- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01844414
UCLA-Amity Parolee Health Promotion Study
Health Promotion Coaching/Vaccine for Homeless Parolees
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Homeless parolees pose a particular challenge for successful reentry into the community as they have underlying mental health issues combined with substance use and abuse and must contend with unstable housing situations, disorganized lives, unemployment, and limited access to health care and social services. Generally about 50% of all parolees scheduled to enroll in community-based drug treatment fail to enroll and less than 10% of enrollees actually complete treatment. Not surprisingly, about two-thirds of all individuals on parole are rearrested and return to custody within three years of release from prison. Recent data also revealed homeless persons who were least likely to complete a Hepatitis A/B (HAV/HBV) vaccine series were young (< 40) men who had been discharged from prison. Therefore, it is critical to engage paroled adults in comprehensive intervention programs that not only protect them from hepatitis B, but also reduce risky behavior, promote access to health care, social and employment services, and enable positive coping and communication skills.
Building upon advice from community partners who have successfully treated parolees and the research team's experience with hepatitis vaccination work, this study is designed to conduct a prospective, three-group study that randomly assigns 700 ready-for-discharge parolees, scheduled to enter a community residential drug treatment program, to enter one of three groups: 1) a PCPC (Parolee Comprehensive Care + Phone Coaching Program), which includes nurse case management and specialized hepatitis education sessions and referrals, the HAV/HBV vaccination series (to all eligible) and coach-facilitated mentoring (mostly by cell-phone); 2) a Parolee Brief Hepatitis Education + HBV vaccination + Phone Coaching (PBCP) Program, which includes brief hepatitis/HIV education, the HAV/HBV vaccination and coach-facilitated mentoring; or 3) a Usual Care (UC) control program, which includes brief general health information, and the HAV/HBV vaccine. This study will advance the research team's knowledge about drug treatment and HBV vaccine completion and recidivism among homeless parolees. Findings from this study can inform targeted interventions and lay the groundwork for health policy decisions that may impact hepatitis and HIV risk reduction and recidivism in this group who are a reservoir for these viruses in the general population, and are returning to prison at unprecedented numbers.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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Los Angeles, California, Estados Unidos, 90007
- Amistad de Los Angeles
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Parolees enrolled in Amity's Amistad's program;
- Age 18-60;
- Discharged from prison or jail within the last six months;
- History of drug use 12 months prior to most recent incarceration;
- Previously homeless prior to most recent incarceration; and
- Willing to provide informed consent
Exclusion Criteria:
- Monolingual speakers of languages other than English; and
- Persons judged to be cognitively impaired by the research staff.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Parolee Comprehensive Care + Phone Coach
PCPC Intervention: Eight specialized nurse case managed hepatitis education sessions, the Hepatitis A/B vaccine series and coach-facilitated mentoring.
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A nurse case managed and specialized hepatitis education program with the hepatitis A/B (HAV/HBV) vaccination series (to all eligible) and coach-facilitated mentoring (mostly by cell-phone).
Otros nombres:
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Experimental: Parolee Brief HBV program + Phone Coach
PBPC Intervention: Eight twenty minute hepatitis education sessions, coach facilitated mentoring and the Hepatitis A/B vaccine series.
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A brief hepatitis/HIV education program with the Hepatitis A/B vaccine series and coach-facilitated mentoring.
Otros nombres:
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Comparador activo: Usual Care Group
UC Control Group: One brief general health information program, one-on-one coaching and the Hepatitis A/B vaccine.
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Control Group: A brief general health information program with one-on-one coaching and the Hepatitis A/B vaccine
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Primary Outcome Measure
Periodo de tiempo: 5 years
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● Number of re-incarcerations
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5 years
|
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Primary Outcome Measure
Periodo de tiempo: 5 years
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● Completion of the Hepatitis A/B vaccine (for HBV negative participants);
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5 years
|
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Primary Outcome Measure
Periodo de tiempo: 5 years
|
● Completion of six months of a community-based residential drug treatment program;
|
5 years
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Secondary Outcome Measure
Periodo de tiempo: 5 years
|
Reduction in drug and alcohol use and sexual risk behaviors;
|
5 years
|
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Secondary Outcome Measure
Periodo de tiempo: 5 years
|
Number of visits to health care or social service providers;
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5 years
|
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Secondary Outcome Measure
Periodo de tiempo: 5 years
|
Improved knowledge of Hepatitis/HIV and communication skills between 6 and 12 months or over the one-year study period;
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5 years
|
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Secondary Outcome Measure
Periodo de tiempo: 5 years
|
Cost Effectiveness of each of the three programs
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5 years
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Adeline Nyamathi, PhD, University of California, Los Angeles
Publicaciones y enlaces útiles
Publicaciones Generales
- Nyamathi A, Marlow E, Zhang S, Hall E, Farabee D, Marfisee M, Khalilifard F, Faucette M, Leake B. Correlates of serious violent crime for recently released parolees with a history of homelessness. Violence Vict. 2012;27(5):793-810. doi: 10.1891/0886-6708.27.5.793.
- Nyamathi A, Leake B, Albarran C, Zhang S, Hall E, Farabee D, Marlow E, Marfisee M, Khalilifard F, Faucette M. Correlates of depressive symptoms among homeless men on parole. Issues Ment Health Nurs. 2011;32(8):501-11. doi: 10.3109/01612840.2011.569111.
- Nyamathi AM, Zhang SX, Wall S, Hall EA, Salem BE, Farabee D, Faucette M, Yadav K. Drug Use and Multiple Sex Partners Among Homeless Ex-Offenders: Secondary Findings From an Experimental Study. Nurs Res. 2016 May-Jun;65(3):179-90. doi: 10.1097/NNR.0000000000000150.
- Nyamathi A, Salem BE, Zhang S, Farabee D, Hall B, Khalilifard F, Leake B. Nursing case management, peer coaching, and hepatitis a and B vaccine completion among homeless men recently released on parole: randomized clinical trial. Nurs Res. 2015 May-Jun;64(3):177-89. doi: 10.1097/NNR.0000000000000083.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Desordenes mentales
- Trastornos inducidos químicamente
- Enfermedades del Sistema Digestivo
- Infecciones por virus de ARN
- Enfermedades virales
- Infecciones
- Infecciones transmitidas por la sangre
- Enfermedades contagiosas
- Enfermedades del HIGADO
- Infecciones por Flaviviridae
- Hepatitis, Viral, Humana
- Infecciones por Hepadnaviridae
- Infecciones por virus de ADN
- Infecciones por enterovirus
- Infecciones por Picornaviridae
- Trastornos relacionados con sustancias
- Hepatitis B
- Hepatitis
- Hepatitis A
- Hepatitis C
Otros números de identificación del estudio
- 10000358
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