PrEP/PEP Strategies for HIV Prevention

Overseen By Colleen Kelley, MD

Age: 18 - 65

Sex: Male

Trial Phase: Phase 4

Sponsor: Emory University

Disqualifiers: HIV positive, Pregnant, Prisoners, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

240 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Patrick Sullivan, MD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

Project PEACH is for cisgender males, aged 18-45, living in the Atlanta area who are HIV-negative and have had at least one male anal sex partner in the past year. Participants must own a smartphone with data service and be willing to use a health-related app. Those enrolled in other HIV trials or without consistent contact methods are excluded.

Inclusion Criteria

I have had a male sexual partner in the past year.

Live in the Atlanta MSA

I identify as a cisgender male.

Exclusion Criteria

I am under 18 years old.

I am not willing to download a health app for the study.

Currently enrolled in an HIV prevention or treatment clinical trial

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person or virtual)

Baseline

Participants attend a baseline visit for consent, initial testing, and app orientation

1 day

1 visit (in-person or virtual)

Treatment and Monitoring

Participants receive PrEP and/or STI PEP, with regular surveys and monitoring for adherence and side effects

24 months

3 visits (in-person or virtual) at months 12 and 24, plus monthly and weekly surveys

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

1 visit (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Daily oral PrEP
• Injectable PrEP
• On-demand oral PrEP
• PrEP discontinuation intervention
• STI PEP

Trial Overview The study tests various PrEP strategies over two years: starting/stopping daily or on-demand oral PrEP, using STI PEP after risky encounters, or switching to injectable PrEP. It includes frequent follow-ups and uses an app for risk monitoring and support services linkage.

How Is the Trial Designed?

Group I: All men in cohort: MSM Experimental Treatment 4 Interventions

Prospective cohort of MSM who are followed either in-person at the PRISM Health Research Clinic and/or virtually with remote study visits. Participants will have the option to switch prevention options at any point during the study by indicating their interest during monthly surveys or contacting study staff directly.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+