Brief, Behavioral Intervention to Reduce Douching Among A... | NCT00207480

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

NCT00207480

Sponsor

Centers for Disease Control and Prevention

Status

Completed

Last Update Posted

Apr 30, 2025Actual

Enrollment

Phase

Not Applicable

Conditions

Vaginal Douching
Bacterial Vaginosis

Interventions

Brief, motivational interviewing intervention

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
U36/CCU300430-24

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2004

Primary Completion Date

Oct 2004Actual

Completion Date

Oct 2004

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 21, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 28, 2025

Last Update Posted Date

Apr 30, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Centers for Disease Control and PreventionFED

Collaborators

Name	Class
Tulane University School of Public Health and Tropical Medicine	OTHER

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Brief, motivational interviewing intervention	Behavioral

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

24 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Patricia Kissinger, PhD, RN	Tulane University School of Public Health and Tropical Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Orleans Women's Health Clinic		New Orleans	Louisiana	70119	United States

Condition Browse Module

MeSH Terms

ID	Term
D016585	Vaginosis, Bacterial

Ancestor Terms

ID	Term
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections
D014627	Vaginitis

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D062405	Motivational Interviewing

Ancestor Terms

ID	Term
D037001	Directive Counseling
D003376	Counseling
D008605	Mental Health Services
D004191	Behavioral Disciplines and Activities

Browse Leaves

Not provided

Browse Branches

Not provided