Comparative cost analysis of point-of-care versus laboratory-based testing to initiate and monitor HIV treatment in South Africa


Autoři: Kate Simeon aff001;  Monisha Sharma aff002;  Jienchi Dorward aff003;  Jessica Naidoo aff003;  Ntuthu Dlamini aff004;  Pravikrishnen Moodley aff005;  Natasha Samsunder aff003;  Ruanne V. Barnabas aff001;  Nigel Garrett aff003;  Paul K. Drain aff001
Působiště autorů: Department of Medicine, School of Medicine, University of Washington, Seattle, Washington, United States of America aff001;  Department of Global Health, Schools of Public Health and Medicine, University of Washington, Seattle, Washington, United States of America aff002;  Centre for the AIDS Programme of Research in South Africa (CAPRISA), University of KwaZulu–Natal, Durban, South Africa aff003;  Prince Cyril Zulu Communicable Disease Clinic, Ethekwini Municipality, Durban, South Africa aff004;  Department of Virology, National Health Laboratory Service and University of KwaZulu-Natal, Durban, South Africa aff005;  Department of Epidemiology, School of Public Health, University of Washington, Seattle, Washington, United States of America aff006;  Discipline of Public Health Medicine, School of Nursing and Public Health, University of KwaZulu-Natal, Durban, South Africa aff007
Vyšlo v časopise: PLoS ONE 14(10)
Kategorie: Research Article
doi: 10.1371/journal.pone.0223669

Souhrn

Background

The number of people living with HIV (PLHIV) in need of treatment monitoring in low-and-middle-income countries has been rapidly expanding, placing an increasing burden on laboratories. Promising new point-of-care (POC) test have the potential to reduce laboratory workloads, but the implementation cost is uncertain. We sought to estimate the costs of decentralized POC testing compared to centralized laboratory testing for PLHIV initiating treatment in South Africa.

Methods

We conducted a microcosting analyses comparing clinic-based POC testing to centralized laboratory testing for HIV viral load, creatinine, and CD4 count monitoring. We completed time-and-motion studies to assess staff time for sample collection and processing. Instrument costs were estimated assuming five-year lifespans and we applied a 3% annual discount rate. Total costs and cost per patient were estimated over a five-year period: the first year of ART initiation and four years of routine HIV monitoring, following World Health Organization ART monitoring guidelines.

Results

We estimated that per-patient costs of POC HIV viral load, CD4, and creatinine tests were USD $25, $11, and $9, respectively, assuming a clinic volume of 50 patients initiated per month. At centralized laboratories, per-patient costs of POC HIV viral load, CD4, and creatinine tests were USD $26, $6, $3. Total monitoring costs of all testing over a 5-year period was $45 higher for POC testing compared to centralized laboratory testing ($210 vs $166).

Conclusions

POC testing for HIV care and treatment can be feasibly implemented within clinics in South Africa, particularly those with larger patient volumes. POC HIV viral load costs are similar to lab-based testing while CD4 count and creatinine testing are more costly as POC tests. Our cost estimates are useful to policymakers in planning resource allocation and can inform cost-effectiveness analyses of POC testing.

Klíčová slova:

Antiretroviral therapy – Clinical laboratories – Creatinine – Government laboratories – HIV – South Africa – Viral load – Laboratory tests


Zdroje

1. UNAIDS. Fact sheet–Latest global and regional statistics on the status of the AIDS epidemic [Internet]. 2016 [cited 2017 Jul 19]. Available from: http://www.unaids.org/en/resources/fact-sheet

2. Adesina A, Stover J, Cross D, NeSmith T, Gauval M, Jenkins S, et al. Combined Global Demand Forecasts for Antiretroviral Medicines and Hiv Diagnostics in Low-and Middle-Income Countries From 2015 To 2020. WHO Tech Rep [Internet]. 2016;(September):64. Available from: http://apps.who.int/iris/bitstream/10665/250088/1/9789241511322-eng.pdf?ua=1

3. African Society for Laboratory Medicine Conference Abstracts [Internet]. African Society for Laboratory Medicine Conference Abstracts. 2012 [cited 2017 Jul 19]. p. 157–412. Available from: http://www.who.int/hiv/amds/amds_diagnostic2016_ppt_ASLM.pdf?ua=1

4. Habiyambere V, Ford N, Low-Beer D, Nkengasong J, Sands A, Pérez González M, et al. Availability and Use of HIV Monitoring and Early Infant Diagnosis Technologies in WHO Member States in 2011–2013: Analysis of Annual Surveys at the Facility Level. PLoS Med. 2016;13(8):1–21.

