Research Project
10321138
Project Summary Globally, suboptimal levels of antiretroviral treatment (ART) adherence and retention are major causes of ongoing HIV transmission, treatment failure, illness, and death. To improve ART outcomes, HIV experts agree that clinical care systems must do two key things: (1) Find nonadherence (identify nonadherent people living with HIV (PLWH) as early as possible); and (2) Support good adherence (implement effective interventions to promote better ART retention and adherence). The SUSTAIN study will pursue both objectives by determining the optimal combination of five evidence-based early nonadherence detection and adherence support compo- nents in local clinics in Cape Town, South Africa. Of these five components, three focus on finding non- adherence: (1) immediate outreach to the patient when standard testing shows unsuppressed virus; (2) pharmacy refill monitoring (PRM) and follow-up; and (3) real-time electronic adherence monitoring (EAM). Two components focus on supporting good adherence by strengthening existing patient support in Cape Town: (4) applying enhanced peer group support using motivational interviewing techniques and (5) weekly check-in texts. Each component is feasible, acceptable, and effective for monitoring or supporting adherence in PLWH in Cape Town or a similar low-resource setting. As informed by Self-Determination Theory, each addresses behavioral mediators that can increase motivation and competence and improve ART adherence and retention. To identify the best combination of components, we will utilize an innovative and practical application of Multiphase Optimization STrategy (MOST), an engineering-inspired approach that is uniquely suited to the testing of separate intervention components and their interactions in combinations to ?optimize? a potent multi- component intervention. Guided by MOST, we propose three specific aims: (1) employ an efficient fractional factorial design to determine the effects of five intervention elements on HIV viral suppression, as well as secondary outcomes; (2) evaluate intervention components to address implementation, service, and client outcomes according to the Proctor framework; and (3) use the effectiveness, cost, and implementation data from Aims 1 and 2 to model the multi-component intervention optimized for cost-effectiveness and implement- ation success. SUSTAIN addresses a crucial NIH priority?strengthening care for PLWH at high risk of treatment failure. It will also be among the first studies to use MOST to improve the HIV care continuum in a resource-constrained setting. The study?s combination of different methods of finding nonadherence and supporting good adherence has high potential to identify cost-effective and scaleable evidence-based inter- ventions and improve HIV treatment outcomes. Inclusion of both real-time electronic monitoring and pharmacy refill monitoring as intervention components will increase understanding of the best uses of technology to support adherence. Importantly, our approach can be used as a template for other settings to identify and implement the most appropriate and effective evidence-based interventions for broad, cost-effective impact.
