Ongoing Dynamic Choice to Address HIV Treatment Interruption in Malawi (CHOICE)

PROJECT SUMMARY Repeat and prolonged treatment interruption (TI) (>28 days out of care) is common and the major threat to HIV epidemic control in eastern and southern Africa. Current services do not work for TI clients in the long-term. interventions for TI clients are limited in duration and services offered. Yet recent evidence shows that TI clients need long-term services tailored to their unique needs. TI clients experience varying and changing barriers to care that require tailored and responsive interventions. There are no one-size fits all intervention. Long-term and dynamic choice of DSD may be the best practical strategy to provide long-term, responsive TI interventions. We will implement a cluster randomized control trial (cRCT) to test the impact of a long-term, dynamic CHOICE intervention on 12-month viral suppression (<50copies/mL) among TI clients in Malawi. TI clients will receive person-centered counseling + ongoing, dynamic choice of how ART services are delivered over 24-months. Clients can combine multiple choices for service delivery at any given time to create personalized intervention packages. Choice of service delivery are informed by preliminary research and the building blocks of differentiated services and include: 1) ART dispensing intervals (1, 3, 6months), location of ART distribution (facility, home, or community), and if they want peer mentorship (if yes – frequency, when, where). Clients can adjust their choice at each ART visit or via hotline throughout study period. We will compare CHOICE to SOC (1-3 counseling sessions + routine facility-based services). Specific Aims are: Aim 1. Test the effectiveness of CHOICE versus SOC on 12-month viral suppression among TI clients in Malawi. We will conduct an individually randomized trial at 12 health facilities (n=800 individuals). Primary outcome is viral suppression (<50copies/mL) at 12-months (study collected sample). Secondary outcomes are: repeat TI and ART coverage (days with ART in possession) at 6, 12 and 24 months. Aim 2: Systematically evaluate the implementation of CHOICE. We will use mixed-methods to understand barriers, facilitators and needed improvements to HCW implementation of CHOICE, clients’ ability to choose DSDs, and equity in intervention implementation and outcomes. Aim 3. Estimate cost and cost-effectiveness of CHOICE. We will use a micro-costing approach to estimate the distribution of care costs by study arm, differences between arms, and incremental cost effectiveness. The trial will set the stage for how to best provide long-term, dynamic choice interventions to TI clients throughout the region. It is timely, feasible, and of high impact.