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HIVPopARTNCT01900977

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

A study testing Universal Testing with immediate ART and Universal Testing with ART eligibility according to National Guidelines in people with HIV, run by HIV Prevention Trials Network at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 44 yearsHealthy volunteers can take part
Conditions the study is for
HIV
What is being tested?
Universal Testing with immediate ART and Universal Testing with ART eligibility according to National Guidelines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48,540 participants
Where
2 sitesin 2 countries
Study dates
Jan 2014to 7 Jul 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 44 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Population Cohort
  • 18 - 44 years of age
  • Able and willing to provide informed consent
  • Residing within catchment area of a designated local health unit and intending to remain so for the next three years
  • Residing in a randomly selected household
  • Case-Control Study 1 Inclusion Criteria:
Show all 20Show fewer
  • At least 18 years of age
  • Able and willing to provide informed consent
  • Resident in the cluster during the first round of testing
  • Visited by a CHiP team and offered testing during the first round of home-based testing
  • Case-Control Study 2 Inclusion Criteria:
  • At least 18 years of age
  • Able and willing to provide informed consent
  • Resident in the cluster during the first round of testing
  • Tested HIV-infected in CHiP home-based testing, or HIV-infected and disclosed that they were previously diagnosed as HIV-infected to CHiP team
  • Case-Control Study 3 Inclusion Criteria:
  • At least 18 years of age
  • Able and willing to provide informed consent
  • Resident in the cluster during the second round of testing
  • Visited by a CHiP team and offered testing during the second round of home-based testing

Who cannot join

  • Population Cohort Exclusion Criteria:
  • Current or planned enrollment in another HIV treatment, prevention, or Pre-Exposure Prophylaxis (PrEP) study
  • Current, planned or prior enrollment in an HIV vaccine study
  • 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.
  • Case-Control Study 1 Exclusion Criteria:
  • Individuals belonging to the Population Cohort or other case-control studies
Show all 13Show fewer
  • Individuals known to be HIV-infected after testing elsewhere.
  • Case-Control Study 2 Exclusion Criteria:
  • Individuals enrolled in the Population Cohort or other case-control studies
  • HIV-infected individuals already on ART before study commences
  • Case-Control Study 3 Exclusion Criteria:
  • Known HIV infected from CHiP data.
  • Individuals belonging to the Population Cohort or other case-control studies

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

South Africa1 site

  • Desmund Tutu TB Centre at Stellenbosch University

    Cape Town, Western Cape, 7505

Other trials in South Africa

Zambia1 site

  • Zambart

    Lusaka

Other trials in Zambia

About this study

Official title: 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.

Read the detailed description

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.

Conditions
HIV
Being tested
Universal Testing with immediate ART, Universal Testing with ART eligibility according to National Guidelines, Standard of Care
Keywords
Universal Test and Treat (UTT), Combination Prevention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Universal Testing with immediate ARTOther

    Also called PopART Intervention, UTT

    • 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 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

  • Universal Testing with ART eligibility according to National GuidelinesOther

    Also called PopART Intervention

    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.

  • Standard of CareOther

Study groups in NCT01900977
Study groupRoleWhat they receive
Arm A Universal Testing w/Immediate ARTActive comparatorNot described
Receives: Other: Universal Testing with immediate ART
Arm B ART according to National GuidelinesActive comparatorNot described
Receives: Other: Universal Testing with ART eligibility according to National Guidelines
Standard of CareOtherIncludes: 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.
Receives: Other: Standard of Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 3 years

Secondary outcomes (13)

  1. HIV incidence over the first, second, and third years of follow-up

    Measured: 3 years

  2. ART adherence and viral suppression

    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)

    Measured: 24 months

  3. Herpes Simplex Virus -2 (HSV-2) incidence

    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

    Measured: 12 months, 24 months, and 36 months

  4. HIV disease progression, retention in care, and death

    Measured: 3 years

  5. ART toxicity

    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

    Measured: 3 years

  6. Sexual risk behavior

    • Self-reported sexual risk behavior at Enrollment, 12 months, 24 months, and 36 months in the Population Cohort

    Measured: 3 years

  7. Case notification rate of tuberculosis (TB)

    • 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

    Measured: 3 years

  8. HIV-related stigma

    • 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

    Measured: 3 years

  9. Uptake of PMTCT

    • 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

    Measured: 3 years

  10. Uptake of male circumcision

    • 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

    Measured: 3 years

  11. ART screening and uptake

    • 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

    Measured: 3 years

  12. HIV testing and retesting

    • 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

    Measured: 3 years

  13. Time between HIV diagnosis and initiation of care

    • 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)

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2013 (estimated)
  2. Study startJan 2014
  3. Primary completion7 Jul 2018
  4. Study completion7 Jul 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
48,540 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01900977
Sponsor's protocol ID
HPTN 071
Other IDs
11865, UM1AI068619
Acronym
PopART
Status last verified
Aug 2022
First submitted
2 Jul 2013
Last updated
26 Aug 2022
Results posted
No
Data monitoring committee
Yes

Publications

  • Bond V, Hoddinott G, Viljoen L, Simuyaba M, Musheke M, Seeley J. Good Health and Moral Responsibility: Key Concepts Underlying the Interpretation of Treatment as Prevention in South Africa and Zambia Before Rolling Out Universal HIV Testing and Treatment. AIDS Patient Care STDS. 2016 Sep;30(9):425-34. doi: 10.1089/apc.2016.0114.

    PubMed 27610464

  • Hargreaves JR, Stangl A, Bond V, Hoddinott G, Krishnaratne S, Mathema H, Moyo M, Viljoen L, Brady L, Sievwright K, Horn L, Sabapathy K, Ayles H, Beyers N, Bock P, Fidler S, Griffith S, Seeley J, Hayes R; HPTN 071 (PopART) study team. HIV-related stigma and universal testing and treatment for HIV prevention and care: design of an implementation science evaluation nested in the HPTN 071 (PopART) cluster-randomized trial in Zambia and South Africa. Health Policy Plan. 2016 Dec;31(10):1342-1354. doi: 10.1093/heapol/czw071. Epub 2016 Jul 3.

    PubMed 27375126

  • Viljoen L, Thorne M, Thomas A, Bond V, Hoddinott G; HPTN 071 (PopART) team. A narrative analysis positioning HIV relative to personal (sexual) relationship challenges in an agony aunt column in the Western Cape, South Africa - Aunty Mona's "love advice". AIDS Care. 2016;28 Suppl 3:83-9. doi: 10.1080/09540121.2016.1178957.

    PubMed 27421055

  • Camlin CS, Seeley J, Viljoen L, Vernooij E, Simwinga M, Reynolds L, Reis R, Plank R, Orne-Gliemann J, McGrath N, Larmarange J, Hoddinott G, Getahun M, Charlebois ED, Bond V. Strengthening universal HIV 'test-and-treat' approaches with social science research. AIDS. 2016 Mar 27;30(6):969-70. doi: 10.1097/QAD.0000000000001008. No abstract available.

    PubMed 26959355

  • Hayes R, Ayles H, Beyers N, Sabapathy K, Floyd S, Shanaube K, Bock P, Griffith S, Moore A, Watson-Jones D, Fraser C, Vermund SH, Fidler S; HPTN 071 (PopART) Study Team. HPTN 071 (PopART): rationale and design of a cluster-randomised trial of the population impact of an HIV combination prevention intervention including universal testing and treatment - a study protocol for a cluster randomised trial. Trials. 2014 Feb 13;15:57. doi: 10.1186/1745-6215-15-57.

    PubMed 24524229

  • Cori A, Ayles H, Beyers N, Schaap A, Floyd S, Sabapathy K, Eaton JW, Hauck K, Smith P, Griffith S, Moore A, Donnell D, Vermund SH, Fidler S, Hayes R, Fraser C; HPTN 071 PopART Study Team. HPTN 071 (PopART): a cluster-randomized trial of the population impact of an HIV combination prevention intervention including universal testing and treatment: mathematical model. PLoS One. 2014 Jan 15;9(1):e84511. doi: 10.1371/journal.pone.0084511. eCollection 2014.

    PubMed 24454728

  • Vermund SH, Fidler SJ, Ayles H, Beyers N, Hayes RJ. Can combination prevention strategies reduce HIV transmission in generalized epidemic settings in Africa? The HPTN 071 (PopART) study plan in South Africa and Zambia. J Acquir Immune Defic Syndr. 2013 Jul;63 Suppl 2(0 2):S221-7. doi: 10.1097/QAI.0b013e318299c3f4.

    PubMed 23764639

  • Vermund SH, Hayes RJ. Combination prevention: new hope for stopping the epidemic. Curr HIV/AIDS Rep. 2013 Jun;10(2):169-86. doi: 10.1007/s11904-013-0155-y.

    PubMed 23456730

  • Sabapathy K, Van den Bergh R, Fidler S, Hayes R, Ford N. Uptake of home-based voluntary HIV testing in sub-Saharan Africa: a systematic review and meta-analysis. PLoS Med. 2012;9(12):e1001351. doi: 10.1371/journal.pmed.1001351. Epub 2012 Dec 4.

    PubMed 23226107

  • Hayes R, Sabapathy K, Fidler S. Universal testing and treatment as an HIV prevention strategy: research questions and methods. Curr HIV Res. 2011 Sep;9(6):429-45. doi: 10.2174/157016211798038515.

    PubMed 21999778

  • Hoddinott G, Myburgh H, de Villiers L, Ndubani R, Mantantana J, Thomas A, Mbewe M, Ayles H, Bock P, Seeley J, Shanaube K, Hargreaves J, Bond V, Reynolds L; HPTN 071 (PopART) Study Team. Households, fluidity, and HIV service delivery in Zambia and South Africa - an exploratory analysis of longitudinal qualitative data from the HPTN 071 (PopART) trial. J Int AIDS Soc. 2018 Jul;21 Suppl 4(Suppl Suppl 4):e25135. doi: 10.1002/jia2.25135.

    PubMed 30027687

  • Bond V, Ngwenya F, Thomas A, Simuyaba M, Hoddinott G, Fidler S, Hayes R, Ayles H, Seeley J; HPTN 071 (PopART) study team. Spinning plates: livelihood mobility, household responsibility and anti-retroviral treatment in an urban Zambian community during the HPTN 071 (PopART) study. J Int AIDS Soc. 2018 Jul;21 Suppl 4(Suppl Suppl 4):e25117. doi: 10.1002/jia2.25117.

    PubMed 30027643

  • Floyd S, Ayles H, Schaap A, Shanaube K, MacLeod D, Phiri M, Griffith S, Bock P, Beyers N, Fidler S, Hayes R; HPTN 071 (PopART) Study Team. Towards 90-90: Findings after two years of the HPTN 071 (PopART) cluster-randomized trial of a universal testing-and-treatment intervention in Zambia. PLoS One. 2018 Aug 10;13(8):e0197904. doi: 10.1371/journal.pone.0197904. eCollection 2018.

    PubMed 30096139

  • Sabapathy K, Mulubwa C, Mathema H, Mubekapi-Musadaidzwa C, Schaap A, Hoddinott G, Hargreaves J, Floyd S, Ayles H, Hayes R; HPTN 071 (PopART) Study Team. Is home-based HIV testing universally acceptable? Findings from a case-control study nested within the HPTN 071 (PopART) trial. Trop Med Int Health. 2018 Jun;23(6):678-690. doi: 10.1111/tmi.13055. Epub 2018 Apr 16.

    PubMed 29608231

  • Bock P, Fatti G, Ford N, Jennings K, Kruger J, Gunst C, Louis F, Grobbelaar N, Shanaube K, Floyd S, Grimwood A, Hayes R, Ayles H, Fidler S, Beyers N; HPTN 071 (PopART) trial team. Attrition when providing antiretroviral treatment at CD4 counts >500cells/muL at three government clinics included in the HPTN 071 (PopART) trial in South Africa. PLoS One. 2018 Apr 19;13(4):e0195127. doi: 10.1371/journal.pone.0195127. eCollection 2018.

    PubMed 29672542

Questions about this trial

What is this clinical trial studying?

A study testing Universal Testing with immediate ART and Universal Testing with ART eligibility according to National Guidelines in people with HIV, run by HIV Prevention Trials Network at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in South Africa, Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01900977, which also lists 48 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2022.

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