A Multilevel, Multiphase Optimization Strategy for PrEP: Patients and Providers in Primary Care
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 1,380
- 试验地点
- 1
- 主要终点
- Clinic-Level PrEP Prescription
研究概览
简要总结
What is known: There are 1.2 million people in the US who meet the indications for PrEP; yet, disparities exist in uptake. For example, only 9% of Black and 16% of Latino individuals, compared to 65% of White individuals, have been prescribed PrEP. At Henry Ford Health (HFH) system, only 10% of eligible patients have been prescribed PrEP. Primary care is an ideal setting for PrEP to be offered as an HIV prevention method since providers see large numbers of patients who are HIV negative, with some who are at increased risk for HIV, and the primary care setting is often the point of entry to the healthcare system. The multiphase optimization strategy (MOST) framework is a novel, innovative way to identify an efficient intervention. What will be done: In this optimization trial, the investigators will test the effectiveness of intervention components, alone and in combination, on new PrEP prescriptions in primary care at HFH. First, feedback will be generated on context-specific (system and individual level) factors for intervention component delivery via focus groups with providers (n=15) and patients eligible for PrEP (n=30). Then, four intervention components will be tested in an optimization trial, with 16 conditions being implemented at 32 clinics. Finally, feedback will be generated on the factors that affected implementation via semi-structured interviews with providers (n=30) and patients (n=30). Participants will be primary care providers (PCPs) and patients eligible for PrEP in Henry Ford Health System. Clinics will be randomized (yes/no) to receive any combination of provider and patient intervention components. Provider intervention components include computer-based simulation training and/or best practice alerts delivered via the electronic health record (EHR). Patient intervention components include HIV risk assessment and/or PrEP informational video - both delivered via the EHR. Primary outcome is the rate of new PrEP prescriptions at the clinic level. Secondary outcomes will include PrEP maintenance, number of HIV tests ordered by a PCP, and number of PCPs trained. Sub analyses will test which factors moderate (e.g., patient sex, race, age, gender, sexual orientation) or mediate (e.g., perceived HIV risk, provider and patient PrEP knowledge) PrEP uptake, focusing on priority populations and disparities in rates of PrEP prescription. Implications: 1) Understanding which intervention components lead to increased PrEP prescriptions will represent an important advance in HIV prevention efforts. 2) Optimizing a multi-level intervention for providers and patients to increase PrEP prescriptions would lead to a new, efficient, evidence-based option. 3) Determining what factors are related to PrEP uptake will help reduce disparities in PrEP initiation among those most in need. 4) Understanding the context specific factors related to intervention component implementation will help identify best methods for replication/adaptation in other healthcare systems.
详细描述
Inclusion criteria for provider participants are: 1) ≥ 18-years old; 2) employed at HFH in primary care, family medicine, or internal medicine; 3) eligible to write prescriptions in the state of MI.
Inclusion criteria for patient participants are: 1) ≥ 18 years old; 2) have an appointment with a Henry Ford primary care clinic during the study period; 3) have an electronic health record (EHR) account; 4) eligible for PrEP prescription.
Exclusion criteria for providers are: 1) not a HFH primary care provider; 2) does not have prescribing privileges in the state of Michigan.
Exclusion criteria for patient participants include: 1) currently prescribed or taking PrEP; 2) living with HIV.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provider:≥ 18-years old
- •Provider: employed at HFH as a primary care provider
- •Provider: eligible to write prescriptions in the state of Michigan
- •Patient: ≥ 18 years old
- •Patient: have an appointment with a Henry Ford primary care clinic during the study period
- •Patient: have an EHR account
- •Patient: meet the indications for PrEP
排除标准
- •Provider: not a HFH primary care provider
- •Provider: does not have prescribing privileges in the state of Michigan
- •Patient: currently prescribed or taking PrEP
- •Patient: living with HIV
研究组 & 干预措施
Risk Assessment
Patient Risk Assessment only
干预措施: HIV Risk Assessment (Behavioral)
Risk Assessment and Video
Patient Risk Assessment and Patient PrEP Video
干预措施: PrEP Informational Video (Behavioral)
Best Practice Alert, Risk Assessment and Video
Best Practice Alert, Patient Risk Assessment, and Patient PrEP Video
干预措施: HIV Risk Assessment (Behavioral)
Training and Video
Provider Training and Patient PrEP Video
干预措施: Computer-based simulation training for providers (Behavioral)
Training and Video
Provider Training and Patient PrEP Video
干预措施: PrEP Informational Video (Behavioral)
Training, Best Practice Alert, Risk Assessment, and Video
Provider Training, Best Practice Alert, Patient Risk Assessment, and Patient PrEP Video
干预措施: Best Practice Alert (Behavioral)
Training, Best Practice Alert, and Risk Assessment
Provider Training, Best Practice Alert, and Patient Risk Assessment
干预措施: Computer-based simulation training for providers (Behavioral)
Training and Best Practice Alert
Provider Training and Best Practice Alert
干预措施: Best Practice Alert (Behavioral)
Training, Best Practice Alert, and Video
Provider Training, Best Practice Alert, and Patient PrEP Video
干预措施: Best Practice Alert (Behavioral)
Training, Best Practice Alert, Risk Assessment, and Video
Provider Training, Best Practice Alert, Patient Risk Assessment, and Patient PrEP Video
干预措施: HIV Risk Assessment (Behavioral)
Training, Best Practice Alert, Risk Assessment, and Video
Provider Training, Best Practice Alert, Patient Risk Assessment, and Patient PrEP Video
干预措施: PrEP Informational Video (Behavioral)
Training and Risk Assessment
Provider Training and Patient Risk Assessment
干预措施: Computer-based simulation training for providers (Behavioral)
No intervention
No intervention
Video
Patient PrEP Video only
干预措施: PrEP Informational Video (Behavioral)
Risk Assessment and Video
Patient Risk Assessment and Patient PrEP Video
干预措施: HIV Risk Assessment (Behavioral)
Best Practice Alert
Best Practice Alert only
干预措施: Best Practice Alert (Behavioral)
Best Practice Alert and Video
Best Practice Alert and Patient PrEP Video
干预措施: Best Practice Alert (Behavioral)
Best Practice Alert and Risk Assessment
Best Practice Alert and Patient Risk Assessment
干预措施: Best Practice Alert (Behavioral)
Best Practice Alert and Video
Best Practice Alert and Patient PrEP Video
干预措施: PrEP Informational Video (Behavioral)
Best Practice Alert, Risk Assessment and Video
Best Practice Alert, Patient Risk Assessment, and Patient PrEP Video
干预措施: Best Practice Alert (Behavioral)
Best Practice Alert, Risk Assessment and Video
Best Practice Alert, Patient Risk Assessment, and Patient PrEP Video
干预措施: PrEP Informational Video (Behavioral)
Training
Provider Training
干预措施: Computer-based simulation training for providers (Behavioral)
Training and Risk Assessment
Provider Training and Patient Risk Assessment
干预措施: HIV Risk Assessment (Behavioral)
Training, Risk Assessment, and Video
Provider Training, Patient Risk Assessment, and Patient PrEP Video
干预措施: Computer-based simulation training for providers (Behavioral)
Training, Risk Assessment, and Video
Provider Training, Patient Risk Assessment, and Patient PrEP Video
干预措施: HIV Risk Assessment (Behavioral)
Training, Risk Assessment, and Video
Provider Training, Patient Risk Assessment, and Patient PrEP Video
干预措施: PrEP Informational Video (Behavioral)
Training and Best Practice Alert
Provider Training and Best Practice Alert
干预措施: Computer-based simulation training for providers (Behavioral)
Training, Best Practice Alert, and Video
Provider Training, Best Practice Alert, and Patient PrEP Video
干预措施: Computer-based simulation training for providers (Behavioral)
Training, Best Practice Alert, and Video
Provider Training, Best Practice Alert, and Patient PrEP Video
干预措施: PrEP Informational Video (Behavioral)
Training, Best Practice Alert, and Risk Assessment
Provider Training, Best Practice Alert, and Patient Risk Assessment
干预措施: HIV Risk Assessment (Behavioral)
Training, Best Practice Alert, Risk Assessment, and Video
Provider Training, Best Practice Alert, Patient Risk Assessment, and Patient PrEP Video
干预措施: Computer-based simulation training for providers (Behavioral)
Training, Best Practice Alert, and Risk Assessment
Provider Training, Best Practice Alert, and Patient Risk Assessment
干预措施: Best Practice Alert (Behavioral)
结局指标
主要结局
Clinic-Level PrEP Prescription
时间窗: Year 1 and Year 5 electronic health record data pull.
The number of new PrEP prescriptions written within 6-months of the study-associated patient appointment. It is defined as a new documented prescription in the patient electronic health records for PrEP (daily pill or injection) at any date between the initial study primary care appointment plus 180 days.
次要结局
- PrEP awareness(Provider pre-post survey and patient demographic and 6- month surveys)
- PrEP prescribing comfort(Pre-intervention and immediately after the intervention for providers)
- PrEP prescribing intentions(Pre-intervention and immediately after the intervention for providers)
- PrEP Knowledge(Provider pre-post survey and patient demographic and 6- month surveys)
研究者
Elizabeth Lockhart
Principal Investigator
Henry Ford Health System
