REDUCTION OF DOUCHING BEHAVIOR IN ADOLESCENT WOMEN

减少青春期女性的冲洗行为

• 批准号: 6661394
• 负责人: MYUNG-HI KIM Oh
• 金额: $ 23.07万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-01 至 2003-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6661394
• 关键词: adolescence (12-20); bacterial disease; behavioral /social science research tag; clinical research; clinical trials; cooperative study; female; health behavior; health education; human subject; sexually transmitted diseases; vaginitis

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.

总体目标是减少冲洗的使用，这种行为与许多不良妇科和生殖健康结果有关，并确定冲洗做法对青少年阴道微生态的影响。具体目标是确定青少年冲洗的社会心理决定因素和行为相关性；将冲洗习惯的变化与青少年性传播疾病的发生率和行为联系起来；并通过比较青少年的感染情况和阴道生态作为结果指标来评估干预措施的有效性。该研究设计是一项随机临床试验。行为干预基于跨理论变革模型。将招募 400 名 14 至 18 岁性活跃女性样本，她们在过去 35 天（5 周）内报告有任何冲洗行为，并将被随机分为：(1) 根据她们的变化阶段量身定制的以客户为中心的干预措施，并由研究护士在基线（15 分钟会议）、基线后 1 个月（15 分钟会议）和 3 个月访视（15 分钟）时提供；或者，（2）安慰剂注意力对照组，他们将在相同的时间内接受额外的咨询，重点是健康的饮食习惯和营养教育。将对参与者进行评估以确定每种生殖器感染的情况。主要结果指标是随机分组后 12 个月时停止灌洗的情况，通过自我报告进行测量，并通过使用妇科事件日历进行确认。次要结果是： 1) 已完成向以下阶段转变的青少年比例采取行动（停止冲洗）； 2) 每隔 3 个月进行一次 12 个月的 STD 和细菌性阴道病发病率测量，并将使用复杂的数据分析方法将收集到的生物和行为数据关联起来。