A Prospective, Longitudinal, Observational Registry of Truvada for HIV -1 Pre-Exposure Prophylaxis (PrEP) of Adults and Adolescents in Europe

Study type

• Study topic:
  Disease /health condition

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

  Effectiveness study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  This is a prospective, longitudinal, observational, and voluntary participation registry designed to characterize the real-world use of Truvada for PrEP to prevent HIV-1 infections in adults and adolescents in Europe.

Study drug and medical condition

• Name of medicine:
  Truvada
• Medical condition to be studied:
  Prophylaxis against HIV infection

Population studied

• Short description of the study population:
  The registry population will consist of adults and adolescents who are HIV-1 negative and are taking Truvada for PrEP. Individuals who have either self-initiated Truvada for PrEP or have been prescribed Truvada for PrEP and are being monitored while on Truvada for PrEP will be informed about the registry by their HCPs at one of the participating sites.; Inclusion Criteria:; -HIV-1 negative adults and adolescents who are deemed to be at high risk for acquiring HIV-1; -HIV-1 negative adults and adolescents who provided consent / assent and, depending on local country regulations, parental or legal guardian permission to participate in the registry; -HIV-1 negative adults and adolescents who are receiving Truvada for HIV PrEP, either as a daily or intermittent regimen, and that are clinically monitored; Exclusion Criteria:; -Individuals currently participating in a clinical study of HIV PrEP
• 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:
  300

Study design details

• Main study objective:
  The primary objective of this study is to characterize the real-world use of Truvada for PrEP to prevent HIV-1 infections in adults and adolescents in Europe.
• Outcomes:
  Describe how Truvada for PrEP is prescribed or self-initiated, Characterize demographics of individuals who were prescribed or are taking Truvada for PrEP, Characterize the nature and frequency of individual monitoring after initiation, Document new cases of HIV diagnoses and development of any resistance to Truvada, and Summarize characteristics of HCPs who prescribe Truvada for PrEP.
• Data analysis plan:
  Descriptive data analysis will be used to summarize the available data. There are no statistical hypotheses to evaluate. Categorical variables will be reported by proportions and continuous variables will be reported by mean, standard deviation, minimum, median, and maximum. Prescriber characteristics will be summarized. Demographics and clinical characteristics of individuals on Truvada for PrEP will be analyzed. The products prescribed and available prescription details, the frequency of monitoring, and any relevant data on adherence monitoring will be summarized. Seroconversion cases and results of resistance testing will be summarized. Reports of treatment-related renal and bone adverse drug reactions (SADRs and ADRs) will be summarized. Females participants in the registry who are pregnant will also be analyzed. Data will be presented overall, and by age group (adolescents and young adults) and risk factors for HIV transmission.