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NCT ID: NCT05693545 Not yet recruiting - Clinical trials for Rheumatic Heart Disease

GOALIE: Intramuscular vs. Enteral Penicillin Prophylaxis to Prevent Progression of Latent RHD Trial

Start date: February 1, 2023
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to determine if twice daily oral penicillin prophylaxis is non-inferior to monthly IM penicillin prophylaxis in preventing latent Rheumatic Heart Disease Progression in children between the ages of 5-17 years. The main objective is to compare the proportion of children aged 5-17 years with latent RHD receiving oral penicillin prophylaxis who progress to worse valvular disease at 2-years compared to children who receive IM penicillin prophylaxis.

NCT ID: NCT05689047 Not yet recruiting - Acute Malaria Clinical Trials

Phase IIa Proof of Concept Study of M5717-Pyronaridine in Adults and Adolescents With Acute Uncomplicated Plasmodium Falciparum Malaria (CAPTURE 1)

Start date: January 23, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetic of the combination M5717 plus pyronaridine in participants with acute uncomplicated Plasmodium falciparum malaria. Pyramax (Artesunate/Pyronaridine) will act as an internal control providing reference safety data and a benchmark for the efficacy evaluation.

NCT ID: NCT05688709 Recruiting - Clinical trials for HIV Disease Progression

Acceptability, Feasibility and Effectiveness of Online Peer Support Group for ART Adherence Among Youth

Start date: August 1, 2022
Phase: N/A
Study type: Interventional

In Uganda, Youth living with HIV/AIDS (YLHIVA) enrolled in HIV treatment experience suboptimal treatment adherence and have lower viral load suppression (VLS) rates compared to younger children or adults. VLS is essential in reducing AIDS related morbidity and mortality (1) yet AIDS-related deaths remain high among YLHIVA. To improve these poor outcomes, there has been an effort by Ministry of Health Uganda (MoH) to prioritize and scale up new adolescent and youth-targeted models of service delivery. "Peer support" increasingly forms part of adolescent and youth-responsive service packages as a class of implementation strategies that can support adolescents to access, engage, and sustain treatment. However, peer support activities in Uganda occur face to face at health care settings(2). This approach presents structural limitations such as the need to travel or schedule an appointment, inconvenient working hours and inadequate safe space for peer support activities. Thus, peer support services may not be readily available at the time when youth need them. With the rapid increase in mobile phone availability among Ugandan youth, online peer support groups (PSGs) have the potential to help YLHIVA access regular support without significant effort or cost. The rollout of online PSGs among YLHIVA in Uganda requires evidence on there acceptability feasibility and effectiveness. Aim: The aim of this study is to explore a WhatsApp peer support group as a strategy to improve ART adherence care among youth aged 15-24 years in Kampala district. Methods: The study will use a mixed methods approach. It will be conducted in two phases; first a formative phase to refine the aspects of the WhatsApp peer support group. These findings will then guide the design and implementation of the second phase; an RCT to assess the acceptability, feasibility and effectiveness of WhatsApp PSG as strategy to improve ART adherence among YLHIVA in Kampala. The RCT is a multicentre, open label assessor-blind, with balanced randomisation (1:1) parallel group superiority trial. Study participants randomized to the control arm will remain on the current standard of care only, while those in the intervention arm will be enrolled on a WhatsApp PSG and receive the current standard. Data will be collected using structured questionnaires, Key Informant Interviews, focus group discussions and in-depth interviews. Quantitative data will be analysed using summary statistics, logistic regression models, generalized linear models and Generalized Estimating Equations while for the qualitative verbatim transcription and thematic analysis will be used. Utility: The study findings will help to advance the knowledge on virtual support as a peer support model in Uganda.

NCT ID: NCT05685498 Recruiting - HIV Testing Clinical Trials

Peer-led HIV Self-testing Among Men in Two Ugandan Fishing Communities

PEST4MEN
Start date: July 18, 2022
Phase: N/A
Study type: Interventional

The goal of this observational study is to assess the feasibility and acceptability of a peer-led HIV self-testing intervention among men in two fishing communities along the shores of Lake Victoria in Uganda. The main objectives of the study are: a) to assess the feasibility of implementing a peer-led HIV self-testing intervention among men in a fishing community context; b) determine the uptake of HIV self-testing among men in the fishing communities, and c) determine linkage to and retention in HIV care among newly diagnosed HIV-positive men following peer-led HIV self-testing. Participants will: - Be administered a baseline questionnaire to assess prior HIV testing behaviors and willingness to self-test for HIV - Receive two HIV self-test kits, one for them and one for someone else that they prefer to give the kit, to determine HIV testing behaviors among men and their significant others - Be administered follow-up questionnaires at one (1), six (6) and 12 months post-baseline to determine linkage to and retention in HIV care among those testing HIV-positive, as well as linkage to appropriate HIV prevention services among those testing HIV-negative.

