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临床试验/NCT01859195
NCT01859195已完成不适用

Monoclonal Antibody-based Multipurpose Microbicides

The Miriam Hospital1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2013年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
1
主要终点
Frequency of Use

研究概览

简要总结

The purpose of this project is to explore women's thoughts, opinions, and ideas about vaginal products. Women who enroll in the project will complete a brief demographics and sexual behavior questionnaire.

详细描述

The purpose of this project is to explore women's thoughts, opinions, and ideas about vaginal products. The investigators will ask women to help design the best strategy for applying a vaginal product using a specific kind of applicator. The investigators want to identify designs that women think would be easy to prepare and insert. Women's thoughts and opinions will help researchers develop new products called microbicides that may protect against HIV and other sexually transmitted diseases, that are easy to use, and that will be acceptable to women who use them. If researchers can make products that are easy to use and that women like to use, the products will be used more often, and more infections will be prevented.

Women who enroll in the project will complete a brief demographics and sexual behavior questionnaire.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • are between the ages of 18 and 45 at prescreening
  • report vaginal sex with a man in the past 12 months at prescreening
  • report negative pregnancy status and no intention to become pregnant during the course of the study
  • report negative or unknown HIV status, and
  • are willing and able to provide informed consent.

排除标准

  • self-report being pregnant, or intention to become pregnant during the course of the study
  • self-report being HIV-positive
  • self-report an allergy or sensitivity to vaginal contraceptive film (VCF), nonoxynol-9 (N9), or product(s) containing N9
  • are unable or unwilling to give informed consent, or
  • have any condition that, in the opinion of the project leader or principle investigator, would compromise the participant's ability to participate in the study.

研究组 & 干预措施

Female Participants

Participants who completed demographics and sexual behavior questionnaire.

结局指标

主要结局

Frequency of Use

时间窗: 1 year

Frequency of product use during specified sex in the past 12 months. Response options: 0= None of the time; 1 = Some of the time, 2 = Half of the time, 3 = Most of the time; 4 = All of the time; 5 = Not applicable (did not have specified sex)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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