m-Health for antiretroviral treatment support : evidence from India

m-Health for adherence support: Evidence from India Background: With antiretroviral therapy (ART) HIV infection is now managed like a chronic disease rather than as a fatal disease. Adherence to ART is essential for treatment success. However the high levels of adherence that are necessary and the multifactorial nature of adherence, make adherence to ART a challenge. The recent years have seen a move towards the development of low cost interventions to support adherence to ART. The ubiquity of mobile phones and the low cost of mobile communication provide an opportunity to support patient adherence with mobile phone based reminders. Aim: To test an mHealth intervention to improve adherence to antiretroviral therapy in HIV patients in South India. Perceptions regarding the intervention and costs of the intervention from the perspective of the national program were studied. Methods: HIV patients in South India receiving the routine standard of antiretroviral treatment and care received adherence reminders on their mobile phones. The reminder comprised of (i) an automated interactive voice response (IVR) call in the local language and (ii) a neutral picture short messaging service (SMS), each received once a week. The intervention was first tested in a cohort with 150 patients already on antiretroviral treatment (Study I). The participants were followed up for one year. All participants received the intervention for first six months along with standard care. For the next six months they received standard of care alone. Adherence was measured periodically using the pill count at follow-ups. A cut off of ≥95% was used to define optimal adherence. A complete case analysis, best and worst case scenario approach were used to assess change in adherence over time. The intervention was subsequently tested in 631 ART naïve patients in a parallel design, randomized trial against standard care over 2 years (Study II). Participants were followed up for a period of two years or till treatment failure (primary end point). Treatment failure was defined as a viral load of >400copies of virus/mm of plasma on two occasions at least one month apart. Further, sixteen participants from the RCT participated in a qualitative study that assessed perceptions regarding the intervention with in-depth interviews (Study III). Costs of the intervention and its components were studied with a micro-costing approach (Study IV). Results: Complete case analysis in revealed that the proportion of participants with optimal adherence increased from 85% to 91% patients in the cohort during the intervention period, the effect persisted for six months after the intervention was discontinued (p=0.016). In the RCT, there was no statistically significant difference in the time to viral failure between the two groups (HR: 0.96; CI 0.64-1.43). There was also no significant difference in the proportions of participants’ adherent to ART between the two groups (IRR: 1.24; CI 0.941.63). Participants’ expressed mixed opinions regarding the usefulness of the mHealth intervention in the RCT. IVR calls were more popular than SMSs. Stigma was identified as an important barrier to the use of the mobile phone reminders for ART adherence support. The Indian NACP would incur a cost of between 79 and 110 INR (USD 1.27–1.77) per patient per year, based on the type of reminder, the number of patients on ART and the number of ART centres. The total program costs for a scale-up of the mHealth intervention to reach the one million patients by 2017 is estimated to be 0.36% of the total 5-year nationalprogram budget. Conclusions: Despite the positive effect of the intervention on adherence in the cohort, we were unable to detect an effect on time to viral failure and adherence to treatment in the trial. Yet, some participants considered the intervention helpful. The costs of such interventions to national programmes are low. It may be advisable to target specific groups of patients such as those with poor adherence rather than all patients and experiment with different designs of the mHealth intervention. LIST OF SCIENTIFIC PAPERS I. Rodrigues R, Shet A, Antony J, Sidney K, Shubha K, Arumugam K, D’Souza GA, De Costa A. Supporting adherence to antiretroviral therapy with mobile phone reminders: results from a cohort in South India. PLoS ONE 2012; 7(8): e40723 doi: 10.1371/journal.pone. 0040723 II. Shet A, DeCosta A, Kumarasamy N, Rodrigues R, Rewari BB, Ashorn P, Eriksson B, Diwan V, and HIVIND Study Team. Effect of mobile telephone reminders on treatment outcome in HIV: evidence from a randomized controlled trial in India. BMJ (Accepted 9 September 2014) III. Rodrigues R, Bogg L, Shet A, Dodderi SK, De Costa A. Mobile phones to support adherence to antiretroviral therapy: what would it cost the Indian National AIDS Control Programme? J Int AIDS Soc. 2014, 17:19036. http://dx.doi. org/10.7448/IAS.17. 1.19036 IV. Rodrigues R, Poongulali S, Balaji K, Atkins S, Ashorn P, De Costa A. “The phone reminder is important but will others get to know about my illness? ’ Patient perceptions of an mHealth intervention to support adherence to antiretroviral treatment in South India. (Manuscript) The papers are referred to in Roman numerals and are called studies in this thesis. LIST OF ADDITIONAL SCIENTIFIC PAPERS 1. Shet A, Arumugam K, Rodrigues R, Rajagopalan N, Shubha K, Raj T, D’Souza G, De Costa A. Designing a mobile phone-based intervention to promote adherence to antiretroviral therapy in South India. AIDS Behav. 2010; 14(3):716-720. 2. De Costa A, Shet A, Kumarasamy N, Ashorn P, Eriksson B, Bogg L, Diwan VK. 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 Med Res Methodol 2010;10: 25.