Do Short Message Reminders Improve ART Adherence? Randomized Control Trial among HIV Clients - Kadoma (Zimbabwe) - KAMP Study Protocol

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DOI: 10.21522/TIJCR.2014.04.01.Art004

Authors : Daniel Chirundu, Pamela N. Magande, Tapesana S., Gershem Madzingaidzo, Mduluza T

Abstract:

Background: Adherence to antiretroviral therapy among clients seeking care at Kadoma City Integrated TB and HIV Care Site has been documented to be 86% as opposed to the expected adherence of 95%. The Zimbabwe 2015 survey for Early Warning Indicators for HIV drug resistance identified Kadoma as a hotspot. Low level adherence to antiretroviral therapy is associated with poor clinical outcomes. We set out to evaluate the efficacy of cell phone –supported short message reminders compared to standard care on adherence among clients receiving antiretroviral therapy at Kadoma, Zimbabwe.
Methods: The study design is a randomized controlled trial. Patients on ART at Rimuka Integrated TB and HIV Care Site will be randomized to receive either a structured weekly text message in addition to standard care (the intervention) or standard care support alone (the control). Respondents will be evaluated at baseline, six months and 12 months after recruitment into the study. Primary outcomes are self-reported adherence to ART and CD4 cell counts at twelve months scheduled follow-up. Secondary outcomes will be opportunistic infections, weight, body mass index (BMI) and retention on ART. Primary analysis will be by ‘intention-to-treat’. 
Discussion: The mHealth concept could be an innovative method in prompting adherence to anti-retroviral therapy in poor resource settings. The trial will evaluate the efficacy of a weekly personalized SMS reminder on adherence among clients on ART at Rimuka Integrated Tuberculosis and HIV clinic Kadoma, Zimbabwe.
Keywords: Adherence, ART, HIV, Kadoma, SMS, RCT

References:

[1]. An-Wen Chan SPIRIT 2013 Statement: Defining Standard Protocol Items for Clinical Trials: Ann Intern Med. 2013; 158:200-207.

[2]. An-Wen Chan: SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials: BMJ | Research Methods and Reporting 31/01/2013 10:33:37.

[3]. Batya Elul, Maria Lahueta, Fatima Abacassamo, Mattew R lamb, Laurence Ahoua, Margaret L. McNairy, et.al. A combination strategy for enhancing linkage to and retention in HIV care among adults newly diagnosed with HIV in Mozambique: study protocol for a site-randomized implementation science study. BMC Infectious Diseases201414:549).

[4]. Braitstein P; Mortality of HIV-1-infected patients in the first year of antiretroviral therapy: comparison between low-income and high-income countries. Lancet. 2006 Mar 11; 367(9513):817-24.

[5]. Cristian Pop-Eleches, Harsha Thirumurthy, James P. Habyarimana, Joshua G. Zivin, Markus P. Goldstein, Damien de Walque, Leslie MacKeenet al. Mobile phone technologies improve adherence to antiretroviral treatment in a resource-limited setting: a randomized controlled trial of text message reminders: AIDS. 2011 March 27; 25(6): 825–834.

[6]. caled-Up Mobile Phone Intervention for HIV Care and Treatment: Protocol for a Facility Randomized Controlled Trial; Journal of Medical Internet Research 2015.).

[7]. De Costa et al, Anita Shet, Nagalingeswaran Kumarasamy, Per Ashorn, Bo Eriksson, Lennart Bogg, Vinod K. Diwan et. al. Design of a randomized trial to evaluate the influence of mobile phone reminders on adherence to first line antiretroviral treatment in South India – the HIVIND study protocol: BMC Medical Research Methodology 2010, 10:25

[8]. Edward L. Machtinger: Adherence to HIV AntiretroviralTherapy: HIV InSite Knowledge Base Chapter) USCF.(2002)

[9]. Gordon S. Doig and Fiona Simpson: Randomization and allocation concealment: A practical guide for researchers. Journal of Critical Care Close: Block 20.2 (Jun 2005): 187-91

[10]. Government of Zimbabwe Guidelines for Antiretroviral Therapy for the Prevention and Treatment of HIV in Zimbabwe. The National Medicine and Therapeutics Policy Advisory Committee 2013).

