PrEP/PEP Strategies for HIV Prevention

Overseen By Colleen Kelley, MD

Age: 18 - 65

Sex: Male

Trial Phase: Phase 4

Sponsor: Emory University

Disqualifiers: HIV positive, Pregnant, Prisoners, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to identify the best methods to prevent HIV among young men who have sex with men (MSM). The study will evaluate various strategies, such as daily pills (oral PrEP), injections (injectable PrEP), and on-demand oral PrEP, to determine their effectiveness in preventing HIV and other sexually transmitted infections (STIs). Participants can switch between these options during the two-year study. It is suitable for HIV-negative men living in the Atlanta area who have had male partners in the past year and are willing to use a health app on their phones. As a Phase 4 trial, the treatments are already FDA-approved and proven effective, allowing participants to contribute to research that enhances understanding of how these treatments benefit more patients.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It focuses on HIV prevention strategies, so it's best to discuss your current medications with the study team.

What is the safety track record for these treatments?

Research has shown that both daily oral PrEP and injectable PrEP are safe and effective for preventing HIV. People without HIV have safely used daily oral PrEP for up to five years, and studies indicate it is well-tolerated with no major side effects. Injectable PrEP, specifically cabotegravir, has also proven safe and significantly reduces the risk of HIV.

On-demand oral PrEP, taken only when needed instead of daily, is safe and effective, particularly for men who have sex with men. Research indicates it works well when taken before and after possible exposure to HIV.

To stop PrEP safely, it is important to know how long to continue after potential exposure to HIV. Although specific data on stopping safely isn't detailed, the focus remains on ensuring protection during and after use.

STI PEP (post-exposure treatment for sexually transmitted infections) is generally safe and well-tolerated, with patients reporting only mild side effects, if any.

Overall, these treatments are considered safe, with research supporting their use in preventing HIV and, in the case of PEP, some STIs. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments for HIV prevention because they offer diverse approaches to suit different needs. Unlike the standard daily oral PrEP, injectable PrEP provides a long-acting option, reducing the need for daily commitment. The on-demand oral PrEP offers flexibility, allowing individuals to take it only when needed around potential exposure. Additionally, the PrEP discontinuation intervention explores safe ways to stop PrEP when it's no longer necessary, and the STI PEP option provides a backup for potential exposure to sexually transmitted infections. These varied methods not only enhance convenience but also aim to improve adherence and cater to individual preferences, which could significantly boost prevention efforts.

What evidence suggests that this trial's treatments could be effective for HIV prevention?

Research has shown that taking daily oral PrEP (pre-exposure prophylaxis) can reduce the risk of contracting HIV by up to 98% when taken correctly. In this trial, participants may choose from various prevention strategies, including daily oral PrEP, injectable PrEP, and on-demand oral PrEP. Studies indicate that injectable PrEP is even more effective, working over 99% of the time. On-demand oral PrEP, taken only when needed, offers about 86% protection against HIV when used properly. Additionally, for those at risk of sexually transmitted infections (STIs), taking doxycycline as STI PEP (post-exposure prophylaxis) has reduced STI rates by 62%. These methods provide strong evidence for lowering the risk of HIV and STIs. ^{1 6 7 8 9}

Who Is on the Research Team?

Patrick Sullivan, MD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have had a male sexual partner in the past year.

Live in the Atlanta MSA

I identify as a cisgender male.

Exclusion Criteria

I am under 18 years old.

Currently enrolled in an HIV prevention or treatment clinical trial

I am not willing to download a health app for the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person or virtual)

Baseline

Participants attend a baseline visit for consent, initial testing, and app orientation

1 day

1 visit (in-person or virtual)

Treatment and Monitoring

Participants receive PrEP and/or STI PEP, with regular surveys and monitoring for adherence and side effects

24 months

3 visits (in-person or virtual) at months 12 and 24, plus monthly and weekly surveys

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

1 visit (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Daily oral PrEP
• Injectable PrEP
• On-demand oral PrEP
• PrEP discontinuation intervention
• STI PEP

Trial Overview 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.

How Is the Trial Designed?

Group I: All men in cohort: MSM Experimental Treatment 4 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.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Citations

1. cdc.gov cdc.gov/mmwr/volumes/74/wr/mm7435a1.htm

Clinical Recommendation for the Use of Injectable ... The two trials reported LEN efficacy at reducing HIV infection as 100% among females and 96% among a primarily male trial population, compared ...

2. academic.oup.com academic.oup.com/ofid/article/12/9/ofaf539/8246006

HIV Oral Pre-exposure Prophylaxis Effectiveness, Adherence ... A temporary discontinuation occurred in 106/1489 users (7.1%), who returned to the PrEP program after 12 months of interruption, while the other ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12465438/

Adherence to on-demand and daily oral pre-exposure ... A study using the iPrEx model inferred HIV risk reduction of 89% (51–98%) after two doses, 96% (95% CI, 60–100%) after three doses, and 98% (67– ...

4. viivhealthcare.com viivhealthcare.com/hiv-news-and-media/news/press-releases/2024/october/real-world-studies-for-apretude/

ViiV Healthcare shows more than 99% effectiveness in real ... Findings from two real-world evidence studies (from OPERA and Trio Health cohorts) showed more than 99% effectiveness of CAB LA for PrEP in ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9096492/

Oral pre-exposure prophylaxis (PrEP) to prevent HIV Daily oral tenofovir was found to be effective, with a 49% reduction in HIV acquisition (RR 0.51, 95% CI 0.29 to 0.92; RD −0.00, 95% CI −0.00 to −0.01). In this ...

6. cdc.gov cdc.gov/hivnexus/hcp/prep/index.html

Clinical Guidance for PrEP | HIV Nexus Daily oral PrEP with F/TAF is recommended to prevent HIV ... data suggest that PrEP is safe and effective for HIV prevention among adolescent patients.

7. prepwatch.org prepwatch.org/products/oral-prep/

Oral PrEP There are currently two daily pills approved and available as oral PrEP. Below are details on each product's distinct characteristics, approval history, ...

8. hiv.gov hiv.gov/hiv-basics/hiv-prevention/using-hiv-medication-to-reduce-risk/pre-exposure-prophylaxis

Pre-Exposure Prophylaxis Is PrEP Safe? PrEP is safe. No significant health effects have been seen in people who are HIV-negative and have taken PrEP for up to 5 years.

9. hivprep.uw.edu hivprep.uw.edu/pdf/hiv-prep-depth-topics/hiv-prep-adolescents/core-concept/all

HIV PrEP for Adolescents and Young Adults - Core Concepts TDF-FTC is considered safe for use in pregnancy. Tenofovir alafenamide-Emtricitabine (TAF-FTC): Daily oral TAF-FTC is recommended as an option.