Trial Outcomes & Findings for Innovative Approaches for Minor Consent: Consent 2.0 (NCT NCT03242954)
NCT ID: NCT03242954
Last Updated: 2021-04-22
Results Overview
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.
COMPLETED
NA
254 participants
Day 1
2021-04-22
Participant Flow
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.
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.
Participant milestones
| Measure |
Adolescents: Consent Condition 1
Autonomous consent
Autonomous consent: Consent requirement where the participant is not required to get anyone's permission to participate in the trial.
|
Adolescents: Consent Condition 2
Adult permission required
Adult permission required: Consent requirement where the participant is required to obtain an adult's permission to participate in the trial.
|
Adolescents: Consent Condition 3
Parental permission required
Parental Permission Required: Consent requirement where the participant is required to obtain their parent's permission to participate in the trial.
|
Parents: Consent Conditions 1-3
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
43
|
45
|
41
|
125
|
|
Overall Study
COMPLETED
|
43
|
45
|
41
|
125
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Gender identity data was not collected on Parent participants.
Baseline characteristics by cohort
| Measure |
Adolescents: Consent Condition 1
n=43 Participants
Autonomous minor consent
Autonomous minor consent: Consent requirement where the participant is not required to get anyone's permission to participate in the trial.
|
Adolescents: Consent Condition 2
n=45 Participants
Adult permission required
Adult permission required: Consent requirement where the participant is required to obtain an adult's permission to participate in the trial.
|
Adolescents: Consent Condition 3
n=41 Participants
Parental permission required
Parental permission required: Consent requirement where the participant is required to obtain their parent's permission to participate in the trial.
|
Parents: Consent Conditions 1-3
n=125 Participants
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
n=254 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
14 years old
|
1 Participants
n=43 Participants
|
1 Participants
n=45 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=125 Participants
|
2 Participants
n=254 Participants
|
|
Age, Customized
15 years old
|
7 Participants
n=43 Participants
|
3 Participants
n=45 Participants
|
5 Participants
n=41 Participants
|
0 Participants
n=125 Participants
|
15 Participants
n=254 Participants
|
|
Age, Customized
16 years old
|
11 Participants
n=43 Participants
|
8 Participants
n=45 Participants
|
15 Participants
n=41 Participants
|
0 Participants
n=125 Participants
|
34 Participants
n=254 Participants
|
|
Age, Customized
17 years old
|
24 Participants
n=43 Participants
|
33 Participants
n=45 Participants
|
21 Participants
n=41 Participants
|
0 Participants
n=125 Participants
|
78 Participants
n=254 Participants
|
|
Age, Customized
>= 18 years old
|
0 Participants
n=43 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=41 Participants
|
125 Participants
n=125 Participants
|
125 Participants
n=254 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=43 Participants
|
24 Participants
n=45 Participants
|
22 Participants
n=41 Participants
|
63 Participants
n=125 Participants
|
132 Participants
n=254 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=43 Participants
|
21 Participants
n=45 Participants
|
19 Participants
n=41 Participants
|
62 Participants
n=125 Participants
|
122 Participants
n=254 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=43 Participants
|
11 Participants
n=45 Participants
|
8 Participants
n=41 Participants
|
18 Participants
n=125 Participants
|
48 Participants
n=254 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=43 Participants
|
33 Participants
n=45 Participants
|
32 Participants
n=41 Participants
|
103 Participants
n=125 Participants
|
198 Participants
n=254 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=43 Participants
|
1 Participants
n=45 Participants
|
1 Participants
n=41 Participants
|
4 Participants
n=125 Participants
|
8 Participants
n=254 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=43 Participants
|
2 Participants
n=45 Participants
|
0 Participants
n=41 Participants
|
3 Participants
n=125 Participants
|
6 Participants
n=254 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=43 Participants
|
0 Participants
n=45 Participants
|
1 Participants
n=41 Participants
|
0 Participants
n=125 Participants
|
1 Participants
n=254 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=43 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=125 Participants
|
2 Participants
n=254 Participants
|
|
Race (NIH/OMB)
Black or African American
|
19 Participants
n=43 Participants
|
27 Participants
n=45 Participants
|
21 Participants
n=41 Participants
|
73 Participants
n=125 Participants
|
140 Participants
n=254 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=43 Participants
|
7 Participants
n=45 Participants
|
14 Participants
n=41 Participants
|
31 Participants
n=125 Participants
|
61 Participants
n=254 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=43 Participants
|
6 Participants
n=45 Participants
|
5 Participants
n=41 Participants
|
8 Participants
n=125 Participants
|
26 Participants
n=254 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=43 Participants
|
3 Participants
n=45 Participants
|
0 Participants
n=41 Participants
|
10 Participants
n=125 Participants
|
18 Participants
n=254 Participants
|
|
Gender Identity
Woman
|
22 Participants
n=43 Participants • Gender identity data was not collected on Parent participants.
