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NCT ID: NCT06087159 Not yet recruiting - Depression, Anxiety Clinical Trials

Promoting Mental Health of Teachers and Caregiver Using a Personalized mHealth Toolkit in Uganda

Start date: August 1, 2024
Phase: N/A
Study type: Interventional

This is a randomized controlled trial with 8 schools (4 intervention and 4 wait-list control schools) including 160 caregivers (80 teachers and 80 parents), with the aim of pilot testing the implementation process, feasibility, acceptability, usage patterns, and efficacy of the mHealth Toolkit for Wellness & Empowering Lives of School Community (mWEL) in Uganda. The mWEL-App is a preventive intervention tool for teachers and parents as a self-help support modality. Caregivers who need support in navigating the toolkit will be supported by P-CHWs. The investigators hypothesize that: 1) relative to the control, caregivers receiving the mWEL will have better efficacy outcomes (mental health literacy, and mental health outcomes); and 2) mWEL implementation will have high acceptability, appropriateness, and feasibility.

NCT ID: NCT06036602 Not yet recruiting - Clinical trials for Ebola Sudan Virus Disease

Monovalent Chimpanzee Adenoviral-Vectored Sudan Ebolavirus Vaccine in Healthy Adults

Start date: February 2024
Phase: Phase 2
Study type: Interventional

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

NCT ID: NCT06036238 Not yet recruiting - HIV/AIDS Clinical Trials

The Outreach and Prevention at ALcohol Venues in East Africa Study (OPAL-East Africa- Aim 2) (OPAL-Aim 2)

OPAL-Aim 2
Start date: May 2024
Phase: N/A
Study type: Interventional

This study will evaluate the effect of a brief alcohol counseling intervention on PrEP and PEP adherence among adults with heavy alcohol use at high risk for HIV, while gaining insights into the facilitators, barriers, and cost-effectiveness of this approach.

NCT ID: NCT05955937 Not yet recruiting - Heart Failure Clinical Trials

ImpleMEntation of a Digital-first Care deLiverY Model for Heart Failure in Uganda

MEDLY Uganda
Start date: August 2024
Phase: N/A
Study type: Interventional

This is a stepped wedge, cluster-randomized study, that will implement a digital-first, multi-component strategy for Heart Failure (HF) to improve HF self-care at 6 Regional Referral Hospital (RRH) outpatient departments in Uganda. The investigators will evaluate both implementation and clinical outcomes using mixed methods. . First, investigators will assess the implementation and clinical effectiveness of an enhanced standard-of-care clinical bundle, and a digital health intervention to improve HF self-care in Uganda (Aim 1). To do this, the investigators will conduct a stepped-wedge, cluster randomized trial that includes a brief control period followed by a clinical care service bundle for HF (Core HF), followed by the introduction of the digital health application (Medly Uganda). The co-primary outcomes will be the Self-Care of HF Index (implementation) and the composite of mortality and HF hospitalization (clinical effectiveness). To ensure standardized basic HF care which will augment self-care, investigators will train providers in an evidence-based HF clinical care service bundle (Core HF) including a care protocol (treatment algorithm for HF), self-care training for patients and providers, and medication stock management prior to the introduction of the digital health intervention (Medly Uganda). Medly Uganda will utilize a patient-facing mobile health application designed to improve self-care among patients with HF. Its principal components are: 1) a patient-facing mobile application that processes patient-reported symptoms and generates algorithm-driven messages to guide self-care and symptom management and 2) a clinician-facing internet dashboard that monitors symptom reports and facilitates nurse-guided management recommendations and physician backup support. The project supports an integrated, digital interface at participating hospitals to monitor and intervene with patients using the mobile health application.

NCT ID: NCT05917210 Not yet recruiting - HIV Clinical Trials

Peer-led Implementation of TB-HIV Education and Adherence Counseling in Uganda

TEACH
Start date: September 2024
Phase: N/A
Study type: Interventional

This cluster-randomized trial in Uganda will 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.

NCT ID: NCT05848973 Not yet recruiting - Depression Clinical Trials

NutriMind: A Combination of Healthy Diet and Psychotherapy to Treat Depression

NutriMind
Start date: September 1, 2023
Phase: N/A
Study type: Interventional

University students in Low- and Middle-Income Countries (LMIC) continue to face growing rates of depression, a common mental health problem. Adding to this burden is the mental health treatment gap, necessitating the need to identify new treatment methods that can easily be implemented at a large scale. This project will test if a healthy diet combined with mindfulness-based cognitive therapy can reduce depressive symptoms among university students in Uganda, a low resource country. The burden of depression is high in sub-Saharan African countries, largely worsened by poverty, hunger and poor public health service, and lately the COVID-19 pandemic. These factors increase psychological distress among young people in sensitive periods of life, such as students who are about to choose their career and establish family. Successfully managing depression in LMIC is likely to depend on low-cost treatment that can easily be managed to large target populations, yet still be at the scientific forefront, proof-based, and culturally acceptable. This can possibly be obtained with an intervention combining healthy diet and cognitive behavioral therapy based on mindfulness principles. While healthy diets and mindfulness cognitive therapy individually can partly lessen the burden of depression, these two therapeutic modalities have not been tested in combination among university students in sub-Saharan Africa, i.e. a synergistic effect that is still to be studied. With the NutriMind Trial, its investigators focus on a neglected global mental health challenge, namely depression among university students in Uganda.

