Optimizing the Efficiency and Implementation of Cash Transfers to Improve Adherence to Antiretroviral Therapy: A Cluster Randomized Controlled Trial (Study Protocol)

Abstract Background : Antiretroviral therapy (ART) for HIV, taken daily, is an effective strategy to clinically suppress the virus, providing the dual benefit of improved survival and vastly decreasing the risk of transmission. However, this highly effective intervention has not yet reached all who could benefit. Cash transfers are increasingly recognized as an effective strategy to motivate behavior change and improve outcomes along the HIV care continuum, including engagement in HIV care and adherence to ART. Despite a growing evidence base and strong theoretical foundation for the cash transfer approach, key questions remain. Specifically, gaps exist in understanding: 1) whether short-term cash transfers can increase viral suppression in larger, effectiveness studies; and 2) an implementation model or set of best practices that facilitate scale up and enhance sustainability. To address these questions and begin to bridge the “know-do gap” with respect to cash transfers, our team is employing an implementation science approach to iterative development of an incentive-based implementation strategy to promote ART uptake and adherence among people living with HIV (PLHIV) in the Lake Zone Region, Tanzania. Methods: We will conduct a type I hybrid implementation – effectiveness trial to test the effectiveness of a cash transfer intervention on the outcome of HIV viral suppression, and concurrently examine the potential for real-world implementation with an mHealth system through measurement of implementation science constructs. Specifically, our team will expand the intervention to 32 clinics and enroll 1,984 PLHIV to (a) evaluate its effectiveness by conducting a cluster randomized controlled trial with clinics as the unit of randomization and 12-month viral suppression as the primary outcome – a key indicator for monitoring progress towards HIV epidemic control; and (b) evaluate the implementation challenges and successes by measuring implementation outcomes at multiple levels (patient, provider, clinic). Discussion: This trial will provide evidence about not only the real-world effectiveness of cash transfers for retention in HIV care and viral suppression, but also on the implementation challenges and successes that will facilitate or hinder wider scale-up within Tanzania and beyond.