Table 1 MDP 301 Uganda: Eligibility criteria

Sexually active

Unable or unwilling to provide a reliable method of contact for the field team

16 years old or above

Likely to move permanently out of the study area within the next year

HIV negative at screening

Likely to have sex more than 14 times a week on a regular basis during the course of following up

Willing to undergo regular HIV testing and receive the result before randomization

Using spermicides regularly

Willing to undergo regular speculum examinations and genital infection screens

Pregnant or within six weeks postpartum at enrolment

Willing to have regular urine pregnancy tests

Had a severe clinical or laboratory abnormality

Willing to use study gel as instructed

Requiring referral for assessment of a clinically suspicious cervical lesion

Willing to receive health education about condoms

Had treatment to the cervix, or to the womb through the cervix, within 30 days of enrolment

Willing and able to give informed consent

Had known latex allergy

Participating, or having participated within 30 days of enrolment, in a clinical trial of an unlicensed product, microbicide, barrier method or any other intervention likely to impact on the outcome of this trial

Considered unlikely to be able to comply with the protocol