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Medical Education & Training |
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Clinical Trial: Education Program to Promote Female Condom Use
This study is currently recruiting patients.
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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
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
California
Center for AIDS Prevention Studies, University of California, San Francisco, San Francisco, California, 94105, United States; Recruiting
Kyung-Hee Choi, PhD, MPH 415-597-9281 khchoi@psg.ucsf.edu
Kyung-Hee Choi, PhD, MPH, Principal Investigator
Kyung-Hee Choi, PhD, MPH, Principal Investigator, University of California, San Francisco
More Information
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
Resources
- 4th Year Medical Student Electives in Women's Health (Women's Health Program, University of Cincinnati College of Medicine)
- Directory of Residency and Fellowship Programs in Women's Health (Office on Women's Health, HHS)

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