Topical Microbicide Acceptability in Young Women

年轻女性对局部杀菌剂的接受度

• 批准号: 6842448
• 负责人: GREGORY D. ZIMET
• 金额: $ 12.49万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-08-01 至 2009-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6842448
• 关键词: adolescence (12-20); antiinfective agents; attitude; communicable disease control; communicable disease transmission; cooperative study; disease /disorder etiology; disease /disorder proneness /risk; human subject; human therapy evaluation; interview; longitudinal human study; microorganism disease chemotherapy; patient oriented research; personal log /diary; questionnaires; self concept; sex behavior; sexually transmitted diseases; therapy compliance; topical drug application; women' s health

The objective of this study is to evaluate acceptability of topical microbicide use for STD prevention among young women from middle adolescence to early adulthood. This project has an integrated methodological approach and makes use of the Biostatistical and Clinical Cores of the CRC proposal. This proposal examines developmental, behavioral, and attitudinal issues relevant to microbicide acceptability. Specific Aims: 1. To assess acceptability as a function of relationship status and different age cohorts across adolescence and young adulthood, including examinations of relationship quality, self-efficacy, and microbicide characteristics as predictors of acceptability. 2. To assess developmental changes in acceptability of topical microbicides over a 4-year time span. 3. To assess acceptability through field trials of a vaginal moisturizer among older adolescents and young adults. Methods: The first specific aim will involve cross-sectional analyses of in-person interviews with partner-specific questions about microbicide acceptability. The second specific aim trill involve longitudinal analysis of the same interview data. Microbicide acceptability will be measured by participant ratings of 14 described microbicides, each uniquely defined along 4 dimensions: 1) timing of application in relation to coitus; 2) vehicle texture; 3) contraceptive action; and efficacy. The third specific aim will be accomplished through the use of daily diary collection in which participants will indicate their reactions to the use of the vaginal moisturizer. 150 young women at high risk for STD are expected to participate for lims 1 and 2 and 100 women to participate for aim 3. The study protocol involves baseline and quarterly in-person interviews for 48 months, baseline and yearly self-report questionnaires, and two 1-month diary periods per year for 3 years. Significance: the work has the potential to inform, methodologically, the structure and development of Phase 2 and 3 clinical trials for microbicides among adolescents.

这项研究的目的是评估青少年中期至成年初的年轻女性中局部杀菌剂的可接受性。该项目具有综合的方法论方法，并利用了CRC提案的生物统计和临床核心。该提案研究了与菌心可接受性相关的发展，行为和态度问题。具体目标：1。评估可接受性与青少年和年轻人的关系状态和不同年龄群的函数，包括对关系质量，自我效能和杀生性特征的检查 作为可接受性的预测因素。 2。评估在4年的时间段内可接受性可接受性的发育变化。 3。通过对年长青少年和年轻人的阴道保湿剂进行现场试验来评估可接受性。方法：第一个具体目的将涉及对个人访谈的横断面分析，并具有有关伴侣可接受性的特定于合作伙伴的问题。第二个特定目标颤音涉及对同一访谈数据的纵向分析。微生物可接受性将通过14个所描述的菌皮的参与者等级来衡量，每个杀菌剂沿着4个维度唯一定义：1）与COITUS相关的应用时间； 2）车辆质地； 3）避孕行动；和功效。第三个特定目标 将通过每日日记收集来实现，参与者将表明他们对使用阴道保湿剂的反应。预计有150名具有性病高风险的年轻妇女将参加LIMS 1和2和100名妇女参加AIM 3。研究方案涉及基线和季度面对面访谈，为期48个月，基线和年度自我报告问卷，每年两份1个月的日记期限为3年。意义：这项工作有潜力从方法论上讲，这是青少年中生液剂的第2阶段和3期临床试验的结构和开发。