Biomarkers of Protocol Compliance and Product Adherence

NCT ID: NCT01804023

Last Updated: 2013-10-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2013-09-30

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.

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

Study Design

• Study Time Perspective: PROSPECTIVE

Study Groups

Healthy women

HEC placebo gel applicators

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

CONRAD

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrea Thurman, M.D.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Clinical Research Center, Eastern Virginia Medical School

Norfolk, Virginia, United States

Countries

United States

Other Identifiers

D13-125

Identifier Type: -

Identifier Source: org_study_id