Cluster Randomized Controlled Trial of the "Mittin" Intervention in Addis Ababa, Ethiopia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,715
- 试验地点
- 2
- 主要终点
- Preference-Aligned Fertility Management (PFM) Index
研究概览
简要总结
The goal of this clinical trial is to learn if the "Mittin" intervention can improve women's ability to manage their fertility in line with their preferences among women aged 15-49 using hormonal contraceptives or intrauterine devices and attending public health centers in Addis Ababa, Ethiopia. The main question it aims to answer is: Does the Mittin intervention increase preference-aligned fertility management, contraceptive method satisfaction, and preferred contraceptive method use among participants compared to standard care?
Researchers will compare women's outcomes in health centers providing the Mittin intervention to women's outcomes in health centers that offer standard care to see if Mittin improves women's ability to act in line with their contraceptive preferences.
Participants will
- Receive either standard contraception services (control arm) or enhanced services (intervention arm)
- Participate in a survey at the beginning of the study
- Participate in surveys 4 and 8 months later
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
- Single (Investigator)
盲法说明
Arm will be masked to the principal investigators until analysis of the primary outcomes at 4 months; prior to this data will be in aggregate form and will not reveal intervention assignment.
入排标准
- 年龄范围
- 15 Years 至 49 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Started or continued using hormonal contraceptive method or copper IUD on day of recruitment
- •Ages 15-49 years
- •Willing to provide phone number and receive follow-up phone call
排除标准
- •Not planning to live in Addis Ababa for the next eight months
- •Can not verbally communicate
- •Not willing to provide consent for the study
研究组 & 干预措施
Standard of care arm
Health centers randomized to the standard of care arm will continue offering standard of care contraceptive counseling as per Ethiopian Ministry of Health guidelines. After completion of the c-RCT, the control arm health centers will receive Mittin materials for use on-site (counseling tools, waiting room posters, and educational handouts).
Mittin Intervention arm
Health centers randomized to receive the Mittin intervention will receive staff training and materials (counseling tools, waiting room posters, and educational handouts) necessary to offer Mittin's side effects counseling and support model in their facilities. Women enrolled in the study in intervention health centers will receive proactive follow-up calls from call center agents to offer support after initiating a new contraceptive method. The call center will also be available on-demand to any person who desires support related to contraceptive options or side effects.
干预措施: Mittin (Behavioral)
结局指标
主要结局
Preference-Aligned Fertility Management (PFM) Index
时间窗: Measured at 4 and 8 months
The PFM Index measures whether use or non-use of contraception aligns with one's preferences. It is a binary measure where 0=no alignment, and 1=alignment.
次要结局
- Method satisfaction(Measured at 4- and 8-months)
- Agency in Contraceptive Decisions Scale(Measured at 4 and 8 months)
- Preferred Method Use(Measured at 4 and 8 months)