The overall goals are to reduce the use of douching, a behavior linked with a number of adverse gynecologic and reproductive health outcomes, and to determine the effects of douching practices on the vaginal microecology of adolescents.
Specific aims are to ascertain psychosocial determinants and behavioral correlates of douching in adolescents; to correlate changes in douching practices with incidence of STDs and behavior among adolescents; and to evaluate the effectiveness of the intervention by comparing adolescents in infections and vaginal ecology as the outcome indicators. The study design is a randomized clinical trial. The behavioral intervention is based on the Transtheoretical Model of Change. A total sample of 400 sexually active females, 14 to 18 years of age, who report any douching practices n past 35 days (5 weeks) will be recruited and randomized into: (1) the client-centered intervention tailored to their stage of change, and delivered by the research nurse at baseline (15-minute session), 1-months after baseline (15-minute session) and at the 3-month visit (15-minutes); or, (2) the placebo-attention control group who will receive an additional counseling at the same length in time, focusing on healthy eating habits and nutrition education. Participants will be assessed for the determination of each genital infection. The primary outcome indicator is cessation of douching measured at 12-month post- randomizing measured by self-report and confirmed by the use of the gynecologic event calendars Secondary outcomes are: 1) the proportion of adolescents who have progressed through the stages of change towards taking action (cessation of douching); and 2) the incidence of STDs and bacterial vaginosis in the 12-month measurements will be made at 3- month intervals and sophisticated data analysis methodology will be used to correlate biological and behavioral data collected.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Program--Cooperative Agreements (U19)
Project #
5U19AI038514-08
Application #
6661394
Study Section
Special Emphasis Panel (ZAI1)
Project Start
2002-09-01
Project End
2003-07-31
Budget Start
1998-10-01
Budget End
1999-09-30
Support Year
8
Fiscal Year
2002
Total Cost
$230,705
Indirect Cost
Name
University of Alabama Birmingham
Department
Type
DUNS #
004514360
City
Birmingham
State
AL
Country
United States
Zip Code
35294
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