Nurse versus doctor management of HIV-infected patients receiving antiretroviral therapy (CIPRA-SA): A randomised non-inferiority trial

The Lancet

Volumn 376, Issue 9734, 2010, Pages 33-40

  Sanne, Ian ^a   Orrell, Catherine ^b   Fox, Matthew P ^c   Conradie, Francesca ^a   Ive, Prudence ^a   Zeinecker, Jennifer ^b   Cornell, Morna ^b   Heiberg, Christie ^b   Ingram, Charlotte ^a   Panchia, Ravindre ^a   Rassool, Mohammed ^a   Gonin, René ^a,d   Stevens, Wendy ^a   Truter, Handré ^a   Dehlinger, Marjorie ^e   Van Der Horst, Charles ^f   McIntyre, James ^g   Wood, Robin ^b  

^a UNIVERSITY OF THE WITWATERSRAND   (South Africa)

^b UNIVERSITY OF CAPE TOWN   (South Africa)

^c BOSTON UNIVERSITY SCHOOL OF PUBLIC HEALTH   (United States)

^d WESTAT   (United States)

^e NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES   (United States)

^f UNIVERSITY OF NORTH CAROLINA SCHOOL OF MEDICINE   (United States)

^g ANOVA HEALTH INSTITUTE   (South Africa)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIRETROVIRUS AGENT; EFAVIRENZ; LAMIVUDINE; LAMIVUDINE PLUS NEVIRAPINE PLUS STAVUDINE; LOPINAVIR PLUS RITONAVIR; NELFINAVIR; STAVUDINE;

ADULT; ANEMIA; ARTICLE; BIOCHEMISTRY; CD4 LYMPHOCYTE COUNT; CENTRAL NERVOUS SYSTEM DISEASE; CLINICAL ASSESSMENT; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIGESTIVE SYSTEM FUNCTION DISORDER; DRUG ERUPTION; DRUG EXPOSURE; FEMALE; FOLLOW UP; FUNDING; HEMATOLOGICAL PARAMETERS; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTED PATIENT; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; HYPERLACTATEMIA; LACTATE BLOOD LEVEL; LIPOATROPHY; LIPODYSTROPHY; MAJOR CLINICAL STUDY; MALE; MONITORING; MORTALITY; NEUTROPENIA; NURSE; OUTCOME ASSESSMENT; PATIENT CARE; PATIENT COUNSELING; PHYSICIAN; PRIMARY MEDICAL CARE; PRIORITY JOURNAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; RISK ASSESSMENT; SAMPLE SIZE; SIDE EFFECT; SKIN DISEASE; SOUTH AFRICA; TOXICITY; TREATMENT FAILURE; TUBERCULOSIS; UTERINE CERVIX DYSPLASIA; VIROTHERAPY; VIRUS LOAD; COMPARATIVE STUDY; DRUG COMBINATION; DRUG MONITORING; HUMAN IMMUNODEFICIENCY VIRUS 1; MULTICENTER STUDY; NURSING;

ADULT; ANTI-RETROVIRAL AGENTS; DRUG MONITORING; DRUG THERAPY, COMBINATION; FEMALE; HIV INFECTIONS; HIV-1; HUMANS; MALE; PHYSICIANS; SOUTH AFRICA; TREATMENT FAILURE;

EID: 77954693434     PISSN: 01406736     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0140-6736(10)60894-X     Document Type: Article

References (40)

