Trial Outcomes & Findings for Parrying the Pitfalls of PrEP: Project PEACH (NCT NCT05072093)

NCT ID: NCT05072093

Last Updated: 2026-04-01

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

240 participants

Primary outcome timeframe

24 month post intervention

Results posted on

2026-04-01

Participant Flow

Participant milestones

Participant milestones
Measure	All Men in Cohort: MSM 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. PrEP discontinuation intervention: Men taking daily oral PrEP (Truvada) will receive a monthly screener through the mobile app. If answers indicate a participant is at risk for PrEP discontinuation, a peer navigator will deliver a motivational interviewing intervention and a clinician will consult with the participant with the intention to avert PrEP discontinuation. Offering of on-demand oral PrEP: Men who are not interested in daily oral PrEP or plan to discontinue daily oral PrEP, will be offered on-demand oral PrEP (Truvada) to take it immediately before/after a sexual encounter. Offering of STI PEP: Men will be offered STI PEP (doxycycline) to use after condomless sex. A single dose of 200 mg to be taken within 24 hours of possible exposure no later than 72 hours after exposure. Participants will be dispensed enough pills to allow for up to 3 weekly doses of 200mg for 3 months. Injectable PrEP: For men who are interested, they will be referred to access Apretude (Cabotegravir injection) every two months. Their use will be monitored through monthly surveys where they can indicate interest in switching to oral PrEP.
Overall Study STARTED	240
Overall Study COMPLETED	71
Overall Study NOT COMPLETED	169

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Parrying the Pitfalls of PrEP: Project PEACH

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Men in Cohort: MSM n=240 Participants 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. PrEP discontinuation intervention: Men taking daily oral PrEP (Truvada) will receive a monthly screener through the mobile app. If answers indicate a participant is at risk for PrEP discontinuation, a peer navigator will deliver a motivational interviewing intervention and a clinician will consult with the participant with the intention to avert PrEP discontinuation. Offering of on-demand oral PrEP: Men who are not interested in daily oral PrEP or plan to discontinue daily oral PrEP, will be offered on-demand oral PrEP (Truvada) to take it immediately before/after a sexual encounter. Offering of STI PEP: Men will be offered STI PEP (doxycycline) to use after condomless sex. A single dose of 200 mg to be taken within 24 hours of possible exposure no later than 72 hours after exposure. Participants will be dispensed enough pills to allow for up to 3 weekly doses of 200mg for 3 months. Injectable PrEP: For men who are interested, they will be referred to access Apretude (Cabotegravir injection) every two months. Their use will be monitored through monthly surveys where they can indicate interest in switching to oral PrEP.
Age, Continuous	30 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	240 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	29 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	211 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	150 Participants n=5 Participants
Race (NIH/OMB) White	46 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	44 Participants n=5 Participants
Region of Enrollment United States	240 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 month post intervention

Outcome measures

Outcome measures
Measure	All Men in Cohort: MSM n=240 Participants 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. PrEP discontinuation intervention: Men taking daily oral PrEP (Truvada) will receive a monthly screener through the mobile app. If answers indicate a participant is at risk for PrEP discontinuation, a peer navigator will deliver a motivational interviewing intervention and a clinician will consult with the participant with the intention to avert PrEP discontinuation. Offering of on-demand oral PrEP: Men who are not interested in daily oral PrEP or plan to discontinue daily oral PrEP, will be offered on-demand oral PrEP (Truvada) to take it immediately before/after a sexual encounter. Offering of STI PEP: Men will be offered STI PEP (doxycycline) to use after condomless sex. A single dose of 200 mg to be taken within 24 hours of possible exposure no later than 72 hours after exposure. Participants will be dispensed enough pills to allow for up to 3 weekly doses of 200mg for 3 months. Injectable PrEP: For men who are interested, they will be referred to access Apretude (Cabotegravir injection) every two months. Their use will be monitored through monthly surveys where they can indicate interest in switching to oral PrEP.
Number of Men Who Discontinue Daily Oral PrEP	18 Participants

PRIMARY outcome

Timeframe: 24 month post intervention

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.

