BackgroundThe suboptimal rate of viral suppression among persons aged 13 years and older and residing in 37 states and the District of Columbia leaves considerable opportunities for onward transmission and contributes to poor health outcomes. Men who have sex with men (MSM) represent one of the most at-risk groups in the United States. There is a clear and continued need for innovative adherence support programs to optimize viral suppression. To address this gap, we designed and are implementing a randomized controlled trial (RCT) to test the efficacy of the Thrive with Me intervention for MSM living with HIV. Critical components of the protocol are presented.ObjectiveThe aim of this study is to describe the protocol for rigorously testing the efficacy of Thrive with Me to improve antiretroviral therapy (ART) adherence among HIV-positive MSM residing in New York City.MethodsA community advisory board and beta testing were used to obtain feedback from HIV-positive MSM on the overall look and feel of Thrive with Me and problems with navigation to finalize intervention components and content. We will enroll 400 HIV-positive MSM residing in the New York City area into a two-arm prospective RCT and follow them for 17 months. Men in the Thrive with Me experimental intervention arm will have access to Thrive with Me for 5 months. Thrive with Me has three primary components: (1) a private social networking feature; (2) tailored HIV and ART adherence information; and (3) medication reminders, self-monitoring, and reflection. Gamification components include badges and leveling up to increase intrinsic motivation to engage with the intervention. Men randomized to the control condition will view a weekly newsletter for 5 months. The newsletter will be delivered via email and contains information on topics related to HIV with the exception of ART adherence. Study assessments will occur at enrollment and 5, 11, and 17 months post enrollment. The primary study outcome is HIV viral load, which is considered an objective indicator of ART adherence.ResultsParticipant recruitment for the RCT began in October 2016, and the data collection period is anticipated to end in the Fall of 2019.ConclusionsThe efficacy trial of Thrive with Me will help to fill gaps in understanding about the utility of multicomponent, technology-based interventions to improve ART adherence among HIV-positive MSM. Of importance is the ability for the results of the Thrive with Me trial to inform best practices for conducting technology-based interventions that incorporate social media features.Trial RegistrationClinicalTrials.gov NCT02704208; https://clinicaltrials.gov/ct2/show/NCT02704208 (Archived by WebCite at http://www.webcitation.org/6zQ8WPra6)Registered Report identifierRR1-10.2196/10182
Background Despite intensive efforts to engage people living with HIV in the United States, less than half of the youth aged 13 to 24 years achieve viral suppression. There is a clear and continued need for innovative behavioral programs that support optimizing adherence among young persons with HIV. Objective There are 3 phases of this project. Phase 1 involves conducting focus groups to obtain feedback from youth about an existing technology-based antiretroviral therapy (ART) adherence intervention. Phase 2 will be used to conduct beta testing with youth to refine and finalize the YouTHrive (YT) intervention. Phase 3 is a randomized controlled trial (RCT) to test the efficacy of the YT intervention among youth living with HIV (YLWH). Methods In phase 1, we will conduct 6 focus groups with approximately 8 youths (aged 15-19 years) and young adults (aged 20-24 years), each in 3 US cities to obtain (1) feedback from YLWH about the look and feel and content of an existing adult-focused Web-based ART adherence intervention and (2) suggestions for adapting the intervention for YLWH similar to themselves. Phase 2 will involve updating the existing intervention to include features and functionality recommended by YLWH in phase 1; it will conclude with beta testing with 12 participants to gain feedback on the overall design and ensure proper functionality and ease of navigation. For phase 3, we will enroll 300 YLWH in 6 US cities (Atlanta, Chicago, Houston, New York City, Philadelphia, and Tampa) into a 2-arm prospective RCT. Participants will be randomized 1:1 to YT intervention or control group. The randomization sequence will be stratified by city and use random permuted blocks of sizes 2 and 4. Participants randomized to the control condition will view a weekly email newsletter on topics related to HIV, with the exception of ART adherence, for 5 months. Participants randomized to the YT intervention condition will be given access to the YT site for 5 months. Study assessments will occur at enrollment and 5, 8, and 11 months post enrollment. The primary outcome that will be assessed is sustained viral load (VL), defined as the proportion of participants in each study arm who have suppressed VL at both the 5- and 11-month assessment; the secondary outcome that will be assessed is suppressed VL at both the 5- and 11-month assessment between drug-using and nondrug-using participants assigned to the YT intervention arm. Results Participant recruitment began in May 2017 for phase 1 of the study. The data collection for aim 3 is anticipated to end in April 2020. Conclusions The efficacy trial of the YT intervention will help to fill gaps in understanding the efficacy of mobile interventions to improve ART adherence among at-risk populations. Trial Registration ClinicalTrials.gov NCT03149757; https://clinicaltrials.gov/ct2/show/NCT03149757 (Archived by WebCite at http://www.webcitation.org/73pw57Cf1) International Registered Report Identifier (IRRID) DERR1-10.2196/11502
