Work2Prevent, an Employment Intervention Program as HIV Prevention for Young Men Who Have Sex With Men and Transgender Youth of Color (Phase 3): Protocol for a Single-Arm Community-Based Trial to Assess Feasibility and Acceptability in a Real-World Setting.

BACKGROUND: In the United States, young cisgender men who have sex with men (YMSM), young transgender women (YTW), and gender nonconforming (GNC) youth face elevated rates of HIV infection. However, racial and ethnic disparities in adolescent HIV infection cannot be attributed to individual-level factors alone and are situated within larger social and structural contexts that marginalize and predispose sexual and gender minority youth of color to HIV. Addressing broader ecological factors that drive transmission requires interventions that focus on the distal drivers of HIV infection, including violence exposure, housing, food insecurity, educational attainment, and employment. Given the ways that economic instability may make YMSM, YTW, and GNC youth of color vulnerable to HIV exposure, this study focuses on employment as an HIV prevention intervention. More specifically, the intervention, called Work2Prevent (W2P), targets economic stability through job readiness and employment as a means of preventing behaviors and factors associated with adolescent and young adult HIV, such as transactional sex work and homelessness. The intervention was adapted from iFOUR, an evidence-based employment program for HIV-positive adults in phase 1 of this study, and pilot tested in a university-based setting in phase 2. OBJECTIVE: This paper aims to describe the protocol for the community-based test phase of W2P. The purpose of this phase was to pilot test a tailored, theoretically informed employment intervention program among YMSM, YTW, and GNC youth of color within a lesbian, gay, bisexual, transgender, and queer (LGBTQ) community setting. METHODS: The employment intervention was pilot tested using a single-arm pretest-posttest trial design implemented among a sample of vulnerable YMSM, YTW, and GNC youth of color using services within a community-based LGBTQ center. Assessments will examine intervention feasibility, acceptability, and preliminary estimates of efficacy. RESULTS: Phase 3 of W2P research activities began in May 2019 and was completed in December 2019. Overall, 41 participants were enrolled in the community-based pilot. CONCLUSIONS: This study will assess intervention feasibility and acceptability in the target populations and determine preliminary efficacy of the intervention to increase employment and reduce vulnerability to HIV when implemented in a community-based setting serving LGBTQ youth of color. Testing the intervention in a community setting is an opportunity to evaluate how recruitment, retention, and other outcomes are impacted by delivery in a venue akin to where this intervention could eventually be used by nonresearchers. If W2P demonstrates feasibility and acceptability, a larger multisite trial implemented in multiple community settings serving YMSM, YTW, and GNC youth of color is planned. TRIAL REGISTRATION: ClinicalTrials.gov NCT03313310; https://clinicaltrials.gov/ct2/show/NCT03313310. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/18051.

Pre-Exposure Prophylaxis Integration Into Family Planning Services at Title X Clinics in the Southeastern United States: Protocol for a Mixed Methods Hybrid Type I Effectiveness Implementation Study (Phase 2 ATN 155).

BACKGROUND: Adolescent and young adult women (AYAW), particularly racial and ethnic minorities, in the Southern United States are disproportionately affected by HIV. Pre-exposure prophylaxis (PrEP) is an effective, scalable, individual-controlled HIV prevention strategy that is grossly underutilized among women of all ages and requires innovative delivery approaches to optimize its benefit. Anchoring PrEP delivery to family planning (FP) services that AYAW already trust, access routinely, and deem useful for their sexual health may offer an ideal opportunity to reach women at risk for HIV and to enhance their PrEP uptake and adherence. However, PrEP has not been widely integrated into FP services, including Title X-funded FP clinics that provide safety net sources of care for AYAW. To overcome potential implementation challenges for AYAW, Title X clinics in the Southern United States are uniquely positioned to be focal sites for conceptually informed and thoroughly evaluated PrEP implementation science studies. OBJECTIVE: The objective of this study is two-fold: to evaluate multilevel factors associated with the level of PrEP adoption and implementation (eg, PrEP screening, counseling, and prescription) within and across 3 FP clinics and to evaluate PrEP uptake, persistence, and adherence among female patients in these clinics over a 6-month follow-up period. METHODS: Phase 2 of Planning4PrEP (Adolescent Medicine Trials Network for HIV/AIDS Interventions 155) is a mixed methods hybrid type 1 effectiveness implementation study to be conducted in three clinics in Metro Atlanta, Georgia, United States. Guided by the Exploration, Preparation, Implementation, and Sustainment framework, this study will prepare clinics for PrEP integration via clinic-wide trainings and technical assistance and will develop clinic-specific PrEP implementation plans. We will monitor and evaluate PrEP implementation as well as female patient PrEP uptake, persistence, and adherence over a 6-month follow-up period. RESULTS: Phase 2 of Planning4PrEP research activities began in February 2018 and are ongoing. Qualitative data analysis is scheduled to begin in Fall 2020. CONCLUSIONS: This study seeks to evaluate factors associated with the level of PrEP adoption and implementation (eg, PrEP screening, counseling, and prescription) within and across 3 FP clinics following training and implementation planning and to evaluate PrEP uptake, persistence, and adherence among female patients over a 6-month follow-up period. This will guide future strategies to support PrEP integration in Title X-funded clinics across the Southern United States. TRIAL REGISTRATION: ClinicalTrials.gov NCT04097834; https://clinicaltrials.gov/ct2/show/NCT04097834. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/18784.

