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



Status:Completed
Healthy:No
Age Range:18 - Any
Updated:10/14/2017
Start Date:April 2011
End Date:June 2012

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

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.

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.

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
We found this trial at
1
site
164 Summit Ave
Providence, Rhode Island 02906
(401) 793-2500
Miriam Hospital The Miriam Hospital is a private, not-for-profit hospital, with a history of providing...
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mi
from
Providence, RI
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