1. Female Condom Intervention Trial (FEMIT) Kyung-Hee Choi, PhD, MPH, Principal Investigator Cynthia Gomez, PhD, Co-Investigator Olga Grinstead, PhD, MPH, Co-Investigator Colleen Hoff, PhD, Co-Investigator/Intervention Director Steve Gregorich, PhD, Co-Investigator/Statistician Wendy Hussey, MPH, Project Manager University of California, San Francisco, San Francisco Center for AIDS Prevention Studies (CAPS) UC SF University of California San Francisco

2. Background: A Need to Promote Female Condoms  A barrier device developed for women  Available since 1994  Provides women with an alternative for disease prevention  Low levels of use  Few clinical trials have demonstrated efficacy in increasing sustained use of the female condom.

3. Research Methods: Study Population  Women attending family planning clinics  Inclusion Criteria African American, Asian, Latina, and White Two or more male partners in the past year 18 to 39 years old  Sample Size: 628 women (157 per ethnic group)  Study Sites: Planned Parenthood clinics in the San Francisco Bay Area

4. Research Design  Random assignment to one of two conditions Female condom skills training (N=314) Women’s health promotion (N=314)  Three data collection points Baseline, 3 months, and 6 months  Outcome measures Primary: Sexual acts protected by female condoms Secondary: Sexual acts protected by male or female condoms

5. Applied Social Learning Theory Theoretical Intervention Domains Contents Information  Safer sex  Female anatomy  HIV and STDs  Female condom Skills &  Proper use of female condoms Self-efficacy  Introducing and Negotiating female condom use  Overcoming barriers to female condom use Social support  Supporting one’s efforts to adopt new strategies facilitating female condom use

6. Female Condom Use Skills Training Four sessions Two individual sessions One group sessions One telephone follow-up A total of 7 hours Techniques Didactic lectures Individual and group discussions Role plays Skills exercises Video viewing Provision of male and female condoms

7. Female Condom Use Skills Training Session 1: My Body, Sex & Condoms Session 2: Personal Matters Session 3: Communication Skills Building Session 4: Telephone Follow-Up

8. Comparison Group Condition: Women’s Health Promotion Intervention Identical format and length Individual and group modes of delivery Four sessions (2 individual, 1 group, and 1 telephone follow-up) A total of 7 hours Similar techniques (i.e., didactic lectures, individual and group discussions, role plays, skills exercises, video viewing) Provision of male and female condoms

9. Study Progress To Date Have developed both Female Condom Skills Training and Women’s Health Promotion Intervention. These interventions are being implemented. To date, 183 women have participated in the interventions.