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Innovative Approaches for Minor Consent: Consent 2.0

NCT03242954 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 254

Last updated 2021-04-22

Study results available
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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.

Conditions

Interventions

OTHER

Autonomous minor consent

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

OTHER

Adult permission required

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

OTHER

Parental permission required

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

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Indiana University

    lead OTHER

Principal Investigators

  • Amy Knopf, PhD, MPH, RN · Indiana University School of Medicine

  • Matthew Psioda, PhD · University of North Carolina, Chapel Hill

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-11-07
Primary Completion
2019-09-15
Completion
2019-09-15

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03242954 on ClinicalTrials.gov