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

NCT ID: NCT01900977

Last Updated: 2022-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48540 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2018-07-07

Brief 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 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Arm A Universal Testing w/Immediate ART

Group Type: ACTIVE_COMPARATOR

Universal Testing with immediate ART

Intervention Type: OTHER

• 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

Arm B ART according to National Guidelines

Group Type: ACTIVE_COMPARATOR

Universal Testing with ART eligibility according to National Guidelines

Intervention Type: OTHER

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 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.

Group Type: OTHER

Standard of Care

Intervention Type: OTHER

Interventions

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

Intervention Type: OTHER

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.

Intervention Type: OTHER

Standard of Care

Intervention Type: OTHER

Other Intervention Names

PopART Intervention; UTT; PopART Intervention

Eligibility Criteria

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

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

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

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. 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.

1. Individuals belonging to the Population Cohort or other case-control studies

2. Individuals known to be HIV-infected after testing elsewhere.

1. Individuals enrolled in the Population Cohort or other case-control studies

2. HIV-infected individuals already on ART before study commences

1. Known HIV infected from CHiP data.

2. Individuals belonging to the Population Cohort or other case-control studies

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Office of the U.S. Global AIDS Coordinator

UNKNOWN

Sponsor Role: collaborator

Bill and Melinda Gates Foundation

OTHER

Sponsor Role: collaborator

London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role: collaborator

Imperial College London

OTHER

Sponsor Role: collaborator

Zambart

OTHER

Sponsor Role: collaborator

Desmond Tutu TB Centre

OTHER

Sponsor Role: collaborator

HIV Prevention Trials Network

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Hayes, BSc, MSc, DSc

Role: STUDY_CHAIR

London School of Hygiene and Tropical Medicine

Sarah Fidler, MBBS, PhD

Role: STUDY_CHAIR

Imperial College London

Helen Ayles, BSc, MBBS, MSc, PhD

Role: PRINCIPAL_INVESTIGATOR

London School of Hygiene and Tropical Medicine

Nulda Beyers, MBChB, FCP, MSc, PhD

Role: PRINCIPAL_INVESTIGATOR

Stellenbosch Univeristy

Peter Bock, MD, MRCP, MRCGP, MPH, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Stellenbosch

Locations

Desmund Tutu TB Centre at Stellenbosch University

Cape Town, Western Cape, South Africa

Zambart

Lusaka, , Zambia

Countries

South Africa; Zambia

References

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.

Reference Type: BACKGROUND

PMID: 27610464 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27375126 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27421055 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26959355 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24524229 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24454728 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23764639 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23456730 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23226107 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21999778 (View on PubMed)

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.

Reference Type: RESULT

PMID: 30027687 (View on PubMed)

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.

Reference Type: RESULT

PMID: 30027643 (View on PubMed)

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.

Reference Type: RESULT

PMID: 30096139 (View on PubMed)

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.

Reference Type: RESULT

PMID: 29608231 (View on PubMed)

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.

Reference Type: RESULT

PMID: 29672542 (View on PubMed)

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.

Reference Type: RESULT

PMID: 29659909 (View on PubMed)

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.

Reference Type: RESULT

PMID: 29369164 (View on PubMed)

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.

Reference Type: RESULT

PMID: 29016524 (View on PubMed)

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.

Reference Type: RESULT

PMID: 29238230 (View on PubMed)

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.

Reference Type: RESULT

PMID: 29251433 (View on PubMed)

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.

Reference Type: RESULT

PMID: 28964756 (View on PubMed)

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.

Reference Type: RESULT

PMID: 28872272 (View on PubMed)

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.

Reference Type: RESULT

PMID: 28665880 (View on PubMed)

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.

Reference Type: RESULT

PMID: 28471766 (View on PubMed)

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.

Reference Type: RESULT

PMID: 28464041 (View on PubMed)

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.

Reference Type: RESULT

PMID: 27405816 (View on PubMed)

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.

Reference Type: RESULT

PMID: 27421057 (View on PubMed)

Burger R, Bell-Mandla N, Harper A, Richardson S, Kanema S, Thomas R, Mwenge L, Wilson E, Floyd S, Bock P, Ayles H, Fidler S, Hayes R, Hauck K; HPTN 071 (PopART) study team. Does enhanced HIV prevention, diagnosis, and linkage to care reduce hospitalisation in high HIV-burden communities in Zambia and South Africa? findings from the HPTN 071 (PopART) randomised trial. PLOS Glob Public Health. 2025 May 8;5(5):e0004373. doi: 10.1371/journal.pgph.0004373. eCollection 2025.

