LA ART requires periodic injections, monthly or every 2 months, eliminating the need for taking daily pills. Clinical trials of a two-drug intramuscular (IM) long-acting regimen of Cabotegravir (CAB) and Rilpivirine (RPV) have demonstrated that LA ART is non-inferior to daily oral ART, showing rates of viral suppression, treatment failure, and drug resistance similar to daily oral ART. A new delivery method, long-acting injectable (LA) ART, offers an alternative to oral regimens which may address some of these adherence challenges. Significant psychosocial and structural barriers include substance use and mental health, inequitable gender norms and roles, and stigma and discrimination associated with HIV and marginalized populations disproportionately affected by the epidemic. Barriers to daily oral ART adherence include those imposed by characteristics of pill regimens and their side effects, health care systems and provider communication issues. Several decades into the use of ART, there is substantial evidence of sub-optimal adherence to oral ART across settings and populations. Daily oral ART can help people living with HIV (PLHIV) to achieve and maintain life-long viral suppression, but requires consistent adherence over a life time. Results suggest the importance of multi-level support systems to optimize patient-provider communication and treatment decision-making clinic staffing, workflow, logistics protocols and infrastructure and cost-related factors within a given health system.Īntiretroviral therapy (ART) to treat human immunodeficiency virus (HIV) is highly effective when taken regularly. Potential solutions included governments subsidizing treatment, ensuring cost is competitive with oral ART, and offering co-pay assistance. Health system level barriers included cost and approvals from national regulatory bodies. Proposed solutions included staff hiring and training, strategic planning around workflow and logistics, and the possibility of offering injections in other settings, including the home. Clinic level barriers included the need for additional skilled individuals to administer injections, shifts in workflow as demand increases and the logistics of cold-chain storage. The main provider concern was identifying appropriate candidates for LA ART proposed solutions focused on patient provider communication and decision making. Proposed solutions included patient education, having designated staff for clinic visit retention, and clinic flexibility with appointment scheduling. Provider perceptions of patient level barriers included challenges with adhering to frequent injection appointments and injection tolerability. Resultsīarriers and proposed solutions to LA ART implementation were identified at the individual, clinic and health system levels. The Consolidated Framework for Implementation Research (CFIR) was drawn on as the conceptual framework underpinning development of a model depicting study findings. Both assessments explored provider views and clinic dynamics related to the introduction of LA ART and were analyzed using thematic content analysis.
Multilevel codes atlasti trial#
This analysis draws on two data sources: (1) open-ended questions embedded in a structured online survey of 329 health care providers participating in the ATLAS-2 M trial across 13 countries and (2) in-depth interviews with 14 providers participating in FLAIR/ ATLAS/ATLAS-2 M trials in the United States and Spain. This study examined the perspectives of health care providers participating in LA ART clinical trials on potential barriers and solutions to LA ART roll-out into real world settings. Long-acting injectable antiretroviral therapy (LA ART) has been shown to be non-inferior to daily oral ART, with high patient satisfaction and preference to oral standard of care in research to date, and has recently been approved for use in the United States and Europe.