Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2025-12-26 @ 4:48 AM
Study NCT ID:
NCT04568460
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-18
First Post:
2020-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Standing Tall (Yima Nkqo)
Sponsor:
Brigham and Women's Hospital
Organization:
Study Overview
Official Title:
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: