Effect of mobile telephone reminders on treatment outcome in HIV: evidence from a randomised controlled trial in India.
OBJECTIVE
To assess whether customised mobile phone reminders would improve adherence to therapy and thus decrease virological failure among HIV infected patients starting antiretroviral treatment (ART).


METHODS
Randomised controlled trial among HIV infected patients initiating antiretroviral treatment.


METHODS
Three diverse healthcare delivery settings in south India: two ambulatory clinics within the Indian national programme and one private HIV healthcare clinic.


METHODS
631 HIV infected, ART naïve, adult patients eligible to initiate first line ART were randomly assigned to mobile phone intervention (n=315) or standard care (n=316) and followed for 96 weeks..


METHODS
The intervention consisted of customised, interactive, automated voice reminders, and a pictorial message that were sent weekly to the patients' mobile phones for the duration of the study.


METHODS
The primary outcome was time to virological failure (viral load >400 copies/mL on two consecutive measurements). Secondary outcomes included ART adherence measured by pill count, death rate, and attrition rate. Suboptimal adherence was defined as mean adherence <95%.


RESULTS
Using an intention-to-treat approach we found no observed difference in time to virological failure between the allocation groups: failures in the intervention and standard care arms were 49/315 (15.6%) and 49/316 (15.5%) respectively (unadjusted hazard ratio 0.98, 95% confidence interval 0.67 to 1.47, P=0.95). The rate of virological failure in the intervention and standard care groups were 10.52 and 10.73 per 100 person years respectively. Comparison of suboptimal adherence was similar between both groups (unadjusted incidence rate ratio 1.24, 95% CI 0.93 to 1.65, P=0.14). Incidence proportion of patients with suboptimal adherence was 81/300 (27.0%) in the intervention arm and 65/299 (21.7%) in the standard care arm. The results of analyses adjusted for potential confounders were similar, indicating no significant difference between the allocation groups. Other secondary outcomes such as death and attrition rates, and subgroup analysis also showed comparable results across allocation groups.


CONCLUSIONS
In this multicentre randomised controlled trial among ART naïve patients initiating first line ART within the Indian national programme, we found no significant effect of the mobile phone intervention on either time to virological failure or ART adherence at the end of two years of therapy.Trial registration Current Controlled Trials ISRCTN79261738.
Department of Pediatrics, St John's Medical College Hospital, Bangalore 560034, India Department of Public Health Sciences, Karolinska Institute, Stockholm 17177, Sweden.
Anita
A
Shet
Department of Public Health Sciences, Karolinska Institute, Stockholm 17177, Sweden Ayesha.de.costa@ki.se.
Ayesha
A
De Costa
YRG Centre for AIDS Research and Education, Chennai 600113, India.
N
N
Kumarasamy
Department of Public Health Sciences, Karolinska Institute, Stockholm 17177, Sweden Department of Community Medicine, St John's Medical College Hospital, Bangalore 560034, India.
Rashmi
R
Rodrigues
National AIDS Control Organization, Department of AIDS Control, Ministry of Health and Family Welfare, Government of India, New Delhi 110001, India.
Bharat Bhusan
BB
Rewari
Department for International Health, University of Tampere School of Medicine, Tampere, Finland.
Per
P
Ashorn
Department of Public Health Sciences, Karolinska Institute, Stockholm 17177, Sweden.
Bo
B
Eriksson
Department of Public Health Sciences, Karolinska Institute, Stockholm 17177, Sweden.
Vinod
V
Diwan
D000293:Adolescent; D000328:Adult; D044966:Anti-Retroviral Agents / Q000008:administration & dosage*; D040421:Cell Phone; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D007194:India; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D017010:Reminder Systems; D019562:Viral Load / Q000187:drug effects; D055815:Young Adult; D016903:Drug Monitoring
D044966:Anti-Retroviral Agents