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PrEP/PEP Strategies for HIV Prevention

Phase 4

Waitlist Available

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

Must not have

Individuals who are not yet adults (infants, children, teenagers)

Adults unable to consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 12 and 24 months post intervention

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am under 18 years old.

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I am unable to give consent for myself.

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I do not identify as a cisgender male.

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I am HIV positive.

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I have not had a male anal sex partner in the last year.

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I am younger than 18 or older than 45.

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I was assigned female at birth.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 12 and 24 months post intervention

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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.

0 / 11Eligibility criteria met