A Self-administered PrEP Decisional Aid for Dissemination With HIV Self-test Kits (DASH)

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan
Study ID
NCT07614165
Status
Enrolling By Invitation

Conditions

  • HIV Prevention
  • Pre-Exposure Prophylaxis (PrEP)

Eligibility Criteria

Sex
ALL
Age
18 Years - 39 Years
Healthy Volunteers
Accepted

Interventions

  • PrEP Decisional Aid for dissemination with Self-administered HIV test kits (DASH) — BEHAVIORAL
    Participants assigned to the intervention arm will be provided with a unique code to access the login for the DASH app. The app provides a PrEP information, explores values and decisions around PrEP, and leads participants through an exploration of their PrEP decisions with links to PrEP resources (local and online) for those interested in findings out more about or starting PrEP. Participants are asked to complete one complete session and return back to the app at any time during their participation.

Study Details

People using HIV self-testing (HIVST) need access to quality HIV-prevention programming, including education and exploration of pre-exposure prophylaxis (PrEP) - an effective biomedical prevention tool that continues to expand in choices and access points in the US. HIVST and PrEP are both central to ending the HIV epidemic, but presently they are not linked together in a systematic way. To address the critical need for PrEP programming to accompany HIV self-testing (HIVST), our study will work with experts and HIVST users to develop and pilot a novel, interactive, mobile friendly PrEP decisional-aid mobile optimized website that helps to raise awareness around PrEP and guides people through a PrEP-decision-making process that matches their needs and values, and links people to resources for local or online PrEP. This PrEP Decisional Aid to accompany Self HIV-test kits (the DASH app) will be in a randomized controlled pilot trial with 120-170 HIV self-test kit users in the CDC's Together TakeMeHome HIV-test kit dissemination program. PrEP uptake at 3-months (primary outcome) will be compared between arms descriptively and with logistic regression models. Change in additional PrEP related factors (knowledge, stigma, decisional conflict, barriers and facilitators) will be assessed as secondary outcomes. Implementation metrics, acceptability and feasibility will also be evaluated quantitatively and qualitatively. Results will inform revisions and recommendations for a decisional aid for raising PrEP awareness and use among self HIV-test users.

Key Dates

Start date
Apr 17, 2026
Status verified
May 2026
Primary completion
Oct 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
170 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • No Intervention: Comparison condition
    Participants in the comparison condition do not receive additional PrEP related information through the project- but have access to PrEP information from the self-test kit and other programs that are available.
  • Experimental: DASH Intervention Arm
    Participants receive access to the DASH app through an emailed link with reminders to use the link at least one during the 3 month study period

Primary Outcome Measure

PrEP Start [ Time Frame: 3 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of MichiganAnn ArborMichigan48109-

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By research site
University of Michigan· Ann Arbor, MI

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