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

Lifespan

Status

Completed

Conditions

Microbicide Delivery System Acceptability

Treatments

Other: low volume gel

Other: high volume gel

Other: vaginal film

Study type

Interventional

Funder types

Other

Industry

NIH

Identifiers

NCT01334827

11800

R33AI076967 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of the study is to compare, contrast, and characterize the range of user perceptions and potential acceptability of three (3) topical vaginal microbicide dosage forms.

Full description

The success of microbicide products will derive from the synergy of their biological functionality and user acceptability. Biological functionality is the integrated result of safe and effective anti-HIV compounds incorporated into dosage forms or devices that successfully deliver those compounds to target tissues, fluids, and pathogens. Acceptability is a multi-factorial phenomenon that accounts for the personal, dyadic, product-related, and social contexts that potentiate - or not - a woman's decision to use a microbicide. Acceptability (assessed, in part, by the users' sensory perceptions of products during use) depends strongly upon dosage forms and/or delivery systems with biophysical functions and/or mechanical and materials properties that are most conducive to human use. Without both, microbicides' potential to decisively alter the public health impact of HIV/AIDS and other sexually transmitted infections will be largely limited. The current protocol will specifically study the impact of gel volume on user perceptions, as well as extend user perception scale development to include those properties and product "behaviors" experienced when using a vaginal film.

Enrollment

48 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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