HealthyNCT02139566
Improving Consent and Survey Procedures for Young MSM in Web-based HIV Prevention
A study testing Video consent (high-tech), Video consent (low-tech) and FAQ format consent in people with Healthy, run by Emory University at 1 site in United States.
Trial summary
A two-part study to test the efficacy of alternative consent procedures and the efficacy of alternative methods to improve survey completion. Read more about this study
- Who is it for?
- Ages 18 to 34 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Video consent (high-tech), Video consent (low-tech) and FAQ format consent
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,405 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 34 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- ages 18-34
- have had sex with another man in the past 12 months
Who cannot join
- female, transgender
- younger than 18 years old
- older than 34 years old
- have not had sex with a man in the past 12 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Rollins School of Public Health, Emory University
Atlanta, Georgia, 30322
About this study
A two-part study to test the efficacy of alternative consent procedures and the efficacy of alternative methods to improve survey completion.
Read the detailed description
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.
- Conditions
- Healthy
- Being tested
- Video consent (high-tech), Video consent (low-tech), FAQ format consent, Standard consent, PDF informed consent document
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video consent (high-tech)Behavioural
Consent provided by an animated video with captions
Video consent (low-tech)Behavioural
This consent is a video production of the informed consent information, taped using a staff member with basic video equipment.
FAQ format consentBehavioural
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.
Standard consentBehavioural
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.
PDF informed consent documentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Hi-tech video consent | Experimental | 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. Receives: Behavioral: Video consent (high-tech); Behavioral: PDF informed consent document |
| Low-tech video consent | Experimental | 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. Receives: Behavioral: Video consent (low-tech); Behavioral: PDF informed consent document |
| FAQ consent | Experimental | 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 Receives: Behavioral: FAQ format consent; Behavioral: PDF informed consent document |
| Standard consent process | Active comparator | 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 Receives: Behavioral: Standard consent; Behavioral: PDF informed consent document |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge of Consent Information
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.
Measured: At baseline (time zero)
Secondary outcomes (2)
Proportion of eligible men who consent
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.
Measured: Time of informed consent (baseline)
Engagement with Consent Information
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.
Measured: Time of consent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2014 (estimated)
- Study startJul 2014
- Primary completionMay 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,405 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Patrick S Sullivan, Emory University
- Investigators
- Patrick S Sullivan, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02139566
- Sponsor's protocol ID
- IRB00065333
- Other IDs
- 1R21HD074502-01A1
- Status last verified
- Jan 2016
- First submitted
- 11 May 2014
- Last updated
- 15 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30381466Hall 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.
PubMed 28264794
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Consent and Survey Procedures for Young MSM in Web-based HIV Prevention
- ClinicalTrials.gov ID
- NCT02139566
- Acronym / sponsor ID
- IRB00065333
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,405 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Jul 2014
- Primary completion
- May 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 15 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A two-part study to test the efficacy of alternative consent procedures and the efficacy of alternative methods to improve survey completion.
Detailed description
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Hi-tech video consent | Experimental | Behavioral: Video consent (high-tech), Behavioral: PDF informed consent documentThis 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. |
| Low-tech video consent | Experimental | Behavioral: Video consent (low-tech), Behavioral: PDF informed consent documentParticipants 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. |
| FAQ consent | Experimental | Behavioral: FAQ format consent, Behavioral: PDF informed consent documentParticipants 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 |
| Standard consent process | Active comparator | Behavioral: Standard consent, Behavioral: PDF informed consent documentParticipants 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 |
Who may qualify
- Ages
- 18 to 34 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- ages 18-34
- have had sex with another man in the past 12 months
Key exclusion criteria (4 listed)
- female, transgender
- younger than 18 years old
- older than 34 years old
- have not had sex with a man in the past 12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video consent (high-tech)Consent provided by an animated video with captions | Behavioural | Hi-tech video consent |
| Video consent (low-tech)This consent is a video production of the informed consent information, taped using a staff member with basic video equipment. | Behavioural | Low-tech video consent |
| FAQ format consentThis 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. | Behavioural | FAQ consent |
| Standard consentThe 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. | Behavioural | Standard consent process |
| PDF informed consent documentA 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. | Behavioural | FAQ consent, Hi-tech video consent, Low-tech video consent, Standard consent process |
Primary outcome
Knowledge of Consent Information
Time frame: 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.
2 secondary outcomes
Proportion of eligible men who consent
Time frame: Time of informed consent (baseline)
Engagement with Consent Information
Time frame: Time of consent
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2016.
- Derived from this study: PubMed 30381466Hall 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.
- Derived from this study: PubMed 28264794Hall 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick S Sullivan, PhD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video consent (high-tech), Video consent (low-tech) and FAQ format consent in people with Healthy, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge of Consent Information (time frame: At baseline (time zero)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02139566, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2016.