HIVNCT02801760
Self-Consent for PrEP Perspectives
An observational study of HIV and PrEP, run by University of North Carolina, Chapel Hill at 11 sites in United States.
Trial summary
This study involves a one-time, web-based quantitative structured self-complete ("web-based") survey for all subjects and a qualitative semi-structured ("qualitative") interview for a selected sub-sample of subjects to evaluate the consent processes in association with research outcomes, specifically early adherence… Read more about this study
- Who is it for?
- Ages 15 to 22 years, men onlyHealthy volunteers can take part
- How many people
- 58 participants
- Where
- 11 sitesUnited States
- Study dates
- Nov 2015to Mar 2016
- Phase
- Observational
- 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 15 to 22 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Study population: YMSM and transgender women who have sex with men who participated in the ATN 110 or ATN 113 study will be recruited to complete the one-time, web-based survey. Subjects who withdrew consent during their participation in the ATN 110 or ATN 113 study or were inadvertently enrolled will not be included in this study. A sub-sample of subjects who completed the web-based survey and indicated willingness to complete the qualitative interview will be selected to complete the qualitative interview. Selection will match subjects with high levels of PrEP adherence (> 4 doses/week) with those with low levels of PrEP adherence (< 4 doses/week). Attempt will be made to include all subjects that seroconverted.
Who may be able to join
- To be considered eligible for enrollment into ATN 137, an individual must meet all of the criteria listed below.
- Is currently or was previously enrolled in the ATN 110 or ATN 113 study; and
- Is willing and able to provide informed consent via online informed consent form (ICF).
Who cannot join
- To be considered eligible for enrollment, an individual must not meet any of the criteria listed below.
- Prematurely discontinued from the ATN 110 or ATN 113 study due to withdrawal of consent or inadvertent enrollment.
- Inability to complete the web-based quantitative structured self-completed survey in its entirety in a single sitting immediately after consent is provided.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Johns Hopkins University
Baltimore, Maryland, 21287
Fenway Institute
Boston, Massachusetts, 02215
Stroger Hospital of Cook County
Chicago, Illinois, 60612
Wayne State University
Detroit, Michigan, 48201
Baylor College of Medicine
Houston, Texas, 77030
Children's Hospital of Los Angeles
Los Angeles, California, 90027
St. Jude Childrens Research Hospital
Memphis, Tennessee, 38105
University of Miami
Miami, Florida, 33101
Tulane Medical Center
New Orleans, Louisiana, 70112
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
University of Southern Florida College of Medicine
Tampa, Florida, 33606
About this study
Official title: Participation in a Biomedical HIV Prevention Clinical Trial: Perspectives of Younger and Older Young Men Who Have Sex With Men (YMSM) and Transgender Women Who Have Sex With Men
This study involves a one-time, web-based quantitative structured self-complete ("web-based") survey for all subjects and a qualitative semi-structured ("qualitative") interview for a selected sub-sample of subjects to evaluate the consent processes in association with research outcomes, specifically early adherence to Pre-exposure Prophylaxis (PrEP) and Human Immunodeficiency Virus (HIV) seroconversion at any point during participation in the ATN 110 or ATN 113 study.
Read the detailed description
Decisional autonomy is a foundational, nearly inviolable principle of contemporary human subjects research. "Autonomy" refers to a deliberative outcome reflecting an individual's choice, outside of controlling influences of other agents. From the perspective of research participation decision-making, autonomy incorporates five elements of consent: competence; disclosure; understanding; voluntariness; and, consent. Adequate research consent processes are thought to be challenged by group-level qualities that define a "vulnerable population" in need of protection from coercion or undue influence. Age (typically less than age 18 in the United States) is a widely accepted status-defining vulnerability. Sexual minority identity or same-sex behavior does not define a "vulnerable" population but 45 Code of Federal Regulations (CFR) 46 subpart A (Common Rule) allows appropriate protections for other vulnerable populations as determined by an individual Institutional Review Board (IRB).
The specific aims of this study address issues within a larger domain of questions about the primacy of decisional autonomy, and associations of autonomous research consent and subsequent participation-associated outcomes. This mixed-methods study will enroll young men who have sex with men (YMSM) and transgender women who have sex with men who are currently or were previously enrolled in the ATN 110 or ATN 113 study.
