Clinical trial NCT01334827: A Formative Study to Explore the Sensory Perceptions of Vaginal Product Users
Official title: Rational Development of Combination Microbicide Therapies: A Formative Study to Explore the Sensory Perceptions of Vaginal Product Users (Project MIST)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Microbicide Delivery System Acceptability
Keywords: topical microbicide
primary prevention
HIV
drug delivery systems
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
Collaborators: name: ImQuest Pharmaceuticals, Inc.
name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2011-04-13
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Mixed Methods Measurement Development study
Primary purpose: OTHER

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
timeFrame: 4-5 visits over an average of 8-12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Miriam Hospital
state: Rhode Island
Study officials:
affiliation: ImQuest Pharmaceuticals
name: Robert Buckheit, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Miriam Hospital
name: Kathleen Morrow, PhD
role: PRINCIPAL_INVESTIGATOR
References: