- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03502226
Evaluation of an Inpatient Sexual Risk Behavior Assessment Program (iRAP)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Sexually transmitted infections (STIs) are disproportionately common among 15-24 year-old females, and can have detrimental effects including pelvic inflammatory disease and infertility. Most STI's are asymptomatic, especially for females, making screening programs essential. Current guidelines recommend HIV screening for all adolescents, and yearly chlamydia and gonorrhea screening for sexually active females under 25 years-old. Yet only one-third of primary care physicians report screening asymptomatic adolescents. Most adolescents report no sexual health discussion during preventative healthcare visits. Furthermore the majority do not regularly attend preventative healthcare visits. Therefore, urgent healthcare visits, often in emergency departments (ED) and inpatient settings, provide an important point of contact.
Given adolescents infrequently obtain outpatient sexual health services, the inpatient stay may serve as a critical intervention point. Other studies have found success with STI screening programs in the ED; none to our knowledge examined the efficacy of an inpatient sexual health screening protocol. Previous pilot data demonstrated, however, significant interest in sexual health information and desire for STI testing among adolescents admitted to a children's hospital.
Investigators conducted an exploratory study to evaluate the feasibility and potential effects of an innovative, individualized electronic inpatient sexual health intervention (iRAP) for adolescent females. The central hypothesis is that the electronic intervention, based on the Trans Theoretical Model (TTM) of behavior change, will significantly increase adolescent females' requests for STI screening and sexual health management.
Investigators enrolled 70 14-18 year-old, medically stable female inpatients admitted to the hospitalist service at Hasbro Children's Hospital for a randomized control trial during a one-year period. Participants were randomized to receive an electronic sexual risk assessment with or without real-time tailored feedback. Feedback was based on the TTM, utilizing readiness for change to determine appropriate messaging. Participants were then able to electronically request sexual health management options, including STI testing, discussion with their inpatient or outpatient physician, or technology-hosted information on contraception. Investigators conducted a chart review of enrolled adolescents to determine if sexual health topics were addressed.
The investigators are examining participation rates, length of time to perform all study elements, and proportion of teens that obtain requested service. Additionally, the investigators are comparing participants' perceived reproductive health risk and uptake of offered services between the intervention and control groups.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Admitted to the Hospitalist service, English speaking, parent available for consent, medically/psychologically stable.
Exclusion Criteria:
- Wards of the state, no parent/guardian for consent, non-English speaking
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Intervention group
Received tailored feedback regarding sexual health risks
|
Electronic feedback based on participants "stage of change" which provided risk reduction behavior regarding their sexual health including use of condoms, contraceptions, and STI testing.
|
|
Sin intervención: Control group
Did not receive tailored feedback.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of participants with requests for sexual health services, as assessed by sexual health options questionnaire
Periodo de tiempo: Immediate
|
All participants were able to request sexual health services while admitted to the hospital (options included: STI testing, speak with their MD, or watching contraception video).
The services were offered using an electronic REDCap questionnaire, with prompt of "Would you like to request X during your hospital stay?" and response options of yes/no.
The outcome will be assessed for each sexual health option (number of participants requesting STI testing, discussion with MD, or contraception video viewing) individually, as well as a variable created to show "any uptake" ie.
request made for any one or more services.
|
Immediate
|
Colaboradores e Investigadores
Patrocinador
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
- Oh-Zopfi Pilot Award 2016-2017
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.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Comportamiento Sexual
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University of MichiganReclutamientoViolencia sexual | Tráfico sexual | Abuso Infantil, Sexual | Delitos sexuales | Sexo comercial | Ofensa sexualEstados Unidos
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University of Nebraska LincolnCenters for Disease Control and Prevention; The Set Me Free Project; Des Moines...TerminadoViolencia sexual | Tráfico sexual | Abuso Infantil, Sexual | Delitos sexuales | Sexo comercial | Ofensa sexualEstados Unidos
-
Radicle ScienceTerminadoFunción sexual | Satisfacción sexualEstados Unidos
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Royal Holloway UniversityNational Health Service, United KingdomTerminadoDisfunción sexual | Agresión sexual | Trastorno sexualReino Unido
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The University of Texas Health Science Center,...United States Department of DefenseReclutamientoAgresión sexual | Acoso sexualEstados Unidos
-
Radicle ScienceTerminadoFunción sexual | Satisfacción sexualEstados Unidos
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McGill University Health Centre/Research Institute...ReclutamientoEsterilidad | Comportamiento Sexual | Función sexual | Técnicas de reproducción asistida | Disfunción sexual femenina | Disfunción sexual e infertilidad | Tecnología de reproducción asistida para la infertilidadCanadá
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Innovation Research & TrainingEunice Kennedy Shriver National Institute of Child Health and Human Development...TerminadoComportamiento Sexual | Violencia Doméstica | Agresión sexualEstados Unidos
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Medstar Health Research InstituteSHE FoundationTerminadoComportamiento Sexual | Actividad sexualEstados Unidos
-
University of BaghdadTerminadoComportamiento Sexual | Trastorno por conflicto de orientación sexual | Trastorno de excitación sexual | Orientación sexual | Sexual; Orientación, Trastorno De RelaciónIrak
Ensayos clínicos sobre Tailored feedback
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Tel-Aviv Sourasky Medical CenterTel Aviv UniversityDesconocido
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University of AarhusDanish Cancer Society; AmbuFlexTerminado
-
VA Office of Research and DevelopmentEmory University; University of MinnesotaReclutamientoTrastorno por uso de sustanciasEstados Unidos
-
Istituto Ortopedico GaleazziReclutamientoHematoma Post-quirúrgico, Reemplazo de Cadera, CirugíaItalia
-
University of HoustonDesconocidoIsquemia cerebral | Secuelas del ictusEstados Unidos
-
Karolinska InstitutetRetiradoTrastornos por uso de sustancias | Dependencia de benzodiacepinas | Abuso de benzodiacepinasSuecia
-
Parc Sanitari Pere VirgiliUniversitat Internacional de CatalunyaTerminadoSíndrome del empujador | Accidente cerebrovascular subagudoEspaña
-
University of GiessenReclutamientoEnfermedad Inflamatoria Intestinal (EII)Alemania
-
Massachusetts General HospitalTerminadoAsfixia Perinatal | Asfixia neonatal | Asfixia de nacimiento
-
Xuanwu Hospital, Beijingthe Alberto Santos Dumont Association for Research SupportDesconocido