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Open Access 01-12-2016 | Study protocol

HealthMap: a cluster randomised trial of interactive health plans and self-management support to prevent coronary heart disease in people with HIV

Authors: Sarity Dodson, Karen M. Klassen, Karalyn McDonald, Tanya Millard, Richard H. Osborne, Malcolm W. Battersby, Christopher K. Fairley, Julie A. Simpson, Paula Lorgelly, Andrew Tonkin, Janine Roney, Sean Slavin, Jasminka Sterjovski, Margot Brereton, Sharon R. Lewin, Levinia Crooks, Jo Watson, Michael R. Kidd, Irith Williams, Julian H. Elliott

Published in: BMC Infectious Diseases | Issue 1/2016

Abstract

Background

The leading causes of morbidity and mortality for people in high-income countries living with HIV are now non-AIDS malignancies, cardiovascular disease and other non-communicable diseases associated with ageing. This protocol describes the trial of HealthMap, a model of care for people with HIV (PWHIV) that includes use of an interactive shared health record and self-management support. The aims of the HealthMap trial are to evaluate engagement of PWHIV and healthcare providers with the model, and its effectiveness for reducing coronary heart disease risk, enhancing self-management, and improving mental health and quality of life of PWHIV.

Methods/Design

The study is a two-arm cluster randomised trial involving HIV clinical sites in several states in Australia. Doctors will be randomised to the HealthMap model (immediate arm) or to proceed with usual care (deferred arm). People with HIV whose doctors are randomised to the immediate arm receive 1) new opportunities to discuss their health status and goals with their HIV doctor using a HealthMap shared health record; 2) access to their own health record from home; 3) access to health coaching delivered by telephone and online; and 4) access to a peer moderated online group chat programme. Data will be collected from participating PWHIV (n = 710) at baseline, 6 months, and 12 months and from participating doctors (n = 60) at baseline and 12 months. The control arm will be offered the HealthMap intervention at the end of the trial. The primary study outcomes, measured at 12 months, are 1) 10-year risk of non-fatal acute myocardial infarction or coronary heart disease death as estimated by a Framingham Heart Study risk equation; and 2) Positive and Active Engagement in Life Scale from the Health Education Impact Questionnaire (heiQ).

Discussion

The study will determine the viability and utility of a novel technology-supported model of care for maintaining the health and wellbeing of people with HIV. If shown to be effective, the HealthMap model may provide a generalisable, scalable and sustainable system for supporting the care needs of people with HIV, addressing issues of equity of access.

Trial registration

Universal Trial Number (UTN) U111111506489; ClinicalTrial.gov Id NCT02178930 submitted 29 June 2014

Global report: UNAIDS report on the global AIDS epidemic 2013. Joint United Nations Programme on HIV/AIDS (UNAIDS). ISBN 978-92-9253-032-7.

Health NCDoP. 2012 HIV/STD Surveillance Report: North Carolina Department of Health and Human Services. State of North Carolina: Division of Public Health; 2012.

Antiretroviral Therapy Cohort C. Life expectancy of individuals on combination antiretroviral therapy in high-income countries: a collaborative analysis of 14 cohort studies. Lancet. 2008;372(9635):293–9. doi:10.1016/S0140-6736(08)61113-7.CrossRef

Harrison KM, Song R, Zhang X. Life expectancy after HIV diagnosis based on national HIV surveillance data from 25 states, United States. J Acquir Immune Defic Syndr. 2010;53(1):124–30. doi:10.1097/QAI.0b013e3181b563e7.CrossRefPubMed

Samji H, Cescon A, Hogg RS, Modur SP, Althoff KN, Buchacz K, et al. Closing the gap: increases in life expectancy among treated HIV-positive individuals in the United States and Canada. PLoS One. 2013;8(12):e81355. doi:10.1371/journal.pone.0081355.CrossRefPubMedPubMedCentral

May M, Gompels M, Delpech V, Porter K, Post F, Johnson M, et al. Impact of late diagnosis and treatment on life expectancy in people with HIV-1: UK Collaborative HIV Cohort (UK CHIC) Study. BMJ. 2011;343:d6016. doi:10.1136/bmj.d6016.CrossRefPubMedPubMedCentral

Palella Jr FJ, Baker RK, Buchacz K, Chmiel JS, Tedaldi EM, Novak RM, et al. Increased mortality among publicly insured participants in the HIV Outpatient Study despite HAART treatment. AIDS. 2011;25(15):1865–76. doi:10.1097/QAD.0b013e32834b3537.CrossRefPubMed

Shah SS, McGowan JP, Smith C, Blum S, Klein RS. Comorbid conditions, treatment, and health maintenance in older persons with human immunodeficiency virus infection in New York City. Clin Infect Dis. 2002;35(10):1238–43. doi:10.1086/343048.CrossRefPubMed

Powderly WG. Integrase inhibitors in the treatment of HIV-1 infection. J Antimicrob Chemother. 2010;65(12):2485–8. doi:10.1093/jac/dkq350.CrossRefPubMed

10.

Vance DE, Mugavero M, Willig J, Raper JL, Saag MS. Aging with HIV: a cross-sectional study of comorbidity prevalence and clinical characteristics across decades of life. J Assoc Nurses AIDS Care. 2011;22(1):17–25. doi:10.1016/j.jana.2010.04.002.CrossRefPubMed

11.

Palella Jr FJ, Baker RK, Moorman AC, Chmiel JS, Wood KC, Brooks JT, et al. Mortality in the highly active antiretroviral therapy era: changing causes of death and disease in the HIV outpatient study. J Acquir Immune Defic Syndr. 2006;43(1):27–34. doi:10.1097/01.qai.0000233310.90484.16.CrossRefPubMed

12.

Lewden C, May T, Rosenthal E, Burty C, Bonnet F, Costagliola D, et al. Changes in causes of death among adults infected by HIV between 2000 and 2005: The “Mortalite 2000 and 2005” surveys (ANRS EN19 and Mortavic). J Acquir Immune Defic Syndr. 2008;48(5):590–8. doi:10.1097/QAI.0b013e31817efb54.CrossRefPubMed

13.

Grulich AE, van Leeuwen MT, Falster MO, Vajdic CM. Incidence of cancers in people with HIV/AIDS compared with immunosuppressed transplant recipients: a meta-analysis. Lancet. 2007;370(9581):59–67. doi:10.1016/S0140-6736(07)61050-2.CrossRefPubMed

14.

Soriano V, Vispo E, Labarga P, Medrano J, Barreiro P. Viral hepatitis and HIV co-infection. Antiviral Res. 2010;85(1):303–15. doi:10.1016/j.antiviral.2009.10.021.CrossRefPubMed

15.

Soriano V, Barreiro P, Sherman KE. The changing epidemiology of liver disease in HIV patients. AIDS Rev. 2013;15(1):25–31.PubMed

16.

Soriano V, Puoti M, Sulkowski M, Cargnel A, Benhamou Y, Peters M, et al. Care of patients coinfected with HIV and hepatitis C virus: 2007 updated recommendations from the HCV-HIV International Panel. AIDS. 2007;21(9):1073–89. doi:10.1097/QAD.0b013e3281084e4d.CrossRefPubMed

17.

Puoti M, Moioli MC, Travi G, Rossotti R. The burden of liver disease in human immunodeficiency virus-infected patients. Semin Liver Dis. 2012;32(2):103–13. doi:10.1055/s-0032-1316473.CrossRefPubMed

18.

Choi AI, Rodriguez RA, Bacchetti P, Bertenthal D, Volberding PA, O’Hare AM. Racial differences in end-stage renal disease rates in HIV infection versus diabetes. J Am Soc Nephrol. 2007;18(11):2968–74. doi:10.1681/ASN.2007040402.CrossRefPubMed

19.

Horberg M, Tang B, Towner W, Silverberg M, Bersoff-Matcha S, Hurley L, et al. Impact of tenofovir on renal function in HIV-infected, antiretroviral-naive patients. J Acquir Immune Defic Syndr. 2010;53(1):62–9. doi:10.1097/QAI.0b013e3181be6be2.CrossRefPubMed

20.

Simioni S, Cavassini M, Annoni JM, Rimbault Abraham A, Bourquin I, Schiffer V, et al. Cognitive dysfunction in HIV patients despite long-standing suppression of viremia. AIDS. 2010;24(9):1243–50. doi:10.1097/QAD.0b013e3283354a7b.PubMed

21.