|
24 Participants
n=45 Participants • Gender identity data was not collected on Parent participants.
|
23 Participants
n=41 Participants • Gender identity data was not collected on Parent participants.
|
—
|
69 Participants
n=129 Participants • Gender identity data was not collected on Parent participants.
|
|
Gender Identity
Gender queer or gender non-conforming
|
0 Participants
n=43 Participants • Gender identity data was not collected on Parent participants.
|
1 Participants
n=45 Participants • Gender identity data was not collected on Parent participants.
|
0 Participants
n=41 Participants • Gender identity data was not collected on Parent participants.
|
—
|
1 Participants
n=129 Participants • Gender identity data was not collected on Parent participants.
|
|
Gender Identity
Man
|
15 Participants
n=43 Participants • Gender identity data was not collected on Parent participants.
|
18 Participants
n=45 Participants • Gender identity data was not collected on Parent participants.
|
14 Participants
n=41 Participants • Gender identity data was not collected on Parent participants.
|
—
|
47 Participants
n=129 Participants • Gender identity data was not collected on Parent participants.
|
|
Gender Identity
Trans woman
|
3 Participants
n=43 Participants • Gender identity data was not collected on Parent participants.
|
1 Participants
n=45 Participants • Gender identity data was not collected on Parent participants.
|
4 Participants
n=41 Participants • Gender identity data was not collected on Parent participants.
|
—
|
8 Participants
n=129 Participants • Gender identity data was not collected on Parent participants.
|
|
Gender Identity
Trans man
|
2 Participants
n=43 Participants • Gender identity data was not collected on Parent participants.
|
0 Participants
n=45 Participants • Gender identity data was not collected on Parent participants.
|
0 Participants
n=41 Participants • Gender identity data was not collected on Parent participants.
|
—
|
2 Participants
n=129 Participants • Gender identity data was not collected on Parent participants.
|
|
Gender Identity
Other
|
1 Participants
n=43 Participants • Gender identity data was not collected on Parent participants.
|
1 Participants
n=45 Participants • Gender identity data was not collected on Parent participants.
|
0 Participants
n=41 Participants • Gender identity data was not collected on Parent participants.
|
—
|
2 Participants
n=129 Participants • Gender identity data was not collected on Parent participants.
|
|
Sexual orientation
Bisexual
|
11 Participants
n=43 Participants • sexual orientation data was not collected on parent participants
|
11 Participants
n=45 Participants • sexual orientation data was not collected on parent participants
|
11 Participants
n=41 Participants • sexual orientation data was not collected on parent participants
|
—
|
33 Participants
n=129 Participants • sexual orientation data was not collected on parent participants
|
|
Sexual orientation
Gay, queer, or same gender loving
|
12 Participants
n=43 Participants • sexual orientation data was not collected on parent participants
|
15 Participants
n=45 Participants • sexual orientation data was not collected on parent participants
|
9 Participants
n=41 Participants • sexual orientation data was not collected on parent participants
|
—
|
36 Participants
n=129 Participants • sexual orientation data was not collected on parent participants
|
|
Sexual orientation
Straight or heterosexual
|
18 Participants
n=43 Participants • sexual orientation data was not collected on parent participants
|
17 Participants
n=45 Participants • sexual orientation data was not collected on parent participants
|
19 Participants
n=41 Participants • sexual orientation data was not collected on parent participants
|
—
|
54 Participants
n=129 Participants • sexual orientation data was not collected on parent participants
|
|
Sexual orientation
Questioning
|
0 Participants
n=43 Participants • sexual orientation data was not collected on parent participants
|
1 Participants
n=45 Participants • sexual orientation data was not collected on parent participants
|
0 Participants
n=41 Participants • sexual orientation data was not collected on parent participants
|
—
|
1 Participants
n=129 Participants • sexual orientation data was not collected on parent participants
|
|
Sexual orientation
Other
|
2 Participants
n=43 Participants • sexual orientation data was not collected on parent participants
|
1 Participants
n=45 Participants • sexual orientation data was not collected on parent participants
|
2 Participants
n=41 Participants • sexual orientation data was not collected on parent participants
|
—
|
5 Participants
n=129 Participants • sexual orientation data was not collected on parent participants
|
PRIMARY outcome
Timeframe: Day 1Comparing 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.
Outcome measures
| Measure |
Adolescents: Consent Condition 1
n=43 Participants
Autonomous minor consent
Autonomous consent: Consent requirement where the participant is not required to get anyone's permission to participate in the trial.
|
Adolescents: Consent Condition 2
n=45 Participants
Adult permission required
Adult permission required: Consent requirement where the participant is required to obtain an adult's permission to participate in the trial.
|
Adolescents: Consent Condition 3
n=41 Participants
Parental permission required
Parental Permission Required: Consent requirement where the participant is required to obtain their parent's permission to participate in the trial.
|
|---|---|---|---|
|
Mean Adolescent WTP Scores
|
3.7 score on a scale
Standard Deviation 0.8
|
3.7 score on a scale
Standard Deviation 1.2
|
3.5 score on a scale
Standard Deviation 0.8
|
PRIMARY outcome
Timeframe: Day 1Population: 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)
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.
