Többszintű, többfázisú optimalizálási stratégia a PrEP-hez (MOST:PrEP) (MOST:PrEP)
Többszintű, többfázisú optimalizálási stratégia a PrEP számára: Betegek és szolgáltatók az alapellátásban
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.
A tanulmány áttekintése
Állapot
Körülmények
Részletes leírás
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.
Tanulmány típusa
Beiratkozás (Becsült)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi helyek
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Michigan
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Detroit, Michigan, Egyesült Államok, 48202
- Henry Ford Health
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Megelőzés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Tényező hozzárendelés
- Maszkolás: Kettős
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
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Nincs beavatkozás: No intervention
No intervention |
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Kísérleti: Video
Patient PrEP Video only |
A short informational video, tailored to the local Detroit context with themes that will focus on introducing PrEP, stigma surrounding taking PrEP, and potential barriers and how to overcome them. |
|
Kísérleti: Risk Assessment
Patient Risk Assessment only |
A risk assessment tool that considers the behaviors - i.e., types of sexual activities, protective behaviors (condoms, PrEP, ART), and other factors (HIV status, sexually transmitted infections) of the respondent. |
|
Kísérleti: Risk Assessment and Video
Patient Risk Assessment and Patient PrEP Video |
A short informational video, tailored to the local Detroit context with themes that will focus on introducing PrEP, stigma surrounding taking PrEP, and potential barriers and how to overcome them. A risk assessment tool that considers the behaviors - i.e., types of sexual activities, protective behaviors (condoms, PrEP, ART), and other factors (HIV status, sexually transmitted infections) of the respondent. |
|
Kísérleti: Best Practice Alert
Best Practice Alert only |
A Best Practice Alert will alert providers to patients who are part of the Centers for Disease Control and Prevention PrEP priority populations. |
|
Kísérleti: Best Practice Alert and Video
Best Practice Alert and Patient PrEP Video |
A short informational video, tailored to the local Detroit context with themes that will focus on introducing PrEP, stigma surrounding taking PrEP, and potential barriers and how to overcome them. A Best Practice Alert will alert providers to patients who are part of the Centers for Disease Control and Prevention PrEP priority populations. |
|
Kísérleti: Best Practice Alert and Risk Assessment
Best Practice Alert and Patient Risk Assessment |
A Best Practice Alert will alert providers to patients who are part of the Centers for Disease Control and Prevention PrEP priority populations. |
|
Kísérleti: Best Practice Alert, Risk Assessment and Video
Best Practice Alert, Patient Risk Assessment, and Patient PrEP Video |
A short informational video, tailored to the local Detroit context with themes that will focus on introducing PrEP, stigma surrounding taking PrEP, and potential barriers and how to overcome them. A risk assessment tool that considers the behaviors - i.e., types of sexual activities, protective behaviors (condoms, PrEP, ART), and other factors (HIV status, sexually transmitted infections) of the respondent. A Best Practice Alert will alert providers to patients who are part of the Centers for Disease Control and Prevention PrEP priority populations. |
|
Kísérleti: Training
Provider Training |
A Computer-Based Simulation training for providers, based on the Centers for Disease Control and Prevention "Guide for Healthcare Professional: Discussing Sexual Health with Your Patients", current PrEP information, and the Social Cognitive Theory. This is a single-session, 30-minute training module contains educational information with animated narration about PrEP, how to take a sexual health history, understanding internal bias, potential patient barriers to PrEP as well as recorded video-simulated encounters, in which providers view different types of patient/provider interactions. |
|
Kísérleti: Training and Video
Provider Training and Patient PrEP Video |
A short informational video, tailored to the local Detroit context with themes that will focus on introducing PrEP, stigma surrounding taking PrEP, and potential barriers and how to overcome them. A Computer-Based Simulation training for providers, based on the Centers for Disease Control and Prevention "Guide for Healthcare Professional: Discussing Sexual Health with Your Patients", current PrEP information, and the Social Cognitive Theory. This is a single-session, 30-minute training module contains educational information with animated narration about PrEP, how to take a sexual health history, understanding internal bias, potential patient barriers to PrEP as well as recorded video-simulated encounters, in which providers view different types of patient/provider interactions. |
|
Kísérleti: Training and Risk Assessment
Provider Training and Patient Risk Assessment |
A risk assessment tool that considers the behaviors - i.e., types of sexual activities, protective behaviors (condoms, PrEP, ART), and other factors (HIV status, sexually transmitted infections) of the respondent. A Computer-Based Simulation training for providers, based on the Centers for Disease Control and Prevention "Guide for Healthcare Professional: Discussing Sexual Health with Your Patients", current PrEP information, and the Social Cognitive Theory. This is a single-session, 30-minute training module contains educational information with animated narration about PrEP, how to take a sexual health history, understanding internal bias, potential patient barriers to PrEP as well as recorded video-simulated encounters, in which providers view different types of patient/provider interactions. |
|
Kísérleti: Training, Risk Assessment, and Video
Provider Training, Patient Risk Assessment, and Patient PrEP Video |
A short informational video, tailored to the local Detroit context with themes that will focus on introducing PrEP, stigma surrounding taking PrEP, and potential barriers and how to overcome them. A risk assessment tool that considers the behaviors - i.e., types of sexual activities, protective behaviors (condoms, PrEP, ART), and other factors (HIV status, sexually transmitted infections) of the respondent. A Computer-Based Simulation training for providers, based on the Centers for Disease Control and Prevention "Guide for Healthcare Professional: Discussing Sexual Health with Your Patients", current PrEP information, and the Social Cognitive Theory. This is a single-session, 30-minute training module contains educational information with animated narration about PrEP, how to take a sexual health history, understanding internal bias, potential patient barriers to PrEP as well as recorded video-simulated encounters, in which providers view different types of patient/provider interactions. |
|
Kísérleti: Training and Best Practice Alert
Provider Training and Best Practice Alert |
A Best Practice Alert will alert providers to patients who are part of the Centers for Disease Control and Prevention PrEP priority populations. A Computer-Based Simulation training for providers, based on the Centers for Disease Control and Prevention "Guide for Healthcare Professional: Discussing Sexual Health with Your Patients", current PrEP information, and the Social Cognitive Theory. This is a single-session, 30-minute training module contains educational information with animated narration about PrEP, how to take a sexual health history, understanding internal bias, potential patient barriers to PrEP as well as recorded video-simulated encounters, in which providers view different types of patient/provider interactions. |
|
Kísérleti: Training, Best Practice Alert, and Video
Provider Training, Best Practice Alert, and Patient PrEP Video |
A short informational video, tailored to the local Detroit context with themes that will focus on introducing PrEP, stigma surrounding taking PrEP, and potential barriers and how to overcome them. A Best Practice Alert will alert providers to patients who are part of the Centers for Disease Control and Prevention PrEP priority populations. A Computer-Based Simulation training for providers, based on the Centers for Disease Control and Prevention "Guide for Healthcare Professional: Discussing Sexual Health with Your Patients", current PrEP information, and the Social Cognitive Theory. This is a single-session, 30-minute training module contains educational information with animated narration about PrEP, how to take a sexual health history, understanding internal bias, potential patient barriers to PrEP as well as recorded video-simulated encounters, in which providers view different types of patient/provider interactions. |
|
Kísérleti: Training, Best Practice Alert, and Risk Assessment
Provider Training, Best Practice Alert, and Patient Risk Assessment |
A risk assessment tool that considers the behaviors - i.e., types of sexual activities, protective behaviors (condoms, PrEP, ART), and other factors (HIV status, sexually transmitted infections) of the respondent. A Best Practice Alert will alert providers to patients who are part of the Centers for Disease Control and Prevention PrEP priority populations. A Computer-Based Simulation training for providers, based on the Centers for Disease Control and Prevention "Guide for Healthcare Professional: Discussing Sexual Health with Your Patients", current PrEP information, and the Social Cognitive Theory. This is a single-session, 30-minute training module contains educational information with animated narration about PrEP, how to take a sexual health history, understanding internal bias, potential patient barriers to PrEP as well as recorded video-simulated encounters, in which providers view different types of patient/provider interactions. |
|
Kísérleti: Training, Best Practice Alert, Risk Assessment, and Video
Provider Training, Best Practice Alert, Patient Risk Assessment, and Patient PrEP Video |
A short informational video, tailored to the local Detroit context with themes that will focus on introducing PrEP, stigma surrounding taking PrEP, and potential barriers and how to overcome them. A risk assessment tool that considers the behaviors - i.e., types of sexual activities, protective behaviors (condoms, PrEP, ART), and other factors (HIV status, sexually transmitted infections) of the respondent. A Best Practice Alert will alert providers to patients who are part of the Centers for Disease Control and Prevention PrEP priority populations. A Computer-Based Simulation training for providers, based on the Centers for Disease Control and Prevention "Guide for Healthcare Professional: Discussing Sexual Health with Your Patients", current PrEP information, and the Social Cognitive Theory. This is a single-session, 30-minute training module contains educational information with animated narration about PrEP, how to take a sexual health history, understanding internal bias, potential patient barriers to PrEP as well as recorded video-simulated encounters, in which providers view different types of patient/provider interactions. |
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Clinic-Level PrEP Prescription
Időkeret: Year 1 and Year 5 electronic health record data pull.
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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. |
Year 1 and Year 5 electronic health record data pull.
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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PrEP Knowledge
Időkeret: Provider pre-post survey and patient demographic and 6- month surveys
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PrEP knowledge will be measured by 6-items assessing PrEP dosing frequency, approved FDA medications, HIV antibody testing prior to PrEP initiation, HIV testing frequency while on PrEP, contraindications to prescribing PrEP, and routine standard of care practices for patients taking PrEP |
Provider pre-post survey and patient demographic and 6- month surveys
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PrEP awareness
Időkeret: Provider pre-post survey and patient demographic and 6- month surveys
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PrEP awareness will be measured by the statement "there is a pill (drug/medication) that a person can take to prevent transmission of HIV from an infected (HIV positive) sex partner to an uninfected (HIV negative) partner." with responses true/false, don't know. |
Provider pre-post survey and patient demographic and 6- month surveys
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PrEP prescribing comfort
Időkeret: Pre-intervention and immediately after the intervention for providers
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PrEP prescribing comfort will be measured by 9- items from the PrEP Information, Motivation, and Behaviors survey. |
Pre-intervention and immediately after the intervention for providers
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PrEP prescribing intentions
Időkeret: Pre-intervention and immediately after the intervention for providers
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PrEP prescribing intentions will be measured by 8- items from the PrEP Information, Motivation, and Behaviors survey. |
Pre-intervention and immediately after the intervention for providers
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Együttműködők és nyomozók
Szponzor
Nyomozók
- Kutatásvezető: Elizabeth Lockhart, PhD, Henry Ford Health
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
- Vérrel terjedő fertőzések
- Urogenitális betegségek
- Nemi szervek betegségei
- Immunrendszeri betegségek
- Fertőzések
- RNS vírusfertőzések
- Vírusos betegségek
- Fertőző betegségek
- Szexuális úton terjedő betegségek, vírusos
- Szexuális úton terjedő betegségek
- Lentivírus fertőzések
- Retroviridae fertőzések
- Immunhiányos szindrómák
- HIV fertőzések
- HIV szeropozitivitás
Egyéb vizsgálati azonosító számok
- R01MD018523-01A1 (Az Egyesült Államok NIH támogatása/szerződése)
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