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Partners Demonstration Project of PrEP and ART

7 de diciembre de 2017 actualizado por: Jared Baeten, University of Washington

An Open Label, Pilot Demonstration and Evaluation Project of Antiretroviral-based HIV-1 Prevention Among High-risk Serodiscordant African Couples

The purpose of this protocol is to determine user preferences for antiretroviral therapy (ART) for HIV-1 infected partners and pre-exposure prophylaxis (PrEP) HIV-1 un-infected partners and to optimize targeted delivery and sustained use of these interventions.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

An open-label, prospective cohort study of higher-risk HIV-1 serodiscordant couples in order to determine barriers and facilitators to uptake and sustained adherence to ART for HIV-1 infected partners and daily oral PrEP for HIV-1 uninfected partners. The investigators developed a risk score tool to identify couples at highest risk for HIV-1 transmission. PrEP was offered as a 'bridge' to ART in the partnership - i.e., until ART initiation by the HIV-infected partner and for the first 6 months after ART is started; ART was recommended following national ART guidelines. A subset (up to 80 couples per site) was invited to participate in qualitative in-depth interview and focus group discussions.

Tipo de estudio

Intervencionista

Inscripción (Actual)

1013

Fase

  • Fase 4

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Kenia
      • Kisumu, Kenia
        • Kemri-Ucsf
      • Thika, Kenia
        • Partners in Prevention-Thika
  • Uganda
      • Bushenyi, Uganda
        • Kabwohe Clinical Research Center
      • Kampala, Uganda
        • Partners in Prevention-Infectious Diseases Institute LTD

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

For couples

  • Risk score defining higher HIV-1 risk (≥6)
  • Sexually active (defined as having had vaginal intercourse at least 6 times in the previous three months)
  • Willing to enter the study as a couple and intending to remain as a couple for the next 12 months
  • Did not participate in the Partners PrEP Study

For HIV-1 uninfected members of the couple (partner participants)

  • Age ≥18
  • Able and willing to provide written informed consent
  • HIV-1 uninfected based on negative HIV-1 rapid tests, both at study screening and at the enrollment visit
  • Adequate renal function, defined by normal creatinine levels and estimated creatinine clearance >60 mL/min
  • Not infected with hepatitis B virus, as determined by a negative hepatitis B surface antigen test
  • Not currently pregnant or breastfeeding
  • Not currently enrolled in an HIV-1 prevention clinical trial
  • Not currently using PrEP
  • Enrollment of individuals with active and serious infections or active clinically significant medical problems will be at the discretion of the site investigator

For HIV-1 infected members of the couple (index participants)

  • Age ≥18
  • Able and willing to provide written informed consent
  • HIV-1 infected based on positive rapid HIV-1 tests, according to national algorithm
  • No history of WHO stage III or IV conditions
  • Not currently using ART
  • Not currently enrolled in an HIV-1 treatment study
  • Note: current pregnancy and breastfeeding are permitted for HIV-1 infected partners

Exclusion Criteria:

  • Otherwise not eligible based on the above inclusion criteria

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Otro: PrEP as a bridge to ART
FTC-TDF PrEP for HIV uninfected partners and ART for HIV infected partners
Droga: FTC-TDF PrEP
FTC-TDF PrEP for HIV-1 uninfected partners
Droga: ART
ART for HIV-1 infected partners

