Parrying the Pitfalls of PrEP: Project PEACH

• Status: Not yet recruiting
• Trial end date: 2025-02-01
• Target enrollment: 0
• Participant gender: Male

Summary

The study is a prospective cohort of young Black 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 are not on PrEP at study initiation and who may decide to start or stop PrEP, change from daily oral PrEP to on-demand PrEP or from on-demand PrEP to daily PrEP, and/or start or stop STI PEP at any point in the study period. If there is trouble enrolling men who are not currently on PrEP, the investigators will expand enrollment criteria to include men currently on 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 PrEP and STI PEP, and to support easy linkage to support services for PrEP counseling and addressing concerns or questions about STI PEP.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Doxycycline; Emtricitabine; Tenofovir

Criteria

Inclusion Criteria:

• Male at birth

• Self-identify as cisgender male

• Ages 18-29 years

• Self-reported Black race

• ≥1 male anal sex partner in the 12 months before the baseline interview

• Not currently taking HIV PrEP

• Able to complete survey instruments in English

• Live in the Atlanta MSA and not planning to move from it over the next 2 years

• 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

Exclusion Criteria:

• Female at birth

• Individuals < 18 years of age or > 29 years of age

• HIV positive status

• Does not report Black as race

• No male anal sex partner in the 12 months before the baseline interview

• Currently taking PrEP

• 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

• Not able to complete survey instruments in English

• 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