Innovative Approaches for Minor Consent: Consent 2.0
Condition: HIV
Study type: Interventional

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.
    

Intervention name(s): Autonomous minor consent; Adult permission required; Parental permission required
Intervention type(s): Other; Other; Other
Intervention description(s): Consent requirement where the participant is not required to get anyone's permission to participate in the trial.; Consent requirement where the participant is required to obtain an adult's permission to participate in the trial.; Consent requirement where the participant is required to obtain their parent's permission to participate in the trial.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention 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)
Primary purpose: Other