GS-EU-276-4027: A Cross Sectional Post Authorization Safety Study to Assess Healthcare Provider’s Level of Awareness of Risk Minimisation Materials for Truvada® for Pre Exposure Prophylaxis in the European Union

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Healthcare providers level of awareness
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Medical condition to be studied:
  HIV infection CDC Group I

Population studied

• Short description of the study population:
  Healthcare Providers (HCPs) from France, Germany, Ireland, the Netherlands, Norway, and the United Kingdom (UK) recruited from the same population of HCPs that were targeted for the distribution of the Truvada for PrEP risk minimisation measures (RMMs) as agreed with the national competent authorities.
• Age groups:
  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)
• Special population of interest:
  Immunocompromised
• Estimated number of subjects:
  200

Study design details

• Main study objective:
  The objective is to determine healthcare providers’ level of awareness of Risk Minimisation Materials and appropriate use and risks associated with Truvada for a PrEP indication
• Data analysis plan:
  Responses to questions for all completed surveys will be analyzed using descriptive statistical analysis. Data from partially completed surveys will be evaluated separately. Characteristics for responders and non-responders will be compared based on country and HCPs specialty. Continuous variables will be described by the mean, standard deviation, median and range. Categorical variables will be described by the number and proportion in each category. The amount of missing data for each variable will be reported. Data will be presented by means of summary tables, graphs and listings. No formal hypothesis testing will be conducted. Gilead considers 80% the threshold for acceptable awareness of the RMMs.