Standing Tall (Yima Nkqo): A Pilot Randomized Controlled Trial of a Community-Based Intervention to Improve Health Outcomes for Young Adults Newly Diagnosed With HIV in South Africa
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Brigham and Women's Hospital
- Enrollment
- 100
- Locations
- 3
- Primary Endpoint
- ART Initiation
Study Overview
Brief 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."
Detailed 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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 24 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Complete an assessment of understanding
- •Provide informed consent
- •Are between ages 18-24
- •Present to Tutu Tester vans in Cape Town OR East London DTHF clinics (Duncan Village Day Hospital, Empilweni Gompo Health Centre, Gompo C Clinic) and test HIV+
- •Are ART-naïve
- •Are English or isiXhosa speakers
- •Reside in the Cape Town or East London metro area
Exclusion Criteria
- •Are pregnant (must be referred to antenatal clinic if living with HIV)
- •Test positive for tuberculosis (must be referred to clinic for TB treatment prior to ART initiation)
- •Are unable to understand the process of informed consent
Arms & Interventions
Standard of Care
This is the standard of care arm. Participants newly diagnosed with HIV will get a referral to the local primary health care setting of their choice for further management, including ART.
Intervention Group Sessions
Intervention group sessions will be delivered by lay health counselors. The sessions will reflect principles of co-learning, participatory design, and empowerment to promote engagement of young people in critical thinking and problem solving - including modeling, roleplaying, and interactive activities.
Intervention: Intervention Group Sessions (Other)
Outcomes
Primary Outcomes
ART Initiation
Time Frame: Six months
ART initiation will be assessed via a self-report measure of participants who will report whether they have or have not initiated ART.
ART Initiation
Time Frame: Three Months
ART initiation will be assessed via a self-report measure of participants who will report whether they have or have not initiated ART.
Secondary Outcomes
- Wellness(Six Months)
- Household Food Security(Six Months)
- Viral Load Suppression(Six Months)
- Mental Health(Six Months)
- Substance Use(Six Months)
- Perceptions of Acceptability(Six Months)
- Stress(Six Months)
- Resilience(Six Months)
- Implementation Factors(Six Months)
- Perceptions of Fidelity(Six Months)
Investigators
Ingrid Theresa Katz, M.D.
Associate Professor
Harvard Medical School (HMS and HSDM)