebo, with or without Hydroxyurea/Hydroxycarbamide Therapy, in Adolescent and Adult Sickle Cell Disease Patients with Frequent Vaso-Occlusive Crises
REFNo: HS5365ES

To compare the efficacy of 5 mg/kg of crizanlizumab versus placebo, with or without hydroxyurea/hydroxycarbamide, on the annualized rate of VOCs* that are healthcare professional (HCP)-managed (including VOCs leading to management at a health care facility or those managed via remote consultation) over the planned 52-week treatment period in SCD patients aged 12 years and older with a history of frequent VOCs (4-12 events in 12 months prior to the screening visit).
To compare the efficacy of 5 mg/kg of crizanlizumab versus placebo, with or without hydroxyurea/hydroxycarbamide, on the annualized rate of all VOCs including VOCs that are HCP-managed (including VOCs leading to management at a health care facility or those managed via remote consultation) and VOCs that are self-managed without recommendations from HCP during the event over the planned 52 week treatment period in SCD patients aged 12 years and older with a history of frequent VOCs (4-12 events in the 12 months prior to the Screeening visit
To evaluate the annualized rate of VOCs by type of management between treatment arms over the planned 52-week treatment period: • VOCs that are HCP-managed at a health care facility • VOCs that are HCP-managed via remote consultation • VOCs that are self-managed without recommendations from HCP during the event • VOCs that are HCP-managed via remote consultation or self-managed without recommendations from HCP during the event
To evaluate the time to first VOC that is HCP managed (including VOCs leading to management at a health care facility or those managed via remote consultation) between treatment arms over the planned 52-week treatment period.
To evaluate the proportion of participants free from VOCs that are HCP-managed (including VOCs leading to management at a health care facility or those managed via remote consultation) between treatment arms over the planned 52-week treatment period.
 Eastern Region, All parishes
 Uganda 2024-12-23 11:34:49 2027-12-23 315 Participants must be aged 12 years and older on the day of signing informed consent. Adolescents include participants aged 12 to <18 years old and adults include participants aged 18 years and older. Novartis Medical and Health Sciences Clinical Trial Non-degree Award
Solomon Kibudde
ID: UNCST-2021-R013747
 PHASE II RANDOMIZED NON-INFERIORITY TRIAL OF HYPOFRACTIONATED RADIOTHERAPY FOR LOCALLY ADVANCED CERVICAL CANCER IN UGANDA.
REFNo: HS5348ES

1) To compare the incidence of grade 3+ gastrointestinal and genitourinary toxicity at 1 year post-treatment with hypofractionated radiotherapy (40 Gy in 16 fractions) and conventional fractionated radiotherapy (45 Gy in 25 fractions) in women with cervical cancer in Uganda.
2) To evaluate and compare local control and cervical cancer-specific survival rates at 1 year after hypofractionated radiotherapy (40 Gy in 16 fractions) versus conventional radiotherapy (45 Gy in 25 fractions).
3) To determine the association between stage-adjusted mean squamous cell carcinoma antigen (SCC-Ag) at 1-month post-treatment with the Progression-free survival at 1- year post-treatment with hypofractionated radiotherapy (40 Gy in 16 fractions) or conventionally fractionated radiotherapy (45 Gy in 25 fractions).
4) To compare the costs of healthcare to patients with cervical cancer treated with hypofractionated radiotherapy (40 Gy in 16 fractions) versus conventional fractionated radiotherapy (45 Gy in 25 fractions).
5) To evaluate patient-reported outcomes and quality of life in patients with cervical cancer treated with hypofractionated radiotherapy (40 Gy in 16 fractions) versus conventional fractionated radiotherapy (45 Gy in 25 fractions).

 Kampala, Mulago
 Uganda 2024-12-23 11:01:22 2027-12-23 120 participants To be considered eligible for this study, participants must meet the following criteria: 1. Females aged 18 years or older 2. Histologically confirmed squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the uterine cervix without prior treatment. 3. FIGO 2018 Stage IB3, IIA, IIB, IIIA, IIIB, IIIC, or IVA. 4. Able to provide written informed consent in English, Luganda, Runyankole, Lango or Lusoga. 5. Willing to attend post-treatment follow-up for up to 12 months. 6. Fit for concurrent chemotherapy with cisplatin. 7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤ 2. 8. Adequate bone marrow function: Absolute neutrophil count ≥ 1,500 cells/mm3 (1.5 x 109/L); Platelets ≥ 100,000 cells/mm3 (100 x 109/L); haemoglobin ≥ 9.0 g/dL; Leukocyte count ≥ 4,000 cells/mm3 (4.0 x 109/L). 9. Adequate renal function: creatinine clearance > 60 mL/mins, calculated using the Cockcroft-gault equation for women. 10. Adequate liver function: AST and ALT < 3 times the upper limit of normal (ULN); and Total bilirubin < 2 x ULN unless attributed to the use of antiretroviral therapy (ART). Exclusion criteria Participants will be excluded from the study if they meet any of the following criteria: 1. Prior hysterectomy. Women with previous total or subtotal hysterectomy have no cervix, and hence the anatomical changes have an impact on the radiotherapy field, and dose prescriptions because they tend to have a higher risk for bowel toxicity from pelvic radiotherapy. Therefore, these women will be excluded due to the likely impact on the results of our study intervention. 2. Clinical and/or radiological evidence of distant metastases. 3. Prior pelvic or abdominal radiotherapy. 4. Presence of bilateral hip prosthesis that could interfere with radiotherapy treatment. 5. History of inflammatory bowel disease or any other condition that could complicate radiotherapy treatment. 6. Participants who are pregnant at the time of enrollment. Pregnant women have a potential risk of radiation exposure to developing fetus, which may result in fetal malformations, growth retardation, or even fatal death. Secondly, their physiological changes alter the pharmacokinetics and pharmacodynamics of concurrent chemotherapy. Therefore, to protect the health of the mother and the unborn child, pregnant women will be excluded from the study. Patients who are found to be pregnant after enrollment will have the study procedures terminated. 7. Concurrent untreated invasive malignancy 8. Uncontrolled concurrent medical/psychiatric diagnosis that would limit compliance with study requirements Uganda Cancer Institute, Varian Medical Systems, and UCI-FHCC Medical and Health Sciences Clinical Trial Degree Award
Jackson Orem
ID: UNCST-2021-R012016
 A Phase III, Randomized, Open-Label, Non-Inferiority Study of Paclitaxel and Pegylated Liposomal Doxorubicin for Treatment of HIV-related Kaposi Sarcoma in Resource-Limited Settings
REFNo: HS4073ES

To describe the incremental cost-effectiveness ratio per QALY gained (as assessed by PROPr) between PLD and PTX,To assess quality of life across PROMIS domains (i.e., cognitive function, physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) with the PROPr tool at start of therapy, mid-treatment, and after treatment with PLD and PTX ,To describe the cost of therapy across AMC sites in sub-Saharan Africa to deliver both PLD and PTX by micro-costing analysis for goods and time-in-motion analysis for services. ,To estimate the objective response rate (defined as the sum of complete and partial responses) for AIDS-KS, response duration and overall survival in each treatment arm. ,To evaluate whether there is sufficient evidence to conclude that PLD is non-inferior to PTX in people with severe AIDS-associated KS receiving concomitant ART in resource-limited settings. ,
 Kampala, Mulago
Uganda 2024-12-10 14:39:24 2027-12-10 130 participants overall and up to 40 participants in Uganda This study will be done in adults above 18 years, both male and female of all tribes, and will recruit participants with HIV-associated Kaposi Sarcoma in Uganda. AIDS Malignancy Consortium Medical and Health Sciences Clinical Trial Non-degree Award
Pontiano Kaleebu
ID: UNCST-2021-R013577
 Open-label, Multicenter Immunogenicity and Safety Trial of MVA-BN® Vaccine in Children From 2 Years to Less Than 12 Years of Age Compared to Adults for the Prevention of Smallpox, Mpox, and Related Orthopoxvirus Infections
REFNo: HS5281ES

To assess immunogenicity of the MVA-BN standard regimen in eliciting neutralizing antibodies against vaccinia virus in children compared to adults. To assess the safety and reactogenicity of the MVA-BN standard regimen in children and adults. To assess neutralizing antibody response to the MVA-BN standard regimen. To assess durability of neutralizing antibody response to the MVA-BN standard regimen.
Wakiso, Entebbe
Mbarara, Mbarara
 Uganda 2024-11-22 17:19:29 2027-11-22 300 Participants The trial population for this trial will be both pediatric (2 to <12 years of age) and adult (18 to 50 years of age) healthy volunteers. Both males and females will be recruited at the research sites in Entebbe and Mbarara. Potential volunteers will be approached in their communities, given information about the trial and those who show interest will be requested to come to the research sites. Bavarian Nordic A/S and funded by the Coalition for Epidemic Preparedness Innovations (CEPI). Medical and Health Sciences Clinical Trial Non-degree Award
Isaac Ssinabulya
ID: UNCST-2021-R004352
 ImpleMEntation of a Digital-first care deLiverY model for heart failure in Uganda (MEDLY Uganda)
REFNo: HS4581ES

In this study, we will implement a digital-first, multi-component strategy for HF (Medly Uganda) and evaluate both implementation and clinical outcomes. The primary objective is to assess the implementation and clinical effectiveness of a digital-first implementation strategy to improve HF self-care in Uganda. We will conduct a stepped-wedge, cluster randomized trial in outpatient departments at 6 Ugandan RRH. The co-primary outcomes will be the Self-Care of HF Index (implementation) and the composite of mortality and HF hospitalization (clinical effectiveness). The secondary objectives will include the following. Conduct a mixed method process evaluation to inform iterative adjustments to the implementation process. We will use a community-engaged approach to systematically collect qualitative and quantitative process data at pre-determined time points based on the Learn-As-You-Go design and make contextually appropriate implementation adaptations. Prior to recruitment, we will also explore patients’ journeys to heart failure diagnosis in Uganda through a qualitative component by conducting in-depth interviews. The aims of this work will be to explore factors associated with patient’s journeys to heart failure diagnosis, including descriptions of initial symptoms, progression, health care referral journey, barriers and facilitators to care, and role of health education and self-care awareness. We will assess the implementation fidelity and sustainability of Medly Uganda with a focus on reach, adoption, and maintenance. Using Medly Uganda meta data from patients (app) and providers (dashboard), we will identify patterns and predictors of usage. We will interview patients and providers to explore these findings, and ensure implementation fidelity. We will also explore patient and provider perspectives on the sustainability of Medly Uganda, using semi-structured interviews to explore patient and provider barriers and facilitators of long-term use, to surface strategies that would optimize Medly Uganda implementation over time. We shall explore cost, cost effectiveness, and sustainability factors for Medly Uganda. We will collect and examine cost data from patients and facilities examining the unit cost (cost per HF patient treated and per HF patient controlled) of control and Medly Uganda scenarios both from a financial and societal perspective. Primary outcomes for cost effectiveness analysis will be the Incremental Cost-Effectiveness Ratio per patient treated and per death averted.
Arua,
Lira,
Mbale,
Masaka,
Mbarara,
Kabarole,
Uganda 2024-11-18 22:56:37 2027-11-18 576 We will consecutively recruit patients 18 years or older presenting for HF care at the medical outpatient NCD and/or cardiac clinics at the 6 participating sites, each a Ugandan public sector Regional Referral Hospital (RRH) located in Arua, Fort Portal, , Lira, Masaka, Mbale and Mbarara. For the secondary objectives 1 and 2 of this study, we will recruit patients, implementers and administrators to participate in the process evaluation, and in reflections on implementation and sustainability. We expect to recruit 12 implementers (2/site at minimum), 22 administrators (2/site, 6 regional representatives, and 4 MoH) as well as 72 patients (8-12 at minimum/site) for qualitative assessment over the course of the study. Our qualitative component will recruit patients 18 years or older with recently diagnosed HF (within past three months), presenting for care at Uganda Heart Institute, or Arua, Masaka, and/ Mbale RRH. National Institutes of Health Medical and Health Sciences Clinical Trial Non-degree Award
Deo Wabwire Ogema
ID: UNCST-2021-R013932
 A Phase 2 Randomized, Adaptive, Dose-Ranging, Open-Label Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis (RAD-TB) Version 2.0, Dated 21 Mar 2024
REFNo: HS5088ES

Primary objectives

(i)To compare Mycobacterial Growth in Tube (MGIT) liquid culture Time to Positivity (TTP) slope over the first 6 weeks of treatment for each experimental treatment arm to the standard of care (SOC) arm.

