Innovative Approaches for Minor Consent: Consent 2.0

Not Applicable

Completed

• Conditions: HIV
• Interventions: Other: Adult permission required; Other: Parental permission required; Other: Autonomous minor consent

• Registration Number: NCT03242954
• Lead Sponsor: Indiana University

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.

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 to determine eligibility. Those eligible will take part in the one-day study visit at that time or will provide contact information to set up the study visit at a later date.

All study participants will attend a one-day study visit at their respective study site. Upon arrival, participants will complete a CASI that collects demographic, social, behavioral, and attitudinal measures. Next, participants will take part in a simulated consent process for two hypothetical trials modeled after ATN 113 and HPTN 077. Study procedures differ for adolescents and parents, so each group is described separately below:

Adolescent Participants: For each hypothetical trial, research staff will lead the participant through a simulated consent process consistent with their randomized consent condition. Then, the participant will complete a CASI assessing Willingness to Participate (WTP) and will work with research staff to complete the University of San Diego (UCSD) Brief Assessment of Capacity to Consent (UBACC).

Parent Participants: For each hypothetical trial, research staff will review the informed consent forms with the parent. The parent will complete a CASI with three vignettes that describe each of the three possible consent conditions. Parents will rate the acceptability of each vignette. Then, the participant will work with research staff to complete the UCSD Brief Assessment of Capacity to Consent (UBACC). Finally, the participant will answer a series of questions via CASI.

A subset of 6-8 adolescents and 6-8 parents per study site will complete a debriefing interview assessing adolescent and parent perspectives on the various consent conditions in greater depth, and to better understand the role of study features, family, and adolescent characteristics in willingness to participate/willingness to support the hypothetical research studies.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-08-03
• Study First Submitted QC: 2017-08-03
• Study First Posted: 2017-08-08
• Study Start: 2017-11-07
• Primary Completion: 2019-09-15
• Study Completion: 2019-09-15
• Results First Submitted: 2021-02-26
• Status Verified: 2021-03
• Results First Submitted QC: 2021-03-25
• Last Update Submitted: 2021-03-25
• Results First Posted: 2021-04-22
• Last Update Posted: 2021-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 254

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adolescents: Consent Condition 2	Adult permission required	Adult permission required
Adolescents: Consent Condition 3	Parental permission required	Parental permission required
Parents: Consent Conditions 1-3	Adult permission required	Autonomous minor consent, adult permission required, and parental permission required
Adolescents: Consent Condition 1	Autonomous minor consent	Autonomous minor consent
Parents: Consent Conditions 1-3	Autonomous minor consent	Autonomous minor consent, adult permission required, and parental permission required
Parents: Consent Conditions 1-3	Parental permission required	Autonomous minor consent, adult permission required, and parental permission required

Primary Outcome Measures

Name	Time	Method
Effects of the Study Agent (Stage of Development and Method of Delivery) on High-risk Minor Adolescents' WTP Scores	Day 1	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.
Effects of the Study Agent (Stage of Development and Method of Delivery) on Parents' Acceptability Scores	Day 1	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.
Mean Adolescent WTP Scores	Day 1	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.
Mean Parent WTS Scores	Day 1	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.

Trial Locations

Locations (4)

Johns Hopkins University/SOM; 🇺🇸 Baltimore, Maryland, United States

Children's Hospital Colorado/Univ of Colorado SOM; 🇺🇸 Aurora, Colorado, United States

University of Chicago; 🇺🇸 Chicago, Illinois, United States

University of South Florida; 🇺🇸 Tampa, Florida, United States