이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

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

2022년 8월 25일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

48540

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 남아프리카
    • Western Cape
      • Cape Town, Western Cape, 남아프리카, 7505
        • Desmund Tutu TB Centre at Stellenbosch University
  • 잠비아
      • Lusaka, 잠비아
        • Zambart

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: Arm A Universal Testing w/Immediate ART
다른: Universal Testing with 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

다른 이름들:
  • PopART Intervention
  • UTT
활성 비교기: Arm B ART according to National Guidelines
다른: Universal Testing with ART eligibility 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.

다른 이름들:
  • PopART Intervention
다른: 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.
다른: 치료의 표준

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
기간
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.
기간: 3 years
3 years

2차 결과 측정

결과 측정
측정값 설명
기간
HIV incidence over the first, second, and third years of follow-up
기간: 3 years
3 years
ART adherence and viral suppression
기간: 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
기간: 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
기간: 3 years
3 years
ART toxicity
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

HIV Prevention Trials Network

협력자

London School of Hygiene and Tropical Medicine
National Institute on Drug Abuse (NIDA)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Mental Health (NIMH)
Imperial College London
Zambart
Desmond Tutu TB Centre
Office of the U.S. Global AIDS Coordinator
The International Initiative for Impact Evaluation (3ie) with support from Bill & Melinda Gates Foundation

수사관

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

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2014년 1월 1일

기본 완료 (실제)

2018년 7월 7일

연구 완료 (실제)

2018년 7월 7일

연구 등록 날짜

최초 제출

2013년 7월 2일

QC 기준을 충족하는 최초 제출

2013년 7월 16일

처음 게시됨 (추정)

2013년 7월 17일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2022년 8월 26일

QC 기준을 충족하는 마지막 업데이트 제출

2022년 8월 25일

마지막으로 확인됨

2022년 8월 1일

추가 정보

이 연구와 관련된 용어

키워드

기타 연구 ID 번호

  • HPTN 071
  • UM1AI068619 (미국 NIH 보조금/계약)
  • 11865 (기타 식별자: DAIDS-ES)

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

에이즈에 대한 임상 시험

치료의 표준에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Croatia

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

3
구독하다