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

Hilary L Surratt, PhD

Status: Invitation-only

Conditions: HIV Prevention

Treatments: Behavioral: CDC PrEP with active referral; Behavioral: TelePrEP

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06845774

R34DA060087-01 (U.S. NIH Grant/Contract)

90392

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Standard of Care

Active Comparator group

Description:

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.

Treatment:

Behavioral: CDC PrEP with active referral

Integrated Telehealth Care

Experimental group

Description:

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.

Treatment:

Behavioral: TelePrEP