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Population Effects of Antiretroviral Therapy to Reduce HIV Transmission (PopART) (PopART)

25 de agosto de 2022 actualizado por: HIV Prevention Trials Network

Population Effects of Antiretroviral Therapy to Reduce HIV Transmission (PopART): A Cluster-randomized Trial of the Impact of a Combination Prevention Package on Population-level HIV Incidence in Zambia and South Africa

PopART is a community randomized trial that is investigating whether a community-wide combination HIV prevention package including annual home-based HIV testing, active referral and the offer of immediate ART for those testing HIV-positive, along with the promotion of proven HIV prevention methods (such as voluntary medical male circumcision, prevention of mother to child transmission and condom use), will help to prevent transmission and substantially reduce new HIV infections. The study is being conducted in 21 communities in Zambia and South Africa (randomized into 3 arms, each with 7 communities) with a total population of approximately 1.2 million individuals.

Descripción general del estudio

Descripción detallada

HIV Prevention Trials Network (HPTN) 071 (PopART) will investigate the impact on HIV incidence of universal voluntary HIV counseling and testing (with referral to care) provided to a community through a house-to-house campaign, in combination with early ART for individuals who are HIV-positive, and other proven preventive interventions. The design of HPTN 071 (PopART) will allow the study team to distinguish between the impact of universal testing with referral for HIV care in accordance with national guidelines, and the impact of universal testing with referral for early ART initiation for those with HIV infection. In addition, HPTN 071 (PopART) will determine if a program of universal voluntary testing, including early ART initiation, is feasible and acceptable when delivered on a large scale to entire communities. Evaluating the effectiveness of universal voluntary HIV counseling and testing with the offer of early ART is a key global health priority.

Tipo de estudio

Intervencionista

Inscripción (Actual)

48540

Fase

  • No aplica

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

    • Western Cape
      • Cape Town, Western Cape, Sudáfrica, 7505
        • Desmund Tutu TB Centre at Stellenbosch University
      • Lusaka, Zambia
        • Zambart

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 a 44 años (Adulto)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  1. Population Cohort

    1. 18 - 44 years of age
    2. Able and willing to provide informed consent
    3. Residing within catchment area of a designated local health unit and intending to remain so for the next three years
    4. Residing in a randomly selected household
  2. Case-Control Study 1 Inclusion Criteria:

    1. At least 18 years of age
    2. Able and willing to provide informed consent
    3. Resident in the cluster during the first round of testing
    4. Visited by a CHiP team and offered testing during the first round of home-based testing
  3. Case-Control Study 2 Inclusion Criteria:

    1. At least 18 years of age
    2. Able and willing to provide informed consent
    3. Resident in the cluster during the first round of testing
    4. Tested HIV-infected in CHiP home-based testing, or HIV-infected and disclosed that they were previously diagnosed as HIV-infected to CHiP team
  4. Case-Control Study 3 Inclusion Criteria:

    1. At least 18 years of age
    2. Able and willing to provide informed consent
    3. Resident in the cluster during the second round of testing
    4. Visited by a CHiP team and offered testing during the second round of home-based testing

Exclusion Criteria:

  1. Population Cohort Exclusion Criteria:

    1. Current or planned enrollment in another HIV treatment, prevention, or Pre-Exposure Prophylaxis (PrEP) study
    2. Current, planned or prior enrollment in an HIV vaccine study
    3. Anything that, in the opinion of the investigator, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
  2. Case-Control Study 1 Exclusion Criteria:

    1. Individuals belonging to the Population Cohort or other case-control studies
    2. Individuals known to be HIV-infected after testing elsewhere.
  3. Case-Control Study 2 Exclusion Criteria:

    1. Individuals enrolled in the Population Cohort or other case-control studies
    2. HIV-infected individuals already on ART before study commences
  4. Case-Control Study 3 Exclusion Criteria:

    1. Known HIV infected from CHiP data.
    2. Individuals belonging to the Population Cohort or other case-control studies

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: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Arm A Universal Testing w/Immediate ART

• Combination prevention package including:

o House-to-house deployment of: Universal HIV counseling and testing; Active linkage to care for individuals diagnosed as HIV-infected, with immediate eligibility for ART; Promotion of male circumcision and prevention of mother to child transmission (PMTCT) services; Provision of condoms; Strengthening of HIV testing and services at health facilities and other venues; Strengthening of male circumcision and prevention of mother-to-child transmission of HIV services available in the community; and Treatment of sexually transmitted infections (STIs) and provision of condoms at health units

Otros nombres:
  • PopART Intervention
  • UTT
Comparador activo: Arm B ART according to National Guidelines

Combination prevention package including:

House-to-house deployment of: Universal HIV counseling and testing; Active linkage to care for individuals diagnosed as HIV-infected, with ART eligibility according to national guidelines; Promotion of male circumcision and PMTCT services; Provision of condoms; Strengthening of HIV testing and services at health facilities and other venues; Strengthening of male circumcision and PMTCT services available in the community; and Treatment of STIs and provision of condoms at health units.