5. Peter T, Zeh C, Katz Z, Elbireer A, Alemayehu B, Vojnov L, et al. Scaling up HIV viral load—Lessons from the large-scale implementation of HIV early infant diagnosis and CD4 testing: J Int AIDS Soc. 2017;20:9–15.

6. Lecher S, Ellenberger D, Kim AA, Fonjungo PN, Agolory S, Borget MY, et al. Scale-up of HIV Viral Load Monitoring—Seven Sub-Saharan African Countries. MMWR Morb Mortal Wkly Rep [Internet]. 2015 Nov 27 [cited 2018 Jun 9];64(46):1287–90. Available from: http://www.ncbi.nlm.nih.gov/pubmed/26605986 doi: 10.15585/mmwr.mm6446a3 26605986

7. Drain PK, Hyle EP, Noubary F, Freedberg KA, Wilson D, Bishai WR, et al. Diagnostic point-of-care tests in resource-limited settings. Vol. 14, The Lancet Infectious Diseases. 2014. p. 239–49. doi: 10.1016/S1473-3099(13)70250-0 24332389

8. Pham MD, Romero L, Parnell B, Anderson DA, Crowe SM, Luchters S. Feasibility of antiretroviral treatment monitoring in the era of decentralized HIV care: a systematic review. AIDS Res Ther [Internet]. 2017 Jan 19 [cited 2017 Aug 14];14(3):1–18. Available from: http://www.ncbi.nlm.nih.gov/pubmed/28103895

9. Vojnov L, Markby J, Boeke C, Harris L, Ford N, Peter T. POC CD4 testing improves linkage to HIV care and timeliness of ART initiation in a public health approach: A systematic review and Meta-Analysis. Vol. 11, PLoS ONE. 2016.

10. Larson B, Schnippel K, Ndibongo B, Long L, Fox MP, Rosen S. How to estimate the cost of point-of-care CD4 testing in program settings: An example using the Alere Pima analyzer in South Africa. PLoS One [Internet]. 2012 [cited 2017 Jul 14];7(4). Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3331987/pdf/pone.0035444.pdf

11. Jani I V, Sitoe NE, Alfai ER, Chongo PL, Quevedo JI, Rocha BM, et al. Effect of point-of-care CD4 cell count tests on retention of patients and rates of antiretroviral therapy initiation in primary health clinics: an observational cohort study. Lancet [Internet]. 2011 Oct 29 [cited 2018 Jun 10];378(9802):1572–9. Available from: https://www-sciencedirect-com.offcampus.lib.washington.edu/science/article/pii/S0140673611610520?via%3Dihub doi: 10.1016/S0140-6736(11)61052-0 21951656

12. Gous NM, Scott LE, Potgieter J, Ntabeni L, Sanne I, Stevens WS. Implementation and Operational Research: Implementation of Multiple Point-of-Care Testing in 2 HIV Antiretroviral Treatment Clinics in South Africa. J Acquir Immune Defic Syndr. 2016;71(2):e34—43. doi: 10.1097/QAI.0000000000000872 26484742

13. Herbert S, Edwards S, Carrick G, Copas A, Sandford C, Amphlett M, et al. Evaluation of PIMA point-of-care CD4 testing in a large UK HIV service. Sex Transm Infect [Internet]. 2012 [cited 2017 Jul 14];88(6):413–7. Available from: http://sti.bmj.com.offcampus.lib.washington.edu/content/sextrans/88/6/413.full.pdf doi: 10.1136/sextrans-2012-050507 22544309