Advancing HIV behavioral science and its integration with recent biomedical prevention strategies-treatment as prevention and pre-exposure prophylaxis (PrEP)-is complicated because traditional definitions of sexual risk (condomless anal sex [CAS] or CAS with a serodiscordant partner) may not suffice given the success of biomedical prevention in the absence of condoms. To better understand how to define and understand risk in the era of biomedical HIV prevention, we assessed correlates of four different definitions of high-risk sexual behavior among a sample of 401 adult HIV-positive MSM (57% African American) residing in the New York City area: (1) a traditional model of risk defined as CAS with an HIV-negative or unknown serostatus partner;(2) a definition that considered participant viral load (VL); (3) a definition that considered partner PrEP use; and (4) a definition that considered participant HIV VL and partner PrEP use. Among participants reporting anal sex (n = 281) with a man in the past 3 months, 42% were considered high risk under Definition 1, 6% under Definition 2, 25% under Definition 3, and 2% under Definition 4. Correlates of risk varied across definitions. For example, while education was the strongest predictor of high-risk sexual behavior in Definitions 1 and 2, alcohol use and enacted stigma were the strongest predictors in the model that only accounted for partner PrEP use (Definition 3). These findings have implications for whom to reach for intervention efforts, the difficulty in meeting recruitment goals, and the types of interventions that should be used.
BACKGROUND Youth account for a disproportionately high rates of new HIV infections in the United States (US). Despite intensive efforts to engage people living with HIV (PLWH) in the US, less than half of 13-24 years old achieve viral suppression. There is a clear and continued need for innovative behavioral programs that support optimizing adherence among young persons with HIV. OBJECTIVE There are three phases of this project. Phase 1 involves conducting focus groups in three cities (New York City, Chicago, and Houston) to obtain feedback from youth about an existing technology-based antiretroviral therapy (ART) adherence intervention. Phase 2 will be used to conduct beta testing with youth to refine and finalize the YouTHrive (YT) intervention. Phase 3 is a randomized controlled trial (RCT) to test the efficacy of the YouTHrive intervention among youth living with HIV (YLWH) in 6 US cities (Atlanta, New York City, Chicago, Houston, Philadelphia, and Tampa). METHODS In Phase 1, we will conduct six focus groups with approximately 8 youths (15-19 years old) and young adults (20-24 years old) each in three US cities to obtain: 1) feedback from YLWH about the “look and feel” and content of an existing adult-focused web-based ART adherence intervention; and 2) suggestions for adapting the intervention for YLWH similar to themselves. Phase 2 will involve collaboration with our technology development partner to update the existing intervention to include features and functionality recommended by YLWH in Phase 1. Phase 2 will conclude with beta testing with 12 participants to ensure that all features are working properly and function in a way that users can easily navigate. For Phase 3, we will enroll 300 YLWH in 6 US cities into a two-arm prospective randomized controlled trial (RCT). Participants randomized to the control condition will view a weekly newsletter for 20 weeks. The newsletter will be delivered via e-mail and will contain information on topics related to HIV, with the exception of ART adherence. Participants randomized to the YT intervention condition will be given access to the YT site for 20 weeks. Study assessments will occur at enrollment and 5, 8, and 11 months postenrollment. RESULTS Participant recruitment began in May 2017 for Phase 1 of the study. The data collection for Aim 3 is anticipated to end in April 2020. CONCLUSIONS The efficacy trial of the YT intervention will help to fill gaps in understanding about the efficacy of mobile interventions to improve ART adherence among at-risk populations. Other important questions remain to be addressed, including how best to incorporate virtual ART interventions into clinical care and when they are most effectively delivered. CLINICALTRIAL ClinicalTrials.gov (NCT03149757); University of North Carolina at Chapel Hill Institutional Review Board (16-3136).
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