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

2026年5月29日 更新者：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.

研究概览

地位

邀请报名

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

170

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • Michigan
      • Ann Arbor、Michigan、美国、48109
        • University of Michigan

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

是的

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：预防
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
无干预：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.
实验性的：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
行为的：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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
PrEP Start
大体时间：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
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
PrEP Information
大体时间：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
大体时间：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

其他结果措施

结果测量
措施说明
大体时间
Decisional Conflict
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of Michigan

合作者

National Institute of Mental Health (NIMH)

调查人员

  • 首席研究员：K Rivet Amico, PhD、University of Michigan

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年4月17日

初级完成 (估计的)

2026年10月31日

研究完成 (估计的)

2026年12月31日

研究注册日期

首次提交

2026年5月8日

首先提交符合 QC 标准的

2026年5月21日

首次发布 (实际的)

2026年5月29日

研究记录更新

最后更新发布 (实际的)

2026年6月3日

上次提交的符合 QC 标准的更新

2026年5月29日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • HUM00284303
  • 5R34MH135799 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

National Data Archive received participant data using a psuedo identification number

IPD 共享时间框架

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

IPD 共享访问标准

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

IPD 共享支持信息类型

  • 研究方案
  • 树液

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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