A Self-administered PrEP Decisional Aid for Dissemination With HIV Self-test Kits (DASH) (DASH)
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
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Michigan
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Ann Arbor、Michigan、アメリカ、48109
- University of Michigan
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参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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介入なし：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.
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実験的：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
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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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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PrEP Start
時間枠：3 months
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Self-reported PrEP initiation determined by a single item asking "Are you currently using PrEP?" [Yes/No]
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3 months
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Theoretical Framework of Acceptability Scale for DASH
時間枠：Month 1 and month 3
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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.
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Month 1 and month 3
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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PrEP Information
時間枠：Baseline, Month 1 and Month 3
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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.
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Baseline, Month 1 and Month 3
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Movement on PrEP Care Continuum
時間枠：Baseline, Month 1 and Month 3
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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.
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Baseline, Month 1 and Month 3
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Decisional Conflict
時間枠：Baseline, Month 1 and Month 3
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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.
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Baseline, Month 1 and Month 3
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PrEP Motivation
時間枠：Baseline, Month 1 and Month 3
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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.
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Baseline, Month 1 and Month 3
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DASH Trustworthiness
時間枠：Month 1
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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.
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Month 1
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System Usability Scale
時間枠：Month 1
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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.
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Month 1
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Perceived Usefulness of DASH
時間枠：Month 1
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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.
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Month 1
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Suspiciousness of DASH
時間枠：Month 1
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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.
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Month 1
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協力者と研究者
スポンサー
捜査官
- 主任研究者：K Rivet Amico, PhD、University of Michigan
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- HUM00284303
- 5R34MH135799 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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