HIV Prevention
Conditions
Brief 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. This study will integrate telehealth PrEP care within local health departments 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.
Interventions
BEHAVIORALCDC PrEP with active referral
The single session SOC utilizes structured risk assessments and educational materials recommended by the CDC, based on the CDC PrEP 101 information, and delivered one-on-one by trained study staff in about 15 minutes. This will be followed by active referral to a local provider; local providers have been identified to receive study referrals in each community. This session will occur the same day or within one week of study enrollment.
BEHAVIORALTelePrEP
The TelePrEP intervention includes an initial one-on-one in person intervention session with trained study staff that: 1) engages in provides basic education on PrEP care tailored for PWID; 2) encourages participation in a telehealth clinical evaluation for PrEP; and, 3) offers the opportunity to participate in point of care baseline testing for PrEP. At the conclusion of session 1, for those who express readiness to link with PrEP care, study staff will immediately facilitate access to the telehealth platform onsite. Four telehealth visits will be offered to access initial and follow-up clinical care for PrEP.
Sponsors
Hilary L Surratt, PhD
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* 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 health department-based SSP at the time of study entry * express willingness to participate in a multi-session intervention and follow-up
Exclusion criteria
* HIV-positive status * current PrEP care.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PrEP Initiation | 3 months post-baseline | Number of participants initiating PrEP |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PrEP Persistence | 3 months post-baseline | Number of participants with PrEP prescription refill |
| PrEP adherence | 3 months post-baseline | Number of participants with tenofovir (TFV) detected in dried blood spot testing |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORHilary L Surratt, PhD
University of Kentucky
Outcome results
None listed