(ii)To compare new Grade 3 or higher adverse events (AEs) (safety) over the first 8weeks of treatment for each experimental treatment arm to the SOC arm.

Secondary Objectives

i)To compare time to stable culture conversion by MGIT liquid culture by week 8
for each experimental treatment arm to the SOC arm.

ii)To compare MGIT liquid culture TTP slope over the first 8 weeks of treatment for
each experimental treatment arm to the SOC arm.

iii) To compare new Grade 3 or higher AEs (safety) over 26 weeks of treatment for
each experimental treatment arm to the SOC arm.

iv) To compare discontinuations of anti-TB drugs for any reason prior to 8 and 26
weeks of treatment for each experimental treatment arm to the SOC arm.

v) To determine the dose- and exposure-response relationships between experimental drug estimated pharmacokinetic (PK) parameters with safety and efficacy.
vi) To compare a composite of efficacy and safety outcomes using a risk-benefit
approach for each experimental treatment arm to the SOC arm.

vii) To compare MGIT liquid culture TTP slope over the first 6 weeks of treatment for Arms 3A-3B and Arms 4A-4B compared to Arm 2.

viii) To compare durable cure by 52 weeks after treatment initiation in each
experimental treatment arm to the SOC arm.

 Kampala, Mulago
 Uganda 2024-11-13 18:02:04 2027-11-13 315 participants Participants will be individuals (male and female) with Xpert MTB/RIF positive drug-susceptible pulmonary TB, living with and without HIV, aged ≥18 years. Pregnant women will be excluded from the study. US National Institute of Allergy and Infectious Diseases. Medical and Health Sciences Clinical Trial Non-degree Award
JOSAPHAT KAYOGOZA BYAMUGISHA
ID: UNCST-2019-R001680
 Heat-stable carbetocin for the treatment of postpartum haemorrhage: a phase III, randomized, double-blind, active controlled, multicountry, multicentre, non-inferiority trial
REFNo: HS5151ES

To evaluate the cost-effectiveness of the PPH treatment with HSC compared to PPH treatment with oxytocin, if HSC is proven non-inferior. ,To evaluate the comparative effects of HSC versus oxytocin on haemodynamic outcomes when used for PPH treatment in women receiving HSC for prophylaxis; ,The primary objective of this trial is to evaluate whether HSC is non-inferior to oxytocin for treatment of PPH in women who receive HSC for PPH prophylaxis, in the prevention of additional blood loss of 500 ml or more at 90 min following randomization. ,
 Kampala, Kawempe
 Uganda 2024-11-13 17:36:53 2027-11-13 700 Pregnant women aged 15 years and above UNDP-UNFPA-UNICEF-WHO-World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP) Medical and Health Sciences Clinical Trial Non-degree Award
Ezekiel Mupere
ID: UNCST-2024-R003962
 A Randomized Clinical trial: Supplemental choline to prevent and treat learning and memory deficits of early iron deficiency. The SupCHO study
REFNo: HS4915ES

Conduct a randomized, placebo-controlled clinical trial to test whether nine months of daily choline supplementation improves hippocampus-dependent neurobehavioral outcomes in 6-month-old infants with iron deficiency anemia.,
 Kampala, Mulago 1
 Uganda 2024-11-13 16:35:35 2027-11-13 300 The study population will comprise infants aged 6 months (±28 days), recruited from pediatric immunization clinics at Mulago National Referral Hospital and Kawempe National Referral Hospital in Uganda. Participants will include both male and female infants, ensuring a balanced representation of sex in the study. The infants will belong to various tribes within Uganda, reflecting the diverse ethnic composition of the country. However, no specific tribe will be excluded, and the study aims to capture a broad spectrum of ethnic backgrounds to ensure the generalizability of the findings. The inclusion criteria will focus on infants with hemoglobin (Hb) levels between 7.0 g/dL and <11.0 g/dL, who are malaria-negative based on a rapid diagnostic test (RDT), and whose mothers are HIV-negative. Exclusion criteria include infants with developmental disorders, severe malnutrition, known sickle cell disease, neurological disorders, or brain injury. Thrasher Research Foundation Medical and Health Sciences Clinical Trial Non-degree Award
Esther Buregyeya
ID: UNCST-2020-R014116
 Secondary distribution of HIV self-testing by Female Sex Workers, pre-exposure prophylaxis (PrEP) starter packs and brief counseling to promote PrEP initiation and persistence among high-risk men in Uganda
REFNo: HS4891ES

Determine acceptability, feasibility, and safety of the intervention, and preliminary estimates of the potential for the intervention, compared to the control, to promote PrEP initiation, adherence, and persistence among male clients,Conduct an initial (stage 1a) small pilot of the intervention and refine it in preparation for the stage 1b pilot trial,Create the proposed Kayungirizi intervention to promote PrEP initiation and persistence among male clients of FSW through qualitative research informing adaptation and integration of components of local models and aspects of evidence-based interventions,Our overall hypothesis is that secondary distribution of HIVST by FSW to their male clients as an entry point to generate demand for PrEP, followed by an FSW-led intervention to address ongoing structural, interpersonal, and individual-level barriers (convenience, confidentiality/stigma, flexibility) will promote PrEP initiation, adherence, and persistence among male clients. ,
 Kampala, Bwaise
Kampala, Bwaise
 Uganda 2024-10-31 17:21:44 2027-10-31 140 Both male clients of Female Sex Workers (FSW) and the FSW Age 18+ National institute of health (NIH) Medical and Health Sciences Clinical Trial Non-degree Award
Nixon Niyonzima
ID: UNCST-2020-R014577
 A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Atezolizumab and Bevacizumab, with or without Tiragolumab, in Patients with Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma (IMBRAVE152)
REFNo: HS5026ES

To evaluate the immune response to tiragolumab and atezolizumab,To characterize the PK profile of atezolizumab plus bevacizumab plus tiragolumab, To evaluate the safety of atezolizumab plus bevacizumab plus tiragolumab compared with atezolizumab plus bevacizumab,To evaluate the efficacy of atezolizumab plus bevacizumab plus tiragolumab compared with atezolizumab plus bevacizumab,
 Kampala, Mulago II
 Uganda 2024-10-14 8:13:47 2027-10-14 10 Patients diagnosed with hepatocellular carcinoma above 18 years of age Hoffman La Roche Medical and Health Sciences Clinical Trial Non-degree Award
Wilfred Opobo
ID:
APPROPRIATENESS OF MALARIA CONTROL POLICY AND FACTORS ASSOCIATED WITH PUBLIC COMPLIANCE IN GULU DISTRICT, UGANDA. A QUALITATIVE STUDY
REFNo: SS3130ES

General objective of the study.
• To examine the factors that influence citizens’ compliance with malaria control policy guidelines in Uganda.

Specific objectives of the study.
• To explore how lay perceptions and understandings of malaria control and prevention measures influence citizens’ compliance with malaria control policy.
• To examine the effectiveness of the national information, education, and communication strategies used to promote citizens’ compliance with malaria control policy guidelines.
• To assess the effectiveness of the district malaria governance structures in promoting citizens’ compliance with malaria control policy guidelines.

Gulu, Paduny
 Uganda 2024-10-08 17:44:59 2027-10-08 50 participants initially Target population. The target population for this study encompasses the residents of Gulu district, as well as the governance structures involved in malaria control interventions within the district. Gulu district is predominantly inhabited by the Acholi tribe. However, study participants from the governance structures such as district local government and ministry of Health come from across Uganda. it is also worth mentioning that increasing urbanization is also making the district more cosmopolitan. The study population will be both male and female from the age of 18 years and above. Self sponsorship Social Science and Humanities Clinical Trial Degree Award
Bruce Kirenga J
ID: UNCST-2019-R001460
 SMART (Smallpox vaccine for Mpox Post-Exposure Prophylaxis: A Cluster Randomized Controlled Trial)
REFNo: HS4726ES

Co-Primary objectives Co-primary: 1) To assess the effectiveness of the Smallpox vaccine in preventing RT-PCR confirmed Mpox infection among contacts of confirmed Mpox infection 2) To assess the effectiveness of the Smallpox vaccine in reducing the severity of symptoms; measured as symptom severity score, based on 12 symptom items (16) each assigned a score of 0 to 5 for a total measure of 0 to 60. These co-primary objectives will be evaluated during the first 28 days after randomization.
 Kisoro, Rubanda
 Uganda 2024-09-27 14:06:23 2027-09-27 1560 10 years and above, Males and females, and all tribes residing within the study area that meet the inclusion criteria will be included in the study. McMaster University Medical and Health Sciences Clinical Trial Non-degree Award
EVA NATUKUNDA
ID: UNCST-2020-R014330
 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: HS4706ES

To provide Continued Access to Study Drug to Participants Who Completed Pediatric Clinical Studies Involving Gilead HIV Treatments
Kampala, lubowa
 Uganda 2024-09-25 12:50:13 2027-09-25 86 5 to 18 years Gilead sciences Medical and Health Sciences Clinical Trial Non-degree Award
Cissy  Kityo
ID: UNCST-2021-R013663
 ACTG NEW WORK CONCEPT SHEET (NWCS) 575: Evaluation of biomarkers to predict TB-IRI
REFNo: HS4876ES

1. Determine whether higher levels of a set of biomarkers in people with HIV and tuberculosis prior to ART initiation may predict the development of TB-IRIS, particularly severe IRIS requiring corticosteroid treatment
2. Assess whether these biomarkers decrease between study entry and ART initiation in the deferred arm (i.e. with more prolonged anti-tuberculous therapy duration)
3. Determine whether these biomarkers can be predictive of other severe outcomes especially deaths.

