Randomized Control Trial Evaluating Impact of Standardized Counseling on Early Discontinuation for Irregular Bleeding in Users of the Contraceptive Implant
试验速览
- 阶段
- 4 期
- 状态
- 进行中(未招募)
- 入组人数
- 348
- 试验地点
- 1
- 主要终点
- Nexplanon Discontinuation Rates
研究概览
简要总结
Clinician counseling for implant users should involve an explanation of the likelihood of irregular bleeding and the possibility of continued or frequent bleeding throughout three years of use. If that counseling does not provide specifics of the actual distribution of bleeding patterns described in published literature, there remains the real possibility of biased or directed counseling, leading to an inaccurate and exaggerated expectation of potential bleeding changes. This study aims to evaluate if a standardized script accompanied by a visual aid regarding expected bleeding profiles, with intention to remove any possibility of negative or positive framing, could change users' expectations and satisfaction with their method, leading to lower discontinuation rates.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
All study team members will be blinded to the randomization, with the exception of the research member who will be delivering the counseling.
入排标准
- 年龄范围
- 18 Years 至 40 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Presenting at the health center to receive an etonogestrel-releasing subdermal implant (Nexplanon) for primarily contraceptive benefits
- •Ability to consent in English
排除标准
- •Have used an etonogestrel-releasing subdermal implant (Nexplanon) within the 12 weeks prior to enrollment
研究组 & 干预措施
Standard of Care Clinician Counseling
Additional Standardized Counseling
干预措施: Additional Standardized Counseling (Other)
结局指标
主要结局
Nexplanon Discontinuation Rates
时间窗: 6 months
Based subjects' self-reported ability to cope with various changes in bleeding patterns, and other demographic information, we will analyze whether an association exists between those who discontinue their method use early due to troublesome bleeding and the counseling they received on the day of method insertion.
次要结局
未报告次要终点
