HIV PreventionNCT01804023
Biomarkers of Protocol Compliance and Product Adherence
An observational study of HIV Prevention, run by CONRAD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Prevention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Sep 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Healthy, non-pregnant, HIV-uninfected women
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Research Center, Eastern Virginia Medical School
Norfolk, Virginia, 23507
About this study
Official title: 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.
Read the 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.
- Conditions
- HIV Prevention
- Being tested
- HEC placebo gel applicators
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEC placebo gel applicatorsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy women | Not described Receives: Other: HEC placebo gel applicators |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity, specificity, PPV, and NPV of the following indicator of vaginal insertion: VIRA
Measured: 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
Measured: 7 days after insertion of vaginal applicators
Degree of correlation of vaginal species obtained from vaginal applicators and vaginal species obtained from vaginal swabs
Measured: 7 days after insertion of vaginal applicators
Sensitivity, specificity, PPV, and NPV of the following indicator of vaginal insertion: VIRA
Measured: 30 days after insertion of vaginal applicators
Sensitivity, specificity, PPV, and NPV of the following indicator of vaginal insertion: UV Light Inspection
Measured: 7 days after insertion of vaginal applicators
Sensitivity, specificity, PPV, and NPV of the following indicator of vaginal insertion: UV Light Inspection
Measured: 30 days after insertion of vaginal applicators
Sensitivity, specificity, PPV, and NPV of the following indicator of vaginal insertion: DNA sequences of vaginal bacteria
Measured: 7 days after insertion of vaginal applicators
Sensitivity, specificity, PPV, and NPV of the following indicator of vaginal insertion: DNA sequences of vaginal bacteria
Measured: 30 days after insertion of vaginal applicators
Sensitivity, specificity, PPV, and NPV of the following indicator of vaginal insertion: Immunohistochemical tests for protein markers
Measured: 7 days after insertion of vaginal applicators
Sensitivity, specificity, PPV, and NPV of the following indicator of vaginal insertion: Immunohistochemical tests for protein markers
Measured: 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
Measured: 30 days after insertion of vaginal applicators
Degree of correlation of vaginal species obtained from vaginal applicators and vaginal species obtained from vaginal swabs
Measured: 30 days after insertion of vaginal applicators
Secondary outcomes (5)
Difference in detection of these markers when applicators are processed within one week versus approximately 30 days after the participant's visit
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 30 days after insertion of vaginal applicators
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- CONRAD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrea Thurman, M.D., Principal investigator, Clinical Research Center, Eastern Virginia Medical School, Norfolk, VA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01804023
- Sponsor's protocol ID
- D13-125
- Status last verified
- Oct 2013
- First submitted
- 1 Mar 2013
- Last updated
- 30 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Objective Biomarkers of Protocol Compliance and Product Adherence With Classic Markers of Compliance and Adherence
- ClinicalTrials.gov ID
- NCT01804023
- Acronym / sponsor ID
- D13-125
- Conditions
- HIV Prevention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- CONRADUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 5 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy women | – | Other: HEC placebo gel applicators |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy, non-pregnant, HIV-uninfected women
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HEC placebo gel applicatorsParticipants 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. | Other | Healthy women |
Primary outcome
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
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Thurman, M.D. principal investigator
Clinical Research Center, Eastern Virginia Medical School, Norfolk, VA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Prevention, run by CONRAD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity, specificity, PPV, and NPV of the following indicator of vaginal insertion: VIRA (time frame: 7 days after insertion of vaginal applicators). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2013; AzTrials last refreshed its copy on 7 Nov 2026.