Pre-Exposure Prophylaxis (PrEP)DASHNCT07614165
A Self-administered PrEP Decisional Aid for Dissemination With HIV Self-test Kits (DASH)
A study testing PrEP Decisional Aid for dissemination with Self-administered HIV test kits (DASH) in people with Pre-Exposure Prophylaxis (PrEP) and HIV Prevention, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Pre-Exposure Prophylaxis (PrEP), HIV Prevention
- What is being tested?
- PrEP Decisional Aid for dissemination with Self-administered HIV test kits (DASH)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-39
- Comfort with English material and communication (oral and written)
- Access to internet
- HIV negative (self-report)
- PrEP Naive (never used PrEP)
Who cannot join
- Ever used PrEP
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Conditions
- Pre-Exposure Prophylaxis (PrEP), HIV Prevention
- Being tested
- PrEP Decisional Aid for dissemination with Self-administered HIV test kits (DASH)
- Keywords
- Pre-exposure Prophylaxis (PrEP), HIV prevention, HIV Self-testing, Decisional Aid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrEP Decisional Aid for dissemination with Self-administered HIV test kits (DASH)Behavioural
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: PrEP Decisional Aid for dissemination with Self-administered HIV test kits (DASH) |
What is being measured
The primary outcome is the main question the study is designed to answer.
PrEP Start
Self-reported PrEP initiation determined by a single item asking "Are you currently using PrEP?" [Yes/No]
Measured: 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.
Measured: Month 1 and month 3
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline, Month 1 and Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start17 Apr 2026
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-Exposure Prophylaxis (PrEP)Studies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled mixed methods implementation hybrid type 1 pilot study
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, K Rivet Amico, University of Michigan
- Investigators
- K Rivet Amico, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07614165
- Sponsor's protocol ID
- HUM00284303
- Other IDs
- 5R34MH135799
- Acronym
- DASH
- Status last verified
- May 2026
- First submitted
- 8 May 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: National Data Archive received participant data using a psuedo identification number
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Self-administered PrEP Decisional Aid for Dissemination With HIV Self-test Kits (DASH)
- ClinicalTrials.gov ID
- NCT07614165
- Acronym / sponsor ID
- DASH / HUM00284303
- Conditions
- Pre-Exposure Prophylaxis (PrEP), HIV Prevention
- Keywords
- Pre-exposure Prophylaxis (PrEP), HIV prevention, HIV Self-testing, Decisional Aid
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 17 Apr 2026 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 29 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled mixed methods implementation hybrid type 1 pilot study
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: PrEP Decisional Aid for dissemination with Self-administered HIV test kits (DASH)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 |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 18-39
- Comfort with English material and communication (oral and written)
- Access to internet
- HIV negative (self-report)
- PrEP Naive (never used PrEP)
Key exclusion criteria (1 listed)
- Ever used PrEP
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | DASH Intervention Arm |
Primary outcome
PrEP Start
Time frame: 3 months
Self-reported PrEP initiation determined by a single item asking "Are you currently using PrEP?" [Yes/No]
Theoretical Framework of Acceptability Scale for DASH
Time frame: Month 1 and month 3
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.
2 secondary outcomes
PrEP Information
Time frame: Baseline, Month 1 and Month 3
Movement on PrEP Care Continuum
Time frame: Baseline, Month 1 and Month 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: Yes. National Data Archive received participant data using a psuedo identification number
Related trials for Pre-Exposure Prophylaxis (PrEP)
Not yet recruiting
Evaluating the Healthy Families PrEP Program for Women at Risk for HIV
HIV, Pregnancy
RecruitingObservational study
Implementation Study of Lenacapavir Pre-exposure Prophylaxis for HIV Prevention
HIV Infections
Active, not recruiting
CAMELLIA Cohort: A Longitudinal Study to Understand Sexual Health and Prevention Among Women in Alabama
Hiv, Sexually Transmitted Diseases
RecruitingPhase 4
Enhancing PrEP Uptake and Retention Among Latine TGW and GBM in the South Using Long-Acting Injectable PrEP
HIV Prevention, HIV Pre-exposure Prophylaxis
Recruiting
Linking Youth to Pre-Exposure Prophylaxis (PrEP) Services
HIV, PrEP
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
K Rivet Amico, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PrEP Decisional Aid for dissemination with Self-administered HIV test kits (DASH) in people with Pre-Exposure Prophylaxis (PrEP) and HIV Prevention, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PrEP Start (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.