Evaluation of a Web-based tailored intervention (TAVIE en santé) to support people living with HIV in the adoption of health promoting behaviours: an online randomized controlled trial protocol

José Côté, Sylvie Cossette, Pilar Ramirez-Garcia, Alexandra De Pokomandy, Catherine Worthington, Marie-Pierre Gagnon, Patricia Auger, François Boudreau, Joyal Miranda, Yann-Gaël Guéhéneuc, Cécile Tremblay, José Côté, Sylvie Cossette, Pilar Ramirez-Garcia, Alexandra De Pokomandy, Catherine Worthington, Marie-Pierre Gagnon, Patricia Auger, François Boudreau, Joyal Miranda, Yann-Gaël Guéhéneuc, Cécile Tremblay

Abstract

Background: Long-term use of antiretroviral therapy, normal aging, and presence of certain risk factors are associated with metabolic disorders that predispose persons living with HIV to diabetes and cardiovascular diseases. The emergence and progression of these disorders can be prevented by adopting healthy behaviours. Based on the theory of planned behaviour, the Web-based tailored intervention TAVIE en santé was developed. The aim of this study is to evaluate the effectiveness of TAVIE en santé in order to support people living with HIV in the adoption of health promoting behaviours.

Methods/design: An online randomized controlled trial with parallel-groups will be conducted across Canada. To participate in this study, people living with HIV must be: ≥ 18 years, able to read/understand French or English, have access to the Internet. A convenience sample of 750 participants will be randomly assigned either to an experimental group (TAVIE en santé, n = 375) or to a control group (websites, n = 375) (1:1 allocation ratio). The TAVIE en santé intervention is composed of seven interactive computer sessions, lasting between 5 and 10 min. The sessions, hosted by a virtual nurse, aim to develop and strengthen skills required for behaviour change. The control group will receive a validated list of five predetermined conventional health-related Websites. The adoption of health behaviour (smoking cessation or physical activity or healthy eating) is the principal outcome. Cognitions (intention, attitude, perceived behavioral control) are the secondary outcomes. Health indicators will also be assessed. All outcomes will be measured with a self-administered online questionnaire and collected three times: at baseline, 3 and 6 months after. The principal analyses will focus on differences between the two trial groups using Intention-to-Treat analysis.

Discussion: This study will yield new results about the efficacy of Web-based tailored health behaviours change interventions in the context of chronic disease. The TAVIE en santé intervention could constitute an accessible complementary service in support of existing specialized services to support people living with HIV adopt health behaviors.

Trial registration: NCT02378766 , assigned on March 3th 2015.

Figures

Fig. 1
Fig. 1
Schedule of enrolment, interventions, and assessments
Fig. 2
Fig. 2
Study flow diagram

