Abstract

Pre-exposure prophylaxis (PrEP) for the prevention of HIV infection among young men who have sex with men is a critical part of the HIV prevention landscape in the US. Given the unique challenges and resources of young MSM negotiating safer sex practices, including PrEP, counseling and supportive discussions to optimize both PrEP use and sexual health protection more generally may facilitate reaching HIV prevention goals. Within the context of a large, open-label PrEP study (ATN110/113), support for sexual health promotion and PrEP use was provided through use of integrated Next Step Counseling (iNSC) as part of study visits. We detail iNSC and, using session documentation collected throughout this study, we characterize iNSC implementation and the content generated from these discussions. We detail features of iNSC, training of counselors and the implementation of iNSC in a multi-site PrEP study with young MSM in the US. Case report forms completed by iNSC counselors at study visits at weeks 4, 8, 12, 24, 36, and 48 were evaluated. Implementation of each intervention step for each discussion is summarized at and across timepoints, as well as features of specific steps (e.g., kinds of facilitators and barriers). Implementation differences by group (e.g., race/ethnicity, age) were examined. iNSC case report forms from 1000 sessions involving 178 unique participants ages 15–22 from sessions conducted between 2013 and 2015 were reviewed. High fidelity to iNSC steps in terms of inclusion in sessions was reported; 98–100% of sessions included critical steps for sexual health protection discussions and 96–98% for PrEP use discussions. The vast majority of sessions appeared to flow in line with iNSC’s emphasis on exploration and open discussion prior to considering specific needs and related strategies. Nearly three-quarters of sessions noted ‘commitment to staying negative’ as a motivator towards sexual health protection (more commonly reported by those identifying as White), while ‘assuming partner is negative’ was the most common challenge (less common for the older cohort), and ‘having access’ to a sexual health protection tool or strategy (besides PrEP) was the most common “need” (more common for those identifying as White or Latino). Carrying dose(s) to have them on-hand when needed was the most common PrEP adherence facilitator, drug and alcohol use was the most common challenge noted, and access to a dose when needed was the most common “need” (more common for participants self-identified as White). iNSC was implemented consistently throughout ATN110/113, and patient-centered discussions about sexual health protection and PrEP-use appeared feasible to incorporate into clinical care visits.

Highlights

  • Pre-exposure prophylaxis (PrEP) is a well-supported HIV prevention strategy [1,2,3], approved by the United States Food and Drug Administration (FDA) since 2012 and increasingly prescribed in the US

  • Various demonstration and open-label PrEP projects have adopted PrEP adherence support strategies ranging from text-message reminders to multi-session Cognitive Behavioral Therapy-based interventions, which vary in terms of time and intensity for PrEP users and care teams alike

  • Integrated Step Counseling was created as a conversational, participant-centered ‘check-in’ on sexual health protection through non-biomedical and biomedical (PrEP) strategies, Implementing Integrated Next Step Counseling (iNSC) with adolescent and young adult men who have sex with men (MSM), we drew from well-established models of adherence that we situated within the larger socio-ecological context in which youth navigate their sexual health and well-being

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Summary

Introduction

Pre-exposure prophylaxis (PrEP) is a well-supported HIV prevention strategy [1,2,3], approved by the United States Food and Drug Administration (FDA) since 2012 and increasingly prescribed in the US. In a recent open-label study within the Adolescent Trials Network (ATN) of young men who have sex with men in the United States (ATN110/113) [11, 12], we adopted a basic PrEP use support package originally developed in the iPrEX open label extension (iPrEX OLE) [13] that includes discussions about sexual health protection generally and specific to PrEP use. Integrated Step Counseling (iNSC) was created as a conversational, participant-centered ‘check-in’ on sexual health protection through non-biomedical and biomedical (PrEP) strategies, Implementing iNSC with adolescent and young adult men who have sex with men (MSM), we drew from well-established models of adherence that we situated within the larger socio-ecological context in which youth navigate their sexual health and well-being. In addition to comprehensive education prior to starting PrEP and instructions once PrEP is prescribed, iNSC is envisioned as a facilitated discussion of sexual health that can be implemented by clinicians or clinical care team members

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