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

This study has been suspended.

Sponsors and Collaborators:	Centers for Disease Control and Prevention Tulane University School of Medicine
Information provided by:	Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:	NCT00207480

Purpose

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.

Condition	Intervention	Phase
Vaginal Douching Bacterial Vaginosis	Behavioral: Brief, motivational interviewing intervention	Phase I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Educational/Counseling/Training, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title:	Brief, Behavioral Intervention to Reduce Douching Among Adolescent and Young Women

Further study details as provided by Centers for Disease Control and Prevention:

Estimated Enrollment:	270
Study Start Date:	October 2004

Detailed 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.

Eligibility

Ages Eligible for Study:	16 Years to 24 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00207480

Locations

United States, Louisiana
Orleans Women's Health Clinic
New Orleans, Louisiana, United States, 70119

Sponsors and Collaborators

Centers for Disease Control and Prevention

Tulane University School of Medicine

Investigators

Principal Investigator:

Patricia Kissinger, PhD, RN

Tulane University School of Medicine

More Information

Study ID Numbers:	CDC-NCHSTP-4415, U36/CCU300430-24
Study First Received:	September 13, 2005
Last Updated:	September 13, 2005
ClinicalTrials.gov Identifier:	NCT00207480
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Genital Diseases, Female
Bacterial Infections
Vaginosis, Bacterial
Vaginitis
Vaginal Diseases

ClinicalTrials.gov processed this record on January 16, 2009