Telemedicine Contraceptive Counselling (TECC) Versus Standard Care - a Pilot and Randomized Controlled Trial of Periabortion Contraceptive Counseling
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 510
- 试验地点
- 2
- 主要终点
- Use of LARC (IUD or progestin implant) at 12 week follow-up
研究概览
简要总结
Overall purpose of the PILOT and RCT:
This research project aims to increase access and uptake of contraception after abortion through the systematic development and testing of a new telemedicine service for contraceptive counselling (TECC). The investigators will perform a pilot study in South Africa, and multicenter randomized controlled trial in South Africa and Kenya with the following specific aims:
详细描述
Overall purpose of the PILOT and RCT:
This research project aims to increase access and uptake of contraception after abortion through the systematic development and testing of a new telemedicine service for contraceptive counselling (TECC). The investigators will perform a pilot study in South Africa, and multicenter randomized controlled trial in South Africa and Kenya with the following specific aims:
- To design and test a user-friendly online service for contraceptive counseling informed by systematic research into the preference and experience of women in our study setting.
- To compare uptake of long-acting reversible contraception (LARC) after TECC and in-person contraceptive counseling.
- To compare rates of choice, uptake, and continuation of LARC or any contraceptive, satisfaction, preference for counseling, recurrent unintended pregnancy, and recurrent abortion after TECC and in-person contraceptive counseling.
PILOT STUDY Objective: To assess the acceptability of a new online e-health service for contraceptive counselling i.e., telemedicine contraceptive counseling (TECC)
Design: A mixed methods pilot study developing and testing a new TECC service preceding a randomized controlled trial Setting and duration: The study will take place at Mitchell's Plain's community health center (CHC) in Western Cape, between February November 2023 and December 2023.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Seeking either surgical or medical abortion
- •≥ 18 years of age
- •Able to communicate and understand spoken and written English
- •With private access to a smart phone
- •Willing to participate in the study procedures
排除标准
- 未提供
结局指标
主要结局
Use of LARC (IUD or progestin implant) at 12 week follow-up
时间窗: 12 weeks
Proportion of participants in each arm with using LARC (IUD or progestin implant) at 12 week follow-up
次要结局
- Choice of LARC on day of consultation(Baseline)
- Use of LARC at 6 months(6 months)
- Use of LARC at 12 months(12 months)
- Unplanned pregnancy within 6 months(6 months)
- Unplanned pregnancy within 12 months(12 months)
- Recurrent abortion within 6 months(6 months)
- Recurrent abortion within 12 months(12 months)
- Preference for counseling model(Baseline)
- Satisfaction with contraceptive counseling(Baseline)
- Decision-competence after contraceptive counseling(Baseline)
- Agency in contraceptive decision making(Baseline)
- Change of contraceptive method(12 months)
研究者
Margit Endler
Associate Professor, MD ObGyn
Karolinska Institutet