Assessing Preference for 3 Female Condoms: A Comparative Evaluation of the PATH Woman's Condom, FC2 and the Reddy 6
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- FHI 360
- 入组人数
- 170
- 试验地点
- 2
- 主要终点
- Preference of female condom by type
研究概览
简要总结
Evaluation of preference for three female condoms (FC).
详细描述
The primary goal of this study was to identify the female condom most preferred by study participants. This provided USAID with data to make informed decisions regarding female condom purchases. The study was conducted in three parts. The objective of Part 1 was to familiarize each participant with the three FC types, to minimize learning curve effect in subsequent phases of study, and to gather information on participant demographics, FC acceptability, device function, safety, preference for each of the condom types, and use of male condoms during the same time period. The objective of Part 2 was to determine actual, "unstated" and "unbiased" preference for a particular type of FC. The objective of Part 3 was to identify reasons for preference of a particular FC type and to document details surrounding product use/non-use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •All women enrolled in this research must meet the following selection criteria:
- •must be at least 18 years of age.
- •must be literate (able to read a newspaper or letter easily).
- •must be sexually active (defined as having at least two vaginal coital acts per week and not being abstinent in the month prior to enrollment).
- •must be in an exclusive (monogamous) sexual relationship with her spouse or partner while participating in this research study.
- •must have been in a sexual relationship with this partner for at least 6 months.
- •must be without evidence of STI as determined through syndromic diagnosis and vaginal examination.
- •must be on hormonal or other non-barrier contraception (e.g. OCs, injectables, IUD, or have had a tubal sterilization or be post-menopausal-defined as 12 months with no period).
- •must be willing to give informed consent.
- •must be able to complete condom use log.
- •must be willing to use the study condoms as directed.
- •must be willing to adhere to the follow-up schedule and all study procedures.
- •must have successfully completed a given phase of study before advancing into subsequent phases (e.g. successfully completing Part 1 before advancing to Part 2, etc.).
- •must be willing to provide research study staff with an address, phone number or other locator information while participating in the study.
- •must be willing to participate in the study for up to six months.
排除标准
- •must not be a sex worker.
- •must not be pregnant (as determined by pregnancy testing) or planning a pregnancy during the time of the research study.
- •must not be breastfeeding.
- •must not have known sensitivities or allergies to latex, polyurethane, vaginal/sexual lubricants or the lubricants used on condoms.
结局指标
主要结局
Preference of female condom by type
时间窗: 3 months
The objective of Part 1 is to familiarize each participant with the use characteristics of the three female condom types in order to minimize learning curve effect in subsequent phases of study. In Part 2, a 'simulated market' will be created in order to determine an unbiased, free choice preference for a particular FC type. Part 3 will detail the reasons for participants' selection/preference of specific FC types.
次要结局
- Safety of each of the female condom types(3 months)
- Function of each of the female condom types(3 Months)