- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01900977
Population Effects of Antiretroviral Therapy to Reduce HIV Transmission (PopART) (PopART)
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
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Western Cape
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Cape Town, Western Cape, South Africa, 7505
- Desmund Tutu TB Centre at Stellenbosch University
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-
-
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Lusaka, Zambia
- Zambart
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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:
- 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
Exclusion Criteria:
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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Arm A Universal Testing w/Immediate ART
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• 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
Other Names:
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Active Comparator: Arm B ART according to National Guidelines
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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.
Other Names:
|
Other: 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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HIV incidence over the first, second, and third years of follow-up
Time Frame: 3 years
|
3 years
|
|
ART adherence and viral suppression
Time Frame: 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
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Herpes Simplex Virus -2 (HSV-2) incidence
Time Frame: 12 months, 24 months, and 36 months
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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
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12 months, 24 months, and 36 months
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HIV disease progression, retention in care, and death
Time Frame: 3 years
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3 years
|
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ART toxicity
Time Frame: 3 years
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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
Time Frame: 3 years
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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)
Time Frame: 3 years
|
|
3 years
|
HIV-related stigma
Time Frame: 3 years
|
|
3 years
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Uptake of PMTCT
Time Frame: 3 years
|
|
3 years
|
Uptake of male circumcision
Time Frame: 3 years
|
|
3 years
|
ART screening and uptake
Time Frame: 3 years
|
|
3 years
|
HIV testing and retesting
Time Frame: 3 years
|
|
3 years
|
Time between HIV diagnosis and initiation of care
Time Frame: 3 years
|
|
3 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Richard Hayes, BSc, MSc, DSc, London School of Hygiene and Tropical Medicine
- Study Chair: Sarah Fidler, MBBS, PhD, Imperial College London
- Principal Investigator: Helen Ayles, BSc, MBBS, MSc, PhD, London School of Hygiene and Tropical Medicine
- Principal Investigator: Nulda Beyers, MBChB, FCP, MSc, PhD, Stellenbosch Univeristy
- Principal Investigator: Peter Bock, MD, MRCP, MRCGP, MPH, PhD, University of Stellenbosch
Publications and helpful links
General Publications
- 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.
- 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.
- 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. Erratum In: AIDS Patient Care STDS. 2017 Jan;31(1):41.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Bradley J, Floyd S, Piwowar-Manning E, Laeyendecker O, Young A, Bell-Mandla N, Bwalya J, Bock P, Fidler S, Ayles H, Hayes RJ; HPTN 071 (PopART) Study Team. Sexually Transmitted Bedfellows: Exquisite Association Between HIV and Herpes Simplex Virus Type 2 in 21 Communities in Southern Africa in the HIV Prevention Trials Network 071 (PopART) Study. J Infect Dis. 2018 Jul 2;218(3):443-452. doi: 10.1093/infdis/jiy178.
- Hargreaves JR, Krishnaratne S, Mathema H, Lilleston PS, Sievwright K, Mandla N, Mainga T, Vermaak R, Piwowar-Manning E, Schaap A, Donnell D, Ayles H, Hayes RJ, Hoddinott G, Bond V, Stangl A; HPTN 071 (PopART) Study Team. Individual and community-level risk factors for HIV stigma in 21 Zambian and South African communities: analysis of data from the HPTN071 (PopART) study. AIDS. 2018 Mar 27;32(6):783-793. doi: 10.1097/QAD.0000000000001757.
- Bock P, Jennings K, Vermaak R, Cox H, Meintjes G, Fatti G, Kruger J, De Azevedo V, Maschilla L, Louis F, Gunst C, Grobbelaar N, Dunbar R, Limbada M, Floyd S, Grimwood A, Ayles H, Hayes R, Fidler S, Beyers N. Incidence of Tuberculosis Among HIV-Positive Individuals Initiating Antiretroviral Treatment at Higher CD4 Counts in the HPTN 071 (PopART) Trial in South Africa. J Acquir Immune Defic Syndr. 2018 Jan 1;77(1):93-101. doi: 10.1097/QAI.0000000000001560.