Brown TT, Qaqish RB. Antiretroviral therapy and the prevalence of osteopenia and osteoporosis: a meta-analytic review. AIDS. 2006;20(17):2165–74. doi:10.1097/QAD.0b013e32801022eb.CrossRefPubMed

22.

Triant VA, Brown TT, Lee H, Grinspoon SK. Fracture prevalence among human immunodeficiency virus (HIV)-infected versus non-HIV-infected patients in a large U.S. healthcare system. J Clin Endocrinol Metab. 2008;93(9):3499–504. doi:10.1210/jc.2008-0828.CrossRefPubMedPubMedCentral

23.

Morrison MF, Petitto JM, Ten Have T, Gettes DR, Chiappini MS, Weber AL, et al. Depressive and anxiety disorders in women with HIV infection. Am J Psychiatry. 2002;159(5):789–96.CrossRefPubMed

24.

Orlando M, Burnam MA, Beckman R, Morton SC, London AS, Bing EG, et al. Re-estimating the prevalence of psychiatric disorders in a nationally representative sample of persons receiving care for HIV: results from the HIV Cost and Services Utilization Study. Int J Methods Psychiatr Res. 2002;11(2):75–82.CrossRefPubMed

25.

Freiberg MS, Chang CC, Kuller LH, Skanderson M, Lowy E, Kraemer KL, et al. HIV infection and the risk of acute myocardial infarction. JAMA Intern Med. 2013;173(8):614–22. doi:10.1001/jamainternmed.2013.3728.CrossRefPubMedPubMedCentral

26.

Hunt PW, Martin JN, Sinclair E, Bredt B, Hagos E, Lampiris H, et al. T cell activation is associated with lower CD4+ T cell gains in human immunodeficiency virus-infected patients with sustained viral suppression during antiretroviral therapy. J Infect Dis. 2003;187(10):1534–43. doi:10.1086/374786.CrossRefPubMed

27.

Brown TT, Cole SR, Li X, Kingsley LA, Palella FJ, Riddler SA, et al. Antiretroviral therapy and the prevalence and incidence of diabetes mellitus in the multicenter AIDS cohort study. Arch Intern Med. 2005;165(10):1179–84. doi:10.1001/archinte.165.10.1179.CrossRefPubMed

28.

Worm SW, Sabin C, Weber R, Reiss P, El-Sadr W, Dabis F, et al. Risk of myocardial infarction in patients with HIV infection exposed to specific individual antiretroviral drugs from the 3 major drug classes: the data collection on adverse events of anti-HIV drugs (D:A:D) study. J Infect Dis. 2010;201(3):318–30. doi:10.1086/649897.CrossRefPubMed

29.

Petoumenos K, Worm S, Reiss P, de Wit S, d’Arminio Monforte A, Sabin C, et al. Rates of cardiovascular disease following smoking cessation in patients with HIV infection: results from the D:A:D study(*). HIV Med. 2011;12(7):412–21. doi:10.1111/j.1468-1293.2010.00901.x.CrossRefPubMedPubMedCentral

30.

Gingo MR. The changing landscape of HIV-related lung disease: non-AIDS lung malignancy as a player in the field. Respirology. 2014;19(3):300–2. doi:10.1111/resp.12249.CrossRefPubMedPubMedCentral

31.

Mdodo R, Frazier EL, Dube SR, Mattson CL, Sutton MY, Brooks JT, et al. Cigarette smoking prevalence among adults with HIV compared with the general adult population in the United States: cross-sectional surveys. Ann Intern Med. 2015;162(5):335–44. doi:10.7326/M14-0954.CrossRefPubMed

32.

Armah KA, Chang CC, Baker JV, Ramachandran VS, Budoff MJ, Crane HM, et al. Prehypertension, hypertension, and the risk of acute myocardial infarction in HIV-infected and -uninfected veterans. Clin Infect Dis. 2014;58(1):121–9. doi:10.1093/cid/cit652.CrossRefPubMedPubMedCentral

33.

Tien PC, Schneider MF, Cox C, Karim R, Cohen M, Sharma A, et al. Association of HIV infection with incident diabetes mellitus: impact of using hemoglobin A1C as a criterion for diabetes. J Acquir Immune Defic Syndr. 2012;61(3):334–40. doi:10.1097/QAI.0b013e31826bfc32.CrossRefPubMedPubMedCentral

34.

