Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-01-04 @ 3:43 AM
Study NCT ID:
NCT07117656
Status:
RECRUITING
Last Update Posted:
2025-08-12
First Post:
2025-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Project Vuselela Feasibility
Sponsor:
Arizona State University
Organization:
Study Overview
Official Title:
Developing and Pilot Testing Project Vuselela for ART and OST Engagement in Johannesburg, South Africa
Status:
RECRUITING
Status Verified Date:
2025-08
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:
PV
Brief Summary:
To develop an intervention that engages family members in supporting HIV and opioid substitution therapy treatment for those who inject drugs in South Africa, and then conduct a pilot study to understand feasibility and preliminary impact on outcomes.
Detailed Description:
In response to increased injection drug use in Johannesburg, South Africa, and low ART and OST treatment retention rates, we will develop and pilot-test the intervention, Project Vuselela. The intervention is designed to engage family members in treatment support using a multi-session skill-building approach that is led by trained peer navigators. Both PLWHIDs and their family members will attend sessions to develop these skills and treatment action plans, facilitated by peer navigators. We will assess PLWHID and family acceptability of the intervention and preliminary impact on PLWHID ART and OST treatment adherence when compared to those in the current program as standard of care. The study will be conducted at Yeoville Clinic in Johannesburg, a setting with high rates of injection drug use and the only OST clinic in the city.
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R34DA062367 | NIH | None | https://reporter.nih.gov/quic… | View |