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Consent 2.0 Summary

Status:

Open

Sites Participating:

  • Johns Hopkins University
  • The University of Chicago
  • University of Colorado Denver, Children’s Hospital Colorado
  • University of South Florida

Staff:

  • Amy Knopf, PhD, Indiana University
    Principal Investigator
  • Becca Baker, Indiana University
    Project Manager

ClinicalTrials.gov Number: NCT03242954

Protocol team:

  • Indiana University 

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. Acceptability will be measured by adolescents’ willingness to participate (WTP) in and parents’ willingness to support (WTS) their adolescent’s participation in two hypothetical biomedical HIV prevention trials that are modeled after PrEP studies.

This study will use a quasi-experimental design. All study participants will complete a computer assisted self- interview (CASI) with demographic, social, behavioral, and attitudinal measures. Adolescent participants will undergo a simulated consent process for each of two hypothetical studies; adolescents will be randomized to one of three consent conditions: 1) parent or guardian permission required, 2) adult permission required, with adolescent choice of parent/guardian or an ombudsman, or 3) autonomous consent. Parent participants also undergo simulated consent for each of the two hypothetical studies, and will read three vignettes that represent each of the three consent conditions. Parents will rate the acceptability of each approach to consent.  Hypothetical Study 1, modeled after ATN 113, is an open-label study of oral TDF-FTC and hypothetical Study 2, modeled after HPTN 077, is a Phase IIa trial of an injectable HIV integrase inhibitor. All participants will complete measures of capacity to consent (UBACC).

A subset of adolescent and parent participants will be selected to participate in a debriefing interview, during which their perspectives will be explored in greater depth.

Schema

Figure 1. Study schema, adolescent participants

Study schema, adolescent participants

Figure 2. Study schema, parent participants

Study schema, parent participants

Legend for both figures: CC – Consent Condition

CC 1: Parent or guardian permission required 
CC 2: Adult permission required, with adolescent choice of parent/guardian or ombudsman
CC 3: Autonomous consent
CASI - Computer assisted self-interview
WTP - Willingness to participate in the study
UBACC - UCSD Brief Assessment of Capacity of Consent
CAB - Cabotegravir (an HIV treatment medication)

Duration

Study participation will last approximately 90 minutes on a single day with no follow-up. Participants who agree to participate in the debriefing interview will require approximately an additional 45 minutes immediately following the completion of the main study procedures.

Sample Size

Adolescents and parents will be recruited from four U.S. cities: Baltimore, MD; Chicago, IL; Denver, CO; and, Tampa, FL.

Approximately 120 (30 per study site) high-risk minor adolescents and 120 (30 per study site) parents of adolescents will be recruited for participation in this study. Of note, the adolescents and parents will not be parent-child dyads; they will be unrelated. A subset of 24-32 (6-8 per study site) adolescents and 24-32 (6-8 per study site) parents will be selected to participate in the debriefing interview.

Eligibility

To be considered eligible for enrollment, an adolescent must meet all the criteria listed below.

  • Age 14-17 inclusive; and
  • Able to read and speak English; and
  • HIV status is negative or unknown; and
  • Engaged in high-risk sexual activity in the last six months; and
  • Not the child of a parent already enrolled in the study.

To be considered eligible for enrollment, a parent must meet all the criteria listed below.

  • Able to read and speak English; and
  • Parent or guardian of an adolescent who is between ages 14-17; and
  • The parent/guardian’s adolescent’s HIV status is either negative or unknown; and
  • Not the parent of a child already enrolled in the study.

Primary Outcome Measure:

1. 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.

Time Frame: Day 1

2. Mean parent WTP 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.

Time Frame: Day 1

Secondary Outcome Measures

3. Mean adolescent UCSD Brief Assessment of Capacity to Consent (UBACC) scores

Comparing mean adolescent UBACC scores to identify group level differences in capacity to consent and to evaluate how capacity to consent influences WTP.

Time Frame: Day 1

4. Mean parent UBACC scores

Comparing mean parent UBACC scores to identify group level differences in capacity to consent and to evaluate how capacity to consent influences WTS.

Time Frame: Day 1

 

 

Learn more about this study at the ClinicalTrials.gov website.