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

Volumn 9, Issue 1, 2014, Pages

  Cori, Anne ^a   Ayles, Helen ^b,c   Beyers, Nulda ^d   Schaap, Ab ^b,c   Floyd, Sian ^c   Sabapathy, Kalpana ^c   Eaton, Jeffrey W ^a   Hauck, Katharina ^e   Smith, Peter ^e   Griffith, Sam ^f   Moore, Ayana ^f   Donnell, Deborah ^g   Vermund, Sten H ^h   Fidler, Sarah ^a   Hayes, Richard ^c   Fraser, Christophe ^a  

^a IMPERIAL COLLEGE LONDON   (United Kingdom)

^b UNIVERSITY OF ZAMBIA   (Zambia)

^c LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE   (United Kingdom)

^d STELLENBOSCH UNIVERSITY   (South Africa)

^e IMPERIAL COLLEGE LONDON   (United Kingdom)

^f FAMILY HEALTH INTERNATIONAL   (United States)

^g USA   (United States)

^h VANDERBILT UNIVERSITY MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIRETROVIRUS AGENT; ANTI HUMAN IMMUNODEFICIENCY VIRUS AGENT;

ARTICLE; BEHAVIOR CHANGE; CD4 LYMPHOCYTE COUNT; CLUSTER ANALYSIS; CONTROLLED STUDY; DISEASE COURSE; HETEROSEXUALITY; HIGHLY ACTIVE ANTIRETROVIRAL THERAPY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; INCIDENCE; MATHEMATICAL MODEL; PREVALENCE; PROPHYLAXIS; RANDOMIZED CONTROLLED TRIAL (TOPIC); SOUTH AFRICA; TREATMENT FAILURE; VIRUS TRANSMISSION; ZAMBIA; HIV INFECTIONS; RANDOMIZED CONTROLLED TRIAL; SERODIAGNOSIS; UTILIZATION;

AIDS SERODIAGNOSIS; ANTI-HIV AGENTS; CLUSTER ANALYSIS; HIV INFECTIONS; HUMANS; SOUTH AFRICA; ZAMBIA;

EID: 84894039576     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0084511     Document Type: Article

References (47)

1. Cohen MS, Chen YQ, McCauley M, Gamble T, Hosseinipour MC, et al. (2011) Prevention of HIV-1 infection with early antiretroviral therapy. N Engl J Med 365:493-505.
2. Donnell D, Baeten JM, Kiarie J, Thomas KK, Stevens W, et al. (2010) Heterosexual HIV-1 transmission after initiation of antiretroviral therapy: a prospective cohort analysis. Lancet 375:2092-2098.
3. Attia S, Egger M, Muller M, Zwahlen M, Low N (2009) Sexual transmission of HIV according to viral load and antiretroviral therapy: systematic review and meta-analysis. AIDS 23:1397-1404.
4. Granich RM, Gilks CF, Dye C, De Cock KM, Williams BG (2009) Universal voluntary HIV testing with immediate antiretroviral therapy as a strategy for elimination of HIV transmission: a mathematical model. Lancet 373:48-57.
5. Tanser F, Barnighausen T, Grapsa E, Zaidi J, Newell ML (2013) High coverage of ART associated with decline in risk of HIV acquisition in rural KwaZulu-Natal, South Africa. Science 339:966-971.
6. Iwuji CC, Orne-Gliemann J, Tanser F, Boyer S, Lessells RJ, et al. (2013) Evaluation of the impact of immediate versus WHO recommendations-guided antiretroviral therapy initiation on HIV incidence: the ANRS 12249 TasP (Treatment as Prevention) trial in Hlabisa sub-district, KwaZulu-Natal, South Africa: study protocol for a cluster randomised controlled trial. Trials 14:230.
7. Novitsky V, Wang R, Bussmann H, Lockman S, Baum M, et al. (2010) HIV-1 subtype C-infected individuals maintaining high viral load as potential targets for the "test-and-treat" approach to reduce HIV transmission. PLoS One 5:e10148.
8. Boily MC, Masse B, Alsallaq R, Padian NS, Eaton JW, et al. (2012) HIV Treatment as Prevention: Considerations in the Design, Conduct, and Analysis of Cluster Randomized Controlled Trials of Combination HIV Prevention. PLoS Med 9:e1001250.
9. Kurth AE, Mayer K, Beauchamp G, McKinstry L, Farrior J, et al. (2012) Clinician practices and attitudes regarding early antiretroviral therapy in the United States. J Acquir Immune Defic Syndr 61:e65-69.
10. Vermund SH, Hodder SL, Justman JE, Koblin BA, Mastro TD, et al. (2010) Addressing research priorities for prevention of HIV infection in the United States. Clin Infect Dis 50 Suppl 3:S149-155.
11. Vermund SH, Fidler SJ, Ayles H, Beyers N, Hayes RJ (2013) 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 63 Suppl 2:S221-227.
12. Vermund SH, Hayes RJ (2013) Combination prevention: new hope for stopping the epidemic. Curr HIV/AIDS Rep 10:169-186.
13. Hayes R, Sabapathy K, Fidler S (2011) Universal testing and treatment as an HIV prevention strategy: research questions and methods. Curr HIV Res 9:429-445.
14. Hayes R, Ayles H, Beyers N, Sabapathy K, Floyd S, et al. (2013) 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. Under review.
15. Garnett GP, Cousens S, Hallett TB, Steketee R, Walker N (2011) Mathematical models in the evaluation of health programmes. Lancet 378:515-525.
16. Eaton JW, Johnson LF, Salomon JA, Barnighausen T, Bendavid E, et al. (2012) HIV Treatment as Prevention: Systematic Comparison of Mathematical Models of the Potential Impact of Antiretroviral Therapy on HIV Incidence in South Africa. PLoS Med 9:e1001245.
17. The HIV Modelling Consortium Treatment as Prevention Editorial Writing Group (2012) HIV treatment as prevention: models, data, and questions-towards evidence-based decision-making. PLoS Med 9:e1001259.
18. The HIV Modelling Consortium Treatment as Prevention Editorial Writing Group (2012) HIV treatment as prevention: models, data, and questions-towards evidence-based decision-making. PLoS Med 9:e1001259. (Pubitemid 39602341)
19. Orroth KK, Freeman EE, Bakker R, Buve A, Glynn JR, et al. (2007) Understanding the differences between contrasting HIV epidemics in east and west Africa: results from a simulation model of the Four Cities Study. Sex Transm Infect 83 Suppl 1:15-16.
20. Hallett TB, Singh K, Smith JA, White RG, Abu-Raddad LJ, et al. (2008) Understanding the impact of male circumcision interventions on the spread of HIV in southern Africa. PLoS ONE 3:e2212.
21. Bezemer D, de Wolf F, Boerlijst MC, van Sighem A, Hollingsworth TD, et al. (2008) A resurgent HIV-1 epidemic among men who have sex with men in the era of potent antiretroviral therapy. AIDS 22:1071-1077. (Pubitemid 351769746)
22. Bezemer D, de Wolf F, Boerlijst MC, van Sighem A, Hollingsworth TD, et al. (2010) 27 years of the HIV epidemic amongst men having sex with men in the Netherlands: an in depth mathematical model-based analysis. Epidemics 2:66-79.
23. Lodi S, Phillips A, Touloumi G, Geskus R, Meyer L, et al. (2011) Time from human immunodeficiency virus seroconversion to reaching CD4+ cell count thresholds, 200, 350, and, 500 Cells/mm (3): assessment of need following changes in treatment guidelines. Clin Infect Dis 53:817-825.
24. Thiebaut R, Pellegrin I, Chene G, Viallard JF, Fleury H, et al. (2005) Immunological markers after long-term treatment interruption in chronically HIV-1 infected patients with CD4 cell count above 400610 (6) cells/l. AIDS 19:53-61. (Pubitemid 40111018)
