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

This study has suspended participant recruitment.

Sponsor:

Collaborator:

Tulane University School of Public Health and Tropical Medicine

Information provided by:

Centers for Disease Control and Prevention

ClinicalTrials.gov Identifier:

NCT00207480

First received: September 13, 2005

Last updated: NA

Last verified: September 2005

History: No changes posted

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

September 13, 2005

Start Date ^ICMJE

October 2004

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

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 ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

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

Condition ^ICMJE

Vaginal Douching
Bacterial Vaginosis

Intervention ^ICMJE

Behavioral: Brief, motivational interviewing intervention

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Suspended

Enrollment ^ICMJE

270

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

16 Years to 24 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00207480

Other Study ID Numbers ^ICMJE

CDC-NCHSTP-4415, U36/CCU300430-24

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Centers for Disease Control and Prevention

Collaborators ^ICMJE

Tulane University School of Public Health and Tropical Medicine

Investigators ^ICMJE

Principal Investigator:

Patricia Kissinger, PhD, RN

Tulane University School of Public Health and Tropical Medicine

Information Provided By

Centers for Disease Control and Prevention

Verification Date

September 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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