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)

NCT06799702 | Not Yet Recruiting DMC

• 2 other identifiers: PROJECT000009015K01DA059329
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

HIV Pre-Exposure Prophylaxis; Hepatitis C Virus; Medications for Opioid Use Disorder; People who inject drugs (PWID); Deep South; Telehealth Intervention

Outcome Measures

Primary Outcomes (3)

• Feasibility of the Intervention

  Feasibility of the telehealth intervention will be assessed during baseline, at 2-months, and 4-months among both PWID and interventionists. Feasibility will be assessed by the completion rates of the interventionist training sessions and the participation/drop-out rates of the PWID.

  Months 31-60

• Acceptability of the telehealth intervention

  Acceptability of the telehealth intervention will be assessed during baseline, at 2-months, and 4-months among both PWID and interventionists. Acceptability will be examined by Likert scale like responses, e.g., "convenient," "a nuisance," "easy to use," and "time-consuming."

  Months 31-60

• Usability of the telehealth intervention

  Usability of the telehealth intervention will be assessed during baseline, at 2-months, and 4-months among both PWID and interventionists. Usability will be assessed with the USE questionnaire, which captures the perceived usefulness, satisfaction, and ease of use.

  Months 31-60

Secondary Outcomes (5)

• Depressive symptoms

  Months 31-60

• Resilience

  Months 31-60

• Intersecting stigma of HIV, HCV, and drug use

  Months 31-60

• Sexual behavior

  Months 31-60

• Risky Injection Bheavior

  Months 31-60

Study Arms (2)

Intervention

EXPERIMENTAL

Intervention

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

Waitlist Control

ACTIVE COMPARATOR

Control

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

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.

Intervention; Waitlist Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Georgia: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

MedLink Georgia

Colbert, Georgia, 30628, United States

Location

MeSH Terms

Conditions

Hepatitis C; Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Central Study Contacts

Mohammad Rifat Haider, Ph.D.

CONTACT

803-477-4289; haider@uga.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 8, 2025
• First Posted: January 29, 2025
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)