Innovative Approaches for Minor Consent: Consent 2.0

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

254 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-07

Study Completion Date

2019-09-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Improving Consent and Survey Procedures for Young MSM in Web-based HIV Prevention

NCT02139566

Healthy

COMPLETED NA

Simplified Consent for HIV Vaccine Trials

NCT00105339

Adolescent Behavior

COMPLETED

Factors Affecting Adherence to Anti-HIV Drug Regimens in Children and Adolescents

NCT00073424

HIV Infections

COMPLETED

Preventing Sexual Transmission of HIV With Anti-HIV Drugs

NCT00074581

HIV Infections

COMPLETED PHASE3

Effectiveness of an Online Prevention Program in Reducing the Risk of STD Infection in Young Adults

NCT00255944

HIV Infections Sexually Transmitted Diseases

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Intervention Type OTHER

Consent requirement where the participant is required to obtain their parent's permission to participate in the trial.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Autonomous minor consent

Consent requirement where the participant is not required to get anyone's permission to participate in the trial.

Intervention Type OTHER

Adult permission required

Consent requirement where the participant is required to obtain an adult's permission to participate in the trial.

Intervention Type OTHER

Parental permission required

Consent requirement where the participant is required to obtain their parent's permission to participate in the trial.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

* 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