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

Springer Science and Business Media LLC - Tập 10 - Trang 1-10 - 2009
Richard T Lester1,2, 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 Kimani1,2, Lawrence Gelmon1,2, Marta Ackers9, Francis A Plummer2,10
1Department of Medical Microbiology, University of Nairobi, Nairobi, Kenya
2Department of Medical Microbiology, University of Manitoba, Health Sciences Centre, Winnipeg, Canada
3BC Centre for Excellence in HIV, St. Paul's Hospital, University of British Columbia, Vancouver, Canada
4School of Kinesiology and Health Sciences, Department of Psychology, York University, York, Canada
5Department of Economics, Georgetown University, Washington, USA
6Division of Allergy and Infectious Diseases, Department of Medicine, University of Washington, Seattle, USA
7University of Nairobi Institute of Tropical and Infectious Diseases (UNITID), Nairobi, Kenya
8Department of Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, Canada
9US Centers for Disease Control and Prevention (CDC), Nairobi, Kenya
10National Microbiology Laboratory, Public Health Agency of Canada, Winnipeg, Canada

Tóm tắt

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. 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. This study protocol tests whether a novel structured mobile phone intervention can positively contribute to ART management in a resource-limited setting. Trial Registration Number: NCT00830622

Tài liệu tham khảo

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