Cabotegravir▼ plus rilpivirine▼ long acting in the US to optimize and measure implementation and experience (CUSTOMIZE) trial

Background
Long-acting HIV treatment will require a paradigm shift for both clinicians and people living with HIV (PLHIV). Supporting clinicians and PLHIV to effectively use long-acting injectables is important for widespread, public health impact in Europe. The proposed study is a mixed-methods hybrid implementation-effectiveness study to help inform successful uptake of the long-acting injectables across US clinical settings.

Goals
The CUSTOMIZE study, a mixed-methods study, evaluated both qualitative and quantitative measures across a range of patient and staff-study participant (SSP) types in the United States (US) to determine the most effective strategies for real-world implementation of the CAB LA + RPV LA injectable regimen. Additionally, the study aimed to identify the barriers to and facilitators of (including solutions for) the successful implementation of the CAB LA + RPV LA regimen in real-world clinical settings.

Design
CUSTOMIZE was a Hybrid III Implementation Effectiveness study conducted over one year, wherein people living with HIV (PLWH) and staff study participants from eight US clinical sites were surveyed at at three different timepoints—baseline, month 4, and month 12. A subgroup of PLWH was selected to participate in interviews via a randomization scheme at baseline and month 12. SSPs were interviewed at month 4 and participated in the monthly facilitation calls (n=8) from June 2019 through January 2020.

View CUSTOMIZE congress posters

  • Clinical outcomes during customize: A hybrid III implementation- effectiveness study focused on implementation of cabotegravir plus rilpivirine (CAB +RPV) LA in US healthcare settings
    Presented at IAS 2021
    Read more
  • Customize: Overall results from a hybrid III implementation-effectiveness study examining implementation of cabotegravir and rilpivirine long-acting injectable for HIV treatment in US healthcare settings; final patient and provider data
    Presented at IAS 2021
    Read more
  • CAB +RPV LA implementation outcomes and acceptability of monthly clinic visits improved during covid-19 pandemic across us healthcare clinics (customize: Hybrid III implementation effectiveness study)
    Presented at IAS 2021
    Read more
  • Qualitative patient-participant perspectives on implementation of monthly cabotegravir ▼ and rilpivirine ▼ long-acting (CAB +RPV LA) injectable in the United States (customize)
    Presented at IDWeek 2021
    Read more

 

NP-GBL-HVX-WCNT-240022 October 2024

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