Clinical trial NCT06799702: Trauma-informed, Resilience-based Telehealth Intervention for Improving HIV Prevention and HCV Care for Persons Who Inject Drugs in the Deep South (Formative Phase)
Official title: Trauma-informed, Resilience-based Telehealth Intervention for Improving HIV Prevention and HCV Care for Persons Who Inject Drugs in the Deep South
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: HIV Pre-exposure Prophylaxis
HEPATITIS C (HCV)
Keywords: HIV Pre-Exposure Prophylaxis
Hepatitis C Virus
Medications for Opioid Use Disorder
Barriers
Facilitators
People who inject drugs (PWID)
Deep South
Lead sponsor: University of Georgia
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2025-01-29
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Investigators will conduct in-depth interviews with adult (≥18 years) PWID who are HIV negative and living in rural areas with representation from all genders and races/ethnicities and 15 key informants (i.e., providers, policymakers) for in-depth interviews.

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.

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

Primary outcomes:
measure: Perceived barriers to and facilitators of HIV Pre-Exposure Prophylaxis (PrEP) uptake and persistence among Persons who inject drugs (PWID)
timeFrame: From enrollment to the end of data collection and analysis at 6 months
measure: Perceived barriers to and facilitators of Hepatitis C Virus (HCV) care uptake and persistence among Persons who inject drugs (PWID)
timeFrame: From enrollment to the end of data collection and analysis at 6 months
measure: Perceived barriers to and facilitators of medications for opioid use disorder (MOUD) uptake and persistence among Persons who inject drugs (PWID)
timeFrame: From enrollment to the end of data collection and analysis at 6 months
measure: Pericieved barriers to and facilitators of participating in a telehealth program
timeFrame: From enrollment to the end of data collection and analysis at 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: