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

NCT04865341 | Completed Results

• 1 other identifier: PRO34897
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

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. 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).

Conditions

Human Immunodeficiency Virus

Keywords

HIV testing; HIV pre-exposure prophylaxis

Outcome Measures

Primary Outcomes (2)

• 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).

  3 months

• Number of Participants With Self-reported PrEP Uptake

  Self-reported PrEP uptake

  3 months

Study Arms (2)

IMB

EXPERIMENTAL

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

Information-Only Control

OTHER

Attention-matched comparison condition (information-only)

Behavioral: Information-Only Control

Interventions

IMB BEHAVIORAL

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.

IMB

Information-Only Control BEHAVIORAL

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).

Information-Only Control

Eligibility Criteria

• Age: 17 Years - 24 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (5)

• John SA, Lopez-Rios J, Starks TJ, Rendina HJ, Grov C. Willingness to Distribute HIV Self-Testing Kits to Recent Sex Partners Among HIV-Negative Gay and Bisexual Men and an Examination of Free-Response Data from Young Men Participating in the Nationwide Cohort. Arch Sex Behav. 2020 Aug;49(6):2081-2089. doi: 10.1007/s10508-020-01752-5. Epub 2020 Jun 3.

  PMID: 32495242 BACKGROUND

• John SA, Walsh JL, Quinn KG, Cho YI, Weinhardt LS. Testing the Interpersonal-Behavior model to explain intentions to use patient-delivered partner therapy. PLoS One. 2020 May 20;15(5):e0233348. doi: 10.1371/journal.pone.0233348. eCollection 2020.

  PMID: 32433680 BACKGROUND

• John SA, Quinn KG, Pleuhs B, Walsh JL, Petroll AE. HIV Post-Exposure Prophylaxis (PEP) Awareness and Non-Occupational PEP (nPEP) Prescribing History Among U.S. Healthcare Providers. AIDS Behav. 2020 Nov;24(11):3124-3131. doi: 10.1007/s10461-020-02866-6.

  PMID: 32300991 BACKGROUND

• Quinn KG, Zarwell M, John SA, Christenson E, Walsh JL. Perceptions of PrEP Use Within Primary Relationships Among Young Black Gay, Bisexual, and Other Men Who Have Sex with Men. Arch Sex Behav. 2020 Aug;49(6):2117-2128. doi: 10.1007/s10508-020-01683-1. Epub 2020 Apr 2.

  PMID: 32240437 BACKGROUND

• Pleuhs B, Quinn KG, Walsh JL, Petroll AE, John SA. Health Care Provider Barriers to HIV Pre-Exposure Prophylaxis in the United States: A Systematic Review. AIDS Patient Care STDS. 2020 Mar;34(3):111-123. doi: 10.1089/apc.2019.0189. Epub 2020 Feb 28.

  PMID: 32109141 BACKGROUND

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Limitations and Caveats

The comparison/control condition was attention-matched with content aligned with the content provided in the experimental condition but limited to information-only constructs; thus, the effect size of the experimental group is likely to be much higher compared to a non-intervention control condition. Primary outcomes were also assessed by self-report, which is subject to social desirability bias.

Results Point of Contact

• Title: Steven A. John, PhD, MPH
• Organization: University of Minnesota Medical School

sajohn@umn.edu

612-625-1500

Study Officials

• Steven A John, MPH, PhD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: April 29, 2021
• Study Start: March 21, 2024
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: May 1, 2026
• Results First Posted: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Approximately available by December 31, 2027 aligned with results publishing; available indefinitely.
• Access Criteria: Data will be findable for the research community through the NIH Data Archive (NDA) Collection

Locations

US (1)