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Open Access Study protocol

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

Ayesha De Costa125*, Anita Shet125, Nagalingeswaran Kumarasamy35, Per Ashorn45, Bo Eriksson15, Lennart Bogg15, Vinod K Diwan15 and the HIVIND study team5

Author affiliations

1 Division of Global Health, Nobels Väg 9, Karolinska Institutet, 171 77 Stockholm, Sweden

2 St Johns National Academy of Health Sciences, Sarjapura Road, Bangalore 560034, India

3 YR Gaitonde Centre for AIDS Research and Education, VHS Campus, Rajiv Gandhi Road, Taramani, Chennai 600113 India

4 Medical School, University of Tampere, ARVO building, Tampere, Finland 33014

5 Cavidi AB, Uppsala Science Park 751 83 Uppsala, Sweden

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Citation and License

BMC Medical Research Methodology 2010, 10:25  doi:10.1186/1471-2288-10-25

Published: 26 March 2010

Abstract

Background

Poor adherence to antiretroviral treatment has been a public health challenge associated with the treatment of HIV. Although different adherence-supporting interventions have been reported, their long term feasibility in low income settings remains uncertain. Thus, there is a need to explore sustainable contextual adherence aids in such settings, and to test these using rigorous scientific designs. The current ubiquity of mobile phones in many resource-constrained settings, make it a contextually appropriate and relatively low cost means of supporting adherence. In India, mobile phones have wide usage and acceptability and are potentially feasible tools for enhancing adherence to medications. This paper presents the study protocol for a trial, to evaluate the influence of mobile phone reminders on adherence to first-line antiretroviral treatment in South India.

Methods/Design

600 treatment naïve patients eligible for first-line treatment as per the national antiretroviral treatment guidelines will be recruited into the trial at two clinics in South India. Patients will be randomized into control and intervention arms. The control arm will receive the standard of care; the intervention arm will receive the standard of care plus mobile phone reminders. Each reminder will take the form of an automated call and a picture message. Reminders will be delivered once a week, at a time chosen by the patient. Patients will be followed up for 24 months or till the primary outcome i.e. virological failure, is reached, whichever is earlier. Self-reported adherence is a secondary outcome. Analysis is by intention-to-treat. A cost-effectiveness study of the intervention will also be carried out.

Discussion

Stepping up telecommunications technology in resource-limited healthcare settings is a priority of the World Health Organization. The trial will evaluate if the use of mobile phone reminders can influence adherence to first-line antiretrovirals in an Indian context.

Trial Registration

Trial registration: ISRCTN79261738.