Education Program to Promote Female Condom Use
Recruitment status was Recruiting
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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 | Intervention |
|---|---|
|
HIV Infections |
Behavioral: Female condom skills training |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Educational/Counseling/Training |
| Official Title: | Female Condom Intervention Trial |
- percent of sex acts protected by female condoms
- percent of sex acts protected by male or female condoms
| Estimated Enrollment: | 400 |
| Study Start Date: | June 2003 |
| Estimated Study Completion Date: | August 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 to 39 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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| Contact: Wendy Hussey, MPH | 415-597-9340 | whussey@psg.ucsf.edu |
| 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 | |
| Principal Investigator: | Kyung-Hee Choi, PhD, MPH | University of California, San Francisco |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00062634 History of Changes |
| Other Study ID Numbers: | HD39118 |
| Study First Received: | June 9, 2003 |
| Last Updated: | June 23, 2005 |
| 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 |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
ClinicalTrials.gov processed this record on June 17, 2013