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

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

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 (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 <i>are</i>. 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. CLINICALTRIAL ClinicalTrials.gov Identifier NCT03511131; https://clinicaltrials.gov/ct2/show/NCT03511131 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/19701

A dyadic approach to understanding safer sex behavior in intimate heterosexual relationships

This study applied a dyadic approach to condom-use research. Partners from 124 heterosexual couples independently completed a questionnaire assessing condom-related attitudes, subjective norms, perceived behavioral control, and intentions to use condoms. Results demonstrate the superiority of a dyadic approach to understanding couples’ condom-use intentions and behavior over traditional, individual-level approaches. The addition of partner effects to the model, via the actor–partner interdependence model, resulted in an increase in the variance accounted for in condom-use intentions and this dyadic model showed better fit compared to the individual-level model. The results suggest that consideration of relationship partners plays an important role in the prediction of safer sex intentions.

Regulatory Focus and Sexuality

Despite recurrent efforts to prevent sexually transmitted diseases through the use of condoms, HIV infections are still prevalent across Europe. Recent research framed by the regulatory focus theory has shown that prevention (vs. promotion) focused individuals are more likely to adopt strategies to protect their health. Therefore, these individuals should also be more motivated to use condoms, because they are more likely to perceive greater health threats. In two cross-sectional pre-registered studies (combined N = 520 Portuguese participants; databases available at doi:10.17605/osf.io/nzkmn) we developed the new Regulatory Focus in Sexuality (RFS) scale (Study 1), and tested if the association between prevention focus and intentions to use condoms was mediated by the perception of health threat (Study 2). Results from Study 1 suggested that the scale is valid and reliable. Results from Study 2 showed, as expected, that a predominant focus on prevention was associated with more condom use intentions with casual and regular sexual partners, because individuals perceived greater threat to their health. Additional exploratory analyses further showed that this mediation occurred only for individuals without a romantic relationship and was independent of how salient the condom use norm was. In contrast, for romantically involved individuals there was no evidence for the mediation by perceived health threat. Instead, a predominant focus on prevention was positively associated with condom use intentions with the regular partner, but only when the condom use norm was more salient. Taken together, these results emphasize the importance of examining individual motivations for safe sex practices.