Innovative Approaches for Minor Consent: Consent 2.0
2 other identifiers
interventional
254
1 country
4
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 and the parents of minor adolescents.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable hiv
Started Nov 2017
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 3, 2017
CompletedFirst Posted
Study publicly available on registry
August 8, 2017
CompletedStudy Start
First participant enrolled
November 7, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2019
CompletedResults Posted
Study results publicly available
April 22, 2021
CompletedApril 22, 2021
March 1, 2021
1.9 years
August 3, 2017
February 26, 2021
March 25, 2021
Conditions
Outcome Measures
Primary Outcomes (4)
Mean Adolescent WTP Scores
Comparing mean adolescent Willingness to Participate (WTP) scores across the three consent conditions and two trial types. WTP scores are based on the response to the question: "If offered the chance, how likely would you be to participate in the study?" Responses are collected using a Likert scale (definitely not participate, probably not participate, might or might not participate, probably participate, definitely participate) and converted to a numeric score with values ranging from 1 (definitely not participate) to 5 (definitely participate) for analysis.
Day 1
Mean Parent WTS Scores
Comparing mean parent Willingness to Support (WTS) scores across the three consent conditions and two trial types. WTS scores are based on the response to the question: "This is an acceptable approach to consent for your teenager's participation in the study." Responses are collected using a Likert scale (strongly disagree, disagree, neither disagree nor agree, agree, strongly agree) and converted to a numeric score with values ranging from 1 (strongly disagree) to 5 (strongly agree) for analysis.
Day 1
Effects of the Study Agent (Stage of Development and Method of Delivery) on High-risk Minor Adolescents' WTP Scores
This data reflects adolescent Willingness to Participate (WTP) scores by study agent/trial type. After review of hypothetical consent documents for 2 study agents in different stages of development and with different methods of delivery (based on real-world studies ATN 113 and HPTN 077), adolescents are asked "If offered the chance, how likely would you be to participate in the study?" Responses are collected using a Likert scale (definitely not participate, probably not participate, might or might not participate, probably participate, definitely participate) and converted to a numeric score with values ranging from 1 (definitely not participate) to 5 (definitely participate) for analysis.
Day 1
Effects of the Study Agent (Stage of Development and Method of Delivery) on Parents' Acceptability Scores
After review of hypothetical consent documents for 2 study agents in different stages of development and with different methods of delivery (based on real-world trials ATN 113 and HPTN 077), parents are presented with vignettes for the 3 different consent conditions (autonomous minor consent, adult permission required, parental permission required) and asked "How acceptable is this approach to research consent?". Responses are collected on a Likert scale (completely unacceptable, unacceptable, neither unacceptable not acceptable, acceptable, completely acceptable) and converted to a numeric score with values ranging from 1 (definitely not acceptable) to 5 (definitely acceptable) for analysis.
Day 1
Study Arms (4)
Adolescents: Consent Condition 1
ACTIVE COMPARATORAutonomous minor consent
Adolescents: Consent Condition 2
ACTIVE COMPARATORAdult permission required
Adolescents: Consent Condition 3
ACTIVE COMPARATORParental permission required
Parents: Consent Conditions 1-3
ACTIVE COMPARATORAutonomous minor consent, adult permission required, and parental permission required
Interventions
Consent requirement where the participant is not required to get anyone's permission to participate in the trial.
Consent requirement where the participant is required to obtain an adult's permission to participate in the trial.
Consent requirement where the participant is required to obtain their parent's permission to participate in the trial.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Child of a parent already enrolled in the study
- 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 of a child already enrolled in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Children's Hospital Colorado/Univ of Colorado SOM
Aurora, Colorado, 80045, United States
University of South Florida
Tampa, Florida, 33606, United States
University of Chicago
Chicago, Illinois, 60637, United States
Johns Hopkins University/SOM
Baltimore, Maryland, 21287, United States
Related Publications (1)
Knopf A, Draucker CB, Fortenberry JD, Ott MA, Arrington-Sanders R, Reirden D, Schneider J, Straub D, Ofner S, Bakoyannis G, Zimet G. Parental Engagement in Consent Processes for Enrollment in Biomedical HIV Prevention Trials: Implications for Minor Adolescents' Willingness to Participate. J Adolesc Health. 2023 May;72(5):703-711. doi: 10.1016/j.jadohealth.2022.11.241. Epub 2023 Jan 14.
PMID: 36646563DERIVED
Results Point of Contact
- Title
- Amy Knopf
- Organization
- Indiana University School of Nursing
Study Officials
- PRINCIPAL INVESTIGATOR
Amy Knopf, PhD, MPH, RN
Indiana University School of Medicine
- STUDY DIRECTOR
Matthew Psioda, PhD
University of North Carolina, Chapel Hill
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistance Professor, IU School of Nursing
Study Record Dates
First Submitted
August 3, 2017
First Posted
August 8, 2017
Study Start
November 7, 2017
Primary Completion
September 15, 2019
Study Completion
September 15, 2019
Last Updated
April 22, 2021
Results First Posted
April 22, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data will be made available after data analyses have been completed, data has been de-identified, and all DASH submission requirements have been met and approved. Data will be available according to NICHD DASH timelines.
- Access Criteria
- Please see DASH guidelines for access criteria.
De-identified study data will be made available in the NICHD Data and Specimen Hub (DASH), a centralized resource for researchers to store de-identified data from NICHD supported studies for use in secondary research. NICHD DASH is a free public resource designed for the scientific research community.