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

29. Mai 2026 aktualisiert von: K Rivet Amico, University of Michigan
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.

Studienübersicht

Status

Anmeldung auf Einladung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

170

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Michigan
      • Ann Arbor, Michigan, Vereinigte Staaten, 48109
        • University of Michigan

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Kein Eingriff: 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
Verhalten: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
PrEP Start
Zeitfenster: 3 months
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
Zeitfenster: 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.
Month 1 and month 3

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
PrEP Information
Zeitfenster: Baseline, Month 1 and Month 3
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
Zeitfenster: Baseline, Month 1 and Month 3
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

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Decisional Conflict
Zeitfenster: Baseline, Month 1 and Month 3
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
Zeitfenster: Baseline, Month 1 and Month 3
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
Zeitfenster: Month 1
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
Zeitfenster: Month 1
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
Zeitfenster: Month 1
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
Zeitfenster: Month 1
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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Michigan

Mitarbeiter

National Institute of Mental Health (NIMH)

Ermittler

  • Hauptermittler: K Rivet Amico, PhD, University of Michigan

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

17. April 2026

Primärer Abschluss (Geschätzt)

31. Oktober 2026

Studienabschluss (Geschätzt)

31. Dezember 2026

Studienanmeldedaten

Zuerst eingereicht

8. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

21. Mai 2026

Zuerst gepostet (Tatsächlich)

29. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

3. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

29. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • HUM00284303
  • 5R34MH135799 (US NIH Stipendium/Vertrag)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

National Data Archive received participant data using a psuedo identification number

IPD-Sharing-Zeitrahmen

NDA data is uploaded quarterly and is available to public for use after the completion of the trial

IPD-Sharing-Zugriffskriterien

NDA has a system that researchers can use to request data access

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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