Data from the web-based survey will be used to test hypotheses about the relationships between participant age, elements of the consent process, and two key participation outcomes (early adherence to PrEP, HIV seroconversion) in the ATN 110 or ATN 113 study. Data from the qualitative interview will be used to explore in further depth age-related vulnerability and disclosure vulnerabilities manifested for participants and whether/how they influenced ATN 110 and ATN 113 study outcomes. The interview will also assess decisional support and the benefits or harms associated with participation.
- Keywords
- HIV, Self-Consent, PrEP, Autonomous Research Consent, Participation-associated Outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Subjects Currently or Previously Enrolled in ATN 110/ATN 113 | Younger and older YMSM and transgender women who have sex with men, ages 15 through 22 years, inclusive, at the time of consent into the ATN 110 or ATN 113 study. | |
| Sub-Sample of Subjects to Complete Qualitative Interview | A sub-sample of subjects who completed the web-based survey and indicated willingness to complete the qualitative interview. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective self-assessment of consent competence as assessed by completion of web-based survey
Measured: Day 1
Retrospective self-assessment of consent competence as assessed by completion of in-depth interview with selected participants
Measured: One-time interview completed no more than 60 days after consent
Retrospective self-assessment of consent disclosure as assessed by completion of web-based survey
Measured: Day 1
Retrospective self-assessment of consent disclosure as assessed by completion of in-depth interview with selected participants
Measured: One-time interview completed no more than 60 days after consent
Retrospective self-assessment of consent understanding as assessed by completion of web-based survey
Measured: Day 1
Retrospective self-assessment of consent understanding as assessed by completion of in-depth interview with selected participants
Measured: One-time interview completed no more than 60 days after consent
Retrospective self-assessment of consent voluntariness as assessed by completion of web-based survey
Measured: Day 1
Retrospective self-assessment of consent voluntariness as assessed by completion of in-depth interview with selected participants
Measured: One-time interview completed no more than 60 days after consent
Use of social support and information seeking in the consent process as assessed by completion of web-based survey
Measured: Day 1
Use of social support and information seeking in the consent process as assessed by completion of in-depth interview with selected participants
Measured: One-time interview completed no more than 60 days after consent
Experienced harms and benefits associated with autonomous research decision-making as assessed by completion of web-based survey
Measured: Day 1
Experienced harms and benefits associated with autonomous research decision-making as assessed by completion of in-depth interview with selected participants
Measured: One-time interview completed no more than 60 days after consent
Experiences with HIV testing and PrEP adherence technologies including home-based HIV testing Wisepill devices and text message adherence reminders as assessed by completion of web-based survey
Measured: Day 1
Experiences with HIV testing and PrEP adherence technologies including home-based HIV testing Wisepill devices and text message adherence reminders as assessed by completion of in-depth interview with selected participants
Measured: One-time interview completed no more than 60 days after consent
Post-ATN 110 or ATN 113 study PrEP use and experiences as assessed by completion of web-based survey
Measured: Day 1
Post-ATN 110 or ATN 113 study PrEP use and experiences as assessed by completion of in-depth interview with selected participants
Measured: One-time interview completed no more than 60 days after consent
Secondary outcomes (8)
Types of vulnerabilities (i.e., age, sexual identity, sexual behavior, and race-related) that influenced ATN 110 and ATN 113 study outcomes as assessed by completion of web-based survey
Measured: Day 1
Types of vulnerabilities (i.e., age, sexual identity, sexual behavior, and race-related) that influenced ATN 110 and ATN 113 study outcomes as assessed by completion of in-depth interview with selected participants
Measured: One-time interview completed no more than 60 days after consent
Need for additional support in the decision making process for clinical trial participation as assessed by web-based survey
Measured: Day 1
Need for additional support in the decision making process for clinical trial participation as assessed by in-depth interview with selected participants
Measured: One-time interview completed no more than 60 days after consent
Self-assessment of adherence as assessed by web-based survey
Measured: Day 1
Self-assessment of adherence as assessed by in-depth interview with selected participants
Measured: One-time interview completed no more than 60 days after consent
Benefit or harm from participation as assessed by completion of web-based survey
Measured: Day 1
Benefit or harm from participation as assessed by completion of in-depth interview with selected participants
Measured: One-time interview completed no more than 60 days after consent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2016 (estimated)
- Study startNov 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Sybil Hosek, Ph.D., Study chair, John Stroger Hospital of Cook CountyJ. Dennis Fortenberry, M.D., Study chair, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02801760
- Sponsor's protocol ID
- ATN 137
- Status last verified
- Jun 2016
- First submitted
- 23 Mar 2016
- Last updated
- 28 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Participation in a Biomedical HIV Prevention Clinical Trial: Perspectives of Younger and Older Young Men Who Have Sex With Men (YMSM) and Transgender Women Who Have Sex With Men
- ClinicalTrials.gov ID
- NCT02801760
- Acronym / sponsor ID
- ATN 137
- Keywords
- HIV, Self-Consent, PrEP, Autonomous Research Consent, Participation-associated Outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH)
- Study start
- Nov 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 16 Jun 2016 (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.
