Female Condom Intervention Trial

Investigator: Kyung-Hee Choi, MPH, PhD
Sponsor: NIH National Institute of Child Health and Human Development

Location(s): United States


Women in the United States urgently need more options to protect themselves against HIV. AIDS incidence among women has grown at alarming rates since 1985 (a 20-fold increase to 10,998 cases in 1998). Heterosexual contact now is the greatest risk for women. African-Americans and Latinas account for more than three-quarters of all female cases. Nonetheless, limited prevention efforts have targeted women. The female condom now offers women a potentially important option for HIV prevention. Yet, little research has been conducted to identify effective approaches to promote this only female-controlled barrier method available to date. We 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. This 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. Its efficacy will be assessed by comparing it to a control condition intervention of equal dosage that focuses on women's general health issues not related to AIDS. The comparison 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 (N=314) or women's general health promotion (N=314). All subjects will be interviewed at baseline, 3 months, and 6 months. Attitudinal, psychosexual, and behavioral data will be collected to evaluate the intervention. The proposed study will expand the field of HIV prevention by developing a new intervention for women. In addition, it will help broaden a range of prevention strategies for women and, in turn, help reduce their risk for HIV infection.