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)

Part of paid clinical trials in Colbert, Georgia.

Sponsor
University of Georgia
Study ID
NCT06799702
Status
Not Yet Recruiting

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Conditions

  • HEPATITIS C (HCV)
  • HIV Pre-exposure Prophylaxis
  • Opioid Use Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Telehealth Behavioral Intervention for promoting HIV and HCV care and MOUD among Persons who inject drugs (PWID) — BEHAVIORAL
    The telehealth intervention will include components from the LIFT intervention: identifying and expressing emotion related to stressors; identifying different stressors and coping difficulties; and developing adaptive strategies to reduce stress. The intervention will also include developing health goals and a health plan on PrEP, DAA, and MOUD, as well as components from RISE-UP: baseline assessment of individual assets (e. g., self-esteem, emotion regulation, positive future orientation), coping with addictive behavior (stress reduction, avoiding unsafe sexual and injection practices, self-care), building relationships (with peers, family, provider), and social support (finding and seeking social support). It will consist of 8 sessions (4 addressing stress and 4 addressing stigma). Each session will last an hour and be conducted weekly for eight consecutive weeks.

Study Details

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.

Key Dates

Start date
Aug 1, 2026
Status verified
Dec 2025
Primary completion
Mar 31, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Intervention
    Intervention
  • Active Comparator: Waitlist Control
    Control

Primary Outcome Measure

Feasibility of the Intervention [ Time Frame: Months 31-60 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MedLink GeorgiaColbertGeorgia30628-

Find similar trials in Colbert, GA

By research site
MedLink Georgia· Colbert, GA

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