 Uganda 2024-09-11 14:10:40 2027-09-11 1,000 A5221 participants were National Institute of Allergy and Infectious Diseases (NIAIDS) Medical and Health Sciences Clinical Trial Non-degree Award
Achilles Katamba
ID: UNCST-2019-R000540
 Peer-led Implementation of TB-HIV Education and Adherence Counselling in Uganda
REFNo: HS4801ES

To evaluate the implementation fidelity and context of a peer-navigation strategy for TB-EC to improve TB treatment and ART outcomes, To determine the feasibility, acceptability, and appropriateness of a peer-navigation strategy for TB-EC and explore the social-behavioral mechanisms for improving adherence and clinical outcomes. ,To evaluate the implementation of a peer-navigation strategy for TB-EC to improve TB treatment completion and ART retention. , To evaluate the effectiveness and implementation of a novel, peer-led TB education and counseling strategy to improve outcomes among persons with tuberculosis (TB) with and without HIV/AIDS and assess the social-behavioral mechanisms underlying the observed treatment effects. ,
 Kampala,
Kampala,
Kampala,
Kampala,
Jinja, Wanyange
Jinja,
Buikwe,
Iganga,
Kiboga,
Mityana,
Butambala,
Wakiso,
Wakiso,
Kayunga,
Kampala,
Kamuli,
Luweero,
Lyantonde,
Mukono,
Uganda 2024-09-10 10:03:57 2027-09-10 1920 index cases Study population in Aim 1: Our target population is adults (age ≥18) starting treatment for TB/TB-HIV in public, private, and private not-for-profit primary care clinics in Uganda. Targeting this population will allow us to assess the impact of the TB-EC on TB and ART treatment adherence and outcomes across a diverse population. Study population Aim 2: For the pilot study to test Aim 2 instruments, we will enroll adults (age ≥18) undergoing evaluation for TB and on TB treatment in primary care clinics. All participants in Aim 1 of the study will participate in the Aim 2 of the study. We administer social and behavioral scales through the surveys that will be conducted in Aim 2. Study population in Aim 3: Aim 3 participants will include a subgroup of individuals enrolled in the Aim 1 trial, their peer navigators, and healthcare workers at study sites. National Institute of health Medical and Health Sciences Clinical Trial Non-degree Award
Milton Musaba Wamboko
ID: UNCST-2019-R000825
 Effectiveness and Safety Dosing of Sodium Bicarbonate in Women with Obstructed Labor in Eastern Uganda: A Phase III Randomized placebo-controlled Trial (SoBicOL- II Study)
REFNo: HS3885ES

General objective
To determine the efficacy and safety of a preoperative infusion of sodium bicarbonate on pH and lactate levels (metabolic acidosis) among women with obstructed labour.
Specific objectives
1. To determine the efficacy of a preoperative infusion of sodium bicarbonate on acidosis, compared with placebo among women with obstructed labour (OL).
2. To determine the safety of a preoperative infusion of sodium bicarbonate compared with placebo among women with obstructed labour (OL).

 Mbale, Kawempe
 Uganda 2024-08-29 18:40:41 2027-08-29 280 Obstructed labour will be diagnosed by either an obstetrician or medical officer using a definition of the American Association of Obstetricians and Gynaecologists (ACOG). In the first stage of labour, the participant should have cervical dilatation >6 cm with ruptured membranes, adequate contractions lasting >4 hours with no change in cervical dilatation or delay in the second active stage of labour (nullipara >2 hours, multipara >1 hour) with adequate uterine contractions. In addition, any two of: the obvious signs of severe obstruction such as caput formation, severe moulding, Bandl’s ring, subconjunctival haemorrhages or an oedematous vulva. Busitema University Medical and Health Sciences Clinical Trial Non-degree Award
GUMA  ASHIRAF
ID:
PREVALENCE, PATTERNS AND CORRELATES OF GENERAL JOINT PAIN AMONG PATIENTS WITH DIABETES MELLITUS ATTENDING DIABETIC CLINIC AT MBARARA REGIONAL REFFERRAL HOSPITAL
REFNo: HS3963ES

To determine the prevalence of general joint pain among patients with DM attending diabetes clinic at MRRH.To determine the patterns of joint pain among patients with DM attending diabetes clinic at MRRH.To determine the associated factors to general joint pain among patients with DM attending diabetes clinic at MRRH.
 Mbarara, Rwebikona
 Uganda 2024-08-29 10:59:36 2027-08-29 242 The study population will be patients with DM attending diabetes clinic at MRRH. The diabetes clinic has a patient census of approximately 1500 patients of which about 80 patients attend every week. The study population is between the age of 18 years to 90 years. Most of the study population are Banyankole, Bakiga and Bahima. The study population is made of both males and females. Guma Ashiraf, Jemba Jovane, Mwesigwa Emma, Bananuka Bernard Medical and Health Sciences Clinical Trial Degree Award
Ruth Namazzi
ID: UNCST-2020-R014305
 Zinc for Infection Prevention in Sickle cell anemia ZIPS-2
REFNo: HS4824ES

The primary objective of the study is to determine if zinc supplementation at 20mg daily is safe and efficacious at reducing all-cause infection in Ugandan children 1.00-4.99 years of age with SCA.Secondary objectives 1. To determine the incidence of adverse events requiring discontinuation of study drug in children ages 1-4.99 supplemented with 20mg of daily zinc vs placebo 2. To determine the incidence of stroke or death in children ages 1-4.99 supplemented with 20mg of daily zinc vs placebo 3. To determine the incidence of infections requiring hospitalization in children ages 1-4.99 supplemented with 20mg of daily zinc vs placebo 4. To determine the incidence of vaso-occlusive crises in children ages 1-4.99 supplemented with 20mg of daily zinc vs placebo 5. To determine the change in transcranial Doppler (TCD) velocity from enrollment to 6-month study endpoint in children ages 1-4.99 supplemented with 20mg of daily zinc vs placebo 6. To determine change in serum zinc deficiency status from enrollment to 6-month study endpoint in children ages 1-4.99 supplemented with 20mg of daily zinc vs placebo 7. To determine the incidence of serious adverse events in children ages 1-4.99 supplemented with 20mg of daily zinc vs placebo 8. To determine the incidence of adverse events in children ages 1-4.99 supplemented with 20mg of daily zinc vs placebo
Jinja, Kakindu
 Uganda 2024-08-28 17:29:12 2027-08-28 100 Children with confirmed SCA between 1.00 and 4.99 years of age, living in the malaria endemic area of mid-eastern Uganda, who attend the Nalufenya Sickle Cell Clinic, Jinja Regional Referral Hospital whose caretakers’ consent to study participation CURES WITHIN REACH, INDIANA UNIVERSITY Medical and Health Sciences Clinical Trial Non-degree Award
Herbert Ainamani Elvis
ID: UNCST-2020-R014674
 The Impact of Self Help Plus and Climate Smart Agriculture on Mental Health and Food Security in the Rhino and Nakivale Refugee Settlements of Uganda
REFNo: HS4691ES

To compare the uptake of HGI between the mothers in the combined intervention group (HGI & SH+) with those in the HGI group living in Nakivale refugee settlement,To assess the effect of SH+ on the development of children aged 3-6 years belonging to participating mothers living in Rhino and Nakivale refugee settlements,To assess the effect of SH+ on the mental health of mothers with children aged 3-6 years living in Rhino and Nakivale refugee settlements ,To assess the perceptions and attitudes towards a home gardening intervention (HGI) among participating mothers living in Nakivale refugee settlement,To assess the effectiveness of Self Help Plus (SH+) and home gardening on maternal mental health, food security and child development in the Rhino and Nakivale refugee settlements of Uganda,
 Uganda 2024-08-26 14:58:27 2027-08-26 900 The target population of the proposed research project consists of refugee mothers (age 18+) with children aged 3-6 years, living in the Nakivale and Rhino refugee camps in Uganda. In Nakivale, the study will recruit 900 mother-child dyads across 30 villages, while in Rhino, 720 dyads from 24 villages will participate. Participating mothers in randomly selected intervention villages will be the recipients of the mental health and/or smart farming intervention. Outcomes will be measured at the level of the mother, the child, and the household. Uppsala University Medical and Health Sciences Clinical Trial Non-degree Award
Monicah Agaba
ID: UNCST-2024-R004221
 The Health-Beauty Paradox among Women in Mbarara City Uganda
REFNo: HS4708ES

iii. To characterise the cardio-metabolic profile of WRA.,ii. To document the risk behaviours and their factors related to these societal beauty perceptions.,i. To document societal beauty perceptions and their determinants.,To understand what, why and how the health-beauty paradox is so deeply entrenched in the culture.,
 Mbarara, Sampled
 Uganda 2024-08-26 10:18:37 2027-08-26 300 For the qualitative study, we target both women and men aged 15 up to 65 years who are residents of Mbarara City. For the quantitative study, we target only women of reproductive age (15 to 49 years) who are residents of Mbarara City. For both studies, their ethnicity is not a key inclusion or exclusion criterion. Global Minds Scholarship and Healthy Diets for Africa project Medical and Health Sciences Clinical Trial Degree Award
Rebecca Nuwematsiko
ID: UNCST-2022-R010501
 Effect and implementation factors of a contextually adapted short message service or phone call intervention to reduce loss to follow-up among presumptive TB patients in North Central Uganda
REFNo: HS3000ES

1.To determine the proportion of pre-diagnosis LTFU among presumptive TB patients and influencing factors in North Central Uganda (Sub-study 1). 2.To explore stakeholder’s perceptions on use of an SMS or phone call intervention to reduce LTFU among presumptive TB patients in health care facilities in North Central Uganda and contextually adapt the interventions (Sub-study 2). 3.To assess the effect of a contextually adapted SMS or phone call intervention to reduce LTFU among presumptive TB patients in health care facilities in North Central Uganda (Sub-study 3). 4.To explore factors that influence implementation of a locally adapted SMS or phone call intervention to reduce LTFU among presumptive TB patients in North Central Uganda (Sub-study 3). 5.To synthesize evidence on effectiveness of mHealth interventions to reduce LTFU in the TB presumption phase in LMICs (Sub-study 4)
Mukono, Mukono
Buikwe, Kawolo
Mityana, Mityana
 Uganda 2024-08-22 13:00:28 2027-08-22 1410 This will include presumptive TB patients aged 18 years and above who present to the study facilities during the study period and do not complete diagnosis on the same day of the hospital visit. Inclusion criteria A presumptive TB patient who is; ? Aged 18 years and above ? Current resident in the study district ? Willing to sign informed consent ? Owning a personal mobile phone (The patient should be in possession of the phone at the time of screening) ? Being able to read ? Those sent for GeneXpert testing ? Presumed for TB within 12 hours ? Patient has not completed TB diagnosis on the same day ? Speaks or reads English or Luganda MILEAGE4TB project hosted at Makerere University School of Public Health Medical and Health Sciences Clinical Trial Degree Award
Grace Kisitu Paul
ID: UNCST-2024-R004102
 Universal2: Pharmacokinetics, safety and acceptability of a solid paediatric fixed-dose combination of darunavir/ritonavir (DRV/r) 120/20mg for children living with HIV
REFNo: HS4762ES

To evaluate the pharmacokinetics and safety of DRV/r 120/20 mg tablets in children greater than or equal to 3 years of age and weighing 10 to less than 25 kg

To evaluate the pharmacokinetics and safety of DRV/r 120/20 mg tablets in children greater than or equal to 3 years of age and weighing 10 to Less than 25 kg

To evaluate the acceptability of DRV/r tablets in children greater than or equal to 3 years of age and weighing 10 to less than 25 kg

To evaluate the short-term efficacy of the DRV/r 120/20 mg tablets in children greater than or equal to 3 years of age and weighing 10 to less than 25 kg

To describe RTV PK parameters as well as darunavir unbound plasma concentrations.