- Viljoen L, Ndubani R, Bond V, Seeley J, Reynolds L, Hoddinott G. Community narratives about women and HIV risk in 21 high-burden communities in Zambia and South Africa. Int J Womens Health. 2017 Nov 29;9:861-870. doi: 10.2147/IJWH.S143397. eCollection 2017.
- Sabapathy K, Mubekapi-Musadaidzwa C, Mulubwa C, Schaap A, Hoddinott G, Stangl A, Floyd S, Ayles H, Fidler S, Hayes R; HPTN 071 (PopART) study team. Predictors of timely linkage-to-ART within universal test and treat in the HPTN 071 (PopART) trial in Zambia and South Africa: findings from a nested case-control study. J Int AIDS Soc. 2017 Dec;20(4):e25037. doi: 10.1002/jia2.25037.
- Thomas R, Burger R, Harper A, Kanema S, Mwenge L, Vanqa N, Bell-Mandla N, Smith PC, Floyd S, Bock P, Ayles H, Beyers N, Donnell D, Fidler S, Hayes R, Hauck K; HPTN 071 (PopART) Study Team. Differences in health-related quality of life between HIV-positive and HIV-negative people in Zambia and South Africa: a cross-sectional baseline survey of the HPTN 071 (PopART) trial. Lancet Glob Health. 2017 Nov;5(11):e1133-e1141. doi: 10.1016/S2214-109X(17)30367-4. Epub 2017 Sep 27.
- Bock P, Phiri C, Piwowar-Manning E, Kosloff B, Mandla N, Young A, James A, Schaap A, Scheepers M, Donnell D, Griffith S, El-Sadr W, Shanaube K, Beyers N, Hayes R, Fidler S, Ayles H; HPTN 071 (PopART) Study Team. Understanding low sensitivity of community-based HIV rapid testing: experiences from the HPTN 071 (PopART) trial in Zambia and South Africa. J Int AIDS Soc. 2017 Aug 29;20(Suppl 6):21780. doi: 10.7448/IAS.20.7.21780.
- Shanaube K, Schaap A, Chaila MJ, Floyd S, Mackworth-Young C, Hoddinott G, Hayes R, Fidler S, Ayles H; HPTN 071 (PopART) Study Team. Community intervention improves knowledge of HIV status of adolescents in Zambia: findings from HPTN 071-PopART for youth study. AIDS. 2017 Jul 1;31 Suppl 3(Suppl 3):S221-S232. doi: 10.1097/QAD.0000000000001530.
- Shanaube K, Schaap A, Floyd S, Phiri M, Griffith S, Chaila J, Bock P, Hayes R, Fidler S, Ayles H; HPTN 071 (PopART) Study Team. What works - reaching universal HIV testing: lessons from HPTN 071 (PopART) trial in Zambia. AIDS. 2017 Jul 17;31(11):1555-1564. doi: 10.1097/QAD.0000000000001514.
- Hayes R, Floyd S, Schaap A, Shanaube K, Bock P, Sabapathy K, Griffith S, Donnell D, Piwowar-Manning E, El-Sadr W, Beyers N, Ayles H, Fidler S; HPTN 071 (PopART) Study Team. A universal testing and treatment intervention to improve HIV control: One-year results from intervention communities in Zambia in the HPTN 071 (PopART) cluster-randomised trial. PLoS Med. 2017 May 2;14(5):e1002292. doi: 10.1371/journal.pmed.1002292. eCollection 2017 May.
- Simwinga M, Bond V, Makola N, Hoddinott G, Belemu S, White R, Shanaube K, Seeley J, Moore A; HPTN 071 (PopART) study team. Implementing Community Engagement for Combination Prevention: Lessons Learnt From the First Year of the HPTN 071 (PopART) Community-Randomized Study. Curr HIV/AIDS Rep. 2016 Aug;13(4):194-201. doi: 10.1007/s11904-016-0322-z.
