Education Program to Promote Female Condom Use

Female Condom Intervention Trial

Sponsoren

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

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

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.

detaillierte Beschreibung

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.

Gesamtstatus Unknown status
Anfangsdatum June 2003
Fertigstellungstermin August 2005
Phase N/A
Studientyp Interventional
Primärer Ausgang
Messen Zeitfenster
percent of sex acts protected by female condoms
Sekundäres Ergebnis
Messen Zeitfenster
percent of sex acts protected by male or female condoms
Einschreibung 400
Bedingung
Intervention

Interventionsart: Behavioral

Interventionsname: Female condom skills training

Teilnahmeberechtigung

Kriterien:

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

Geschlecht: Female

Mindestalter: 18 Years

Maximales Alter: 39 Years

Gesunde Freiwillige: Accepts Healthy Volunteers

Insgesamt offiziell
Nachname Rolle Zugehörigkeit
Kyung-Hee Choi, PhD, MPH Principal Investigator University of California, San Francisco
Gesamtkontakt

Nachname: Wendy Hussey, MPH

Telefon: 415-597-9340

Email: [email protected]

Ort
Einrichtung: Status: Kontakt: Kontakt Backup: Ermittler: Center for AIDS Prevention Studies, University of California, San Francisco Wendy Hussey, MPH 415-597-9340 [email protected] Kyung-Hee Choi, PhD, MPH Principal Investigator
Standort Länder

United States

Überprüfungsdatum

October 2004

Schlüsselwörter
Hat den Zugriff erweitert No
Bedingung Durchsuchen
Studiendesign Info

Zuweisung: Randomized

Interventionsmodell: Parallel Assignment

Hauptzweck: Educational/Counseling/Training

Maskierung: Single

Quelle: ClinicalTrials.gov