 Uganda 2024-08-22 11:45:22 2027-08-22 50 Children with HIV, from 3 years of age, requiring DRV/r: • weighing 10 to less than 25 kg with 1 or 2 DRV resistance-associated mutations (RAM) * Or • weighing 10 to less than 20 kg requiring DRV/r, with no DRV RAM* *DRV RAMs: V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V Fondazione Penta ETS Medical and Health Sciences Clinical Trial Non-degree Award
Agaba Katureebe Ishmael
ID: UNCST-2024-R004089
 Getting a GRIP on Hypertension in Uganda: Giving Repetitive Isometric Exercise for Blood Pressure Control (GRIP in Uganda)
REFNo: HS4712ES

To assess knowledge, attitudes, and practices (KAP) about HTN and experience with IHT (if applicable) ,To measure HTN medication adherence for those prescribed HTN medication during their follow-up, which will be measured through pill counting (counting the remaining amount of pills for prescribed medication).,To assess the need for HTN medication at endline, as per clinical and MOH guidelines, which will be measured through changes in BP levels at week 12,To evaluate the effects of Isometric Hand Training (IHT) on resting diastolic Blood Pressure when compared to standard care after 12 weeks ,To evaluate the effects of Isometric Hand Training (IHT) on resting Systolic Blood Pressure when compared to standard care after 12 weeks ,To determine the efficacy of Isometric Hand Training (IHT) in a population of Hypertension (HTN) patients compared to standard care after 12 weeks of care,
 Jinja, Ivunamba
 Uganda 2024-08-22 11:38:26 2027-08-22 250 adult participants We intend to enroll 250 adult participants men and women aged 18 years and above. Participants will be persons who seek care at the Soft Power Mukagwa Allan Stone community clinic in Kyabirwa jinja. These come from Jinja and the neighboring districts of Iganga, Luuka, Kamuli and Mayuge in East Central sub-region. The area is predominantly inhabited by Basoga and then minority Baganda, Bagisu, Banyole etc. Eligibility criteria Inclusion criteria are: 1) diagnosis of stage 1 HTN (BP >140-159/90-99 mmHg ), which is based on the clinic and MOH definitions , 2) not currently taking HTN medication, 3) not having been on HTN medication in the past 3 months, and 4) age > 18 years and older. Exclusion criteria are: 1) diagnosis of stage 1 HTN and currently taking HTN medication, 2) diagnosis of stage 2 HTN, 3) diabetes, 4) history of recent myocardial infarction (in the past year), 5) congestive heart failure, 6) complete heart block, 7) unstable angina, 8) Glomerular Filtration rate of 90 or lower, 9) any pregnancy associated HTN, 10) any limitation (e.g., limited hand mobility) preventing proper performance of IHT exercise, and 11) any other condition that alters autonomic nervous system function. Canadian Institutes of Health Research (CIHR) Medical and Health Sciences Clinical Trial Non-degree Award
Proscovia Nabunya
ID: UNCST-2019-R000970
 Testing the Feasibility and Acceptability of a Combination Intervention to Address Mental Health among Refugee Youth in Uganda
REFNo: SS2834ES

This proposed two-year study will be conducted in two phases. The first phase seeks to understand whether the COVID-19 pandemic had differential impact on refugee youth living in different settings. The second phase will test the feasibility and acceptability of an innovative combination intervention that has not been previously tested among refugee youth to address psychological problems that have increased since the onset of the COVID-19 pandemic. Aim 1. To examine the mental health impact of COVID-19 on refugee youth living in Bidibidi refugee settlement compared to refugee youth living in urban centers (Arua town) in northern Uganda. Aim 2. To test the feasibility, acceptability and preliminary short-term impact of an innovative intervention combining the youth readiness intervention (YRI) with youth development accounts and financial literacy training (YDA-FLT) to address the mental health impact of COVID-19 among refugee youth living in Bidibidi refugee settlement in northern Uganda.
Uganda 2024-08-19 11:03:04 2027-08-19 200 The total sample size needed for the Refugee Youth COVID-19 study is 200 refugee youth, 15 to 24 years of age. Specifically, we will recruit 100 refugee youth from the five zones within Bidibidi Refugee settlement and another 100 youth among refugee youth living in Arua town (urban center). Youth will be recruited from centrally located ration distribution centers in the settlement, through churches, and youth advocacy groups led by refugee youth in Arua town that we will partner with. For the pilot RCT component, we will only include the 100 participants in Bidibidi refugee settlement with 50 randomized to the treatment group and the other 50 randomized to usual care group. Washington University in St. Louis Social Science and Humanities Clinical Trial Non-degree Award
Peter Olupot-Olupot Olupot
ID: UNCST-2020-R014798
 SMAART-MAP trial Severe Malaria A Research and Trials consortium - Multisite Adaptive Platform trial
REFNo: HS4547ES

OBJECTIVES
The objective of the SMAART-MAP trial is to identify promising adjunctive therapies to take forward into a large Phase III trial in severe malaria with a mortality endpoint. The adaptive platform design enables additional domains to be added so a range of adjunctive therapies can be tested, across multiple clinical presentations of severe malaria, in a timely manner.

PRIMARY OBJECTIVE(S)
To explore within each domain the therapeutic efficacy of the intervention using an early indicator such as a biomarker or clinical assessment at 24-72 hours.

SECONDARY OBJECTIVE(S)
? To assess the impact of the interventions on clinical outcomes (readmission and
mortality) on all children 28 days and 90 days after randomization
? To assess the impact of the interventions on Grade 3 or 4 adverse events, and adverse
events of any grade related to the interventions or comparators.
? To assess the impact of proposed definitions for severe malaria based on platelet counts
?150,000/µL and plasma pfHRP2 concentrations ?800 ng/mL on differences between
randomized groups
? In a sub study, to determine the performance characteristics of a POC pfHRP2 test
compared with quantitative plasma pfHRP2 concentrations determined from plasma.

 Mbale, North central
Soroti, Pioneer Ward
Agago, Oreet
 Uganda 2024-08-16 11:01:14 2027-08-16 150 per domain Hospitalized children with severe malaria Imperial College London Medical and Health Sciences Clinical Trial Non-degree Award
VINCENT MUBANGIZI
ID: UNCST-2024-R004232
 Opti-MaP (Optimising Implementation of Maternal and Perinatal Death Surveillance and Response to prevent avoidable future deaths in Uganda
REFNo: HS4630ES

To review existing tools, develop and adapt a harmonised toolbox of resources to optimise MPDSR implementationTo co-design customised an "intervention package" using the toolboxTo evaluate effectiveness and cost-effectiveness of the "customised intervention package" to reduce perinatal and maternal mortalityTo develop and adapt a harmonised toolbox of resources to optimise MPDSR implementation
 Kamwenge, All parishes
Kyenjojo, All parishes
Lyantonde, All parishes
 Uganda 2024-08-06 18:02:24 2027-08-06 For work packages 2-7, the sample size will be determined when the interviewers reach a point of saturation. For the intervention phase (work package 8), the estimated sample size is 4032. Adult males and females plus emancipated minors in the study area regardless of their tribe will be involved in the study. We will also interview key stake holders in the central ministries and bodies. We will interview persons who have lost a women due to pregnancy related causes or had a still birth or a baby died within 28 days of birth Merlin L Willcox Medical and Health Sciences Clinical Trial Non-degree Award
Cissy  Kityo
ID: UNCST-2021-R013663
 A Phase 4, Open-Label, Rollover Study to Provide Continued Access to Cabotegravir Long-acting Injection and Rilpivirine Long-acting Injection to Participants Living with Human Immunodeficiency Virus Type 1 (HIV-1) Infection Who Participated in Long-Acting Combination Therapy Studies.
REFNo: HS4452ES

The secondary objective is to assess the long-term safety and tolerability of CAB LA + RPV LA by evaluating the incidence of serious adverse events (SAEs), pregnancies, adverse events (AEs) leading to discontinuation of CABLA +RPV LA, and AEs considered to be related to the study intervention.,The primary objective of the study is to provide continued CAB LA + RPV LA access to participants who were enrolled and treated with CAB LA + RPV LA in the parent studies, and who, at the time of roll-over, experience and are expected to continue to experience clinical benefit from this treatment.,
 Wakiso, Katabi
Wakiso, Lubowa
Kampala, Mulago
Kabarole, Buyinga
Uganda 2024-08-06 17:32:50 2027-08-06 710 in Uganda Virologically suppressed adults who have had a detectable HIV viral load in prior 2 years of taking first-line ART or who have disengaged from HIV care. Janssen-Cilag International NV Medical and Health Sciences Clinical Trial Non-degree Award
alfred bulamu
ID: UNCST-2023-R008638
 Uganda Translational Breast Cancer Screening Research Center with Innovations in MRI and Genetic Testing.
REFNo: HS4689ES

Implementation of breast MRI with genetic testing as BC screening method for women at high risk of BC by July 2029 (Phase 6) , Continuous Trainings for radiologists, radiographers and laboratory staffs on the modern technologies of MRI and Genetic testing (phase 3 to phase 6) ,Evaluating the feasibility of screening BC using MRI and genetic testing for high risk women by December 2028 (phase 5),Large scale education of the community about BC by July 2028 (phase 3 and phase 4).,Large scale determination of the utility of genetic testing as a screening modality for BC in Uganda by perform mutational genetic analysis for women at high-risk aged19 years to 80 years by July 2028 (phase 3 and phase 4) , Large scale determination of the utility of quantitative breast MRI for screening women at high risk BC aged 19 years to 80 years by July 2028 (phase 3 and phase 4) ,Training of the users on equipment i.e. Radiologists, Radiographers and laboratory staffs by 2025 (phase 2) ,Securing and installation of lab equipment for genetic testing by 2025 (Phase 2,Securing and installation of MRI with Breast coils by July 2025 (Phase 2),To build capacity for 20 laboratory health care workers in genetic testing technologies by December 2023 (phase 1).,To build capacity for 30 radiology health professionals in modern breast Imaging with MRI by December 2023 (Phase 1),To determine the utility of quantitative breast MRI for screening women at high risk breast cancer aged 19 years to 80 years by July 2024 (phase 1),To determine the utility of genetic testing as a screening modality for BC in Uganda by perform mutational genetic analysis for women at high-risk of BC aged 19 years to 80 years, by July 2024 (phase1),To build a long-lasting infrastructure for research, clinical screening in Uganda and training using modern technologies. ,To offer improved access to Breast Cancer screening in Uganda through quantitative MRI and genetic testing research center,
 All Districts, All parishes
 Uganda 2024-08-06 17:27:31 2027-08-06 100 participants All women at the risk of breast Cancer between the Ge of 19 year to 80years of all the tribes in the different regions Kiphart Foundation Medical and Health Sciences Clinical Trial Non-degree Award
Moses Oketch
ID: UNCST-2024-R004313
 Long-Term Impacts of Improved Childhood Literacy
REFNo: SS2796ES

