Parrying the Pitfalls of PrEP: Project PEACH

PHASE4CompletedINTERVENTIONAL
Enrollment

240

Participants

Timeline

Start Date

November 20, 2021

Primary Completion Date

March 31, 2025

Study Completion Date

March 31, 2025

Conditions
HIVSTI
Interventions
BEHAVIORAL

PrEP discontinuation intervention

Men taking daily oral PrEP (Truvada) will receive a monthly screener through the mobile app. If answers to screener questions indicate a participant is at risk for PrEP discontinuation, then a peer navigator will deliver a motivational interviewing intervention and a clinician will consult with the participant. These efforts are intended to avert PrEP discontinuation.

DRUG

Offering of on-demand oral PrEP

For men who are not interested in daily oral PrEP or plan to discontinue daily oral PrEP, the investigators will offer on-demand oral PrEP (Truvada) which will allow them to take it immediately before/after a sexual encounter. It is hoped that this will serve as an alternative to daily oral PrEP use that is desirable for some people.

DRUG

Offering of STI PEP

All men in the cohort will be offered STI PEP (doxycycline) to use after condomless sex with the goal of averting STI diagnoses. At a dosage of 200 mg to be taken in a single dose ideally within 24 hours of possible exposure (e.g. condomless anal sex) and no later than 72 hours after exposure. Participants will be dispensed enough pills to allow for up to 3 weekly doses of 200mg doxycycline (i.e. 6 pills/week) for 3 months (the interval between STI testing visits).

DRUG

Injectable PrEP

For men who are interested in injectable PrEP, they will be referred to local providers to access Apretude (Cabotegravir injection) every two months. In the study, their use of the medication will be monitored through monthly surveys during which they have the option to indicate interest in switching to oral PrEP.

Trial Locations (1)

30322

PRISM Research Center, Atlanta

All Listed Sponsors
collaborator

National Institute of Mental Health (NIMH)

NIH

lead

Emory University

OTHER

NCT05072093 - Parrying the Pitfalls of PrEP: Project PEACH | Biotech Hunter | Biotech Hunter