Improving Choice And Use Of Biomedical HIV Prevention For Women In Uganda: A Couples-based Approach (CUPID)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This is a hybrid type 1 effectiveness-implementation study designed to refine, evaluate effectiveness, and assess implementation of a couples-based shared decision-making intervention (CUPID) within public health settings where HIV pre-exposure prophylaxis (PrEP) choice is offered to women in Uganda. The following are the aims of the study:
Aim 1: Refine CUPID intervention content and implementation to support women's PrEP choice and use in public health settings.
Aim 2: Assess the effectiveness of the CUPID intervention on PrEP use (uptake, persistence, and adherence) among Ugandan women.
Aim 3: Assess CUPID intervention implementation outcomes, and barriers and strategies to address them, to inform the adoption and integration of CUPID to support women's PrEP uptake and use.
The study population will include (Aim 1): PrEP delivery staff, Peer navigators & stakeholders; and (Aims 2 and 3): Women accessing PrEP and their sexual partners; PrEP delivery staff.
Sites will be drawn from high-volume health facilities providing PrEP choice in Uganda, including Gulu Regional Referral Hospital, Namakwekwe Health Centre III, Kitgum Hospital, Bison Health Centre III, Mukono Hospital and Wakiso Health Center IV. Sites will include health facilities and the community catchment areas where services are delivered.
The CUPID decision tool offers a patient-centered approach to encourage an informed and active role in decision making by providing couples with knowledge about available PrEP options, encouraging shared responsibility for HIV prevention, and helping to clarify their needs and values relevant to prevention decisions.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Kampala, Uganda
- Reclutamiento
- Makerere University-Johns Hopkins University Research Collaboration MU-JHU Care
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Contacto:
- Dr. Brenda Gati Mirembe, MBChB, MSc
- Número de teléfono: (+256) 200 404 100
- Correo electrónico: bgati@mujhu.org
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
All Aims:
- Able and willing to provide written informed consent
- Fluent in English or the dominant language spoken in the health facility's region.
Aim 1:
- Age ≥18 years
Meets one of the following criteria:
- Performs tasks related to PrEP outreach and/or delivery in former CATALYST study areas. This may include clinic and non-clinic positions.
- Is a member of one of the three regional CATALYST CABs
- Willing to participate in a focus group discussion
Aim 2:
- Aged 18 years or older
- Attending a PrEP follow-up visit
- Able and willing to complete all study procedures.
Aim 3:
- Age ≥18 years
Meets one of the following criteria:
- CUPID couples' decision tool user
- A CUPID intervention provider (member of a CHT or other PrEP Provider)
- A provider offering PrEP choice through a health facility where CUPID is implemented
- MOH or District Health Official
- Willing to complete a questionnaire and participate in a qualitative interview (individual or dyadic)
Exclusion Criteria:
All Aims: Participants will be excluded who have any condition that, in the opinion of the MPI or designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
Aim 2:
Exclusion criteria: Participants aged 15-17 years
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: N / A
- Modelo Intervencionista: Asignación Secuencial
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: CUPID shared decision-making counseling intervention
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The CUPID shared decision-making counseling intervention involves delivery of a paper-based, shared decision-making tool in community and clinic settings by PrEP delivery staff and Community Health Teams affiliated with each health facility.
The intervention is designed as a single session in which a couple will go through the decision tool, guided by a trained member of a Community Health Team (which can include Community Health Extension Workers, Peer Educators, PrEP Ambassadors, Village Health Teams, or other personnel affiliated with MOH clinics trained to operate in communities), with onsite support, as needed, from a PrEP delivery staff, counselors, or other health providers.
The CUPID shared decision-making model provides a patient-centered approach to encourage an informed and active role in decision making by providing couples with knowledge about the available options and helping to clarify their needs and values relevant to the decision.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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PrEP persistence
Periodo de tiempo: Weekly for 48 weeks
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Number of PrEP refill/administration visits by women per week: 2nd refill visits for oral PrEP, PrEP ring and injectable cabotegravir (~3 month persistence); 1st refill (at 6 months) for injectable lenacapavir
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Weekly for 48 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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PrEP uptake
Periodo de tiempo: Weekly for 64 weeks
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Number of PrEP initiations by women per week
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Weekly for 64 weeks
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6-month PrEP persistence
Periodo de tiempo: Weekly for 36 weeks
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Number of 6-month PrEP refill/administration visits per week
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Weekly for 36 weeks
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PrEP use: Objective adherence
Periodo de tiempo: Weekly for 48 weeks
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Percentage of adherence objective markers collected at the PrEP refill/administration visit per week demonstrating adherent PrEP use.
PrEP refill visits will be 2nd refill visits for oral PrEP, PrEP ring and injectable cabotegravir (~3 months after initiation); 1st refill (at 6 months) for injectable lenacapavir
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Weekly for 48 weeks
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Brenda Gati Mirembe, MBChB, MSc, Makerere University-Johns Hopkins Research Collaboration /MU-JHU CARE LTD
- Investigador principal: Carolyne A Akello, MBChB, MSc, MU-JHU Research Collaboration/ Ministry of Health
- Investigador principal: Alexandra M Minnis, PhD, MPH, RTI International
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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
- R01MH137873 (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
- 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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