Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

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

This study has been completed.
Sponsor:
Collaborators:
ImQuest Pharmaceuticals, Inc.
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
The Miriam Hospital
ClinicalTrials.gov Identifier:
NCT01334827
First received: April 11, 2011
Last updated: September 27, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition
Microbicide Delivery System Acceptability

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

Further study details as provided by The Miriam Hospital:

Primary Outcome Measures:
  • Qualitative User Perception Narratives [ Time Frame: 4-5 visits over an average of 8-12 weeks ] [ Designated as safety issue: No ]
    Qualitative summaries and interpretations of User Perceptions of the 3 dosage forms: descriptions of female and male experiences with different dosage forms and their perceptions and interpretations of form acceptability domains.

  • User Perception Scale Scores [ Time Frame: 4-5 visits over an average of 8-12 weeks ] [ Designated as safety issue: No ]
    Quantitative User Perception Scale Scores across 3 dosage forms: ranges, means, standard deviations.
Enrollment: 48
Study Start Date: April 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
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
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Individuals residing in the greater Providence RI metropolitan area

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01334827

Locations
United States, Rhode Island
Miriam Hospital
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
The Miriam Hospital
ImQuest Pharmaceuticals, Inc.
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Robert Buckheit, PhD ImQuest Pharmaceuticals
Principal Investigator: Kathleen Morrow, PhD The Miriam Hospital
  More Information

No publications provided

Responsible Party: The Miriam Hospital
ClinicalTrials.gov Identifier: NCT01334827     History of Changes
Other Study ID Numbers: 11800, R33AI076967
Study First Received: April 11, 2011
Last Updated: September 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by The Miriam Hospital:
topical microbicide
primary prevention
HIV
AIDS
drug delivery systems

ClinicalTrials.gov processed this record on March 03, 2015