Sexually Transmitted Diseases:
An Intervention to Reduce Vaginal Douching Among Adolescent and Young Adult Women: A Randomized, Controlled Trial
Grimley, Diane M. PhD*; Oh, M Kim MD†; Desmond, Reneé A. PhD‡; Hook, Edward W. III MD§; Vermund, Sten H. MD, PhD∥
From the * Department of Health Behavior, School of Public Health, the † Department of Pediatrics, Division of Adolescent Medicine, Department of Medicine, the ‡ Division of Hematology and Oncology, Department of Medicine, the § Division of Infectious Diseases, Department of Medicine, and the ∥ Department of Epidemiology, School of Public Health, University of Alabama at Birmingham, Birmingham, Alabama
The study was supported by grant U19A135814-06, UAB STD CRC (Principal Investigator: Hook; Project Principal Investigator: Oh) from the National Institute of Allergies and Infectious Diseases.
Correspondence: Diane M. Grimley, PhD, School of Public Health, Department of Health Behavior, RPHB 227, 1530 3rd Ave. South, Birmingham, AL 35294-0022. E-mail: email@example.com.
Received for publication January 24, 2005 and accepted April 27, 2005.
Objective: The objective of this study was to evaluate an intervention to reduce vaginal douching among adolescent and young women who report douching.
Study: This study consisted of a randomized, controlled trial of 275 primarily black adolescent and young adults aged 14 to 23 years. All women participated in 3 15-minute individualized counseling sessions. The experimental group received interventions based on their stage of readiness for ceasing vaginal douching. The comparison condition emphasized healthy eating and nutrition. The primary outcome measure was douching cessation (i.e., no douching in the preceding 3 months) at the 6-and 12-month assessment; a secondary outcome was progression through the stages of change toward douching cessation.
Results: Based on an intention-to-treat model, participants assigned to the douching intervention group were significantly more likely to report having stopped douching at 6 months (relative risk [RR], 1.34; 95% confidence interval [CI], 1.03–1.73) and at 12 months (RR, 1.60; 95% CI, 1.28–2.00). At baseline, 89.9% of all women reported no intention to stop douching. Also based on an intention-to-treat model, there were no differences in stage across the 2 groups at 6 months (P = 0.29); however, at 12 months, the difference between the intervention and comparison group was statistically significant (P = 0.008).
Conclusion: Stage-matched interventions can reduce douching among adolescent and young adult women.
VAGINAL DOUCHING HAS BEEN LINKED to a number of adverse reproductive health outcomes, including increased risk for pelvic inflammatory disease (PID),1–4 ectopic pregnancy,5–8 preterm birth,9 reduced fertility,10,11 increased susceptibility to sexually transmitted infections (STIs),12–14 including human immunodeficiency (HIV) infection,15,16 cervical carcinoma,17–19 and bacterial vaginosis (BV).20–22 Although cause and effect has been debated,23 the evidence suggests that vaginal douching increases the risk of negative health outcomes.24–26
Despite these inauspicious associations, many women in the United States continue to douche regularly,27 often initiating the practice at a young age.27,28 Results from the 1995 National Survey of Family Growth27 indicated that 27% of reproductive-aged women douched regularly with the behavior being more prevalent among black than white women (55% vs. 21%). Among adolescents, 37% of black and 11% of white girls reported regular douching. A recent review of vaginal douching suggests that the behavior is currently being initiated at earlier ages compared with older generations of women.24
Lower educational attainment,29,31 lower income,32 black race,29 and living in the southeastern region of United States29,31 are characteristics of women who are more likely to douche. Behavioral factors associated with vaginal douching include early initiation of sexual intercourse, higher number of lifetime sexual partners, more frequent intercourse, history of STIs, cigarette smoking, and infrequent condom use.7,8,33,34 In a nationwide study of 342 adolescent girls with or at high risk for HIV, those who were more sexually active, were black, had dropped out of high school, and/or were HIV-infected were more likely to douche.28 Hence, women and girls at highest risk of reproductive tract infections and adverse pregnancy outcomes are the most likely to douche.