- Bond V, Chiti B, Hoddinott G, Reynolds L, Schaap A, Simuyaba M, Ndubani R, Viljoen L, Simwinga M, Fidler S, Hayes R, Ayles H, Seeley J; HPTN 071 (PopART) study team. "The difference that makes a difference": highlighting the role of variable contexts within an HIV Prevention Community Randomised Trial (HPTN 071/PopART) in 21 study communities in Zambia and South Africa. AIDS Care. 2016;28 Suppl 3:99-107. doi: 10.1080/09540121.2016.1178958.
- Wilson E, Donnell D, Skalland T, Floyd S, Moore A, Bell-Mandla N, Bwalya J, Kasese N, Dunbar R, Shanaube K, Kosloff B, Laeyendecker O, Agyei Y, Hoddinott G, Bock P, Fidler S, Hayes R, Ayles H; HPTN 071 (PopART) Study Team. Impact of universal testing and treatment on sexual risk behaviour and herpes simplex virus type 2: a prespecified secondary outcomes analysis of the HPTN 071 (PopART) community-randomised trial. Lancet HIV. 2022 Nov;9(11):e760-e770. doi: 10.1016/S2352-3018(22)00253-3.
- Donnell D. Practical issues in operationalizing the design and outcome evaluation of cluster randomized trials. Clin Trials. 2022 Aug;19(4):407-415. doi: 10.1177/17407745221087465. Epub 2022 Apr 8.
- Phiri MM, Schaap A, Simwinga M, Hensen B, Floyd S, Mulubwa C, Simuyaba M, Chiti B, Bond V, Shanaube K, Fidler S, Hayes R, Ayles H; HPTN 071 (PopART) Study team. Closing the gap: did delivery approaches complementary to home-based testing reach men with HIV testing services during and after the HPTN 071 (PopART) trial in Zambia? J Int AIDS Soc. 2022 Jan;25(1):e25855. doi: 10.1002/jia2.25855.
- Bell-Mandla NF, Sloot R, Maarman G, Griffith S, Moore A, Floyd S, Hayes R, Fidler S, Ayles H, Bock P; HPTN 071 (PopART) study team. Improving retention of community-recruited participants in HIV prevention research through Saturday household visits; findings from the HPTN 071 (PopART) study in South Africa. BMC Med Res Methodol. 2021 Nov 8;21(1):242. doi: 10.1186/s12874-021-01415-6.
- Bond V, Hoddinott G, Viljoen L, Ngwenya F, Simuyaba M, Chiti B, Ndubani R, Makola N, Donnell D, Schaap A, Floyd S, Hargreaves J, Shanaube K, Fidler S, Bock P, Ayles H, Hayes R, Simwinga M, Seeley J; HPTN071 (PopART) study team. How 'place' matters for addressing the HIV epidemic: evidence from the HPTN 071 (PopART) cluster-randomised controlled trial in Zambia and South Africa. Trials. 2021 Apr 6;22(1):251. doi: 10.1186/s13063-021-05198-5.
- Stangl AL, Pliakas T, Mainga T, Steinhaus M, Mubekapi-Musadaidzwa C, Viljoen L, Dunbar R, Schaap A, Floyd S, Mandla N, Bond V, Hoddinott G, Fidler S, Hayes R, Ayles H, Bock P, Donnell D, Hargreaves JR; HPTN 071 (PopART) study team. The effect of universal testing and treatment on HIV stigma in 21 communities in Zambia and South Africa. AIDS. 2020 Nov 15;34(14):2125-2135. doi: 10.1097/QAD.0000000000002658.
