HIV Clinical Trial - Standing Tall (Yima Nkqo)

Status Active, not recruiting

Clinical Trial Summary

The investigators propose the Standing Tall study, a prospective randomised study of strategy to optimize community-based ART initiation in South Africa. Investigators will work closely with community members to integrate community-based ART. One hundred participants will be enrolled and followed for a total of up to 6 months. Those in the intervention arm will be provided with the ST intervention which includes a behavioral component and access to ART. The intervention will be linked to a clinic through a "Nurse Initiated Management of ART."

Clinical Trial Description

The premise for our study is based on three decades of HIV research that supports the need for multi-component, multisystem interventions to promote testing, and adherence to treatment and care for young people living with HIV. The proposed intervention, Standing Tall, is informed and guided by Social Action Theory - a conceptual framework reflecting a holistic understanding of health behavior and motivational factors that foster and maintain behavior change. Standing Tall, a pilot randomized controlled trial, is designed to address multi-factorial barriers using (1) a socio-behavioral group intervention; (2) social support; (3) provision of immediate ART and refills. The primary outcome is ART initiation at three months, and the secondary outcome is viral load suppression at six months. Other tertiary/exploratory outcomes include behavioral outcomes and process evaluation of the intervention itself, and the use of point-of-care diagnostics. The administrative supplemental funding provides support for an additional objective of this study: to understand how best to use point-of-care (POC) testing in clinical practice in order to improve HIV care and treatment for South African young people. Understanding patient perspectives and perceived barriers is critical to developing feasible, acceptable, and effective protocols for implementing POC testing. The primary aim for achieving this objective is to assess patient perspectives regarding POC testing through in-depth, semi-structured interviews among study participants enrolled in Standing Tall's second aim. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04568460
Study type	Interventional
Source	Brigham and Women's Hospital
Contact
Status	Active, not recruiting
Phase	Phase 2
Start date	November 25, 2020
Completion date	March 31, 2024

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.