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NCT ID: NCT06285110 Recruiting - Hiv Clinical Trials

HIV-1 Subtype-specific Drug Resistance in Patients Failing Dolutegravir (DTG) Based Regimen

DTG-Resist
Start date: June 13, 2022
Phase:
Study type: Observational

This is a prospective observational study enrolling People Living with HIV (PLHIV) who are on a Dolutegravir-based AntiRetroviral Treatment (ART) regimen and experiencing virologic failure. Virologic failure is defined as two consecutive viral load measurements of >1000 copies/mL of blood. The main aim of the study is to identify the drug-resistance mutations in the viral genome that are associated with this failure. To achieve this goal, patients fulfilling the eligibility criteria will be invited for a single study visit for the collection of blood. The extracted HIV virus will be sequenced through whole genome sequencing methods to identify the drug-resistance mutations. The study is conducted in 15-20 countries within six regions of the IeDEA cohort (International epidemiology Databases to Evaluate AIDS).

NCT ID: NCT06279962 Completed - Mental Illness Clinical Trials

Survey Experiment to Estimate Level of Mental Illness Stigma Based on Condition and Gender

Start date: June 15, 2023
Phase: N/A
Study type: Interventional

This study aims to measure levels of mental illness stigma based on condition and gender of the participants and individual portrayed with mental illness.

NCT ID: NCT06270160 Recruiting - Social Skills Clinical Trials

Livelihoods Intervention With Urban Refugee Youth in Kampala, Uganda

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

Displaced and refugee youth in Uganda are more vulnerable to health risks due to financial insecurity. As such, the investigators aim to explore the utility of an intervention aimed at improving livelihoods, called Creating Futures. Creating Futures is a group intervention that aims to help young people build their livelihoods, and was designed for use with youth (18-24) in urban informal settlements in South Africa. Since there is a dearth of knowledge regarding efficacious interventions in refugee camps/settlements to engage young people in HIV testing and linkage to care, the investigators will harness various health promotion techniques including mHealth, comics, and the Creating Futures livelihoods intervention to address the urgent needs for: 1) HIV testing interventions with refugee/displaced adolescent and young people in Kampala, and 2) innovative HIV self test (HIVST) delivery strategies to increase linkage to confirmatory testing and HIV care. The investigators will conduct a three-arm cluster randomized controlled trial (cRCT) to evaluate the effectiveness of HIVST delivery methods among AYP living in Kampala. The specific objectives are to: Evaluate the feasibility and effectiveness of: 1) HIVST alone; 2) HIVST in combination with mHealth; and 3) HIVST, mHealth and Creating Futures in combination in increasing routine HIV testing, HIV status knowledge, and linkage to confirmatory testing and HIV care. The investigators aim to examine if adding a livelihoods program to HIV self-testing improves HIV prevention outcomes and other facets of well-being among urban refugee youth in Kampala.

NCT ID: NCT06253715 Not yet recruiting - Tuberculosis Clinical Trials

Shortened Regimen for Drug-susceptible TB in Children

SMILE-TB
Start date: September 30, 2024
Phase: Phase 3
Study type: Interventional

While drug-susceptible tuberculosis (TB) disease in children currently requires four to six months of treatment, most children may be able to be cured with a shorter treatment of more powerful drugs. Shorter treatment may be easier for children to tolerate and finish as well as ease caregiver strain from managing treatment side effects and supporting children over many months. The primary objective of this study is to evaluate if a 2-month regimen (including isoniazid (H), rifapentine (P), pyrazinamide (Z) and moxifloxacin (M)) is as safe and effective as a 4- to 6-month regimen (isoniazid, rifampicin (R), pyrazinamide, ethambutol (E)) in curing drug-susceptible TB disease in children under 10 years old. The study is also evaluating the safety of the HPZM in children with and without HIV.

NCT ID: NCT06237439 Recruiting - Depressive Symptoms Clinical Trials

Sharing HaRT in New Expanses

SHiNE
Start date: August 21, 2023
Phase: N/A
Study type: Interventional

The goal of this parallel cluster randomized control (CRT) trial is to evaluate a group-based mind-body intervention (Move with HaRT) in survivors of human trafficking. The main study aims are: 1. Determine effectiveness of the Move with HaRT intervention on PTSD, depression, and anxiety symptoms among survivors of human trafficking in Uganda 2. Explore participant characteristics (e.g., age, trafficking history, food security) that may moderate the intervention effectiveness. 3. Understand potential barriers and facilitators to future implementation and scale-up. Participants will complete: - Complete three surveys (baseline, endline, and 3 month follow-up) - Participate in either Services as Usual or Move with HaRT groups - Qualitative in-depth interviews Researchers will compare Move with HaRT with Services as Usual to see effects on mental health symptoms.