- Jones HS, Floyd S, Stangl A, Bond V, Hoddinott G, Pliakas T, Bwalya J, Mandla N, Moore A, Donnell D, Bock P, Fidler S, Hayes R, Ayles H, Hargreaves JR; HPTN 071 (PopART) Study Team. Association between HIV stigma and antiretroviral therapy adherence among adults living with HIV: baseline findings from the HPTN 071 (PopART) trial in Zambia and South Africa. Trop Med Int Health. 2020 Oct;25(10):1246-1260. doi: 10.1111/tmi.13473. Epub 2020 Aug 26.
- Floyd S, Shanaube K, Yang B, Schaap A, Griffith S, Phiri M, Macleod D, Sloot R, Sabapathy K, Bond V, Bock P, Ayles H, Fidler S, Hayes R; HPTN 071 (PopART) study team. HIV testing and treatment coverage achieved after 4 years across 14 urban and peri-urban communities in Zambia and South Africa: An analysis of findings from the HPTN 071 (PopART) trial. PLoS Med. 2020 Apr 2;17(4):e1003067. doi: 10.1371/journal.pmed.1003067. eCollection 2020 Apr.
- Eshleman SH, Piwowar-Manning E, Wilson EA, Lennon D, Fogel JM, Agyei Y, Sullivan PA, Weng L, Moore A, Laeyendecker O, Kosloff B, Bwalya J, Maarman G, van Deventer A, Floyd S, Bock P, Ayles H, Fidler S, Hayes R, Donnell D; HPTN 071 (PopART) Study Team. Determination of HIV status and identification of incident HIV infections in a large, community-randomized trial: HPTN 071 (PopART). J Int AIDS Soc. 2020 Feb;23(2):e25452. doi: 10.1002/jia2.25452.
- Stangl AL, Lilleston P, Mathema H, Pliakas T, Krishnaratne S, Sievwright K, Bell-Mandla N, Vermaak R, Mainga T, Steinhaus M, Donnell D, Schaap A, Bock P, Ayles H, Hayes R, Hoddinott G, Bond V, Hargreaves JR; HPTN 071 (PopART) Study Team. Development of parallel measures to assess HIV stigma and discrimination among people living with HIV, community members and health workers in the HPTN 071 (PopART) trial in Zambia and South Africa. J Int AIDS Soc. 2019 Dec;22(12):e25421. doi: 10.1002/jia2.25421.
- Hayes RJ, Donnell D, Floyd S, Mandla N, Bwalya J, Sabapathy K, Yang B, Phiri M, Schaap A, Eshleman SH, Piwowar-Manning E, Kosloff B, James A, Skalland T, Wilson E, Emel L, Macleod D, Dunbar R, Simwinga M, Makola N, Bond V, Hoddinott G, Moore A, Griffith S, Deshmane Sista N, Vermund SH, El-Sadr W, Burns DN, Hargreaves JR, Hauck K, Fraser C, Shanaube K, Bock P, Beyers N, Ayles H, Fidler S; HPTN 071 (PopART) Study Team. Effect of Universal Testing and Treatment on HIV Incidence - HPTN 071 (PopART). N Engl J Med. 2019 Jul 18;381(3):207-218. doi: 10.1056/NEJMoa1814556.
- Fatti G, Grimwood A, Nachega JB, Nelson JA, LaSorda K, van Zyl G, Grobbelaar N, Ayles H, Hayes R, Beyers N, Fidler S, Bock P. Better Virological Outcomes Among People Living With Human Immunodeficiency Virus (HIV) Initiating Early Antiretroviral Treatment (CD4 Counts >/=500 Cells/microL) in the HIV Prevention Trials Network 071 (PopART) Trial in South Africa. Clin Infect Dis. 2020 Jan 16;70(3):395-403. doi: 10.1093/cid/ciz214.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- HPTN 071
- UM1AI068619 (U.S. NIH Grant/Contract)
- 11865 (Other Identifier: DAIDS-ES)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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City University of New York, School of Public HealthNew York State Psychiatric Institute; University of KwaZulu; International Initiative... and other collaboratorsCompleted