References

    1. Jenkin P, Koch T, Kralik D. The experience of fatigue for adults living with HIV. J Clin Nurs. 2006;15(9):1123–31. doi: 10.1111/j.1365-2702.2006.01343.x.
    1. Tsai Y-F, Holzemer WL, Leu H-S. An evaluation of the effects of a manual on management of HIV/AIDS symptoms. Int J STD AIDS. 2005;16(9):625–9. doi: 10.1258/0956462054944516.
    1. Deeks SG, Lewin SR, Havlir DV. The end of AIDS: HIV infection as a chronic disease. Lancet. 2013;382(9903):1525–33. doi: 10.1016/S0140-6736(13)61809-7.
    1. Passaes CP, Saez-Cirion A. HIV cure research: advances and prospects. Virology. 2014;454–455:340–52. doi: 10.1016/j.virol.2014.02.021.
    1. Bradbury RA, Samaras K. Antiretroviral therapy and the human immunodeficiency virus-improved survival but at what cost? Diabetes Obes Metabol. 2008;10:441–50. doi: 10.1111/j.1463-1326.2007.00760.x.
    1. Butt A, McGinnis K, Rodriguez-Barradas M, Crystal S, Simberkoff M, Goetz M, et al. HIV infection and the risk of diabetes mellitus. AIDS. 2009;23(10):1227–34. doi: 10.1097/QAD.0b013e32832bd7af.
    1. Friis-Moller N, Weber R, Reiss P, Thiébaut R, Kirk O, d’Arminio Monforte A, et al. Cardiovascular disease risk factors in HIV patients–association with antiretroviral therapy. Results from the DAD study. AIDS. 2003;17(8):1179–93. doi: 10.1097/00002030-200305230-00010.
    1. Samaras K. Prevalence and pathogenesis of diabetes mellitus in HIV-1 infection treated with combined antiretroviral therapy. J Acquir Immune Defic Syndr. 2009;50(5):499–505. doi: 10.1097/QAI.0b013e31819c291b.
    1. Sax PE. Assessing risk for cardiovascular disease in patients with human immunodeficiency virus: why it matters. Circulation. 2010;121:620–2. doi: 10.1161/CIR.0b013e3181d2c863.
    1. Lifson A, Lando H. Smoking and HIV: prevalence, health risks, and cessation strategies. Curr HIV AIDS Rep. 2012;9(3):223–30. doi: 10.1007/s11904-012-0121-0.
    1. Nahvi S, Cooperman NA. Review: the need for smoking cessation among HIV-positive smokers. AIDS Educ Prev. 2009;21(Supplement 3):14–27. doi: 10.1521/aeap.2009.21.3_supp.14.
    1. 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.
    1. Moscou-Jackson G, Commodore-Mensah Y, Farley J, DiGiacomo M. Smoking-cessation interventions in people living with HIV infection: a systematic review. J Assoc Nurses AIDS Care. 2014;25(1):32–45. doi: 10.1016/j.jana.2013.04.005.
    1. Cioe PA. Smoking cessation interventions in HIV-infected adults in North America: a literature review. J Addict Behav Ther Rehabil. 2013;2(3):1000112. doi: 10.4172/2324-9005.1000112.
    1. Santos-Lozano A, Garatachea N. Physical activity measurements using accelerometers and pedometers in HIV-infected people. J AIDS Clinic Res . 2011;2(5). doi:10.4172/2155-6113.1000126.
    1. Schuelter-Trevisol F, Wolff FH, Alencastro PR, Grigoletti S, Ikeda ML, Brandão AB, et al. Physical activity: do patients infected with HIV practice? How much? A systematic review. Curr HIV Res. 2012;10(6):487–97. doi: 10.2174/157016212802429794.
    1. Klassen K, Goff LM. Dietary intakes of HIV-infected adults in urban UK. Eur J Clin Nutr. 2013;67(8):890–3. doi: 10.1038/ejcn.2013.109.
    1. Giudici KV, Duran AC, Jaime PC. Inadequate food intake among adults living with HIV. Sao Paulo Med J. 2013;131(3):145–52.
    1. Joy T, Keogh HM, Hadigan C, Lee H, Dolan SE, Fitch K, et al. Dietary fat intake and relationship to serum lipid levels in HIV-infected patients with metabolic abnormalities in the HAART era. AIDS. 2007;21(12):1591–600. doi: 10.1097/QAD.0b013e32823644ff.
    1. Samaras K. The burden of diabetes and hyperlipidemia in treated HIV infection and approaches for cardiometabolic care. Curr HIV AIDS Rep. 2012;9:206–17. doi: 10.1007/s11904-012-0124-x.
