Evaluation of a stepped care eHealth HIV prevention program for diverse adolescent MSM: Protocol for a hybrid type 1 effectiveness-implementation trial of SMART (Preprint)

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.