- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01804023
Biomarkers of Protocol Compliance and Product Adherence
October 29, 2013 updated by: CONRAD
Comparison of Objective Biomarkers of Protocol Compliance and Product Adherence With Classic Markers of Compliance and Adherence
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Virginia
-
Norfolk, Virginia, United States, 23507
- Clinical Research Center, Eastern Virginia Medical School
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Healthy, non-pregnant, HIV-uninfected women
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Healthy women
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Sensitivity, specificity, PPV, and NPV of the following indicator of vaginal insertion: VIRA
Time Frame: 7 days after insertion of vaginal applicators
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
30 days after insertion of vaginal applicators
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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
|
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
|
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
|
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
|
30 days after insertion of vaginal applicators
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Andrea Thurman, M.D., Clinical Research Center, Eastern Virginia Medical School, Norfolk, VA
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2013
Primary Completion (Actual)
September 1, 2013
Study Completion (Actual)
September 1, 2013
Study Registration Dates
First Submitted
March 1, 2013
First Submitted That Met QC Criteria
March 1, 2013
First Posted (Estimate)
March 5, 2013
Study Record Updates
Last Update Posted (Estimate)
October 30, 2013
Last Update Submitted That Met QC Criteria
October 29, 2013
Last Verified
October 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- D13-125
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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