Otros nombres:
  • PopART Intervention
Otro: Standard of Care

Includes:

Strengthening of HIV testing and ART services according to national guidelines at health facilities and other venues; Strengthening of male circumcision and PMTCT services available at health facilities and other venues in the community; and Treatment of STIs and provision of condoms at health facilities and other venues in the community.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
HIV incidence measured over 3 years in the Population Cohort, with the primary analysis including HIV incidence measured between Months 12 and 36 of the study.
Periodo de tiempo: 3 years
3 years

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
HIV incidence over the first, second, and third years of follow-up
Periodo de tiempo: 3 years
3 years
ART adherence and viral suppression
Periodo de tiempo: 24 months
HIV viral load at 24 months in HIV-infected members of the Population Cohort who initiated HIV care and ART after commencement of the PopART intervention in the community (if funding available)
24 months
Herpes Simplex Virus -2 (HSV-2) incidence
Periodo de tiempo: 12 months, 24 months, and 36 months
Incident HSV-2 infections at 12 months, 24 months, and 36 months for all individuals in the Population Cohort who were HSV-2-uninfected at enrollment
12 months, 24 months, and 36 months
HIV disease progression, retention in care, and death
Periodo de tiempo: 3 years
3 years
ART toxicity
Periodo de tiempo: 3 years

ART safety and clinical events among Population Cohort participants initiating ART after commencement of the PopART intervention in the community, measured using routine health center data, and

ART safety and clinical events among health center attendees who initiated ART after commencement of the PopART intervention in the community, measured using routine health center data

3 years
Sexual risk behavior
Periodo de tiempo: 3 years
o Self-reported sexual risk behavior at Enrollment, 12 months, 24 months, and 36 months in the Population Cohort
3 years
Case notification rate of tuberculosis (TB)
Periodo de tiempo: 3 years
  • Case notification rates of bacteriologically-confirmed TB diagnosed among the general population of patients seeking care at health centers as recorded by health centers
  • TB mortality among TB cases in the community as recorded by health centers
3 years
HIV-related stigma
Periodo de tiempo: 3 years
  • Self-reported data on stigma indicators at enrollment, 12 months, 24 months, and 36 months in the Population Cohort
  • Qualitative interviews in selected members of the general population in Arms A, B, and
3 years
Uptake of PMTCT
Periodo de tiempo: 3 years
  • Self-reported use of services for PMTCT at Enrollment, 12 months, 24 months, and 36 months among HIV-infected women in the Population Cohort who had been pregnant in the prior 12 months
  • Uptake of PMTCT services at health centers
  • Uptake of PMTCT as indicated in data collected in households by CHiPs
3 years
Uptake of male circumcision
Periodo de tiempo: 3 years
  • Self-reported circumcision status/uptake at Enrollment, 12 months, 24 months, and 36 months of men in the Population Cohort
  • Uptake of circumcision in the community as indicated in health center data
  • Uptake of circumcision as indicated in data collected in households by CHiPs
3 years
ART screening and uptake
Periodo de tiempo: 3 years
  • The proportion of Population Cohort members, identified as HIV-infected who screen for ART eligibility, and who subsequently initiate ART
  • Proportion of community members, identified as HIV-infected in data from CHiP teams, who screen for ART eligibility, and who subsequently initiate ART, as indicated in health center data
3 years
HIV testing and retesting
Periodo de tiempo: 3 years
  • Self-reported recent HIV testing at Enrollment, 12 months, 24 months, and 36 months in the Population Cohort
  • The number of adults (16 years and older) in the household and the number of HIV tests performed as indicated in data from CHiP teams and health centers
3 years
Time between HIV diagnosis and initiation of care
Periodo de tiempo: 3 years
  • The proportion of Population Cohort members initiating HIV care within 3 months of a positive HIV diagnosis
  • The proportion of community members initiating HIV care within 3 months of HIV diagnosis as indicated in data from CHiP teams (provision of HIV positive result) and health center data (date of care initiation)
3 years

Colaboradores e Investigadores

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

Investigadores

  • Silla de estudio: Richard Hayes, BSc, MSc, DSc, London School of Hygiene and Tropical Medicine
  • Silla de estudio: Sarah Fidler, MBBS, PhD, Imperial College London
  • Investigador principal: Helen Ayles, BSc, MBBS, MSc, PhD, London School of Hygiene and Tropical Medicine
  • Investigador principal: Nulda Beyers, MBChB, FCP, MSc, PhD, Stellenbosch Univeristy
  • Investigador principal: Peter Bock, MD, MRCP, MRCGP, MPH, PhD, University of Stellenbosch

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 (Actual)

1 de enero de 2014

Finalización primaria (Actual)

7 de julio de 2018

Finalización del estudio (Actual)

7 de julio de 2018

Fechas de registro del estudio

Enviado por primera vez

2 de julio de 2013

Primero enviado que cumplió con los criterios de control de calidad

16 de julio de 2013

Publicado por primera vez (Estimar)

17 de julio de 2013

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

26 de agosto de 2022

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

25 de agosto de 2022

Última verificación

1 de agosto de 2022

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • HPTN 071
  • UM1AI068619 (Subvención/contrato del NIH de EE. UU.)
  • 11865 (Otro identificador: DAIDS-ES)

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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