Outcome measures

Outcome measures
Measure	All Men in Cohort: MSM n=240 Participants 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. PrEP discontinuation intervention: Men taking daily oral PrEP (Truvada) will receive a monthly screener through the mobile app. If answers indicate a participant is at risk for PrEP discontinuation, a peer navigator will deliver a motivational interviewing intervention and a clinician will consult with the participant with the intention to avert PrEP discontinuation. Offering of on-demand oral PrEP: Men who are not interested in daily oral PrEP or plan to discontinue daily oral PrEP, will be offered on-demand oral PrEP (Truvada) to take it immediately before/after a sexual encounter. Offering of STI PEP: Men will be offered STI PEP (doxycycline) to use after condomless sex. A single dose of 200 mg to be taken within 24 hours of possible exposure no later than 72 hours after exposure. Participants will be dispensed enough pills to allow for up to 3 weekly doses of 200mg for 3 months. Injectable PrEP: For men who are interested, they will be referred to access Apretude (Cabotegravir injection) every two months. Their use will be monitored through monthly surveys where they can indicate interest in switching to oral PrEP.
Number of Men Who Initiate On-demand Oral PrEP	59 Participants

PRIMARY outcome

Timeframe: 24 month post intervention

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.

Outcome measures

Outcome measures
Measure	All Men in Cohort: MSM n=240 Participants 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. PrEP discontinuation intervention: Men taking daily oral PrEP (Truvada) will receive a monthly screener through the mobile app. If answers indicate a participant is at risk for PrEP discontinuation, a peer navigator will deliver a motivational interviewing intervention and a clinician will consult with the participant with the intention to avert PrEP discontinuation. Offering of on-demand oral PrEP: Men who are not interested in daily oral PrEP or plan to discontinue daily oral PrEP, will be offered on-demand oral PrEP (Truvada) to take it immediately before/after a sexual encounter. Offering of STI PEP: Men will be offered STI PEP (doxycycline) to use after condomless sex. A single dose of 200 mg to be taken within 24 hours of possible exposure no later than 72 hours after exposure. Participants will be dispensed enough pills to allow for up to 3 weekly doses of 200mg for 3 months. Injectable PrEP: For men who are interested, they will be referred to access Apretude (Cabotegravir injection) every two months. Their use will be monitored through monthly surveys where they can indicate interest in switching to oral PrEP.
Number of Men Who Initiate Long-acting Injectable PrEP	12 Participants

PRIMARY outcome

Timeframe: Baseline, 12 and 24 months post intervention

Population: Number of participants analyzed per time point includes total number of participants that completed each follow up lab testing.

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

Outcome measures

Outcome measures
Measure	All Men in Cohort: MSM n=240 Participants 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. PrEP discontinuation intervention: Men taking daily oral PrEP (Truvada) will receive a monthly screener through the mobile app. If answers indicate a participant is at risk for PrEP discontinuation, a peer navigator will deliver a motivational interviewing intervention and a clinician will consult with the participant with the intention to avert PrEP discontinuation. Offering of on-demand oral PrEP: Men who are not interested in daily oral PrEP or plan to discontinue daily oral PrEP, will be offered on-demand oral PrEP (Truvada) to take it immediately before/after a sexual encounter. Offering of STI PEP: Men will be offered STI PEP (doxycycline) to use after condomless sex. A single dose of 200 mg to be taken within 24 hours of possible exposure no later than 72 hours after exposure. Participants will be dispensed enough pills to allow for up to 3 weekly doses of 200mg for 3 months. Injectable PrEP: For men who are interested, they will be referred to access Apretude (Cabotegravir injection) every two months. Their use will be monitored through monthly surveys where they can indicate interest in switching to oral PrEP.
Number of STI Diagnoses Baseline	77 Participants
Number of STI Diagnoses 12 months post-intervention	33 Participants
Number of STI Diagnoses 24 months post-intervention	21 Participants

