- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00062634
Education Program to Promote Female Condom Use
Female Condom Intervention Trial
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Wendy Hussey, MPH
- Telefonnummer: 415-597-9340
- E-post: whussey@psg.ucsf.edu
Studieorter
-
-
California
-
San Francisco, California, Förenta staterna, 94105
- Rekrytering
- Center for AIDS Prevention Studies, University of California, San Francisco
-
Kontakt:
- Wendy Hussey, MPH
- Telefonnummer: 415-597-9340
- E-post: whussey@psg.ucsf.edu
-
Kontakt:
- Kyung-Hee Choi, PhD, MPH
- Telefonnummer: 415-597-9281
- E-post: khchoi@psg.ucsf.edu
-
Huvudutredare:
- Kyung-Hee Choi, PhD, MPH
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Utbildning/Rådgivning/Träning
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vad mäter studien?
Primära resultatmått
Resultatmått |
---|
percent of sex acts protected by female condoms
|
Sekundära resultatmått
Resultatmått |
---|
percent of sex acts protected by male or female condoms
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Kyung-Hee Choi, PhD, MPH, University of California, San Francisco
Studieavstämningsdatum
Studera stora datum
Studiestart
Avslutad studie
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- HD39118
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