Optimizing Low Threshold TelePrEP Care in Syringe Service Programs for People Who Inject Drugs in Appalachia

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The expansion of HIV pre-exposure prophylaxis (PrEP) care has been endorsed as a key strategy for reducing new HIV infections, however, PrEP trials among people who inject drugs (PWID) are rare and uptake of PrEP has been minimal, most notably in rural areas. Structural barriers to healthcare access, lack of providers, and inadequate infrastructure to deliver PrEP are challenges in many rural areas. In addition, PWID often have social determinant barriers to PrEP care. This study will integrate telehealth PrEP care within syringe services programs (SSPs), a venue already routinely accessed by PWID, to reduce structural barriers to evidence-based HIV prevention through co-located comprehensive PrEP services, and test this against a standard of care approach in a pilot randomized clinical trial. The primary objective is to examine preliminary efficacy and effect sizes of novel integrated telehealth care versus standard education and active referral on the primary outcome of PrEP initiation in HIV-negative participants who inject drugs.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: t
View:

• be at least 18 years of age

• report at least one occasion of injection drug use in the past month

• report an indication for PrEP in the past six months consistent with CDC guidelines for PrEP care

• be a documented client of the county SSP at the time of study entry

• express willingness to participate in a multi-session intervention and follow-up

Locations
United States
Kentucky
University of Kentucky
RECRUITING
Lexington
Contact Information
Primary
Hilary L Surratt, PhD
hilary.surratt@uky.edu
18595622458
Time Frame
Start Date: 2025-09-25
Estimated Completion Date: 2027-01-13
Participants
Target number of participants: 80
Treatments
Active_comparator: Standard of Care
One session standard of care (SOC) PrEP education (an in-use PrEP intervention based on CDC guidelines) with active referral to a local PrEP provider.
Experimental: Integrated Telehealth Care
A multi-session PrEP education and intervention session that provides tailored PrEP education onsite combined with point-of-care PrEP testing and telehealth access to a PrEP provider.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute on Drug Abuse (NIDA)
Leads: Hilary L Surratt, PhD

This content was sourced from clinicaltrials.gov