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  
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
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