14. Larson BA, Schnippel K, Ndibongo B, Xulu T, Brennan A, Long L, et al. Rapid point-of-care CD4 testing at mobile HIV testing sites to increase linkage to care: an evaluation of a pilot program in South Africa. [Internet]. Vol. 61, Journal of acquired immune deficiency syndromes (1999). 2012 [cited 2017 Jul 14]. p. e13–7. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3458178/pdf/nihms386336.pdf

15. Gueudin M, Baron A, Alessandri-Gradt E, Lemee V, Mourez T, Etienne M, et al. Performance evaluation of the new HIV-1 quantification assay, Xpert HIV-1 viral load, on a wide panel of HIV-1 variants. J Acquir Immune Defic Syndr [Internet]. 2016;72(5):521–6. Available from: http://journals.lww.com/jaids/pages/default.aspx%5Cnhttp://ovidsp.ovid.com/ovidweb.cgi?T=JS&CSC=Y&NEWS=N&PAGE=fulltext&D=emed18b&AN=609208627%5Cnhttp://ovidsp.ovid.com/ovidweb.cgi?T=JS&CSC=Y&NEWS=N&PAGE=fulltext&D=prem&AN=27007866 doi: 10.1097/QAI.0000000000001003 27007866

16. Kosack CS, De Kieviet W, Bayrak K, Milovic A, Page AL. Evaluation of the Nova StatSensor® XpressTM creatinine point-of-care handheld analyzer. PLoS One [Internet]. 2015 [cited 2017 Jul 14];10(4). Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4401790/pdf/pone.0122433.pdf

17. UNAIDS. Ending Aids Progress Towards the 90-90-90 Targets. Glob Aids Updat [Internet]. 2017;198. Available from: http://www.unaids.org/sites/default/files/media_asset/Global_AIDS_update_2017_en.pdf

18. Human Sciences Research Council. HIV Impact Assessment Summary. 2018 [cited 2019 Feb 11];(July). Available from: http://www.hsrc.ac.za/uploads/pageContent/9234/SABSSMV_Impact_Assessment_Summary_ZA_ADS_cleared_PDFA4.pdf

19. National Health Laboratory Service. State Price List 2013. 2013; Available from: http://www.health.gov.za/docs/programes/2014/NHLS-StatePriceList2013ANNEXURE-M.pdf

20. Dorward J, Garrett N, Quame-Amaglo J, Samsunder N, Ngobese H, Ngomane N, et al. Protocol for a randomised controlled implementation trial of point-of-care viral load testing and task shifting: the Simplifying HIV TREAtment and Monitoring (STREAM) study. BMJ Open [Internet]. 2017 Sep 27 [cited 2018 Apr 17];7(9):e017507. Available from: doi: 10.1136/bmjopen-2017-017507 28963304

21. Drummond M, Sculpher M, Torrance G, O’Brian B, Stoddart G. Methods for The Economic Evaluation of Health Care Programmes [Internet]. 3rd ed. New York: Oxford University Press; 2005 [cited 2019 Jun 11]. Available from: https://www.researchgate.net/publication/227467531_Methods_for_The_Economic_Evaluation_of_Health_Care_Programmes

22. WHO | WHO-CHOICE [Internet]. WHO. World Health Organization; 2014 [cited 2019 Aug 25]. Available from: https://www.who.int/choice/cost-effectiveness/en/

23. National Department of Health South Africa. Clinical Guidelines for the Management of Hiv & Aids in Adults and Adoloscents—[Internet]. 2010 [cited 2017 Jul 14]. p. 42. Available from: http://www.who.int/hiv/pub/guidelines/south_africa_art.pdf

24. XE: Convert ZAR/USD. South Africa Rand to United States Dollar [Internet]. [cited 2016 Jul 12]. Available from: https://www.xe.com/currencyconverter/convert/?Amount=1&From=ZAR&To=USD

