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

NCT07614165 | Enrolling By Invitation

• 2 other identifiers: HUM002843035R34MH135799
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief 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 Prevention; Pre-Exposure Prophylaxis (PrEP)

Keywords

Pre-exposure Prophylaxis (PrEP); HIV prevention; HIV Self-testing; Decisional Aid

Outcome Measures

Primary Outcomes (2)

• PrEP Start

  Self-reported PrEP initiation determined by a single item asking "Are you currently using PrEP?" \[Yes/No\]

  3 months

• Theoretical Framework of Acceptability Scale for DASH

  Adapted from the Theoretical Framework of Acceptability Scale. 9 items assess affective attitudes, burden, perceived effectiveness, intervention coherence, opportunity costs, self-efficacy and ethicality- with likert scale of 1 to 5. A total acceptability score can be calculated by summing responses to items producing a range of 9 to 45 with higher scores reflecting higher overall acceptability.

  Month 1 and month 3

Secondary Outcomes (2)

• PrEP Information

  Baseline, Month 1 and Month 3

• Movement on PrEP Care Continuum

  Baseline, Month 1 and Month 3

Other Outcomes (6)

• Decisional Conflict

  Baseline, Month 1 and Month 3

• PrEP Motivation

  Baseline, Month 1 and Month 3

• DASH Trustworthiness

  Month 1

Study Arms (2)

Comparison condition

NO INTERVENTION

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.

DASH Intervention Arm

EXPERIMENTAL

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

Behavioral: PrEP Decisional Aid for dissemination with Self-administered HIV test kits (DASH)

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.

DASH Intervention Arm

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-39
• Comfort with English material and communication (oral and written)
• Access to internet
• HIV negative (self-report)
• PrEP Naive (never used PrEP)

You may not qualify if:

• Ever used PrEP

Sponsors & Collaborators

• University of Michigan: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Study Officials

• K Rivet Amico, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Health Behavior and Health Equity and Professor of Global Public Health, School of Public Health

Model Details: Randomized controlled mixed methods implementation hybrid type 1 pilot study

Study Record Dates

• First Submitted: May 8, 2026
• First Posted: May 29, 2026
• Study Start: April 17, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 3, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: NDA data is uploaded quarterly and is available to public for use after the completion of the trial
• Access Criteria: NDA has a system that researchers can use to request data access

Locations

US (1)