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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
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Educational/Counseling/Training
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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
  More Information

No publications provided

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

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

ClinicalTrials.gov processed this record on November 19, 2014