A Phase II, Randomized, Open-Label, Pharmacokinetic and Behavioral Study of the Use of Intermittent Oral Emtricitabine/Tenofovir Disoproxil Fumarate Pre-Exposure Prophylaxis (PrEP) : HPTN 067

Project Type: protocol | Intervention and risk factors: PreP | Risk populations: Men who have sex with men (MSM), Women at risk | Setting: United States, Africa | Type of study: Public health | Stage: After

Study objectives

Primary Objective of HPTN 067:

To test the hypothesis that recommending intermittent (non-daily) usage of oral FTC/TDF chemoprophylaxis, compared with recommending daily usage, will be associated with:

  •  Equivalent coverage of sex events with pre- and post-exposure dosing
  • Lower number of pills needed for coverage and fewer pills used
  • Decreased self-reported symptoms/side effects (both severity and frequency) during 24 weeks of self-administered use

Modelling objectives

To develop new mathematical models using HPTN 067 data to assess the impact and cost-effectiveness of intermittent(non-daily) usage of oral FTC/TDF in different risk population and settings.

Collaborators

Study PIs:

Robert M. Grant, MD, MPH
Gladstone Institute of Virology and Immunology
Associate Professor of Medicine, University of California, San Francisco

Frits van Griensven, PhD, MPH
Associate Professor of Epidemiology and Biostatistics, University of California, San Francisco

Additional Funding

The HPTN Modelling Centre, which is funded by the U.S. National Institutes of Health (NIH UM1 AI068617) through HPTN fully funded this work.

Resources