A Multi-Level Integrated Strategy to Optimize PrEP Adherence and Accelerate Implementation at Scale

Scalable interventions that facilitate adherence to HIV pre-exposure prophylaxis (PrEP) are urgently needed to address the alarming HIV incidence in in the U.S. PrEP reduces the risk of acquiring HIV by >92%; but it has not achieved implementation at a scale sufficient to curb the growth of the US HIV epidemic. There are multi-level barriers to PrEP adherence, including interpersonal and structural barriers. To optimize health in PrEP coverage, individuals must have access to service options that reduce their exposure to these barriers. Many Men Many Voices (3MV) is a group-level behavioral intervention that demonstrated efficacy for increasing healthcare-seeking behaviors. Client-centered care coordination (C4) addresses social barriers through a service model that trains staff to deliver autonomy-supportive care and addresses structural barriers via an integrated online platform to improve the continuity of coordination between service providers. Our goal is to combine two evidence-based interventions into a multi-level integrated strategy that directly addresses interpersonal barriers via 3MV, extends 3MV effects into service-delivery settings by training staff on key concepts, and then addresses structural barriers by linking men to a network of services via the online C4 platform. We will pursue the following aims with 2 implementing agencies located in high HIV incidence communities (1) determine the efficacy of an integrated 3MV+ C4 for increasing PrEP adherence; (2) ascertain the optimal dose of C4 implementation for maximizing its effect on PrEP adherence; (3) identify the critical leverage points in the implementation ecosystem to target for change. 48 egocentric networks of men (N=480; mean network size n=10) will be recruited in two collaborating sites in Dallas/Ft. Worth and Bronx/Harlem. Networks will all begin with a 3-month control phase and be randomized into either the C4 arm or the C4+3MV arm. The Learn-as-you-go (LAGO) statistical methodology will be used to optimize the strategy and associated costs by generating statistical recommendations for modifying pre-specified components of C4. Qualitative interviews will explore the factors affecting variation in implementation between the three cities. Lastly, we will develop a policy brief accounting for the political economy and non-economic welfare effects of 3MV+C4. This study advances HIV prevention science by generating evidence for an intervention that will contribute to health optimization in the impact of PrEP on the HIV epidemic. Our research also uses innovative statistical and interdisciplinary methods that allow us to maximize 3MV and C4’s effects on adherence by: (1) optimizing elements observed to be contributing to increases in adherence and (2) streamlining excess elements to reduce implementation time and costs; thus, enhancing scale-up potential in End the HIV Epidemic communities.