FACTS 001 Study

The FACTS 001 study is a phase III, multi-centre, double-blind, randomised, placebo controlled trial that will test if tenofovir gel, when used before and after sex, is safe and effective at preventing sexually transmitted HIV and human simplex virus (HSV-2), the virus that causes genital herpes. The FACTS 001 was launched in October 2011, and will enrol 2,900 HIV-uninfected women aged 18-40 at nine clinical trial sites across South Africa.

The goals of the FACTS 001 study are to:

  • Confirm whether using tenofovir gel dosing before and after sex is effective in preventing HIV and HSV-2 infection
  • Generate evidence to better understand what level of effectiveness the gel can provide against HIV
  • Establish whether use of tenofovir gel before and after sex can prevent HIV in women in a variety of settings across South Africa
  • Provide the additional safety and efficacy data needed for product registration, with an indication for coitally-dependent dosing

In July 2010, the CAPRISA 004 study found that tenofovir gel reduces women’s risk of HIV infection by 39% when women inserted the gel into the vagina before and after sex. Amongst women who reported using the gel at least 80% of the time, the study showed a 54% reduction in HIV infection. In the same study, tenofovir gel also lowered women’s risk of getting genital herpes by 51%.

There is an urgent need to repeat the CAPRISA 004 study to confirm whether the gel really protects women against HIV infection and herpes infection.

Three women who work on FACTS

Staff at the first FACTS 001 protocol training in Johannesburg, South Africa, June 2011.

FACTS 001 study design
Information on study objectives, participant eligibility, trial sites, regulatory issues and ethics, counseling and adherence support. Read more.

FACTS 001 adherence programme
Details on how FACTS 001 supports participants to use study product correctly, as well as measures and monitors adherence to product during and after the study.  Read more

FACTS 001 study product
Background on tenofovir gel and gel licensure issues. Read more.