Prospective Study to Assess Usage, Adherence, Effectiveness of Cabotegravir LA for Pre-Exposure Prophylaxis in the United States in the OPERA Cohort (219844)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Effectiveness 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

• Short description of the study population:
  This study includes adults and adolescents initiating a new PrEP formulation: either as oral PrEP or LA-PrEP.
• Age groups:
  Adolescents (12 to < 18 years)

  Adults (18 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  10000

Study design details

• Study design:
  This is a Cohort study. ; Analyses will be conducted cumulatively at three time points through this study. ; For each analysis, all primary/secondary objectives have specific follow-up periods.; ;
• Main study objective:
  Description of effectiveness, adherence, and usage of cabotegravir (CAB) LA for PrEP and monitor incidence of HIV and HIV treatment outcomes for cases of HIV acquisition among participants on CAB LA for PrEP in the United States.; ;
• Outcomes:
  Primary Outcomes; - Number of participants with baseline characteristics including demographic and clinical characteristics of oral and LA PrEP users; - Adherence and usage patterns of CAB OLI and/or LA-PrEP, number of participants with HIV and STIs while on CAB OLI and/or LA PrEP; - Number of participants receiving HIV treatment and having virologic suppression after HIV acquisition; ; Secondary Outcomes; - Number of participants with incomplete initiation of CAB LA for PrEP;
• Data analysis plan:
  For Primary Objective 1, baseline characteristics will be described and statistical comparisons between PrEP type (CAB LA vs daily oral) will be conducted using chi-square tests for categorical variables and Wilcoxon-Mann-Whitney tests for continuous variables, as appropriate. ; ; For Primary Objective 2, adherence and usage pattern outcomes will be described among CAB PrEP users. ; ; For Primary Objective 3, incidence of STIs and HIV will be described as a frequency and an incidence rate among CAB PrEP users. ; ; For Primary Objective 4, follow-up care and virologic outcomes will be described as median (IQR) values for continuous data and relative frequencies for categorical data among individuals who acquired HIV while on CAB PrEP. ; ; For Secondary Objective 1, select baseline demographic and clinical characteristics and ISR will be assessed among individuals with only one injection (i.e., loading dose) who have sufficient follow-up after the loading dose to observe delayed or missed second doses.