HIVNCT03242954

Innovative Approaches for Minor Consent: Consent 2.0

A study testing Autonomous minor consent, Adult permission required and Parental permission required in people with HIV, run by Indiana University at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 14 to 17 yearsHealthy volunteers can take part
Conditions the study is for: HIV
What is being tested?: Autonomous minor consent, Adult permission required and Parental permission required
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 254 participants
Where: 4 sitesUnited States
Study dates: 7 Nov 2017to 15 Sep 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 14 to 17 years
All sexes
Healthy volunteers accepted
Child

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

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Children's Hospital Colorado/Univ of Colorado SOM
Aurora, Colorado, 80045
Johns Hopkins University/SOM
Baltimore, Maryland, 21287
University of Chicago
Chicago, Illinois, 60637
University of South Florida
Tampa, Florida, 33606

Other trials in United States

About this study

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)

Read the 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.

Conditions: HIV
Being tested: Autonomous minor consent, Adult permission required, Parental permission required

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Autonomous minor consentOther
Consent requirement where the participant is not required to get anyone's permission to participate in the trial.
Adult permission requiredOther
Consent requirement where the participant is required to obtain an adult's permission to participate in the trial.
Parental permission requiredOther
Consent requirement where the participant is required to obtain their parent's permission to participate in the trial.

Study groups in NCT03242954
Study group	Role	What they receive
Adolescents: Consent Condition 1	Active comparator	Autonomous minor consent Receives: Other: Autonomous minor consent
Adolescents: Consent Condition 2	Active comparator	Adult permission required Receives: Other: Adult permission required
Adolescents: Consent Condition 3	Active comparator	Parental permission required Receives: Other: Parental permission required
Parents: Consent Conditions 1-3	Active comparator	Autonomous minor consent, adult permission required, and parental permission required Receives: Other: Autonomous minor consent; Other: Adult permission required; Other: Parental permission required

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Adolescent WTP Scores
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.
Measured: Day 1
Mean Parent WTS Scores
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.
Measured: Day 1
Effects of the Study Agent (Stage of Development and Method of Delivery) on High-risk Minor Adolescents' WTP Scores
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.
Measured: Day 1
Effects of the Study Agent (Stage of Development and Method of Delivery) on Parents' Acceptability Scores
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.
Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Nov 201715 Sep 2019

First posted8 Aug 2017
Study start7 Nov 2017
Primary completion15 Sep 2019
Study completion15 Sep 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HIVStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
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)
Enrolment: 254 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03242954
Sponsor's protocol ID: 17-0538
Other IDs: 5U24HD089880-02
Status last verified: Mar 2021
First submitted: 3 Aug 2017
Last updated: 22 Apr 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

Publications

Knopf A, Draucker CB, Fortenberry JD, Ott MA, Arrington-Sanders R, Reirden D, Schneider J, Straub D, Ofner S, Bakoyannis G, Zimet G. Parental Engagement in Consent Processes for Enrollment in Biomedical HIV Prevention Trials: Implications for Minor Adolescents' Willingness to Participate. J Adolesc Health. 2023 May;72(5):703-711. doi: 10.1016/j.jadohealth.2022.11.241. Epub 2023 Jan 14.
PubMed 36646563

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 22 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT03242954
Acronym / sponsor ID: 17-0538
Conditions: HIV
Study type: Interventional
Recruitment status: Completed
Enrolment: 254 participants (actual)
Lead sponsor: Indiana UniversityUniversity, hospital or other
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study start: 7 Nov 2017 (actual)
Primary completion: 15 Sep 2019 (actual)
Study completion: 15 Sep 2019 (actual)
First posted: 8 Aug 2017 (actual)
Results: Posted 22 Apr 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4
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.

Arm	Type	Receives
Adolescents: Consent Condition 1	Active comparator	Other: Autonomous minor consentAutonomous minor consent
Adolescents: Consent Condition 2	Active comparator	Other: Adult permission requiredAdult permission required
Adolescents: Consent Condition 3	Active comparator	Other: Parental permission requiredParental permission required
Parents: Consent Conditions 1-3	Active comparator	Other: Autonomous minor consent, Other: Adult permission required, Other: Parental permission requiredAutonomous minor consent, adult permission required, and parental permission required

Who may qualify

Ages: 14 to 17 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Autonomous minor consentConsent requirement where the participant is not required to get anyone's permission to participate in the trial.	Other	Adolescents: Consent Condition 1, Parents: Consent Conditions 1-3
Adult permission requiredConsent requirement where the participant is required to obtain an adult's permission to participate in the trial.	Other	Adolescents: Consent Condition 2, Parents: Consent Conditions 1-3
Parental permission requiredConsent requirement where the participant is required to obtain their parent's permission to participate in the trial.	Other	Adolescents: Consent Condition 3, Parents: Consent Conditions 1-3

Primary outcome

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.
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.
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.
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.

