Effect of Structured Counseling on Continuation Rates of Long Acting Reversible Contraception Among Clients Requesting Early Removal: A Multicenter Randomized Controlled Trial (PLACE Trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 900
- 试验地点
- 6
- 主要终点
- Continuation Rate of Long-Acting Reversible Contraception (LARC) at 6 Months
研究概览
简要总结
Study Overview Summary
This randomized controlled trial will evaluate the effectiveness of structured counseling in improving the continuation rates of long-acting reversible contraception (LARC) among women in Islamabad, Pakistan, who present to family planning clinics for early removal of their contraception devices (copper-T IUD or Jadelle implant). The study, starting December 15, 2025, will recruit women from three federal government-approved clinics.
The trial will randomly assign participants to either an intervention group, where they will receive culturally sensitive counseling to encourage continued use of LARC, or a control group, where contraception will be removed upon client request without counseling. The goal is to determine if structured counseling can increase the likelihood of women continuing their LARC method.
详细描述
Study Overview
This randomized controlled trial aims to assess the effectiveness of structured counseling on the continuation rates of long-acting reversible contraception (LARC) among women who present to family planning clinics in Islamabad, Pakistan, for early (within two years of use) removal of their contraception devices. The study will specifically target women who seek to remove either the copper-T intrauterine contraceptive device (IUD) or the Jadelle subdermal implant.
Starting December 15th, 2025, the research team will recruit eligible participants from three major federal government-approved family planning clinics in Islamabad. The clinics will serve as the intervention and control settings, with half of the healthcare providers trained in a standardized, culturally sensitive counseling approach, while the other half will provide standard care by simply removing the contraceptive device upon request.
The trial will aim to determine whether structured counseling can effectively increase the likelihood of women continuing with their LARC method as compared to the control group, where no counseling intervention is provided.
Study Design
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women presenting at the clinics exclusively for removal of a copper-T IUD or Jadelle subdermal implant within 2 years of use and within the first 2 months of the study.
排除标准
- •Women not wishing to participate or unable to provide informed consent.
结局指标
主要结局
Continuation Rate of Long-Acting Reversible Contraception (LARC) at 6 Months
时间窗: The total study duration will be eight months: the first two months will be allocated to enrolling participants and completing their baseline visits, followed by a six-month follow-up period for all enrolled clients.
The primary outcome of the study is the rate of LARC continuation in women who received either structured counseling (intervention arm) or standard care (control arm) for the continuation of their intrauterine contraceptive device (IUD) or subdermal implant (Jadelle). The continuation rate will be assessed at a 6-month follow-up after the initial clinic visit. Intervention Group: Participants who receive structured, culturally sensitive counseling will be encouraged to continue using their LARC method unless they meet the WHO criteria for removal (e.g., medical complications, side effects, or personal preference). Control Group: Participants in the control group, who receive standard care (removal of the device upon request without any counseling), will be asked to return for a 6-month follow-up to determine if they have continued or discontinued their contraception method. Unit of measurement: Percentage of women that continued the chosen method following the visit.
次要结局
- Client Satisfaction and Factors Influencing Contraceptive Continuation(Eight months)
- Factors Influencing Contraceptive Continuation(Eight months)
研究者
Muhammad Ibrahim Khan
Principal Investigator
Pakistan Institute of Medical Sciences