Long-acting injectable antiretroviral therapy (LAI ART) is anticipated to be a major advance in the management of HIV infection. However, how this therapeutic innovation will be received among patients and providers remains unclear. At present, there are few data with which to forecast, let alone, plan for incorporation of this innovation in HIV care into practice. Our preliminary studies demonstrate excitement for LAI ART among participants in research trials of this mode of ART administration, with possibly less enthusiasm among HIV care providers. With the proposed research studies, we seek to gain a deeper understanding of the perceptions regarding LAI ART among diverse groups of PLHIV in the US and their care providers. This understanding will be used to inform the roll-out of LAI ART, including the development of tools that PLHIV and providers can use to guide shared decision-making when choosing among treatment options.
PROJECT SUMMARY Antiretroviral therapy (ART), at present, requires life-long, daily administration to achieve and maintain viral suppression, prevent drug-resistance, and reduce infectiousness. While ART is increasingly convenient, patients may experience pill-fatigue - especially if prescribed additional medications for co-morbid conditions ? as well as low-level but quality-of-life-limiting adverse effects of oral ART, particularly gastrointestinal disturbances. Long acting injectable (LAI) ART formulations are being developed as an alternative to standard oral ART. Two LAI agents are completing Phase III drug development trials: rilpivirine (RPV) and cabotegravir (CAB) ? co- administered intramuscularly (IM) every 4 or 8 weeks. Despite the promise and the potential drawbacks of LAI ART, the acceptability and potential uptake of this advance in HIV therapeutics by people living with HIV (PLHIV) and their providers remains largely unexplored. As LAI ART enters late-stage development, it is imperative that there be an in-depth understanding of how patients and providers will make decisions about the use of these agents. The primary goal of this proposal is to achieve a deep understanding of perceptions of LAI ART among PLHIV and their providers relative to existing oral ART to foster shared decision-making by patients and clinicians as they navigate newly-expanded treatment options. Specifically: x In Aim 1, we will conduct in-depth interviews with PLHIV and HIV care providers at four geographically distinct CNICS clinics to characterize perceptions, preferences, and decision-making processes relevant to LAI ART among a diverse sample of PLHIV, as well as among their healthcare providers. x In Aim 2, we will develop and administer a quantitative survey informed by the Aim 1 findings to PLHIV and HIV care providers across all eight CNICS sites to identify factors (individual, medical, and structural) that are associated with preferences related to injectable LAI versus oral ART. x In Aim 3, materials and tools to facilitate shared decision-making between patients and providers considering LAI ART as HIV therapy will be developed based on findings from Aim 1 and 2, interviews with PLHIV and prescribing providers, and mock patient-provider interactions with the draft tool. This research will be based within the Center for AIDS Research (CFAR) Network of Integrated Clinical Systems (CNICS), a collaborative of eight large HIV clinical centers across the US that cares for over 32,000 PLHIV. Our close and strong working relationship with CNICs provides us access to a well-characterized cohort of PLHIV, as well as to their providers ? both of whom will eventually face decision-making regarding LAI versus oral ART. Collectively, the proposed research will provide not only elucidate the factors that will be weighed by PLHIV and HIV care providers following the availability of LAI ART, but also will produce practical tools to support decision-making regarding HIV treatment that is shared, informed, and leads to the selection of the option that best fits the individual patient.
