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Home > "E" Clinical Trials Conditions > Education Program to Promote Female Condom Use  Education Program to Promote Female Condom Use
Education Program to Promote Female Condom Use
For Condition: HIV Infections
Status: Not yet recruiting
Sponsor(s): National Institute of Child Health and Human Development (NICHD) ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Educational/Counseling/Training, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/39 Years
Genders: Female
Protocol Entry 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
Total Enrollment: 628
Location and Contact Information:
Overall Study Official:
Kyung-HeeChoi, Principal Investigator, University of California, San Francisco
Center for AIDS Prevention Studies, University of California, San Francisco
San Francisco, California, 94105
United States
Wendy Hussey 415-597-9340
Additional Information:
Study ID Numbers: HD39118;
Study Start Date: June 2003
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00062634
Other Hiv Infections Studies:
1. A Study of Retrovir in the Treatment of Psoriasis in HIV-Positive Patients
2. Effectiveness of Interleukin-2 (IL-2) Plus Anti-HIV Therapy in HIV-Positive Patients
3. A Phase II Double-Blind Study of Two Doses of SC-49483 in Combination With Zidovudine (ZDV) Versus ZDV
4. A Study of Trimetrexate With Leucovorin Rescue for AIDS Patients Who Are Refractory to Standard Therapies for Pneumocystis carinii Pneumonia
5. Kidney Transplants in People with HIV Infection
Related Studies:
Other HIV Infections Clinical Trials
Other California Clinical Trials
Other San Francisco Clinical Trials
Education Program to Promote Female Condom Use
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