Innovative Approaches for Minor Consent: Consent 2.0

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.

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