Mobile-health (mHealth) Intervention to Support HIV Self-testing and PrEP Uptake Among Young Men Who Have Sex With Men

The research activity designated as a clinical trial is our pilot RCT where investigators will then enroll 120 YMSM and randomly assign individuals to one of two experimental groups: (1) information-only (I), and (2) information + motivation + behavioral skills (IMB). Randomization will be blinded using Qualtrics, and randomization will occur in a ratio of 1:1 between the two groups. Individuals assigned to group 1 will receive attention-matched information-only content about HIVST and PrEP related information. Intervention content will be based upon the formative research. After completion of the baseline survey, randomization, and intervention, participants will be followed for a period of three months. Individuals will be surveyed at 1- and 3-months post intervention to assess our primary endpoints of HIVST and PrEP uptake. Preliminary impact will be assessed using within- and between-subjects analyses. First, investigators will test the performance of randomization by chi-squared comparisons and ANOVAs for categorical and continuous variables, respectively. Second, investigators will test for differential attrition by treatment group at 1- and 3-month follow-up assessments. Third, investigators will assess post-intervention HIV testing and PrEP uptake using factorial logistic regressions to determine between-group differences, adjusting for any breakdowns in randomization or differential attrition. Fourth, investigators will test for changes in stage of change indicators by randomized group, time, and group*time interaction, with similar adjustment procedures, using GEE; this analysis will help us determine a trend towards HIVST or PrEP uptake were investigators to extend the length of follow-up. Power: Our study has 80% power to detect a ½ stage average difference (d = 0.68; α = 0.05) on the PrEP cascade comparing the three experimental groups combined to the information-only control assuming 80% retention. As the purpose of this study is to pilot the RCT, investigators have not powered this study to determine differences between the experimental group compared to the control group (which is planned for the full RCT in a future R01). Finally, investigators will conduct within-subjects tests comparing baseline and follow-up IMB construct scale scores stratified by group as an evaluation of internal validity (i.e., did the interventions have an effect on the targeted constructs?).

Inclusion criteria

• 17-24 years old;
• Individuals who self-identify as male (including transgender men) and report any male sexual partners in the past 6 months;
• Resident of the US based on home address;
• HIV-negative or unknown status based on self-report; and
• Self-reported risk for HIV (based on CDC criteria for PrEP use) defined as reporting any of the following in the past six months:

• Bacterial STI
• Condomless anal sex (CAS) with a casual male sexual partner
• CAS with an HIV-positive or unknown status main partner
• CAS with an HIV-negative main partner who reports CAS with other male partners.

Exclusion criteria

• Current PrEP use;
• Unstable, serious psychiatric symptoms;
• Currently suicidal/homicidal; and
• Evidence of gross cognitive impairment.