Development of a Tailored HIV Prevention Intervention for Young Men (myDEx)
2019年6月25日 更新者：Jose Bauermeister、University of Pennsylvania
This study uses an interactive design and development process to develop tailored messages that align YMSM's relationship experiences and desires with HIV prevention strategies.
The study includes a tailored online prevention, intervention, as well as an attention control non--tailored HIV prevention (NTHP) comparison intervention.
The pilot RCT will compare the intervention (N=120) to NTHP (N=60) to assess intervention feasibility and acceptability, and gather preliminary behavioral data to inform a subsequent application.
Follow-up assessments will be collected at thirty (30), sixty (60), and ninety (90) days post-intervention.
調査の概要
詳細な説明
A resurgence of new HIV cases among young men who have sex with men (YMSM; ages 18--24) has underscored the importance of developing culturally- and developmentally- informed HIV programs for YMSM. The investigators are developing and pilot testing a tailored, web- based intervention called myDEx that focuses on delivering HIV prevention messages based on single YMSM's relationship expectations and partner--seeking behaviors. To maximize intervention appeal and appropriateness, the investigators have convened a youth advisory board (YAB) to provide insight and feedback during the 3--stage intervention development process. Using an iterative design and development process, they have developed tailored messages that align YMSM's relationship experiences and desires with HIV prevention strategies. The investigators designed and developed the myDEx tailored online prevention intervention, as well as an attention- control non--tailored HIV/AIDS prevention (NTHP) comparison intervention. After developing both interventions, the investigators used usability testing procedures to collect preliminary data from 16 YMSM on the proposed intervention's design and acceptability. Recommended changes were added to the intervention prior to launching a small pilot randomized controlled trial (RCT). The pilot RCT will compare myDEx (N=120) to NTHP (N=60) to assess intervention feasibility and acceptability, and gather preliminary behavioral data to inform a subsequent application. Assessments will be collected at 30, 60, and 90 days follow--up.
Specific Aims include:
- To develop a tailored (myDEx) and non-tailored (NTHP) HIV prevention intervention focused on addressing HIV risk behaviors among single YMSM;
- To collect preliminary data on the feasibility, acceptability, and intervention content of the myDEx (N=16) in preparation for a small pilot RCT; and,
- To implement a small pilot RCT of the refined myDEx (N=120) as compared to the NTHP (N=60) intervention, in order to evaluate its feasibility and acceptability and gather preliminary efficacy results in reducing sexual risk behaviors.
研究の種類
介入
入学 (実際)
180
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19104
- University of Pennsylvania
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～24年 (大人)
健康ボランティアの受け入れ
はい
受講資格のある性別
男
説明
Inclusion Criteria:
- Cis-gender male
- Self-report as being single
- Self report as HIV-negative at baseline
- Speak and read English
- Report unprotected anal intercourse with a male partner in prior six (6) months
- Have access to computer or smartphone device
Exclusion Criteria:
- Transgender identity
- HIV positive diagnosis
- Not residing in the United States
- Does not engage in male-to-male sexual behavior
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：myDEx Intervention
The proposed intervention will consist of a 6-session web-based program.
Cognizant of challenges maintaining users' attention in a web application and to facilitate delivery through a smartphone, the investigators will design each session to be no more than 20 minutes in length.
In the course of these 6 sessions, YMSM will have a total of 120 minutes of intervention exposure.
Across sessions, the investigators will emphasize the importance of sexual decision-making across different partner types, help YMSM consider what type of relationship(s) they want, and align these relationship desires with safer sex practices.
|
myDEx will consist of a 6-session online program.
Cognizant of challenges maintaining users' attention in a web application and to facilitate delivery through a smartphone, the investigators will design each session to be no more than 20 minutes in length.
In the course of these 6 sessions, participants will have a total of 120 minutes of intervention exposure.
Across sessions, the investigators will emphasize the importance of sexual decision-making across different partner types, help men consider what type of relationship(s) they want, and align these relationship desires with safer sex practices.
