Protocolo de métodos mixtos para el estudio WISSPR (WiSSPr)
Protocolo de métodos mixtos para el estudio WISSPR: mujeres en el trabajo sexual, estigma y barreras psicosociales para la profilaxis previa a la exposición en Zambia
WiSSPr is a prospective observational cohort study grounded in community-based participatory research principles with a community advisory board (CAB) of key population (KP) civil society organi sations (KP-CSOs) and the Ministry of Health (MoH).
Descripción general del estudio
Descripción detallada
WiSSPr is a prospective observational cohort study grounded in community-based participatory research principles with a community advisory board (CAB) of key population (KP) civil society organi sations (KP-CSOs) and the Ministry of Health (MoH). The study will administer a one-time psychosocial survey vetted by the CAB and follow 300 WESW in the electronic medical record for three months to measure PrEP initiation (#/% ever taking PrEP) and persistence (immediate discontinuation and a medication possession ratio). The study will conduct in-depth interviews with a purposive sample of 18 women, including 12 WESW and 6 peer navigators who support routine HIV screening and PrEP delivery, in two community hubs serving KPs since October 2021. The study seeks to value KP communities as equal contributors to the knowledge production process by actively engaging KP-CSOs throughout the research process. Expected outcomes include quantitative measures of PrEP initiation and persistence among WESW, and qualitative insights into the enablers and barriers to PrEP use informed by participants' lived experiences. https://doi.org/10.1136/bmjopen-2023-080218
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Lusaka, Zambia
- Centre for Infectious Disease Research Zambia
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
The study population is composed of adult WESW who are living or working within the catchment areas of two community hubs located within urban Lusaka. Based on CIDRZ's prior published work, we anticipate that the study population will be comprised largely (63%) of younger women (18 - 29 years old).
Descripción
Inclusion Criteria
Participants must meet all of the following criteria:
- Identify as a cisgender or transgender woman.
- Be 18 years of age or older.
- Earn a significant amount of income from exchanging sex for money or goods within the last 3 months.
- Be HIV-negative and eligible for PrEP according to national guidelines.
- Not be planning to transfer care to another site within the next 30 days.
- Speak English, ChiNyanja, or IchiBemba.
- Be willing and able to provide written informed consent.
Exclusion Criteria
Participants will be excluded if they meet any of the following criteria:
- Do not identify as a woman.
- Are under 18 years of age.
- Have not earned a significant amount of income from exchanging sex for money or goods, or have done so for less than 3 months.
- Are HIV-positive, have an unknown HIV status, or are ineligible for PrEP.
- Are planning to transfer care to another site within the next 30 days.
- Are unable to speak English, ChiNyanja, or IchiBemba.
- Are unwilling or unable to provide written informed consent.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: PROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
PrEP initiators
women who initiate on PrEP |
oral PrEP |
|
PrEP refusers
women who refuse PrEP |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
PrEP initiation (#/% ever taken PrEP)
Periodo de tiempo: 3 months
|
PrEP initiation (Number or percentage of Women Engaging in Sex Work (WESW) initiating on PrEP) |
3 months
|
|
PrEP Persistence (#/ % eligible refills obtained until first discontinuation)
Periodo de tiempo: 3 months
|
PrEP persistence. Number or percentage of women engaging in sex work with high levels of stigma who will persist on PrEP |
3 months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Ramya Kumar, PhD, MPH, University of Washington
Publicaciones y enlaces útiles
Enlaces Útiles
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- UJMT Fogarty Fellowship 2023
- D43TW009340 (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
Vulnerable population of sex workers in a country where sex work is largely criminalized, and there is a risk of harm if the data is identifiable even with common identifiers like name is removed.
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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