Randomized Controlled Trial of a Remote Coaching mHealth Adherence Intervention in Youth Living with HIV.

Youth living with HIV (YLWH) in the US have low rates of viral suppression (VS). In a prospective randomized clinical trial (ATN152) that enrolled 89 YLWH on antiretroviral therapy (ART) with detectable viral load, we evaluated a 12 week triggered escalating real-time adherence (TERA) intervention with remote coaching, electronic dose monitoring (EDM), and outreach for missed/delayed doses compared to standard of care (SOC). Median [Q1, Q3] percent days with EDM opening was higher in TERA (72% (47%, 89%)) versus SOC (41% (21%, 59%); p < 0.001) and incidence of numbers of 7 day gaps between openings were lower (TERA to SOC ratio: 0.40; 95% CI 0.30, 0.53; p < 0.001). There were no differences in VS at week 12 (TERA 35%; 95% CI 21%, 51% versus SOC 36%; 95% CI 22%, 51%; p > 0.99) or later time-points. The intervention improved adherence but not VS in heavily ART-experienced YLWH. Remote coaching more closely tailored to the unique dosing patterns and duration of need for youth struggling to reach VS warrants further investigation.

Employment as HIV Prevention: An Employment Support Intervention for Adolescent Men Who Have Sex With Men and Adolescent Transgender Women of Color.

BACKGROUND: The purpose of this study was to adapt and pilot-test an employment support, primary HIV intervention tailored to the needs of adolescent men who have sex with men and adolescent transgender women of color. SETTING: The intervention was implemented in 2 settings: controlled environment (Phase 1) and real-world community-based (Phase 2) setting in Chicago, IL. METHODS: Eighty-seven adolescent men who have sex with men and adolescent transgender women of color ages 16-24 participated in Work2Prevent , a 4-session employment and HIV prevention intervention, designed to increase job-readiness and reduce HIV risk. Intervention sessions consisted of group activities: educational games, roleplaying/modeling behavior, and self-regulation exercises. Participants were assessed at baseline, postintervention, and 8-month (Phase 1) or 3-month follow-up (Phase 2). RESULTS: Participants evaluated Work2Prevent as feasible and acceptable, rating intervention quality, usefulness, and satisfaction highly. Overall, 59.6% (Phase 1) and 85.0% (Phase 2) participants attended 2 or more sessions. At 8 months, Phase 1 participants reported a mean increase of 11.4 hours worked per week. Phase 2 participants reported a mean increase of 5.2 hours worked per week and an increase in job-seeking self-efficacy. Phase 2 participants also reported a decrease in transactional sex work. CONCLUSION: Work2Prevent is one of the first structural primary HIV interventions to specifically focus on adolescent employment readiness. Findings suggest Work2Prevent is feasible and acceptable, improved adolescent employment outcomes, and reduced HIV risk associated with transactional sex work. Our study underscores the need for alternative pathways, such as addressing socioeconomic determinants, to prevent adolescent HIV infection.

Correlates of High HIV Viral Load and Antiretroviral Therapy Adherence Among Viremic Youth in the United States Enrolled in an Adherence Improvement Intervention.

A sizable portion of youth (ages 13-24) living with HIV in the United States have unsuppressed viral load. The AIDS Interventions (ATN) 152 study [evaluating the Triggered Escalating Real-Time Adherence (TERA) intervention] baseline data were examined to identify correlates of high viremia (>5000 copies/mL) and self-reported adherence, which can help in planning of differentiated services for viremic youth. Depression, HIV-stigma, and cannabis use were common in this sample of 87 youth. Almost half (48%) had high viremia, which associated with enacted stigma, moderate- to high-risk alcohol use, mental health diagnosis, and age ≥21. Self-reported adherence was related to viral load and associated with mental and physical health functioning, depression, social support, self-confident decision-making, total and internalized stigma, adherence motivation, and report of a missed a care visit in the past 6 months. Mental health emerged as a common correlate of viral load and adherence. Clinical Trial Registration number: NCT03292432.

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.

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.

Triggered Escalating Real-Time Adherence Intervention to Promote Rapid HIV Viral Suppression Among Youth Living With HIV Failing Antiretroviral Therapy: Protocol for a Triggered Escalating Real-Time Adherence Intervention.

BACKGROUND: Youth living with HIV (YLWH) are confronted with many self-care challenges that can be experienced as overwhelming in the context of normal developmental processes that characterize adolescence and young adulthood. A sizable minority of YLWH have unsuppressed viral loads in the United States attributable to antiretroviral therapy (ART) nonadherence. Interventions to promote sustained viral suppression in YLWH are needed. OBJECTIVE: The aim of this study is to evaluate the efficacy of the Triggered Escalating Real-Time Adherence (TERA) intervention in comparison with standard of care (SOC) in YLWH (aged 13-24 years) failing ART on (1) primary outcome measures-HIV viral suppression (VLS), defined as both <200 copies/ml and <50 copies/ml at 12 weeks, and (2) secondary outcome measures-VLS rates and rates of ART adherence at 24, 36, and 48 weeks as well as patterns of adherence over time as measured by an electronic dose monitoring (EDM) device. METHODS: The TERA study is a phase 2, multisite clinical trial conducted with 120 YLWH failing ART (randomized 1:1 to TERA or SOC) at participating clinical sites within the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN). Participants are followed for a total of 48 weeks. For TERA arm participants, the first 12 weeks involve delivery of the intervention. For all participants, clinical outcomes are collected throughout follow-up, and adherence is assessed using EDM over the full 48 weeks. During the 12-week intervention period, TERA arm participants receive 3 remote coaching sessions delivered in clinic via videoconferencing timed to coincide with baseline and follow-up clinical visits, text message reminders when the EDM has not been opened at dose time (which escalate to 2-way theory-informed short message service coaching interactions in response to real-time nonadherence), and review of dosing graphs produced by EDM at follow-up visits. RESULTS: Launch dates for enrollment varied by site. Enrollment began in April 2018 and is expected to be completed by August 2019, with results presented by the second quarter of 2021. CONCLUSIONS: Effective, generalizable, and scalable approaches to rapidly assist YLWH failing to achieve and sustain VLS may have a substantial impact on individual health and efforts to curb transmission. Coaching for a brief but intensive period from remote coaches and using communication channels common to youth may offer multiple unique advantages in promoting self-care. TRIAL REGISTRATION: ClinicalTrials.gov NCT03292432; https://clinicaltrials.gov/ct2/show/NCT03292432 (Archived by WebCite at http://www.webcitation.org/768J8ijjp). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/11416.