A Formative Study to Explore the Sensory Perceptions of Vaginal Product Users

Study Overview
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Brief Summary
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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
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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.

Official Title
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Rational Development of Combination Microbicide Therapies: A Formative Study to Explore the Sensory Perceptions of Vaginal Product Users (Project MIST)

Conditions
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Microbicide Delivery System Acceptability

Intervention / Treatment
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* Other: high volume gel
* Other: low volume gel
* Other: vaginal film


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Mixed Methods Measurement Development study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Formulations<br>high volume gel; low volume gel; vaginal film | Other: high volume gel<br>* 4 mL HEC<br>* Other names: Gray;Other: low volume gel<br>* 2 mL HEC<br>* Other names: Red;Other: vaginal film<br>* 1 x 2 intravaginal quick-dissolving film<br>* Other names: Blue;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means | USPE Sum of averaged item means/# items (min:max 1:5); 1=Do not agree at all;2=Agree a little;3=Agree somewhat;4=Agree a lot;5=Agree completely. Products:Low volume gel, high volume gel, film.Initial Penetration:Smoothness/lubricity; Initial Lubrication:Coating/lubricating; Spreading Behavior:Ease of stroke, product spread; Product Awareness:Feel intravaginally during sex (movement, felt betw vaginal wall-penis); Perceived Wetness:Covering entire vagina; as after orgasm; Stimulating: enhanced pleasure; Messiness:Perceptions of watery/messiness; Leakage:Sensations of leaking during/after sex; in pubic hair; need to clean; Pre-coital Leakage:Product felt/leakage noticed on panty liner before sex; Naturalness:Sensation of naturalness; leakage looked like vaginal fluid; Lubricity:Wetness before sex; slipperiness/lubricity during sex; Effortful:Effort needed at penetration; effort difficulty/dryness; Pleasure:Partner's stimulation; Noticeable:Male sensation during sex, messiness, thickness | 4-5 visits over an average of 8-12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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topical microbicide, primary prevention, HIV, drug delivery systems