Biomarkers of Protocol Compliance and Product Adherence
Completed · Has a placebo group
Conditions studied: HIV Prevention
In brief
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 DNA/protein markers) to determine which, if any, warrant use in a clinical trial of a new vaginal microbicide. The study will also determine whether indicators of semen can be detected on applicators and the degree to which they correlate with reported intercourse, and the correlation between vaginal bacteria detected by a vaginal swab and those detected from the applicator. In addition, the study will determine whether several factors that may be encountered in a clinical trial are likely to affect detection of these markers, including storage for 30 days vs. 7 days, wiping applicators after use, the presence of gel, and inter- and intra-woman variability. The study will also assess safety.
Key facts
- Study ID
- NCT01804023
- Run by
- CONRAD
- People needed
- 40
- Starts
- 2013-03-01
- Expected to finish
- 2013-09-01
- Last updated by the study team
- 2013-10-30
Who can join
Age: 18 and older, up to 50. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Clinical Research Center, Eastern Virginia Medical School — Norfolk, Virginia, United States
Full record on ClinicalTrials.gov
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