Effectiveness of a Web-Based Intervention to Support Medication Adherence Among People Living With HIV: Web-Based Randomized Controlled Trial

José Côté, Geneviève Rouleau, Maria Pilar Ramirez-Garcia, Patricia Auger, Réjean Thomas, Judith Leblanc, José Côté, Geneviève Rouleau, Maria Pilar Ramirez-Garcia, Patricia Auger, Réjean Thomas, Judith Leblanc

Abstract

Background: Taking antiretroviral therapy (ART) is part of the daily life of people living with HIV. Different electronic health (eHealth) initiatives adjunctive to usual care have been proposed to support optimal medication adherence. A web-based intervention called HIV Treatment, Virtual Nursing Assistance, and Education or VIH-TAVIE (from its French version Virus de l'immunodéficience humaine-Traitement assistance virtuelle infirmière et enseignement) was developed to empower people living with HIV to manage their ART and symptoms optimally.

Objective: We aimed to evaluate the effectiveness of VIH-TAVIE in a web-based randomized controlled trial (RCT).

Methods: This RCT was entirely web-based, including recruitment, consent granting, questionnaire completion, and intervention exposure (consultation with VIH-TAVIE [experimental group] or websites [control group]). To be eligible for the study, people living with HIV had to be 18 years or older, be on ART for at least 6 months, have internet access, and have internet literacy. Participants were randomly assigned to either the experimental group (n=45) or control group (n=43). The primary outcome was ART adherence. The secondary outcomes included self-efficacy regarding medication intake, symptom-related discomfort, skills and strategies, and social support. All outcomes were measured with a self-administered web-based questionnaire at the following three time points: baseline and 3 and 6 months later. A generalized linear mixed model was built to assess the evolution of ART adherence over time in both groups.

Results: The sample included 88 participants, and of these, 73 (83%) were men. The median age of the participants was 42 years. Participants had been diagnosed with HIV a median of 7 years earlier (IQR 3-17) and had been on ART for a median of 5 years (IQR 2-12). The proportion of treatment-adherent participants at baseline was high in both groups (34/41, 83% in the experimental group and 30/39, 77% in the control group). Participants also reported high treatment adherence, high self-efficacy, and high skills; perceived good social support; and experienced low discomfort from symptoms. Analyses revealed no intergroup difference regarding ART adherence (OR 1.9, 95% CI 0.6-6.4).

Conclusions: This study highlights the challenges and lessons learned from conducting an entirely web-based RCT among people living with HIV. The challenges were related to the engagement of people living with HIV on the following three levels: starting the web-based study (recruitment), completing the web-based intervention (engagement), and continuing the study (retention). The results contribute to the existing body of knowledge regarding how to conduct web-based evaluation studies of eHealth interventions aimed at developing and strengthening personal skills and abilities.

Trial registration: ClinicalTrials.gov NCT01510340; https://ichgcp.net/clinical-trials-registry/NCT01510340.

Keywords: antiretroviral therapy; medication adherence; nursing; people living with HIV; self-management; web-based intervention; web-based randomized controlled trial.

Conflict of interest statement

Conflicts of Interest: JC and MPRG declare granting of licensing options for marketing VIH-TAVIE. The remaining authors declare no conflict of interest.

©José Côté, Geneviève Rouleau, Maria Pilar Ramirez-Garcia, Patricia Auger, Réjean Thomas, Judith Leblanc. Originally published in JMIR Public Health and Surveillance (http://publichealth.jmir.org), 20.04.2020.

Figures

Figure 1
Figure 1
Flow diagram. The measurement time points are baseline (T0) and 3 months (T3) and 6 months later (T6).
Figure 2
Figure 2
Adherence over time. The solid bars represent the estimated proportion of treatment-adherent participants, and the error bars (lines) indicate the corresponding 95% CIs from the generalized linear mixed model. The measurement time points are baseline (T0) and 3 months (T3) and 6 months later (T6).