    1. Lustria ML, Noar SM, Cortese J, Van Stee SK, Glueckauf RL, Lee J. A meta-analysis of web-delivered tailored health behavior change interventions. J Health Commun. 2013;18(9):1039–69. doi: 10.1080/10810730.2013.768727.
    1. Krebs P, Prochaska J, Rossi J. A meta-analysis of computer-tailored interventions for health behavior change. Prev Med. 2010;51(3–4):214–21. doi: 10.1016/j.ypmed.2010.06.004.
    1. Jaggers JR, Dudgeon W, Blair SN, Sui X, Burgess S, Wilcox S, et al. A home-based exercise intervention to increase physical activity among people living with HIV: study design of a randomized clinical trial. BMC Public Health. 2013;13:502. doi: 10.1186/1471-2458-13-502.
    1. Roos R, Myezwa H, van Aswegen H, Musenge E. Effects of an education and home-based pedometer walking program on ischemic heart disease risk factors in people infected with HIV: a randomized trial. J Acquir Immune Defic Syndr. 2014;67(3):268–76. doi: 10.1097/QAI.0000000000000299.
    1. Lazzaretti RK, Kuhmmer R, Sprinz E, Polanczyk CA, Ribeiro JP. Dietary intervention prevents dyslipidemia associated with highly active antiretroviral therapy in human immunodeficiency virus type 1–infected individuals a randomized trial. J Am Coll Cardiol. 2012;59(11):979–88. doi: 10.1016/j.jacc.2011.11.038.
    1. Pellowski JA, Kalichman SC. Recent advances (2011-2012) in technology-delivered interventions for people living with HIV. Curr HIV AIDS Rep. 2012;9:326–34. doi: 10.1007/s11904-012-0133-9.
    1. Saberi P, Johnson MO. Technology-based self-care methods of improving antiretroviral adherence: a systematic review. PLoS One. 2011;6(11):e27533. doi: 10.1371/journal.pone.0027533.
    1. Ajzen I. The theory of planned behavior. Organ Behav Hum Dec Process. 1991;50:179–211. doi: 10.1016/0749-5978(91)90020-T.
    1. Godin G. Les comportements dans le domaine de la santé : comprendre pour mieux intervenir. Les Presses de l’Université de Montréal. 2012.
    1. Canada PHAo . HIV and AIDS in Canada: surveillance report to December 31, 2013: Minister of Public Works and Government Services Canada. 2014.
    1. Schubart JR, Stuckey HL, Ganeshamoorthy A, Sciamanna CN. Chronic health conditions and internet behavioral interventions. Comput Informat Nurs. 2011;29(2):TC9–20.
    1. Prochaska JO, Butterworth S, Redding CA, Burden V, Perrin N, Leo M, et al. Initial efficacy of MI, TTM Tailoring and HRI’s with multiple behavior for employee health promotion. Prev Med. 2008;46:226–31. doi: 10.1016/j.ypmed.2007.11.007.
    1. Noonan D, Jiang Y, Duffy SA. Utility of biochemical verification of tobacco cessation in the Department of Veterans Affairs. Addict Behav. 2013;38(3):1792–5. doi: 10.1016/j.addbeh.2012.11.006.
    1. Velicer WF, Prochaska JO, Rossi JS, Snow MG. Assessing outcome in smoking cessation studies. Psychol Bull. 1992;111(1):23–41. doi: 10.1037/0033-2909.111.1.23.
    1. Plotnikoff RC, Taylor LM, Wilson PM, Courneya KS, Sigal RJ, Birkett N, et al. Factors associated with physical activity in Canadian adults with diabetes. Med Sci Sports Exerc. 2006;38(8):1526–34. doi: 10.1249/01.mss.0000228937.86539.95.
    1. Godin G, Jobin J, Bouillon J. Assessment of leisure time exercise behavior by self-report: a concurrent validity study. Rev Canad Sante Publique. 1986;77(5):359–62.
    1. Godin G, Shephard RJ. A simple method to assess exercise behavior in the community. Can J Appl Sport Sci. 1985;10:141–6.
    1. Canadian Diabetes Association The Canadian Diabetes Association 2003 clinical practice guidelines for the prevention and management of diabetes in Canada. Can J Diabetes. 2003;2003:27(2).
