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NCT ID: NCT06037876 Completed - Trichuriasis Clinical Trials

Efficacy of Ivermectin-albendazole vs Albendazole Alone in School-aged Children Infected With Trichuris Trichiura

FACEITeffic
Start date: October 9, 2023
Phase: Phase 3
Study type: Interventional

The goal of this parallel open-label randomized controlled superiority trial is to demonstrate that co-administered ivermectin (200 µg/kg) plus albendazole (400 mg) is superior to albendazole (400 mg) monotherapy in terms of cure rates against Trichuris trichiura infections assessed by Kato-Katz at 14-21 days post-treatment in individuals aged 6-12 years. The main questions it aims to answer are: - Is single oral dose combined ivermectin-albendazole superior to albendazole alone in terms of cure rates and egg reduction rates against T. trichiura infections in children aged 6-12 years in Uganda? - Is single oral dose combined ivermectin-albendazole superior to albendazole alone in terms of cure rates and egg reduction rates against co-infecting soil-transmitted helminth infections such as Ascaris lumbricoides and hookworm in children aged 6-12 years in Uganda? - Is single oral dose combined ivermectin-albendazole as tolerable and safe as albendazole monotherapy in children aged 6-12 years in Uganda? Participants will be asked to provide two stool samples at baseline that will be subjected to microscopic analysis using the Kato-Katz thick smear technique for detection of soil-transmitted helminth eggs. T. trichiura-infected participants will be: - clinically examined for general health, anthropometric parameters including height and weight as well as temperature - randomly assigned to either receive one single oral dose of combined ivermectin and albendazole or albendazole monotherapy - checked for any potential adverse events and will undergo a brief questionnaire on specific symptoms 3h after drug administration - asked to provide another two stool samples to be microscopically examined for helminth eggs 14-21 days post-treatment Researchers will compare individuals treated with ivermectin-albendazole and albendazole alone to see if the proportion of T. trichiura egg-negative individuals and/or reduction in egg counts differs between these two groups 14-21 days after treatment.

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: NCT06000059 Recruiting - Mental Health Issue Clinical Trials

Mental Health Stigma in Rural Uganda

Start date: August 10, 2023
Phase: N/A
Study type: Interventional

The investigators aim to elucidate attitudes and stigma towards mental illness in the pathways to mental healthcare among key stakeholders, such as traditional healers, religious leaders, families of those with mental illness, and those with mental illness. Investigators also will measure the levels of stigma expressed by members of the general community based on gender of the individual with mental illness and the specific mental health condition. Additionally, the investigators hope to convert the previously conducted theater intervention to a radio production, which is the most commonly used form of media in Uganda, and test its effectiveness for changing attitudes and reducing stigma towards mental illness throughout society.

NCT ID: NCT05994495 Recruiting - Clinical trials for Sexually Transmitted Diseases

Utility and Acceptability of a Molecular Test in the Management of Sexually Transmitted Diseases in Uganda

ASTRHA
Start date: January 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to assess utility and acceptability of a molecular test in comparison with clinical syndromic approach in the management of sexually transmitted diseases (STD) at STD clinic of Mulago National Referral Hospital in Uganda. The main questions it aims to answer are: - Does new molecular test improve appropriateness of therapy compared with the clinical syndromic approach without or with limited laboratory tests in the management of STDs? - Are new molecular tests both clinically useful and acceptable in a Low-Middle Income Country for the management of STDs? Participants will be put into two groups ("A" or "B"): - Participants in group "A" will have a pus swab collected from urethra or vagina or a urine sample. After the result of the test, patients will be prescribed a specific drug. - Participants in group "B" will have a pus swab collected from urethra or vagina or a urine sample, but participants in group "B" and their doctor will not know the results of the test. So, participants in group "B" will be given treatment in the standard way, according to the current clinical practice.

