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Clinical Trial Summary

The proposed study will involve adolescent (17-24 years old) men who have sex with men (described as YMSM hereafter) who meet eligibility criteria to participate in each study. Prospective study candidates will receive a copy of the IRB-approved informed consent forms and, if they choose to participate, will provide consent before enrollment into this study. Involvement of human subjects is detailed in the Research Strategy portion of this proposal, Recruitment and Retention Plan, and Protection of Human Subjects sections. Briefly, we will develop and pilot a randomized controlled trial (RCT) to support HIV self-testing (HIVST) and pre-exposure prophylaxis (PrEP) uptake. Intervention content will be focused on constructs of the Information-Motivation-Behavioral Skills (IMB) model. To reduce cost and increase feasibility, we plan to incorporate previously developed content as much as possible-we see integration of this content as a major strength. We will include professionally produced videos about HIV testing and PrEP and other resources including the geo-targeted directories to find clinic settings that offer HIV testing and PrEP, all of which are publicly available. We believe our approach of guiding YMSM through intervention modules based on theory will help improve content retention/use and ultimately influence constructs posited to result in behavior change. We foresee using multiple forms of attention-matched material, media, and programming to engage (and retain engagement) of YMSM throughout the brief single-session intervention (45-60 minutes). Intervention content is subject to change depending on feedback from focus groups, survey results, YAB feedback, and usability testing. Primary endpoints of this study include HIVST and PrEP uptake, including stage of change towards HIVST and PrEP uptake. Secondary outcomes include changes in IMB model indicators (e.g., HIV prevention knowledge).


Clinical Trial 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 (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; 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, 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?). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04865341
Study type Interventional
Source Medical College of Wisconsin
Contact Steven A John, MPH, PhD
Phone 414-955-7700
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date June 2022
Completion date September 2023

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