An interventional study of IMB and Information-Only Control in Human Immunodeficiency Virus, sponsored by Medical College of Wisconsin. Completed at 1 site in United States. Open to male participants aged 17 Years to 24 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-01.
Sponsored by Medical College of Wisconsin · Not applicable, Interventional, and Prevention
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. 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, investigators 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, investigators plan to incorporate previously developed content as much as possible-investigators see integration of this content as a major strength. Investigators will include content 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. Investigators 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. Investigators foresee using multiple forms of attention-matched material, media, and programming to engage (and retain engagement) of YMSM throughout the intervention. Intervention content was developed on feedback from focus groups, survey results, youth advisory board 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).
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?).
2,040 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 272 are open to participants now.
This study's enrollment of 118 is above the median of 105 across 1,543 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →Medical College of Wisconsin is the lead sponsor of 540 studies on the registry; 120 are open to participants now.
Of its 71 completed or terminated interventional studies of FDA-regulated products, 56 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Self-reported risk for HIV (based on CDC criteria for PrEP use) defined as reporting any of the following in the past six months:
Exclusion Criteria:
Individuals randomized to this arm will receive a behavioral intervention based on the Information-Motivation-Behavior (IMB) model designed to increase HIV self-testing, among other protective behaviors.
Behavioral: IMB
Attention-matched comparison condition (information-only)
Behavioral: Information-Only Control
Intervention content will be focused on the Information-Motivation-Behavioral Skills (IMB) model. We plan to incorporate previously developed content as much as possible and will include content about HIV testing and PrEP and other resources. 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 intervention.
Intervention content will be focused on the information construct of the Information-Motivation-Behavioral Skills (IMB) model. We plan to incorporate previously developed content as much as possible and will include professionally produced videos about HIV testing and PrEP and other resources. 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).
Number of Participants With Self-reported Self-administration of HIV Testing
Self-reported self-administration of HIV testing within the past 3 months (i.e., since baseline assessment).
Time frame: 3 months
Number of Participants With Self-reported PrEP Uptake
Self-reported PrEP uptake
Time frame: 3 months
Individuals were recruited to participate in the randomized controlled trial from social media via Meta, Grindr-a men-for-men geosocial networking app, and referrals from other studies conducted at the Center for AIDS Intervention Research beginning March 2024 with enrollment complete by July 2024. We iteratively refined ads in partnership with a youth advisory board and queer-led professional marketing firm to recruit a diverse sample of YSMM by race/ethnicity.
| Milestone | Experimental IMB Group | Information-Only Control |
|---|---|---|
| Started | 58 | 60 |
| Completed | 58 | 60 |
| Not completed | 0 | 0 |
Self-reported self-administration of HIV testing within the past 3 months (i.e., since baseline assessment).
| Participants | Experimental IMB Group | Information-Only Control |
|---|---|---|
| Number of Participants With Self-reported Self-administration of HIV Testing | 46 | 44 |
Self-reported PrEP uptake
| Participants | Experimental IMB Group | Information-Only Control |
|---|---|---|
| Number of Participants With Self-reported PrEP Uptake | 9 | 10 |
Collected over From enrollment until end of follow-up, up to 3 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Experimental IMB Group | — | 0/58 (0%) | 0/58 (0%) |
| Information-Only Control | — | 0/60 (0%) | 0/60 (0%) |
| Age, Continuous(Years) | Experimental IMB Group | Information-Only Control | Total |
|---|---|---|---|
| Mean | 21.3 ± 2.2 | 21.8 ± 2.1 | 21.5 ± 2.2 |
| Sex/Gender, Customized(Participants) | Experimental IMB Group | Information-Only Control | Total |
|---|---|---|---|
| Cisgender male | 52 | 57 | 109 |
| Transgender male or non-binary | 6 | 3 | 9 |
| Race/Ethnicity, Customized(Participants) | Experimental IMB Group | Information-Only Control | Total |
|---|---|---|---|
| Asian American/Pacific Islander | 5 | 6 | 11 |
| Black or African American | 13 | 7 | 20 |
| Hispanic or Latino/x | 17 | 25 | 42 |
| White | 22 | 18 | 40 |
| Multiracial or another category | 1 | 4 | 5 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Datasets will be deposited in the NIMH Data Archive (NDA)
Supporting information: Study protocol, Sap, Analytic code
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Acquired Immunodeficiency Syndrome→
Medical College of Wisconsin