CUSTOMIZE is the first-ever implementation science study that aims to identify successful methods of integrating the investigational once-monthly, long-acting regimen of cabotegravir and rilpivirine for the treatment of HIV-1 into clinical practices in the US. These findings build on recently presented healthcare provider and clinical staff survey perspectives and were presented today at the 2020
The CUSTOMIZE study was launched in
As part of a survey given to patient participants after the first four months of the study, the majority (91%) said they continued to perceive the once-monthly injectable regimen as highly acceptable for treating their HIV and an appropriate treatment option for their life. Healthcare providers and clinical staff outlined several key recommendations to best facilitate the implementation of the injectable regimen across a number of criteria, including clinic set-up, injection administration, and appointment management.
Patient perspectives from CUSTOMIZE
During the study, 105 virologically suppressed adults living with HIV at eight participating clinical sites received once-monthly cabotegravir and rilpivirine and were surveyed on the regimen's acceptability for treating their HIV and appropriateness for their life. The perspectives of these participants were positive overall, with a large proportion (>91%) indicating they agreed or completely agreed at the beginning of the study and after four months of treatment that the once-monthly regimen was both appropriate and acceptable.
Prior to initiating treatment with once-monthly cabotegravir and rilpivirine, participants were asked a series of questions about their current antiretroviral therapy (ART). At the study start, one-third of participants (33%) reported hiding their oral ART from others, and one in five participants (22%) reported they had difficulty remembering to take their daily ART. Interest in a 'more convenient treatment option' (83%) was a top reason among trial participants for choosing to enrol in the CUSTOMIZE study.
Access to care was assessed after four months, with the majority of participants (84%) reporting that monthly clinic visits were very or extremely acceptable and 66% of participants reporting no logistical challenges to their clinic administered once-monthly injection. Although pain or soreness from their injection was cited by 58% of participants as their most common worry at the start of the trial, only 28% of participants continued to report injection pain or soreness as a concern after four months of treatment. Adherence to treatment among trial participants remained high over the course of four months with nearly all injections (95%) received within a +/- 7-day treatment window around the target treatment date, further supporting patient acceptance of monthly visits.
Healthcare provider and clinical staff perspectives from CUSTOMIZE
Interviews were conducted at study initiation and after four months with 24 physicians, nurses, and administrators to evaluate barriers and facilitators to the implementation of once-monthly cabotegravir and rilpivirine. After four months of implementation, interviews with staff study participants revealed key recommendations on best practices to facilitate clinic set-up, injection administration, and appointment management. While some staff had initial concerns about implementation, at the interim analysis these concerns were perceived as surmountable, requiring minor purchases or minimal practical changes to clinical practice. Overall, study participants viewed operationalizing this injectable regimen as an important and achievable goal that will facilitate patient preferences and treatment adherence.
When planning to implement once-monthly cabotegravir and rilpivirine, staff study participants recommended that clinics create a process for managing the flow of patients that included identifying designated rooms for administering injections, establishing proper refrigeration space, identifying a person to track appointment schedules, and creating a system for rescheduling and reminders. To alleviate the potential impact of missed appointments and facilitate implementation, participants recommended that administrators explore ways to improve transportation support through public transit vouchers and ride-sharing programs, explore the flexibility of allowing walk-in appointments, and modifying the working hours of nurses to increase coverage for injection administration. Lastly, as administering injections may be new for HIV practitioners, participants recommended face-to-face injection trainings among staff as well as administering initial injections during such trainings to increase confidence among new adopters.
The full 12-month results from the CUSTOMIZE study will be presented at an upcoming medical meeting. The corresponding CARISEL study, which will examine the implementation of the long-acting regimen of cabotegravir and rilpivirine in certain European healthcare settings, started in
The long-acting regimen of cabotegravir and rilpivirine was approved by
About CUSTOMIZE (NCT04001803)
CUSTOMIZE is a single-arm, multicenter, one-year evaluation of the effect of an implementation strategy on the degree of acceptability, appropriateness, feasibility, fidelity and sustainability of clinic practices to deliver the investigational once-monthly, injectable regimen of cabotegravir and rilpivirine to appropriate patients living with HIV. The study evaluates both qualitative and quantitative measures across a range of clinic types, including university hospitals as well as private and public clinics, with varied geographic and demographic representation.
A suite of educational items, training aids, treatment and resource planning tools, appointment reminders and patient-directed support items were made available as part of this study. Staff study participants from each site (physician/primary care practitioner, nurse/medication administration personnel, administrator/clinic manager) took part in the study through participation in surveys and interviews. Sustainment of implementation strategies was assessed via surveys and semi-structured interviews of staff study participants as well as patient study participants. The primary endpoint was change from baseline to Month 12 in site survey responses for acceptability, appropriateness and feasibility.
About the long-acting regimen of cabotegravir and rilpivirine
The long-acting regimen of cabotegravir and rilpivirine is an investigational regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in patients who are virologically stable and suppressed (HIV-1 RNA less than 50 copies/mL). The complete regimen combines the integrase strand transfer inhibitor (INSTI) cabotegravir, developed by
INSTIs, like cabotegravir, inhibit HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV replication cycle and is also responsible for establishing chronic infection. Rilpivirine is an NNRTI that works by interfering with an enzyme called reverse transcriptase, which in turn stops the virus from multiplying.
CABENUVA (cabotegravir and rilpivirine extended release injectable suspensions) is currently only approved in
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