Deeks SG, Phillips AN. HIV infection, antiretroviral treatment, ageing, and non-AIDS related morbidity. BMJ. 2009;338:a3172. doi:10.1136/bmj.a3172.CrossRefPubMed

35.

Wilson IB, Laws MB, Safren SA, Lee Y, Lu M, Coady W, et al. Provider-focused intervention increases adherence-related dialogue but does not improve antiretroviral therapy adherence in persons with HIV. J Acquir Immune Defic Syndr. 2010;53(3):338–47. doi:10.1097/QAI.0b013e3181c7a245.CrossRefPubMedPubMedCentral

36.

Nakagawa F, May M, Phillips A. Life expectancy living with HIV: recent estimates and future implications. Curr Opin Infect Dis. 2013;26(1):17–25. doi:10.1097/QCO.0b013e32835ba6b1.CrossRefPubMed

37.

Bloch M, Hoy J, Cunningham N, Roth N, Bailey M, Pierce A, et al. Adherence to HIV Treatment Guidelines for Comorbid Disease Assessment and Initiation of Antiretroviral Therapy. J Acquir Immune Defic Syndr. 2012;59(5):478–88. doi:10.1097/QAI.0b013e31824a5473.CrossRefPubMed

38.

Chan D, Gracey D, Bailey M, Richards D, Dalton B. Screening and management of cardiovascular disease in Australian adults with HIV infection. Sex Health. 2013;10(6):495–501. doi:10.1071/sh13009.CrossRefPubMed

39.

Seventh National HIV Strategy 2014-2017. Commonwealth of Australia 2014. ISBN: 978-1-74186-168-6.

40.

Gifford AL, Laurent DD, Gonzales VM, Chesney MA, Lorig KR. Pilot randomized trial of education to improve self-management skills of men with symptomatic HIV/AIDS. J Acquir Immune Defic Syndr Hum Retrovirol. 1998;18(2):136–44.CrossRefPubMed

41.

Gifford AL, Sengupta S. Self-management health education for chronic HIV infection. AIDS Care. 1999;11(1):115–30. doi:10.1080/09540129948243.CrossRefPubMed

42.

Inouye J, Flannelly L, Flannelly KJ. The effectiveness of self-management training for individuals with HIV/AIDS. J Assoc Nurses AIDS Care. 2001;12(5):71–82.CrossRefPubMed

43.

Gifford AL, Groessl EJ. Chronic disease self-management and adherence to HIV medications. J Acquir Immune Defic Syndr. 2002;31 Suppl 3:S163–6.CrossRefPubMed

44.

Wilson PW, D’Agostino RB, Levy D, Belanger AM, Silbershatz H, Kannel WB. Prediction of coronary heart disease using risk factor categories. Circulation. 1998;97(18):1837–47.CrossRefPubMed

45.

Osborne RH, Elsworth GR, Whitfield K. The Health Education Impact Questionnaire (heiQ): an outcomes and evaluation measure for patient education and self-management interventions for people with chronic conditions. Patient Educ Couns. 2007;66(2):192–201. doi:10.1016/j.pec.2006.12.002.CrossRefPubMed

46.

European Association for Cardiovascular Prevention, Rehabilitation, Reiner Z, Catapano AL, De Backer G, Graham I, et al. ESC/EAS Guidelines for the management of dyslipidaemias: the Task Force for the management of dyslipidaemias of the European Society of Cardiology (ESC) and the European Atherosclerosis Society (EAS). Eur Heart J. 2011;32(14):1769–818. doi:10.1093/eurheartj/ehr158.CrossRef

47.

Lee A, Gin T, Chui PT, Tan PE, Chiu CH, Tam TP, et al. The accuracy of urinary cotinine immunoassay test strip as an add-on test to self-reported smoking before major elective surgery. Nicotine Tob Res. 2013;15(10):1690–5. doi:10.1093/ntr/ntt039.CrossRefPubMed

48.

Yeh E, Levasseur G, Kaiserman MJ. Evaluation of urinary cotinine immunoassay test strips used to assess smoking status. Nicotine Tob Res. 2011;13(11):1045–51. doi:10.1093/ntr/ntr127.CrossRefPubMed

49.

