Microbicide-Use Adherence, Acceptability, and Attitudes Among Sexually Active Young Women Participating in a Phase I Microbicide Trial (MTN 004) "Tell Juliana"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 3
- 主要终点
- Microbicide use adherence as measured by e-mail messages
研究概览
简要总结
ATN 062 is designed to gain scientific knowledge of microbicide-use adherence, acceptability, and attitudes among sexually active young women
详细描述
ATN 062 will take place in parallel to another study, MTN 004, "Phase I Study of the Safety and Acceptability of 3% w/w SPL7013 Gel (VivaGel™) Applied Vaginally in Sexually Active Young Women." ATN 062 will use quantitative and qualitative research methods. The quantitative method will consist of a computerized diary used by participants during the 14 days of the gel trial of MTN 004. The qualitative methods will include email messages sent by participants to a research assistant as a supplement to the diaries, as well as in-depth interviews through teleconferences to contextualize the recorded events. All study activities will be timed to coincide with those of MTN 004
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 24 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Currently enrolled in MTN
- •Willing and able to provide written informed consent for ATN
- •Willing to participate as required by protocol, including completion of all assessments and follow-ups.
排除标准
- •Refuses to have teleconferences audio recorded.
- •Any social or medical condition that, in the investigator's opinion, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
结局指标
主要结局
Microbicide use adherence as measured by e-mail messages
时间窗: 21 days (through end of study)
Microbicide use adherence as measured by in-depth interviews via teleconference
时间窗: 21 days (through end of study)
Microbicide use attitudes as measured by a computerized phone diary
时间窗: 21 days (through end of study)
Microbicide use attitudes as measured by e-mail messages
时间窗: 21 days (through end of study)
Microbicide use adherence as measured by a computerized phone diary
时间窗: 21 days(through end of study)
Microbicide use acceptability as measured by a computerized phone diary
时间窗: 21 days (through end of study)
Microbicide use acceptability as measured by e-mail messages
时间窗: 21 days (through end of study)
Microbicide use acceptability as measured by in-depth interviews via teleconferences
时间窗: 21 days (through end of study)
Microbicide use attitudes as measured by in-depth interviews via teleconferences
时间窗: 21 days (through end of study)
次要结局
未报告次要终点