PACTR2010060002133418
Not yet recruiting
未知
A study to determine the feasibility of conducting a microbicide trial of daily vaginal gel and to inform the way adherence should be assessed
ConditionsHIV/AIDS
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- HIV/AIDS
- Sponsor
- Medical Research Council
- Enrollment
- 225
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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