1. Egger M, May M, Chêne G, et al, for the ART Cohort Collaboration. Prognosis of HIV-1-infected patients starting highly active antiretroviral therapy: a collaborative analysis of prospective studies. Lancet 2002; 360: 119-129 (Pubitemid 34786200)
2. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Nov 3, 2008. http://www.aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf (accessed Nov 25, 2009).
3. Kitahata MM, Van Rompaey SE, Shields AW. Physician experience in the care of HIV-infected persons is associated with earlier adoption of new antiretroviral therapy. J Acquir Immune Defic Syndr 2000; 24: 106-114
4. Landon BE, Wilson IB, McInnes K, et al. Physician specialization and the quality of care for human immunodeficiency virus infection. Arch Intern Med 2005; 165: 1133-1139
5. Kitahata MM, Koepsell TD, Deyo RA, et al. Physicians' experience with the acquired immunodeficiency syndrome as a factor in patients' survival. N Engl J Med 1996; 334: 701-706
6. Laine C, Markson LE, McKee LJ, et al. The relationship of clinic experience with advanced HIV and survival of women with AIDS. AIDS 1998; 12: 417-424
7. Romanelli F, Matheny SC. HIV infection: the role of primary care. Am Fam Physician 2009; 80: 946-952
8. UNAIDS, WHO. AIDS epidemic update. November, 2009. http://data.unaids. org/pub/Report/2009/jc1700-epi-update-2009-en.pdf (accessed June 6, 2010).
9. WHO. The World Health Report 2006: working together for health. Geneva: World Health Organization, 2006. http://www.who.int/whr/2006/en/(accessed Dec 30, 2009).
10. A National Human Resources Plan for Health to provide skilled human resources for healthcare adequate to take care of all South Africans. http://www.doh.gov.za/docs/discuss/2006/hrh-plan/chapt2.pdf (accessed June 6, 2010).
11. Lehmann U. Strengthening human resources for primary health care. In: Barron P, Roma-Reardon J, eds. South African health review 2008. Durban: Health Systems Trust, 2008: 163-77. http://www.hst.org.za/publications/841 (accessed Dec 30, 2009).
12. Gilks CF, Crowley S, Ekpini R, et al. The WHO public-health approach to antiretroviral treatment against HIV in resourcelimited settings. Lancet 2006; 368: 505-510
13. WHO. Scaling up antiretroviral therapy in resource-limited settings. Guidelines for a public health approach. Geneva: World Health Organization, 2002. http://www.who.int/hiv/pub/prev-care/pub18/en (accessed June 6, 2010).
14. Muula AS, Chipeta J, Siziya S, et al. Human resources requirements for highly active antiretroviral therapy scale up in Malawi. BMC Health Serv Res 2007; 7: 208.
15. Bedelu M, Ford N, Hilderbrand K, Reuter H. Implementing antiretroviral therapy in rural communities: the Lusikisiki model of decentralized HIV/AIDS care. J Infect Dis 2007; 196: S464-68.
16. Miles K, Clutterbuck DJ, Seitio O, Sebegod M, Riley A. Antiretroviral treatment roll-out in a resource-constrained setting: capitalizing on nursing resources in Botswana. Bull World Health Organ 2007; 85: 555-560
17. van Griensven J, De Naeyer L, Uwera J, et al. Success with antiretroviral treatment for children in Kigali, Rwanda: experience with health center/nurse-based care. BMC Pediatr 2008; 8: 39.
18. Assefa Y, Kloos H. The public health approach to antiretroviral (ART) service scale up in Ethiopia: the first two years of free ART. Ethiop Med J 2008; 46: 401-406
19. Logan AG, Milne BJ, Achber C, Campbell WP, Haynes RB. Work-site treatment of hypertension by specially trained nurses. A controlled trial. Lancet 1979; 314: 1175-1178
20. South African National Department of Health. HIV and AIDS and STI strategic plan for South Africa, 2007-2011. http://www.doh.gov.za/docs/misc/ stratplan-f.html (accessed June 6, 2010).
21. Comprehensive International Program for Research on AIDS in South Africa. http://www.cipra-sa.co.za/project1.asp (accessed June 8, 2010).
