Evaluation of a Stepped-Care eHealth HIV Prevention Program for Diverse Adolescent Men Who Have Sex With Men: Protocol for a Hybrid Type 1 Effectiveness Implementation Trial of SMART

Abstract

Background Adolescent men who have sex with men (AMSM), aged 13 to 18 years, account for more than 80% of teen HIV occurrences. Despite this disproportionate burden, there is a conspicuous lack of evidence-based HIV prevention programs. Implementation issues are critical as traditional HIV prevention delivery channels (eg, community-based organizations, schools) have significant access limitations for AMSM. As such, eHealth interventions, such as our proposed SMART program, represent an excellent modality for delivering AMSM-specific intervention material where youth are. Objective This randomized trial aimed to test the effectiveness of the SMART program in reducing condom-less anal sex and increasing condom self-efficacy, condom use intentions, and HIV testing for AMSM. We also plan to test whether SMART has differential effectiveness across important subgroups of AMSM based on race and ethnicity, urban versus rural residence, age, socioeconomic status, and participation in an English versus a Spanish version of SMART. Methods Using a sequential multiple assignment randomized trial design, we will evaluate the impact of a stepped-care package of increasingly intensive eHealth interventions (ie, the universal, information-based SMART Sex Ed; the more intensive, selective SMART Squad; and a higher cost, indicated SMART Sessions). All intervention content is available in English and Spanish. Participants are recruited primarily from social media sources using paid and unpaid advertisements. Results The trial has enrolled 1285 AMSM aged 13 to 18 years, with a target enrollment of 1878. Recruitment concluded in June 2020. Participants were recruited from 49 US states as well as Puerto Rico and the District of Columbia. Assessments of intervention outcomes at 3, 6, 9, and 12 months are ongoing. Conclusions SMART is the first web-based program for AMSM to take a stepped-care approach to sexual education and HIV prevention. This design indicates that SMART delivers resources to all adolescents, but more costly treatments (eg, video chat counseling in SMART Sessions) are conserved for individuals who need them the most. SMART has the potential to reach AMSM to provide them with a sex-positive curriculum that empowers them with the information, motivation, and skills to make better health choices. Trial Registration ClinicalTrials.gov Identifier NCT03511131; https://clinicaltrials.gov/ct2/show/NCT03511131 International Registered Report Identifier (IRRID) DERR1-10.2196/19701

The Young Men and Media Study: A Pilot Randomized Controlled Trial of a Community-Informed, Online HIV Prevention Intervention for 14–17-Year-Old Sexual Minority Males

“…Despite disproportionate risk for HIV among ASMM in the U.S. [ 1 , 2 ], few HIV prevention interventions have been developed to meet the sexual health needs of ASMM younger than 18 years old [ 7 , 8 ], and only two interventions have been developed for ASMM younger than 16 years old [ 6 , 9 ]. The Young Men and Media study sought to develop and pilot test a community-informed, online sexual health program specifically for 14–17-year-old ASMM.…”

“…Results indicate that the intervention is feasible, acceptable, and may positively impact sexual health outcomes. Further, to our knowledge, only one other published intervention and one intervention currently under investigation that have attempted to intervene with ASMM as young at 14 years old [ 6 , 9 ]. As early intervention prior to or around the age of sexual debut is critical to the development and maintenance of healthy sexual behaviors [ 10 ], with additional assessment and development the Young Men and Media intervention may be useful in addressing the sexual health needs of these young ASMM.…”

“…Participants (N = 154) were recruited from March 27, 2020 to May 8, 2020 via online advertisements and posts on social media sites (e.g., Facebook, Instagram). Eligibility criteria were: (1) age 14 to 17 years, (2) cisgender male, (3) selfidentify as gay/bisexual, report being sexually attracted to males, and/or report having voluntary sexual contact with a male partner (past year), (4) have intentionally viewed pornography (deemed necessary because the intervention included a pornography literacy component), ( 5) reside in the U.S., (6) have a personal email address, and (7) be new to the study.…”

“…Despite this need, few HIV prevention interventions have been designed for sexual minority males younger than 18 years of age. Currently under evaluation, the SMART program is a stepped-care package of increasingly intensive eHealth interventions targeting HIV-related sexual behaviors among sexual minority males 13–18 years old [ 6 ]. Queer Sex Ed, a predecessor to the SMART program, is an online sexual health intervention for sexual and gender minority adolescents ages 16–20 years that teaches users about condom use, coming out, sexual identity, healthy relationships, and sexual pleasure while providing users with resources for local HIV testing and birth control [ 7 ].…”

“…Online interventions can be an efficient, convenient, and salient platform through which to address ASMM's HIV prevention needs [33,34]. Indeed, several of the HIV prevention efforts developed for adolescent and young adult sexual minority men have used the Internet to either recruit participants or deliver HIV prevention intervention content [6,7,9,[35][36][37][38]. Therefore, we capitalized on the Internet's suitability to develop and test an HIV prevention intervention for ASMM.…”