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

25. srpna 2022 aktualizováno: 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.

Přehled studie

Detailní popis

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.

Typ studie

Intervenční

Zápis (Aktuální)

48540

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

    • Western Cape
      • Cape Town, Western Cape, Jižní Afrika, 7505
        • Desmund Tutu TB Centre at Stellenbosch University
      • Lusaka, Zambie
        • Zambart

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 44 let (Dospělý)

Přijímá zdravé dobrovolníky

Ano

Pohlaví způsobilá ke studiu

Všechno

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Prevence
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Aktivní komparátor: 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

Ostatní jména:
  • PopART Intervention
  • UTT
Aktivní komparátor: 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.

Ostatní jména:
  • PopART Intervention
Jiný: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Časové okno
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.
Časové okno: 3 years
3 years

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
HIV incidence over the first, second, and third years of follow-up
Časové okno: 3 years
3 years
ART adherence and viral suppression
Časové okno: 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
Časové okno: 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
Časové okno: 3 years
3 years
ART toxicity
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Vyšetřovatelé

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

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

1. ledna 2014

Primární dokončení (Aktuální)

7. července 2018

Dokončení studie (Aktuální)

7. července 2018

Termíny zápisu do studia

První předloženo

2. července 2013

První předloženo, které splnilo kritéria kontroly kvality

16. července 2013

První zveřejněno (Odhad)

17. července 2013

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

26. srpna 2022

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

25. srpna 2022

Naposledy ověřeno

1. srpna 2022

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • HPTN 071
  • UM1AI068619 (Grant/smlouva NIH USA)
  • 11865 (Jiný identifikátor: DAIDS-ES)

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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