Parrying the Pitfalls of PrEP: Project PEACH

NCT05072093 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: STUDY000006085R01MH123724-02
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Prevention; Doxycycline; Apretude

Outcome Measures

Primary Outcomes (4)

• Number of Men Who Discontinue Daily Oral PrEP

  MSM taking daily oral PrEP will complete monthly screener surveys delivered through study app to assess for PrEP stop intentions. After early identification, they will receive Motivational Interviewing (MI) to avoid discontinuation. Participants that discontinue PrEP will be measured.

  24 month post intervention

• Number of Men Who Initiate On-demand Oral PrEP

  MSM who decline daily oral PrEP will be prescribed TDF/FTC fixed dose combination, 2 doses 2-24 hrs before sex and single dose 24 and 48 hours after first dose.

  24 month post intervention

• Number of Men Who Initiate Long-acting Injectable PrEP

  Number of men who are not interested in daily oral PrEP or on-demand oral PrEP will be offered Long-acting injectable PrEP through referral to outside providers.

  24 month post intervention

• Number of STI Diagnoses

  All men in cohort will be evaluated for STI diagnoses at baseline, 12 and 24 month post intervention.

  Baseline, 12 and 24 months post intervention

Study Arms (1)

All men in cohort: MSM

EXPERIMENTAL

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.

Behavioral: PrEP discontinuation intervention; Drug: Offering of on-demand oral PrEP; Drug: Offering of STI PEP; Drug: Injectable PrEP

Interventions

PrEP discontinuation intervention BEHAVIORAL

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.

All men in cohort: MSM

Offering of on-demand oral PrEP DRUG

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.

Also known as: emtricitabine/tenofovir disoproxil, Truvada

All men in cohort: MSM

Offering of STI PEP DRUG

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).

Also known as: doxycycline

All men in cohort: MSM

Injectable PrEP DRUG

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.

Also known as: Apretude, Cabotegravir

All men in cohort: MSM

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Males at birth are eligible for the study
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male at birth
• Self-identify as Cisgender Male
• Ages 18-45 years
• ≥1 male anal sex partner in the 12 months before the baseline interview
• Live in the Atlanta MSA
• Owns cell phone with data service
• Willing to download a health-related app to their cell phone as part of the research study
• Able to provide ≥ 2 means of contact
• Not currently enrolled in another HIV prevention clinical trial
• Confirmed HIV-negative at baseline visit

You may not qualify if:

• Female at birth
• Do not self-identify as Cisgender Male
• Individuals \< 18 years of age or \> 45 years of age
• HIV positive status
• No male anal sex partner in the 12 months before the baseline interview
• Does not own mobile phone with data service
• Not willing to download a health-related app to their cell phone as part of the research study
• Live outside the metro Atlanta MSA and/or planning to move from Atlanta area in the next 2 years
• Currently enrolled in an HIV prevention or treatment clinical trial
• Adults unable to consent
• Individuals who are not yet adults (infants, children, teenagers)
• Pregnant women
• Prisoners

Sponsors & Collaborators

• Emory University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

PRISM Research Center

Atlanta, Georgia, 30322, United States

Location

Related Publications (1)

• Aldredge A, Carter D, DeCree CA, Gardner EV, Herring GB, Kaabi O, Moges-Banks R, Valencia R, Kelley CF, Sullivan PS. Preventing Premature Pre-Exposure Prophylaxis Discontinuation and Sexually Transmitted Infections Among Men Who Have Sex With Men (Project PEACH): Protocol for a Prospective Cohort Study. JMIR Res Protoc. 2025 Apr 23;14:e56096. doi: 10.2196/56096.

  PMID: 40267471 DERIVED

MeSH Terms

Conditions

Sexually Transmitted Diseases

Interventions

Emtricitabine; Tenofovir; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Doxycycline; cabotegravir

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Drug Combinations; Pharmaceutical Preparations; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Patrick Sullivan
• Organization: Emory University

pssulli@emory.edu

404-727-2038

Study Officials

• Patrick Sullivan, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 28, 2021
• First Posted: October 8, 2021
• Study Start: November 20, 2021
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: April 1, 2026
• Results First Posted: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 3 months and ending 5 years following primary publication.
• Access Criteria: Researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal. Proposals should be directed to pssulli@emory.edu. To gain access, data requestor will need to sign a data access agreement.

Locations

US (1)