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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: HIV Pre-exposure Prophylaxis
• Intervention / Treatment: Behavioral: PrEP Decisional Aid for dissemination with Self-administered HIV test kits (DASH)

Detailed Description

This mixed methods intervention development and implementation hybrid (type 1) study will pilot a self-administered PrEP Decisional Aid for dissemination with Self-administered HIV test kits (DASH). Recruiting from Together TakeMeHome (TTMH) HIVST kit recipients, the proposed pilot has 3 specific aims. The first aim was to develop the PrEP decisional aid for dissemination with self-administered HIV test kits (DASH) through iterative expert and community consultation.

AIM 2- Pilot DASH with TTMH HIVST kit recipients and determine direction and magnitude of impact on PrEP awareness, intentions and starts. HIVST recipients from TTMH will be recruited into a 3-month pilot completing online surveys assessing PrEP awareness, knowledge, intentions, and use at baseline, and 1- and 3-month follow-up. Participants randomly assigned to the DASH arm, versus the measures-only arm, receive the DASH link post baseline. A minimum of 120 and maximum of 170 (to reach 60 intervention arm participants who complete 1 full session of the DASH app) will be enrolled. PrEP uptake at 3-months (primary outcome) will be compared between arms descriptively and with logistic regression models (both intent to treat and as-treated). Change in additional PrEP related factors (knowledge, stigma, decisional conflict, barriers and facilitators) will be assessed as secondary outcomes. Longitudinal growth modelling will be used to analyze over-time data between study arms. H2: DASH arm participants will have more self-reported PrEP starts (primary) by 3 months than those in the comparison condition. H3: DASH arm participants will report more favorable secondary outcomes on follow-up surveys.

AIM 3- Conduct mixed methods evaluation of acceptability, feasibility and experiences with the DASH. All participants will complete a brief survey on acceptability of the PrEP-related resources received (DASH or standard for what is locally available). Patterns of utilization of DASH components, including use of links to PrEP services, will be summarized. Qualitative virtual in-depth interviews with 30 participants (20 DASH, 10 control) will explore nuanced aspects of PrEP decision making and expand on the quantitative data. H4: DASH will be evaluated as acceptable and feasible.

• Study Type: Interventional
• Enrollment (Estimated): 170
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Ever used PrEP

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
PrEP Information	Accurate information about PrEP is assessed using using 10 items stated- 5 states as self-ratings of information (I know...) and 5 as facts with answer options of True, False, Not sure/don't know. Scores are summed across all items with a range of 0 (no perceived knowledge and none correct) to 10 (true to all perceived knowledge questions and correct on all factual items). Higher scores reflect higher knowledge/information accuracy about PrEP. Outcomes use baseline to determine gains in knowledge over time.	Baseline, Month 1 and Month 3
Movement on PrEP Care Continuum	Movement through the PrEP continuum of care is calculated at month 1 and month 3. Participants are characterized as not interested in PrEP, interested in PrEP, spoke with a navigator about PrEP since starting the DASH project, spoke with a provider about PrEP since starting the DASH project, or started PrEP. Movement is identified by determing if the participant has made forward movement in this process or has maintained being on PrEP between month 1 and month 3 surveys. Stage is ordinal and descriptive.	Baseline, Month 1 and Month 3

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decisional Conflict	The Decisional Conflict Scale adapted for PrEP related decisions is a 16 item measure providing states and likert scale response (5 points ranging from strongly disagree=4 to strongly agree=0). Subscales include informed decisions (3 items), values clarity (3 items), support (3 items), uncertainty (3 items) and effective decision (4 items). Each subscale is created by summing the responses items, dividing by the total number of items in the scale, and multiplying by 25. Scores range from 0 (good decision) to 100 (bad decision). A total score is created by summing all 16 items, dividing by 16, and multiplying by 25 with a range of 0 [no decisional conflict] to 100 [extremely high decisional conflict]. Total score will be used for the outcome.	Baseline, Month 1 and Month 3
PrEP Motivation	PrEP motivation is measured with 17 items created for the study that assesses attitudes and beliefs, distrust, and facilitators of PrEP use framed as statements with a 5 point likert scale (strongly disagree=1 to strongly agree=5). All items are summed and divided by 17 to create a total motivation scale score (average response, range of 1 to 5). Higher scores reflect higher motivation to use PrEP.	Baseline, Month 1 and Month 3
DASH Trustworthiness	Adapted Trust and Suspicion IT Scale, 6 items adapted to reflect DASH from the measure's trustworthiness scale assess trust in the information provided by the DASH app (statements with 7-point likert response options of Strongly disagree to strongly agree). Items are totaled and divided by 6 to create an average trust in DASH score (range of 1 to 7) with higher scores reflecting higher levels of trust.	Month 1
System Usability Scale	10 items (statements) from the System Usability Scale adapted to reflect experiences, thoughts, and beliefs around DASH with 5-point likert scale response options (0=strongly disagree to 4= strongly agree) assess overall "usability" of the DASH app. After reverse scoring items reflecting burden/low usability, item responses are summed and multiplied by 2.5 producing a range of 0 to 100 with higher scores reflecting higher usability.	Month 1
Perceived Usefulness of DASH	Perceived Usefulness created for this study advised by previous evaluations of decisional aid tools. 9 items assessing general and specific characteristics of the app that were "helpful", "useful". and "facilitative" for PrEP related awareness and decision making. A 5-point likert scale (strongly disagree=1 to strongly agree) is used with total score (divided by 9) providing an average agreement (range of 1 to 5) with usefulness. Higher scores reflect higher levels of perceived usefulness of the DASH app.	Month 1
Suspiciousness of DASH	Suspicion of DASH is assessed with 4 items from the Trustworthiness and IT Suspicion scale's suspicion subscale (statements with 7-point likert response options of Strongly disagree to strongly agree). After reverse scoring relevant items, scores are summed and divided by 4 to create an average (range of 1 to 7) with higher scores reflecting higher levels DASH suspicion.	Month 1

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: K Rivet Amico, PhD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: May 8, 2026
• First Submitted That Met QC Criteria: May 21, 2026
• First Posted (Actual): May 29, 2026

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: PrEP, HIV prevenition, Self-test kits
• Other Study ID Numbers: HUM00284303; 5R34MH135799 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: National Data Archive received participant data using a psuedo identification number
• IPD Sharing Time Frame: NDA data is uploaded quarterly and is available to public for use after the completion of the trial
• IPD Sharing Access Criteria: NDA has a system that researchers can use to request data access
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No