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)

University of Georgia (UGA)

Status: Begins enrollment in 5 months

Conditions: Opioid Use Disorder; HEPATITIS C (HCV); HIV Pre-exposure Prophylaxis

Treatments: Behavioral: Telehealth Behavioral Intervention for promoting HIV and HCV care and MOUD among Persons who inject drugs (PWID)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06799702

K01DA059329 (U.S. NIH Grant/Contract)

PROJECT000009015

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• People who actively inject drugs verified by visible injection stigmata (needle tracks)
• HIV negative
• Adult (≥18 years)
• lives in rural areas

Exclusion criteria

• Living with HIV
• Lives in urban areas
• Not proficient in English

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Intervention

Experimental group

Description:

Intervention

Treatment:

Behavioral: Telehealth Behavioral Intervention for promoting HIV and HCV care and MOUD among Persons who inject drugs (PWID)

Waitlist Control

Active Comparator group

Description:

Control

Treatment:

Behavioral: Telehealth Behavioral Intervention for promoting HIV and HCV care and MOUD among Persons who inject drugs (PWID)