Clinic-based HIV Identification and Prevention Project Using Electronic Resources
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,170
- 试验地点
- 1
- 主要终点
- Number of PrEP prescriptions written for each patient
研究概览
简要总结
Hybrid Type II effectiveness-implementation trial to investigate whether electronic medical and sexual history data collection with HIV risk categorization/scoring will increase pre-exposure prophylaxis (PrEP) uptake among cis-gender women attending routine well-woman gynecologic preventative visits.
详细描述
Forty-two Obgyn providers will be randomized into 1 of three arms. Patients of enrolled providers who attend an ObGyn clinic for any preventative visit will complete an electronic history form (eHxForm) before clinic through a message sent through the patient portal (MyChart), email, or secure text messaging. The sexual history questions will be scored and categorized into 3 categories. Patients with a low score (0-3) will receive an electronic message offering a laboratory HIV test per USPSTF guidelines. If she accepts, then an automated Epic order will be placed for the provider to sign during the office visit.
Patients with a medium/high score (4-10) will be assigned a study arm based on their provider's group (arm 1: control, arm 2: patient will view score and a PrEP video, arm 3: procedures in arm 2 PLUS providers will receive an electronic health record alert that the patient may have HIV risk factors. This will occur automatically via programming integrated into the electronic health record. The primary outcome is PrEP uptake. The implementation strategy will be evaluated using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients of enrolled providers aged 15-65 years
- •Presenting for preventive care (i.e., well-woman exam, sexually transmitted infection testing, pre-conception counseling, or birth control).
排除标准
- •Pregnant and has established prenatal care, i.e., visit is for prenatal care
- •Non-English or non-Spanish speaking
- •Living with HIV
- •Unable to complete the eHxForm
研究组 & 干预措施
Standard of Care
Participants in this arm will receive standard of care
干预措施: Control (Behavioral)
Patient Level + Multilevel
Participants in the arm will receive the patient level and multi-level intervention
干预措施: Patient Level (Behavioral)
Patient Level + Multilevel
Participants in the arm will receive the patient level and multi-level intervention
干预措施: Multilevel (Behavioral)
Multilevel
Participants in this arm will receive the multi-level intervention
干预措施: Multilevel (Behavioral)
结局指标
主要结局
Number of PrEP prescriptions written for each patient
时间窗: 4 weeks
Number of PrEP prescriptions written for each patient up to 4 weeks after office visit.
次要结局
- Cost-Effectiveness Analysis (Incremental cost-effectiveness ratios)(Approximately 5 years)
- Cost-Effectiveness Analysis (Return on Investment)(Approximately 5 years)
- Cost-Effectiveness Analysis (Total Budget)(Approximately 5 years)
- Proportion of patients who complete the Electronic History Form (eHxForm)(6 months)