Self-Consent for PrEP Perspectives

HIV Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02801760
• Other study ID #: ATN 137
• Status: Completed
• Phase: N/A
• First received: March 23, 2016
• Last updated: February 27, 2017
• Start date: November 2015
• Est. completion date: March 2016

Study information

• Verified date: June 2016
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 15 Years to 22 Years

Eligibility

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.

Related Conditions & MeSH terms

• HIV
• PrEP

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	Fenway Institute	Boston	Massachusetts
United States	Stroger Hospital of Cook County	Chicago	Illinois
United States	Wayne State University	Detroit	Michigan
United States	Baylor College of Medicine	Houston	Texas
United States	Children's Hospital of Los Angeles	Los Angeles	California
United States	St. Jude Childrens Research Hospital	Memphis	Tennessee
United States	University of Miami	Miami	Florida
United States	Tulane Medical Center	New Orleans	Louisiana
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	University of Southern Florida College of Medicine	Tampa	Florida

Sponsors (3)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Mental Health (NIMH), National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retrospective self-assessment of consent competence as assessed by completion of web-based survey		Day 1
Primary	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
Primary	Retrospective self-assessment of consent disclosure as assessed by completion of web-based survey		Day 1
Primary	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
Primary	Retrospective self-assessment of consent understanding as assessed by completion of web-based survey		Day 1
Primary	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
Primary	Retrospective self-assessment of consent voluntariness as assessed by completion of web-based survey		Day 1
Primary	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
Primary	Use of social support and information seeking in the consent process as assessed by completion of web-based survey		Day 1
Primary	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
Primary	Experienced harms and benefits associated with autonomous research decision-making as assessed by completion of web-based survey		Day 1
Primary	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
Primary	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
Primary	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
Primary	Post-ATN 110 or ATN 113 study PrEP use and experiences as assessed by completion of web-based survey		Day 1
Primary	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	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
Secondary	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
Secondary	Need for additional support in the decision making process for clinical trial participation as assessed by web-based survey		Day 1
Secondary	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
Secondary	Self-assessment of adherence as assessed by web-based survey		Day 1
Secondary	Self-assessment of adherence as assessed by in-depth interview with selected participants		One-time interview completed no more than 60 days after consent
Secondary	Benefit or harm from participation as assessed by completion of web-based survey		Day 1
Secondary	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

External Links

•   ATN Website