Grant: Partnerships for Health System Improvement (PHSI)

Unity Health Toronto

$400,000.00

Optimizing the Delivery of HIV Postexposure Prophylaxis: A randomized controlled trial of text messaging support and physician/nurse role optimization

EF 2014-15

Résumé

Non-occupational HIV post-exposure prophylaxis (nPEP), in which uninfected persons use 28 days of antiretroviral drugs shortly after a sexual HIV exposure, is a standard of care intervention for preventing HIV. However, two key implementation challenges – poor patient retention in care and excessive reliance on infectious disease (ID) physicians – have limited its clinical and public health impact in Canada, where new infections still occur at unacceptable rates. We will address these two problems in a 2x2 factorial randomized controlled trial (RCT) evaluating two novel models of nPEP delivery, each of which could dramatically change how health systems in Canada and beyond roll out this existing, underutilized, effective intervention. Problem 1: Retention in care nPEP patients must complete a 4 month series of follow-up HIV tests and clinic assessments, as this is the only way to ensure the intervention worked. It also offers critical opportunities to link these high-risk patients to other forms of care. Yet only 50% of patients complete this follow-up,8 raising concerns about potential undiagnosed HIV and other sexually transmitted infections despite these patients’ initial willingness to access care.Our proposed solution is to adapt the ‘WelTel’ mobile phone-based text messaging system to improve retention of nPEP patients in care. WelTel is a low cost, semi-automated, interactive platform developed by team member RL and that has been proven to improve HIV health outcomes in prior RCTs. Our pilot data suggest high feasibility (97.1% of our nPEP patients own a smartphone) and acceptability (66.7% are willing to text). This intervention will be delivered by a community-based organization, maximizing relevance of our findings to readily available non-clinical personnel across the healthcare system. Problem 2: Reliance on ID physicians For historical reasons, nPEP is usually provided by hospital ID specialist physicians, resulting in high healthcare costs and limited access. Our proposed solution is to optimize the scope of practice of nurses and physicians by having sexual health clinic nurses provide nPEP follow-up, since they are experienced in sexual health and available in health units nationwide. We have pilot experience with nurse-led nPEP initiation at two sites in Ottawa, led by team member PO, and preliminary data suggests high feasibility and acceptability. This proposal builds on that success by expanding to Toronto and having nurses lead care over the entire 4 months of nPEP follow-up. This model could reduce healthcare costs and is readily reproducible across the healthcare system. Design We will evaluate these interventions in a multicenter 2x2 factorial RCT among 336 HIV-uninfected patients starting nPEP. The primary outcome is completion of a full course of nPEP medication and receipt of an HIV test result from the nPEP provider at 4 months. We hypothesize that a) text message support will improve the proportion of nPEP patients from 50% to 70%, and b) nurse-led nPEP follow-up will be non-inferior to that by ID physicians (non-inferiority margin 15%). Partners Over $100K in research infrastructure (randomization, DSMC, data management) will be provided by the CIHR Canadian HIV Trials Network (Partner 1), a nationwide partnership with >20 years’ RCT experience. $30K in senior staff time for coordinating KTE activities will be provided in-kind by the Ontario Ministry of Health & Long-Term Care (Partner 2).

Ministère

Canadian Institutes of Health Research

Programme

Partnerships for Health System Improvement (PHSI)

Bénéficiaire

Unity Health Toronto

Emplacement

Ontario, Canada

Type de bénéficiaire

Other

Type

Grant

Source

CIHR Funding Decisions Database

Tel que publié

317691

Name

Tan Darrell H

Region

Ontario

Country

Canada

Orgtype

Institution Paid; Research Institution

Partnername

CIHR Pan-Canadian Network for HIV and STBBI Clinical Trials Research (BC); Ontario Ministry of Health and Long Term Care

