Process evaluation of pragmatic cluster randomized trials of digital adherence technologies for tuberculosis treatment support: a mixed methods study in five countries

Abstract

BackgroundDigital adherence technologies (DATs) could improve the person-centredness of TB treatment. Acceptability of DATs is high, though evidence of their effectiveness is varied. Our objective was to understand the fidelity of DAT interventions within five cluster-randomized trials.MethodsTwo DATs (smart pill box, medication labels) were assessed, with real-time adherence data made available to healthcare providers (HCPs) on a digital platform in Ethiopia, the Philippines, South Africa, Tanzania, and Ukraine. The process evaluation framework assessed four components: inputs, processes, outputs, and outcomes. Fidelity of the most important intervention components was evaluated by quantitative indicators, with analysis conducted by country and DAT type. Content analysis of qualitative sub-studies supplemented some indicators.ResultsEngagement with DATs was high among persons with TB (PwTB). Pillbox users showed high levels of sustained engagement, with digitally recorded doses ranging from 82% to 91%. Sole ownership of a mobile phone was highest in South Africa (90%) and lowest in the Philippines (63%). Differences were also observed in the frequency of logins by HCPs to the adherence platform and the type of device used. In the Philippines and Ukraine, >50% of logins were from mobile phones. In Ethiopia, Tanzania, and Ukraine there was at least one login to the platform on 71% of weekdays per facility, compared with the Philippines and South Africa at 42% and 52%, respectively. A feeling of connection between PwTB and their HCP was reported by over 95% of participants surveyed in Ethiopia and Tanzania, this was 84% in South Africa and 76% Philippines, a finding underpinned by qualitative data.ConclusionWe observed varying levels of intervention fidelity between countries. Timeliness and intensity of utilization of real-time data, and taking required actions are impacted by staff and health system capacity. Acceptance of DATs is high; therefore, future work should focus on identifying optimal intervention strategies.