25. Koenig SP, Schackman BR, Riviere C, Leger P, Charles M, Severe P, et al. Clinical impact and cost of monitoring for asymptomatic laboratory abnormalities among patients receiving antiretroviral therapy in a resource-poor setting. Clin Infect Dis [Internet]. 2010 Sep 1 [cited 2018 Apr 19];51(5):600–8. Available from: http://www.ncbi.nlm.nih.gov/pubmed/20649436 doi: 10.1086/655762 20649436

26. Gupta A, Juneja S, Vitoria M, Habiyambere V, Nguimfack BD, Doherty M, et al. Projected Uptake of New Antiretroviral (ARV) Medicines in Adults in Low- and Middle-Income Countries: A Forecast Analysis 2015–2025. Sluis-Cremer N, editor. PLoS One [Internet]. 2016 Oct 13 [cited 2019 Feb 11];11(10):e0164619. Available from: https://dx.plos.org/10.1371/journal.pone.0164619 doi: 10.1371/journal.pone.0164619 27736953

27. Jain V, Chang W, Byonanebye DM, Owaraganise A, Twinomuhwezi E, Amanyire G, et al. Estimated costs for delivery of HIV antiretroviral therapy to individuals with CD4+ T-cell counts >350 cells/uL in rural Uganda. PLoS One [Internet]. 2015 [cited 2018 May 19];10(12):e0143433. Available from: http://www.ncbi.nlm.nih.gov/pubmed/26632823 doi: 10.1371/journal.pone.0143433 26632823

28. Hyle EP, Jani I V, Lehe J, Su AE, Wood R, Quevedo J, et al. The Clinical and Economic Impact of Point-of-Care CD4 Testing in Mozambique and Other Resource-Limited Settings: A Cost-Effectiveness Analysis. PLoS Med [Internet]. 2014 [cited 2017 Jul 14];11(9). Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4165752/pdf/pmed.1001725.pdf

29. Frank SC, Cohn J, Dunning L, Sacks E, Walensky RP, Mukherjee S, et al. Articles Clinical effect and cost-effectiveness of incorporation of point-of-care assays into early infant HIV diagnosis programmes in Zimbabwe: a modelling study. Lancet HIV [Internet]. 2019 [cited 2019 Feb 11]; Available from: http://dx.doi.org/10.1016/S2352-3018

30. Global TB Programme World Health Organization. Xpert MTB/RIF implementation manual Technical and operational ‘how-to’: practical considerations [Internet]. 2014 [cited 2019 Feb 11]. Available from: www.who.int

31. Menzies NA, Berruti AA, Berzon R, Filler S, Ferris R, Ellerbrock T V, et al. The cost of providing comprehensive HIV treatment in PEPFAR-supported programs. AIDS [Internet]. 2011 Sep 10 [cited 2017 Aug 15];25(14):1753–60. Available from: http://www.ncbi.nlm.nih.gov/pubmed/21412127 doi: 10.1097/QAD.0b013e3283463eec 21412127

32. Rosen S, Long L. How Much Does It Cost to Provide Antiretroviral Therapy for HIV / AIDS in Africa? [Internet]. Boston; 2006 [cited 2017 Aug 15]. Available from: https://www.bu.edu/av/iaen/research-library-1/docs/13387/Rosen Cost of ART in Africa.pdf

33. Girdwood SJ, Nichols BE, Moyo C, Crompton T, Chimhamhiwa D, Rosen S. Optimizing viral load testing access for the last mile: Geospatial cost model for point of care instrument placement. Yotebieng M, editor. PLoS One [Internet]. 2019 Aug 26 [cited 2019 Aug 31];14(8):e0221586. Available from: http://dx.plos.org/10.1371/journal.pone.0221586 doi: 10.1371/journal.pone.0221586 31449559

34. Nichols BE, Girdwood SJ, Crompton T, Stewart-Isherwood L, Berrie L, Chimhamhiwa D, et al. Impact of a borderless sample transport network for scaling up viral load monitoring: results of a geospatial optimization model for Zambia. J Int AIDS Soc [Internet]. 2018 Dec 1 [cited 2019 Aug 31];21(12):e25206. Available from: doi: 10.1002/jia2.25206 30515997


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2019 Číslo 10