Douching Cessation with Biological Endpoints

描述(由申请人提供)：阴道冲洗与许多不良生殖结局有关。为了解决这个问题，我们完成了一项基于手动、理论驱动的停止冲洗干预的随机临床试验(RCT)，根据意向治疗模型，在6个月评估(RR=1.34，95%可信区间[103-1.73])和12个月(RR=1.60，95%CI[1.28-2.00])的基础上，接受干预的青春期和年轻成年女性比接受对比营养干预的青少年和年轻成年女性更有可能报告在前90天内没有冲洗。基于这一成功，并利用我们研究团队开发的音频、计算机辅助、自我访谈(ACASI)行为改变技术的灵活性和高效性，以及目前生物技术的进步，拟议的研究的目标是：(1)针对14至19岁的青少年制定、实施和进行冲洗停止干预措施；(2)确定冲洗对冲洗者和一组从未冲洗的年轻女性阴道菌群的影响。具体目标是：(1)开发一种基于理论的、多媒体的、ACASI实施的行为干预措施，以停止冲洗，该干预将是标准化、可持续和可复制的；(2)进行随机对照试验，比较接受ACASI提供的冲洗停止干预的年轻女性的冲洗停止率与ACASI多项健康风险清单的比较；(3)前瞻性地确定冲洗和冲洗行为的变化对阴道微生物区系组成的影响；(4)确定冲洗对BV治疗后恢复正常微生物群的调节作用，并将这些影响与接受过BV治疗但从未冲洗过的女性进行比较；以及，(5)确定BV的患病率和发病率，并评估淋病、衣原体和阴道毛滴虫在洗脸者和从未洗澡的对照组中的感染率。

DESCRIPTION (provided by applicant): 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.