Reference Type: DERIVED

PMID: 40339051 (View on PubMed)

Skalland TM, de Dieu Tapsoba J, Zangeneh SZ, Floyd S, Ayles H, Bock P, Fidler S, Eshleman SH, Hayes RJ, Donnell D; HPTN 071 (PopART) Study Team. A survey weighted analysis of HPTN 071 (PopART) primary outcome of HIV incidence. AIDS Res Ther. 2025 Mar 7;22(1):30. doi: 10.1186/s12981-025-00720-0.

Reference Type: DERIVED

PMID: 40055795 (View on PubMed)

Steinhaus MC, Nicholson TJ, Pliakas T, Harper A, Lilleston P, Mainga T, Milimo D, Jennings K, Grobbelaar N, Louis F, Liebenberg H, Hayes RJ, Fidler S, Ayles H, Bock P, Hoddinott G, Hargreaves JR, Bond V, Stangl AL; HPTN 071 (PopART) study team. Prevalence and risk of burnout among HIV service providers in South Africa and Zambia: findings from the HPTN 071 (PopART) trial. Hum Resour Health. 2024 Jul 8;22(1):50. doi: 10.1186/s12960-024-00934-9.

Reference Type: DERIVED

PMID: 38978065 (View on PubMed)

Telisinghe L, Floyd S, MacLeod D, Schaap A, Dunbar R, Bwalya J, Bell-Mandla N, Piwowar-Manning E, Donnell D, Shaunaube K, Bock P, Fidler S, Hayes RJ, Ayles HM; HPTN 071 (PopART) study team. Incidence of self-reported tuberculosis treatment with community-wide universal testing and treatment for HIV and tuberculosis screening in Zambia and South Africa: A planned analysis of the HPTN 071 (PopART) cluster-randomised trial. PLoS Med. 2024 May 31;21(5):e1004393. doi: 10.1371/journal.pmed.1004393. eCollection 2024 May.

Reference Type: DERIVED

PMID: 38820246 (View on PubMed)

Chaila MJ, Mcleod D, Vermund SH, Mbolongwe-Thornicroft M, Mbewe M, Mubekapi-Musadaidzwa C, Harper A, Schaap A, Floyd S, Hoddinott G, Hayes R, Fidler S, Ayles H, Shanaube K; HPTN 071 (PopART) for Youth (P-ART-Y) Study Team. Assessment of a screening tool to aid home-based identification of adolescents (aged 10-14) living with HIV in Zambia and South Africa: HPTN 071 (PopART) study. PLoS One. 2024 Feb 16;19(2):e0266573. doi: 10.1371/journal.pone.0266573. eCollection 2024.

Reference Type: DERIVED

PMID: 38363733 (View on PubMed)

Klinkenberg E, Floyd S, Shanaube K, Mureithi L, Gachie T, de Haas P, Kosloff B, Dodd PJ, Ruperez M, Wapamesa C, Burnett JM, Kalisvaart N, Kasese N, Vermaak R, Schaap A, Fidler S, Hayes R, Ayles H; TREATS study team. Tuberculosis prevalence after 4 years of population-wide systematic TB symptom screening and universal testing and treatment for HIV in the HPTN 071 (PopART) community-randomised trial in Zambia and South Africa: A cross-sectional survey (TREATS). PLoS Med. 2023 Sep 8;20(9):e1004278. doi: 10.1371/journal.pmed.1004278. eCollection 2023 Sep.

Reference Type: DERIVED

PMID: 37682971 (View on PubMed)

Skalland T, Ayles H, Bock P, Bwalya J, Shanaube K, Kasese N, Dupre M, Kosloff B, Floyd S, Wilson E, Moore A, Eshleman S, Fidler S, Hayes R, Donnell D; HPTN 071 (PopART) Study Team. Community- and individual-level correlates of HIV incidence in HPTN 071 (PopART). J Int AIDS Soc. 2023 Aug;26(8):e26155. doi: 10.1002/jia2.26155.

Reference Type: DERIVED

PMID: 37643290 (View on PubMed)

Yang B, Sloot R, Floyd S, Awoniyi D, Griffith S, Ayles H, Fidler S, Hayes R, Vermund SH, Bock P; HPTN 071 (PopART) study team. Brief Report: How Do We Reach Men? Offering HIV Testing in Evenings and Weekends in the HPTN 071 (PopART) Community-Based Trial in South Africa. J Acquir Immune Defic Syndr. 2023 Aug 1;93(4):300-304. doi: 10.1097/QAI.0000000000003197.

Reference Type: DERIVED

PMID: 37001128 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36332653 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35393864 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35001530 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34749654 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33823907 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32773484 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32745296 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32240156 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32072743 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31840400 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31314965 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30877753 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Informed Consent Form

View Document

Other Identifiers

11865

Identifier Type: OTHER

Identifier Source: secondary_id

UM1AI068619

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HPTN 071

Identifier Type: -

Identifier Source: org_study_id