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

25 de agosto de 2022 atualizado 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.

Visão geral do estudo

Descrição detalhada

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 estudo

Intervencional

Inscrição (Real)

48540

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

      • Lusaka, Zâmbia
        • ZAMBART
    • Western Cape
      • Cape Town, Western Cape, África do Sul, 7505
        • Desmund Tutu TB Centre at Stellenbosch University

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 44 anos (Adulto)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Prevenção
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: 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

Outros nomes:
  • PopART Intervention
  • UTT
Comparador Ativo: 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.

Outros nomes:
  • PopART Intervention
Outro: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Prazo
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.
Prazo: 3 years
3 years

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
HIV incidence over the first, second, and third years of follow-up
Prazo: 3 years
3 years
ART adherence and viral suppression
Prazo: 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
Prazo: 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
Prazo: 3 years
3 years
ART toxicity
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Cadeira de estudo: Richard Hayes, BSc, MSc, DSc, London School of Hygiene and Tropical Medicine
  • Cadeira de estudo: 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

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de janeiro de 2014

Conclusão Primária (Real)

7 de julho de 2018

Conclusão do estudo (Real)

7 de julho de 2018

Datas de inscrição no estudo

Enviado pela primeira vez

2 de julho de 2013

Enviado pela primeira vez que atendeu aos critérios de CQ

16 de julho de 2013

Primeira postagem (Estimativa)

17 de julho de 2013

Atualizações de registro de estudo

Última Atualização Postada (Real)

26 de agosto de 2022

Última atualização enviada que atendeu aos critérios de controle de qualidade

25 de agosto de 2022

Última verificação

1 de agosto de 2022

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • HPTN 071
  • UM1AI068619 (Concessão/Contrato do NIH dos EUA)
  • 11865 (Outro identificador: DAIDS-ES)

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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