Preventing Premature Pre-Exposure Prophylaxis Discontinuation and Sexually Transmitted Infections Among Men Who Have Sex With Men (Project PEACH): Protocol for a Prospective Cohort Study

BackgroundThere is an ongoing syndemic of HIV and sexually transmitted infections (STIs) in the United States, particularly among men who have sex with men (MSM). We have increasingly effective and diverse measures of prevention, including various types of pre-exposure prophy...

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Main Authors: Amalia Aldredge, Derrius Carter, Candice A DeCree, Elliot V Gardner, Gina Bailey Herring, Oumaima Kaabi, Rebecca Moges-Banks, Rachel Valencia, Colleen Frances Kelley, Patrick Sean Sullivan
Format: Article
Language:English
Published: JMIR Publications 2025-04-01
Series:JMIR Research Protocols
Online Access:https://www.researchprotocols.org/2025/1/e56096
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author Amalia Aldredge
Derrius Carter
Candice A DeCree
Elliot V Gardner
Gina Bailey Herring
Oumaima Kaabi
Rebecca Moges-Banks
Rachel Valencia
Colleen Frances Kelley
Patrick Sean Sullivan
author_facet Amalia Aldredge
Derrius Carter
Candice A DeCree
Elliot V Gardner
Gina Bailey Herring
Oumaima Kaabi
Rebecca Moges-Banks
Rachel Valencia
Colleen Frances Kelley
Patrick Sean Sullivan
author_sort Amalia Aldredge
collection DOAJ
description BackgroundThere is an ongoing syndemic of HIV and sexually transmitted infections (STIs) in the United States, particularly among men who have sex with men (MSM). We have increasingly effective and diverse measures of prevention, including various types of pre-exposure prophylaxis (PrEP) for HIV prevention and doxycycline postexposure prophylaxis (doxyPEP) for STI prevention. As options expand, we need to understand how to use a combination of these strategies and other supports for MSM to best curb the syndemic. ObjectiveWe designed a patient-preference trial to understand patient preferences for PrEP and doxyPEP, how preferences may change over time, and methods for preventing premature discontinuation of PrEP. MethodsWe enrolled HIV-negative MSM in metropolitan Atlanta, Georgia. Participants could elect to take PrEP (daily or on-demand), doxyPEP, both, or neither, along with app-based support to evaluate for risk factors of discontinuation or behavioral changes that might affect their choice of prevention methods. Participants were able to switch prevention methods at any time. Oral PrEP and doxyPEP users are currently being offered quarterly in-person or at-home HIV, syphilis, gonorrhea, and chlamydia testing along with opportunities for motivational interviewing. ResultsWe enrolled individuals from November 2021 to September 2023. Among 240 participants, the median age was 30 (IQR 25-35), 63% (n=150) self-identified as non-Hispanic Black, and 69% (n=166) were insured. Most participants (n=144, 60%) elected to take daily PrEP plus doxyPEP, with a smaller proportion taking on-demand PrEP plus doxyPEP (n=34, 14%) or daily PrEP without doxyPEP (n=33, 14%). ConclusionsWe designed an ongoing study to evaluate the preferences for PrEP and doxyPEP among MSM in metropolitan Atlanta. Enrollment was completed in 22 months and included a diverse cohort of MSM that will be followed longitudinally to evaluate prevention preferences over time. At baseline, most participants preferred to take a combination of daily PrEP and doxyPEP for HIV and STI prevention. Trial RegistrationClinicaltrials.gov NCT05072093; https://clinicaltrials.gov/study/NCT05072093 International Registered Report Identifier (IRRID)DERR1-10.2196/56096
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spelling doaj-art-3e5fcf65b48f4fbb970bdf0035952bbd2025-08-20T03:15:03ZengJMIR PublicationsJMIR Research Protocols1929-07482025-04-0114e5609610.2196/56096Preventing Premature Pre-Exposure Prophylaxis Discontinuation and Sexually Transmitted Infections Among Men Who Have Sex With Men (Project PEACH): Protocol for a Prospective Cohort StudyAmalia Aldredgehttps://orcid.org/0000-0002-8044-4298Derrius Carterhttps://orcid.org/0009-0001-9092-3954Candice A DeCreehttps://orcid.org/0009-0002-8741-5104Elliot V Gardnerhttps://orcid.org/0009-0004-7558-196XGina Bailey Herringhttps://orcid.org/0000-0002-2306-1194Oumaima