Despite the abundance of evidence in support of associations between douching and adverse health outcomes, published reports on the beneficial aspects of douching appear more limited. However, some recent reports from developing countries conclude that douching, depending on timing of douching and type of product used, is associated with human papillomavirus regression,35,36 reduced risk of HIV/STIs,37 and favorable changes in vaginal ecology.38,39 The participants in these studies were at very high risk for STIs.30
In the United States, only one clinical trial has been conducted with women who douche.40 Although douching cessation was not the outcome, a comparison of douching with another form of vulvar hygiene (vaginal wipes) was evaluated, and the results indicated that there was little or no indication of a greater risk of PID among women assigned to the douche product during 1 year of follow up.
Yet, women who douche tend to use other feminine hygiene products, including vaginal wipes, at a fairly high rate compared with women who do not douche (P <0.01).41 Moreover, without behavioral intervention, women who douche have been resistant to change.42,43 At the same time, one recent study found that women discouraged from douching by a physician or nurse were more likely to have stopped the practice,44 suggesting that education can be an effective tool for risk reduction.42,44 Yet to date, no behavioral interventions have been conducted with douching cessation as the primary outcome. We conducted a randomized, controlled trial to evaluate the efficacy of a theory-based behavioral intervention to encourage adolescent and young women who douche to cease the behavior.
The theoretical framework guiding development of this douching reduction intervention was the transtheoretical model of change often referred to as the “stages of change model.”45 Client-centered (individualized) counseling that assesses a person's readiness for behavior change has been accepted as a tenet of sexually transmitted disease (STD)/HIV prevention counseling,46,47 and holds promise for intervening on an equally intimate and personal behavior such as douching.
The stages of change model describes the process of change through a continuum of 5 stages: 1) from precontemplation (not thinking about change), 2) to contemplation (considering making a change in the foreseeable future, defined here as within the next 3 months), 3) to preparation (planning to change in the next month), 4) to action (initiating a behavior change), and 5) to maintenance (sustaining the behavior change over time). In this model, identification of an individual's stage of change allows for the tailoring of interventions to match where a person may be in the process of change leading to more relevant and, thus, more effectively targeted messages.48–52
Materials and Methods
The study was conducted from August 2001 to June 2003 in an urban city in the southeastern United States. Participants were recruited from a hospital-based adolescent clinic during routine visits and through flyers posted at a local university. Eligible females were between 14 and 23 years of age and reported douching at least once within the preceding 35 days (5 weeks). The 35-day cutoff was used to permit inclusion of women who douched only after menses, the most prevalent douching practice among women.53–56 Exclusions for study participation included unwillingness to provide written informed consent, pregnancy, or having a serious medical condition or mental dysfunction deemed to potentially interfere with follow up. The University of Alabama at Birmingham Institutional Review Board reviewed and approved the study protocol.
Of the 327 females who met the eligibility criteria, 275 (84%) agreed to participate in the study, completed the baseline survey, and were randomized to study conditions. Participants were compensated $20 per visit for their time and travel.
The study was a randomized, controlled trial. Assignment to study conditions was conducted following the baseline assessment. Participants were then randomly assigned to receive either the douching reduction intervention or a nutritional health promotion messages as described subsequently.