[11]. Garrett Mehl and Alain Labrique; Prioritizing integrated mHealth strategies for universal health coverage: Science 345, 1284 (2014))

[12]. Gunther Eysenbach: CONSORT-EHEALTH: Improving and Standardizing Evaluation Reports of Web-based and Mobile Health Interventions J Med Internet Res. 2011 Oct-Dec; 13(4): e126.

[13]. J.A. Lewis' & D. Machin Intention to treat - who should use ITT? Br. J. Cancer 1993 647-650.

[14]. John G. Adair. The Hawthorne Effect: A Reconsideration of the Methodological Artifact Journal of Applied Psychology1984).

[15]. Kelly L L'Engle, Kimberly Green, Stacey M Succop; Amos Laar, Samuel Wambugu

[16]. Little RJA, Rubin DB: Statistical analysis with missing data. New York: John Wiley & Sons; 1987

[17]. Mocroft A, et al; Decline in the AIDS and death rates in the Euro SIDA study: an observational study. Lancet. 2003 Jul;362(9377):22-9

[18]. Mbuagbaw L, Thabane L, Ongolo-Zogo P, Lester RT, Mills E, Volmink J, et. al. The Cameroon Mobile Phone SMS (CAMPS) trial: A protocol for a randomized controlled trial of mobile phone text messaging versus usual care for improving adherence to highly active anti-retroviral therapy: Trials 2011, 12:5

[19]. Maduka O, Tobin-West CI: Adherence counseling and reminder text messages improve uptake of antiretroviral therapy in a tertiary hospital in Nigeria. Niger J ClinPract 2013; 16: 302–08

[20]. Palella F.J, Delaney K.M, Moorman A.C, Loveless M.O, Fuhrer J, Satten A.G et. al.: Declining morbidity and mortality among patients with advanced human immunodeficiency virus infection. HIV Outpatient Study Investigators. N Engl J Med 1998; 338:853-60.

[21]. Paterson DL, Swindells S, Mohr J, Brester M, Vergis EN, Squier C, et al.: Adherence to Protease Inhibitor Therapy and Outcomes in Patients with HIV Infection. Ann Intern Med. 2000;

[22]. Russell S. Pioneering S.F: AIDS ward celebrates its first 20 years. San Francisco Chronicle. San Francisco, July 26, 2003: A-19.

[23]. Reiter G., Stewart K., Bangsberg D. Elements of success in HIV clinical care: Multiple interventions that promote adherence. Topics in HIV Medicine 2000; 8:21-30.

[24]. Rosa Garcia; Robert T. Schooley; Roberto Badaró. An Adherence Trilogy is Essential for Long Term HAART Success: The Brazilian Journal of Infectious Diseases 2003.

[25]. Reiter GS, Stewart KE, Wojtusik L. Elements of success in HIV clinical care: Multiple interventions that promote adherence. Topics in HIV Medicine 2000: 867

[26]. Richard T Lester, Edward J Mills, Antony kariri, paulRitvo, Michael Chung, William jack, james Habyarimana: The HAART cell phone adherence trial WelTel Kenya1): a randomized controlled trial protocol: Trials 2009.

[27]. Schulz KF, Altman DG, Moher D: CONSORT 2010 Statement: Updated guidelines for reporting parallel group randomised trials. J Clin, Epidemiol. 2010, 63:834-840.

[28]. UNAIDS, Aids by numbers. AIDS is not yet over but it can. UNAIDS 2016

[29]. WHO. Global health sector response to HIV, 2000-2015: focus on innovations in Africa: progress report WHO 2015

[30]. University of Minnesota Centre for Bioethics A Guide to Research Ethics: University of Minnesota Centre for Bioethics.

[31]. UNITED STATES. The Belmont report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research: Bethesda, Md. The Commission (1978).

[32]. Williams JR: The Declaration of Helsinki and Public health: Bulletin of the World Health Organization 2008; 86: 650-651.