Economic situation,
 Amolatar,
Dokolo,
UK 2024-08-05 14:01:33 2027-08-05 6581 Former participants of a study on the impact of an early-grade literacy intervention. The study was implemented from 2009 to 2011. The respondents are aged between 19 and 24 years old, with an average age of 21 years. Center for Global Development Social Science and Humanities Clinical Trial Non-degree Award
Jenny Löfgren
ID: UNCST-2024-R005428
 Outcomes of paediatric inguinal hernia repair performed by surgeons versus medical officers
REFNo: HS4508ES

Calculate and compare costs and cost-effectiveness between the two groups. ,Compare patient related outcomes between the group that has been operated on by medical officers versus those who were operated by general surgeons. ,The general objective of the proposed study is to investigate the possibility of task sharing between general surgeons and medical officers in inguinal hernia repair in children in Uganda. ,
 Soroti,
Mubende,
Iganga,
Sweden 2024-07-23 15:30:50 2027-07-23 341 Children, both girls and boys, 1-12 years old. Swedish Research Council Medical and Health Sciences Clinical Trial Degree Award
Nura Izath
ID: UNCST-2022-R009201
 Autothermo-a wearable continuous temperature measuring bracelet with a central display screen.
REFNo: HS3034ES

To assess the performance of Autothermo- a wearable continuous temperature measuring bracelet and a central display screen in comparison to the standard thermometer.,To assess the feasibility and acceptability of Autothermo among health workers and parents/caregivers of admitted neonates at Mbarara Regional Referral Hospital(MRRH).,
 Mbarara, Kamukuzi
 Uganda 2024-07-22 16:57:35 2027-07-22 The sample size of the health workers: Convenient sample of 4 out of 6 health workers engaged in the management and care of newborns admitted at Neonatal Intensive Care Unit-MRRH will be enrolled in the study. These study participants who will be nurses on duty will observe the use of Autothermo, ask a few questions and document findings at the end of each shift. The remaining two nurses will be recruited as study research nurses who will enroll and use Autothermo to monitor temperatures of the admitted newborns during the study period. The sample size for parents or caregivers will be calculated basing on the Kish and Leslie where P (0.5) will be the probability of parents or caregivers who will express willingness to have their newborns’ temperatures monitored with Autothermo and q (1-p) will be the probability of those who will not express willingness to use Autothermo. The study will use a precision of 0.126 and a Z of 1.96 giving a total of 60 parents or caregivers to be recruited into the study. Taking Feasibility and Acceptability of Autothermo: The study will include health workers and parents or primary caregivers of newborn. Parents and caregivers who are 18 years and above will be recruited and all health workers in the Neonatal Intensive Care Unit. The parents or caregivers will be informed that the Autothermo bracelet will be removed at any time at their request. Autothermo Performance Assessment: All neonates (0 to 28 days) admitted to the neonatal unit of MRRH during the study period will be screened for inclusion into the study. Ministry of ICT and National Guidance Medical and Health Sciences Clinical Trial Non-degree Award
Grace Kisitu Paul
ID: UNCST-2024-R004102
 UNIVERSAL1: Pharmacokinetic study of an optimized dose ratio of dolutegravir/emtricitabine/tenofovir alafenamide fumarate: expediting a UNIVERSAL first line regimen for all children living with HIV in Africa
REFNo: HS4280ES

Primary objective:
To evaluate the pharmacokinetics and short-term safety of DTG and FTC/TAF administered to children living with HIV using a novel dose ratio

Secondary objective:
To evaluate the short-term efficacy of DTG and FTC/TAF
formulations in children using a novel dose ratio

 Uganda 2024-07-19 3:45:20 2027-07-19 50 Children aged between 28 days and ≤10 years old weighing ≥3 to <25kg diagnosed with HIV. Fondazione Penta ETS Medical and Health Sciences Clinical Trial Non-degree Award
Janet Nakigudde
ID: UNCST-2019-R000444
 PROMOTING MENTAL HEALTH OF TEACHERS AND CAREGIVERS USING A PERSONALIZED MHEALTH TOOLKIT IN UGANDA
REFNo: HS4431ES

3. To examine feasibility of mWEL-T and mWEL-P with parents and teachers from urban and rural regions (including examining feasibility of the implementation procedures and intervention efficacy) (n=160, 80 parents and 80 teachers from urban and rural regions).,To conduct a user-centered testing study to optimize usability of the Teacher and Parent versions of mWEL- mWEL-T and mWEL-P,1. To build a school system capacity (by establishing a cross-discipline digital health leadership & learning collaborative (n=10) and training a group of peer-community health workers (P-CHW) (n=30; 15 peer teachers and 15 peer parents) to implement the mWEL that is developed,The aim of the study is to test mWEL a newly developed mobile app and user-engagement strategies for mental health management and promotion targeting teachers and parents,
 Kampala, kibuli
Nakaseke, Nakaseke
 Uganda 2024-07-17 14:03:01 2027-07-17 For the proposal sample size N=160 for the full sample The study will enroll parent, teachers and caregivers of children. We shall consider parents who are at least 18 years old, and have a child aged 6-14 years in the enrolled school This study is sponsor by the United States National Institute of Mental Health through a collaboration with New York University, Department of Population Health, New York School of Medicine and Makerere University College of Health Sciences, Department of Psychiatry Medical and Health Sciences Clinical Trial Non-degree Award
Eugene Ruzagira
ID: UNCST-2023-R008282
 Implementing oral (event-driven and daily) and long-acting Pre-exposure prophylaxis (PrEP) in mobile men in Sub-Saharan Africa: a phase 3b, open-label, hybrid type 2 implementation and effectiveness trial (MOBILE MEN)
REFNo: HS4366ES

Overall Objective
To assess effectiveness and implementation of long-acting cabotegravir (CAB-LA) and oral Truvada (both daily and event driven) through comparison of uptake, retention in care, coital coverage, and participant choice.
Masaka, Masaka
 Uganda 2024-07-02 15:08:06 2027-07-02 400 mobile men. HIV negative men aged 18+ years in South Africa and Uganda. Men who are mobile for work, and in the past 6-months have travelled for work or to find work and spent at least one night away from home for work-related purposes. Men male at birth, able and willing to provide informed consent and willing to have an HIV test. MRC/UVRI &LSHTM Uganda Research Unit Medical and Health Sciences Clinical Trial Non-degree Award
SABRINA KITAKA BAKEERA
ID: UNCST-2020-R014290
 SEARCH2: A Randomized Control Trial of Telephonic Reminders for HPV Vaccination among Adolescent Girls in Kampala, Uganda
REFNo: HS3929ES


General Objective
To conduct a randomized control trial to assess the impact of text message and automated phone reminders on HPV vaccination.

Specific Objectives:
1.To assess the impact of text message and automated phone reminders on HPV vaccination.
Sub-objectives include:
1) To assess if text message and automated phone reminders were equally effective
2) To examine subgroup effects (girl: age, site, school status [in or out of school], grade, relationship with caregiver; caregiver: age, education, employment, income, marital status, distance to health facility, language), when possible depending on the degree of variability observed
3) to assess for possible additive or subtractive effects of receiving two series of message for families of girls who may have been in the intervention for both initiation and completion

Kampala, Adolescent Clinic
Kampala, Kawala HC 3
Kampala, Kiswa HC 3
Kampala, Kisenyi HC 3
 Uganda 2024-07-02 12:45:18 2027-07-02 296 Target population: Families of adolescent girls in Uganda Study population: Families of adolescent girls who visited any of the following health centers: Kisenyi HC IV, Kiswa HC III, or Kawaala HC III or Makerere/Mulago/Columbia Adolescent Health Clinic at Mulago National Referral Hospital Accessible population: Families of adolescent girls who visited any of the following health centers: Kisenyi HC IV, Kiswa HC III, or Kawaala HC III or Makerere/Mulago/Columbia Adolescent Health Clinic at Mulago National Referral Hospital who meet the following selection criteria. National Institutes of Health USA Medical and Health Sciences Clinical Trial Non-degree Award
Elizabeth namukwaya namukwaya
ID: UNCST-2021-R013177
 PARASTOP-Paracetamol with strong opioids
REFNo: HS4423ES

To explore whether placebo with strong opioids compared to paracetamol with strong opioids changes pain intenisty for different doses of opioids, different cancers and quality of lifeintensity,To establish whether placebo with strong opioids compared to paracetamol with strong opioids changes opioid related side-effects,changes in opioid requirements and global rating of improvement,To establish whether placebo with strong opioids compared to paracetamol together with strong opioids provides non-inferior analgesia for cancer related pain,To establish whether the analgesic efficacy of strong opioids after withdrawal of paracetamol is non-inferior compared the analgesic efficacy of strong opioids used together with paracetamol for cancer-related pain.,
 Kampala, Mulago
Kampala, makinndye
 Uganda 2024-07-02 12:41:56 2027-07-02 25 cases and 25 controls Participants are eligible to be included in the study only if all of the following criteria apply: 1. Participant must be ≥ 18 years of age inclusive, at the time of signing the informed consent. 2. ≥50 kg study dose of paracetamol favours that weight 3. Participants who are under palliative care or oncology service review 4. Diagnosis of metastatic cancer. This includes all incurable solid malignancy in an advanced stage, either locally advanced or metastatic. This also includes malignant lymphoma in the palliative setting and multiple myeloma with bone disease. 5. Clinician-predicted life expectancy >2 months 6. Receiving daily regular strong opioids for cancer pain 7. Receiving stable scheduled opioid dose last 48 hours* 8. Receiving paracetamol 1 gram x three or four times a day for at least five days 9. Average pain intensity past 24 hours ≥ 2 and ≤ 7 (NRS 0-10)* 10. Able to take study drug/placebo as tablets 11. Able to comply with all study procedures 12. Capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol * It is allowed to repeat procedure within the screening period without considering the participant being a rescreen 5.2. Exclusion Criteria Participants are excluded from the study if any of the following criteria apply: 1. History of allergy or hypersensitivity to any of the active substances or excipients in the study drug 2. Known severe liver or renal failure equivalent with CTCAE Grade 3 or 4* precluding continuation of paracetamol. (*Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0) 3. Participants receiving subcutaneous, intravenous, intrathecal, or epidural opioid therapy 4. Participants receiving systemic anticancer treatment during the intervention period if they are anticipated to have increasing pain or other symptoms related to the treatment 5. Co-enrolment in other drug trials. Participants will not be enrolled in any other on-going interventional clinical trial. Study participants may be enrolled in non-interventional research (e.g. questionnaire, tissue collection studies) 6. Previously enrolled in this study 7. Pregnant or lactating women SouthEastern Norway Regional Health Authority Medical and Health Sciences Clinical Trial Non-degree Award
DAVID KITYA
ID: UNCST-2022-R009620
 Assessment of Accuracy, Precision, and Feasibility of a Handheld Near-Infrared Light Device (InfraScanner 2500™) in Detecting Intracranial Hemorrhage in Patients Admitted to Mbarara Regional Referral Hospital
REFNo: HS4141ES