Instname2

Health Services and Policy Research

Theme2

Health systems / services

Prcname2

Partnerships for Health System Improvement

Projecttitle

Optimizing the Delivery of HIV Postexposure Prophylaxis: A randomized controlled trial of text messaging support and physician/nurse role optimization

Programtype2

Operating Grants

Orgnameinp2

Unity Health Toronto

Cihramount2

$400,000

Cihrequipment2

Programname2

Partnerships for Health System Improvement (PHSI)

Keyworddelim

Factorial; Healthcare Provider Role Optimization; Hiv Prevention; Post-Exposure Prophylaxis; Randomized Controlled Trial; Retention In Care; Task-Shifting; Text Messaging Support

Abstract

<html> <body>Non-occupational HIV post-exposure prophylaxis (nPEP), in which uninfected persons use 28 days of antiretroviral drugs shortly after a sexual HIV exposure, is a standard of care intervention for preventing HIV. However, two key implementation challenges – poor patient retention in care and excessive reliance on infectious disease (ID) physicians – have limited its clinical and public health impact in Canada, where new infections still occur at unacceptable rates. We will address these two problems in a 2x2 factorial randomized controlled trial (RCT) evaluating two novel models of nPEP delivery, each of which could dramatically change how health systems in Canada and beyond roll out this existing, underutilized, effective intervention. Problem 1: Retention in care nPEP patients must complete a 4 month series of follow-up HIV tests and clinic assessments, as this is the only way to ensure the intervention worked. It also offers critical opportunities to link these high-risk patients to other forms of care. Yet only 50% of patients complete this follow-up,8 raising concerns about potential undiagnosed HIV and other sexually transmitted infections despite these patients’ initial willingness to access care.Our proposed solution is to adapt the ‘WelTel’ mobile phone-based text messaging system to improve retention of nPEP patients in care. WelTel is a low cost, semi-automated, interactive platform developed by team member RL and that has been proven to improve HIV health outcomes in prior RCTs. Our pilot data suggest high feasibility (97.1% of our nPEP patients own a smartphone) and acceptability (66.7% are willing to text). This intervention will be delivered by a community-based organization, maximizing relevance of our findings to readily available non-clinical personnel across the healthcare system. Problem 2: Reliance on ID physicians For historical reasons, nPEP is usually provided by hospital ID specialist physicians, resulting in high healthcare costs and limited access. Our proposed solution is to optimize the scope of practice of nurses and physicians by having sexual health clinic nurses provide nPEP follow-up, since they are experienced in sexual health and available in health units nationwide. We have pilot experience with nurse-led nPEP initiation at two sites in Ottawa, led by team member PO, and preliminary data suggests high feasibility and acceptability. This proposal builds on that success by expanding to Toronto and having nurses lead care over the entire 4 months of nPEP follow-up. This model could reduce healthcare costs and is readily reproducible across the healthcare system. Design We will evaluate these interventions in a multicenter 2x2 factorial RCT among 336 HIV-uninfected patients starting nPEP. The primary outcome is completion of a full course of nPEP medication and receipt of an HIV test result from the nPEP provider at 4 months. We hypothesize that a) text message support will improve the proportion of nPEP patients from 50% to 70%, and b) nurse-led nPEP follow-up will be non-inferior to that by ID physicians (non-inferiority margin 15%). Partners Over $100K in research infrastructure (randomization, DSMC, data management) will be provided by the CIHR Canadian HIV Trials Network (Partner 1), a nationwide partnership with >20 years’ RCT experience. $30K in senior staff time for coordinating KTE activities will be provided in-kind by the Ontario Ministry of Health & Long-Term Care (Partner 2).</body> </html>

Competitiondate

201410

Approvedterm2

3 yrs 0 mth

Pinamesdelim

Bogoch, Isaac; Murray, James; Tan, Darrell H

Approvedterm

3 ans 0 mois

Cihrcontribution2

Knowledge Translation Branch~ $400,000~ $0~

Voir les données sources CIHR Funding Decisions Database (Canadian Institutes of Health Research)