Clinical trial NCT02801760: Self-Consent for PrEP Perspectives
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV
PrEP
Keywords: HIV
Self-Consent
PrEP
Autonomous Research Consent
Participation-associated Outcomes
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: National Institute of Mental Health (NIMH)
First posted: 2016-06-16
Enrollment: 58
Sex: MALE
Minimum age (years): 15
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Retrospective self-assessment of consent competence as assessed by completion of web-based survey
timeFrame: Day 1
measure: Retrospective self-assessment of consent competence as assessed by completion of in-depth interview with selected participants
timeFrame: One-time interview completed no more than 60 days after consent
measure: Retrospective self-assessment of consent disclosure as assessed by completion of web-based survey
timeFrame: Day 1
measure: Retrospective self-assessment of consent disclosure as assessed by completion of in-depth interview with selected participants
timeFrame: One-time interview completed no more than 60 days after consent
measure: Retrospective self-assessment of consent understanding as assessed by completion of web-based survey
timeFrame: Day 1
measure: Retrospective self-assessment of consent understanding as assessed by completion of in-depth interview with selected participants
timeFrame: One-time interview completed no more than 60 days after consent
measure: Retrospective self-assessment of consent voluntariness as assessed by completion of web-based survey
timeFrame: Day 1
measure: Retrospective self-assessment of consent voluntariness as assessed by completion of in-depth interview with selected participants
timeFrame: One-time interview completed no more than 60 days after consent
measure: Use of social support and information seeking in the consent process as assessed by completion of web-based survey
timeFrame: Day 1
measure: Use of social support and information seeking in the consent process as assessed by completion of in-depth interview with selected participants
timeFrame: One-time interview completed no more than 60 days after consent
measure: Experienced harms and benefits associated with autonomous research decision-making as assessed by completion of web-based survey
timeFrame: Day 1
measure: Experienced harms and benefits associated with autonomous research decision-making as assessed by completion of in-depth interview with selected participants
timeFrame: One-time interview completed no more than 60 days after consent
measure: 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
timeFrame: Day 1
measure: 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
timeFrame: One-time interview completed no more than 60 days after consent
measure: Post-ATN 110 or ATN 113 study PrEP use and experiences as assessed by completion of web-based survey
timeFrame: Day 1
measure: Post-ATN 110 or ATN 113 study PrEP use and experiences as assessed by completion of in-depth interview with selected participants
timeFrame: One-time interview completed no more than 60 days after consent
Secondary outcomes:
measure: 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
timeFrame: Day 1
measure: 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
timeFrame: One-time interview completed no more than 60 days after consent
measure: Need for additional support in the decision making process for clinical trial participation as assessed by web-based survey
timeFrame: Day 1
measure: Need for additional support in the decision making process for clinical trial participation as assessed by in-depth interview with selected participants
timeFrame: One-time interview completed no more than 60 days after consent
measure: Self-assessment of adherence as assessed by web-based survey
timeFrame: Day 1
measure: Self-assessment of adherence as assessed by in-depth interview with selected participants
timeFrame: One-time interview completed no more than 60 days after consent
measure: Benefit or harm from participation as assessed by completion of web-based survey
timeFrame: Day 1
measure: Benefit or harm from participation as assessed by completion of in-depth interview with selected participants
timeFrame: One-time interview completed no more than 60 days after consent
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital of Los Angeles
state: California
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Tampa
country: United States
facility: University of Southern Florida College of Medicine
state: Florida
city: Chicago
country: United States
facility: Stroger Hospital of Cook County
state: Illinois
city: New Orleans
country: United States
facility: Tulane Medical Center
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Fenway Institute
state: Massachusetts
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Memphis
country: United States
facility: St. Jude Childrens Research Hospital
state: Tennessee
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: John Stroger Hospital of Cook County
name: Sybil Hosek, Ph.D.
role: STUDY_CHAIR
affiliation: Indiana University School of Medicine
name: J. Dennis Fortenberry, M.D.
role: STUDY_CHAIR
References: