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Education Program to Promote Female Condom Use

This study is currently recruiting participants.
Verified by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), October 2004

Sponsored by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00062634
  Purpose

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 Intervention
HIV Infections
Behavioral: Female condom skills training

MedlinePlus related topics:   AIDS   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Educational/Counseling/Training, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:   Female Condom Intervention Trial

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

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

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

Estimated Enrollment:   400
Study Start Date:   June 2003
Estimated Study Completion Date:   August 2005

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.

  Eligibility
Ages Eligible for Study:   18 Years to 39 Years
Genders 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

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

Investigators
Principal Investigator:     Kyung-Hee Choi, PhD, MPH     University of California, San Francisco    
  More Information


Study ID Numbers:   HD39118
First Received:   June 9, 2003
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00062634
Health Authority:   United States: Federal Government

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  

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on November 20, 2008




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