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OpenTrials
Completed

NCT Number: NCT01865799

A Prospective, Observational, Drug Utilization Study of Subjects Taking Truvada for Pre-exposure Prophylaxis in the USA

This is a prospective, 3-year observational study to describe drug utilization in uninfected individuals (UIs) who initiate emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) (Truvada®) for a pre-exposure prophylaxis (PrEP) indication.

An electronic source of pharmacy/medical encounter information will be used to assess the demographics and other characteristics of the subjects prescribed FTC/TDF or its components in a prospective fashion. The data provider will supply all the de-identified information regarding each visit/interaction that the subject has had with the health system and all the diagnoses and medications that the UI has had prospectively and retrospectively for the length of time captured by the source selected.

200 physicians who prescribe FTC/TDF for a PrEP indication will be sampled from the same source.

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Key information

Conditions

Pre-exposure Prophylaxis for Prevention of HIV Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Gilead Sciences, Inc.

Foster City, California, 94404, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Patient/ Uninfected Individual
  • Adult (any sex/gender, including transgender) ≥18 years old
  • Taking FTC/TDF prescribed for any indication or its components Prescriber
  • Possesses an active health care professional license in good standing, with the authority to prescribe prescription medications, either independently (eg, physician) or under legally permissible arrangements for prescribing under physician supervision (eg, Nurse Practitioner or Physician Assistant)
  • Practice site is within the USA
  • Having prescribed FTC/TDF for a PrEP indication

Key Exclusion Criteria:

  • There are no exclusion criteria for individuals or prescribers

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Treatment and study plan

Primary outcomes

  1. Drug utilization of uninfected individuals who are prescribed FTC/TDF for a PrEP indication, including gaps in therapy

    Time frame: Month 36

Secondary outcomes

  1. Demographics and clinical characteristics of uninfected individuals who are prescribed FTC/TDF for a PrEP indication

    Time frame: Months 6, 12, 18, 24, 30, and 36

    Demographics (including age, gender and if available, race and ethnicity) and clinical characteristics (including diagnoses, procedures, and laboratory test results) will be summarized by 1) exposure group and 2) overall using descriptive statistics (sample size, mean, standard deviation, median, interquartile range, minimum and maximum) for continuous data, and by the number of participants for categorical data; age will be calculated as age in years at exposure.

  2. Demographics of prescribers of FTC/TDF for a PrEP indication

    Time frame: Months 6, 12, 18, 24, 30, and 36

    Demographics (including gender, medical degree, medical specialty, number of years in medical practice, and setting of care) of prescribers of FTC/TDF for a PrEP indication will be summarized using descriptive statistics (sample size, mean, standard deviation, median, interquartile range, minimum and maximum) for continuous data and by the number prescribers for categorical data.

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
May 31, 2013
Registry last updated
Mar 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.