Parrying the Pitfalls of PrEP: Project PEACH

Summary

The study is a prospective cohort of young MSM who are followed for 2 years either in-person at the PRISM Health Research Clinic and/or virtually with telehealth study visits. Follow-up visits occur as frequently as every 3 months, or as appropriate to clinical needs of HIV PrEP or STI PEP. The investigators will enroll men who may decide to start or stop PrEP, change from daily oral PrEP to on-demand oral PrEP or from on-demand oral PrEP to daily PrEP, to start or stop STI PEP at any point in the study period, or injectable PrEP as an alternative to daily oral PrEP or on-demand oral PrEP. All men will be provided with the study's mobile smart phone app to support early identification of risks for PrEP discontinuation, to provide information about STI PEP and document usage patterns of on-demand oral PrEP and STI PEP, and to support easy linkage to support services for PrEP counseling and addressing concerns or questions about STI PEP and injectable PrEP.

Conditions

• HIV
• STI

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.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH)

  collaborator NIH

• Emory University

  lead OTHER

Principal Investigators

• Patrick Sullivan, MD · Emory University

Study Design

Allocation

NA

Purpose

PREVENTION

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-11-20

Primary Completion

2025-03-31

Completion

2025-03-31

FDA Drug

Yes

Countries

• United States

Study Locations