- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00062634
Education Program to Promote Female Condom Use
Female Condom Intervention Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Wendy Hussey, MPH
- Phone Number: 415-597-9340
- Email: whussey@psg.ucsf.edu
Study Locations
-
-
California
-
San Francisco, California, United States, 94105
- Recruiting
- Center for AIDS Prevention Studies, University of California, San Francisco
-
Contact:
- Wendy Hussey, MPH
- Phone Number: 415-597-9340
- Email: whussey@psg.ucsf.edu
-
Contact:
- Kyung-Hee Choi, PhD, MPH
- Phone Number: 415-597-9281
- Email: khchoi@psg.ucsf.edu
-
Principal Investigator:
- Kyung-Hee Choi, PhD, MPH
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Educational/Counseling/Training
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
percent of sex acts protected by female condoms
|
Secondary Outcome Measures
Outcome Measure |
---|
percent of sex acts protected by male or female condoms
|
Collaborators and Investigators
Investigators
- Principal Investigator: Kyung-Hee Choi, PhD, MPH, University of California, San Francisco
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HD39118
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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