Table 1 MDP 301 Uganda: eligibility criteria
Eligible | Ineligible |
|---|---|
• Sexually active • 16 years old or above • HIV-negative at screening • Willing to undergo regular HIV testing and receive the result before randomisation • Willing to undergo regular speculum examinations and genital infection screens • Willing to have regular urine pregnancy tests • Willing to use study gel as instructed • Willing to receive health education about condoms • Willing and able to give informed consent | • Unable or unwilling to provide a reliable method of contact for the field team • Likely to move permanently out of the area within the next year • Likely to have sex more than 14 times a week on a regular basis during the course of follow-up • Using spermicides regularly • Pregnant or within 6 weeks postpartum at enrolment • Had a severe clinical or laboratory abnormality • Requiring referral for assessment of a clinically suspicious cervical lesion • Had treatment to the cervix, or to the womb through the cervix, within 30 days of enrolment • 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 |