NCT ID: NCT05797662 Not yet recruiting - Kaposi Sarcoma Clinical Trials

A Study of Propranolol to Treat Kaposi Sarcoma

Start date: July 1, 2025
Phase: Phase 2
Study type: Interventional

A clinical study of propranolol for the treatment of Kaposi Sarcoma in children and adults. This study will be an open-label single armed treatment trial that will test the effectiveness and the safety of treating Kaposi Sarcoma with propranolol.

NCT ID: NCT05771519 Not yet recruiting - HIV Infections Clinical Trials

Developing an HIV Disclosure Intervention for Men in Uganda

DASH
Start date: May 2025
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to test an HIV disclosure intervention that the investigators are developing focused on men living with HIV in Uganda. The main questions the investigators are trying to answer is whether the HIV disclosure intervention the investigators develop will help men who receive this intervention to disclose their HIV status to a greater extent than men who receive standard care. Participants assigned to the intervention group will likely participate in the following: - Sexual health education - Cognitive behavioral therapy strategies - Problem-solving skills building - Motivational interviewing - Developing a personalized HIV disclosure plan - Communication skills building - Role-playing disclosure strategies

NCT ID: NCT05407883 Not yet recruiting - Clinical trials for Driver Yield to Pedestrians

Effectiveness of School Traffic Warden Programme on Road User Behaviour

Traward
Start date: June 6, 2022
Phase: N/A
Study type: Interventional

Hypothesis: Crossing roads at points that lack traffic control measures increase the risk of pedestrian motor vehicle collisions. Therefore, implementing a low cost traffic warden programme at school crossing points reduce the risk of pedestrian road traffic crashes. Objective: The investigators aim to determine the effectiveness of a school traffic warden programme on road user behaviour at primary school crossings in Kampala Uganda

NCT ID: NCT05343546 Not yet recruiting - Misoprostol Clinical Trials

Ideal Timing of Intrauterine Contraception Insertion After Medical Management of First Trimester Incomplete Abortion

PAIC
Start date: June 2022
Phase: N/A
Study type: Interventional

Background: Unintended pregnancies continue to cause a public health threat in Low and Middle Income countries yet with restrictive abortion laws. Over 40% of these unintended pregnancies end up as unsafe abortions leading to significant maternal morbidity and mortality. With ovulation occurring between 5-10 days after first trimester abortion, 47% of the women conceive shortly afterwards yet nearly 50% of the women never return for follow up. This study seeks to investigate effectiveness of early insertion of Intrauterine contraception (IUC) (within one week after medical Post abortion care (mPAC)) compared to Standard IUC insertion (between 2-4 weeks post PAC), in Uganda with the ultimate aim of increasing the uptake of IUC post 1st trimester medical management of incomplete abortion. Hypothesis: Null hypothesis: Early Insertion of IUC has higher expulsion rates and continued use than standard insertion after medical management among women with first trimester incomplete abortion at six months within a non-inferiority margin of 7.5%. Alternate hypothesis: Early Insertion of IUC has similar expulsion rates and continued use as standard insertion after medical management among women with first trimester incomplete abortion at six months within a non-inferiority margin of 7.5%. Methods: A Non-inferiority RCT of 2,076 participants will be conducted in 15 health facilities within Central Uganda. Baseline participant characteristics will be analyzed using descriptive statistics. For continuous variables, statistical tests such as Fisher's exact test, t-test, ANOVA and Wilcoxon-Mann-Whitney test will be used as appropriate. Binary logistic regression model will be used for factors associated with the dependent variable uptake of intrauterine contraception with p-value set <0.05 as level of significance. Intention to treat and per protocol analysis will be used for the RCTs. Study utility: A greater proportion of women undergoing medical post abortion care for incomplete abortion will receive their intended post abortion IUC within the first days after the PAC treatment compared with routine insertion at a scheduled follow up visit 2-4 weeks later. Though there could be higher expulsion rates in the early versus the standard IUC insertion, continued use at 6 months following abortion will be higher in the early insertion group as compared to the standard insertion group thereby reducing unplanned and unwanted pregnancy.