25. May M, Boulle A, Phiri S, Messou E, Myer L, et al. (2010) Prognosis of patients with HIV-1 infection starting antiretroviral therapy in sub-Saharan Africa: a collaborative analysis of scale-up programmes. Lancet 376:449-457.
26. Fernandez Guerrero ML, Rivas P, Molina M, Garcia R, De Gorgolas M (2005) Long-term follow-up of asymptomatic HIV-infected patients who discontinued antiretroviral therapy. Clin Infect Dis 41:390-394. (Pubitemid 41022119)
27. Touloumi G, Pantazis N, Antoniou A, Stirnadel HA, Walker SA, et al. (2006) Highly active antiretroviral therapy interruption: predictors and virological and immunologic consequences. J Acquir Immune Defic Syndr 42:554-561. (Pubitemid 44162423)
28. Gabillard D, Lewden C, Ndoye I, Moh R, Segeral O, et al. (2013) Mortality, AIDS-morbidity and loss to follow-up by current CD4 cell count among HIV-1 infected adults receiving antiretroviral therapy in Africa and Asia: data from the ANRS 12222 collaboration. J Acquir Immune Defic Syndr 62:555-561.
29. Gras L, Kesselring AM, Griffin JT, van Sighem AI, Fraser C, et al. (2007) CD4 cell counts of 800 cells/mm3 or greater after 7 years of highly active antiretroviral therapy are feasible in most patients starting with 350 cells/mm3 or greater. J Acquir Immune Defic Syndr 45:183-192. (Pubitemid 46869811)
30. Egger M, Spycher BD, Sidle J, Weigel R, Geng EH, et al. (2011) Correcting mortality for loss to follow-up: a nomogram applied to antiretroviral treatment programmes in sub-Saharan Africa. PLoS Med 8:e1000390.
31. Auvert B, Taljaard D, Lagarde E, Sobngwi-Tambekou J, Sitta R, et al. (2005) Randomized, controlled intervention trial of male circumcision for reduction of HIV infection risk: the ANRS 1265 Trial. PLoS Med 2:e298.
32. Gray RH, Kigozi G, Serwadda D, Makumbi F, Watya S, et al. (2007) Male circumcision for HIV prevention in men in Rakai, Uganda: a randomised trial. Lancet 369:657-666.
33. Bailey RC, Moses S, Parker CB, Agot K, Maclean I, et al. (2007) Male circumcision for HIV prevention in young men in Kisumu, Kenya: a randomised controlled trial. Lancet 369:643-656. (Pubitemid 46281312)
34. Mills E, Cooper C, Anema A, Guyatt G (2008) Male circumcision for the prevention of heterosexually acquired HIV infection: a meta-analysis of randomized trials involving 11, 050 men. HIV Med 9:332-335. (Pubitemid 352015640)
35. Wawer MJ, Makumbi F, Kigozi G, Serwadda D, Watya S, et al. (2009) Circumcision in HIV-infected men and its effect on HIV transmission to female partners in Rakai, Uganda: a randomised controlled trial. Lancet 374:229-237.
36. Mehta SD, Gray RH, Auvert B, Moses S, Kigozi G, et al. (2009) Does sex in the early period after circumcision increase HIV-seroconversion risk? Pooled analysis of adult male circumcision clinical trials. AIDS 23:1557-1564.
37. UNAIDS/WHO (2008) Epidemiological Country Profiles - HIV and AIDS 2008.
38. Ayles HM, Sismanidis C, Beyers N, Hayes RJ, Godfrey-Faussett P (2008) ZAMSTAR, The Zambia South Africa TB and HIV Reduction Study: design of a 262 factorial community randomized trial. Trials 9:63.
39. Sismanidis C, Moulton LH, Ayles H, Fielding K, Schaap A, et al. (2008) Restricted randomization of ZAMSTAR: a 262 factorial cluster randomized trial. Clin Trials 5:316-327.
40. Mckay MD, Beckman RJ, Conover WJ (1979) A Comparison of Three Methods for Selecting Values of Input Variables in the Analysis of Output from a Computer Code. Technometrics 21:239-245. (Pubitemid 9452235)
41. Bechange S, Bunnell R, Awor A, Moore D, King R, et al. (2010) Two-year follow-up of sexual behavior among HIV-uninfected household members of adults taking antiretroviral therapy in Uganda: no evidence of disinhibition. AIDS Behav 14:816-823.
42. Kennedy C, O'Reilly K, Medley A, Sweat M (2007) The impact of HIV treatment on risk behaviour in developing countries: a systematic review. AIDS Care 19:707-720. (Pubitemid 46944272)
43. Mattson CL, Campbell RT, Bailey RC, Agot K, Ndinya-Achola JO, et al. (2008) Risk compensation is not associated with male circumcision in Kisumu, Kenya: a multi-faceted assessment of men enrolled in a randomized controlled trial. PLoS One 3:e2443.
44. Coates T, Eshleman S, Chariyalertsak S, Chingono A, Gray G, et al. (2013) Community-level Reductions in Estimated HIV Incidence: HIV Prevention Trials Network 043, Project Accept. CROI. Atlanta: abstract number W-173.
45. Cohen MS, Dye C, Fraser C, Miller WC, Powers KA, et al. (2012) HIV treatment as prevention: debate and commentary-will early infection compromise treatment-as-prevention strategies? PLoS Med 9:e1001232.
46. Lurie MN, Williams BG, Zuma K, Mkaya-Mwamburi D, Garnett GP, et al. (2003) Who infects whom? HIV-1 concordance and discordance among migrant and non-migrant couples in South Africa. AIDS 17:2245-2252. (Pubitemid 37338898)
47. Tanser F, Barnighausen T, Hund L, Garnett GP, McGrath N, et al. (2011) Effect of concurrent sexual partnerships on rate of new HIV infections in a highprevalence, rural South African population: a cohort study. Lancet 378:247-255.