HIV
Conditions
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.
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.
Interventions
OTHERAutonomous minor consent
Consent requirement where the participant is not required to get anyone's permission to participate in the trial.
OTHERAdult permission required
Consent requirement where the participant is required to obtain an adult's permission to participate in the trial.
OTHERParental permission required
Consent requirement where the participant is required to obtain their parent's permission to participate in the trial.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
14 Years to 17 Years
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Adolescent WTP Scores | 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 | 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 | 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 | 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. |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| Adolescents: Consent Condition 1 Autonomous minor consent
Autonomous minor consent: Consent requirement where the participant is not required to get anyone's permission to participate in the trial. | 43 |
| 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. | 45 |
| 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. | 41 |
| Parents: Consent Conditions 1-3 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. | 125 |
| Total | 254 |
Baseline characteristics
| Characteristic | Adolescents: Consent Condition 2 | Adolescents: Consent Condition 1 | Total | Parents: Consent Conditions 1-3 | Adolescents: Consent Condition 3 |
|---|---|---|---|---|---|
| Age, Customized 14 years old | 1 Participants | 1 Participants | 2 Participants | 0 Participants | 0 Participants |
| Age, Customized 15 years old | 3 Participants | 7 Participants | 15 Participants | 0 Participants | 5 Participants |
| Age, Customized 16 years old | 8 Participants | 11 Participants | 34 Participants | 0 Participants | 15 Participants |
| Age, Customized 17 years old | 33 Participants | 24 Participants | 78 Participants | 0 Participants | 21 Participants |
| Age, Customized >= 18 years old | 0 Participants | 0 Participants | 125 Participants | 125 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants | 11 Participants | 48 Participants | 18 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 33 Participants | 30 Participants | 198 Participants | 103 Participants | 32 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 8 Participants | 4 Participants | 1 Participants |
| Gender Identity Gender queer or gender non-conforming | 1 Participants | 0 Participants | 1 Participants | — | 0 Participants |
| Gender Identity Man | 18 Participants | 15 Participants | 47 Participants | — | 14 Participants |
| Gender Identity Other | 1 Participants | 1 Participants | 2 Participants | — | 0 Participants |
| Gender Identity Trans man | 0 Participants | 2 Participants | 2 Participants | — | 0 Participants |
| Gender Identity Trans woman | 1 Participants | 3 Participants | 8 Participants | — | 4 Participants |
| Gender Identity Woman | 24 Participants | 22 Participants | 69 Participants | — | 23 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 1 Participants | 6 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 27 Participants | 19 Participants | 140 Participants | 73 Participants | 21 Participants |
| Race (NIH/OMB) More than one race | 6 Participants | 7 Participants | 26 Participants | 8 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 2 Participants | 2 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 5 Participants | 18 Participants | 10 Participants | 0 Participants |
| Race (NIH/OMB) White | 7 Participants | 9 Participants | 61 Participants | 31 Participants | 14 Participants |
| Sex: Female, Male Female | 24 Participants | 23 Participants | 132 Participants | 63 Participants | 22 Participants |
| Sex: Female, Male Male | 21 Participants | 20 Participants | 122 Participants | 62 Participants | 19 Participants |
| Sexual orientation Bisexual | 11 Participants | 11 Participants | 33 Participants | — | 11 Participants |
| Sexual orientation Gay, queer, or same gender loving | 15 Participants | 12 Participants | 36 Participants | — | 9 Participants |
| Sexual orientation Other | 1 Participants | 2 Participants | 5 Participants | — | 2 Participants |
| Sexual orientation Questioning | 1 Participants | 0 Participants | 1 Participants | — | 0 Participants |
| Sexual orientation Straight or heterosexual | 17 Participants | 18 Participants | 54 Participants | — | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 43 | 0 / 45 | 0 / 41 | 0 / 125 |
| other Total, other adverse events | 0 / 43 | 0 / 45 | 0 / 41 | 0 / 125 |
| serious Total, serious adverse events | 0 / 43 | 0 / 45 | 0 / 41 | 0 / 125 |
Outcome results
Primary
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.
Time frame: Day 1
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adolescents: Consent Condition 1 | 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 |
| Adolescents: Consent Condition 1 | 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 |
| Adolescents: Consent Condition 2 | Effects of the Study Agent (Stage of Development and Method of Delivery) on High-risk Minor Adolescents' WTP Scores | Study agent 1 - ATN 113 | 3.7 score on a scale | Standard Deviation 1.3 |
| Adolescents: Consent Condition 2 | 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 1.2 |
| Adolescents: Consent Condition 3 | 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 0.9 |
| Adolescents: Consent Condition 3 | Effects of the Study Agent (Stage of Development and Method of Delivery) on High-risk Minor Adolescents' WTP Scores | Study agent 2 - HPTN 077 | 3.4 score on a scale | Standard Deviation 1 |
p-value: 0.432495% CI: [0.001, 0.073]GEE Linear model
Primary
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.
Time frame: Day 1
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adolescents: Consent Condition 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 |
| Adolescents: Consent Condition 1 | 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 |
| Adolescents: Consent Condition 1 | 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 |
| Adolescents: Consent Condition 1 | 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 |
| Adolescents: Consent Condition 1 | 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 |
| Adolescents: Consent Condition 1 | 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 |
p-value: <0.000195% CI: [0.175, 0.374]GEE Linear model
Primary
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.
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adolescents: Consent Condition 1 | Mean Adolescent WTP Scores | 3.7 score on a scale | Standard Deviation 0.8 |
| Adolescents: Consent Condition 2 | Mean Adolescent WTP Scores | 3.7 score on a scale | Standard Deviation 1.2 |
| Adolescents: Consent Condition 3 | Mean Adolescent WTP Scores | 3.5 score on a scale | Standard Deviation 0.8 |
p-value: 0.514895% CI: [0.001, 0.101]Regression, Linear
Primary
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.
Time frame: Day 1
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adolescents: Consent Condition 1 | Mean Parent WTS Scores | Parent Consent Condition 1: Autonomous minor consent | 2.6 score on a scale | Standard Deviation 1.5 |
| Adolescents: Consent Condition 1 | Mean Parent WTS Scores | Parent Consent Condition 2: Adult permission required | 3.1 score on a scale | Standard Deviation 1.5 |
| Adolescents: Consent Condition 1 | Mean Parent WTS Scores | Parent Consent Condition 3: Parental permission required | 4.4 score on a scale | Standard Deviation 1 |
p-value: <0.000195% CI: [0.169, 0.389]Regression, Linear