This study involves a one-time, web-based quantitative structured self-complete ("web-based") survey for all subjects and a qualitative semi-structured ("qualitative") interview for a selected sub-sample of subjects to evaluate the consent processes in association with research outcomes, specifically early adherence to Pre-exposure Prophylaxis (PrEP) and Human Immunodeficiency Virus (HIV) seroconversion at any point during participation in the ATN 110 or ATN 113 study.
Detailed description
Decisional autonomy is a foundational, nearly inviolable principle of contemporary human subjects research. "Autonomy" refers to a deliberative outcome reflecting an individual's choice, outside of controlling influences of other agents. From the perspective of research participation decision-making, autonomy incorporates five elements of consent: competence; disclosure; understanding; voluntariness; and, consent. Adequate research consent processes are thought to be challenged by group-level qualities that define a "vulnerable population" in need of protection from coercion or undue influence. Age (typically less than age 18 in the United States) is a widely accepted status-defining vulnerability. Sexual minority identity or same-sex behavior does not define a "vulnerable" population but 45 Code of Federal Regulations (CFR) 46 subpart A (Common Rule) allows appropriate protections for other vulnerable populations as determined by an individual Institutional Review Board (IRB).
The specific aims of this study address issues within a larger domain of questions about the primacy of decisional autonomy, and associations of autonomous research consent and subsequent participation-associated outcomes. This mixed-methods study will enroll young men who have sex with men (YMSM) and transgender women who have sex with men who are currently or were previously enrolled in the ATN 110 or ATN 113 study.
Data from the web-based survey will be used to test hypotheses about the relationships between participant age, elements of the consent process, and two key participation outcomes (early adherence to PrEP, HIV seroconversion) in the ATN 110 or ATN 113 study. Data from the qualitative interview will be used to explore in further depth age-related vulnerability and disclosure vulnerabilities manifested for participants and whether/how they influenced ATN 110 and ATN 113 study outcomes. The interview will also assess decisional support and the benefits or harms associated with participation.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects Currently or Previously Enrolled in ATN 110/ATN 113 | – | –Younger and older YMSM and transgender women who have sex with men, ages 15 through 22 years, inclusive, at the time of consent into the ATN 110 or ATN 113 study. |
| Sub-Sample of Subjects to Complete Qualitative Interview | – | –A sub-sample of subjects who completed the web-based survey and indicated willingness to complete the qualitative interview. |
Who may qualify
- Ages
- 15 to 22 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- YMSM and transgender women who have sex with men who participated in the ATN 110 or ATN 113 study will be recruited to complete the one-time, web-based survey. Subjects who withdrew consent during their participation in the ATN 110 or ATN 113 study or were inadvertently enrolled will not be included in this study. A sub-sample of subjects who completed the web-based survey and indicated willingness to complete the qualitative interview will be selected to complete the qualitative interview. Selection will match subjects with high levels of PrEP adherence (> 4 doses/week) with those with low levels of PrEP adherence (< 4 doses/week). Attempt will be made to include all subjects that seroconverted.
Key inclusion criteria (3 listed)
- To be considered eligible for enrollment into ATN 137, an individual must meet all of the criteria listed below.
- Is currently or was previously enrolled in the ATN 110 or ATN 113 study; and
- Is willing and able to provide informed consent via online informed consent form (ICF).
