Self-Consent for PrEP Perspectives

Completed

Conditions studied: HIV, PrEP

In brief

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.

Key facts

Study ID

NCT02801760

Run by

University of North Carolina, Chapel Hill

People needed

58

Starts

2015-11-01

Expected to finish

2016-03-01

Last updated by the study team

2017-02-28

Who can join

Age: 15 and older, up to 22. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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