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)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Colorado
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Aurora, Colorado, Estados Unidos, 80045
- Children's Hospital Colorado/Univ of Colorado SOM
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Florida
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Tampa, Florida, Estados Unidos, 33606
- University of South Florida
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Illinois
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Chicago, Illinois, Estados Unidos, 60637
- University of Chicago
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Maryland
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Baltimore, Maryland, Estados Unidos, 21287
- Johns Hopkins University/SOM
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: 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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Comparador activo: 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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Comparador activo: 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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Comparador activo: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Mean Adolescent WTP Scores
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Amy Knopf, PhD, MPH, RN, Indiana University School of Medicine
- Director de estudio: Matthew Psioda, PhD, University of North Carolina, Chapel Hill
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 17-0538
- 5U24HD089880-02 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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Ensayos clínicos sobre VIH
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Ensayos clínicos sobre Autonomous minor consent
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University of FloridaEunice Kennedy Shriver National Institute of Child Health and Human Development... y otros colaboradoresTerminadoInvestigación en comunicación | Actitud del Personal de Salud | Confianza | Actitud hacia las computadoras | Relaciones investigador-sujetoEstados Unidos
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Ataturk UniversityTerminadoCirugía artroscópica de hombroTurquía (Türkiye)
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Kadem KocTerminadoDolor Postoperatorio | Dolor de hombro | Procedimiento quirúrgico, no especificadoTurquía (Türkiye)
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Zagazig UniversityReclutamiento
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Misr University for Science and TechnologyActivo, no reclutandoDolor | El manejo del dolor | Manejo del dolor en el cuidado posoperatorioEgipto