miPlan: A Randomized Controlled Trial of miPlan Intervention vs. Standard of Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 225
- 试验地点
- 1
- 主要终点
- LARC uptake
研究概览
简要总结
Using our experience in digital media, behavior theory, client-centered interventions, and family planning, we have prototyped a digital application ("app")-miPlan-to be used in the clinic waiting room prior to a contraceptive visit. The goal of this research is to refine the app and conduct a randomized controlled trial of the miPlan intervention vs. standard care. The aim of this study is to understand miPlan's impact. The primary outcome is LARC uptake at clinic discharge. The secondary outcomes are contraceptive use at discharge, self-efficacy and decisional balance for highly effective contraception post-app use, contraceptive satisfaction, and intention to continue method use. The research will consist of baseline activities as well as a three-month follow-up call.
详细描述
Using our experience in digital media, behavior theory, client-centered interventions, and family planning, we have prototyped a digital application ("app")-miPlan-to be used in the clinic waiting room prior to a contraceptive visit. The goal of this research is to refine the app and conduct a randomized controlled trial of the miPlan intervention vs. standard care contraceptive counseling. The aim of this study is to understand miPlan's impact in terms of contraceptive knowledge, intentions and behaviors. The primary outcome is LARC uptake, which will be measured via chart review at clinic discharge, i.e. immediately following a patient's family planning visit. The secondary outcomes are contraceptive use at discharge (measured via chart review immediately following patient's family planning visit), self-efficacy and decisional balance (both measured via adapted validated scales for each) for highly effective contraception post-app use (measured immediately following intervention and prior to contraceptive counseling session), contraceptive satisfaction (measured at 3 months post baseline), and intention to continue method use (measured at 3 months post baseline). The research will consist of baseline activities as well as a three-month follow-up call.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 29 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •African American or Latina female and sexually active with a male partner(s) within the past 6 months,
- •age 15 to 29 years
- •present for contraception initiation
- •English speaking
排除标准
- •not currently pregnant or intending pregnancy within the next 6 months
- •and not currently using LARC
- •not highly intending LARC at enrollment
研究组 & 干预措施
Intervention
After completing baseline the baseline questionnaire, women randomized to the intervention group will receive an iPad, along with a brief tutorial on iPad navigation, and use the miPlan app for up to 15 minutes. They will complete a post-intervention survey before proceeding to standard of care contraceptive counseling.
干预措施: miPlan intervention (Behavioral)
Control
After completing baseline the baseline questionnaire, women randomized to the control arm will proceed to standard of care contraceptive counseling.
结局指标
主要结局
LARC uptake
时间窗: at time of intervention (baseline (0 weeks)
uptake of the implant or IUD at time of intervention (measured via contraceptive method choice and delivery by checkbox)
次要结局
- change in self-efficacy for contraception at 12 weeks(baseline (0 weeks) and 12 weeks)
- contraceptive use(at time of intervention (baseline (0 weeks)))
- change in decisional balance for highly effective methods at 12 weeks(baseline (0 weeks) and 12 weeks)
- contraceptive satisfaction(12 weeks post-enrollment)
- intention to continue method use(12 weeks post enrollment)