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アクティブコンパレータ：Non-tailored HIV Prevention
The investigators will create a 6-session web-based attention-control comparison to match myDEx in time and attention yet have non-tailored and non-interactive content (NTHP).
NTHP will include HIV/STI information currently available on sex education websites.
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The investigators will create a 6-session attention-control comparison to match the intervention in time and attention yet have non-tailored and non-interactive content (NTHP).
NTHP will include HIV/STI information currently available on sex education websites.
The attention-control condition allows the investigators to avoid confounding due to content and ensures that all participants receive some HIV prevention content given their high vulnerability to HIV.
Further, this comparison will help critically examine the extent to which tailoring increases the acceptability to the program, above and beyond having a non-tailored, non-interactive intervention.
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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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Number of Participants With Change in Number of Risky Sexual Partnerships
時間枠：Count of participants from baseline to 90-day follow-up reported
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The investigators estimated the change in the total number of participants who reported engaging in condomless anal intercourse from baseline to 90-day follow-up.
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Count of participants from baseline to 90-day follow-up reported
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Number of Participants With Change in HIV Testing Behavior
時間枠：Count of participants from baseline to 90-day follow-up reported
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The investigators estimated the number of participants who reported testing for HIV from baseline to 90-day follow-up.
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Count of participants from baseline to 90-day follow-up reported
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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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Change in Self-efficacy Motivations to Engage in HIV Prevention Behaviors
時間枠：Baseline to 90-day follow-up period
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The investigators will measure the change in safer sex self-efficacy over time using the HIV Risk Behavior Self-Efficacy Scale by Fisher, Fisher, Misovich, Kimble & Malloy (1996).
The scale is measured on a 4-point scale (range 1-4), where higher scores mean less self-efficacy to negotiate safer sex with partners met online.
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Baseline to 90-day follow-up period
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Changes in Psychological Well-being
時間枠：Baseline to 90-day follow-up period
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The investigators will measure symptoms of depression and anxiety using the Brief Symptom Inventory by Derogatis & Spencer (1982).
Higher mean scores (scale 1-4) indicate greater symptoms of psychological distress.
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Baseline to 90-day follow-up period
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Jose A Bauermeister, PhD、University of Pennsylvania
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Choi SK, Golinkoff J, Michna M, Connochie D, Bauermeister J. Correlates of Engagement Within an Online HIV Prevention Intervention for Single Young Men Who Have Sex With Men: Randomized Controlled Trial. JMIR Public Health Surveill. 2022 Jun 27;8(6):e33867. doi: 10.2196/33867.
- Connochie D, Tingler RC, Bauermeister JA. Young men who have sex with men's awareness, acceptability, and willingness to participate in HIV vaccine trials: Results from a nationwide online pilot study. Vaccine. 2019 Oct 8;37(43):6494-6499. doi: 10.1016/j.vaccine.2019.08.076. Epub 2019 Sep 13.
- Bauermeister JA, Tingler RC, Demers M, Harper GW. Development of a Tailored HIV Prevention Intervention for Single Young Men Who Have Sex With Men Who Meet Partners Online: Protocol for the myDEx Project. JMIR Res Protoc. 2017 Jul 19;6(7):e141. doi: 10.2196/resprot.7965.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2016年11月1日
一次修了 (実際)
2017年5月1日
研究の完了 (実際)
2017年5月1日
試験登録日
最初に提出
2016年7月16日
QC基準を満たした最初の提出物
2016年7月21日
最初の投稿 (見積もり)
2016年7月22日
学習記録の更新
投稿された最後の更新 (実際)
2019年7月16日
QC基準を満たした最後の更新が送信されました
2019年6月25日
最終確認日
2019年6月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- R34MH101997 (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?
はい
IPD プランの説明
The investigators will assure the timely release and sharing of data two years after the publication of the main trial findings from the final dataset.
Study variables will be available; however, the investigators will protect the rights and privacy of human subjects by redacting all identifiers from the dataset.
The de-identified data from this project will be available through individual requests directed to the Principal Investigator.
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。