A pilot randomized controlled trial (RCT) of daily versus weekly interactive voice response calls to support adherence among antiretroviral treatment patients in India.

Background: There are more than two million people living with HIV (PLH) in India, with more than 30% on antiretroviral treatment (ART) estimated to be non-adherent. This study aimed to (I) document adherence rates and related factors among ART patients in a large ART clinic in India, and (II) pilot test daily and weekly interactive voice response (IVR) calls to improve ART adherence and related outcomes.

Methods: ART patients reporting missing at least one dose in prior 6 months (N=362) were enrolled and assessed via self-report and medical record review. Participants were randomized to one of two conditions: (I) twice-daily IVR call reminders with self-management support messaging, plus a weekly IVR adherence assessment; or (II) an attention control, with only weekly IVR adherence assessment. Participants completed study assessments at baseline, 2-, 4-, and 6-months with high retention (88% to 96%).

Results: Intention-to-treat analyses found limited support for intervention effects for improving or maintaining ART adherence or CD4 counts between the two study arms over 6-months follow-up. Adherence increased significantly in the six months prior to baseline from about 65% to >95% with perfect adherence based on pill counts from medical records and consistent with patient self-report measures, which presented ceiling effects for detecting improvements in ART adherence in response to IVR intervention exposure. There was also limited support for intervention effects on secondary, self-management outcomes.

Conclusions: High levels of adherence were sustained throughout the 6-month RCT. IVR regulation changes in India delayed study launch for 6 months, which likely allowed mobilization of improved adherence at the clinic, provider and patient levels in anticipation of the study launch. Therefore, ceiling effects limited inferences on intervention effects to improve adherence. Results suggest that clinic-level adherence monitoring may be sufficient to mobilize adherence improvements by providers and patients.

Trial registration: ClinicalTrials.gov registration #NCT02118454.