NCT ID: NCT06212570 Not yet recruiting - Abdominal Neoplasm Clinical Trials

KeyScope Study in Uganda

Start date: January 1, 2025
Phase: N/A
Study type: Interventional

KeyScope and KeyLoop (collectively called KeySuite) are laparoscopic prototypes that the investigators have designed for the resources, needs and challenges of low- and middle- income countries (LMICs). KeyScope is a laparoscope that plugs into a laptop computer to display images during surgery. It links to a telementoring application so that experienced surgeons can mentor surgeons in capacity-building partnerships. KeyLoop is a laparoscopic retractor that lifts the abdominal wall during surgery, obviating the need for a constant power supply and medical-grade carbon dioxide. The investigators will perform a clinical First-in-Human study at the Uganda Cancer Institute. Ugandan surgeons will use the KeySuite devices to perform biopsies of intra-abdominal tumors.

NCT ID: NCT06205056 Not yet recruiting - Clinical trials for Human Immunodeficiency Virus

Evaluation of Safety and Immunogenicity of Ad26.Mos4.HIV and CH505 TF chTrimer Combination in Healthy Adults

RV591
Start date: January 2024
Phase: Phase 1
Study type: Interventional

This is a Phase I, randomized, double-blind, placebo-controlled clinical study to define the safety and immunogenicity resulting from a rapid dose-escalating vaccination schedule as compared to that of a co-administered, dose-consistent vaccination schedule. Participants randomized to receive vaccines will get either dose-consistent injections of CH505 TF chTrimer+ALFQ co-administered with Ad26.Mos4.HIV or rapid, dose-escalating injections of CH505 TF chTrimer+ALFQ with an Ad26.Mos4.HIV prime, followed by dose-consistent injection of CH505 TF chTrimer+ALFQ co-administered with Ad26.Mos4.HIV

NCT ID: NCT06192160 Not yet recruiting - Clinical trials for Pulmonary Tuberculosis

Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis

RAD-TB
Start date: April 15, 2024
Phase: Phase 2
Study type: Interventional

A5409/RAD-TB is an adaptive Phase 2 randomized, controlled, open-label, dose-ranging, platform protocol to evaluate the safety and efficacy of multidrug regimens for the treatment of adults with drug-susceptible pulmonary tuberculosis (TB). A5409 hypothesizes that novel regimens for the treatment of pulmonary tuberculosis will result in superior early efficacy, as determined by longitudinal mycobacteria growth indicator tube (MGIT) liquid culture time to positivity (TTP) measurements over the first 6 weeks of treatment, and will have acceptable safety and tolerability over 8 weeks of treatment relative to standard of care [(SOC) isoniazid/rifampicin/pyrazinamide/ethambutol (HRZE)]. The study will run for 52 weeks, inclusive of 26 weeks of TB treatment comprised of 8 weeks of experimental or SOC treatment (based on treatment arm assignment) followed by 18 weeks of SOC treatment with 45 participants in each experimental treatment arm and at least 90 participants in the SOC arm.

NCT ID: NCT06171217 Recruiting - Sickle Cell Disease Clinical Trials

Realizing Effectiveness Across Continents With Hydroxyurea

REACH
Start date: October 27, 2023
Phase: Phase 2
Study type: Interventional

REACH is a prospective, phase I/II open-label dose escalation trial of hydroxyurea for children with confirmed SCA between 3 and 10 years of age. The short-term goal is to obtain critical pilot data regarding the feasibility, safety, and benefit of hydroxyurea for children with SCA in multiple distinct research settings in Africa. Based on that information, the longer-term goal is to make hydroxyurea more widely available for children with SCA in Africa, particularly those identified with SCA through expanded newborn screening programs.

NCT ID: NCT06169514 Not yet recruiting - Pneumonia Clinical Trials

Health Systems and Policy Contexts of Medical Oxygen

MOXY-HSP
Start date: July 2024
Phase:
Study type: Observational

This is a mixed-methods program evaluation from a health systems and policy perspective, involving (i) stakeholder analysis, (ii) policy-implementation gap analysis, and (iii) comparative country case studies. This study aims to understand how national oxygen strategies achieve impact at national, and subnational level, across country contexts, at what cost. The the investigators seek to: 1. Involve policymakers, implementers (including private sector), and medical oxygen users in identifying challenges and understanding potential solutions to medical oxygen access; 2. Generate new data on how medical oxygen systems work and can be improved from multiple perspectives; 3. Draw lessons on medical oxygen that can directly inform national and global practice and policy. This study will be conducted in 6 of the 9 countries participating in the Clinton Health Access Initiative (CHAI) led Medical Oxygen Implementation (MOXY) program (Uganda, Nigeria, Rwanda, Liberia, Lao PDR, Cambodia). Key informants will be selected representing government, non-governmental agencies, professional associations, private sector, and civil society. This study will be completed over 4 years, with timelines varying between country study sites.