Use these findings to evaluate the InfraScanner 2500™\'s ability to accurately detect intracranial hemorrhages in darker-skinned populations within LMICs. ,Determine whether the InfraScanner 2500™ detects intracranial hemorrhage (ICH) with adequate precision relative to CT scans to be used as an effective triage tool to prioritize imaging and need for level of clinical monitoring in an African, LMIC population.,To demonstrate that the InfraScanner 2500™ is capable of detecting and ruling out intracranial hematomas at rates similar to CT scan in patients hospitalized at Mbarara Regional Referral Hospital who have sustained or are suspected to have sustained head trauma.,
 Mbarara, Kamukuzi
 Uganda 2024-06-24 0:30:16 2027-06-24 180 12 years and above Duke Global Neurology Neurosurgery Medical and Health Sciences Clinical Trial Non-degree Award
Hannah Kibuuka
ID: UNCST-2020-R014355
 PROTECT-APT 1 _ Master Protocol for Early Treatment and Post-Exposure Prophylaxis of COVID-19 Adaptive Platform Trial V3.0 dated 02 June 2023 and Appendix C entitled “A phase 2 safety and efficacy study of upamostat for early outpatient treatment of COVID-19” V3.0 dated 01 June, 2023
REFNo: HS3116ES

To determine if early treatment with upamostat can shorten time to sustained symptom alleviation or resolution in participants infected with SARS-CoV-2.
Kabarole, Baza
 Uganda 2024-06-24 0:12:16 2027-06-24 40 Adult male and female participants aged 18 years and above FHI Clinical Medical and Health Sciences Clinical Trial Non-degree Award
Jonathan Izudi
ID: UNCST-2019-R000469
 Integrating Tuberculosis Treatment into Community Pharmacies to improve TB/HIV outcomes in Uganda: the Community Pharmacy Tuberculosis Treatment (COPHAT) study
REFNo: HS4397ES

To evaluate the implementation and preliminary effectiveness of integrating TB treatment into community pharmacies among people with TB/HIV.,To adapt a person-centered strategy for integrating TB treatment into community pharmacies using a human-centered design methodology.,To explore the barriers and facilitators to integrating TB treatment into community pharmacies among people with TB/HIV.,The main objective of this Community Pharmacy Tuberculosis Treatment (COPHAT) study is to develop and pilot an implementation strategy focused on integrating TB treatment into community pharmacies among people with TB/HIV in Kampala, Uganda. ,
 Kampala, Kisugu
Kampala, Kisenyi
Kampala, Kaawala
Kampala, Kitebi
Kampala, Komamboga
Kampala, Kiswa
 Uganda 2024-06-21 17:46:35 2027-06-21 126 People with TB/HIV, ART focal persons, TB focal persons, MoH officials, and Community Pharmacy health workers, aged 18 years and over, irrespective of tribe. National Institutes of Health Medical and Health Sciences Clinical Trial Non-degree Award
Cissy  Kityo
ID: UNCST-2021-R013663
 A Phase 2a/2b Study Evaluating Safety, Immunogenicity, and Therapeutic Efficacy of ID93 + GLA-SE Vaccination in Participants with Rifampicin-Susceptible Pulmonary TB
REFNo: HS3834ES

1.2 Secondary Objectives 1.2.1 Phase 2a and 2b: To evaluate the proportion of participants with a quantifiable RS ratio after therapeutic vaccination with ID93 + GLA-SE compared to placebo. 1.2.2 Phase 2a: To evaluate the kinetics of cellular immunogenicity of ID93 + GLA-SE through 12 months post second dose of study product. 1.2.3 Phase 2a: To evaluate the kinetics of humoral immunogenicity of ID93 + GLA-SE through 12 months post second dose of study product. 1.2.4 Phase 2a: To evaluate innate immune changes in response to ID93 + GLA-SE through 2 weeks post second dose of study product. 1.2.5 Phase 2b: To compare therapeutic vaccination with ID93 + GLA-SE, to placebo, with respect to the proportion of participants with TB-related unfavorable outcomes at 540 days after study entry, which is approximately 18 months after start of TB treatment, in subgroups defined by: Hard-to-treat phenotype and not hard-to-treat phenotype, where hard-to-treat phenotype is defined as smear Grade ?3 and cavitary disease on chest radiograph at TB diagnosis.1.3 Exploratory Objectives 1.3.1 Phase 2a: To compare therapeutic vaccination with ID93 + GLA-SE to placebo, with respect to: • The safety and immunogenicity of ID93 + GLA-SE in participants living with and without HIV. • The quantitative RS ratio at time points relative to vaccination and TB treatment as indicated in the Schedule of Evaluations (SOE). • The magnitude and quality of immune responses with respect to the composition of the intestinal microbiota. 1.3.2 Phase 2b: To compare therapeutic vaccination with ID93 + GLA-SE to placebo, with respect to the proportion of participants with TB-related unfavorable outcomes at 540 days after study entry, which is approximately 18 months after start of TB treatment, adjusted for • Pharmacokinetics (PK) assessments of first-line TB drugs (exposure) during TB treatment as per the SOE. • Levels of participant adherence to standard of care (SOC) TB treatment measured using self-reporting and urine acetyl-isoniazid (AcINH) from start to end of TB treatment. 1.3.3 Phase 2b: To compare therapeutic vaccination with ID93 + GLA-SE to placebo, with respect to the proportion of participants with TB-related unfavorable outcomes at 540 days after study entry, which is approximately 18 months after start of TB treatment, stratified by bacterial burden at start of TB treatment. 1.3.4 Phase 2a and 2b: To develop the composite predictive model of TB drug response by using measures of adherence, drug exposure (PK), immune response, gut microbiota, and participant phenotype. 1.3.5 Phase 2a and 2b: To compare therapeutic vaccination with ID93 + GLA-SE to placebo, with respect to proportion of participants with sputum culture conversion at baseline at time of randomization and at Step 2, Days 30, 120, and 150, which are approximately 2, 5, and 6 months after start of TB treatment. 1.3.6 Phase 2a and 2b: To compare therapeutic vaccination with ID93 + GLA-SE to placebo, with respect to cumulative relapse from end of TB treatment up to end of study follow-up, that is, Step 2, Days 420, 450, 480, and 510, for Groups 1, 2, 3 (&5), and 4 (&5), respectively. 1.3.7 Phase 2a and 2b: To compare therapeutic vaccination with ID93 + GLA-SE to placebo, with respect to lung function and health-related quality of life, as measured by spirometry and the St. George’s Respiratory Questionnaire. 1.3.8 Phase 2a and 2b: To compare the within-person change in lung function tests over time from the first dose of therapeutic vaccination with ID93 + GLA-SE to placebo. 1.3.9 Phase 2a and 2b: To compare therapeutic vaccination with ID93 + GLA-SE to placebo, with respect to resolution of transcriptomic biomarkers of TB disease. 1.3.10 Phase 2b: To identify correlates of protection for unfavorable TB outcomes. 1.3.11 Phase 2b: To estimate the effect of the vaccine on the proportion of participants with TB-related unfavorable outcomes among participants living with and without HIV. 1.3.12 Phase 2a and 2b: To conduct analyses related to furthering the understanding of TB, HIV, immunology, vaccines, and clinical trial conduct.,1.1 Primary Objectives 1.1.1 Phase 2a and 2b: To evaluate safety of a two-dose ID93 + GLA-SE vaccine regimen administered 60 days apart on Step 2, Days 0 and 60, with TB treatment administered, at approximately: 1.1.1.1 Months 4 and 6 after start of TB treatment (Group 1) 1.1.1.2 Months 3 and 5 after start of TB treatment (Group 2) 1.1.1.3 Months 2 and 4 after start of TB treatment (Group 3 and Group 5, if this vaccination schedule is adopted for Group 5) 1.1.1.4 Months 1 and 3 after start of TB treatment (Group 4 and Group 5, if this vaccination schedule is adopted for Group 5) 1.1.2 Phase 2a and 2b: To determine if therapeutic vaccination with ID93 + GLA-SE will increase the magnitude of vaccine-specific cellular responses compared to placebo at 2 weeks post second dose of study product. 1.1.3 Phase 2b: To estimate the effect of the vaccine on the proportion of participants with TB-related unfavorable outcomes (treatment failure, TB recurrence, or death due to TB) at Day 540 after study entry, which is approximately 18 months after start of TB treatment (Group 5 combined with either Group 3 or Group 4, depending on which vaccination schedule is selected for Group 5).,
 Kampala,
Uganda 2024-06-05 17:42:17 2027-06-05 100 Individuals with or without HIV, 18 years or older male or female (any tribe) with bacteriologically confirmed rifampicin-susceptible pulmonary TB receiving locally provided SOC TB treatment. Enrollment of participants living with HIV will be capped at 20% in each group. National Institute of Allergy and Infectious Diseases 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
Adoke Yeka
ID: UNCST-2021-R004300
 A randomized, open-label, multicenter study to compare efficacy, safety and tolerability of KLU156 with Coartem® in the treatment of uncomplicated Plasmodium falciparum malaria in adults and children ? 5 kg body weight followed by an Extension phase with repeated KLU156 treatment.
REFNo: HS3732ES

This study aims to confirm the efficacy, safety and tolerability of KLU156, a fixed dose combination of ganaplacide (KAF156) and a solid dispersion formulation of lumefantrine (lumefantrine-SDF), when administered once daily for three days in adults and children ? 5 kg body weight and ? 2 months of age suffering from uncomplicated P.Falciparum malaria (with or without other plasmodium spp. co-infection). In the Extension phase, the safety, tolerability and efficacy of repeated treatment with KLU156 will be assessed for a maximum of two years in patients who did not experience early treatment failure(ETF), who did not experience any study treatment-related SAE (Serious Adverse Event) previously and who gave informed consent to participate in the Extension phase.
 Tororo, Tororo
 Uganda 2024-05-29 9:37:35 2027-05-29 1500 male and female patients’ ≥ 5 kg body weight and ≥ 2 months of age will be randomized in the study Novartis Medical and Health Sciences Clinical Trial Non-degree Award
Jane Achan Edwin
ID: UNCST-2023-R005498
 Evaluation of the protective efficacy of a spatial repellent to reduce malaria prevalence in Uganda: Study protocol for a cluster-randomized double-blinded control trial: The Mossie-GO trial
REFNo: HS4196ES

The study’s primary objective is to demonstrate and quantify the protective efficacy (PE) of Mossie-GO, an active spatial repellent system disseminating transfluthrin, in reducing the prevalence of malaria infection in children ? 5 years of age.

