- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02139566
Improving Consent and Survey Procedures for Young MSM in Web-based HIV Prevention
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Georgia
-
Atlanta, Georgia, États-Unis, 30322
- Rollins School of Public Health, Emory University
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
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.
|
|
Expérimental: 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.
|
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.
|
|
Expérimental: 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
|
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.
|
|
Comparateur actif: 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
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Knowledge of Consent Information
Délai: At baseline (time zero)
|
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.
|
At baseline (time zero)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Proportion of eligible men who consent
Délai: Time of informed consent (baseline)
|
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.
|
Time of informed consent (baseline)
|
|
Engagement with Consent Information
Délai: Time of consent
|
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.
|
Time of consent
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Patrick S Sullivan, PhD, Emory University
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- IRB00065333
- 1R21HD074502-01A1 (Subvention/contrat des NIH des États-Unis)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .