A Self-administered PrEP Decisional Aid for Dissemination With HIV Self-test Kits (DASH)
NCT07614165 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 170
Last updated 2026-05-29
Summary
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.
Conditions
- HIV Pre-exposure Prophylaxis
Interventions
- BEHAVIORAL
-
PrEP Decisional Aid for dissemination with Self-administered HIV test kits (DASH)
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.
Sponsors & Collaborators
-
National Institute of Mental Health (NIMH)
collaborator NIH - lead OTHER
Principal Investigators
-
K Rivet Amico, PhD · University of Michigan
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 39 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-04-17
- Primary Completion
- 2026-10-31
- Completion
- 2026-12-31
Countries
- United States
Study Locations
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