Clinical trial NCT00062634: Education Program to Promote Female Condom Use
Official title: Female Condom Intervention Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HIV Infections
Keywords: Female condom use
Male condom use
AIDS education
AIDS prevention
HIV Seronegativity
Lead sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor class: NIH
First posted: 2003-06-12
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: ECT

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.

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

Primary outcomes:
measure: percent of sex acts protected by female condoms
Secondary outcomes:
measure: percent of sex acts protected by male or female condoms
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Center for AIDS Prevention Studies, University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Kyung-Hee Choi, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: