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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02801760
Other study ID # ATN 137
Secondary ID
Status Completed
Phase N/A
First received March 23, 2016
Last updated February 27, 2017
Start date November 2015
Est. completion date March 2016

Study information

Verified date June 2016
Source University of North Carolina, Chapel Hill
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 58
Est. completion date March 2016
Est. primary completion date March 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 15 Years to 22 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Johns Hopkins University Baltimore Maryland
United States Fenway Institute Boston Massachusetts
United States Stroger Hospital of Cook County Chicago Illinois
United States Wayne State University Detroit Michigan
United States Baylor College of Medicine Houston Texas
United States Children's Hospital of Los Angeles Los Angeles California
United States St. Jude Childrens Research Hospital Memphis Tennessee
United States University of Miami Miami Florida
United States Tulane Medical Center New Orleans Louisiana
United States Children's Hospital of Philadelphia Philadelphia Pennsylvania
United States University of Southern Florida College of Medicine Tampa Florida

Sponsors (3)

Lead Sponsor Collaborator
University of North Carolina, Chapel Hill National Institute of Mental Health (NIMH), National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Retrospective self-assessment of consent competence as assessed by completion of web-based survey Day 1
Primary 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
Primary Retrospective self-assessment of consent disclosure as assessed by completion of web-based survey Day 1
Primary 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
Primary Retrospective self-assessment of consent understanding as assessed by completion of web-based survey Day 1
Primary 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
Primary Retrospective self-assessment of consent voluntariness as assessed by completion of web-based survey Day 1
Primary 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
Primary Use of social support and information seeking in the consent process as assessed by completion of web-based survey Day 1
Primary 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
Primary Experienced harms and benefits associated with autonomous research decision-making as assessed by completion of web-based survey Day 1
Primary 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
Primary 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
Primary 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
Primary Post-ATN 110 or ATN 113 study PrEP use and experiences as assessed by completion of web-based survey Day 1
Primary 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 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
Secondary 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
Secondary Need for additional support in the decision making process for clinical trial participation as assessed by web-based survey Day 1
Secondary 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
Secondary Self-assessment of adherence as assessed by web-based survey Day 1
Secondary Self-assessment of adherence as assessed by in-depth interview with selected participants One-time interview completed no more than 60 days after consent
Secondary Benefit or harm from participation as assessed by completion of web-based survey Day 1
Secondary 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
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