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Open Access Highly Accessed Study protocol

The HAART cell phone adherence trial (WelTel Kenya1): a randomized controlled trial protocol

Richard T Lester12*, Edward J Mills3, Antony Kariri1, Paul Ritvo4, Michael Chung5, William Jack6, James Habyarimana6, Sarah Karanja1, Samson Barasa1, Rosemary Nguti1, Benson Estambale7, Elizabeth Ngugi1, T Blake Ball2, Lehana Thabane8, Joshua Kimani12, Lawrence Gelmon12, Marta Ackers9 and Francis A Plummer102

Author Affiliations

1 Department of Medical Microbiology, University of Nairobi, UNITID Building, Nairobi, Kenya

2 Department of Medical Microbiology, University of Manitoba, Health Sciences Centre, Winnipeg, Manitoba, Canada

3 BC Centre for Excellence in HIV, St. Paul's Hospital, University of British Columbia, Vancouver, BC, Canada

4 School of Kinesiology and Health Sciences, Department of Psychology, York University, York, Ontario, Canada

5 Department of Economics, Georgetown University, Washington, USA

6 Division of Allergy and Infectious Diseases, Department of Medicine, University of Washington, Seattle, WA, USA

7 University of Nairobi Institute of Tropical and Infectious Diseases (UNITID), Nairobi, Kenya

8 Department of Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, Ontario, Canada

9 US Centers for Disease Control and Prevention (CDC), Nairobi, Kenya

10 National Microbiology Laboratory, Public Health Agency of Canada, Winnipeg, Manitoba, Canada

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Trials 2009, 10:87  doi:10.1186/1745-6215-10-87

Published: 22 September 2009

Abstract

Background

The objectives are to compare the effectiveness of cell phone-supported SMS messaging to standard care on adherence, quality of life, retention, and mortality in a population receiving antiretroviral therapy (ART) in Nairobi, Kenya.

Methods and Design

A multi-site randomized controlled open-label trial. A central randomization centre provided opaque envelopes to allocate treatments. Patients initiating ART at three comprehensive care clinics in Kenya will be randomized to receive either a structured weekly SMS ('short message system' or text message) slogan (the intervention) or current standard of care support mechanisms alone (the control). Our hypothesis is that using a structured mobile phone protocol to keep in touch with patients will improve adherence to ART and other patient outcomes. Participants are evaluated at baseline, and then at six and twelve months after initiating ART. The care providers keep a weekly study log of all phone based communications with study participants.

Primary outcomes are self-reported adherence to ART and suppression of HIV viral load at twelve months scheduled follow-up. Secondary outcomes are improvements in health, quality of life, social and economic factors, and retention on ART. Primary analysis is by 'intention-to-treat'. Sensitivity analysis will be used to assess per-protocol effects. Analysis of covariates will be undertaken to determine factors that contribute or deter from expected and determined outcomes.

Discussion

This study protocol tests whether a novel structured mobile phone intervention can positively contribute to ART management in a resource-limited setting.

Trial Registration

Trial Registration Number: NCT00830622