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PrEP/PEP Strategies for HIV Prevention

Phase 4
Recruiting
Led By Patrick Sullivan, MD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
≥1 male anal sex partner in the 12 months before the baseline interview
Self-identify as Cisgender Male
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 12 and 24 months post intervention
Awards & highlights

Study Summary

This trial is studying the use of different methods of pre-exposure prophylaxis (PrEP), post-exposure prophylaxis (PEP), and/or injectable PrEP among young men who have sex with men.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include digestive issues from oral PrEP, reactions at injection sites from injectable PrEP, and general medication-related risks like allergies or liver toxicity. The specific side effects will depend on the type of intervention used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had a male sexual partner in the past year.
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I identify as a cisgender male.
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I am between 18 and 45 years old.
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I was assigned male at birth.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 12 and 24 months post intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 12 and 24 months post intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in number of STI diagnoses from baseline at 12 and 24 months
Number of men who discontinue daily oral PrEP
Number of men who initiate long-acting injectable PrEP
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: All men in cohort: MSMExperimental Treatment4 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.

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,640 Previous Clinical Trials
2,560,496 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,786 Previous Clinical Trials
2,689,567 Total Patients Enrolled
Patrick Sullivan, MDPrincipal InvestigatorEmory University
1 Previous Clinical Trials
22,445 Total Patients Enrolled

Media Library

Offering of STI PEP Clinical Trial Eligibility Overview. Trial Name: NCT05072093 — Phase 4
HIV/AIDS Research Study Groups: All men in cohort: MSM
HIV/AIDS Clinical Trial 2023: Offering of STI PEP Highlights & Side Effects. Trial Name: NCT05072093 — Phase 4
Offering of STI PEP 2023 Treatment Timeline for Medical Study. Trial Name: NCT05072093 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the purpose of providing Post-Exposure Prophylaxis for Sexually Transmitted Infections?

"Typically, HIV infections are treated with Offering of STI PEP. This medication is also capable of managing other illnesses such as q fever, severe acne and disease."

Answered by AI

How can I become a participant in this experiment?

"Qualified contenders for this clinical trial should have HIV and be in the 18-45 age bracket. 200 patients are being admitted into the program."

Answered by AI

How secure is the provision of post-exposure prophylaxis for sexually transmitted infections?

"STI PEP has attained approval for clinical use, thus our team graded its safety a 3 on the scale from 1 to 3."

Answered by AI

Are there historical precedents of Offering of STI PEP trials?

"Currently, Offering of STI PEP is being evaluated in 131 active studies with 36 Phase 3 trials. Most are centred around Boylston, Massachusetts but across the country there are 1661 sites that offer clinical trial services related to this intervention."

Answered by AI

For what number of participants is this clinical experiment recruiting?

"Affirmative. According to clinicaltrials.gov, this medical study is currently enrolling patients; the trial was first launched on November 20th 2021 and has been refreshed most recently on June 2nd 2022. 200 participants must be recruited from one particular centre for completion of the experiment."

Answered by AI

Does the upper age limit for this medical trial encompass those aged 80 and above?

"This clinical trial has implemented an age restriction, mandating that participants be between 18 and 45 years old."

Answered by AI

Are there any available openings for participants in this research project?

"Indeed, the information on clinicaltrials.gov reveals that this research is still in progress and recruiting participants. The initial posting was made back on November 20th 2021 with the most recent edits having been done June 2nd 2022; 200 patients are required from a single facility."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Parrying the Pitfalls of PrEP: Project PEACH
Patrick S Sullivan 2021. "Parrying the Pitfalls of PrEP: Project PEACH". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05072093.
~47 spots leftby Feb 2025
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