跳至主要内容
临床试验/NCT06334341
NCT06334341Enrolling By Invitation不适用

A Multilevel, Multiphase Optimization Strategy for PrEP: Patients and Providers in Primary Care

Henry Ford Health System1 个研究点 分布在 1 个国家目标入组 1,380 人开始时间: 2024年6月19日最近更新:
适应症
干预措施

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

Experimental

Patient Risk Assessment only

干预措施: HIV Risk Assessment (Behavioral)

Risk Assessment and Video

Experimental

Patient Risk Assessment and Patient PrEP Video

干预措施: PrEP Informational Video (Behavioral)

Best Practice Alert, Risk Assessment and Video

Experimental

Best Practice Alert, Patient Risk Assessment, and Patient PrEP Video

干预措施: HIV Risk Assessment (Behavioral)

Training and Video

Experimental

Provider Training and Patient PrEP Video

干预措施: Computer-based simulation training for providers (Behavioral)

Training and Video

Experimental

Provider Training and Patient PrEP Video

干预措施: PrEP Informational Video (Behavioral)

Training, Best Practice Alert, Risk Assessment, and Video

Experimental

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

Experimental

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

Experimental

Provider Training and Best Practice Alert

干预措施: Best Practice Alert (Behavioral)

Training, Best Practice Alert, and Video

Experimental

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

Experimental

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

Experimental

Provider Training, Best Practice Alert, Patient Risk Assessment, and Patient PrEP Video

干预措施: PrEP Informational Video (Behavioral)

Training and Risk Assessment

Experimental

Provider Training and Patient Risk Assessment

干预措施: Computer-based simulation training for providers (Behavioral)

No intervention

No Intervention

No intervention

Video

Experimental

Patient PrEP Video only

干预措施: PrEP Informational Video (Behavioral)

Risk Assessment and Video

Experimental

Patient Risk Assessment and Patient PrEP Video

干预措施: HIV Risk Assessment (Behavioral)

Best Practice Alert

Experimental

Best Practice Alert only

干预措施: Best Practice Alert (Behavioral)

Best Practice Alert and Video

Experimental

Best Practice Alert and Patient PrEP Video

干预措施: Best Practice Alert (Behavioral)

Best Practice Alert and Risk Assessment

Experimental

Best Practice Alert and Patient Risk Assessment

干预措施: Best Practice Alert (Behavioral)

Best Practice Alert and Video

Experimental

Best Practice Alert and Patient PrEP Video

干预措施: PrEP Informational Video (Behavioral)

Best Practice Alert, Risk Assessment and Video

Experimental

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

Experimental

Best Practice Alert, Patient Risk Assessment, and Patient PrEP Video

干预措施: PrEP Informational Video (Behavioral)

Training

Experimental

Provider Training

干预措施: Computer-based simulation training for providers (Behavioral)

Training and Risk Assessment

Experimental

Provider Training and Patient Risk Assessment

干预措施: HIV Risk Assessment (Behavioral)

Training, Risk Assessment, and Video

Experimental

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

Experimental

Provider Training, Patient Risk Assessment, and Patient PrEP Video

干预措施: HIV Risk Assessment (Behavioral)

Training, Risk Assessment, and Video

Experimental

Provider Training, Patient Risk Assessment, and Patient PrEP Video

干预措施: PrEP Informational Video (Behavioral)

Training and Best Practice Alert

Experimental

Provider Training and Best Practice Alert

干预措施: Computer-based simulation training for providers (Behavioral)

Training, Best Practice Alert, and Video

Experimental

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

Experimental

Provider Training, Best Practice Alert, and Patient PrEP Video

干预措施: PrEP Informational Video (Behavioral)

Training, Best Practice Alert, and Risk Assessment

Experimental

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

Experimental

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

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elizabeth Lockhart

Principal Investigator

Henry Ford Health System

研究点 (1)

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