Education Program to Promote Female Condom Use

NCT ID: NCT00062634

Last Updated: 2005-06-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-06-30
• Study Completion Date: 2005-08-31

Brief Summary

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.

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.

Conditions

HIV Infections

Keywords

Female condom use; Male condom use; AIDS education; AIDS prevention; HIV Seronegativity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: ECT
• Blinding Strategy: SINGLE

Interventions

Female condom skills training

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: lead

Principal Investigators

Kyung-Hee Choi, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

Center for AIDS Prevention Studies, University of California, San Francisco

San Francisco, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Wendy Hussey, MPH

Role: CONTACT

Phone: 415-597-9340

Email: whussey@psg.ucsf.edu

Facility Contacts

Wendy Hussey, MPH

Role: primary

Kyung-Hee Choi, PhD, MPH

Role: backup

Other Identifiers

HD39118

Identifier Type: -

Identifier Source: org_study_id