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Education Program to Promote Female Condom Use

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ClinicalTrials.gov Identifier: NCT00062634
Recruitment Status : Unknown
Verified October 2004 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was:  Recruiting
First Posted : June 12, 2003
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:

Study Description
Brief Summary:
The female condom offers women a potentially important option for HIV prevention. This study will develop and evaluate a health education program to increase female condom use among ethnically diverse women.

Condition or disease Intervention/treatment
HIV Infections Behavioral: Female condom skills training

Detailed Description:

AIDS incidence among women has grown at alarming rates since 1985. Heterosexual contact is now the greatest risk for HIV infection in women. Women in the United States urgently need more options to protect themselves against HIV. Nonetheless, limited prevention efforts have targeted women. The female condom is a potentially important option for HIV prevention in women. However, little research has been conducted to identify effective approaches to promote the female condom as the only female-controlled barrier method available to date. This study will develop a theoretically and empirically based intervention to increase female condom use among ethnically diverse women who engage in multiple sexual partnerships.

The proposed female condom skills training intervention applies social cognitive theory. It also incorporates our extensive previous research that examined female condom acceptability and identified the attitudinal, interpersonal, and sociocultural factors affecting female condom use. The intervention consists of four sessions: 1) individual safer sex education and condom use skills training; 2) group discussion of barriers to female condom use; 3) group condom negotiation skills training; and 4) individual condom use counseling. The efficacy of the intervention will be assessed by comparing it to a control condition intervention that focuses on women's general health issues unrelated to HIV/AIDS. The control condition intervention has four sessions: 1) individual health education; 2) group discussion of women's health problems and related risk behaviors; 3) group discussion of healthy living; and 4) individual health risk reduction counseling.

This study will use a randomized clinical trial design. Study participants will be randomly assigned to one of two conditions: female condom skills training or women's general health promotion. All participants will be interviewed at study entry, 3 months, and 6 months. Attitudinal, psychosexual, and behavioral data will be collected to evaluate the intervention.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Educational/Counseling/Training
Official Title: Female Condom Intervention Trial
Study Start Date : June 2003
Estimated Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. percent of sex acts protected by female condoms

Secondary Outcome Measures :
  1. percent of sex acts protected by male or female condoms

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  • African American, Asian American, Latina, or White
  • Two or more male sexual partners in the year prior to study entry
  • English speaking

Exclusion Criteria

  • Commercial sex workers
  • Planning to move within 6 months of study entry
  • Allergic to polyurethane, latex, or lubricants
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00062634


Contacts
Contact: Wendy Hussey, MPH 415-597-9340 whussey@psg.ucsf.edu

Locations
United States, California
Center for AIDS Prevention Studies, University of California, San Francisco Recruiting
San Francisco, California, United States, 94105
Contact: Wendy Hussey, MPH    415-597-9340    whussey@psg.ucsf.edu   
Contact: Kyung-Hee Choi, PhD, MPH    415-597-9281    khchoi@psg.ucsf.edu   
Principal Investigator: Kyung-Hee Choi, PhD, MPH         
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Kyung-Hee Choi, PhD, MPH University of California, San Francisco
More Information

ClinicalTrials.gov Identifier: NCT00062634     History of Changes
Other Study ID Numbers: HD39118
First Posted: June 12, 2003    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: October 2004

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Female condom use
Male condom use
AIDS education
AIDS prevention
HIV Seronegativity

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