Biomarkers of Protocol Compliance and Product Adherence
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ClinicalTrials.gov Identifier: NCT01804023 |
Recruitment Status :
Completed
First Posted : March 5, 2013
Last Update Posted : October 30, 2013
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Condition or disease | Intervention/treatment |
---|---|
HIV Prevention | Other: HEC placebo gel applicators |
Study Type : | Observational |
Actual Enrollment : | 40 participants |
Time Perspective: | Prospective |
Official Title: | Comparison of Objective Biomarkers of Protocol Compliance and Product Adherence With Classic Markers of Compliance and Adherence |
Study Start Date : | March 2013 |
Actual Primary Completion Date : | September 2013 |
Actual Study Completion Date : | September 2013 |
Group/Cohort | Intervention/treatment |
---|---|
Healthy women |
Other: HEC placebo gel applicators
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. |
- Sensitivity, specificity, PPV, and NPV of the following indicator of vaginal insertion: VIRA [ Time Frame: 7 days after insertion of vaginal applicators ]
- Number of applicators on which Y chromosome-associated genes can be detected and degree of correlation between detection and the number of days since last penile/vaginal intercourse [ Time Frame: 7 days after insertion of vaginal applicators ]
- Degree of correlation of vaginal species obtained from vaginal applicators and vaginal species obtained from vaginal swabs [ Time Frame: 7 days after insertion of vaginal applicators ]
- Sensitivity, specificity, PPV, and NPV of the following indicator of vaginal insertion: VIRA [ Time Frame: 30 days after insertion of vaginal applicators ]
- Sensitivity, specificity, PPV, and NPV of the following indicator of vaginal insertion: UV Light Inspection [ Time Frame: 7 days after insertion of vaginal applicators ]
- Sensitivity, specificity, PPV, and NPV of the following indicator of vaginal insertion: UV Light Inspection [ Time Frame: 30 days after insertion of vaginal applicators ]
- Sensitivity, specificity, PPV, and NPV of the following indicator of vaginal insertion: DNA sequences of vaginal bacteria [ Time Frame: 7 days after insertion of vaginal applicators ]
- Sensitivity, specificity, PPV, and NPV of the following indicator of vaginal insertion: DNA sequences of vaginal bacteria [ Time Frame: 30 days after insertion of vaginal applicators ]
- Sensitivity, specificity, PPV, and NPV of the following indicator of vaginal insertion: Immunohistochemical tests for protein markers [ Time Frame: 7 days after insertion of vaginal applicators ]
- Sensitivity, specificity, PPV, and NPV of the following indicator of vaginal insertion: Immunohistochemical tests for protein markers [ Time Frame: 30 days after insertion of vaginal applicators ]
- Number of applicators on which Y chromosome-associated genes can be detected and degree of correlation between detection and the number of days since last penile/vaginal intercourse [ Time Frame: 30 days after insertion of vaginal applicators ]
- Degree of correlation of vaginal species obtained from vaginal applicators and vaginal species obtained from vaginal swabs [ Time Frame: 30 days after insertion of vaginal applicators ]
- Difference in detection of these markers when applicators are processed within one week versus approximately 30 days after the participant's visit [ Time Frame: 30 days after insertion of vaginal applicators ]
- Difference in the sensitivity, specificity, NPV and PPV of detection of these markers when applicators are wiped off after removal from the vagina [ Time Frame: 7 days after insertion of vaginal applicators ]
- Difference in detection of these markers when gel is present, either from a current applicator insertion and gel expulsion or from previous and current applicator insertion and gel expulsion [ Time Frame: 7 days after insertion of vaginal applicators ]
- Difference in the sensitivity, specificity, NPV and PPV of detection of these markers when applicators are wiped off after removal from the vagina [ Time Frame: 30 days after insertion of vaginal applicators ]
- Difference in detection of these markers when gel is present, either from a current applicator insertion and gel expulsion or from previous and current applicator insertion and gel expulsion [ Time Frame: 30 days after insertion of vaginal applicators ]

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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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 Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01804023
United States, Virginia | |
Clinical Research Center, Eastern Virginia Medical School | |
Norfolk, Virginia, United States, 23507 |
Principal Investigator: | Andrea Thurman, M.D. | Clinical Research Center, Eastern Virginia Medical School, Norfolk, VA |
Responsible Party: | CONRAD |
ClinicalTrials.gov Identifier: | NCT01804023 |
Other Study ID Numbers: |
D13-125 |
First Posted: | March 5, 2013 Key Record Dates |
Last Update Posted: | October 30, 2013 |
Last Verified: | October 2013 |