Innovative Approaches for Minor Consent: Consent 2.0

HIV Clinical Trial

Official title:

Innovative Approaches for Minor Consent: Consent 2.0 - A Multi-Center Study of the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03242954
• Other study ID #: 17-0538
• Secondary ID: 5U24HD089880-02
• Status: Completed
• Phase: N/A
• Start date: November 7, 2017
• Est. completion date: September 15, 2019

Study information

• Verified date: March 2021
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 254
• Est. completion date: September 15, 2019
• Est. primary completion date: September 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV

Intervention

Other:
• Autonomous minor consent
Consent requirement where the participant is not required to get anyone's permission to participate in the trial.
• Adult permission required
Consent requirement where the participant is required to obtain an adult's permission to participate in the trial.
• Parental permission required
Consent requirement where the participant is required to obtain their parent's permission to participate in the trial.

Locations

Country	Name	City	State
United States	Children's Hospital Colorado/Univ of Colorado SOM	Aurora	Colorado
United States	Johns Hopkins University/SOM	Baltimore	Maryland
United States	University of Chicago	Chicago	Illinois
United States	University of South Florida	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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