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| ID | Type | Description | Link |
|---|---|---|---|
| 5U24HD089880-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adolescents: Consent Condition 1 | Active Comparator | Autonomous minor consent |
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| Adolescents: Consent Condition 2 | Active Comparator | Adult permission required |
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| Adolescents: Consent Condition 3 | Active Comparator | Parental permission required |
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| Parents: Consent Conditions 1-3 | Active Comparator | Autonomous minor consent, adult permission required, and parental permission required |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autonomous minor consent | Other | Consent requirement where the participant is not required to get anyone's permission to participate in the trial. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Day 1 |
| Effects of the Study Agent (Stage of Development and Method of Delivery) on Parents' Acceptability Scores |
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Note: Age limits apply to adolescent participants and to the adolescent children of parent participants.
Adolescent Inclusion Criteria
Adolescent Exclusion Criteria
Parent Inclusion Criteria
Parent Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Amy Knopf, PhD, MPH, RN | Indiana University | Principal Investigator |
| Matthew Psioda, PhD | University of North Carolina, Chapel Hill | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Colorado/Univ of Colorado SOM | Aurora | Colorado | 80045 | United States | ||
| University of South Florida |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36646563 | Derived | 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. |
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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.
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.
Please see DASH guidelines for access criteria.
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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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.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Adolescents: Consent Condition 2 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Day 1 |
|
Adverse event data were collected on all participants during their one-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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amy Knopf | Indiana University School of Nursing | 206-356-9430 | asknopf@iu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Mar 12, 2018 | Feb 24, 2021 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 18, 2018 | Mar 24, 2021 | Prot_SAP_001.pdf |
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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.
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| Adult permission required | Other | Consent requirement where the participant is required to obtain an adult's permission to participate in the trial. |
|
| Parental permission required | Other | Consent requirement where the participant is required to obtain their parent's permission to participate in the trial. |
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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. |
| Day 1 |
| Tampa |
| Florida |
| 33606 |
| United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Johns Hopkins University/SOM | Baltimore | Maryland | 21287 | United States |
Adult permission required Adult permission required: Consent requirement where the participant is required to obtain an adult's permission to participate in the trial. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | sex assigned at birth | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Gender Identity | Gender identity data was not collected on Parent participants. | Count of Participants | Participants |
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| Sexual orientation | sexual orientation data was not collected on parent participants | Count of Participants | Participants |
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| OG001 |
| 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. |
| OG002 | 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. |
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| 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. | 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) | Posted | Mean | Standard Deviation | score on a scale | Day 1 |
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|
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Day 1 |
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|
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Day 1 |
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| 0 |
| 43 |
| 0 |
| 43 |
| 0 |
| 43 |
| EG001 | 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. | 0 | 45 | 0 | 45 | 0 | 45 |
| EG002 | 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. | 0 | 41 | 0 | 41 | 0 | 41 |
| EG003 | 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. | 0 | 125 | 0 | 125 | 0 | 125 |
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| 15 years old |
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| 16 years old |
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| 17 years old |
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| >= 18 years old |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Gender queer or gender non-conforming |
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| Man |
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| Trans woman |
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| Trans man |
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| Other |
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| Gay, queer, or same gender loving |
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| Straight or heterosexual |
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| Questioning |
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| Other |
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| Autonomous minor consent study agent HPTN 077 |
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| Adult permission required study agent HPTN 077 |
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| Parental permission required study agent HPTN 077 |
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