Innovative Approaches for Minor Consent: Consent 2.0
Innovative Approaches for Minor Consent: Consent 2.0 - A Multi-Center Study of the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN)
Обзор исследования
Статус
Условия
Подробное описание
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.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Colorado
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Aurora, Colorado, Соединенные Штаты, 80045
- Children's Hospital Colorado/Univ of Colorado SOM
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Florida
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Tampa, Florida, Соединенные Штаты, 33606
- University Of South Florida
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Illinois
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Chicago, Illinois, Соединенные Штаты, 60637
- University of Chicago
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Maryland
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Baltimore, Maryland, Соединенные Штаты, 21287
- Johns Hopkins University/SOM
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Другой
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Активный компаратор: Adolescents: Consent Condition 1
Autonomous minor consent
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Consent requirement where the participant is not required to get anyone's permission to participate in the trial.
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Активный компаратор: Adolescents: Consent Condition 2
Adult permission required
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Consent requirement where the participant is required to obtain an adult's permission to participate in the trial.
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Активный компаратор: Adolescents: Consent Condition 3
Parental permission required
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Consent requirement where the participant is required to obtain their parent's permission to participate in the trial.
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Активный компаратор: Parents: Consent Conditions 1-3
Autonomous minor consent, adult permission required, and parental permission required
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Consent requirement where the participant is not required to get anyone's permission to participate in the trial.
Consent requirement where the participant is required to obtain an adult's permission to participate in the trial.
Consent requirement where the participant is required to obtain their parent's permission to participate in the trial.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Mean Adolescent WTP Scores
Временное ограничение: Day 1
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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
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Mean Parent WTS Scores
Временное ограничение: Day 1
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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
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Effects of the Study Agent (Stage of Development and Method of Delivery) on High-risk Minor Adolescents' WTP Scores
Временное ограничение: Day 1
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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.
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Day 1
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Effects of the Study Agent (Stage of Development and Method of Delivery) on Parents' Acceptability Scores
Временное ограничение: Day 1
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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.
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Day 1
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Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Amy Knopf, PhD, MPH, RN, Indiana University School of Medicine
- Директор по исследованиям: Matthew Psioda, PhD, University of North Carolina, Chapel Hill
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Другие идентификационные номера исследования
- 17-0538
- 5U24HD089880-02 (Грант/контракт NIH США)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
Сроки обмена IPD
Критерии совместного доступа к IPD
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- САП
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .
Клинические исследования Autonomous minor consent
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University of FloridaEunice Kennedy Shriver National Institute of Child Health and Human Development... и другие соавторыЗавершенныйКоммуникационные исследования | Отношение медицинского персонала | Доверять | Отношение к компьютерам | Отношения между исследователем и субъектомСоединенные Штаты