Key exclusion criteria (3 listed)
- To be considered eligible for enrollment, an individual must not meet any of the criteria listed below.
- Prematurely discontinued from the ATN 110 or ATN 113 study due to withdrawal of consent or inadvertent enrollment.
- Inability to complete the web-based quantitative structured self-completed survey in its entirety in a single sitting immediately after consent is provided.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Retrospective self-assessment of consent competence as assessed by completion of web-based survey
Time frame: Day 1
Retrospective self-assessment of consent competence as assessed by completion of in-depth interview with selected participants
Time frame: One-time interview completed no more than 60 days after consent
Retrospective self-assessment of consent disclosure as assessed by completion of web-based survey
Time frame: Day 1
Retrospective self-assessment of consent disclosure as assessed by completion of in-depth interview with selected participants
Time frame: One-time interview completed no more than 60 days after consent
Retrospective self-assessment of consent understanding as assessed by completion of web-based survey
Time frame: Day 1
Retrospective self-assessment of consent understanding as assessed by completion of in-depth interview with selected participants
Time frame: One-time interview completed no more than 60 days after consent
Retrospective self-assessment of consent voluntariness as assessed by completion of web-based survey
Time frame: Day 1
Retrospective self-assessment of consent voluntariness as assessed by completion of in-depth interview with selected participants
Time frame: One-time interview completed no more than 60 days after consent
Use of social support and information seeking in the consent process as assessed by completion of web-based survey
Time frame: Day 1
Use of social support and information seeking in the consent process as assessed by completion of in-depth interview with selected participants
Time frame: One-time interview completed no more than 60 days after consent
Experienced harms and benefits associated with autonomous research decision-making as assessed by completion of web-based survey
Time frame: Day 1
Experienced harms and benefits associated with autonomous research decision-making as assessed by completion of in-depth interview with selected participants
Time frame: One-time interview completed no more than 60 days after consent
Experiences with HIV testing and PrEP adherence technologies including home-based HIV testing Wisepill devices and text message adherence reminders as assessed by completion of web-based survey
Time frame: Day 1
Experiences with HIV testing and PrEP adherence technologies including home-based HIV testing Wisepill devices and text message adherence reminders as assessed by completion of in-depth interview with selected participants
Time frame: One-time interview completed no more than 60 days after consent
Post-ATN 110 or ATN 113 study PrEP use and experiences as assessed by completion of web-based survey
Time frame: Day 1
Post-ATN 110 or ATN 113 study PrEP use and experiences as assessed by completion of in-depth interview with selected participants
Time frame: One-time interview completed no more than 60 days after consent
8 secondary outcomes
Types of vulnerabilities (i.e., age, sexual identity, sexual behavior, and race-related) that influenced ATN 110 and ATN 113 study outcomes as assessed by completion of web-based survey
Time frame: Day 1
Types of vulnerabilities (i.e., age, sexual identity, sexual behavior, and race-related) that influenced ATN 110 and ATN 113 study outcomes as assessed by completion of in-depth interview with selected participants
Time frame: One-time interview completed no more than 60 days after consent
Need for additional support in the decision making process for clinical trial participation as assessed by web-based survey
Time frame: Day 1
Need for additional support in the decision making process for clinical trial participation as assessed by in-depth interview with selected participants
Time frame: One-time interview completed no more than 60 days after consent
Self-assessment of adherence as assessed by web-based survey
Time frame: Day 1
Self-assessment of adherence as assessed by in-depth interview with selected participants
Time frame: One-time interview completed no more than 60 days after consent
Benefit or harm from participation as assessed by completion of web-based survey
Time frame: Day 1
Benefit or harm from participation as assessed by completion of in-depth interview with selected participants
Time frame: One-time interview completed no more than 60 days after 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 28 Feb 2017.
- ATN WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Sybil Hosek, Ph.D. study chair
John Stroger Hospital of Cook County
J. Dennis Fortenberry, M.D. study chair
Indiana University
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV and PrEP, run by University of North Carolina, Chapel Hill at 11 sites 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 3 inclusion and 3 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 28 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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?
Retrospective self-assessment of consent competence as assessed by completion of web-based survey (time frame: Day 1). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Feb 2017.