An intervention manual to guide study personnel was developed specifically for this project. The manual was divided into 5 sections each representing a different stage of change. Other components of the model (i.e., decisional balance [advantages and disadvantages of douching], self-efficacy, and the processes of change) were used to refine the stage-matched douching interventions. This manual was used to guide the intervention facilitator to present the appropriate behavior change strategies for each participant's current stage of change to promote progression toward douching cessation. Briefly stated, at a douching intervention session, participants who reported no intention to change (precontemplation stage) were provided information regarding the potential health risks associated with douching. If at the current visit, a participant reported that she was thinking about stopping douching (contemplation stage) but ambivalent about change, she was assisted with weighing her perceived pros and cons associated with douching and provided tactics to counter the negative aspects of changing. A participant who stated that she was planning to stop douching soon (in the next 30 days) was assisted with making her commitment to change stronger, setting a quit date, and finding healthy role models to support her in her decision. Women in the intervention group who had moved to the action stage (stopped douching but for less than 3 months), contingency plans were made for specific situations in which they might lack confidence or feel that they may relapse back to douching. Finally, participants who had not douched in the past 6 months (maintenance stage) were provided support and encouragement, and relapse prevention strategies were reinforced.
After baseline assessment, participants were randomly assigned to either the douching reduction intervention or the nutrition promotion comparison condition using a permuted blocked randomization scheme. The randomization was stratified by stage of change. The douching intervention consisted of 3 15-minute, client-centered intervention sessions (at baseline, 1 month, and 3 months) tailored to each participant's stage of change. The comparison group also involved client-centered counseling sessions at the same time points and for the same lengths of time as the intervention condition using a manual that focused on provision of healthy eating and nutrition education and were provided with an antidouching message as part of their standard of care.
Data were collected at baseline, 6, and 12 months in both arms of the trial. At each visit, a trained female research assistant administered a questionnaire assessing basic demographic characteristics and a series of douching-related questions. Sexual behaviors such as age at first intercourse, frequency of recent sexual intercourse, number of partners, condom use, and STD history were also assessed. Each participant's current stage of change was determined by assessing both short- and long-term intentions to stop vaginal douching and, at follow-up visits, the interval since last douching. The primary outcome of interest was specified as cessation of douching (defined as self-report of no douching in the preceding 90 days) at 12 months postrandomization. A secondary outcome was the proportion of participants who had progressed through the stages of change toward douching cessation.
Sample size calculations were conducted based on previous studies using 3 counseling sessions to promote progress through the stages of change.48,57,58 We projected 30% douching cessation within the intervention group as compared with a 10% reduction in the nutrition comparison condition. A total sample size of 164 (82 per group) would provide statistical power = 0.90 with a 2-tailed test and type 1 error rate set at 0.05. However, we oversampled based on concerns that as many as 40% of study participants may not complete the study. To control for the potential bias of a high dropout rate, we used an intention-to-treat protocol in which women lost to follow up were assumed to have not quit their douching practices. Thus, we enrolled 275 adolescents and young adult women who had douched in the past 35 days over a 30-month timespan.
At baseline, demographic, psychosocial mediators, sexual behaviors, and STD prevalence at enrollment were summarized for the 2 treatment arms were compared by chi-squared analyses for nominal variables and the t test for continuous variables. Variables that differed between the treatment groups were considered potential confounders in the outcome analyzes. The effectiveness of the intervention was assessed as the difference in the prevalence of douching at 6 and 12 months between the treatment groups. The douching intervention effectiveness was assessed by logistic regression to compute the adjusted odds ratio for quitting douching. Stage of change at both 6 and 12 months was compared between the 2 conditions using chi-squared analyses and exact test. Douching cessation was the primary outcome variable for each follow-up visit at 6 and 12 months (“Have you douched in the past 90 days?”). Confounders also included in the logistic regression included age at baseline, number of partners (lifetime and past 30 days), and douching frequency at baseline. Stage progression between visits was defined as advancing one or more stages between study visits. For defining sustained douching cessation over time, the 2 later stages (action and maintenance) were combined and compared with the 3 preaction stages (precontemplation, contemplation, and preparation) at each follow-up visit.
In consideration of the dropouts in the outcome analysis, a secondary analysis was performed in which all participants not completing the trial were considered as “still douching” and analyzed in the originally assigned treatment group. All analyses were performed using SAS, version 9.0 (SAS Institute Inc., Cary, NC).
