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Clinical Trial Summary

The study is a prospective cohort of young Black MSM who are followed for 2 years either in-person at the PRISM Health Community Clinic and/or virtually with telehealth study visits. Follow-up visits occur as frequently as every 3 months, or as appropriate to clinical needs of HIV PrEP or STI PEP. The investigators will enroll men who are not on PrEP at study initiation and who may decide to start or stop PrEP, change from daily oral PrEP to on-demand PrEP or from on-demand PrEP to daily PrEP, and/or start or stop STI PEP at any point in the study period. If there is trouble enrolling men who are not currently on PrEP, the investigators will expand enrollment criteria to include men currently on PrEP. All men will be provided with the study's mobile smart phone app to support early identification of risks for PrEP discontinuation, to provide information about STI PEP and document usage patterns of on-demand PrEP and STI PEP, and to support easy linkage to support services for PrEP counseling and addressing concerns or questions about STI PEP.


Clinical Trial Description

Young Black men who have sex with me (MSM) are disproportionately impacted by the U.S. HIV epidemic. Pre-exposure prophylaxis, or PrEP, is a relatively newer HIV prevention strategy that involves taking HIV antiviral medications either daily or on-demand to prevent HIV infection following high risk sexual activity. Both daily and on-demand PrEP have been shown to prevent infection if taken consistently and correctly. A prior research with this high-risk population in Atlanta, where it was offered daily PrEP to study participants, resulted in significant PrEP interest and initiation however high rates of PrEP discontinuation throughout the study were of great concern and, in some cases, led to HIV infection. Additionally, the study found high rates of bacterial sexually transmitted infection (STI) diagnoses both independent of, and concurrent with, higher PrEP use leading to concerns that condoms are not being used among young Black MSM on PrEP. The proposed work will expand upon the previous study with an intervention focus for young Black MSM in Atlanta with aims of (1) preventing daily PrEP discontinuation; (2) offering on-demand PrEP as an alternative for MSM not interested in daily PrEP; and, (3) decreasing the incidence of bacterial STIs by offering STI post-exposure prophylaxis (PEP) which involves taking doxycycline immediately following high risk sexual behavior. The study will involve a cohort of 300 Black MSM aged 18-29 in Atlanta who will be followed for two years. Participants will be recruited online from social media and dating websites, and in-person from different venues and events where young Black MSM are known to attend. Men will take a short online eligibility screener either on a tablet, if recruited in-person, or on their own device if recruited online. Participants will be compensated for the various study activities (e.g., study visits, online behavioral surveys, weekly/monthly surveys). If men screen eligible, they will be invited to a baseline study visit that will occur either in-person at the research clinic or virtually. Because of the ongoing COVID-19 pandemic, the plan is to offer participants the option of conducting study activities virtually or in-person. Consent will occur at the beginning of the baseline visit. Following the baseline visit, all participants will have two more study visits at months 12 and 24. At the three study visits, participants will be tested for HIV, STIs and drugs of abuse and take an online behavioral survey. Participants will also take an online behavioral survey at months 4, 7 and 19. At all study visits, participants will discuss with the study counselor the various prevention options the study is offering-daily PrEP, on-demand PrEP and STI PEP. If a participant elects to begin any of these, study staff will assist them in accessing PrEP from a community pharmacy and STI PEP (doxycycline) from the Emory Investigational Drug Service. Participants who start PrEP and/or STI PEP will take short weekly surveys for the first 2 weeks to monitor use and side effects. Following that 2-week period, daily PrEP users will get a monthly survey to try and detect warning signs of discontinuation so that the study can intervene to prevent that from happening. On-demand PrEP and STI PEP users will continue to get weekly surveys to monitor use and side effects. PrEP and STI PEP users will have a 3-monthly visit-either in-person or virtually-to monitor their use and to test for HIV and STIs. PrEP users will also have their kidney function monitored by creatinine testing. Participants electing to do their study activities virtually will be sent specimen collection kits so that they can self-collect specimens for all the required labs. They will mail back the specimens to the lab in a pre-paid postage mailer. All participants will be required to download the study app at the baseline visit and will be oriented to using it to retrieve study communication, surveys, lab results, etc. Additionally, the app will be used to schedule and conduct video conferencing sessions between participants and study clinicians/staff. If a participant reports warning signs of PrEP discontinuation, a peer navigator on staff will reach out through the app to try and schedule a counseling session that will use a motivational interviewing approach to support PrEP persistence. The proposed work is of great significance for the field as novel approaches to preventing early discontinuation of PrEP are of utmost importance for preventing HIV transmission among young, Black MSM. If engaging with them frequently and assessing for warning signs of discontinuation is shown to be an effective strategy for intervening and preventing stoppage, then the implications for future interventions by community PrEP providers and clinicians is significant. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05072093
Study type Interventional
Source Emory University
Contact Colleen Kelley, MD
Phone 404-712-1823
Email [email protected]
Status Not yet recruiting
Phase Phase 4
Start date October 2021
Completion date January 2025

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