Integrating HPV Vaccination Into HIV Care Services for Adolescent Girls Living With HIV in Zambia
Integrating HPV Vaccination Into HIV Care Services for Adolescent Girls Living With HIV in Zambia: A Mixed-Methods Feasibility and Implementation Evaluation Study
HPV vaccination can prevent up to 90% of cervical cancer cases, but adolescents living with HIV (ALHIV) require additional doses for sufficient protection beyond the single dose recommended for adolescent girls in Zambia. There are challenges to ensuring ALHIV receive all necessary doses without increasing burden and stigma on the girls. Integrating HPV vaccination into ART clinics can be an effective approach to doing so but requires a multi-pronged strategy for successful implementation.
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Michelle Silver, PhD, ScM
- Número de teléfono: 314-454-7903
- Correo electrónico: michelle.silver@wustl.edu
Copia de seguridad de contactos de estudio
- Nombre: Jean Hunleth, PhD, MPH
- Número de teléfono: 314-747-8066
- Correo electrónico: jean.hunleth@wustl.edu
Ubicaciones de estudio
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Copperbelt
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Ndola, Copperbelt, Zambia
- Tropical Diseases Research Centre Ndola
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Contacto:
- Sam Miti, MD
- Número de teléfono: +260 96 6293508
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Investigador principal:
- Sam Miti, MD
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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:
- Healthcare workers providing HIV, adolescent or vaccination services at one of the 3 study sites (including registration, data collection, clinical care, pharmacy, administration)
- Facility leadership, district, provincial, national health managers and program coordinators
Exclusion Criteria:
- No involvement in HIV, adolescent or vaccination services
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Tertiary Care Cohort
Participants in this arm will complete the multi-component training that aims at improving healthcare worker competencies around HPV and HPV vaccines. Participants will complete pre- and post- training questionnaires, as well as quantitative surveys administered at baseline, 6 months, and 12 months that measure implementation outcomes. |
The HPV-HIV integration training covers six core modules. The six core modules include HPV epidemiology and vaccine indications, identification of eligible adolescents, adolescent-centered communication, workflow integration procedures, documentation and reporting systems, and strategies to reduce missed opportunities. The training will occur over a period of 3 days. Participants will receive facilitator manuals, screening tools, referral algorithms, and job aids. Audit & Feedback of vaccination data will support integration and documentation. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Tertiary Care Cohort: Changes in HPV knowledge
Periodo de tiempo: At time of pre-training assessment (day 1) and at time of post-training assessment (day 3) (total estimated time: 3 days)
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Changes in HPV knowledge will be assessed by changes in the HPV knowledge portion of the pre/post training questionnaire. This portion of the questionnaire is composed of 10 questions that are answered True/False/Don't Know. Correct answers are scored as 1 point. The total score is calculated by the number of questions answered correctly with a total score range of 0-10. A higher score represents higher knowledge. |
At time of pre-training assessment (day 1) and at time of post-training assessment (day 3) (total estimated time: 3 days)
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Tertiary Care Cohort: Changes in HPV vaccine knowledge
Periodo de tiempo: At time of pre-training assessment (day 1) and at time of post-training assessment (day 3) (total estimated time: 3 days)
|
Changes in HPV vaccine knowledge will be assessed by changes in the HPV vaccine knowledge portion of the pre/post training questionnaire. This portion of the questionnaire is composed of 6 questions with one question being open ended, three questions answered as True/False/Don't Know, and two questions answered as Strongly disagree, Disagree, Agree, Strongly agree, or Don't Know. Correct answers are scored as 1 point. The total score is calculated by the number of questions answered correctly with a total score range of 0-6. A higher score represents higher knowledge. |
At time of pre-training assessment (day 1) and at time of post-training assessment (day 3) (total estimated time: 3 days)
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Tertiary Care Cohort: Changes in Self-Efficacy and Provider Confidence score
Periodo de tiempo: At time of pre-training assessment (day 1) and at time of post-training assessment (day 3) (total estimated time: 3 days)
|
Changes in Self-Efficacy and Provider Confidence score will be assessed by changes in the Self-Efficacy and Provider Confidence portion of the Post Training Survey. This portion of the questionnaire is composed of 4 questions answered as either Strongly disagree, Disagree, Neither agree nor disagree, Agree, or Strongly agree. Correct answers are scored as 1 point. The total score is calculated by the number of questions answered correctly with a total score range of 0-4. A higher score represents greater self-efficacy/confidence. |
At time of pre-training assessment (day 1) and at time of post-training assessment (day 3) (total estimated time: 3 days)
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Tertiary Care Cohort: Proportion of eligible/invited staff that attended training
Periodo de tiempo: At start of training through completion of training (total estimated time: 3 days)
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At start of training through completion of training (total estimated time: 3 days)
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|
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Tertiary Care Cohort: Feasibility as assessed by training attendance
Periodo de tiempo: At start of training through completion of training (total estimated time: 3 days)
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At start of training through completion of training (total estimated time: 3 days)
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Tertiary Care Cohort: Feasibility of Intervention Measure (FIM) score
Periodo de tiempo: At time of post-session survey completion on day 3 (total estimated time: 1 day)
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FIM will be assessed by implementation champions' response to the 4 items in from the FIM measure on the follow up survey. FIM is measured by a 5-point Likert scale: 1-Completely disagree, 2-Disagree, 3-Neither agree nor Disagree, 4-Agree, or 5-Completely agree. A higher score indicates greater feasibility of the intervention in practice. Scores above 3.0 are typically viewed as favorable/positive. |
At time of post-session survey completion on day 3 (total estimated time: 1 day)
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Tertiary Care Cohort: Adoption measured as rate of HPV vaccination
Periodo de tiempo: Through 12 months post training (total estimated time: 12 months 3 days)
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Rate of HPV vaccination will be assessed through vaccination records. |
Through 12 months post training (total estimated time: 12 months 3 days)
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Tertiary Care Cohort: Acceptability measured as Acceptability of Intervention Measure (AIM) score
Periodo de tiempo: At time of post-session survey completion on day 3 (total estimated time: 1 day)
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AIM will be assessed by implementation champions' response to the 4 items of the AIM measure on the follow up survey. AIM is 5-point Likert scale question measured as follows: 1-Completely disagree, 2-Disagree, 3-Neither agree nor Disagree, 4-Agree, or 5-Completely agree. A higher score indicates greater acceptability. Scores above 3.0 are typically viewed as favorable/positive. |
At time of post-session survey completion on day 3 (total estimated time: 1 day)
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Tertiary Care Cohort: Appropriateness measured as Intervention Appropriateness Measure (IAM) score
Periodo de tiempo: At time of post-session survey completion on day 3 (total estimated time: 1 day)
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IAM will be assessed by implementation champions' response to 4 items from the IAM measure on the follow up survey. IAM is measured by a 5-point Likert scale: 1-Completely disagree, 2-Disagree, 3-Neither agree nor Disagree, 4-Agree, or 5-Completely agree. A higher score indicates greater appropriateness of the intervention. Scores above 3.0 are typically viewed as favorable/positive. |
At time of post-session survey completion on day 3 (total estimated time: 1 day)
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Michelle Silver, PhD, ScM, Washington University School of Medicine
- Investigador principal: Jean Hunleth, PhD, MPH, Washington University School of Medicine
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
Palabras clave
Otros números de identificación del estudio
- 202211001
- U01CA275033 (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
Deidentified individual participant data that support publication findings will be shared upon request following publication. Requests for any additional data must include a proposal for use of the requested data.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
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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