Addressing Implementation Science Gaps for Doxycycline Post-Exposure Prophylaxis (doxy-PEP) Among Men Who Have Sex with Men Who Use Antiretrovirals for HIV Treatment or Prevention

Abstract

Abstract Addressing Implementation Science Gaps for Doxycycline Post-Exposure Prophylaxis (doxy-PEP) Among Men Who Have Sex with Men Who Use Antiretrovirals for HIV Treatment or Prevention Background: The epidemic of bacterial sexually transmitted infections (STIs) among men who have sex with men (MSM) in the US is unremitting, as demonstrated by 2.5 million diagnoses of chlamydia (CT), gonorrhea (GC), and syphilis reported in 2019 and 56% increases in GC cases and 74% increases in syphilis since 2019. Doxycycline is an inexpensive, widely available, and well-tolerated antimicrobial that has activity against CT, syphilis, and GC isolates that are susceptible to tetracycline. Recent studies have found that post-exposure prophylaxis with doxycycline (doxy-PEP) reduced incident CT, GC, and syphilis in populations of MSM. Lessons learned about user and provider barriers to implementing novel prevention interventions for which there may be divergent perspectives among MSM on preexposure prophylaxis (PrEP) or living with HIV (MLWH) and health care providers (HCPs). Biomedical HIV prevention through PrEP and treatment with antiretroviral (ARVs) are effective and almost eliminate HIV transmission when ARVs are used effectively to prevent HIV acquisition (PrEP) or transmission (undetectable equals untransmittable for people living with HIV) among MSM. Several factors may influence introduction and implementation of doxy-PEP in routine care, including sexual pleasure, partner communication, and perceived risk; however, few behavioral science evaluations have examined this in the context of biomedical STI prevention tools such as doxy-PEP. Furthermore, HCPs play an important role in the introduction of new medical interventions, yet little is known about HCPs perspectives on doxy-PEP to date. This study aimed to understand how doxy-PEP use influences MSM’s motivations and experiences with sexual decision-making, including pleasure-seeking and sexual quality of life, sampling both MSM who currently use PrEP and MSM living with HIV. Methods: We conducted two qualitative analyses; for the first study (Chapters 2 and 3), we leveraged existing research infrastructure to nest a qualitative evaluation in an ongoing randomized, open-label trial of doxy-PEP (R01AI143439). We recruited both MSM HIV-negative on PrEP and living with HIV who were randomized to take a single dose of doxycycline after condomless sex (“doxy-PEP”) and consented to participate in the in-depth interviews guided by the Sexual Health Model. We examined how doxy-PEP influences sexual health and safer sex, positive sexuality, and intimacy and relationships. For the second study (Chapter 4), we recruited HCPs from major cities with high STI rates according to the Center for Disease Control (CDC) through newsletters, emails, and in-person outreach to referrals from participants and local community-based organizations to identify providers known to be advocates for sexual health. HCPs with PrEP prescribing expertise and a large panel of MSM patients were invited to participate. The Diffusion of Innovation Theory guided the in-depth interviews. We examined knowledge of doxy-PEP, perspectives on prescribing doxy-PEP for bacterial STI prevention, and what it would take to get doxy-PEP implemented in their health setting. Results: In the first analysis of IDIs among MSM on PrEP and living with HIV, we interviewed 24 MSM on PrEP, participants reported that doxy-PEP improved their quality of life and was associated with more enjoyable sex experiences and increased intimacy. Participants generally felt doxy-PEP offered 'peace of mind' by reducing stress and anxiety associated with acquiring or transmitting an STI. Men also reported that taking doxy-PEP led to more open communication about their HIV status and PrEP use, STI testing, and sharing STI/HIV results and that doxy-PEP provided an additional layer of protection. We interviewed 19 MSM living with HIV, participants taking doxy-PEP reported less worry about STI transmission, and that doxy-PEP provided sexual freedom to have the type of sex they desired and decreased anxiety related to rejection from sexual partners because of their HIV status. In the second analysis, 30 HPs reported that while they thought doxy-PEP provided another tool in a toolkit to prevent STIs, they also had concerns about prescribing doxy-PEP for STI prevention, specifically related to antibiotic resistance, and identified the need for more data to understand the long-term safety of doxy-PEP. HCPs reported that normative guidelines about doxy-PEP would facilitate provider adoption of doxy-PEP and prescriptive practices. Conclusion: There is excitement and hope for the potential benefits of doxy-PEP use among MSM and their HPs. Sexual pleasure will be essential in messaging and introduction of doxy-PEP use among MSM, regardless of HIV status. Formalized guidelines and messaging for HCPs are needed to introduce doxy-PEP prescription into widespread clinical practice.