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Ability to recruit high-risk HIV-1 serodiscordant couples: Screen-to-eligible ratio.
Periodo de tiempo: 24 months
High-risk couples defined by a validated risk scoring tool. Ability to recruit high-risk HIV-1 serodiscordant couples will be measured as screen-to-eligible ratio of HIV-1 serodiscordant couples.
24 months
Ability to recruit high-risk HIV-1 serodiscordant couples: Eligible couples who decide to enroll in the cohort.
Periodo de tiempo: 24 months
High-risk couples defined by a validated risk scoring tool. We will measure the proportion of eligible couples who decide to enroll in the cohort.
24 months
Ability to recruit high-risk HIV-1 serodiscordant couples: Costs of screening and targeting high-risk couples decide to enroll in the cohort.
Periodo de tiempo: 24 months
High-risk couples were defined by a validated risk scoring tool. The cost-effectiveness analysis will follow World Health Organization (WHO) guidelines and report summary estimates for the PrEP intervention which allow comparison to other strategies to decrease HIV-1 transmission among serodiscordant couples. Costs of offering and delivering PrEP as a bridging strategy to ART, including recruitment costs for targeting higher-risk couples and PrEP delivery and monitoring costs will be collected. The incremental cost-effectiveness ratio (ICER) per HIV related infection, death and Disability-Adjusted Life Year (DALY) averted will be estimated. Results will be reported as the ICER of PrEP compared to current practice per incident HIV-1 case, HIV related death and DALY averted.
24 months
User preferences for ART initiation for HIV-1 infected partners and PrEP for HIV-1 uninfected partners: preferred ART-based HIV prevention method.
Periodo de tiempo: 24 months
Measure the number of couples choosing to use PrEP or ART for HIV-1 prevention or both.
24 months
User preferences for ART initiation for HIV-1 infected partners and PrEP for HIV-1 uninfected partners: reasons for choice and concerns about both methods.
Periodo de tiempo: 24 months
Quantitative questionnaire will be used to elicit reasons for the choice and concerns about both methods. Reasons for or concerns about both methods measured as proportion of participants reporting a particular reason for or concerns about both methods
24 months
PrEP initiation by HIV uninfected partners.
Periodo de tiempo: 24 months

Measure the number of HIV-1 uninfected partners initiating PrEP.

