Debunking Myths About Contraceptive Safety Among Women in Kingston, Jamaica
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
- Self-reported initiation of LARC (dichotomous variable for either IUD or implant use vs. neither use)
研究概览
简要总结
The primary hypothesis is that the intervention video - based on strategies from cognitive psychology - can correct women's misinformation about long-acting reversible contraception (LARC) and result in higher use of LARC. While there are no direct benefits to participants from being in the study, the research could benefit women in general by providing evidence to help prevent unintended pregnancy. Unlike many interventions that are not feasible for scaling up once shown to be effective in changing people's behavior, the proposed intervention has been carefully designed to impose a low burden to clinic staff and require few resources for translating to wider use. Thus, the investigators expect the intervention to have high potential for influencing clinical care and research for addressing the overall goal of reducing unintended pregnancy.
详细描述
The investigators will conduct a randomized trial (RT) of consenting adult women (N=220) to test the effectiveness of the final intervention video.
Participants in the RT will complete the "Enrollment Questionnaire" and then will be randomized to either watch a short video on 1) debiasing about LARC safety (intervention arm; n=110) or 2) vector control (control arm; n=110) (Figure 2). Participants then will have the option of receiving routine contraceptive services that follow standard care. After three months, trained interviewers will contact participants to administer the short "Follow-up Questionnaire" via telephone. To corroborate participant reporting of contraception use during follow-up, the investigators also will extract data on LARC use from participant medical records.
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
- 18 Years 至 25 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •present at the Comprehensive Health Centre;
- •18-25 years of age; and
- •sexually active (defined as ≥1 penile-vaginal act in past month);
排除标准
- •known to be pregnant;
- •sterilized;
- •breastfeeding;
- •currently using the IUD or implant; or
- •want pregnancy in the next 12 months
结局指标
主要结局
Self-reported initiation of LARC (dichotomous variable for either IUD or implant use vs. neither use)
时间窗: within 3 months of enrollment
Based on survey question on use of the IUD (y/n) and implant (y/n)
次要结局
- Self-reported attitudes toward LARC-related bleeding patterns(3 months after enrollment)
- Self-reported belief about IUD safety(3 months after enrollment)
- Self-reported belief about implant safety(3 months after enrollment)
研究者
Maria F. Gallo, PhD
Associate Professor
Ohio State University