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NCT00207480 Clinical Trial

Brief, Behavioral Intervention to Reduce Douching Among Adolescent and Young Women

Bacterial Vaginosis Clinical Trial

Official title:
Brief, Behavioral Intervention to Reduce Douching Among Adolescent and Young Women

Clinical Trial Details — Status: Suspended

Administrative data
NCT number NCT00207480
Other study ID # CDC-NCHSTP-4415
Secondary ID U36/CCU300430-24
Status Suspended
Phase Phase 1
First received September 13, 2005
Last updated September 13, 2005
Start date October 2004

Study information
Verified date September 2005
Source Centers for Disease Control and Prevention
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

This study will implement and test a brief, tailored individual-level intervention to be used in two New Orleans adolescent clinics with female patients aged 16-24 who douche.

Description:

The study implements a client-centered behavioral intervention (CCBI) based on Prochaska’s Transtheoretical Model of Change (TMC) and the intervention will use Miller’s Motivational Interviewing (MI) techniques. This intervention will be evaluated using (1) an audio/computer-assisted self-administered interview (ACASI) survey to assess changes in respondents’ douching knowledge, attitudes, and practices, and (2) biological testing for Bacterial Vaginosis.

Recruitment information / eligibility
Status Suspended
Enrollment 270
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 16 Years to 24 Years
Eligibility Inclusion Criteria:

- Women attending between the ages of 16 and 24 who have douched at least once in the last 180 days, agree to a test for Bacterial Vaginosis, and agree to allow us to contact you by telephone or in person for a follow-up interview and testing for bacterial vaginosis.

Exclusion Criteria:

- currently pregnant, non-English speaking

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training

Related Conditions & MeSH terms

Intervention

Behavioral:
• Brief, motivational interviewing intervention

Locations
Country Name City State
United States Orleans Women's Health Clinic New Orleans Louisiana

Sponsors (2)
Lead Sponsor Collaborator
Centers for Disease Control and Prevention Tulane University School of Public Health and Tropical Medicine

Country where clinical trial is conducted

United States, 

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