Outcome measures
| Measure |
Adolescents: Consent Condition 1
n=125 Participants
Autonomous minor consent
Autonomous consent: Consent requirement where the participant is not required to get anyone's permission to participate in the trial.
|
Adolescents: Consent Condition 2
Adult permission required
Adult permission required: Consent requirement where the participant is required to obtain an adult's permission to participate in the trial.
|
Adolescents: Consent Condition 3
Parental permission required
Parental Permission Required: Consent requirement where the participant is required to obtain their parent's permission to participate in the trial.
|
|---|---|---|---|
|
Mean Parent WTS Scores
Parent Consent Condition 1: Autonomous minor consent
|
2.6 score on a scale
Standard Deviation 1.5
|
—
|
—
|
|
Mean Parent WTS Scores
Parent Consent Condition 2: Adult permission required
|
3.1 score on a scale
Standard Deviation 1.5
|
—
|
—
|
|
Mean Parent WTS Scores
Parent Consent Condition 3: Parental permission required
|
4.4 score on a scale
Standard Deviation 1.0
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1This 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.
Outcome measures
| Measure |
Adolescents: Consent Condition 1
n=43 Participants
Autonomous minor consent
Autonomous consent: Consent requirement where the participant is not required to get anyone's permission to participate in the trial.
|
Adolescents: Consent Condition 2
n=45 Participants
Adult permission required
Adult permission required: Consent requirement where the participant is required to obtain an adult's permission to participate in the trial.
|
Adolescents: Consent Condition 3
n=41 Participants
Parental permission required
Parental Permission Required: Consent requirement where the participant is required to obtain their parent's permission to participate in the trial.
|
|---|---|---|---|
|
Effects of the Study Agent (Stage of Development and Method of Delivery) on High-risk Minor Adolescents' WTP Scores
Study agent 1 - ATN 113
|
3.6 score on a scale
Standard Deviation 1.1
|
3.7 score on a scale
Standard Deviation 1.3
|
3.6 score on a scale
Standard Deviation 0.9
|
|
Effects of the Study Agent (Stage of Development and Method of Delivery) on High-risk Minor Adolescents' WTP Scores
Study agent 2 - HPTN 077
|
3.8 score on a scale
Standard Deviation 0.9
|
3.8 score on a scale
Standard Deviation 1.2
|
3.4 score on a scale
Standard Deviation 1.0
|
PRIMARY outcome
Timeframe: Day 1Population: 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.
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.
Outcome measures
| Measure |
Adolescents: Consent Condition 1
n=125 Participants
Autonomous minor consent
Autonomous consent: Consent requirement where the participant is not required to get anyone's permission to participate in the trial.
|
Adolescents: Consent Condition 2
Adult permission required
Adult permission required: Consent requirement where the participant is required to obtain an adult's permission to participate in the trial.
|
Adolescents: Consent Condition 3
Parental permission required
Parental Permission Required: Consent requirement where the participant is required to obtain their parent's permission to participate in the trial.
|
|---|---|---|---|
|
Effects of the Study Agent (Stage of Development and Method of Delivery) on Parents' Acceptability Scores
Parental permission required study agent HPTN 077
|
4.4 score on a scale
Standard Deviation 1.1
|
—
|
—
|
|
Effects of the Study Agent (Stage of Development and Method of Delivery) on Parents' Acceptability Scores
Autonomous minor consent study agent ATN 113
|
2.7 score on a scale
Standard Deviation 1.6
|
—
|
—
|
|
Effects of the Study Agent (Stage of Development and Method of Delivery) on Parents' Acceptability Scores
Adult permission required study agent ATN 113
|
3.1 score on a scale
Standard Deviation 1.6
|
—
|
—
|
|
Effects of the Study Agent (Stage of Development and Method of Delivery) on Parents' Acceptability Scores
Parental permission required study agent ATN 113
|
4.3 score on a scale
Standard Deviation 1.2
|
—
|
—
|
|
Effects of the Study Agent (Stage of Development and Method of Delivery) on Parents' Acceptability Scores
Autonomous minor consent study agent HPTN 077
|
2.6 score on a scale
Standard Deviation 1.5
|
—
|
—
|
|
Effects of the Study Agent (Stage of Development and Method of Delivery) on Parents' Acceptability Scores
Adult permission required study agent HPTN 077
|
3.1 score on a scale
Standard Deviation 1.6
|
—
|
—
|
Adverse Events
Adolescents: Consent Condition 1
Adolescents: Consent Condition 2
Adolescents: Consent Condition 3
Parents: Consent Conditions 1-3
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place