Improving Consent and Survey Procedures for Young MSM in Web-based HIV Prevention
調査の概要
状態
条件
詳細な説明
Men who have sex with men are the risk population most heavily impacted by HIV in the United States by any measure; in 2009, at least 61% of new HIV infections were estimated to have occurred in MSM. MSM are experiencing an increase in HIV transmission that has been occurring since at least 1990, and accelerated in multiple North American and European countries from 2000-2005. The expansion of the HIV epidemic has been proposed to be attributable, in part, to the extent to which the internet has facilitated sexual connectivity among MSM.
Researchers have attempted to reach MSM for HIV prevention research and intervention on the internet. In the past 10 years, there has been a proliferation of internet surveys and HIV research studies among men who have sex with men that utilize the internet for data collection and, in some cases, the delivery of HIV prevention content. The development of internet-based interventions has been recently identified as especially promising because of its potential for scalability. However, there are also important limitations to internet-based data collections and prevention studies. The most important of these relate to representativeness and opportunities to introduce bias to data collections and differences in access to and use of internet among different subgroups of MSM. Equally important, although less discussed, are the unique ethical and human research protections challenges posed by online sexual health prevention studies.
The investigators will conduct a series of experiments that will result in improved knowledge of how to conduct internet-based HIV prevention research with MSM in ways that improve the protection of human subjects and decrease biases in data collections. The design will consist of preparatory online qualitative research with up to 100 MSM, followed by two cross-sectional randomized controlled trials of MSM recruited online; a total of 2440 MSM will be enrolled in the two randomized quantitative studies (1,440 in Study 1 to determine optimal methods to provide informed consent, online, and 1000 in Study 2 to determine how to best improve retention in online surveys). About 2440 men will be enrolled in the study in total. This summary describes Study 1; a separate submission will be completed for Study 2.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
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Georgia
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Atlanta、Georgia、アメリカ、30322
- Rollins School of Public Health, Emory University
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- ages 18-34
- have had sex with another man in the past 12 months
Exclusion Criteria:
- female, transgender
- younger than 18 years old
- older than 34 years old
- have not had sex with a man in the past 12 months
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
- 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 |
---|---|
実験的:Hi-tech video consent
This group will be shown a professionally animated video that presents the major components of the informed consent document.
Intervention is Video Consent (high-tech) PDF informed consent document.
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Consent provided by an animated video with captions
A PDF of the full consent document will be available for download, through hyperlink on the consent page.
This is provided for video (low-tech), video (high-tech), FAQ format, and standard informed consent.
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実験的:Low-tech video consent
Participants in this arm will be provided with informed consent information through viewing a "talking head" video produced by a non-professional presenter, with widely available and inexpensive video equipment.
Intervention is "video consent (low-tech)", PDF informed consent document.
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A PDF of the full consent document will be available for download, through hyperlink on the consent page.
This is provided for video (low-tech), video (high-tech), FAQ format, and standard informed consent.
This consent is a video production of the informed consent information, taped using a staff member with basic video equipment.
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実験的:FAQ consent
Participants in this arm will be provided with informed consent content through an interactive "frequently asked questions" format, in which the participant will click on a question and be shown text that provides an answer to that question.
Major informed consent topics will have one or more question and answer pairs.
Intervention is "FAQ format consent", PDF informed consent document
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A PDF of the full consent document will be available for download, through hyperlink on the consent page.
This is provided for video (low-tech), video (high-tech), FAQ format, and standard informed consent.
This consent modality will present the basic information from the informed consent in an interactive, "frequently asked questions" format.
Upon clicking each question, the participant will be shown a short text response to that question.
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アクティブコンパレータ:Standard consent process
Participants in this arm will be provided with informed consent content by being shown a standard informed consent document in a scrolling window within the browser window, PDF informed consent document
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A PDF of the full consent document will be available for download, through hyperlink on the consent page.
This is provided for video (low-tech), video (high-tech), FAQ format, and standard informed consent.
The standard consent form will present the full informed consent document in a scrolling text window within the browser window.
Participants will be asked to review the document online.
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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 |
---|---|---|
Knowledge of Consent Information
時間枠:At baseline (time zero)
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Correct knowledge of key aspects of the consent document will be operationalized by a count of the correctly answered consent recall items placed at the end of the survey, expressed as the number of correct items as a continuous measure.
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At baseline (time zero)
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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 |
---|---|---|
Proportion of eligible men who consent
時間枠:Time of informed consent (baseline)
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The proportion of eligible men who consent to participate in the study; this secondary outcome is applicable only to the randomized study of alternative forms of informed consent administration.
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Time of informed consent (baseline)
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Engagement with Consent Information
時間枠:Time of consent
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We will measure engagement with the consent information by recording the amount of time a participant spends on the consent page before clicking to the first page of the survey.
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Time of consent
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Patrick S Sullivan, PhD、Emory University
出版物と役立つリンク
一般刊行物
- Hall E, Sanchez T, Stephenson R, Stein AD, Sineath RC, Zlotorzynska M, Sullivan P. Randomised controlled trial of incentives to improve online survey completion among internet-using men who have sex with men. J Epidemiol Community Health. 2019 Feb;73(2):156-161. doi: 10.1136/jech-2018-211166. Epub 2018 Oct 31.
- Hall EW, Sanchez TH, Stein AD, Stephenson R, Zlotorzynska M, Sineath RC, Sullivan PS. Use of Videos Improves Informed Consent Comprehension in Web-Based Surveys Among Internet-Using Men Who Have Sex With Men: A Randomized Controlled Trial. J Med Internet Res. 2017 Mar 6;19(3):e64. doi: 10.2196/jmir.6710.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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
- IRB00065333
- 1R21HD074502-01A1 (米国 NIH グラント/契約)
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。