Trial record 10 of 38 for:    " October 06, 2010":" November 05, 2010"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Acceptability Study of Vaginal Films for HIV Prevention (FACE)

This study has been completed.
Sponsor:
Collaborator:
Doris Duke Charitable Foundation
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01231763
First received: October 28, 2010
Last updated: February 8, 2011
Last verified: February 2011
  Purpose

This study is being done to find out what women would want in a film vaginal product for human immunodeficiency virus (HIV) prevention, especially what it should look like and how to apply it.

The investigators hypothesize that women will prefer a smooth, clear, and rectangular quick-dissolve vaginal film for HIV prevention over a textured, opaque, square quick-dissolve vaginal film.


Condition Intervention
HIV Infections
Anti-Infective Agents
Other: No intervention (not applicable)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Film Acceptability Characterization and Evaluation

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Preferred physical characteristics of a vaginal film product [ Time Frame: One visit lasting two hours ] [ Designated as safety issue: No ]
    Preferred texture, shape, size, and appearance of a vaginal film product via focus group discussion and questionnaires


Secondary Outcome Measures:
  • Valued vaginal product characteristics [ Time Frame: One visit lasting two hours ] [ Designated as safety issue: No ]
    Desired characteristics of vaginal products such as lubrication, prescription status, and contraceptive function via focus group discussion and questionnaires

  • Impressions regarding vaginal films [ Time Frame: One visit lasting two hours ] [ Designated as safety issue: No ]
    Impressions about vaginal films such as ease of use, comfort, and effect on sexual pleasure via focus group discussion and questionnaires


Enrollment: 84
Study Start Date: November 2010
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Healthy volunteers Other: No intervention (not applicable)
No intervention (not applicable)
Other Name: No intervention (not applicable)

Detailed Description:

The lives of 25 million people have ended due to HIV-related causes since the start of the AIDS epidemic in 1981 (1). Each year, AIDS continues to claim the lives of millions of people, with an estimated two million deaths worldwide in 2008 (2). Heterosexual transmission of HIV accounts for the majority of new infections and disproportionately affects women both in the United States and globally (2, 3). There is an urgent need for agents to prevent the sexual transmission of HIV, particularly agents that may be controlled by women.

Quick dissolve films such as Listerene® Breath Strips have been developed for inexpensive delivery of drugs and vitamins. As products for HIV prevention, quick dissolve films offer a host of potential advantages including low cost, control by the receptive partner, discreet and applicator-free use, low mess, portability, easy storage, stability, targeting to site of exposure, reduction of systemic toxicity by bypassing first-pass metabolism, and the incorporation of multiple active microbicidal compounds (4, 5).

In the course of developing agents for HIV prevention, determination of valued characteristics is important for product refinement and for enhancement of future use likelihood. Knowledge regarding acceptability can also inform product promotion and educational campaigns (6).

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Women aged 18-30 years from the Pittsburgh, Pennsylvania area who express interest in the study. Enrollment is expected to achieve racial and ethnic demographics representative of Allegheny County, Pennsylvania in terms of approximately 0.2 percent American Indian and Alaska Native, 2.5 percent Asian, and 1.5 percent Hispanic or Latino (7). Allegheny County is 82.8 percent white and 13.2 percent black or African American (7). For enrollment in this study, we would like to achieve at least 40 percent black or African American in order to collect a more diverse set of film microbicide preferences. The remainder of enrollment is expected to be white.

Criteria

Inclusion Criteria:

  • Female 18-30 years old at time of enrollment
  • Able to provide written informed consent

Exclusion Criteria:

  • Not sexually active, defined as no vaginal sex at any time in the past year
  • Pregnant by self-report
  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: NCT01231763

Locations
United States, Pennsylvania
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States, 15213
Magee-Womens Research Institute
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Doris Duke Charitable Foundation
Investigators
Principal Investigator: Sharon Hillier, PhD University of Pittsburgh
  More Information

Publications:
Responsible Party: Sharon Hillier, PhD, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01231763     History of Changes
Other Study ID Numbers: PRO10080621 (UPittsburgh IRB#)
Study First Received: October 28, 2010
Last Updated: February 8, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
HIV prevention
Vaginal film
Microbicide
Administration, intravaginal

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on August 18, 2014