Self-Consent for PrEP Perspectives

NCT02801760 | Completed

• 1 other identifier: ATN 137
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 11

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.

Conditions

HIV; PrEP

Keywords

HIV; Self-Consent; PrEP; Autonomous Research Consent; Participation-associated Outcomes

Outcome Measures

Primary Outcomes (16)

• 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 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

  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

Study Arms (2)

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.

Eligibility Criteria

• Age: 15 Years - 22 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute on Drug Abuse (NIDA): collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (11)

Children's Hospital of Los Angeles

Los Angeles, California, 90027, United States

Location

University of Miami

Miami, Florida, 33101, United States

Location

University of Southern Florida College of Medicine

Tampa, Florida, 33606, United States

Location

Stroger Hospital of Cook County

Chicago, Illinois, 60612, United States

Location

Tulane Medical Center

New Orleans, Louisiana, 70112, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Fenway Institute

Boston, Massachusetts, 02215, United States

Location

Wayne State University

Detroit, Michigan, 48201, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

St. Jude Childrens Research Hospital

Memphis, Tennessee, 38105, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Links

• ATN Website

Study Officials

• Sybil Hosek, Ph.D.

  John Stroger Hospital of Cook County

  STUDY CHAIR

• J. Dennis Fortenberry, M.D.

  Indiana University School of Medicine

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2016
• First Posted: June 16, 2016
• Study Start: November 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: February 28, 2017

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)