Top-Up Study
- Conditions
- HIV/AIDS
- Registration Number
- PACTR2010060002133418
- Lead Sponsor
- Medical Research Council
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Female
- Target Recruitment
- 225
Women aged 18 years and above at enrolment
Likely to be sexually active at entry and during follow-up
Willing to use study gel as instructed
Willing to return applicators every week day
Willing to attend the clinic every 4 weeks and be interviewed
Willing to be followed up and interviewed if she defaults
Willing to receive health education about condoms
Willing to undergo pregnancy tests on a monthly basis
Willing and able to give informed consent
Using a product in a trial, or otherwise e.g. licensed spermicide, that is likely to impact on the outcome of this study and she is unwilling to stop use for the duration of study
Unable to agree a reliable method of contact with the field team
Likely to move out of the area within the next 3 months
Pregnant (including positive pregnancy test at enrolment)
Has clinical condition considered by the study management group to make enrolment inadvisable
Considered by the study personnel to be unlikely to be able to comply with the study procedures
Previously enrolled on MDP301 trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adherence to daily use of gel
- Secondary Outcome Measures
Name Time Method Consistency of adherence measure;Retention;Reasons for non-adherence