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)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Telehealth Behavioral Intervention for promoting HIV and HCV care and MOUD among Persons who inject drugs (PWID).
- Who it may be relevant to
- Registry conditions: HIV Pre-exposure Prophylaxis, HEPATITIS C (HCV), Opioid Use Disorder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Trauma-informed, Resilience-based Telehealth Intervention for Improving HIV Prevention and HCV Care for Persons Who Inject Drugs in the Deep South
Overview
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.
Detailed 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.
Interventions
- Behavioral Telehealth Behavioral Intervention for promoting HIV and HCV care and MOUD among Persons who inject drugs (PWID)
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), cop
Primary outcome measures
- Feasibility of the Intervention [Time frame: Months 31-60]
- Acceptability of the telehealth intervention [Time frame: Months 31-60]
- Usability of the telehealth intervention [Time frame: Months 31-60]
Secondary outcome measures (5)
- Depressive symptoms [Time frame: Months 31-60]
- Resilience [Time frame: Months 31-60]
- Intersecting stigma of HIV, HCV, and drug use [Time frame: Months 31-60]
- Sexual behavior [Time frame: Months 31-60]
- Risky Injection Bheavior [Time frame: Months 31-60]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 1 center
- MedLink Georgia — Colbert
Identifiers
NCT: NCT06799702 · PROJECT000009015 · K01DA059329