Of 275 participants, 137 were randomized to the douching reduction intervention and 138 to the nutrition promotion condition. No significant differences were observed at baseline for any demographic, douching, or sexual behavior-related variables between the 2 treatment groups (see Table 1) with the exception of douching to control vaginal itching, a behavior that was significantly more common in the control group. Over 90% of the young women were black. Consistent with previous studies,5,29,41,54–56 the majority of all women reported using commercial products, douching after menses, and to feel “fresh and clean.”
As anticipated, there was a 41% (n = 112) attrition rate over the 12-month period. Of participants allocated to the douching intervention, 94 (68.6%) reached the 6-month assessment and 84 (61.3%) completed the 12-month assessment. Of the 138 participants allocated to the healthy eating and nutrition condition, 98 (71.0%) completed the 6-month assessment and 79 (57.2%) completed the 12-month assessment. Comparison of baseline characteristics for those who completed the follow up versus those who did not revealed only one significant difference. Women who douched more frequently (more than once a month) were less likely to complete the study than those who reported douching once a month (56.3% vs. 42.1%, chi-squared = 5.36, P = 0.02) and served as a potential confounding in the outcome analyses.
Intervention Effects: Douching Prevalence
The effect of the intervention on douching status for participants with data at 6 and 12 months is presented in Table 2. At the 6-month assessment, participants in the douching reduction intervention were more likely to report not douching in the preceding 90 days as compared with those in the nutrition promotion condition (30.9% vs. 17.4%; chi-squared = 4.80, P = 0.03). Participants who received the intervention were more likely to have stopped douching (relative risk [RR], 2.20; 95% confidence interval [CI], 1.08, 4.47) compared with controls. At 12 months, this difference increased with still more participants in the douching intervention reporting not douching in the preceding 90 days as compared with those in the nutrition comparison condition (48.8% vs. 21.5%; chi-squared = 13.23, P = 0.0003). Participants who received the intervention were more likely to have stopped douching than the controls (RR, 3.49; 95% CI, 1.66–7.32). The treatment effect was unchanged at 6 months or 12 months when adjusting for “douching for relief of vaginal itch” at baseline, an element that was not balanced between the groups by randomization. Douching frequency at baseline (1 month or >1 per month) was not a significant confounder in the outcome analyses.
Based on an intention-to-treat model in an unadjusted analyses, participants assigned to the douching intervention group were significantly more likely to have stopped douching at 6 months (RR, 1.34; 95% CI, 1.03–1.73) and at 12 months (RR, 1.60; 95% CI, 1.28–2.00) compared with controls.
Secondary Outcome: Stage of Change Progression
The effects of the douching intervention on stage progression are presented in Table 3. At baseline, most participants in each group (89.8% in both the intervention and the comparison condition) were in the precontemplation stage reporting no intention to change their douching behaviors. At 6 months, there was a marginal difference in stage distribution between the 2 conditions (P = 0.10). At 12 months, the difference in stage distribution between the intervention and comparison groups was statistically significant (P = 0.04). Combining women in the 2 later, action-oriented stages (action and maintenance) of douching cessation and comparing them with women in the earlier, preaction stages (precontemplation, contemplation and, preparation), more women receiving the douching intervention had progressed through the stages at the 6-month assessment (41.7%) than the comparison group (28.6%), but the difference was only of marginal significance (chi-squared = 3.61, P = 0.07). However, by 12 months, significantly more participants in the douching intervention group had progressed to the latter stages (not douching for either 3 months [action stage] or 6 months [maintenance stage] vs. participants in the control condition [53.7% vs. 28.2%; chi-squared = 10.69, P = 0.0001]). When stratifying by douching frequency, there was no confounding by frequency of douching by stage of change (crude RR, 0.67 and the Mantel-Haenszel RR, 0.69 at 6 months; crude RR, 0.50 and Mantel-Haenszel RR, 0.51 at 12 months).
