A Formative Study to Explore the Sensory Perceptions of Vaginal Product Users (Project-MIST)

Inclusion Criteria:

Women who:

• are between the ages of 18 and 45
• report vaginal sex with their male sexual partner in the past 6 months
• report being in a monogamous sexual relationship with their male partner
• report consistent use of an effective birth control method: e.g., hormonal contraceptive, IUD, bilateral tubal ligation, Essure® or any non-incisional permanent birth control procedure, hysterectomy (partial or total, with/without oophorectomy), partner's vasectomy/salpingectomy
• are able to tolerate film use, as measured by pelvic exam at Visit 1B
• are willing to refrain from any vaginal product use (inclusive of douching) for 48 hours before Visit 1B and until they complete all study activities (except for study-related products)
• are willing to refrain from having vaginal intercourse 24 hours before Visit 1B and Visits 2-4
• are willing to use condoms for vaginal-penile sex between all study visits (Visits 1A - 4)
• are willing to refrain from any non-penile vaginal penetration during dosage form evaluation visits (Visits 2-4)
• are willing to undergo HIV testing and receive test results and counseling.

Men who:

• are at least 18 years of age
• report vaginal sex with their female sexual partner in the past 6 months
• report being in a monogamous sexual relationship with their female sexual partner
• are willing to refrain from having vaginal intercourse 24 hours before Visit 1B and Visits 2-4
• are willing to use condoms for vaginal-penile sex between all of study visits (Visits 1A-4)
• are willing to refrain from any non-penile vaginal penetration during dosage form evaluation visits (Visits 2-4)
• are willing to use a non-lubricated latex condom (provided) for penile-vaginal intercourse during dosage form evaluation visits (Visits 2-4)
• are willing to undergo HIV testing and receive test results and counseling.

Exclusion Criteria:

Women and men will be ineligible if:

• they are unable or unwilling to give informed consent
• their partner is unable or unwilling to give informed consent
• they are currently enrolled in other vaginal product study/studies
• they are STI (Neisseria gonorrhea, Chlamydia trachomatis, bacterial vaginosis, trichomoniasis, syphilis), HIV positive upon screening (Visit 1A), or pregnant (females) at any study visit
• they are breastfeeding, or have completed menopause (i.e., at least 12 months without menstrual periods) (female participants only)
• they are currently attempting to get pregnant or have an intention to get pregnant during their participation in the study
• they have clinically significant abnormal pelvic findings and/or findings requiring therapy as a function of clinical exam at Visits 1A and/or 1B (female participants only)
• they report being within 30 days of their last pregnancy outcome or gynecologic surgical procedure
• they have known, or suspected, allergies to any component of the study products or similar ingredients in other products
• they have known, or suspected, allergies to latex
• they have any condition that, in the opinion of the study clinician or principle investigator, would compromise the participant´s ability to participate in the study