Telehealth for HIV Prevention
(PROTECT Trial)

Recruiting in Palo Alto (17 mi)

Overseen byHilary L Surratt, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Hilary L Surratt, PhD

No Placebo Group

Trial Summary

What is the purpose of this trial?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 Criteria

The PROTECT Trial is for adults over 18 who inject drugs and have used needles in the past month. They must be clients of a syringe service program, willing to join multiple sessions, and not currently on PrEP or HIV-positive. It's aimed at those who meet CDC guidelines for needing PrEP but haven't started it.

Inclusion Criteria

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

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

Be a documented client of the county SSP at the time of study entry

+2 more

Exclusion Criteria

I am currently on PrEP medication.

I am HIV-positive.

Participant Groups

This trial tests if telehealth can help people who inject drugs start using PrEP (a medication to prevent HIV) by integrating it into syringe services programs. Participants will either receive standard education with active referral or novel integrated telehealth care.

2Treatment groups

Experimental Treatment

Active Control

Group I: Integrated Telehealth CareExperimental Treatment1 Intervention

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.

Group II: Standard of CareActive Control1 Intervention

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.