22. Department of Health. Guidelines for good practice in the conduct of clinical trials with human participants in South Africa. Department of Health: Pretoria, 2006. http://www.doh.gov.za/nhrec/norms/gcp.pdf (accessed Nov 25, 2009).
23. National Institutes of Health. Required education in the protection of human research participants policy. June 5, 2000. http://grants.nih.gov/grants/ guide/notice-files/NOT-OD-00-039.html (accessed Nov 25, 2009).
24. Castro KG, Ward JW, Slutsker L, et al. 1993 revised classification system for HIV infection and expanded surveillance case definition for aids among adolescents and adults. MMWR Recomm Rep 1992; 41: 1-19.
25. Division of AIDS table for grading the severity of adult and pediatric adverse events. December, 2004. http://www.ucdmc.ucdavis.edu/clinicaltrials/ documents/DAIDS-AE-GradingTable-FinalDec2004.pdf (accessed April 16, 2009).
26. South African National Antiretroviral Treatment Guidelines, National Department of Health, South Africa. 1st edn, 2004. http://www.doh.gov.za/docs/ factsheets/guidelines/artguidelines04/intro.pdf (accessed June 6, 2010).
27. WHO. Addendum to 2006 WHO guidelines on antiretroviral therapy for HIV infection in adults and adolescents. New dosage recommendations for stavudine (d4t). Geneva: World Health Organization, 2007. http://www.who.int/hiv/art/ ARTadultsaddendum.pdf (accessed Nov 25, 2009).
28. Charalambous S, Grant AD, Day JH, et al. Establishing a work place antiretroviral therapy programme in South Africa. AIDS Care 2007; 19: 34-41.
29. Shumbushe F, van Griesven J, Lowrance D, et al. Task shifting for scale-up of HIV care: evaluation of nurse-centered antiretroviral treatment at rural health centers in Rwanda. Plos Med 2009; 6: e1000163.
30. Cohen R, Lynch S, Bygrave H, et al. Antiretroviral treatment outcomes from a nurse-driven, community-supported HIV/AIDS treatment programme in Lesotho: observational cohort assessment at two years. J IAS 2009; 12: 23.
31. Fairall L, Zwarenstein M, Bateman ED, et al. Educational outreach to nurses improves tuberculosis case detection and primary care of respiratory illness: a pragmatic cluster randomised controlled trial. BMJ 2005; 331: 750-754
32. Keitz SA, Box TL, Homan RK, Bartlett JA, Oddone EZ. Primary care for patients infected with human immunodeficiency virus: a randomised controlled trial. J Gen Intern Med 2001; 16: 573-582
33. Smith S, Robinson J, Hollyer J, et al. Combining specialist and primary health care teams for HIV positive patients: retrospective and prospective studies. BMJ 1996; 312: 416-420
34. Laurant M, Reeves D, Hermens R, et al. Substitution of doctors by nurses in primary care. Cochrane Database Syst Rev 2005; 2: CD001271.
35. WHO. Towards universal access by 2010. How WHO is working with countries to scale-up HIV prevention, treatment, care and support. Geneva: World Health Organization, 2006.
36. Granich RM, Gilks CF, Dye C, De Cock KM, Williams BG. Universal voluntary HIV testing with immediate antiretroviral therapy as a strategy for elimination of HIV transmission: a mathematical model. Lancet 2009; 373: 48-57.
37. WHO. Antiretroviral therapy for HIV infection in adults and adolescents. Recommendations for a public health approach (2006 revision). Geneva: World Health Organization, 2006. http://www.who.int/hiv/pub/arv/adult/en/index.html (accessed Nov 25, 2009).
38. Clinical guidelines for the management of HIV & AIDS in adults and adolescents. National Department of Health, South Africa. 2nd edn, 2010. http://www.doh.gov.za/docs/(accessed June 6, 2010).
39. Boulle A, Orrell C, Kaplan R, et al. Substitutions due to antiretroviral toxicity or contraindication in the first 3 years of antiretroviral therapy in a large South African cohort. Antivir Ther 2007; 12: 753-760
40. Fox MP, Sydney Rosen S. Patient retention in antiretroviral therapy programs up to three years on treatment in sub-Saharan Africa, 2007-2009: systematic review. Trop Med Int Health 2010; 15 (suppl 1): 1-15.