Kaabihttps://orcid.org/0009-0003-7995-0294Rebecca Moges-Bankshttps://orcid.org/0009-0001-4489-8946Rachel Valenciahttps://orcid.org/0000-0002-9130-7176Colleen Frances Kelleyhttps://orcid.org/0000-0001-5611-0119Patrick Sean Sullivanhttps://orcid.org/0000-0002-7728-0587 BackgroundThere is an ongoing syndemic of HIV and sexually transmitted infections (STIs) in the United States, particularly among men who have sex with men (MSM). We have increasingly effective and diverse measures of prevention, including various types of pre-exposure prophylaxis (PrEP) for HIV prevention and doxycycline postexposure prophylaxis (doxyPEP) for STI prevention. As options expand, we need to understand how to use a combination of these strategies and other supports for MSM to best curb the syndemic. ObjectiveWe designed a patient-preference trial to understand patient preferences for PrEP and doxyPEP, how preferences may change over time, and methods for preventing premature discontinuation of PrEP. MethodsWe enrolled HIV-negative MSM in metropolitan Atlanta, Georgia. Participants could elect to take PrEP (daily or on-demand), doxyPEP, both, or neither, along with app-based support to evaluate for risk factors of discontinuation or behavioral changes that might affect their choice of prevention methods. Participants were able to switch prevention methods at any time. Oral PrEP and doxyPEP users are currently being offered quarterly in-person or at-home HIV, syphilis, gonorrhea, and chlamydia testing along with opportunities for motivational interviewing. ResultsWe enrolled individuals from November 2021 to September 2023. Among 240 participants, the median age was 30 (IQR 25-35), 63% (n=150) self-identified as non-Hispanic Black, and 69% (n=166) were insured. Most participants (n=144, 60%) elected to take daily PrEP plus doxyPEP, with a smaller proportion taking on-demand PrEP plus doxyPEP (n=34, 14%) or daily PrEP without doxyPEP (n=33, 14%). ConclusionsWe designed an ongoing study to evaluate the preferences for PrEP and doxyPEP among MSM in metropolitan Atlanta. Enrollment was completed in 22 months and included a diverse cohort of MSM that will be followed longitudinally to evaluate prevention preferences over time. At baseline, most participants preferred to take a combination of daily PrEP and doxyPEP for HIV and STI prevention. Trial RegistrationClinicaltrials.gov NCT05072093; https://clinicaltrials.gov/study/NCT05072093 International Registered Report Identifier (IRRID)DERR1-10.2196/56096https://www.researchprotocols.org/2025/1/e56096
spellingShingle Amalia Aldredge
Derrius Carter
Candice A DeCree
Elliot V Gardner
Gina Bailey Herring
Oumaima Kaabi
Rebecca Moges-Banks
Rachel Valencia
Colleen Frances Kelley
Patrick Sean Sullivan
Preventing Premature Pre-Exposure Prophylaxis Discontinuation and Sexually Transmitted Infections Among Men Who Have Sex With Men (Project PEACH): Protocol for a Prospective Cohort Study
JMIR Research Protocols
title Preventing Premature Pre-Exposure Prophylaxis Discontinuation and Sexually Transmitted Infections Among Men Who Have Sex With Men (Project PEACH): Protocol for a Prospective Cohort Study
title_full Preventing Premature Pre-Exposure Prophylaxis Discontinuation and Sexually Transmitted Infections Among Men Who Have Sex With Men (Project PEACH): Protocol for a Prospective Cohort Study
title_fullStr Preventing Premature Pre-Exposure Prophylaxis Discontinuation and Sexually Transmitted Infections Among Men Who Have Sex With Men (Project PEACH): Protocol for a Prospective Cohort Study
title_full_unstemmed Preventing Premature Pre-Exposure Prophylaxis Discontinuation and Sexually Transmitted Infections Among Men Who Have Sex With Men (Project PEACH): Protocol for a Prospective Cohort Study
title_short Preventing Premature Pre-Exposure Prophylaxis Discontinuation and Sexually Transmitted Infections Among Men Who Have Sex With Men (Project PEACH): Protocol for a Prospective Cohort Study
title_sort preventing premature pre exposure prophylaxis discontinuation and sexually transmitted infections among men who have sex with men project peach protocol for a prospective cohort study
url https://www.researchprotocols.org/2025/1/e56096
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