Innovative Approaches for Minor Consent: Consent 2.0

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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HIV

Intervention / Treatment
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* Other: Autonomous minor consent
* Other: Adult permission required
* Other: Parental permission required


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Consent 2.0 has a parallel group-like design for adolescents. Adolescents will be randomized into 1 of 3 consent conditions using a randomized block design that is stratified by study site and the adolescent's natal sex. The order in which the hypothetical trials are presented to adolescents will be randomized using a block design. A subset of 6-8 adolescents per site will be selected for a debriefing interview. Consent 2.0 has a crossover-like design for parents. Parents will provide feedback on all three consent conditions and for both hypothetical trials. The order in which the hypothetical trials are presented to parents will be determined using a randomized block design that is stratified by study site and the parent's adolescent's natal sex. The presentation order for the 3 consent condition vignettes for each hypothetical trial will be determined using a randomized block design. A subset of 6-8 parents by site will be selected for debriefing interview.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Adolescents: Consent Condition 1<br>Autonomous minor consent | Other: Autonomous minor consent<br>* Consent requirement where the participant is not required to get anyone's permission to participate in the trial.<br>|
| Active Comparator: Adolescents: Consent Condition 2<br>Adult permission required | Other: Adult permission required<br>* Consent requirement where the participant is required to obtain an adult's permission to participate in the trial.<br>|
| Active Comparator: Adolescents: Consent Condition 3<br>Parental permission required | Other: Parental permission required<br>* Consent requirement where the participant is required to obtain their parent's permission to participate in the trial.<br>|
| Active Comparator: Parents: Consent Conditions 1-3<br>Autonomous minor consent, adult permission required, and parental permission required | Other: Autonomous minor consent<br>* Consent requirement where the participant is not required to get anyone's permission to participate in the trial.<br>Other: Adult permission required<br>* Consent requirement where the participant is required to obtain an adult's permission to participate in the trial.<br>Other: Parental permission required<br>* Consent requirement where the participant is required to obtain their parent's permission to participate in the trial.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |