Biomarkers of Protocol Compliance and Product Adherence
Condition: HIV Prevention
Study type: Observational

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 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.
    

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 participant, but not inserted into the vagina and the gel will be expelled
      into a waste container. Four applicators (#5 to 8) will be inserted into the participant's
      vagina, one at a time, by the investigator, removed, and then the gel will be expelled into a
      waste container. Two applicators (#9 and 10) will be inserted into the participant's vagina,
      one at a time, and gel will be expelled into the participant's vagina. Finally, two
      applicators (#11 and 12) will be inserted into the participant's vagina, one at a time, by
      the investigator, removed and then the gel expelled into a waste container. Applicators #11
      and 12 will then be wiped clean with a paper towel. Thus, each participant will provide a
      total of 12 applicators, half of which will be processed within one week of her visit and
      half of which will be processed in approximately one month of her visit. Three readers
      blinded to the status of the applicators (sham, inserted with or without gel expulsion) will
      determine, by VIRA and UV light assessment, whether or not the applicators were inserted
      vaginally. Additional laboratory personnel, who will also be blinded to the status of the
      applicators, will process the applicators for DNA and protein markers of product adherence
      and protocol compliance.
    

Intervention name(s): HEC placebo gel applicators
Intervention type(s): Other
Intervention description(s): Participants will handle, but not insert, 4 applicators containing HEC placebo gel.
Participants will vaginally insert and removed 8 applicators containing HEC placebo gel. Gel will be expelled in to the vagina from only 2 applicators.
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy, non-pregnant, HIV-uninfected women