The study’s secondary objective is to measure the impact of the intervention on entomological correlates of transmission including vector densities and host seeking behaviour. Insecticide resistance in the local mosquito population will also be explored.

Buikwe, N/A
Jinja, N/A
 Uganda 2024-05-23 14:23:11 2027-05-23 5600 The population will include children less than 5 years of age living in selected households in the selected villages. We will include children of both sexes and of all tribes in the selected villages. AFRICA POWER Medical and Health Sciences Clinical Trial Non-degree Award
Josephine Najjuma Nambi
ID: UNCST-2021-R013717
 Developing and testing a simulation-based intervention to improve stroke nursing care in Mbarara Regional Referral Hospital
REFNo: HS3535ES

6. Pilot test the simulation-based nursing intervention for feasibility, acceptability, functionality, quality of life, and preliminary health outcomes among stroke patients at MRRH. ,5. Develop a simulation-based stroke training packet/intervention for nurses to improve stroke care and management at Mbarara Regional Referral Hospital,4. Explore the barriers and facilitators for stroke management, and training among health care professionals at Mbarara Regional Referral Hospital ,The general objective of the study is to develop and pilot a simulation-based stroke intervention to improve stroke management at MRRH ,
 Mbarara, Kyamugorani
 Uganda 2024-05-07 13:49:58 2027-05-07 168 Age 18-100, Both male and Female and all tribes Self-sponsored Medical and Health Sciences Clinical Trial Degree Award
Jenny Löfgren
ID: UNCST-2024-R005428
 Simulation-based training for mesh inguinal hernia repair under local anaesthesia - a randomized trial
REFNo: HS4058ES

Assess the learning curve of mesh inguinal hernia repair for novice learners and how it is affected by simulation based training prior to supervised surgery on patients.
Soroti,
Mubende,
Iganga,
Sweden 2024-05-02 12:38:06 2027-05-02 440 Trainees: intern doctors with an interest in surgery and who are not already routinely performing inguinal hernia mesh repair Patients: Adult (18 years and above), otherwise healthy (ASA 1-2) men with primary, reducible, groin hernia Karolinska Institutet Medical and Health Sciences Clinical Trial Degree Award
Christopher Turyatunga Bernard
ID: UNCST-2023-R006842
 Drivers, profiling and drugs resistance effects, outcomes and cost-effectiveness of diagnostic and Syndromic interventions among urogenital discharging patients in southwestern Uganda
REFNo: HS3796ES

Establish the aetiology and sensitivity profile of urogenital discharges among patients in south western Uganda. ,5. Evaluate the Comparative cost effectiveness of diagnostic and Syndromic approaches in the management of patients with urogenital discharges in south western Uganda.,4. Compare the treatment outcomes between syndromic and diagnostic approaches in the management of patients with urogenital discharges in south western Uganda.,3. Determine the drivers of drugs resistance among patients with urogenital discharges in south western Uganda. ,2. Determine the effect of drugs’ resistance on the management of patients with urogenital discharges in south western Uganda.,This study is aimed at establishing the drivers, profiling and effect of drugs resistance, comparative treatment outcomes and cost-effectiveness of diagnostic and Syndromic interventions on patients with urogenital discharges in southwestern Uganda, and it is a parallel randomized intervention at STI clinics of Kabale and Mbarara Regional Referral Hospitals and Kisiizi Mission Hospital.,
 Uganda 2024-04-26 9:21:22 2027-04-26 476 Females and males Participants aged 15 to 60 years, with urethral and abnormal vaginal discharges void of HIV/AIDS, Diabetes Mellitus and pregnancy who have sought treatment more than once in the previous three months. MUST and STUDY Participants Medical and Health Sciences Clinical Trial 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. Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Social Science and Humanities Clinical Trial Non-degree Award
Patricia NAHIRYA Ntege Nahirya
ID: UNCST-2019-R001117
 Long-Term Follow-Up of CAB LA for Participants in HPTN 083 and HPTN 084 CAB PrEP Studies at Risk of HIV Acquisition.
REFNo: HS3876ES

Primary Objective
• To describe new HIV infections in adult and adolescent participants at risk of HIV acquisition included in the HPTN 084 studies and their associated sub-studies.

Secondary Objective
• To describe any serious adverse events (SAEs), Grade 3 and Grade 4 ISRs, and AEs leading to withdrawal in adult and adolescent participants included in the HPTN 084 studies and their associated sub-studies.


 Kampala, Mulago
 Uganda 2024-04-04 8:20:33 2027-04-04 146 Participants must be currently enrolled and ongoing in one of the following studies: • HPTN 083 • HPTN 084 • HPTN 083 and HPTN 084 adolescent and pregnancy sub-studies Participants who have permanently withdrawn from prior CAB PrEP studies cannot enroll into this study. 2. Evidence of continued benefit (HIV negative and at risk) from CAB LA during participation in the parent study/sub-study. 3. Participants must have a nonreactive HIV test at Screening (rapid test, antigen/antibody test and HIV-1 RNA from the parent study/sub-study) and Day 1 (a rapid test and HIV Immunoassay [Antigen/Antibody test]) Males and Females: All participants who are engaging in sexual activity should be counselled on safer sexual practices including the use and benefit/risk of effective barrier methods (e.g., male condom) and on the risk of acquiring HIV and other STIs. Females: Cisgender female participants who are of childbearing potential and who are engaging in sexual activity that could lead to pregnancy, must talk to the investigator about recommended contraception options (Section 11.1). Contraception will be optional in this study. Condoms are recommended in addition, because their appropriate use is the only contraception method effective for preventing HIV-1 transmission. Pregnant participants from the HPTN 084 study are eligible to enroll into this study f they meet all eligibility criteria ViiV Healthcare UK Limited Medical and Health Sciences Clinical Trial Non-degree Award
KANIKA  Jean-Claude MASSAMBA
ID:
effectiveness of vaginal misoprostol versus vaginal dinoprostone among pregnant women undergoing labor induction at Jinja regional Referral Hospital. (REC Approval: BSU-REC-2023-244)
REFNo: HS4007ES

To assess the Peripartum fetal complications as well as the maternal obstetrics outcomes in vaginal misoprostol group versus vaginal dinoprostone group at Jinja Referral Regional Teaching-Hospital maternity ward. ,The main goal of this study is to compare the effectiveness of vaginal misoprostol to vaginal dinoprostone and identify the feto-maternal complications in women undergoing labor induction at Jinja Referral Regional Teaching-maternity Hospital\'s unit.,
 Jinja, Jinja
 Democratic Republic of Congo 2024-03-28 18:36:47 2027-03-28 136 Pregnant women between 37 weeks + 0 day to 41 weeks + 6 days of gestation attending antenatal clinic at Jinja RRH and who have indications of labor induction and consent to participate in the study. Principal Investigator Medical and Health Sciences Clinical Trial Degree Award
Jonathan Izudi
ID: UNCST-2019-R000469
 Effectiveness of Multi-Month Dispensing of Anti-Tuberculosis Drugs (MULTI-DAT) Versus Standard of Care on Treatment Success Rate Among People with Drug Susceptible Tuberculosis in Rural Eastern Uganda
REFNo: HS3953ES

To evaluate the effectiveness of MULTI-DAT on cure and treatment success rates at 6 months of treatment compared to the standard of care (SOC) using an open-label, individually randomized controlled trial or RCT (Aim 2). ,To explore stakeholder perceptions regarding the relevance and appropriateness of MULTI-DAT, including the delivery of MULTI-DAT among people with drug-susceptible PTB aged ?15 years using a qualitative study (Aim 1).,Overall, the MORAD study will focus on the practicability and effectiveness of MULTI-DAT among people with drug-susceptible pulmonary TB (PTB) aged ?15 years on the standard 6-month anti-TB treatment regimen in eastern Uganda,
 Soroti, Soroti
Kumi, Kumi
Serere, Serere
Not Applicable (N/A), Soroti
 Uganda 2024-03-27 18:52:57 2027-03-27 66 stakeholders (Aim 1); 260 participants in a 1:1 ratio (Aim 2) Aim 1: i) TB focal persons with ≥1 year of work experience; other stakeholders with ≥3 years of work experience in TB; ii) People with TB on treatment for ≥4 months including the respective treatment supporters. Aim 2: People with drug-susceptible PTB ≥15 years. UC Berkeley Medical and Health Sciences Clinical Trial Non-degree Award
Ahmed Ddungu
ID: UNCST-2019-R000944
 CHARACTERIZATION OF TUBERCULOSIS ASSOCIATED LUNG FIBROSIS AND RESPIRATORY IMPAIRMENT, AND PREVENTION USING DOXYCYCLINE IN A DOUBLE BLIND RANDOMISED CONTROLLED TRIAL
REFNo: HS3385ES

To characterise/describe TB associated lung fibrosis and TB associated chronic respiratory impairment (where appropriate: burden and severity, radiological phenotype based on high resolution CT, clinical phenotype based on symptoms and lung function status, and predictors/ associations (including with selected biomarkers)); and to assess the efficacy of doxycycline as an adjuvant therapy to prevent TALF amongst patients with advanced TB
 Kampala, Mulago
 Uganda 2024-03-20 15:59:56 2027-03-20 0200 - Age of 18 – 65 years - sex : Male and Female - Tribe (Non discriminatory of tribe) - Index PTB episode (sputum smear positive or GeneXpert positive with rifampicin susceptibility) - Baseline Chest X-ray showing infiltrates in at least 2 lung zones (≥30% lung involvement) meeting criteria for moderate/advanced PTB - HIV uninfected (clinical trial ) - Subjects willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. - Able to give written informed consent. Makerere University Research and innovation Fund and Makerere University Lung Institute through the MAKNCD PROGRAM Medical and Health Sciences Clinical Trial Degree Award
Pontiano  Kaleebu
ID: UNCST-2020-R019901
 Field Performance Evaluation of the TrinScreen™ HIV rapid test kit
REFNo: HS3878ES

1. To describe the performance (sensitivity and specificity) of the TrinScreen™ rapid test, when compared to the national testing algorithm.

2. To describe the performance (sensitivity and specificity) of the TrinScreen™ rapid test compared to the reference testing (Genscreen ULTRA HIV1/2 Ag/Ab EIA followed by the Murex diasorin HIV1/2 Ag/Ab combination).


