IMB-guided Intervention to Encourage PrEP Uptake Among Young Men Who Have Sex With Men

Summary

Participation Requirements

Description

The research activity designated as a clinical trial is our pilot RCT where we will then enroll 120 YMSM and randomly assign individuals to one of four experimental groups: (1) information-only (I), (2) information + motivation (IM), (3) information + behavioral skills (IB), and (4) full IMB model (...

The research activity designated as a clinical trial is our pilot RCT where we will then enroll 120 YMSM and randomly assign individuals to one of four experimental groups: (1) information-only (I), (2) information + motivation (IM), (3) information + behavioral skills (IB), and (4) full IMB model (IMB). Randomization will be blinded using Qualtrics, and randomization will occur in a ratio of 1:1:1:1 between the four groups. Individuals assigned to groups 1-3 will receive attention-matched information-only filler content (e.g., information about physical activity and diet), but note that group (1) information-only will still receive HIVST and PrEP related information; attention-matched filler content will cover the one or two theoretical sections excluded from that condition arm. Intervention content will be based upon the formative research, but preliminary content is identified in Table 4 of the Research Strategy. 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, we will test the performance of randomization by chi-squared comparisons and ANOVAs for categorical and continuous variables, respectively. Second, we will test for differential attrition by treatment group at 1- and 3-month follow-up assessments. Third, we 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, we 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 we to extend the length of follow-up. Power: Our study has 80% power to detect a ½ stage average difference (d = 0.68; ? = 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, we have not powered this study to determine differences by each experimental group compared to the control group (which is planned for the full RCT in a future R01). Finally, we 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?).

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