Self-Consent for PrEP Perspectives

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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HIV, PrEP

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 22 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects Currently or Previously Enrolled in ATN 110/ATN 113<br>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<br>A sub-sample of subjects who completed the web-based survey and indicated willingness to complete the qualitative interview. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Self-assessment of adherence as assessed by in-depth interview with selected participants |  | One-time interview completed no more than 60 days after consent | 
| Benefit or harm from participation as assessed by completion of web-based survey |  | Day 1 | 
| Benefit or harm from participation as assessed by completion of in-depth interview with selected participants |  | One-time interview completed no more than 60 days after consent | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Self-Consent, PrEP, Autonomous Research Consent, Participation-associated Outcomes