Proportion of samples with detectable and quantifiable PrEP levels
24 months
PrEP adherence: Self-reported missed doses of PrEP.
Periodo de tiempo: 24 months
Measure the proportion of visits when HIV-uninfected partner reported missing 1) any dose of PrEP in the prior quarter 2) 2 or more consecutive doses of PrEP.
24 months
PrEP adherence: Detectable and quantifiable PrEP levels in plasma.
Periodo de tiempo: 24 months
Measure the proportion of plasma samples of HIV-1 uninfected partners with detectable and quantifiable PrEP levels.
24 months
PrEP adherence: PrEP hold.
Periodo de tiempo: 24 months
Measure the total number of HIV-1 uninfected partners with PrEP hold designated as a safety issue.
24 months
ART initiation.
Periodo de tiempo: 24 months
Measure the number of HIV-1 infected partners initiating ART.
24 months
ART Adherence.
Periodo de tiempo: 24 months
Measure the number of HIV-1 infected partners with suppressed plasma HIV-1 RNA levels.
24 months
Correlates of preferences, uptake and adherence to ART and PrEP: Sexual frequency.
Periodo de tiempo: 24 months
Proportion of visits when participants report having sex.
24 months
Correlates of preferences, uptake and adherence to ART and PrEP: Condom use frequency.
Periodo de tiempo: 24 months
Proportion of visits when participants report having condomless sex.
24 months
Correlates of preferences, uptake and adherence to ART and PrEP: Outside partners for HIV-1 uninfected partners.
Periodo de tiempo: 24 months
Proportion of visits when HIV-1 uninfected partners report outside partners.
24 months
Correlates of preferences, uptake and adherence to ART and PrEP: Gender of the HIV-1 uninfected partner.
Periodo de tiempo: 24 months
Proportion of couples in which the HIV-1 uninfected partner is female.
24 months
Correlates of preferences, uptake and adherence to ART and PrEP: Fertility intentions.
Periodo de tiempo: 24 months
Proportion of couples with desire to conceive a child.
24 months
Correlates of preferences, uptake and adherence to ART and PrEP: Relationship dissolution.
Periodo de tiempo: 24 months
Number of couples continuing their relationship during follow up.
24 months
Correlates of preferences, uptake, and adherence to ART and PrEP: Depression and substance use.
Periodo de tiempo: 24 months
Annual interviewer-administered questionnaire to collect depression and substance use indicators. Measure proportion of participants with depression and substance use.
24 months
Correlates of preferences, uptake and adherence to ART and PrEP: ART initiation by HIV-1 infected partner.
Periodo de tiempo: 24 months
Proportion of HIV-1 infected partners initiating ART.
24 months
Correlates of preferences, uptake and adherence to ART and PrEP: Number of children.
Periodo de tiempo: 24 months
Proportion of partnership reporting to have children at baseline.
24 months
Correlates of preferences, uptake and adherence to ART and PrEP: CD4 count.
Periodo de tiempo: 24 months
Proportion of HIV infected partners with CD4 count >200, >350, >500.
24 months
Correlates of preferences, uptake and adherence to ART and PrEP: WHO stage of HIV-1 infected partner.
Periodo de tiempo: 24 months
Proportion HIV-1 infected partners with WHO HIV-1 stage 1, 2, 3, or 4.
24 months
Feasibility to PrEP discontinuation in couples when the HIV-1 infected partner initiates ART.
Periodo de tiempo: 24 months
We will conduct in-depth interviews and focus group discussions. Qualitative analyses will identify and describe key themes and explore variation within themes of participants' attitudes and understanding of PrEP discontinuation.
24 months
PrEP use and pregnancy: HIV-1 infection.
Periodo de tiempo: 24 months
Number of HIV-1 infections among women who continue PrEP in pregnancy.
24 months
PrEP use and pregnancy: Congenital abnormalities among infants born to female Participants taking PrEP.
Periodo de tiempo: 24 months
Infant outcomes measured as the number of live-born infants born to female participants taking PrEP that had any congenital anomalie.
24 months
PrEP use and pregnancy: Any serious adverse event.
Periodo de tiempo: 24 months
Number of women who continue PrEP in pregnancy with any serious adverse event.
24 months
Infant growth for women who continue PrEP in pregnancy: Length.
Periodo de tiempo: 24 months
Length of infants born to female Participants taking PrEP. The slope of the linear model of the growth of infants (length) during the entirety of follow-up. The length of the infant measured as a z-score, in terms of standard deviations from the age and gender specific median using the World Health Organization growth curve, accounting for skewness. The slope, representing the change over time of the z-score, will be calculated using all available z-scores over study duration and regressing against study month.
24 months
Infant growth for women who continue PrEP in pregnancy: Weight.
Periodo de tiempo: 24 months
The slope of the linear model of the growth of infants (weight) during the entirety of follow-up. The weight of the infant was measured as a z-score, in terms of standard deviations from the age and gender specific median using the World Health Organization growth curve, accounting for skewness. The slope, representing the change over time of the z-score, will be calculated using all available z-scores over study duration and regressing against study month.
24 months
Infant growth for women who continue PrEP in pregnancy: Head circumference.
Periodo de tiempo: 24 months
The slope of the linear model of the growth of infants (head circumference) during the entirety of follow-up. The head circumference of the infant will be measured as a z-score, in terms of standard deviations from the age and gender specific median using the World Health Organization growth curve, accounting for skewness. The slope, representing the change over time of the z-score, will be calculated using all available z-scores over study duration and regressing against study month.
24 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

University of Washington

Colaboradores

National Institute of Mental Health (NIMH)
United States Agency for International Development (USAID)
Bill and Melinda Gates Foundation

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de noviembre de 2012

Finalización primaria (Actual)

1 de junio de 2016

Finalización del estudio (Actual)

1 de junio de 2016

Fechas de registro del estudio

Enviado por primera vez

10 de mayo de 2016

Primero enviado que cumplió con los criterios de control de calidad

14 de mayo de 2016

Publicado por primera vez (Estimar)

18 de mayo de 2016

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

8 de diciembre de 2017

Última actualización enviada que cumplió con los criterios de control de calidad

7 de diciembre de 2017

Última verificación

1 de diciembre de 2017

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • STUDY00001674
  • R01MH095507 (Subvención/contrato del NIH de EE. UU.)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

Data from the Partners Demonstration Project are available by contacting the International Clinical Research Center at the University of Washington (icrc@uw.edu).

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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