Results and safety

Results posted to the registry on 22 Apr 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Adolescents: Consent Condition 1	43	43
Adolescents: Consent Condition 2	45	45
Adolescents: Consent Condition 3	41	41
Parents: Consent Conditions 1-3	125	125

Primary outcome: Mean Adolescent WTP Scores

Time frame: Day 1. Mean (Standard Deviation). Unit: score on a scale

Measure	Adolescents: Consent Condition 1 n = 43	Adolescents: Consent Condition 2 n = 45	Adolescents: Consent Condition 3 n = 41
Value	3.7 (0.8)	3.7 (1.2)	3.5 (0.8)

Adolescents: Consent Condition 1 vs Adolescents: Consent Condition 2 vs Adolescents: Consent Condition 3: Cohen's f square: 0.011 (95% CI 0.001 to 0.101), p = 0.5148, Regression, Linear

Primary outcome: Mean Parent WTS Scores

Time frame: Day 1. Mean (Standard Deviation). Unit: score on a scale

Measure	Parents: Consent Conditions 1-3 n = 125
Parent Consent Condition 1: Autonomous minor consent	2.6 (1.5)
Parent Consent Condition 2: Adult permission required	3.1 (1.5)
Parent Consent Condition 3: Parental permission required	4.4 (1.0)

Parents: Consent Conditions 1-3: Cohen's f square: 0.306 (95% CI 0.169 to 0.389), p <.0001, Regression, Linear

Population analysed: All parent participants commented on their Willingness to Support (WTS) each of the three consent conditions (autonomous minor consent, adult permission required, and parental permission required). For this reason, the Number Analyzed in each row of the table equals the total number of parent participants for the study (n=125)

Primary outcome: Effects of the Study Agent (Stage of Development and Method of Delivery) on High-risk Minor Adolescents' WTP Scores

Time frame: Day 1. Mean (Standard Deviation). Unit: score on a scale

Measure	Adolescents: Consent Condition 1 n = 43	Adolescents: Consent Condition 2 n = 45	Adolescents: Consent Condition 3 n = 41
Study agent 1 - ATN 113	3.6 (1.1)	3.7 (1.3)	3.6 (0.9)
Study agent 2 - HPTN 077	3.8 (0.9)	3.8 (1.2)	3.4 (1.0)

Adolescents: Consent Condition 1 vs Adolescents: Consent Condition 2 vs Adolescents: Consent Condition 3: Cohen's f square: 0.008 (95% CI 0.001 to 0.073), p = 0.4324, GEE Linear model

Primary outcome: Effects of the Study Agent (Stage of Development and Method of Delivery) on Parents' Acceptability Scores

Time frame: Day 1. Mean (Standard Deviation). Unit: score on a scale

Measure	Parents: Consent Conditions 1-3 n = 125
Autonomous minor consent study agent ATN 113	2.7 (1.6)
Adult permission required study agent ATN 113	3.1 (1.6)
Parental permission required study agent ATN 113	4.3 (1.2)
Autonomous minor consent study agent HPTN 077	2.6 (1.5)
Adult permission required study agent HPTN 077	3.1 (1.6)
Parental permission required study agent HPTN 077	4.4 (1.1)

Parents: Consent Conditions 1-3: Cohen's f square: 0.260 (95% CI 0.175 to 0.374), p <.0001, GEE Linear model

Population analysed: All parent participants commented on their Willingness to Support (WTS) each of the three consent conditions for each of the 2 trial types. For this reason, the Number Analyzed in each row of this data table equals the total number of parent participants for the study (n=125) as they all answered WTS for each.

Adverse events

Time frame: Adverse event data were collected on all participants during their one-time study visit. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Adolescents: Consent Condition 1	0 of 43 (0%)	0 of 43 (0%)	0 of 43
Adolescents: Consent Condition 2	0 of 45 (0%)	0 of 45 (0%)	0 of 45
Adolescents: Consent Condition 3	0 of 41 (0%)	0 of 41 (0%)	0 of 41
Parents: Consent Conditions 1-3	0 of 125 (0%)	0 of 125 (0%)	0 of 125

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36646563Knopf A, Draucker CB, Fortenberry JD, Ott MA, Arrington-Sanders R, Reirden D, Schneider J, Straub D, Ofner S, Bakoyannis G, Zimet G. Parental Engagement in Consent Processes for Enrollment in Biomedical HIV Prevention Trials: Implications for Minor Adolescents' Willingness to Participate. J Adolesc Health. 2023 May;72(5):703-711. doi: 10.1016/j.jadohealth.2022.11.241. Epub 2023 Jan 14.
Individual participant dataSharing planned: Yes. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Amy Knopf, PhD, MPH, RN principal investigator

Indiana University

Matthew Psioda, PhD study director

University of North Carolina, Chapel Hill

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Autonomous minor consent, Adult permission required and Parental permission required in people with HIV, run by Indiana University at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Adolescent WTP Scores (time frame: Day 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03242954, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2021.