Vaginal douching has been associated with a number of adverse reproductive outcomes. In an effort to address this issue, we have completed a randomized clinical trial (RCT) of a manual-based, theory-driven douching cessation intervention in which adolescent and young adult women who received the intervention were more likely than those who received a comparison nutrition intervention to report not douching in the preceding 90 days at the 6-month assessment (RR=1.34, 95% confidence interval [Cl] [103 -1.73]) and at 12 months (RR=1.60, 95% Cl [1.28 -2.00]) based on an intent-to-treat model. Building on this success and capitalizing on the flexibility and efficiency of audio, computer-assisted, self-interviewing (ACASI) behavior change technology developed by our research team, along with current advances in biotechnolgy, the goals of the proposed study are: (1) to develop, implement and conduct a douching cessation intervention for adolescents 14 to 19 years who douche and, (2) to determine the effects of douching on vaginal flora composition among douchers and a comparison group of young women who have never douched. The, specific aims are: (1) to develop a theory-based, multimedia, ACASI administered behavioral intervention for douching cessation that will be standardized, sustainable and, replicable;(2) to perform a RCT comparing douching cessation rates in young women receiving the ACASI-delivered intervention for douching cessation to a comparison ACASI multiple health risk inventory;(3) to prospectively determine the effects of douching and douching behavior change on vaginal microflora composition;(4) to determine the modulating effects of douching on restoration of normal microflora after treatment of BV and to compare these effects with females who have been treated for BV but have never douched;and, (5) to determine the prevalence and incidence of BV along with an evaluation of frequency rates of infection due to gonorrhoea, chlamydia, and Trichomonas vaginalis among douchers and a comparison group of females who have never douched.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Research Project (R01)
Project #
5R01HD051646-04
Application #
7903896
Study Section
Behavioral Medicine, Interventions and Outcomes Study Section (BMIO)
Program Officer
Kaufman, Steven
Project Start
2007-07-01
Project End
2012-06-30
Budget Start
2010-07-01
Budget End
2011-06-30
Support Year
4
Fiscal Year
2010
Total Cost
$502,500
Indirect Cost
Name
University of Alabama Birmingham
Department
Public Health & Prev Medicine
Type
Schools of Public Health
DUNS #
063690705
City
Birmingham
State
AL
Country
United States
Zip Code
35294