NCT ID: NCT05684081 Active, not recruiting - Polio Clinical Trials

Effect of Digital Payment to Campaign Health Workers on Vaccination Coverage

Start date: July 1, 2022
Phase: N/A
Study type: Interventional

Introduction: Good quality OPV campaigns can interrupt and possibly prevent transmission of the polio virus. Health care worker performance and motivation are prerequisites for the success of such campaigns. Complete, transparent and timely payments are, in turn, prerequisites for the sustenance of health care worker motivation and thereby efforts. To date, most such health care workers have been paid in cash, with chronic payment issues that have negatively affected campaign quality and vaccination coverage. Cash-based payments are often plagued with multiple delays in funds disbursements, cash leakages, and a lack of accountability and financial transparency. These difficulties have prompted a transition to digitized payments that are perceived to be faster, more convenient, traceable, reliable, easier and more reasonable to set up. The roll-out phase of these digital payment interventions has not been quantitatively evaluated and the effect of digital payments on the motivation, satisfaction and performance of health workers is not known. Therefore, this study will compare digitized payment of polio vaccination campaign health care workers with cash-based payment with regards to health care worker motivation, satisfaction and performance. Findings from this study may inform the operationalization of digital financial systems, and the transition towards cross-campaign digital payments. Primary Objectives: 1. To compare the motivation, satisfaction and performance of vaccination health care workers in areas where they are paid using mobile money versus in cash, 2. To explore how gender norms and relations influence health workers' response to payment systems (mobile money versus cash payments) and how these affect the health workers' performance and motivation in polio vaccination campaigns and Secondary objectives: 1. To compare vaccination campaign quality in areas where health care workers are paid using mobile money versus in cash 2. To compare vaccination coverage in areas where campaign health care workers are paid using mobile money versus in cash. 3. To estimate the incremental cost of the intervention. Methods: This will be a mixed methods study including a cluster-randomized controlled implementation trial and a qualitative study. A total of 60 districts be randomized to implement either a digital payment system for polio campaign vaccinators during the polio campaign or the traditional cash-based payment system.

NCT ID: NCT05668611 Not yet recruiting - Clinical trials for Rheumatic Heart Disease

Train the Trainer Curriculum to Scale up AI Supported Echo for RHD Screening in a Public Health System

ADD-RHD 2B
Start date: January 3, 2023
Phase: N/A
Study type: Interventional

The first primary objective of this study is to determine the diagnostic performance (sensitivity and specificity) of primary MOH nurses who have completed certification in focused echocardiography acquisition and interpretation by expert trainers to accurately identify patients who are screen positive and screen negative for rheumatic heart disease. The second primary objective is to determine the diagnostic performance (sensitivity and specificity) of secondary MOH nurses who have completed certification in focused echocardiography acquisition and interpretation by MOH nurse trainers to accurately identify patients who are screen positive and screen negative for rheumatic heart disease.

NCT ID: NCT05662098 Recruiting - Sickle Cell Disease Clinical Trials

Alternative Dosing And Prevention of Transfusions (ADAPT)

Start date: June 16, 2022
Phase: Early Phase 1
Study type: Interventional

ADAPT is a prospective cohort study at Jinja Regional Referral Hospital (JRRH) primarily to assess the effect of hydroxyurea on blood transfusion utilization and secondarily to determine the feasibility of PK-guided hydroxyurea dosing.

NCT ID: NCT05660980 Not yet recruiting - HIV-1-infection Clinical Trials

Study of Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in Virologically Suppressed Children Living With HIV-1, Two to Less Than 12 Years of Age

Start date: May 1, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of the study is to evaluate the pharmacokinetics (PK), safety, tolerability, and acceptability of a long-acting injectable Cabotegravir and Rilpivirine in Virologically Suppressed Children Living with HIV-1, Two to Less Than 12 Years of Age

NCT ID: NCT05656287 Recruiting - Tuberculosis Clinical Trials

My Mobile Wallet: An Intervention for Tuberculosis Medication Adherence in Rural Uganda

M_wallet
Start date: April 14, 2022
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to develop My Mobile Wallet- a behavioral and economic intervention to support tuberculosis treatment adherence in rural southwestern Uganda. The main question[s] it aims to answer are: • Determine the optimal design and develop My Mobile Wallet as an intervention to support tuberculosis medication adherence • Assess the initial feasibility and acceptability of using My Mobile Wallet to support tuberculosis medication. Participants will use My Mobile Wallet intervention for a period of six months. Researchers will compare My Mobile Wallet intervention versus standard care to see if there is an impact on tuberculosis medication adherence.

NCT ID: NCT05640648 Enrolling by invitation - Tuberculosis Clinical Trials

Human-centered Design and Communities of Practice to Improve Delivery of Home-based Tuberculosis Contact Investigation in Uganda

HCD CoP
Start date: March 7, 2022
Phase: N/A
Study type: Interventional

In a previous randomized control trial, the investigators identified gaps in the implementation of tuberculosis (TB) contact investigation at multiple levels of the service delivery cascade. Drawing on prior experiences, the investigators have recently developed a novel strategy to enhance the implementation of routine contact investigation procedures. This user-centered implementation strategy was created through serial prototyping guided by human-centered design (HCD) and employs communities of practice (CoP) as an adjunctive adaptation and sustainment strategy. The investigators are now conducting a stepped-wedge, cluster-randomized implementation trial in 12 study sites in Uganda to determine if the resulting user-centered implementation strategy enhances the delivery of TB contact investigation and other implementation outcomes, and also improves health outcomes.