An Employment Intervention Program (Work2Prevent) for Young Men Who Have Sex With Men and Transgender Youth of Color (Phase 2): Protocol for a Single-Arm Mixed Methods Pilot Test to Assess Feasibility and Acceptability.

BACKGROUND: Young cisgender men who have sex with men (YMSM), young transgender women (YTW), and gender nonconforming (GNC) youth of color face substantial economic and health disparities. In particular, HIV risk and infection among these groups remains a significant public health issue. In 2017, 17% of all new HIV diagnoses were attributed to male-to-male sexual contact among adolescents and young adults aged 13 to 24 years. However, such disparities cannot be attributed to individual-level factors alone but rather are situated within larger social and structural contexts that marginalize and predispose YMSM, YTW, and GNC youth of color to increased HIV exposure. Addressing social and structural risk factors requires intervention on distal drivers of HIV risk, including employment and economic stability. The Work2Prevent (W2P) study aims to target economic stability through job readiness and employment as a structural-level intervention for preventing adolescent and young adult HIV among black and Latinx YMSM, YTW, and GNC youth. This study seeks to assess intervention feasibility and acceptability in the target populations and determine preliminary efficacy of the intervention to increase employment and reduce sexual risk behaviors. OBJECTIVE: The goal of the research is to pilot-test a tailored, theoretically informed employment intervention program among YMSM, YTW, and GNC youth of color. This intervention was adapted from Increased Individual Income and Independence, an existing evidence-based employment program for HIV-positive adults during phase 1 of the W2P study. METHODS: The employment intervention will be pilot-tested among vulnerable YMSM, YTW, and GNC youth of color in a single-arm pre-post trial to assess feasibility, acceptability, and preliminary estimates of efficacy. RESULTS: Research activities began in March 2018 and were completed in November 2019. Overall, 5 participants were enrolled in the pretest and 51 participants were enrolled in the pilot. CONCLUSIONS: Interventions that address the social and structural drivers of HIV exposure and infection are sorely needed in order to successfully bend the curve in the adolescent and young adult HIV epidemic. Employment as prevention has the potential to be a scalable intervention that can be deployed among this group. TRIAL REGISTRATION: ClinicalTrials.gov NCT03313310; https://clinicaltrials.gov/ct2/show/NCT03313310. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/16401.

An Employment Intervention Program (Work2Prevent) for Young Men Who Have Sex With Men and Transgender Youth of Color (Phase 1): Protocol for Determining Essential Intervention Components Using Qualitative Interviews and Focus Groups.

BACKGROUND: HIV continues to have a disparate impact on young cisgender men who have sex with men (YMSM), young trans women (YTW), and gender-nonconforming (GNC) youth who are assigned male at birth. Outcomes are generally worse among youth of color. Experiences of discrimination and marginalization often limit educational attainment and may even more directly limit access to gainful employment. Though seemingly distal, these experiences influence young people's proximity to HIV risk by limiting their access to health care and potentially moving them toward sex work as a means of income as well as increased substance use. Work2Prevent (W2P) aims to achieve economic stability through employment as a structural-level intervention for preventing adolescent and young adult HIV infection. The study will pilot-test an effective, theoretically driven employment program (increased individual income and independence [iFOUR]), for HIV-positive adults, and adapt it to the needs of black and Latinx YMSM, YTW, and GNC youth aged 16 to 24 years who are vulnerable to HIV exposure. OBJECTIVE: This paper aimed to describe the protocol for the exploratory phase of W2P. The purpose of this phase was to determine the essential components needed for a structural-level employment intervention aimed at increasing job-seeking self-efficacy and career readiness among black and Latinx YMSM, YTW, and GNC youth aged 16 to 24 years. METHODS: The exploratory phase of the W2P study consisted of in-depth interviews and focus groups with members of the target community as well as brief interviews with lesbian, gay, bisexual, transgender, and queer (LGBTQ)-inclusive employers. The study team will conduct in-depth interviews with up to 12 YMSM and 12 YTW and GNC youth, up to 10 focus groups with a maximum of 40 YMSM and 40 YTW and GNC youth, and up to 40 brief interviews with LGBTQ-inclusive employers. Participants will be recruited through a community-based recruiter, passive recruitment in community spaces and on social media, and active recruitment by research staff in community spaces serving LGBTQ youth. RESULTS: In-depth interviews were conducted with 21 participants, and 7 focus groups were conducted with 46 participants in total. In addition, 19 brief interviews with LGBTQ-inclusive employers were conducted. The analysis of the data is underway. CONCLUSIONS: Preliminary findings from the formative phase of the study will be used to inform the tailoring and refinement of the iFOUR adult-based intervention into the youth-focused W2P intervention curriculum. Perspectives from YMSM, YTW, GNC youth, and LGBTQ-inclusive employers offer a multidimensional view of the barriers and facilitators to adolescent and young adult LGBTQ employment. This information is critical to the development of a culturally appropriate and relevant youth-focused intervention. TRIAL REGISTRATION: ClinicalTrials.gov NCT03313310; https://clinicaltrials.gov/ct2/show/NCT03313310. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/16384.