National Vascular Disease Prevention Alliance. Guidelines for the management of absolute cardiovascular disease risk. 2012. The National Stroke Foundation, Australia. ISBN: 978-0-9872830-1-6

50.

Hawthorne G, Richardson J, Osborne R. The Assessment of Quality of Life (AQoL) instrument: a psychometric measure of health-related quality of life. Qual Life Res. 1999;8(3):209–24.CrossRefPubMed

51.

Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995;33(3):335–43.CrossRefPubMed

52.

Herek GM, Saha S, Burack J. Stigma and Psychological Distress in People With HIV/AIDS. Basic Appl Soc Psych. 2013;35(1):41–54. doi:10.1080/01973533.2012.746606.CrossRef

53.

ASHM Sub-Committee for Guidance on HIV Management. 2013 Antiretroviral Guidelines with Australian Commentary. Sydney: Australasian Society for HIV Medicine; 2013.

54.

StatCorp. Stata Statistical Software: Release 13. College Station: StataCorp LP; 2013.

55.

Osborne RH DS, Batterham R, Buchbinder R, McCabe M, Ginnifer Y, Cavill S. Chronic disease self-management (CDSM) for people with musculoskeletal and mental health problems - a new flexible web-based system to serve patients, clinicians and organisations. Ann Rheum Dis. 2012;71:122. doi:WOS:000208898500404.CrossRef

56.

Battersby MWAA, Reece MM, Markwick MJ, Collins JP. The partners in health scale. Aust J Prim Health. 2003;9(3):41–52. doi:10.1071/PY03022.CrossRef

57.

Millard T, Elliott J, Slavin S, McDonald K, Rowell S, Girdler S. The positive outlook study- a randomised controlled trial evaluating the effectiveness of an online self-management program targeting psychosocial issues for men living with HIV: a study protocol. BMC Public Health. 2014;14:106. doi:10.1186/1471-2458-14-106.CrossRefPubMedPubMedCentral

58.

Martin A, Bloch M, Amin J, Baker D, Cooper DA, Emery S, et al. Simplification of antiretroviral therapy with tenofovir-emtricitabine or abacavir-Lamivudine: a randomized, 96-week trial. Clin Infect Dis. 2009;49(10):1591–601. doi:10.1086/644769.CrossRefPubMed

59.

Chodosh J, Morton SC, Mojica W, Maglione M, Suttorp MJ, Hilton L, et al. Meta-analysis: chronic disease self-management programs for older adults. Ann Intern Med. 2005;143(6):427–38.CrossRefPubMed

60.

Benner JS, Erhardt L, Flammer M, Moller RA, Rajicic N, Changela K, et al. A novel programme to evaluate and communicate 10-year risk of CHD reduces predicted risk and improves patients’ modifiable risk factor profile. Int J Clin Pract. 2008;62(10):1484–98. doi:10.1111/j.1742-1241.2008.01872.x.CrossRefPubMedPubMedCentral

61.

Lee KJ, Simpson JA. Introduction to multiple imputation for dealing with missing data. Respirology. 2014;19(2):162–7. doi:10.1111/resp.12226.CrossRefPubMed

62.

Sterne JA, White IR, Carlin JB, Spratt M, Royston P, Kenward MG, et al. Multiple imputation for missing data in epidemiological and clinical research: potential and pitfalls. BMJ. 2009;338:b2393. doi:10.1136/bmj.b2393.CrossRefPubMedPubMedCentral

Title: HealthMap: a cluster randomised trial of interactive health plans and self-management support to prevent coronary heart disease in people with HIV
Authors: Sarity Dodson
Karen M. Klassen
Karalyn McDonald
Tanya Millard
Richard H. Osborne
Malcolm W. Battersby
Christopher K. Fairley
Julie A. Simpson
Paula Lorgelly
Andrew Tonkin
Janine Roney
Sean Slavin
Jasminka Sterjovski
Margot Brereton
Sharon R. Lewin
Levinia Crooks
Jo Watson
Michael R. Kidd
Irith Williams
Julian H. Elliott
Publication date: 01-12-2016
Publisher: BioMed Central
Published in: BMC Infectious Diseases / Issue 1/2016
Electronic ISSN: 1471-2334
DOI: https://doi.org/10.1186/s12879-016-1422-5

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Abstract

Background

Methods/Design

Discussion

Trial registration

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