References

    1. Daher J, Vijh R, Linthwaite B, Dave S, Kim J, Dheda K, Peter T, Pai NP. Do digital innovations for HIV and sexually transmitted infections work? Results from a systematic review (1996-2017) BMJ Open. 2017;7(11):e017604. doi: 10.1136/bmjopen-2017-017604.
    1. Amankwaa I, Boateng D, Quansah DY, Akuoko CP, Evans C. Effectiveness of short message services and voice call interventions for antiretroviral therapy adherence and other outcomes: A systematic review and meta-analysis. PLoS One. 2018;13(9):e0204091. doi: 10.1371/journal.pone.0204091.
    1. Cooper V, Clatworthy J, Whetham J, Consortium E. mHealth Interventions To Support Self-Management In HIV: A Systematic Review. Open AIDS J. 2017;11:119–132. doi: 10.2174/1874613601711010119. doi: 10.2174/1874613601711010119.
    1. Quintana Y, Gonzalez Martorell EA, Fahy D, Safran C. A Systematic Review on Promoting Adherence to Antiretroviral Therapy in HIV-infected Patients Using Mobile Phone Technology. Appl Clin Inform. 2018;9(2):450–466. doi: 10.1055/s-0038-1660516.
    1. World Health Organization . Consolidated Guidelines On The Use Of Antiretroviral Drugs For Treating And Preventing Hiv Infection: Recommendations For A Public Health Approach. London: World Health Organization; 2013. p. 271.
    1. Naar-King S, Outlaw AY, Sarr M, Parsons JT, Belzer M, Macdonell K, Tanney M, Ondersma SJ, Adolescent Medicine Network for HIV/AIDS Interventions Motivational Enhancement System for Adherence (MESA): pilot randomized trial of a brief computer-delivered prevention intervention for youth initiating antiretroviral treatment. J Pediatr Psychol. 2013;38(6):638–648. doi: 10.1093/jpepsy/jss132.
    1. Schnall R, Wantland D, Velez O, Cato K, Jia H. Feasibility testing of a web-based symptom self-management system for persons living with HIV. J Assoc Nurses AIDS Care. 2014;25(4):364–371. doi: 10.1016/j.jana.2013.09.002.
    1. Kurth AE, Spielberg F, Cleland CM, Lambdin B, Bangsberg DR, Frick PA, Severynen AO, Clausen M, Norman RG, Lockhart D, Simoni JM, Holmes KK. Computerized counseling reduces HIV-1 viral load and sexual transmission risk: findings from a randomized controlled trial. J Acquir Immune Defic Syndr. 2014;65(5):611–620. doi: 10.1097/QAI.0000000000000100.
    1. Hersch RK, Cook RF, Billings DW, Kaplan S, Murray D, Safren S, Goforth J, Spencer J. Test of a web-based program to improve adherence to HIV medications. AIDS Behav. 2013;17(9):2963–2976. doi: 10.1007/s10461-013-0535-8.
    1. Fisher JD, Amico KR, Fisher WA, Cornman DH, Shuper PA, Trayling C, Redding C, Barta W, Lemieux AF, Altice FL, Dieckhaus K, Friedland G, LifeWindows T. Computer-based intervention in HIV clinical care setting improves antiretroviral adherence: the LifeWindows Project. AIDS Behav. 2011;15(8):1635–1646. doi: 10.1007/s10461-011-9926-x.
    1. Côté J, Godin G, Garcia PR, Gagnon M, Rouleau G. Program development for enhancing adherence to antiretroviral therapy among persons living with HIV. AIDS Patient Care STDS. 2008;22(12):965–975. doi: 10.1089/apc.2008.0124.
    1. Gottlieb L, Rowat K. The McGill model of nursing: a practice-derived model. ANS Adv Nurs Sci. 1987 Jul;9(4):51–61. doi: 10.1097/00012272-198707000-00008.
    1. Gottlieb LN. Strengths-based Nursing Care: Health And Healing For Person And Family. New York: Springer Publishing Company; 2012. p. 448.
    1. Bandura A. Self-efficacy: The exercise of control. New York: W.H. Freeman; 1997.
    1. Côté J, Godin G, Ramirez-Garcia P, Rouleau G, Bourbonnais A, Guéhéneuc Y, Tremblay C, Otis J. Virtual intervention to support self-management of antiretroviral therapy among people living with HIV. J Med Internet Res. 2015;17(1):e6. doi: 10.2196/jmir.3264.
    1. Eysenbach G, CONSORT- E. CONSORT-EHEALTH: improving and standardizing evaluation reports of Web-based and mobile health interventions. J Med Internet Res. 2011;13(4):e126. doi: 10.2196/jmir.1923.
    1. Côté J, Godin G, Guéhéneuc Y, Rouleau G, Ramirez-Garcìa P, Otis J, Tremblay C, Fadel G. Evaluation of a real-time virtual intervention to empower persons living with HIV to use therapy self-management: study protocol for an online randomized controlled trial. Trials. 2012;13:187. doi: 10.1186/1745-6215-13-187.
    1. Bangsberg DR. Less than 95% adherence to nonnucleoside reverse-transcriptase inhibitor therapy can lead to viral suppression. Clin Infect Dis. 2006;43(7):939–941. doi: 10.1086/507526.
    1. Godin G, Gagné C, Naccache H. Validation of a self-reported questionnaire assessing adherence to antiretroviral medication. AIDS Patient Care STDS. 2003;17(7):325–332. doi: 10.1089/108729103322231268.
