Status:
COMPLETED
Innovative Approaches for Minor Consent: Consent 2.0
Lead Sponsor:
Indiana University
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
HIV
Eligibility:
All Genders
14-17 years
Phase:
NA
Brief Summary
The purpose of this study is to examine how the consent process affects the acceptability of participation in biomedical HIV prevention trials, from the perspective of behaviorally high-risk minors an...
Detailed Description
Potential participants will be recruited from clinical settings and HIV testing centers. If interested in participation, they will take a short Computer Assisted Self-Interview (CASI) screening survey...
Eligibility Criteria
Inclusion
- Note: Age limits apply to adolescent participants and to the adolescent children of parent participants.
- Adolescent Inclusion Criteria
- Age 14-17 inclusive
- Able to read and speak English
- HIV status is negative or unknown
- Engaged in high-risk sexual activity in the last six months
- Adolescent Exclusion Criteria
- Child of a parent already enrolled in the study
- Parent Inclusion Criteria
- Able to read and speak English
- Parent or guardian of an adolescent who is between ages 14-17
- The parent/guardian's adolescent's HIV status is either negative or unknown
- Parent Exclusion Criteria
- Parent of a child already enrolled in the study
Exclusion
Key Trial Info
Start Date :
November 7 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 15 2019
Estimated Enrollment :
254 Patients enrolled
Trial Details
Trial ID
NCT03242954
Start Date
November 7 2017
End Date
September 15 2019
Last Update
April 22 2021
Active Locations (4)
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1
Children's Hospital Colorado/Univ of Colorado SOM
Aurora, Colorado, United States, 80045
2
University of South Florida
Tampa, Florida, United States, 33606
3
University of Chicago
Chicago, Illinois, United States, 60637
4
Johns Hopkins University/SOM
Baltimore, Maryland, United States, 21287