Clinical Trial

Trauma-informed, Resilience-based Telehealth Intervention for Improving HIV Prevention and HCV Care for Persons Who Inject Drugs in the Deep South (Pilot Testing: Aim3)

Not Yet Recruiting
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Summary
Evaluate the feasibility, acceptability, and usability of the intervention (primary outcomes) and coping skills and resilience (secondary outcomes) of the telehealth intervention over two months (8 weekly sessions) in a waitlist-controlled, randomized pilot trial using a cross-over design among 40 PWID. The primary outcomes will be feasibility, acceptability, and usability of the intervention. Secondary outcomes will be increased coping skills and resilience, which in turn, will increase status neutral HIV and HCV care and MOUD uptake (longer-term outcomes). Outcomes will be assessed using pre- and post-intervention surveys.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2025-01-27; most recent amendment 2025-12-17.
Status change: Enrolling by Invitation → Not Yet Recruiting 2025-12-17
Status change: Not Yet Recruiting → Enrolling by Invitation 2025-09-01
Trial Details
NCT Number NCT06799702
Lead Sponsor University of Georgia
Collaborators: National Institute on Drug Abuse (NIDA)
Conditions HIV Pre-exposure Prophylaxis, HEPATITIS C (HCV), Opioid Use Disorder
Enrollment 50 participants
Start Date 2026-08-01
Primary Completion 2028-03-31 (estimated)
Study Completion 2028-07-31 (estimated)
Updated on ClinicalTrials.gov 2025-12-18