    1. Justice AC, Holmes W, Gifford AL, Rabeneck L, Zackin R, Sinclair G, Weissman S, Neidig J, Marcus C, Chesney M, Cohn SE, Wu AW, Adult AIDS Clinical Trials Unit Outcomes Committee Development and validation of a self-completed HIV symptom index. J Clin Epidemiol. 2001 Dec;54 Suppl 1:S77–90. doi: 10.1016/s0895-4356(01)00449-8.
    1. Sherbourne CD, Stewart AL. The MOS social support survey. Social Science & Medicine. 1991 Jan;32(6):705–714. doi: 10.1016/0277-9536(91)90150-B.
    1. Anderson D, Bilodeau B, Deshaies G, Gilbert M, Jobin J. [French-Canadian validation of the MOS Social Support Survey] Can J Cardiol. 2005 Aug;21(10):867–73.
    1. Tuldrà A, Fumaz CR, Ferrer MJ, Bayés R, Arnó A, Balagué M, Bonjoch A, Jou A, Negredo E, Paredes R, Ruiz L, Romeu J, Sirera G, Tural C, Burger D, Clotet B. Prospective randomized two-Arm controlled study to determine the efficacy of a specific intervention to improve long-term adherence to highly active antiretroviral therapy. J Acquir Immune Defic Syndr. 2000;25(3):221–228. doi: 10.1097/00126334-200011010-00003.
    1. Pradier C, Bentz L, Spire B, Tourette-Turgis C, Morin M, Souville M, Rebillon M, Fuzibet J, Pesce A, Dellamonica P, Moatti J. Efficacy of an educational and counseling intervention on adherence to highly active antiretroviral therapy: French prospective controlled study. HIV Clin Trials. 2003;4(2):121–131. doi: 10.1310/brbv-3941-h1pp-ndry.
    1. Haynes RB, Ackloo E, Sahota N, McDonald HP, Yao X. Interventions for enhancing medication adherence. Cochrane Database Syst Rev. 2008;(2):CD000011. doi: 10.1002/14651858.CD000011.pub3.
    1. Molenberghs G, Verbeke G. Models for Discrete Longitudinal Data. In: Springer Science & Business Media , editor. Part IV. Subject-specific Models. New York: Springer Science & Business Media; 2006. pp. 255–306.
    1. SAS/STAT 9.2 User’s Guide. Cary, North Carolina: SAS Institute Inc; 2008. [2018-08-10]. The GLIMMIX Procedure .
    1. Zhang Y, Li X. Uses of information and communication technologies in HIV self-management: A systematic review of global literature. International Journal of Information Management. 2017 Apr;37(2):75–83. doi: 10.1016/j.ijinfomgt.2016.11.003.
    1. Bezabhe WM, Chalmers L, Bereznicki LR, Peterson GM. Adherence to Antiretroviral Therapy and Virologic Failure: A Meta-Analysis. Medicine (Baltimore) 2016;95(15):e3361. doi: 10.1097/MD.0000000000003361. doi: 10.1097/MD.0000000000003361.
    1. Pham Q, Wiljer D, Cafazzo JA. Beyond the Randomized Controlled Trial: A Review of Alternatives in mHealth Clinical Trial Methods. JMIR Mhealth Uhealth. 2016;4(3):e107. doi: 10.2196/mhealth.5720.
    1. Price A, Vasanthan L, Clarke M, Liew SM, Brice A, Burls A. SMOOTH: Self-Management of Open Online Trials in Health analysis found improvements were needed for reporting methods of internet-based trials. J Clin Epidemiol. 2019;105:27–39. doi: 10.1016/j.jclinepi.2018.08.017.
    1. O'Connor S, Hanlon P, O'Donnell CA, Garcia S, Glanville J, Mair FS. Understanding factors affecting patient and public engagement and recruitment to digital health interventions: a systematic review of qualitative studies. BMC Med Inform Decis Mak. 2016;16(1):120. doi: 10.1186/s12911-016-0359-3.
    1. Millard T, Agius PA, McDonald K, Slavin S, Girdler S, Elliott JH. The Positive Outlook Study: A Randomised Controlled Trial Evaluating Online Self-Management for HIV Positive Gay Men. AIDS Behav. 2016;20(9):1907–1918. doi: 10.1007/s10461-016-1301-5.
    1. Sieverink F, Kelders SM, van Gemert-Pijnen JEWC. Clarifying the Concept of Adherence to eHealth Technology: Systematic Review on When Usage Becomes Adherence. J Med Internet Res. 2017;19(12):e402. doi: 10.2196/jmir.8578.
    1. Watson NL, Mull KE, Heffner JL, McClure JB, Bricker JB. Participant Recruitment and Retention in Remote eHealth Intervention Trials: Methods and Lessons Learned From a Large Randomized Controlled Trial of Two Web-Based Smoking Interventions. J Med Internet Res. 2018;20(8):e10351. doi: 10.2196/10351.
    1. Santarossa S, Kane D, Senn CY, Woodruff SJ. Exploring the Role of In-Person Components for Online Health Behavior Change Interventions: Can a Digital Person-to-Person Component Suffice? J Med Internet Res. 2018;20(4):e144. doi: 10.2196/jmir.8480.
    1. Al-Durra M, Nolan RP, Seto E, Cafazzo JA, Eysenbach G. Nonpublication Rates and Characteristics of Registered Randomized Clinical Trials in Digital Health: Cross-Sectional Analysis. J Med Internet Res. 2018;20(12):e11924. doi: 10.2196/11924.

Source: PubMed

3
Abonnieren