Based on an intention-to-treat model, there was no difference in stage progression across the 2 groups at 6 months (P = 0.29); however, at 12 months, there was a significant difference with more women in the intervention group in the action and maintenance stages (had stopped douching) as compared with controls (P = 0.008).
We examine the concordance between douching cessation at 6- and 12-month follow ups (sustained douching cessation). Only 4 (4 of 38, 10.2%) participants who reported stopping douching at 6 months had relapsed during the 6- and 12-month follow-up assessments. However, of these 4 women, only one regressed to a preaction stage (preparation) and reported current douching but planned to stop in the next 30 days, whereas the remaining 3 participants who had “slipped” back to douching at the 6-month assessment were “back on track” at 12 months and reported not douching in the past 3 months (were in the action stage).
Like in previous studies,42,43 the majority of women in the current study were resistant to the notion of stopping their douching behavior at enrollment. This is the first randomized, controlled trial demonstrating that a theory-based, behavioral intervention can result in a substantial reduction in douching among adolescent and young adult women. Compared with baseline status, our intervention appears to have contributed to a nearly 50% reduction in douching. The trial intervention used a novel method of douching education based on the stages-of-change behavioral model that proved more successful than routine antidouching messages provided in the context of usual care.
The efficacy of our douching cessation intervention may be attributable, in part, to the stage-matched interventions. A unique aspect of the study was that nearly 90% of participants reported having no intention to stop douching at the time of enrollment. That 3, brief, stage-matched interventions could move such a substantial proportion of women to stop douching suggests the efficacy of stage-matched intervention approaches. In addition, the brevity of the intervention (a total of 45 minutes provided over 3 separate visits) suggests that interventions of this sort might readily be incorporated into public health efforts to reduce douching.
In terms of sustained douching cession, nearly 90% of the women assigned to the intervention group who reported not douching at 6 months were not douching at the 12-month assessment. Moreover, unlike other behavioral interventions, the stage-matched treatment effect accumulated rather than deteriorated over time. With staged-matched interventions, the goal is to provide individuals with intervention strategies that match where they are in the process of change so they will become better prepared to take action, potentially preventing the threat of relapse from taking action to soon.59 Because the majority of participants had no intention to stop douching at enrollment resulted in a slow but steady progression through the stages of change overtime. With other health behaviors such smoking cessation,45 the highest quit rates for participants who had no intention to stop smoking at enrollment were found at 18 months postintervention. These findings point out that behavior change is a process and that it takes time for individuals who initially have no intention to change to take successful action.
Several study limitations should be acknowledged. First, like any study conducted in a defined population, our findings may not be applicable to adolescent and young adult women with different sociodemographic or behavioral characteristics. Additional studies carried out in other settings are needed. At the same time, however, our study population, young, predominantly black women living in the southeastern United States, represents a group in whom douching is particularly common. Second, the current study relied on self-report of douching for outcome measurement, introducing potential concerns regarding the reliability of the outcome measures. Self-report of douching cessation has yet to be formally evaluated; however, previous studies have established the reliability and validity of self-reported, sex-related behaviors, which also involve sensitive and personal information.60–63 Third, randomization failed to balance girls and women who reported douching to control vaginal itching with significantly more such women in the comparison group. Controlling for this difference in the analysis, however, did not change the results. Fourth, no studies to date have demonstrated that reduction in douching if achieved by an intervention would be associated with beneficial changes in any of the identified adverse health outcomes. Future prospective studies are needed that examine the influence of douching behavior and douching cessation on vaginal milieu30 such as microflora.64 Despite these limitations, this is the first study to use a randomized, controlled trial to evaluate the efficacy of a brief, behavioral intervention targeting douching cessation with dose-equivalent comparison condition to minimize Hawthorne effects.
Although national rates of douching have declined over recent years, the behavior remains prevalent among American women, particularly among black adolescents and young adults. Our study demonstrates that staged-matched interventions targeting adolescent and young adult women can substantially reduce vaginal douching.
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