    1. Paxton AE, Strycker LA, Toobert DJ, Ammerman AS, Glasgow RE. Starting the conversation performance of a brief dietary assessment and intervention tool for health professionals. Am J Prev Med. 2011;40(1):67–71. doi: 10.1016/j.amepre.2010.10.009.
    1. Jilcott SB, Keyserling TC, Samuel-Hodge CD, Johnston LF, Gross MD, Ammerman AS. Validation of a brief dietary assessment to guide counseling for cardiovascular disease risk reduction in an underserved population. J Am Diet Assoc. 2007;107(2):246–55. doi: 10.1016/j.jada.2006.11.006.
    1. Ajzen I, Fishbein M. Understanding attitudes and predicting social behaviour. Englewood Cliffs, NJ: Prentice-Hall; 1980.
    1. Fishbein M, Ajzen I. Predicting and changing behaviour: the reasoned action approach. New York, NY: Taylor & Francis; 2010.
    1. Côté J, Godin G, Guéhéneuc YG, Rouleau G, Ramirez-Garcia P, Otis J, et al. Evaluation of a real-time virtual intervention to empower persons living with HIV for therapy self-management: study protocol for an online randomized controlled trial. Trials 2012;13(187). doi:10.1186/1745-6215-13-18.
    1. Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krleza-Jeric K, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200–7. doi: 10.7326/0003-4819-158-3-201302050-00583.
    1. Eysenbach G, CONSORT-EHEALTH Group CONSORT-EHEALTH: improving and standardizing evaluation reports of web-based and mobile health interventions. J Med Internet Res. 2011;13e(4):e126. doi: 10.2196/jmir.1923.
    1. Michalak EE, Szabo A. Guidelines for internet research: an update. Eur Psychol. 1998;3(1):70–5.
    1. Nosek BA, Banaji MR. E-research: ethics, security, design, and control in psychological research on the internet. J Soc Issues. 2002;58(1):161–76. doi: 10.1111/1540-4560.00254.
    1. Paul J, Seib R, Prescott T. The internet and clinical trials: background, online resources, examples and issues. J Med Internet Res. 2005;7(1):e5. doi: 10.2196/jmir.7.1.e5.
    1. Hershberger PE, Kavanaugh K, Hamilton R, Klock SC, Merry L, Olshansky E, et al. Development of an informational web site for recruiting research participants: process, implementation, and evaluation. Comput Informat Nurs. 2011;29(10):544–51. doi: 10.1097/NCN.0b013e318224b52f.
    1. Bennett GG, Glasgow RE. The delivery of public health interventions via the Internet: actualizing their potential. Annu Rev Public Health. 2009;30:273–92. doi: 10.1146/annurev.publhealth.031308.100235.
    1. Wright KB. Researching internet-based populations: advantages and disavantages of online survey research, online questionnaire authoring software packages, and web survey services. J Comput-Mediat Commun. 2005;10(3):article 11.
    1. Bull S, Pratte K, Whitesell N, Rietmeijer C, McFarlane M. Effects of an Internet-based intervention for HIV prevention: the Youthnet trials. AIDS Behav. 2009;13(3):474–87. doi: 10.1007/s10461-008-9487-9.
    1. Glasgow RE, Nelson CC, Kearney KA, Reid R, Ritzwoller DP, Strecher VJ, et al. Reach, engagement, and retention in an Internet-based weight loss program in a multi-site randomized controlled trial. J Med Internet Res. 2007;9(2):e11. doi: 10.2196/jmir.9.2.e11.
    1. Stoponni MA, Alexander GL, McClure JB, Carroll NM, Divine GW, Calvi JH, et al. Recruitement to a randomized web-based nutritional intervention trial: characteristics of participants compared to non-participants. J Med Internet Res. 2009;11(3):e38. doi: 10.2196/jmir.1086.
    1. Andrews D, Nonnecke B, Preece J. Electronic survey methodology: a case study in reaching hard-to-involve internet users. Int J Hum Comput Interact. 2003;16(2):185–210. doi: 10.1207/S15327590IJHC1602_04.

Source: PubMed

Sponsorer och medarbetare

Medicinska tillstånd

Läkemedelsinterventioner

3
Prenumerera