Self-Consent for PrEP Perspectives
Condition: HIV; PrEP
Study type: Observational

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.
    

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.
      
Keywords: HIV; Self-Consent; PrEP; Autonomous Research Consent; Participation-associated Outcomes