Female Condom Intervention Trial (FEMIT)

Kyung-Hee Choi, PhD, MPH, Principal InvestigatorCynthia Gomez, PhD, Co-Investigator

Olga Grinstead, PhD, MPH, Co-InvestigatorColleen Hoff, PhD, Co-Investigator/Intervention Director

Steve Gregorich, PhD, Co-Investigator/StatisticianWendy Hussey, MPH, Project Manager

University of California, San Francisco, San FranciscoCenter for AIDS Prevention Studies (CAPS) UCSF

University of CaliforniaSan Francisco

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.

Research Methods: Study Population

Women attending family planning clinics

Inclusion CriteriaAfrican American, Asian, Latina, and WhiteTwo 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

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

Applied Social Learning TheoryTheoretical InterventionDomains Contents

Information  Safer sex  Female anatomy HIV and STDs Female condom

Skills &  Proper use of female condomsSelf-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

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

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

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

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.