CAB LA PrEP Cohort: Prospective Cohort Study to Assess Effectiveness and Safety of, and Adherence and Resistance to Cabotegravir for Pre-Exposure Prophylaxis in the United States (217671)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  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

• Age groups:
  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  0

Study design details

• Study design:
  This will be a 5-year long prospective cohort study of adults and adolescents ≥35 kgs initiating CAB LA for PrEP in real-world clinical setting in the United States.
• Main study objective:
  Following the initiation of CAB LA for PrEP, the study will aim to assess usage patterns, adherence, effectiveness, safety, and resistance among individuals diagnosed with HIV infection.
• Outcomes:
  - Participants with incidence and diagnosis of HIV; - Participants receiving CAB LA PrEP with diagnosis of HIV; - Time to diagnosis of incident HIV; - CAB PrEP users receiving ART regimen and with VL testing for prevalent and incident HIV infections; - Participants with adherence to CAB LA PrEP, resistance to INSTIs and specific mutations, DILI, hypersensitivity reactions
• Data analysis plan:
  Descriptive analyses will summarize baseline characteristics of study participants and covariables will be reported as frequencies/median (IQR) at baseline and at follow-up. Time to HIV diagnosis will be assessed using Kaplan-Meier curve. Cox proportional hazards models will be constructed to compare time to HIV diagnosis adjusting for participant characteristics. Adherence will be estimated using the date of injections over 6 and 12-month periods. Frequency of resistance will be described among individuals who acquire HIV infection while on CAB LA for PrEP.