NCT ID: NCT05989802 Recruiting - Tuberculosis Clinical Trials

Rapid Research in Diagnostics Development for TB Network (R2D2 Kids) and Assessing Diagnostics At POC for TB in Children (ADAPT for Kids)

Start date: January 26, 2024
Phase: N/A
Study type: Interventional

Every year there are an estimated 230,000 childhood deaths from TB. There is an urgent need for novel tests for TB diagnosis in children under 15 years. The Rapid Research in Diagnostics Development for TB Network (R2D2 Kids) and the Assessing Diagnostics at Point-of-care for Tuberculosis in children (ADAPT for Kids) studies seek to reduce the burden of TB worldwide by evaluating faster, simpler, and less expensive TB triage and diagnostic tests for use in children.

NCT ID: NCT05965245 Recruiting - Depression Clinical Trials

Suubi-Mhealth: A Mobile Health Intervention to Address Depression Among Youth

Start date: November 23, 2022
Phase: N/A
Study type: Interventional

The overall goal of this study is to develop an mHealth intervention (Suubi-Mhealth) for use among Ugandan youth (14-17 years) with comorbid HIV and depression, taking into account their unique contextual, cultural, and developmental needs. This digital therapy intervention delivered via a mobile application, will utilize the core tenets of cognitive-behavioral therapy (CBT) found to improve depression and ART adherence.

NCT ID: NCT05964842 Recruiting - Tuberculosis Clinical Trials

Using SMS Reminders, Phone Calls and Money Incentives to Enhance Linkage to Care of Presumptive TB Patients in Uganda

MILEAGE4TB
Start date: August 14, 2023
Phase: N/A
Study type: Interventional

The major challenge in meeting the WHO's End TB Strategy- reducing tuberculosis (TB) deaths by 90% and incidence by 80% is the cascading patient loss-to-follow-up (LTFU) along the continuum of TB care. A systematic review found high levels of pre-treatment LTFU-ranging from 4 to 38%, and was higher in sub-Saharan Africa (18%) compared to Asia (13%). Consequences of pre-diagnosis and pre-treatment LTFU are; untreated TB patients are infectious and can transmit TB to others and not starting TB treatment at all, causes high morbidity and mortality. Therefore, monitoring outcomes of presumptive TB patients is equally important as monitoring treatment outcomes. Short message service (SMS), phone calls and mobile money (MM) incentives have shown promise by improving health outcomes such as uptake of immunization, adherence to TB treatment and antiretroviral therapy (ART). However, there is limited knowledge their effect in increasing linkage to care and treatment for presumptive TB patients in Uganda and sub-Saharan Africa. The aim of this study is therefore to leverage SMS reminders, phone call and MM incentives in improving linkage to care of presumptive TB patients. This will be a five arm multi-center individual randomized controlled trial implemented in selected high-volume health facilities in Uganda among 1548 presumptive TB patients. The study population will be presumptive TB patients aged 18 years and above identified within the study facilities who do not complete TB diagnosis same day. Completion of TB diagnosis will refer to submitting a sample and obtaining results from the test. Our hypothesis is that using SMS reminders, phone call and Mobile Money incentives will result in increase in the proportion of presumptive TB patients that complete diagnosis and pre-treatment TB cases that initiate treatment.

NCT ID: NCT05958225 Recruiting - Stress Clinical Trials

SEE Change Evaluation - Impacts of Personal Agency Training on Ugandan Entrepreneurs

SEE-Change
Start date: September 19, 2023
Phase: N/A
Study type: Interventional

This study is proposed as an individually randomized control trial (RCT) designed to assess the short-term impacts (follow up at six months) of a personal agency training on a range of economic and health outcomes for micro and small entrepreneurs in Western and Central Uganda. Participants will be randomly selected and assigned to either the intervention group (n=400) or wait-listed control group (n=400). The intervention will include the standard Empowered Entrepreneur training curriculum which includes personal agency alongside basic business training that has been developed by the SEE Change team. This training will take place over three consecutive days (approximately 25 hours of content).

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.