An observational study evaluating long-acting injectable cabotegravir (CAB-LA; APRETUDE) healthcare provider and user experience and utilization for pre-exposure prophylaxis (PrEP) against HIV in Canada (223857)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation

  Evaluation of patient-reported outcomes
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Cross-sectional

Study drug and medical condition

• Medicinal product name:
  APRETUDE
• Study drug International non-proprietary name (INN) or common name:
  CABOTEGRAVIR
• Anatomical Therapeutic Chemical (ATC) code:
  (J05AJ04) cabotegravir

  cabotegravir
• Medical condition to be studied:
  HIV infection

Population studied

• Short description of the study population:
  The study population includes HCPs comprised of physicians, nurses, and pharmacists who prescribe or administer CAB-LA, and users of CAB-LA 16 years of age or older.
• Age groups:
  • Adolescents (12 to < 18 years)
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  350

Study design details

• Study design:
  Non-interventional study
• Main study objective:
  To evaluate the effectiveness of the aRMMs for CAB-LA within Canada, among HCPs and CAB-LA users.
• Setting:
  A cross-sectional survey of HCPs prescribing/administering CAB-LA and users of CAB-LA, to be conducted from December 2025 – April 2026; and a retrospective analysis of CAB-LA user data in the APRETUDE Supports Patient Support Program database, to be conducted from July 2024 – October 2027.
• Outcomes:
  1. Number of HCPs who have used aRMMs for CAB-LA using KAB survey.; 2. Number of CAB-LA users who have used aRMMs for CAB-LA using KAB survey.; 3. Number of HCPs with knowledge of key CAB-LA risk messages within the HCP-specific aRMMs using KAB survey.; 4. Number of users with knowledge of key CAB-LA risk messages within the user-specific aRMMs using KAB survey.; 5. HCP (prescribers’) attitudes regarding the importance of selecting individuals who will adhere to the CAB-LA dosing schedule and attend follow-up visits using KAB survey.; 6. HCP and user behaviors as they relate to key CAB-LA risk messages within the aRMMs using KAB surveys.; 7. Description of HCPs’ decision-making process regarding the choice between oral PrEP and CAB-LA using HCP surveys.; 8. Descriptions of HCPs’ experience implementing, prescribing, or managing CAB-LA and oral PrEP in clinical practice and among individuals eligible for PrEP, including HIV-testing using HCP surveys.; 9. Description of HCPs’ use of CAB-LA oral lead-in and oral bridging using HCP surveys.; 10. Description of HCPs’ management of pharmacokinetic (PK) tail among those who discontinue CAB-LA using HCP surveys.; 11. Description of HCPs’ attitudes towards CAB-LA using HCP surveys.; 12. Description of CAB-LA users’ demographic and clinical characteristics for the participants in the APRETUDE Supports Program database that initiated CAB-LA between.; 13. Description of CAB-LA users’ decision-making process regarding the choice between oral PrEP and CAB-LA.; 14. Description of CAB-LA users’ experience using CAB-LA.; 15. Description of CAB-LA users’ utilization patterns for the participants in the APRETUDE Supports Program database that initiated CAB-LA between 15-July 2024 and October 2026.
• Data analysis plan:
  The study will primarily be descriptive, survey-based for both CAB-LA users and healthcare providers.
• Summary results:
  Results will be presented overall for HCPs and CAB-LA users, as well as stratified by characteristics of interest at the end of the study