Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:46 PM
Ignite Modification Date:
2025-12-24 @ 7:46 PM
NCT ID:
NCT02908503
Eligibility Criteria:
Inclusion Criteria:
1. Female, Age 18-40
2. Able and willing to provide written informed consent to be screened for and enrolled in the study.
3. Able and willing to provide adequate locator information at screening.
4. HIV-uninfected based on documented testing performed in the previous 6 months or by study staff at screening.
5. In general good health as determined by the site clinician
6. Agree to abstain from any intravaginal or rectal product or device or penetration (including vaginal, anal, or oral sex, masturbation, or sex toys) between each film insertion and the collection of the CVL approximately 24 hours later. Agree to be sexually abstinent for 48 hours prior to the study visits (from enrollment to visit 10). Sexual activity in the 48 hours prior to screening is acceptable.
7. Willingness to undergo all study-related assessments and procedures, including multiple speculum examinations, and follow all other study-related procedures
8. At screening and enrollment, agrees not to participate in other research studies involving drugs, medical devices, or vaginal products while enrolled in this trial and to abstain from vaginal product usage with the exception of tampons over the study period.
Exclusion Criteria:
Women who meet any of the following criteria by participant report will be excluded from the study. Of note, the study is limited to premenopausal women with an intact uterus because the mucosal immune environment differs substantially between pre- and post- menopausal women. Therefore, inclusion of post-menopausal women would introduce heterogeneity into the population.
1. Previous participation in a vaginal film study where participant was randomized to use film (i.e. FAME 02; FAME 04). Note: If participant was randomized to the gel arm, then she would be potentially eligible for participation in FLAG.
2. Menopausal at screening (as defined as amenorrhea for one year or more without an alternative etiology)
3. Hysterectomy
4. Participant report of any of the following at screening:
1. Known adverse reaction to any of the study products (ever)
2. Known adverse reaction to latex (ever)
3. Non- therapeutic injection drug use in the 12 months prior to screening
4. Surgical procedure involving the pelvis in the 90 days prior to screening (includes dilation and curettage or evacuation, and cryosurgery; does not include cervical biopsy for evaluation of an abnormal pap smear or IUD placement)
5. Participation in a drug, spermicide and/or microbicide study in the 30 days prior to screening or anticipated participation in an investigational drug study in the next 8 weeks
6. Currently pregnant or pregnancy within 90 days prior to screening
7. Lactating
8. Use of a diaphragm, NuvaRing®, or spermicide for contraception 5.) Urogenital infection or suspected infection within 14 days of enrollment including: symptomatic candidiasis, trichomonas vaginalis, and symptomatic bacterial vaginosis; or cervical infection, including Neisseria gonorrhoeae (GC), Chlamydia trachomatis (CT), or mucopurulent cervicitis; syphilis; HSV lesions, or other sores (Note: participants seropositive for HSV without active lesions will not be excluded); acute pelvic inflammatory disease; urinary tract infection
6\. Antibiotic or antifungal therapy (vaginal or systemic) within 7 days of enrollment
7\. Menses or other vaginal bleeding at the time of enrollment\* or expecting menses in the 5 days after enrollment.
\*Note, for women with monthly cycles, every attempt will be made to enroll these participants in the first half of their menstrual cycle. Women who have vaginal bleeding at the scheduled Enrollment Visit may return at a different date to be re-examined and possibly enrolled provided they are still within the screening window (maximum of 30 days between screening and enrollment) and meet all criteria.
8\. Any condition that, in the opinion of the Investigator, would preclude provision of consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT02908503
Study Brief:
Protocol Section:
NCT02908503