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

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ClinicalTrials.gov Identifier: NCT00207480
Recruitment Status : Suspended
First Posted : September 21, 2005
Last Update Posted : September 21, 2005
Sponsor:
Collaborator:
Tulane University School of Public Health and Tropical Medicine
Information provided by:
Centers for Disease Control and Prevention

Brief 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.

Condition or disease Intervention/treatment Phase
Vaginal Douching Bacterial Vaginosis Behavioral: Brief, motivational interviewing intervention Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Educational/Counseling/Training
Official Title: Brief, Behavioral Intervention to Reduce Douching Among Adolescent and Young Women
Study Start Date : October 2004




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Ages Eligible for Study:   16 Years to 24 Years   (Child, Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Public Health and Tropical Medicine
Investigators
Principal Investigator: Patricia Kissinger, PhD, RN Tulane University School of Public Health and Tropical Medicine

ClinicalTrials.gov Identifier: NCT00207480     History of Changes
Other Study ID Numbers: CDC-NCHSTP-4415
U36/CCU300430-24
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: September 21, 2005
Last Verified: September 2005

Additional relevant MeSH terms:
Vaginosis, Bacterial
Bacterial Infections
Vaginitis
Vaginal Diseases
Genital Diseases, Female