NCT01231763

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2010

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 1, 2010

Completed
Same day until next milestone

Study Start

First participant enrolled

November 1, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

February 9, 2011

Status Verified

February 1, 2011

Enrollment Period

3 months

First QC Date

October 28, 2010

Last Update Submit

February 8, 2011

Conditions

HIV InfectionsAnti-Infective Agents

Keywords

HIV preventionVaginal filmMicrobicideAdministration, intravaginal

Outcome Measures

Primary Outcomes (1)

  • Preferred physical characteristics of a vaginal film product

    Preferred texture, shape, size, and appearance of a vaginal film product via focus group discussion and questionnaires

    One visit lasting two hours

Secondary Outcomes (2)

  • Valued vaginal product characteristics

    One visit lasting two hours

  • Impressions regarding vaginal films

    One visit lasting two hours

Study Arms (1)

Healthy volunteers

Other: No intervention (not applicable)

Interventions

No intervention (not applicable)OTHER

No intervention (not applicable)

Healthy volunteers

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Magee-Womens Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

Magee-Womens Research Institute

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (7)

  • Joint United Nations Programme on HIV/AIDS. 08 Report on the global AIDS epidemic. 2008 Available from: http://www.unaids.org/en/KnowledgeCentre/HIVData/GlobalReport/2008/2008_Global_report.asp.

    BACKGROUND

  • Joint United Nations Programme on AIDS, WHO. AIDS Epidemic Update. 2009 Available from: http://data.unaids.org/pub/Report/2009/JC1700_Epi_Update_2009_en.pdf.

    BACKGROUND

  • Centers for Disease Control and Prevention (CDC). Subpopulation estimates from the HIV incidence surveillance system--United States, 2006. MMWR Morb Mortal Wkly Rep. 2008 Sep 12;57(36):985-9.

    PMID: 18784639BACKGROUND

  • Sassi AB, McCullough KD, Cost MR, Hillier SL, Rohan LC. Permeability of tritiated water through human cervical and vaginal tissue. J Pharm Sci. 2004 Aug;93(8):2009-16. doi: 10.1002/jps.20107.

    PMID: 15236450BACKGROUND

  • Romano J, Malcolm RK, Garg S, Rohan LC, Kaptur PE. Microbicide delivery: formulation technologies and strategies. Curr Opin HIV AIDS. 2008 Sep;3(5):558-66. doi: 10.1097/COH.0b013e328305b96e.

    PMID: 19373022BACKGROUND

  • Mantell JE, Myer L, Carballo-Dieguez A, Stein Z, Ramjee G, Morar NS, Harrison PF. Microbicide acceptability research: current approaches and future directions. Soc Sci Med. 2005 Jan;60(2):319-30. doi: 10.1016/j.socscimed.2004.05.011.

    PMID: 15522488BACKGROUND

  • U.S. Census Bureau. Allegheny County QuickFacts. [updated 4-22-2010]; Available from: http://quickfacts.census.gov/qfd/states/42/42003.html.

    BACKGROUND

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Sharon Hillier, PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 28, 2010

First Posted

November 1, 2010

Study Start

November 1, 2010

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

February 9, 2011

Record last verified: 2011-02

Locations

US(2)