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

Brian Mustanski, David A Moskowitz, Kevin O Moran, Michael E Newcomb, Kathryn Macapagal, Carlos Rodriguez-Díaz, H Jonathon Rendina, Eric B Laber, Dennis H Li, Margaret Matson, Ali J Talan, Cynthia Cabral, Brian Mustanski, David A Moskowitz, Kevin O Moran, Michael E Newcomb, Kathryn Macapagal, Carlos Rodriguez-Díaz, H Jonathon Rendina, Eric B Laber, Dennis H Li, Margaret Matson, Ali J Talan, Cynthia Cabral

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://ichgcp.net/clinical-trials-registry/NCT03511131.

International registered report identifier (irrid): DERR1-10.2196/19701.

Keywords: HIV prevention; adolescents; eHealth; implementation science; men who have sex with men; mobile phone.

Conflict of interest statement

Conflicts of Interest: None declared.

©Brian Mustanski, David A Moskowitz, Kevin O Moran, Michael E Newcomb, Kathryn Macapagal, Carlos Rodriguez-Díaz, H Jonathon Rendina, Eric B Laber, Dennis H Li, Margaret Matson, Ali J Talan, Cynthia Cabral. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 11.08.2020.

Figures

Figure 1
Figure 1
SMART participant intervention progression. Survey assessments are conducted at baseline (0 M), 3 months (3 M), 6 months (6 M), 9 months (9 M), and 12 months (12 M). An embedded regime is the path or sequence of specified interventions to which a participant may be randomized. The circled letter “R” refers to the point at which participants are randomized to an embedded regime, or in the case of responders to SSE (see R* ), either follow-up only or access to SMART Squad after the 6-month assessment. Dashed embedded regime paths represent responder pathways. AMSM: adolescent men who sleep with men; SSE: SMART Sex Ed.
Figure 2
Figure 2
Participant entrance into SMART: from advertisement to enrollment. SSE: SMART Sex Ed.
Figure 3
Figure 3
Overview of the 4 SMART Sex Ed modules. STI: sexually transmitted infection.
Figure 4
Figure 4
Overview of the 8 SMART Squad episodes: main concepts and active learning components. Main concepts refer to learning objectives or topics covered by episodes. Interactive lessons refer to activities that provide positive motivations and skills for sexual health. Reflection refers to open-ended questions asked of participants as an activity within an episode. Decision support refers to skills-based activities to identify solutions to health barriers. PEP: postexposure prophylaxis; PrEP: pre-exposure prophylaxis; STI: sexually transmitted infection.

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Source: PubMed

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