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相关。为了解决这一问题，我们完成了一项基于手动、理论驱动的灌洗停止干预的随机临床试验（RCT），在6个月评估中，接受干预的青少年和年轻成年女性比接受对照营养干预的女性更有可能报告在前90天内没有灌洗（RR=1.34，95%置信区间[CI] [103 - 1.73]）和12个月时（RR=1.60，95% CI [1.28 - 2.00]）基于意向治疗模型。基于这一成功，并利用我们的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效率，沿着生物技术的最新进展，拟议研究的目标是：（1）为14至19岁的青少年制定、实施和开展停止灌洗干预措施，（2）确定冲洗对冲洗者和从未冲洗过的年轻妇女的阴道植物群组成的影响。具体目标是：（1）开发一种基于理论的、多媒体的、ACASI管理的、用于冲洗停止的行为干预，该干预将是标准化的、可持续的和可复制的;（2）进行一项随机对照试验，将接受ACASI提供的冲洗停止干预的年轻女性的冲洗停止率与对照ACASI多重健康风险量表进行比较;（3）前瞻性地确定冲洗和冲洗行为改变对阴道菌群组成的影响;（四）确定BV治疗后冲洗对恢复正常菌群的调节作用，并将这些作用与接受过BV治疗但从未进行过冲洗;（5）确定BV的患病率和发病率沿着并评估冲洗者和从未进行过冲洗的女性对照组中淋病、衣原体和阴道毛滴虫感染的频率。

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.