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Self-Consent for PrEP Perspectives

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ClinicalTrials.gov Identifier: NCT02801760
Recruitment Status : Completed
First Posted : June 16, 2016
Last Update Posted : February 28, 2017
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief 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 to Pre-exposure Prophylaxis (PrEP) and Human Immunodeficiency Virus (HIV) seroconversion at any point during participation in the ATN 110 or ATN 113 study.

Condition or disease
HIV PrEP

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.

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Study Type : Observational
Actual Enrollment : 58 participants
Observational Model: Cohort
Time Perspective: Retrospective
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
Study Start Date : November 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort
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.



Primary Outcome Measures :
  1. Retrospective self-assessment of consent competence as assessed by completion of web-based survey [ Time Frame: Day 1 ]
  2. 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 ]
  3. Retrospective self-assessment of consent disclosure as assessed by completion of web-based survey [ Time Frame: Day 1 ]
  4. 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 ]
  5. Retrospective self-assessment of consent understanding as assessed by completion of web-based survey [ Time Frame: Day 1 ]
  6. 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 ]
  7. Retrospective self-assessment of consent voluntariness as assessed by completion of web-based survey [ Time Frame: Day 1 ]
  8. 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 ]
  9. Use of social support and information seeking in the consent process as assessed by completion of web-based survey [ Time Frame: Day 1 ]
  10. 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 ]
  11. Experienced harms and benefits associated with autonomous research decision-making as assessed by completion of web-based survey [ Time Frame: Day 1 ]
  12. 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 ]
  13. 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 ]
  14. 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 ]
  15. Post-ATN 110 or ATN 113 study PrEP use and experiences as assessed by completion of web-based survey [ Time Frame: Day 1 ]
  16. 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 ]

Secondary Outcome Measures :
  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 web-based survey [ Time Frame: Day 1 ]
  2. 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 ]
  3. Need for additional support in the decision making process for clinical trial participation as assessed by web-based survey [ Time Frame: Day 1 ]
  4. 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 ]
  5. Self-assessment of adherence as assessed by web-based survey [ Time Frame: Day 1 ]
  6. 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 ]
  7. Benefit or harm from participation as assessed by completion of web-based survey [ Time Frame: Day 1 ]
  8. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   15 Years to 22 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.

Criteria

Inclusion Criteria:

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).

Exclusion Criteria:

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02801760


Locations
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United States, California
Children's Hospital of Los Angeles
Los Angeles, California, United States, 90027
United States, Florida
University of Miami
Miami, Florida, United States, 33101
University of Southern Florida College of Medicine
Tampa, Florida, United States, 33606
United States, Illinois
Stroger Hospital of Cook County
Chicago, Illinois, United States, 60612
United States, Louisiana
Tulane Medical Center
New Orleans, Louisiana, United States, 70112
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Fenway Institute
Boston, Massachusetts, United States, 02215
United States, Michigan
Wayne State University
Detroit, Michigan, United States, 48201
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
St. Jude Childrens Research Hospital
Memphis, Tennessee, United States, 38105
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
Investigators
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Study Chair: Sybil Hosek, Ph.D. John Stroger Hospital of Cook County
Study Chair: J. Dennis Fortenberry, M.D. Indiana University School of Medicine
Additional Information:
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02801760    
Other Study ID Numbers: ATN 137
First Posted: June 16, 2016    Key Record Dates
Last Update Posted: February 28, 2017
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of North Carolina, Chapel Hill:
HIV
Self-Consent
PrEP
Autonomous Research Consent
Participation-associated Outcomes