The Quatro Study: Acceptability Study of (Placebo) Vaginal Delivery Forms for Preventing HIV and Unintended Pregnancy Among Young Women in Zimbabwe and South Africa
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 422
- 试验地点
- 2
- 主要终点
- Change from baseline in ratings and relative preference rankings of four vaginal delivery forms
研究概览
简要总结
The purpose of The Quatro Study is to assess the acceptability, preferences, user experience and effect on sexual behavior of four different vaginal microbicide or multi-purpose technology (MPT) delivery forms, using placebo products in 18-30 year old African women: rapidly disintegrating vaginal insert, intravaginal ring (IVR), film and gel. The study also examines adherence to the dosage forms through objective markers, developed for each dosage form prior to the commencement of the study.
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 30 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 18-30
- •In good health, as determined by the site Investigator or designee based on clinical history
- •Willing and able to comply with study procedures and attend monthly follow-up visits
- •Willing and able to provide informed consent
- •Fluent in one of the languages being used in the study (English, Shona or Zulu)
- •Not intending to travel or move out of the research catchment area for the next 6 months
- •Sexually active defined by vaginal intercourse with a male at least 4 times per month in the past 3 months and plan to be sexually active during the study duration
排除标准
- •HIV positive
- •Pregnant, or intention to become pregnant during the clinical study
- •Prior participation in any HIV-prevention or MPT product demonstration study or clinical trial
- •Any current or historical health (including vaginal or genitourinary conditions) or psychological issues that the site Investigator or his/her designee determines should exclude the potential participant
研究组 & 干预措施
Month 2
In a cross-over design, women will be randomized to a sequence of product use. Each product will be tested by every participant for 1 month in a 4-period cross-over design.
干预措施: Placebo Vaginal Film (Other)
Month 1
In a cross-over design, women will be randomized to a sequence of product use. Each product will be tested by every participant for 1 month in a 4-period cross-over design.
干预措施: Placebo Vaginal Film (Other)
Month 2
In a cross-over design, women will be randomized to a sequence of product use. Each product will be tested by every participant for 1 month in a 4-period cross-over design.
干预措施: Placebo Intravaginal ring (IVR) (Other)
Month 3
In a cross-over design, women will be randomized to a sequence of product use. Each product will be tested by every participant for 1 month in a 4-period cross-over design.
干预措施: HEC Placebo Gel (Other)
Month 1
In a cross-over design, women will be randomized to a sequence of product use. Each product will be tested by every participant for 1 month in a 4-period cross-over design.
干预措施: Placebo Intravaginal ring (IVR) (Other)
Month 1
In a cross-over design, women will be randomized to a sequence of product use. Each product will be tested by every participant for 1 month in a 4-period cross-over design.
干预措施: HEC Placebo Gel (Other)
Month 1
In a cross-over design, women will be randomized to a sequence of product use. Each product will be tested by every participant for 1 month in a 4-period cross-over design.
干预措施: Placebo Vaginal Insert (Other)
Month 2
In a cross-over design, women will be randomized to a sequence of product use. Each product will be tested by every participant for 1 month in a 4-period cross-over design.
干预措施: HEC Placebo Gel (Other)
Month 2
In a cross-over design, women will be randomized to a sequence of product use. Each product will be tested by every participant for 1 month in a 4-period cross-over design.
干预措施: Placebo Vaginal Insert (Other)
Month 3
In a cross-over design, women will be randomized to a sequence of product use. Each product will be tested by every participant for 1 month in a 4-period cross-over design.
干预措施: Placebo Vaginal Insert (Other)
Month 3
In a cross-over design, women will be randomized to a sequence of product use. Each product will be tested by every participant for 1 month in a 4-period cross-over design.
干预措施: Placebo Vaginal Film (Other)
Month 3
In a cross-over design, women will be randomized to a sequence of product use. Each product will be tested by every participant for 1 month in a 4-period cross-over design.
干预措施: Placebo Intravaginal ring (IVR) (Other)
Month 4
In a cross-over design, women will be randomized to a sequence of product use. Each product will be tested by every participant for 1 month in a 4-period cross-over design.
干预措施: HEC Placebo Gel (Other)
Month 4
In a cross-over design, women will be randomized to a sequence of product use. Each product will be tested by every participant for 1 month in a 4-period cross-over design.
干预措施: Placebo Vaginal Insert (Other)
Month 4
In a cross-over design, women will be randomized to a sequence of product use. Each product will be tested by every participant for 1 month in a 4-period cross-over design.
干预措施: Placebo Vaginal Film (Other)
Month 4
In a cross-over design, women will be randomized to a sequence of product use. Each product will be tested by every participant for 1 month in a 4-period cross-over design.
干预措施: Placebo Intravaginal ring (IVR) (Other)
结局指标
主要结局
Change from baseline in ratings and relative preference rankings of four vaginal delivery forms
时间窗: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5
次要结局
- Attributes least and most favored for the vaginal delivery forms as measured by discreet choice experiment(Month 5)
- Adherence assessed by objective biomarkers, utilizing antibodies, tagged recombinant proteins, biochemical assays and/or spectroscopy(Baseline, Month 1, Month 2, Month 3, Month 4, Month 5)
- Adherence assessed by self report via questionnaire(Baseline, Month 1, Month 2, Month 3, Month 4, Month 5)