EDURANT / EVIPLERA Health Care Professional Survey (HCP survey on RPV)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  On-line survey

Study drug and medical condition

• Name of medicine:
  EVIPLERA
• Name of medicine, other:
  EDURANT
• Medical condition to be studied:
  HIV infection

Population studied

• Short description of the study population:
  HIV treating Health Care Professional who must see at least 10 HIV patients per month, have recently prescribed/dispensed/instructed patients to take Edurant and/or Eviplera within the last 3 months and will be the person most involved, within their current work setting, in instructing patients on how to take their HIV medication.
• 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:
  289

Study design details

• Main study objective:
  The objective of the survey is to gain an understanding of the effectiveness of the current prescribing conditions in minimising the risk of virological failure and development of resistance associated with taking EDURANT or EVIPLERA without food.
• Outcomes:
  To consider the current prescribing conditions sufficient to minimise the risk of patients taking EDURANT / EVIPLERA without a meal / food, at least 80% of HCPs will correctly identify the instructions for these products relating to food intake (Q2 in on-line survey). Additionally, it will be necessary for at least 80% of patients, on average, to be given the instruction that EDURANT must be taken with a meal / EVIPLERA must be taken with food / a meal when prescribed the treatment for the first time.
• Data analysis plan:
  Upon completion of the survey by the required sample respondents (N=289), data collected during the course of the survey will be aggregated and tabulated. All questions will be analysed individually as well as cross-tabulated with other survey questions to allow for more in-depth analysis. Most commonly anticipated cross-tabulations will include HCP type and prescription level (high versus medium versus low). Answers to open-ended questions will be grouped together and assigned to aggregated answer codes for the purposes of analysis and reporting.For each question, the base of the respondents answering it will bepresented. All results included will be significance tested (95% CI) and where significant differences are observed these will be highlighted.