Adaptation of POCT for pharmacies to reduce risk and optimize access to care in HIV, the APPROACH study protocol: examining acceptability and feasibility

Jason Kielly,Hai Nguyen,Kristine Day,Stephanie Hancock,Jacqueline Gahagan,Shabnam Asghari,Carlo Marra,Christine Hughes,Deborah V Kelly

doi:10.1186/s40814-018-0252-1

Abstract

BackgroundApproximately 1 in 5 Canadians with HIV are unaware of their status. In many provinces and especially rural communities, barriers to HIV testing include lack of access, privacy concerns, and stigma. The availability of HIV point-of-care testing (POCT) is limited across Canada. Pharmacists are well positioned to address barriers by offering rapid HIV POCT and facilitating linkage to care.MethodsWe will use a type-2 hybrid implementation-effectiveness design to assess a pilot HIV POCT model in one urban and one rural pharmacy in each of two Canadian provinces over 6 months. In this feasibility trial the research aims include developing and assisting pharmacies in implementing the model, evaluating processes/determinants of program implementation, evaluating the model’s effects on client outcomes, preferences, and testing satisfaction. Using a community-based research approach, the research team will engage community stakeholders in each province including individuals with lived experience to inform the development of the pharmacy-based HIV testing model and support the research team throughout the study. A multipronged promotion campaign will be used to promote the study and facilitate recruitment. The pharmacy-based testing model will include pre/post-test counseling and linkage to care plans in addition to pharmacist-administered HIV POCT. Pharmacists will complete a comprehensive training program prior to implementing the testing model. Client demographics and satisfaction will be assessed by surveys and interviews. Pharmacists will document time required for testing and participate in a post-study focus group to discuss barriers/enablers. Implementation will be assessed qualitatively and quantitatively. The process of developing and implementing the model will be described using qualitative data and a logic model. Acceptability and barriers/enablers will be examined qualitatively based on survey responses. A preliminary costing assessment will consider the client, pharmacy, and government perspectives.DiscussionThe results of this pilot will inform modifications to the HIV POCT model to optimize effectiveness and increase scalability. The study has national importance, providing valuable information on improving access to HIV testing. Future applications of this research may expand the role of pharmacists in offering POCT for other sexually transmitted/bloodborne infections as tests become available in Canada.Trial registrationClinicaltrials.gov, NCT03210701

Highlights

1 in 5 Canadians with human immunodeficiency virus (HIV) are unaware of their status
The APPROACH study will use a type-2 hybrid study design [17] to help address the following important questions: Can we identify characteristics of a pharmacy-based HIV point-of-care testing (POCT) program to (a) reach people at increased risk of HIV, especially those who have never been tested; (b) be broadly adopted across different settings; (c) be consistently implemented by different pharmacy staff members with moderate levels of training and expertise; (d) produce replicable and long-lasting effects; and (e) at a reasonable cost?
Team development and governance To ensure contextual factors are appropriately considered, the research team will be supported by provincial advisory committees (PAC)

Summary

Introduction

In many provinces and especially rural communities, barriers to HIV testing include lack of access, privacy concerns, and stigma. Low perceived risk of infection, inability/reluctance to access traditional healthcare services for testing, lack of testing outside of daytime business hours, delays for appointment times, and waiting for test results are significant barriers [6, 7]. Those at highest risk, including people who inject drugs, men who have sex with men, and sex workers are especially affected by accessibility barriers [8]. Innovative approaches that make testing more accessible and overcome barriers may help to identify infections earlier, facilitate transition into care, reduce spread of infection, and reach the UNAIDS “90-90-90” target by 2020, to end the HIV epidemic [9, 10]

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