3. Estimate the proportion of inconclusive test results by Trinscreen™

Kampala, Naguru
Wakiso, kigongo
Gomba, mpigi
Kayunga, Kawolo
Mukono, Mukono
Mpigi, Nkozi
Wakiso, Mityana
Wakiso, wagagai
Kayunga, Kayunga
 Uganda 2024-03-14 12:38:09 2027-03-14 1550 - Adults above 18 years of age - Willing to have an HIV test. - Eligible for testing as per the National HIV testing service eligibility screening tool - Documented co Trinity Biotech Manufacturing Ltd Medical and Health Sciences Clinical Trial Non-degree Award
Kamoga Ronald
ID: UNCST-2019-R001524
 VAGUS NERVE STIMULATION IN A RAT MODEL OF ALZHEIMER’S DISEASE-LIKE SYMPTOMS: MORPHOLOGICAL, IMMUNOHISTOCHEMICAL, MOLECULAR AND BEHAVIORAL CHANGES
REFNo: HS3781ES

1. To conduct a scoping review of literature on vagus nerve stimulation in Alzheimer's-disease and related dementias.
2. To determine behavioral changes associated with vagus nerve stimulation in a rat model of Alzheimer-like symptoms.
3. To evaluate the morphological, Immunohistochemical and molecular changes in the Hippocampus, prefrontal cortex and medial temporal cortex associated with chronic stimulation of the vagus nerve in a rat model of Alzheimer’s-like disease.

 Mbarara, Medical cell
 Uganda 2024-02-26 13:43:22 2027-02-26 42 Wistar rats Wistar rats bewteen 3 months and 7 months old Self sponsorship Medical and Health Sciences Clinical Trial Degree Award
Sarah Lofgren
ID: UNCST-2019-R001647
 Supervised Treadmill intervention to Reduce Inflammation and Depression through Exercise in HIV: The STRIDE Pilot Study
REFNo: HS3358ES

The objective of this study is to determine the feasibility and acceptability of an aerobic intervention via a treadmill among individuals with HIV and depression in Uganda.
3.1 Primary Endpoint: Feasibility and acceptability of Exercise as a treatment for depression in Ugandans with HIV. This will be measured by:
-Percent completion of the prescribed aerobic exercise intervention, as assessed by research staff logging participation.

3.2 Secondary Endpoint(s)/ Outcome(s):
- acceptability of the intervention assessed via a post intervention survey
-feasibility and acceptability of using a wearable exercise tracker to assess the volume of exercise, based on calories burned and steps achieved, during the intervention period among Ugandans with HIV and depression.
- measure the mean and standard deviation of baseline and 8-week serum BDNF and IL-6 level to estimate an effect size and power a future study.
- measure the mean and standard deviation of baseline and 8-week depression score via PHQ-9 to estimate an effect size and power a future study.
- measure the mean and standard deviation in aerobic fitness baseline and at 8 weeks measured via METS/watts achieved and total time/distance to estimate the effect size for a future intervention.
Wakiso, Lweeza
 USA 2024-02-26 13:41:23 2027-02-26 24 • Enrolled in Mildmay HIV clinic • Adults 18-45 years old • HIV positive • Receiving HIV therapy • HIV viral suppression (<400 copies/mL) per chart review • Mild to Moderate (PHQ9 score >5 but >20) • Not currently engaged in a formal exercise program or manual labor such as construction or delivery requiring a manual bike or walking • Able to walk/run on a treadmill • Informed consent University of Minnesota, Makerere University Medical and Health Sciences Clinical Trial Non-degree Award
Julian Adong
ID: UNCST-2021-R013487
 Retention through mHealth for adolescents and young adults with HIV in care
REFNo: HS3722ES

Test the acceptability, feasibility, and preliminary impact of the developed adolescent-tailored mHealth intervention for retention in care of AYWH who are new to or newly re-engaging in care,Iteratively develop a social media-based adolescent-tailored mHealth intervention to improve retention in care for AYWH who are new or newly re-engaging in care,Define the cognitive, environmental, and behavioural challenges and their impact on behavioural intention for AYWH who are new or newly re-engaging in HIV care,To develop and test an mHealth intervention for retention in care for adolescents and young adults with HIV,
 Mbarara, kamukuzi
Mbarara, kamukuzi
 Uganda 2024-02-26 13:34:00 2027-02-26 105 We will enroll male and female adolescents and young adult participants with HIV aged 15-24. and health care workers aged 18 and above. National Institutes of Health/Fogarty International Center Medical and Health Sciences Clinical Trial Non-degree Award
Bruce Kirenga J
ID: UNCST-2019-R001460
 SOLIDARITY TRIAL-A phase I/II Randomized Placebo controlled trial to evaluate the Safety and Immunogenicity of Sudan Ebolavirus in Uganda
REFNo: HS3190ES

Phase I (rVSV-SUDV)
1. To determine the safety of rVSV-SUDV candidate SUDV vaccine among adult healthy volunteers in Uganda.
2. To determine the immunogenicity of rVSV-SUDV candidate SUDV vaccine.

Phase II (ChAdox1, CAd3 and rVSV-SUDV)
Primary objectives
1. To determine the safety of ChAdox1, CAd3 and rVSV-SUDV candidate SUDV vaccines among healthy volunteers and persons with stable comorbidities.
2. To determine the immunogenicity of ChAdox1, CAd3 and rVSV-SUDV candidate SUDV vaccines.
Secondary objectives
1. To determine the durability of SUDV-specific induced immune responses following vaccination.
2. To determine the factors associated with optimal vaccine-induced immune responses.
3. To determine the putative cross reactivity by the SUDV vaccine candidates against other ebolaviruses (e.g. Bundibugyo ebolavirus (BUDV) and EBOV).

Exploratory objectives
1. To determine the effect of SUDV vaccines on host gene expression.
2. To determine the T and B cell specific responses and immune profiling in response to vaccination.
3. To determine the effect of SUDV vaccines on the host metabolome.
4. To determine the effect of SUDV vaccines on host innate immune responses.

 Kabarole, Fort portal
Kampala, Mulago I
Kayunga, Kayunga
Mbarara, Rubindi
Wakiso, Nkumba
Mubende, Kikanddwa
Masaka, Kabonera
 Uganda 2024-02-26 13:31:25 2027-02-26 2121 participants will be recruited in phase II and phase I will recruit 250 participants healthy volunteers both male and females will be recruited in the study regardless of the ethnic group they belong to. The participants will recruit people aged 6-65 in to phase I and phase to World Health Organization and Ministry of Health Uganda Medical and Health Sciences Clinical Trial Non-degree Award
Betty Mwesigwa
ID: UNCST-2020-R014667
 Sabin 003: A Phase 2, Randomized, Double-blind, Placebo-Controlled Trial to Evaluate Safety, Tolerability, and Immune Responses of an Investigational Monovalent Chimpanzee Adenoviral-Vectored Sudan Ebolavirus Vaccine in Healthy Adults
REFNo: HS3628ES

To evaluate the safety and tolerability of cAd3-EBO S vaccine
 Kampala, Central
Kampala, Central
Kampala, Central
 Uganda 2024-02-13 17:35:43 2027-02-13 125 participants 18 to 70-year old healthy adults Sabin Vaccine Institute Medical and Health Sciences Clinical Trial Non-degree Award
Juliet Babirye Ndimwibo
ID:
TREAT INTERACT: Implementing a user involved education- and health system interactive task-shifting approach for child mental health promotion in Uganda
REFNo: HS3144ES

Based on findings from objectives 1-2, develop implementation advice to guide policymakers in school-based child and adolescent mental health (CAMH) management, integration with the health system, and how to implement and sustain large-scale evidence-informed CAMH interventions to contribute towards achieving universal mental health coverage. ,Develop, implement and evaluate an intersectoral supervision, referral and communication model between the health and education sector.,Implement the adapted module-based TREATment mhGAP school program and investigate effective implementation strategies and client outcomes.,Intervention mapping to adapt the mhGAP-IG to a primary school setting, and implementation mapping to develop implementation strategies with user involvement,The main objective of the TREAT INTERACT study is to adapt, implement and evaluate the impact of an adapted school version of the mhGAP-IG that aims to prevent, identify, refer and treat mental health problems in children and adolescents in Uganda through a user involved task-shifting implementation of the mhGAP-IG among primary school staff. This work is divided into 4 work Packages (WPs); each of the specific objectives below represents a single work package.,
 Mbale, Primary schools
 Uganda 2024-02-02 12:05:35 2027-02-02 612 teachers Teachers and pupils at primary schools Norwegian research Council Medical and Health Sciences Clinical Trial Non-degree Award
Harriet Ajilong
ID: UNCST-2022-R005889
 Assessing Vitamin D serum levels in HIV-positive adolescents 10-19 years with depression in Northern Uganda
REFNo: HS3454ES

To determine the burden of depression in HIV-positive adolescents at Gulu RRH,To assess for serum Vitamin D levels in HIV Positive adolescents 10-19 years with depressive symptoms in Gulu Regional Referral Hospital Methods,
 Gulu, Laroo
 Uganda 2024-01-24 22:30:43 2027-01-24 380 participants HIV Positive adolescents at Gulu Regional Referral Hospital Child Global Research Fellowship Medical and Health Sciences Clinical Trial Non-degree Award
Zubair Lukyamuzi
ID: UNCST-2021-R013107
 Feasibility and Acceptability of a Barbershop Based HIV Prevention Initiative Among Heterosexual Men in Kalangala Islands, Uganda: A Cluster Randomized Trial
REFNo: HS3430ES

1. To compare completion of self-initiated HIV testing between intervention and control groups
2. To evaluate the preliminary effectiveness of the intervention on change in behaviors associated with HIV acquisition
3. To compare interest in or use of HIV prevention services between intervention and control groups
4. To evaluate the preliminary effectiveness of the intervention on incident STIs
Kalangala, Bugala Island
 Uganda 2024-01-08 13:20:21 2027-01-08 up 250 the study population will be men aged at least 16 at risk of HIV in Kalangala Division of AIDS (DAIDS), United States (US) National Institute of Allergy and Infectious Diseases (NIAID), US National Institutes of Health (NIH) Medical and Health Sciences Clinical Trial Non-degree Award
Timothy  Muwonge Ronald
ID: UNCST-2020-R014680
 Achieving HIV viral suppression in refugee settlements in Uganda with Head StART: a cluster randomized trial evaluating the effectiveness of community ART delivery for people newly diagnosed with HIV
REFNo: HS2935ES

To estimate the programmatic cost and budget impact of implementing the Head StART intervention in refugee settlements in Uganda. ,To assess Head StART implementation across refugee settlement sites to understand the impact of contextual factors on study outcomes. ,To evaluate the effectiveness of “Head StART,” the expansion of community ART delivery to people newly diagnosed with HIV, in achieving HIV viral suppression in refugee settlements in Uganda. ,The primary objective of this research is to evaluate the effectiveness of expanding community ART delivery to clients newly diagnosed with HIV.,
 Uganda 2024-01-05 9:11:58 2027-01-05 1200 We will recruit adult persons living with HIV aged 18 and above and accessing care from health care centers in refugee camps in Uganda. National Institute of Health Medical and Health Sciences Clinical Trial Non-degree Award
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