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)

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Georgia

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

People who actively inject drugs verified by visible injection stigmata (needle tracks)

HIV negative

Adult (≥18 years)

lives in rural areas

Disqualifiers

Living with HIV

Lives in urban areas

Not proficient in English

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: InterventionExperimental treatment 1 intervention
Group B: Waitlist ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Months 31-60
2

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."

Time frame
Months 31-60
3

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.

Time frame
Months 31-60

Secondary outcomes

1

Depressive symptoms

The Center for Epidemiologic Studies Depression (CES-D) Scale (20 items) will be used to measure depressive symptoms. CES-D Scores range from 0 to 60, with high scores indicating greater depressive symptoms.

Time frame
Months 31-60
2

Resilience

The 10-item Connor-Davidson Resilience Scale (CD-RISC) scale will be used to measure resilience. Scores range from 0-40, where higher scores indicate greater resilience.

Time frame
Months 31-60
3

Intersecting stigma of HIV, HCV, and drug use

The 16-item Anticipated HIV Stigma Scale will be used to measure HIV stigma. Scores range from 16-64, where higher scores reflect higher stigma. The 33-item HCV Stigma Scale (HCV-SS) will be used to measure HCV-related stigma. The total score range for this scale is 33 to 132, with higher scores indicating greater perceived stigma. The 8-item Perceived Stigma of Substance Abuse Scale (PSAS) will be used to measure the drug use stigma. Scores range from 8-32, where a higher score reflects higher stigma. Intersectional stigma scores will be calculated using the formula, d = square root of (a-squared + b-squared + c-squared), where d is the intersectional stigma score, and a is the HIV-related stigma score, b is the HCV-related stigma score, and c is the drug use stigma score. The score ranges from 37.5-150.2, and the higher the score, the higher the intersecting stigma.

Time frame
Months 31-60
4

Sexual behavior

Sexual practices like protected sex, risky sex (sex under the influence, sex in return of drugs/money, unprotected anal/vaginal sex, multiple partners, not knowing partnmer's HIV status)

Time frame
Months 31-60

Other outcomes

Sponsors and contacts

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University of Georgia

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

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