A group randomized trial using an appointment system to improve adherence to ART at reproductive and child health clinics implementing Option B+ in Tanzania

<div><p>Introduction</p><p>In October 2013, Tanzania adopted Option B+ under which HIV-positive pregnant women are initiated on antiretroviral therapy in reproductive and child health clinics at diagnosis. Studies have shown that adherence and retention to antiretroviral treatment can be problematic.</p><p>Methods</p><p>We implemented a group randomized controlled trial in 24 reproductive and child health clinics in eight districts in Mbeya region. The trial tested the impact of implementing paper-based appointment tracking and community outreach systems on the rate of missed appointments and number of days covered by dispensed antiretroviral medications among women previously established on antiretroviral therapy. We used interrupted time series analysis to assess study outcomes. Clinic staff and patients in intervention clinics were aware of the intervention because of change in clinic procedures; data collectors knew the study group assignment.</p><p>Results</p><p>Three months pre-intervention, we identified 1924 and 1226 patients established on antiretroviral therapy for six months or more in intervention and control clinics, respectively, of whom 83.4% and 86.9% had one or more post-intervention visits. The unadjusted rate of missed visits declined from 36.5% to 34.4% in intervention clinics and increased from 38.9% to 45.5% in control clinics following the intervention. Interrupted time series analyses demonstrated a net decrease of 13.7% (95% CI [-15.4,-12.1]) for missed visits at six months post-intervention. Similar differential changes were observed for visits missed by 3, 7, 15, or 60 days.</p><p>Conclusion</p><p>Appointment-tracking and community outreach significantly improved appointment-keeping for women on antiretroviral therapy. The facility staff controlled their workload better, identified missing patients rapidly, and worked with existing community organizations. There is now enough evidence to scale up this approach to all antiretroviral therapy and Option B+ reproductive and child health clinics in Tanzania as well as to evaluate the intervention in medical clinics that treat other chronic health conditions.</p><p>Trial registration</p><p>Registry for International Development Impact Evaluations ID-<a target="_blank">55310280d8757</a></p></div

Baseline characteristics and unadjusted outcomes among established patients included in the study.

<p>Baseline characteristics and unadjusted outcomes among established patients included in the study.</p

Participant selection and flow during the trial.

<p>The waterfall diagram presents sample sizes and exclusions in selecting clinics to participate in the study (top), and in selecting and following patients in intervention (left) and control (right) clinics following random assignment in relation to dates of assessments and the intervention (middle).</p

Time series of monthly study outcomes in intervention and control clinics and their differences over time among established patients.

<p>The figures present the monthly values of the eight study outcomes from August 2014 until March 2016 averaged across all clinics in the intervention (solid lines) and control (long dashed lines) groups, as well as the monthly differences between these values (short dashed lines). The intervention began in July 2015 (represented by the solid vertical lines) and continued with monthly supervisory visits in the following four months.</p

Results of aggregate interrupted time series models predicting post-intervention changes in level and trend in the monthly differences between intervention (n = 1924)^& and control (n = 1226)^& groups, and estimated differences at six months post-intervention.

<p>Results of aggregate interrupted time series models predicting post-intervention changes in level and trend in the monthly differences between intervention (n = 1924)<a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0184591#t002fn002" target="_blank">^&</a> and control (n = 1226)<a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0184591#t002fn002" target="_blank">^&</a> groups, and estimated differences at six months post-intervention.</p