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Trial record 2 of 2 for:    HPTN 077 | HIV | NIH

Innovative Approaches for Minor Consent: Consent 2.0

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03242954
Recruitment Status : Completed
First Posted : August 8, 2017
Results First Posted : April 22, 2021
Last Update Posted : April 22, 2021
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Amelia Knopf, Indiana University

Brief 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.

Condition or disease Intervention/treatment Phase
HIV Other: Autonomous minor consent Other: Adult permission required Other: Parental permission required Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 254 participants
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
Official Title: Innovative Approaches for Minor Consent: Consent 2.0 - A Multi-Center Study of the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN)
Actual Study Start Date : November 7, 2017
Actual Primary Completion Date : September 15, 2019
Actual Study Completion Date : September 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Active Comparator: Adolescents: Consent Condition 1
Autonomous minor consent
Other: Autonomous minor consent
Consent requirement where the participant is not required to get anyone's permission to participate in the trial.

Active Comparator: Adolescents: Consent Condition 2
Adult permission required
Other: Adult permission required
Consent requirement where the participant is required to obtain an adult's permission to participate in the trial.

Active Comparator: Adolescents: Consent Condition 3
Parental permission required
Other: Parental permission required
Consent requirement where the participant is required to obtain their parent's permission to participate in the trial.

Active Comparator: Parents: Consent Conditions 1-3
Autonomous minor consent, adult permission required, and parental permission required
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.




Primary Outcome Measures :
  1. Mean Adolescent WTP Scores [ Time Frame: Day 1 ]

    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.


  2. Mean Parent WTS Scores [ Time Frame: Day 1 ]

    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.


  3. Effects of the Study Agent (Stage of Development and Method of Delivery) on High-risk Minor Adolescents' WTP Scores [ Time Frame: Day 1 ]
    This data reflects adolescent Willingness to Participate (WTP) scores by study agent/trial type. After review of hypothetical consent documents for 2 study agents in different stages of development and with different methods of delivery (based on real-world studies ATN 113 and HPTN 077), adolescents are asked "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.

  4. Effects of the Study Agent (Stage of Development and Method of Delivery) on Parents' Acceptability Scores [ Time Frame: Day 1 ]
    After review of hypothetical consent documents for 2 study agents in different stages of development and with different methods of delivery (based on real-world trials ATN 113 and HPTN 077), parents are presented with vignettes for the 3 different consent conditions (autonomous minor consent, adult permission required, parental permission required) and asked "How acceptable is this approach to research consent?". Responses are collected on a Likert scale (completely unacceptable, unacceptable, neither unacceptable not acceptable, acceptable, completely acceptable) and converted to a numeric score with values ranging from 1 (definitely not acceptable) to 5 (definitely acceptable) for analysis.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   14 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03242954


Locations
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United States, Colorado
Children's Hospital Colorado/Univ of Colorado SOM
Aurora, Colorado, United States, 80045
United States, Florida
University of South Florida
Tampa, Florida, United States, 33606
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Maryland
Johns Hopkins University/SOM
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Indiana University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Amy Knopf, PhD, MPH, RN Indiana University School of Medicine
Study Director: Matthew Psioda, PhD University of North Carolina, Chapel Hill
  Study Documents (Full-Text)

Documents provided by Amelia Knopf, Indiana University:
Informed Consent Form  [PDF] March 12, 2018

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Responsible Party: Amelia Knopf, Assistance Professor, IU School of Nursing, Indiana University
ClinicalTrials.gov Identifier: NCT03242954    
Other Study ID Numbers: 17-0538
5U24HD089880-02 ( U.S. NIH Grant/Contract )
First Posted: August 8, 2017    Key Record Dates
Results First Posted: April 22, 2021
Last Update Posted: April 22, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified study data will be made available in the NICHD Data and Specimen Hub (DASH), a centralized resource for researchers to store de-identified data from NICHD supported studies for use in secondary research. NICHD DASH is a free public resource designed for the scientific research community.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Data will be made available after data analyses have been completed, data has been de-identified, and all DASH submission requirements have been met and approved. Data will be available according to NICHD DASH timelines.
Access Criteria: Please see DASH guidelines for access criteria.
URL: https://dash.nichd.nih.gov/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No