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Education Program to Promote Female Condom Use - Article


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Medical Education & Training




Clinical Trial: Education Program to Promote Female Condom Use

This study is currently recruiting patients.

Sponsored by: National Institute of Child Health and Human Development (NICHD)
Information provided by: National Institute of Child Health and Human Development (NICHD)

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 Treatment or Intervention
HIV Infections
 Behavior: Female condom skills training

MedlinePlus related topics:  AIDS

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: 
Primary Outcomes: percent of sex acts protected by female condoms
Secondary Outcomes: percent of sex acts protected by male or female condoms
Expected Total Enrollment:  400

Study start: June 2003;  Expected completion: December 2005
Last follow-up: August 2005;  Data entry closure: September 2005

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   -   39 Years,  Genders Eligible for Study:  Female

Accepts Healthy Volunteers

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

Location and Contact Information

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

California
      Center for AIDS Prevention Studies, University of California, San Francisco, San Francisco,  California,  94105,  United States; Recruiting
Wendy Hussey, MPH  415-597-9340    whussey@psg.ucsf.edu 
Kyung-Hee Choi, PhD, MPH  415-597-9281    khchoi@psg.ucsf.edu 
Kyung-Hee Choi, PhD, MPH,  Principal Investigator

Study chairs or principal investigators

Kyung-Hee Choi, PhD, MPH,  Principal Investigator,  University of California, San Francisco   

More Information

Study ID Numbers:  HD39118
Record last reviewed:  October 2004
Last Updated:  October 20, 2004
Record first received:  June 9, 2003
ClinicalTrials.gov Identifier:  NCT00062634
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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December 4, 2008



Page Updated: November 5, 2004
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