Back to resultsBrief, Behavioral Intervention to Reduce Douching Among Adolescent and Young Women
Primary Purpose
Vaginal Douching, Bacterial Vaginosis
Status
Suspended
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Brief, motivational interviewing intervention
Sponsored by
About this trial
This is an interventional educational/counseling/training trial for Vaginal Douching
Eligibility 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
Sites / Locations
- Orleans Women's Health Clinic
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00207480
First Posted
September 13, 2005
Last Updated
September 13, 2005
Sponsor
Centers for Disease Control and Prevention
Collaborators
Tulane University School of Public Health and Tropical Medicine
1. Study Identification
Unique Protocol Identification Number
NCT00207480
Brief Title
Brief, Behavioral Intervention to Reduce Douching Among Adolescent and Young Women
Official Title
Brief, Behavioral Intervention to Reduce Douching Among Adolescent and Young Women
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Suspended
Study Start Date
October 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Centers for Disease Control and Prevention
Collaborators
Tulane University School of Public Health and Tropical Medicine
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaginal Douching, Bacterial Vaginosis
7. Study Design
Primary Purpose
Educational/Counseling/Training
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
270 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Brief, motivational interviewing intervention
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia Kissinger, PhD, RN
Organizational Affiliation
Tulane University School of Public Health and Tropical Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orleans Women's Health Clinic
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70119
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Brief, Behavioral Intervention to Reduce Douching Among Adolescent and Young Women
We'll reach out to this number within 24 hrs