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

HIV Clinical Trial

— PopART  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01900977
• Other study ID #: HPTN 071
• Secondary ID: 11865UM1AI068619
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: July 7, 2018

Study information

• Verified date: August 2022
• Source: HIV Prevention Trials Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48540
• Est. completion date: July 7, 2018
• Est. primary completion date: July 7, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 44 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV

Intervention

Other:
• 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
• 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.
• Standard of Care

Locations

Country	Name	City	State
South Africa	Desmund Tutu TB Centre at Stellenbosch University	Cape Town	Western Cape
Zambia	Zambart	Lusaka

Sponsors (10)

Lead Sponsor

Collaborator

HIV Prevention Trials Network

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

Countries where clinical trial is conducted

South Africa,  Zambia, 

References & Publications (27)

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/µ — View Citation

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 In — View Citation

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- — View Citation

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 with — View Citation

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. — View Citation

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 — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

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 ris — View Citation

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. Epub 2016 Jul 3. — View Citation

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. — View Citation

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 re — View Citation

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. Review. — View Citation

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 Af — View Citation

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 Zambi — View Citation

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 — View Citation

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. Review. — View Citation

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 s — View Citation

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 — View Citation

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- — View Citation

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 — View Citation

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:S221-7. doi: 10.1097/QAI.0b013e318299c3f4. — View Citation

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. Review. — View Citation

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 201 — View Citation

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. — View Citation

* Note: There are 27 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		3 years
Secondary	HIV incidence over the first, second, and third years of follow-up		3 years
Secondary	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)	24 months
Secondary	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	12 months, 24 months, and 36 months
Secondary	HIV disease progression, retention in care, and death		3 years
Secondary	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	3 years
Secondary	Sexual risk behavior	o Self-reported sexual risk behavior at Enrollment, 12 months, 24 months, and 36 months in the Population Cohort	3 years
Secondary	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	3 years
Secondary	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	3 years
Secondary	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	3 years
Secondary	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	3 years
Secondary	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	3 years
Secondary	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	3 years
Secondary	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)	3 years