Education Program to Promote Female Condom Use

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2004 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00062634
First received: June 9, 2003
Last updated: June 23, 2005
Last verified: October 2004

June 9, 2003
June 23, 2005
June 2003
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percent of sex acts protected by female condoms
Same as current
Complete list of historical versions of study NCT00062634 on ClinicalTrials.gov Archive Site
percent of sex acts protected by male or female condoms
Same as current
Not Provided
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Education Program to Promote Female Condom Use
Female Condom Intervention Trial

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Educational/Counseling/Training
HIV Infections
Behavioral: Female condom skills training
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
August 2005
Not Provided

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
Female
18 Years to 39 Years
Yes
Contact: Wendy Hussey, MPH 415-597-9340 whussey@psg.ucsf.edu
United States
 
NCT00062634
HD39118
Not Provided
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Not Provided
Principal Investigator: Kyung-Hee Choi, PhD, MPH University of California, San Francisco
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
October 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP