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

25. August 2022 aktualisiert von: 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.

Studienübersicht

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

48540

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

      • Lusaka, Sambia
        • Zambart
    • Western Cape
      • Cape Town, Western Cape, Südafrika, 7505
        • Desmund Tutu TB Centre at Stellenbosch University

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 44 Jahre (Erwachsene)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: 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

Andere Namen:
  • PopART Intervention
  • UTT
Aktiver Komparator: 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.

Andere Namen:
  • PopART Intervention
Sonstiges: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
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.
Zeitfenster: 3 years
3 years

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
HIV incidence over the first, second, and third years of follow-up
Zeitfenster: 3 years
3 years
ART adherence and viral suppression
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 3 years
3 years
ART toxicity
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

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

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. Januar 2014

Primärer Abschluss (Tatsächlich)

7. Juli 2018

Studienabschluss (Tatsächlich)

7. Juli 2018

Studienanmeldedaten

Zuerst eingereicht

2. Juli 2013

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

16. Juli 2013

Zuerst gepostet (Schätzen)

17. Juli 2013

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

26. August 2022

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

25. August 2022

Zuletzt verifiziert

1. August 2022

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • HPTN 071
  • UM1AI068619 (US NIH Stipendium/Vertrag)
  • 11865 (Andere Kennung: DAIDS-ES)

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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