Biomarkers of Protocol Compliance and Product Adherence

NCT01804023 | Completed

• 1 other identifier: D13-125
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV Prevention

Outcome Measures

Primary Outcomes (12)

• Sensitivity, specificity, PPV, and NPV of the following indicator of vaginal insertion: VIRA

  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

  7 days after insertion of vaginal applicators

• Degree of correlation of vaginal species obtained from vaginal applicators and vaginal species obtained from vaginal swabs

  7 days after insertion of vaginal applicators

• Sensitivity, specificity, PPV, and NPV of the following indicator of vaginal insertion: VIRA

  30 days after insertion of vaginal applicators

• Sensitivity, specificity, PPV, and NPV of the following indicator of vaginal insertion: UV Light Inspection

  7 days after insertion of vaginal applicators

• Sensitivity, specificity, PPV, and NPV of the following indicator of vaginal insertion: UV Light Inspection

  30 days after insertion of vaginal applicators

• Sensitivity, specificity, PPV, and NPV of the following indicator of vaginal insertion: DNA sequences of vaginal bacteria

  7 days after insertion of vaginal applicators

• Sensitivity, specificity, PPV, and NPV of the following indicator of vaginal insertion: DNA sequences of vaginal bacteria

  30 days after insertion of vaginal applicators

• Sensitivity, specificity, PPV, and NPV of the following indicator of vaginal insertion: Immunohistochemical tests for protein markers

  7 days after insertion of vaginal applicators

• Sensitivity, specificity, PPV, and NPV of the following indicator of vaginal insertion: Immunohistochemical tests for protein markers

  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

  30 days after insertion of vaginal applicators

• Degree of correlation of vaginal species obtained from vaginal applicators and vaginal species obtained from vaginal swabs

  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

  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

  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

  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

  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

  30 days after insertion of vaginal applicators

Study Arms (1)

Healthy women

Other: HEC placebo gel applicators

Interventions

HEC placebo gel applicators OTHER

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.

Healthy women

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy, non-pregnant, HIV-uninfected women

You may qualify if:

• 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

Sponsors & Collaborators

• CONRAD: lead

Study Sites (1)

Clinical Research Center, Eastern Virginia Medical School

Norfolk, Virginia, 23507, United States

Location

Study Officials

• Andrea Thurman, M.D.

  Clinical Research Center, Eastern Virginia Medical School, Norfolk, VA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2013
• First Posted: March 5, 2013
• Study Start: March 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: October 30, 2013

Record last verified: 2013-10

Locations

US (1)