The PROTECT (PrEP Optimization Through Telehealth Care and Treatment) Trial

Official title

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

Overview

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

• Behavioral CDC 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.
• Behavioral TelePrEP
  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 tele

Primary outcome measures

• PrEP Initiation [Time frame: 3 months post-baseline]
• PrEP Initiation [Time frame: 6 months post-baseline]

Secondary outcome measures (4)

• PrEP Persistence [Time frame: 3 months post-baseline]
• PrEP Persistence [Time frame: 6 months post-baseline]
• PrEP adherence [Time frame: 3 months post-baseline]
• PrEP adherence [Time frame: 6 months post-baseline]

Eligibility criteria

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.

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

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

United States · 1 center

• University of Kentucky — Lexington

Identifiers

NCT: NCT06845774 · 90392 · R34DA060087-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