Microbicides Development Programme Top-Up study

Would women be prepared to use a vaginal gel every day to prevent HIV?

What is this study about?

The most common way in which HIV (the Human Immunodeficiency Virus) is spread is through sexual contact between men and women. Although condoms offer very good protection, it is not always possible for a woman to get her partner to use them. So there is an urgent need for other methods of protection that women can use to protect themselves.

Microbicide gels, that are currently being developed and tested, are one such method. These gels may prevent women becoming infected with HIV during sex if they are put in the vagina. A number of studies looking at whether these gels are safe and whether they work have already been carried out, and others are still ongoing. Up until now no product has been shown to prevent HIV infection. However, new products continue to be developed, and studies need to be carried out to find out whether these new products work.

Some microbicides that are currently being tested must be inserted into the vagina before every sex act. The disadvantage of this is that sex is sometimes unplanned, so women don’t always know when to insert gel. Some of the new microbicides that are being developed can be inserted every day, whether women are planning to have sex or not. This may make the gels easier to use.

Before we can test whether or not daily microbicides work, we first have to do a study to find out whether daily use will be acceptable to women. This is what the Top-Up study is about.

In the Top-Up study we want to find out what women think about using a microbicide gel every day, whether this is acceptable to them, and what the best way is to ensure that they use the gel.

The gel that will be used in Top-Up is not a microbicide. It is a placebo gel which has no activity against HIV. The Top-Up study will test the process of getting women to use a gel every day and return the used gel applicators. It also aims to find out what men think about their partners using a gel every day.

The gel that will be used in Top-Up is safe, but it will not prevent HIV or other sexually transmitted infections.

Type of study

Randomised trial

Who is funding the study?

Top-up is funded by the UK Department for International Development (DFID), the UK Medical Research Council (MRC), the European and Developing Countries Clinical Trials Partnership (EDCTP), CONRAD and the International Partnership for Microbicides (IPM).

When is it taking place?

This trial started recruiting women in May 2010.

Where is it taking place?

Durban, South Africa | Mazabuka, Zambia | Mwanza, Tanzania | Masaka, Uganda | Manhiça & Maputo, Mozambique

Who is included?

Participants will be recruited from populations similar to the current MDP trial populations, or populations that would be targeted in a future MDP trial. The women will be aged 18 years or above and sexually active.