Status:
COMPLETED
Biomarkers of Protocol Compliance and Product Adherence
Lead Sponsor:
CONRAD
Conditions:
HIV Prevention
Eligibility:
FEMALE
18-50 years
Brief Summary
The purpose of this study is to compare tests of vaginal insertion of applicators(visual inspection of returned applicators (VIRA), inspection of returned applicators under ultraviolet (UV) light, and...
Detailed Description
Screening tests will be performed to detect exclusion criteria. After confirming the absence of point-of-care exclusion criteria, four applicators (#1 to 4, "sham" applicators) will be handled by the ...
Eligibility Criteria
Inclusion
- 18 to 50 years old
- In good health, as evidenced by history
- No use of vaginal medications in the past 7 days
- At least 3 days from the end of their last menses
- Willing and able to comply with study procedures
Exclusion
- Surgery or biopsy of the vagina or cervix within 30 days
- Have a history of a total hysterectomy (removal of the uterus and cervix)
- Pregnancy
- Positive buccal HIV test
- Other conditions that, in the opinion of the investigator, would constitute contraindications to participation in the study or would compromise the ability to comply with study protocols, such as any major chronic illness or a major psychiatric disorder (e.g., schizophrenia)
- Current participation in any other drug or device study, or any study which, in the opinion of the investigator, would jeopardize interpretation of results of this study
Key Trial Info
Start Date :
March 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01804023
Start Date
March 1 2013
End Date
September 1 2013
Last Update
October 30 2013
Active Locations (1)
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1
Clinical Research Center, Eastern Virginia Medical School
Norfolk, Virginia, United States, 23507