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

Not Applicable

Completed

• Conditions: Human Immunodeficiency Virus
• Interventions: Behavioral: IMB

• Registration Number: NCT04865341
• Lead Sponsor: Medical College of Wisconsin

Brief 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, 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 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. 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 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).

Detailed Description

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 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. 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?).

Study Timeline

• Study First Submitted: 2021-04-26
• Study First Submitted QC: 2021-04-26
• Study First Posted: 2021-04-29
• Study Start: 2024-03-21
• Primary Completion: 2024-08-31
• Study Completion: 2024-08-31
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-06
• Last Update Posted: 2024-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 118

Inclusion Criteria

1. 17-24 years old;

2. Individuals who self-identify as male (including transgender men) and report any male sexual partners in the past 6 months;

3. Resident of the US based on home address;

4. HIV-negative or unknown status based on self-report; and

5. Self-reported risk for HIV (based on CDC criteria for PrEP use) defined as reporting any of the following in the past six months:

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
IMB	IMB	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.

Primary Outcome Measures

Name	Time	Method
Change in the number of self-reported HIV self-tests	3 months	Self-reported self-administration of HIV testing within the past 3 months (i.e., since baseline assessment).
PrEP uptake	3 months	Self-reported PrEP uptake

Trial Locations

Locations (1)

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States