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

Not yet recruiting

• Conditions: HIV Pre-exposure Prophylaxis; HEPATITIS C (HCV)

• Registration Number: NCT06799702
• Lead Sponsor: University of Georgia

Brief Summary

Explore the perceptions of people who inject drugs (PWID) and healthcare providers and policymakers to identify barriers to and facilitators of PrEP uptake and persistence as the primary focus, with HCV care and MOUD uptake as secondary foci, in the context of ACEs and intersectional stigma.

Detailed Description

Investigators will recruit 30 PWID (15 in-care for PrEP, HCV, and/or MOUD and 15 not-in-care) for in-depth, one-on-one, semi-structured interviews which will include questions on trauma history; intersecting stigmas; HIV and HCV risk perception; current challenges they face in accessing/using PrEP, DAA, and/or MOUD; how they view service integration in human service settings; knowledge of and preferences for PrEP, DAA, and/or MOUD; and perceived barriers to and facilitators of PrEP, DAA, and/or MOUD uptake and adherence. Interviews will also include questions on barriers to and facilitators of participating in a telehealth program; and preferred features of a telehealth intervention, i.e., number, length, frequency, contents of the sessions, interface, and online resources.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-08
• Study First Submitted QC: 2025-01-27
• Last Update Submitted: 2025-01-27
• Study First Posted: 2025-01-29
• Last Update Posted: 2025-01-29
• Study Start: 2025-02-15
• Primary Completion: 2025-06-15
• Study Completion: 2025-08-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Perceived barriers to and facilitators of HIV Pre-Exposure Prophylaxis (PrEP) uptake and persistence among Persons who inject drugs (PWID)	From enrollment to the end of data collection and analysis at 6 months	Current challenges PWID face in accessing and using PrEP; how PWID view service integration in human service settings; knowledge of and preferences for PrEP; and perceived barriers to and facilitators of PrEP uptake and adherence
Perceived barriers to and facilitators of Hepatitis C Virus (HCV) care uptake and persistence among Persons who inject drugs (PWID)	From enrollment to the end of data collection and analysis at 6 months	Current challenges PWID face in accessing and using Directly-Acting Antivirals (DAA) for hepatitis C virus; how PWID view service integration in human service settings; knowledge of and preferences for HCV care; and perceived barriers to and facilitators of DAA uptake and adherence.
Perceived barriers to and facilitators of medications for opioid use disorder (MOUD) uptake and persistence among Persons who inject drugs (PWID)	From enrollment to the end of data collection and analysis at 6 months	Current challenges PWID face in accessing and using MOUD; how PWID view service integration in human service settings; knowledge of and preferences for MOUD; and perceived barriers to and facilitators of MOUD uptake and adherence.
Pericieved barriers to and facilitators of participating in a telehealth program	From enrollment to the end of data collection and analysis at 6 months	Investigators will also elicit barriers to and facilitators of participating in a telehealth program faced by PWID; and their preferred features of a telehealth intervention, i.e., number, length, frequency, contents of the sessions, interface, and online resources.