Self-Consent for PrEP Perspectives

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.

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.