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

Innovative Approaches for Minor Consent: Consent 2.0

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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition HIV
Interventions Other: Autonomous minor consent
Other: Adult permission required
Other: Parental permission required
Enrollment 254
Recruitment Details 1,366 individuals were screened at 4 study sites in the United States (Chicago, Denver, Baltimore, and Tampa) between May 2018 and September 2019. Of those screened, 422 met all eligibility criteria and 254 were randomized, enrolled, and completed the 1-time study visit.
Pre-assignment Details All parent participants are considered one study 'arm' as they were not randomized to just one of the three consent conditions (as the adolescent participants were), but rather were presented with information on all 3 consent conditions and commented on the acceptability of each.
Arm/Group Title Adolescents: Consent Condition 1 Adolescents: Consent Condition 2 Adolescents: Consent Condition 3 Parents: Consent Conditions 1-3
Hide Arm/Group Description

Autonomous consent

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

Adult permission required

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

Parental permission required

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

Autonomous consent, Adult permission required and Parental permission required

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

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

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

Period Title: Overall Study
Started 43 45 41 125
Completed 43 45 41 125
Not Completed 0 0 0 0
Arm/Group Title Adolescents: Consent Condition 1 Adolescents: Consent Condition 2 Adolescents: Consent Condition 3 Parents: Consent Conditions 1-3 Total
Hide Arm/Group Description

Autonomous minor consent

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

Adult permission required

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

Parental permission required

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

Autonomous minor consent, adult permission required, and parental permission required

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

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

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

Total of all reporting groups
Overall Number of Baseline Participants 43 45 41 125 254
Hide Baseline Analysis Population Description
All parent participants are considered one study arm as they were not randomized to just one of the three consent conditions (as the adolescent participants were), but rather were presented with information on all 3 consent conditions and commented on the acceptability of each.
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 45 participants 41 participants 125 participants 254 participants
14 years old
1
   2.3%
1
   2.2%
0
   0.0%
0
   0.0%
2
   0.8%
15 years old
7
  16.3%
3
   6.7%
5
  12.2%
0
   0.0%
15
   5.9%
16 years old
11
  25.6%
8
  17.8%
15
  36.6%
0
   0.0%
34
  13.4%
17 years old
24
  55.8%
33
  73.3%
21
  51.2%
0
   0.0%
78
  30.7%
>= 18 years old
0
   0.0%
0
   0.0%
0
   0.0%
125
 100.0%
125
  49.2%
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 45 participants 41 participants 125 participants 254 participants
Female
23
  53.5%
24
  53.3%
22
  53.7%
63
  50.4%
132
  52.0%
Male
20
  46.5%
21
  46.7%
19
  46.3%
62
  49.6%
122
  48.0%
[1]
Measure Description: sex assigned at birth
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 45 participants 41 participants 125 participants 254 participants
Hispanic or Latino
11
  25.6%
11
  24.4%
8
  19.5%
18
  14.4%
48
  18.9%
Not Hispanic or Latino
30
  69.8%
33
  73.3%
32
  78.0%
103
  82.4%
198
  78.0%
Unknown or Not Reported
2
   4.7%
1
   2.2%
1
   2.4%
4
   3.2%
8
   3.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 45 participants 41 participants 125 participants 254 participants
American Indian or Alaska Native
1
   2.3%
2
   4.4%
0
   0.0%
3
   2.4%
6
   2.4%
Asian
0
   0.0%
0
   0.0%
1
   2.4%
0
   0.0%
1
   0.4%
Native Hawaiian or Other Pacific Islander
2
   4.7%
0
   0.0%
0
   0.0%
0
   0.0%
2
   0.8%
Black or African American
19
  44.2%
27
  60.0%
21
  51.2%
73
  58.4%
140
  55.1%
White
9
  20.9%
7
  15.6%
14
  34.1%
31
  24.8%
61
  24.0%
More than one race
7
  16.3%
6
  13.3%
5
  12.2%
8
   6.4%
26
  10.2%
Unknown or Not Reported
5
  11.6%
3
   6.7%
0
   0.0%
10
   8.0%
18
   7.1%
Gender Identity   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 45 participants 41 participants 0 participants 129 participants
Woman
22
  51.2%
24
  53.3%
23
  56.1%
69
  53.5%
Gender queer or gender non-conforming
0
   0.0%
1
   2.2%
0
   0.0%
1
   0.8%
Man
15
  34.9%
18
  40.0%
14
  34.1%
47
  36.4%
Trans woman
3
   7.0%
1
   2.2%
4
   9.8%
8
   6.2%
Trans man
2
   4.7%
0
   0.0%
0
   0.0%
2
   1.6%
Other
1
   2.3%
1
   2.2%
0
   0.0%
2
   1.6%
[1]
Measure Analysis Population Description: Gender identity data was not collected on Parent participants.
Sexual orientation   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 45 participants 41 participants 0 participants 129 participants
Bisexual
11
  25.6%
11
  24.4%
11
  26.8%
33
  25.6%
Gay, queer, or same gender loving
12
  27.9%
15
  33.3%
9
  22.0%
36
  27.9%
Straight or heterosexual
18
  41.9%
17
  37.8%
19
  46.3%
54
  41.9%
Questioning
0
   0.0%
1
   2.2%
0
   0.0%
1
   0.8%
Other
2
   4.7%
1
   2.2%
2
   4.9%
5
   3.9%
[1]
Measure Analysis Population Description: sexual orientation data was not collected on parent participants
1.Primary Outcome
Title Mean Adolescent WTP Scores
Hide Description

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.

Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Adolescents: Consent Condition 1 Adolescents: Consent Condition 2 Adolescents: Consent Condition 3
Hide Arm/Group Description:

Autonomous minor consent

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

Adult permission required

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

Parental permission required

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

Overall Number of Participants Analyzed 43 45 41
Mean (Standard Deviation)
Unit of Measure: score on a scale
3.7  (0.8) 3.7  (1.2) 3.5  (0.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adolescents: Consent Condition 1, Adolescents: Consent Condition 2, Adolescents: Consent Condition 3
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5148
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Cohen's f square
Estimated Value 0.011
Confidence Interval (2-Sided) 95%
0.001 to 0.101
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.208
Estimation Comments [Not Specified]
2.Primary Outcome
Title Mean Parent WTS Scores
Hide Description

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.

Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
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)
Arm/Group Title Parents: Consent Conditions 1-3
Hide Arm/Group Description:

Autonomous minor consent, Adult permission required, and Parental permission required

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

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

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

Overall Number of Participants Analyzed 125
Mean (Standard Deviation)
Unit of Measure: score on a scale
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)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Parents: Consent Conditions 1-3
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Cohen's f square
Estimated Value 0.306
Confidence Interval (2-Sided) 95%
0.169 to 0.389
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.149
Estimation Comments [Not Specified]
3.Primary Outcome
Title Effects of the Study Agent (Stage of Development and Method of Delivery) on High-risk Minor Adolescents' WTP Scores
Hide Description 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.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Adolescents: Consent Condition 1 Adolescents: Consent Condition 2 Adolescents: Consent Condition 3
Hide Arm/Group Description:

Autonomous minor consent

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

Adult permission required

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

Parental permission required

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

Overall Number of Participants Analyzed 43 45 41
Mean (Standard Deviation)
Unit of Measure: score on a scale
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)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adolescents: Consent Condition 1, Adolescents: Consent Condition 2, Adolescents: Consent Condition 3
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4324
Comments [Not Specified]
Method GEE Linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Cohen's f square
Estimated Value 0.008
Confidence Interval (2-Sided) 95%
0.001 to 0.073
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.213
Estimation Comments [Not Specified]
4.Primary Outcome
Title Effects of the Study Agent (Stage of Development and Method of Delivery) on Parents' Acceptability Scores
Hide Description 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.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Parents: Consent Conditions 1-3
Hide Arm/Group Description:

Autonomous minor consent, Adult permission required, and Parental permission required

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

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

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

Overall Number of Participants Analyzed 125
Mean (Standard Deviation)
Unit of Measure: score on a scale
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)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Parents: Consent Conditions 1-3
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method GEE Linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Cohen's f square
Estimated Value 0.260
Confidence Interval (2-Sided) 95%
0.175 to 0.374
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.149
Estimation Comments [Not Specified]
Time Frame Adverse event data were collected on all participants during their one-time study visit
Adverse Event Reporting Description All parent participants are considered one study 'arm' as they were not randomized to just one of the three consent conditions (as the adolescent participants were), but rather were presented with information on all 3 consent conditions and commented on the acceptability of each.
 
Arm/Group Title Adolescents: Consent Condition 1 Adolescents: Consent Condition 2 Adolescents: Consent Condition 3 Parents: Consent Conditions 1-3
Hide Arm/Group Description

Autonomous minor consent

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

Adult permission required

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

Parental permission required

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

Autonomous minor consent, adult permission required, and parental permission required

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

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

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

All-Cause Mortality
Adolescents: Consent Condition 1 Adolescents: Consent Condition 2 Adolescents: Consent Condition 3 Parents: Consent Conditions 1-3
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/43 (0.00%)   0/45 (0.00%)   0/41 (0.00%)   0/125 (0.00%) 
Hide Serious Adverse Events
Adolescents: Consent Condition 1 Adolescents: Consent Condition 2 Adolescents: Consent Condition 3 Parents: Consent Conditions 1-3
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/43 (0.00%)   0/45 (0.00%)   0/41 (0.00%)   0/125 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Adolescents: Consent Condition 1 Adolescents: Consent Condition 2 Adolescents: Consent Condition 3 Parents: Consent Conditions 1-3
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/43 (0.00%)   0/45 (0.00%)   0/41 (0.00%)   0/125 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Amy Knopf
Organization: Indiana University School of Nursing
Phone: 206-356-9430
EMail: asknopf@iu.edu
Layout table for additonal information
Responsible Party: Amelia Knopf, Indiana University
ClinicalTrials.gov Identifier: NCT03242954    
Other Study ID Numbers: 17-0538
5U24HD089880-02 ( U.S. NIH Grant/Contract )
First Submitted: August 3, 2017
First Posted: August 8, 2017
Results First Submitted: February 26, 2021
Results First Posted: April 22, 2021
Last Update Posted: April 22, 2021