Adverse Events

All Men in Cohort: MSM

Serious events: 2 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	All Men in Cohort: MSM n=240 participants at risk 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. PrEP discontinuation intervention: Men taking daily oral PrEP (Truvada) will receive a monthly screener through the mobile app. If answers indicate a participant is at risk for PrEP discontinuation, a peer navigator will deliver a motivational interviewing intervention and a clinician will consult with the participant with the intention to avert PrEP discontinuation. Offering of on-demand oral PrEP: Men who are not interested in daily oral PrEP or plan to discontinue daily oral PrEP, will be offered on-demand oral PrEP (Truvada) to take it immediately before/after a sexual encounter. Offering of STI PEP: Men will be offered STI PEP (doxycycline) to use after condomless sex. A single dose of 200 mg to be taken within 24 hours of possible exposure no later than 72 hours after exposure. Participants will be dispensed enough pills to allow for up to 3 weekly doses of 200mg for 3 months. Injectable PrEP: For men who are interested, they will be referred to access Apretude (Cabotegravir injection) every two months. Their use will be monitored through monthly surveys where they can indicate interest in switching to oral PrEP.
Gastrointestinal disorders Nausea	0.42% 1/240 • Number of events 1 • Information on adverse events was collected starting at the time when participants gave consent to participate in the study and continued through the final assessment (up to 24 months).
Renal and urinary disorders Increased creatinine	0.42% 1/240 • Number of events 1 • Information on adverse events was collected starting at the time when participants gave consent to participate in the study and continued through the final assessment (up to 24 months).

Other adverse events

Other adverse events
Measure	All Men in Cohort: MSM n=240 participants at risk 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. PrEP discontinuation intervention: Men taking daily oral PrEP (Truvada) will receive a monthly screener through the mobile app. If answers indicate a participant is at risk for PrEP discontinuation, a peer navigator will deliver a motivational interviewing intervention and a clinician will consult with the participant with the intention to avert PrEP discontinuation. Offering of on-demand oral PrEP: Men who are not interested in daily oral PrEP or plan to discontinue daily oral PrEP, will be offered on-demand oral PrEP (Truvada) to take it immediately before/after a sexual encounter. Offering of STI PEP: Men will be offered STI PEP (doxycycline) to use after condomless sex. A single dose of 200 mg to be taken within 24 hours of possible exposure no later than 72 hours after exposure. Participants will be dispensed enough pills to allow for up to 3 weekly doses of 200mg for 3 months. Injectable PrEP: For men who are interested, they will be referred to access Apretude (Cabotegravir injection) every two months. Their use will be monitored through monthly surveys where they can indicate interest in switching to oral PrEP.
Gastrointestinal disorders Nausea	6.7% 16/240 • Number of events 16 • Information on adverse events was collected starting at the time when participants gave consent to participate in the study and continued through the final assessment (up to 24 months).
General disorders Hair loss	0.42% 1/240 • Number of events 1 • Information on adverse events was collected starting at the time when participants gave consent to participate in the study and continued through the final assessment (up to 24 months).
Skin and subcutaneous tissue disorders Skin irritation at phlebotomy site	0.42% 1/240 • Number of events 1 • Information on adverse events was collected starting at the time when participants gave consent to participate in the study and continued through the final assessment (up to 24 months).
General disorders Pain when walking	0.42% 1/240 • Number of events 1 • Information on adverse events was collected starting at the time when participants gave consent to participate in the study and continued through the final assessment (up to 24 months).
Renal and urinary disorders Proteinuria	0.42% 1/240 • Number of events 1 • Information on adverse events was collected starting at the time when participants gave consent to participate in the study and continued through the final assessment (up to 24 months).
General disorders Weight loss	0.42% 1/240 • Number of events 1 • Information on adverse events was collected starting at the time when participants gave consent to participate in the study and continued through the final assessment (up to 24 months).

Additional Information

Dr. Patrick Sullivan

Emory University

Phone: 404-727-2038

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place