A Mobile-Based App (MyChoices) to Increase Uptake of HIV Testing and Pre-Exposure Prophylaxis by Young Men Who Have Sex With Men: Protocol for a Pilot Randomized Controlled Trial

BACKGROUND: HIV incidence is growing most rapidly in the United States among young men who have sex with men (YMSM). Overwhelming evidence demonstrates that routine testing and expanded use of pre-exposure prophylaxis (PrEP) would dramatically reduce the population burden of HIV; however, uptake of both interventions is suboptimal among young adults. The use of mobile phone apps by YMSM is ubiquitous and may offer unique opportunities for public health interventions. MyChoices is a theory-driven app to increase HIV testing and PrEP uptake. It was developed by an interdisciplinary team based on feedback from a diverse sample of YMSM. OBJECTIVE: The aim of this paper is to describe the protocol for the refinement, beta testing, and pilot randomized controlled trial (RCT) to examine the acceptability and feasibility of the MyChoices app. METHODS: This 3-phase study includes 4 theater testing groups for app refinement with a total of approximately 30 YMSM; for beta testing, including quantitative assessments and exit interviews, with approximately 15 YMSM over a 2-month period; and for a pilot RCT with 60 YMSM. The pilot will assess feasibility, acceptability, and preliminary efficacy of the MyChoices app, compared with referrals only, in increasing HIV testing and PrEP uptake. All participants will be recruited at iTech clinical research sites in Boston, MA, and Bronx, NY. RESULTS: App refinement is underway. Enrollment for the pilot RCT began in October 2018. CONCLUSIONS: MyChoices is one of the first comprehensive, theory-driven HIV prevention apps designed specifically for YMSM. If MyChoices demonstrates acceptability and feasibility in this pilot RCT, a multicity, 3-arm randomized controlled efficacy trial of this app and another youth-optimized app (LYNX) versus standard of care is planned within iTech. If shown to be efficacious, the app will be scalable, with the ability to reach YMSM across the United States as well as be geographically individualized, with app content integrated with local prevention and testing activities

A Pre-Exposure Prophylaxis Adherence Intervention (LifeSteps) for Young Men Who Have Sex With Men: Protocol for a Pilot Randomized Controlled Trial

BACKGROUND: New HIV infections occur at a disproportionately high rate among young men who have sex with men (YMSM). It is, therefore, essential that comprehensive HIV prevention strategies, specifically tailored to their needs and perceptions, are developed, tested, and disseminated. Antiretroviral pre-exposure prophylaxis (PrEP) is effective in decreasing HIV transmission among men who have sex with men; however, adherence is critical to its efficacy. In open-label studies among YMSM, adherence was suboptimal. Hence, behavioral approaches that address the unique challenges to YMSM PrEP adherence are needed. OBJECTIVE: This study aims to describe the protocol for intervention refinement and a pilot randomized controlled trial (RCT) of a PrEP adherence intervention, LifeSteps for pre-exposure prophylaxis for young men who have sex with men (LSPY). METHODS: This study includes the following 2 phases: formative qualitative interviews with approximately 20 YMSM and 10 key informants for intervention adaptation and refinement and a pilot RCT of up to 50 YMSM to assess the feasibility, acceptability, and preliminary efficacy of the LSPY, compared with the PrEP standard of care, to improve PrEP adherence. Participants will be recruited at 3 iTech subject recruitment venues in the United States. RESULTS: Phase 1 is expected to begin in June 2018, and enrollment of phase 2 is anticipated to begin in early 2019. CONCLUSIONS: Few rigorously developed and tested interventions have been designed to increase PrEP adherence among YMSM in community settings, despite this population's high HIV incidence. The long-term goal of this intervention is to develop scalable protocols to optimize at-risk YMSM's PrEP uptake and adherence to decrease the HIV incidence

Until Society Evolves: Access to Gender-Affirming Care in Historic Assessment Criteria and Current Models of Care

Contemporary debates about access to gender-affirming care for transgender and gender diverse (TGD) individuals include whether this care can be provided on an informed consent basis or whether access should require mental health assessment (Bockting, 2009; Cavanaugh et al., 2016). Current standards of care which recommend mental health assessment are largely based upon the expert consensus of gender identity researchers and clinicians (Coleman et al., 2012; Levine, 2009). In this study, I aimed to explicate the historical and cultural context that informed this expert consensus, and to connect this historical context to current debates on access to care. Aim 1, a synthesis of the historical context regarding gender-affirming care, used Foucauldian Genealogy and Inductive Thematic Coding to analyze archival data on the criteria for access to care. Six themes emerged from the analysis. The first grouping of three themes (Cure vs. Medical Rehabilitation, Prevention of Transsexualism vs. Societal Acceptance, and Assimilation vs. Ambiguity) outline first the attempt to “cure” gender diverse identities, then the attempt to “prevent” these identities in youth, and finally the normative “assimilation” criteria used by clinicians and researchers to restrict access to gender-affirming care. The second grouping of three themes (Protecting Patients vs. Self-Determination, Reality vs. Fantasy, and Objectivity vs. Empathy) outline trans community perspectives on the criteria for access to care, the shift in access to care with the probationary “real-life test,” and the impact of trans community challenges and provider humility on changes in criteria. Aim 2 synthesized the current (2012-2021) academic literature on access to gender-affirming care using Qualitative Metasynthesis and Critical Discourse Analysis. Two major themes, the Assessment Model vs. the Informed Consent Model (ICM), emerged from the analysis. The criteria for access to gender-affirming care showed both continuity and discontinuity over time. Broadly, Assessment Model authors prioritized the prevention of post-transition regret, while ICM authors prioritized patient autonomy. To rectify historical and ongoing harm as expressed by TGD individuals, providers can center practices that support patient autonomy and center cultural humility

A Pre-Exposure Prophylaxis Adherence Intervention (LifeSteps) for Young Men Who Have Sex With Men: Protocol for a Pilot Randomized Controlled Trial

New HIV infections occur at a disproportionately high rate among young men who have sex with men (YMSM). It is, therefore, essential that comprehensive HIV prevention strategies, specifically tailored to their needs and perceptions, are developed, tested, and disseminated. Antiretroviral pre-exposure prophylaxis (PrEP) is effective in decreasing HIV transmission among men who have sex with men; however, adherence is critical to its efficacy. In open-label studies among YMSM, adherence was suboptimal. Hence, behavioral approaches that address the unique challenges to YMSM PrEP adherence are needed. This study aims to describe the protocol for intervention refinement and a pilot randomized controlled trial (RCT) of a PrEP adherence intervention, LifeSteps for pre-exposure prophylaxis for young men who have sex with men (LSPY). This study includes the following 2 phases: formative qualitative interviews with approximately 20 YMSM and 10 key informants for intervention adaptation and refinement and a pilot RCT of up to 50 YMSM to assess the feasibility, acceptability, and preliminary efficacy of the LSPY, compared with the PrEP standard of care, to improve PrEP adherence. Participants will be recruited at 3 iTech subject recruitment venues in the United States. Phase 1 is expected to begin in June 2018, and enrollment of phase 2 is anticipated to begin in early 2019. Few rigorously developed and tested interventions have been designed to increase PrEP adherence among YMSM in community settings, despite this population's high HIV incidence. The long-term goal of this intervention is to develop scalable protocols to optimize at-risk YMSM's PrEP uptake and adherence to decrease the HIV incidence. DERR1-10.2196/10661

Additional file 1: of Comparing self- and provider-collected swabbing for HPV DNA testing in female-to-male transgender adult patients: a mixed-methods biobehavioral study protocol

Diagram & Definition of Terms. (PDF 311 kb

Additional file 2: of Comparing self- and provider-collected swabbing for HPV DNA testing in female-to-male transgender adult patients: a mixed-methods biobehavioral study protocol

Provider Assessment and Interaction Tool. (DOCX 34 kb

Additional file 3: of Comparing self- and provider-collected swabbing for HPV DNA testing in female-to-male transgender adult patients: a mixed-methods biobehavioral study protocol

Patient Satisfaction Survey. (DOC 48 kb