EVALUATION OF A USER-FILLED, PAPER APPLICATOR FOR DELIVERY OF TENOFOVIR 1% GEL AMONG WOMEN IN RURAL KWAZULU-NATAL, SOUTH AFRICA
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Overall acceptability
研究概览
简要总结
To assess the acceptability of a user-filled, paper, applicator for delivery of tenofovir (TFV) gel among women at high risk of acquiring human immunodeficiency virus (HIV) in rural KwaZulu-Natal, South Africa.
详细描述
CAPRISA 070 is designed to enroll rural women who exit from CAPRISA 008 - an ongoing trial assessing implementation, effectiveness and safety of TFV gel in KwaZulu-Natal, South Africa. All study participants in CAPRISA 008 have also participated in CAPRISA 004 and thus have several years of experience using TFV gel with the prefilled, plastic applicator. CAPRISA 070 will allow us to assess acceptability of the user-filled, paper applicator among women who have had extensive experience with the pre-filled, plastic applicator and are well-positioned to provide feedback and comparisons on a new gel delivery method.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Age 18 years and older
- •Women who previously participated in CAPRISA 008
- •Able and willing to provide first person informed consent to be screened for, and to enroll in, the study
- •Allow access to their CAPRISA 008 data, including study exit data
- •Able and willing to provide adequate locator information for study retention purposes
- •Sexually active (at least one coital act in the last 3 months prior to screening)
- •HIV negative
- •Negative pregnancy test *
- •Agree to use a non-barrier form of contraceptive
- •Agree to adhere to study visits and procedures
- •breastfeeding is not exclusionary but participants must be informed of the presence of TFV in breast milk in negligible amounts
排除标准
- •Has creatinine clearance ,<50ml/min, as estimated using the method of Cockcroft and Gault
- •Has any other condition, that based on the opinion of the investigator or designee would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of the study outcome data, or otherwise interfere with achieving the study objectives
研究组 & 干预措施
TFV 1% Gel
TFV 1% gel with the user-filled paper applicator
干预措施: TFV 1% gel (Drug)
结局指标
主要结局
Overall acceptability
时间窗: over 3 months of use
Overall acceptability of user-filled, paper applicator compared to prefilled, plastic applicator
context of use
时间窗: over three months
Description of context of use of user-filled, paper applicator
challenges encountered
时间窗: over three months
Challenges encountered during use of user-filled, paper applicator and recommendations to address challenges
Applicator Preference
时间窗: Over three months
Applicator preferences between the user-filled, paper applicator and prefilled, plastic applicator
次要结局
未报告次要终点