Self-Consent for PrEP Perspectives

University of North Carolina (UNC)

Status: Completed

Conditions: HIV; PrEP

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT02801760

ATN 137

Details and patient eligibility

About

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.

Full 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.

Enrollment: 58 patients

Sex: Male

Ages: 15 to 22 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

58 participants in 2 patient groups

Subjects Currently or Previously Enrolled in ATN 110/ATN 113

Description:

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

Description:

A sub-sample of subjects who completed the web-based survey and indicated willingness to complete the qualitative interview.