Improving Choice And Use Of Biomedical HIV Prevention For Women In Uganda: A Couples-based Approach (CUPID)
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Kampala, Uganda
- Recrutamento
- Makerere University-Johns Hopkins University Research Collaboration MU-JHU Care
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Contato:
- Dr. Brenda Gati Mirembe, MBChB, MSc
- Número de telefone: (+256) 200 404 100
- E-mail: bgati@mujhu.org
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: N / D
- Modelo Intervencional: Atribuição sequencial
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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PrEP persistence
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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PrEP uptake
Prazo: 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
Prazo: 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
Prazo: 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
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- R01MH137873 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Prazo de Compartilhamento de IPD
Critérios de acesso de compartilhamento IPD
Tipo de informação de suporte de compartilhamento de IPD
- CIF
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