Self-Consent for PrEP Perspectives

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.

Study Overview

• Status: Completed
• Conditions: PrEP; HIV

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 Type: Observational
• Enrollment (Actual): 58

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90027
      • Children's Hospital of Los Angeles
  • Florida
    • Miami, Florida, United States, 33101
      • University of Miami
    • Tampa, Florida, United States, 33606
      • University of Southern Florida College of Medicine
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Stroger Hospital of Cook County
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Tulane Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Fenway Institute
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Wayne State University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia
  • Tennessee
    • Memphis, Tennessee, United States, 38105
      • St. Jude Childrens Research Hospital
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 22 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Retrospective self-assessment of consent competence as assessed by completion of web-based survey	Day 1
Retrospective self-assessment of consent competence as assessed by completion of in-depth interview with selected participants	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	Day 1
Retrospective self-assessment of consent disclosure as assessed by completion of in-depth interview with selected participants	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	Day 1
Retrospective self-assessment of consent understanding as assessed by completion of in-depth interview with selected participants	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	Day 1
Retrospective self-assessment of consent voluntariness as assessed by completion of in-depth interview with selected participants	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	Day 1
Use of social support and information seeking in the consent process as assessed by completion of in-depth interview with selected participants	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	Day 1
Experienced harms and benefits associated with autonomous research decision-making as assessed by completion of in-depth interview with selected participants	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	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	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	Day 1
Post-ATN 110 or ATN 113 study PrEP use and experiences as assessed by completion of in-depth interview with selected participants	One-time interview completed no more than 60 days after consent

Secondary Outcome Measures

Outcome Measure	Time Frame
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	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	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	Day 1
Need for additional support in the decision making process for clinical trial participation as assessed by in-depth interview with selected participants	One-time interview completed no more than 60 days after consent
Self-assessment of adherence as assessed by web-based survey	Day 1
Self-assessment of adherence as assessed by in-depth interview with selected participants	One-time interview completed no more than 60 days after consent
Benefit or harm from participation as assessed by completion of web-based survey	Day 1
Benefit or harm from participation as assessed by completion of in-depth interview with selected participants	One-time interview completed no more than 60 days after consent

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: National Institute on Drug Abuse (NIDA); National Institute of Mental Health (NIMH)
• Investigators: Study Chair: Sybil Hosek, Ph.D., John Stroger Hospital of Cook County; Study Chair: J. Dennis Fortenberry, M.D., Indiana University School of Medicine

Publications and helpful links

Helpful Links

• ATN Website

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: March 23, 2016
• First Submitted That Met QC Criteria: June 13, 2016
• First Posted (Estimate): June 16, 2016

Study Record Updates

• Last Update Posted (Actual): February 28, 2017
• Last Update Submitted That Met QC Criteria: February 27, 2017
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: HIV; PrEP; Self-Consent; Autonomous Research Consent; Participation-associated Outcomes
• Other Study ID Numbers: ATN 137

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No