rPlan Multimedia Dual Protection Intervention to Reduce Health Disparities
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Change in Frequency of Recent Condom Use (by Itself, With no Other Method)
研究概览
简要总结
The investigators will develop a digital application (app)-"rPlan dual protection" (rPlan)-to be used in the clinic waiting room prior to a gynecological and/or contraceptive visit. The goal of this research is to develop the app and conduct a feasibility, acceptability and effectiveness assessment of rPlan to examine improvement in dual protection behaviors, enhancement of contraceptive adherence and continuation, increase of condom use and decrease of sexually transmitted infection (STI) and human immunodeficiency virus(HIV) infection. The research will consist of baseline activities and a 12-week in-clinic survey and STI test, as well as a retrospective chart review.
详细描述
Using the investigators' experience in digital media, behavior theory, client-centered interventions, and family planning, the investigators will develop a digital application ("app")-rPlan-to be used in the clinic waiting room prior to a gynecological and/or contraceptive visit. The goal of this research is to develop the app and conduct a feasibility, acceptability and effectiveness assessment of rPlan.
This study will develop rPlan, a three-part intervention that includes a precounseling app that promotes dual protection, motivational interviewing-informed counseling, and concomitant printed educational materials.
The research will proceed in two phases. In Phase I, the investigators will assemble a 10-member stakeholder advisory team to enhance the PreCounselor app to focus on dual protection, train reproductive health counselors in motivational interviewing, and create concomitant printed educational materials. In Phase II, the feasibility, acceptability, and effectiveness of the intervention will be assessed. The specific aims are to:
Aim 1: Develop the rPlan intervention by (1) enhancing the pretested PreCounselor app to focus on dual protection, (2) training reproductive health counselors, and (3) creating concomitant printed educational materials.
Aim 2: Conduct a pre/post feasibility, acceptability, and effectiveness assessment of rPlan to examine improvement in dual protection behaviors, enhancement of contraceptive adherence and continuation, increase of condom use, and decrease of STI/HIV infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 24 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •African American (AA) female and sexually active with a male partner(s) within the past 6 months;
- •Age 15-24 years;
- •Initiating contraception;
- •English speaking
排除标准
- •Not currently pregnant or intending pregnancy within the next 6 months
- •Not currently using the implant or intrauterine device (IUD).
结局指标
主要结局
Change in Frequency of Recent Condom Use (by Itself, With no Other Method)
时间窗: Baseline, 3 months
Reported frequency of use of condoms alone (without another method) in past 3 months 5 option close-ended question, ranging from 1 - none of the time, to 5 - every time
Change in Frequency of Recent Dual Method Use
时间窗: Baseline, 3 months
Reported frequency of use of condoms with another contraceptive method in past 3 months 5 option close-ended question, ranging from 1 - none of the time, to 5 - every time
次要结局
- Change in Negative Condom Attitudes(Baseline, 3 months)
- Change in Contraceptive Effectiveness Knowledge(Baseline (pre-app use), 3 months)
- Current Main Method of Contraception(Baseline, 3 months)
- Change in Future Intentions to Use Condoms(Baseline (pre-app use), Immediately post-app use)
- Change in Self-efficacy for Condom Use(Baseline (pre-rPlan), 3 months)
- Change in Number of Recent Sexual Partners(Baseline, 3 months)
- Change in Consistency of Recent Contraceptive Use(Baseline, 3 months)
- Change in Future Intentions to Use IUD(Baseline (pre-app use), Immediately post-app use)
- Change in Future Intentions to Use Implant(Baseline (pre-app use), Immediately post-app use)
- Change in Self-efficacy for Contraceptive Use(Baseline, 3 months)
- Change in Negative Contraceptive Attitudes(Baseline (pre-rPlan), 3 months)
- Change in Endorsement of Positive Motivators for Contraceptive Use(Baseline (pre-rPlan), 3 months)
- Results of STI Test(Baseline, 3 months)
- Change in Endorsement of Positive Motivators for Condom Use(Baseline (pre-rPlan), 3 months)