Isaac Ssinabulya
ID: UNCST-2021-R004352
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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.
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Arua,
Lira,
Mbale,
Masaka,
Mbarara,
Kabarole,
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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 |
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Deo Wabwire Ogema
ID: UNCST-2021-R013932
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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.
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Kampala, Mulago
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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 |
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JOSAPHAT KAYOGOZA BYAMUGISHA
ID: UNCST-2019-R001680
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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. ,
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Kampala, Kawempe
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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 |
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Ezekiel Mupere
ID: UNCST-2024-R003962
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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.,
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Kampala, Mulago 1
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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 |
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Esther Buregyeya
ID: UNCST-2020-R014116
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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. ,
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Kampala, Bwaise
Kampala, Bwaise
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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 |
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