A New APPROACH to HIV Testing: Adaptation of POCT for Pharmacies to Reduce Risk and Optimize Access to Care in HIV - A Type II Hybrid Implementation-Effectiveness Study
Phase: NA
Conditions: HIV Infections
Sponsor: Memorial University of Newfoundland

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Expanding access to HIV testing in Canadian community pharmacies: 
Findings from the APPROACH study 
 
 
 
Corresponding author: 
Dr. Deborah Kelly 
School of Pharmacy, Memorial University of Newfoundland 
75 Tiffany Court 
St. John’s, NL  A1A 0L1 
Trial Registration: Retrospectively registered with clinicaltrials.gov (NCT03210701) on July 6, 2017. 
Document Date: 2016/07/29 
 
 

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Methods 
The APPROACH study was funded by a grant from the Canadian Institute of Health Research. We used 
a type-2 hybrid implementation-effectiveness study design1 to develop and assess the feasibility and 
acceptability of a pharmacist-provided HIV POCT program in two Canadian provinces: Newfoundland 
and Labrador (NL) and Alberta (AB).  A mixed methods design incorporated self-report questionnaire 
data, telephone interviews of participants, pharmacist focus groups, analysis of workload logs, and 
situational analysis to assess the uptake, acceptability and feasibility of the HIV POCT program.  
Development of the HIV POCT program 
A full description of our study methods has been published.2 Advisory Committees were established in 
each province to provide input into the program design, linkages to care pathways, and promotional 
plans to invite the public to participate in the new HIV POCT program. Each Advisory Committee was 
comprised of key provincial stakeholders deemed critical to the success of the program, including 
pharmacists and managers, HIV-experienced health workers, public health, policy makers, and 
community representatives from organizations who work with individuals at risk of HIV, and 
individuals themselves with lived experience.  
One urban (population > 100, 000) and one rural (population < 100, 000) pharmacy in each province 
were selected to participate in the study. Three of the pharmacies were large chain pharmacies and 
were open seven days per week; two pharmacies were open during the evenings. One pharmacy was 
independently owned and operated with daytime hours Monday to Friday and limited weekend 
hours. The two pharmacies in urban settings were centrally located and provided opioid substitution 
therapy services. Testing was offered by appointment (all four sites) or as walk-in during advertised 

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testing hours (two sites). All pharmacies had a private room for counselling and performing POCT. At 
least one trained pharmacist tester was available at each participating pharmacy. 
Pharmacists completed a training program that consisted of an online self-study module, in-person 
training day, in-pharmacy competency assessment, and proficiency assessment. Details of the training 
program have been published.2 The training program covered the consent process, pre- and post-test 
counselling, how to administer the HIV POCT and interpret the test result. Pharmacists were provided 
with tools to aid in counselling, contact information for the linkages to care and client support 
services in their area. 
Study procedures and population 
Participants were not actively recruited by the pharmacists but rather the availability of HIV POCT 
through participating pharmacies was promoted through news media, social media, posters displayed 
throughout each community, as well as through active promotion by community partners and 
organizations who worked with at-risk individuals. Paid advertising through Grindr, a geosocial 
networking and online dating application geared toward gay, bi, trans, and queer people,3 was also 
used for a limited period during the study in NL. 
Adults aged 18 years or older were eligible to participate if they provided written informed consent, 
and had an active healthcare number (for linkage to care purposes). Participants who indicated they 
had been previously diagnosed with HIV infection or had a previous positive HIV test were not 
eligible.  
Potential participants could request HIV testing at one of the participating pharmacies during 
advertised testing hours or by appointment. Potential participants were taken to a private counselling 
room where they met with the pharmacist who screened participants for eligibility and completed the 

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testing process (Figure 1). The INSTI® HIV-1/HIV-2 rapid antibody test (BioLytical Laboratories, 
Richmond, BC, Canada) was administered free of charge using a finger-prick blood sample. Results 
were read within 60 seconds by the pharmacist and the participant was advised of their result. 
Participants received pre and post-test counselling based on national testing guidelines4, including 
advice regarding additional sexually transmitted and bloodborne infection (STBBI) testing. In the 
event of a reactive test result, the pharmacist provided the participant with a bloodwork requisition 
to obtain confirmatory HIV testing and additional supports and counselling were offered. 
Confirmatory test results were received by a designated health provider (physician or nurse 
practitioner) per the linkage to care plan in each province.  
Data collection 
Pharmacists recorded the date, participant study ID, test lot number, test result, and time to 
complete each test in a work log. Participants were asked to complete two de-identified (pre and post 
testing) questionnaires, which were blinded from the pharmacist. The first questionnaire included 
demographic data (age, gender, ethnicity, relationship status, highest education attained, and income 
level) as well as information about HIV risk factors and previous HIV testing history. The second 
questionnaire assessed perception of the testing experience including factors which influenced their 
decision to be tested at the pharmacy and whether they would have sought HIV testing elsewhere if 
not at the pharmacy. Satisfaction questions were aimed to differentiate influences of the pharmacy 
testing environment from the characteristics of the HIV POCT.  
Participants were also offered the choice of participating in a telephone interview with a research 
assistant (RA) at a later time to permit a more in-depth exploration of their testing experience and 
their motivation for choosing to be tested at the pharmacy. Clients who agreed were offered the 

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option to have their name entered into a draw for grocery gift certificates in appreciation for their 
time. Semi-structured interviews were conducted by two RAs, one in each province, to explore 
questions about their testing experience at the pharmacy including why they chose to get tested, 
what they liked and did not like about their testing experience, and willingness to pay for testing. 
To assess the pharmacists’ perceptions of the testing program, pharmacist testers attended a focus 
group with members of the research team in each province after the end of the study. Pharmacists 
were asked about how well the training and program resources supported them to offer the program, 
as well as questions aimed at understanding the impact of offering the testing program on their 
workload, the work environment/staff response, sense of professional role and satisfaction. 
Discussions also explored their fidelity to the testing process, what modifications to the program were 
made and why, and the implications for scalability and sustainability of the pharmacist testing 
program.  
Data analysis 
Participant characteristics, responses to satisfaction measures on the participant questionnaire, and 
pharmacist time to offer HIV POCT were analyzed using descriptive statistics. Pre-testing 
questionnaire data was used to calculate a Denver HIV Risk Score5,6 for each participant, as a means 
to predict their probability of having an undiagnosed HIV infection. Analysis of variance (ANOVA) was 
used to assess differences in participants’ Denver HIV Risk Scores between provinces, and urban 
versus rural testing sites, and multivariate analysis of variance (MANOVA) was used to assess 
differences in participant satisfaction with the testing experience based on province, urban/rural 
testing site, sex, and history of prior HIV testing. Fisher’s Exact tests were used to assess whether 
history of prior HIV testing depended on province or urban/rural centre for testing.  

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Qualitative data were analysed using a thematic analysis approach.7 Interview transcripts and 
extensive field notes were included for analysis from the participant interviews and pharmacist focus 
groups. Transcripts from participant interviews were coded using an open or emergent scheme where 
codes were developed and modified throughout the coding process. Descriptive codes were assigned 
to identify recurring concepts, and sub-themes were then identified and grouped into significant 
broader themes. Coding was performed independently by two RAs to improve inter-rater reliability. 
After completing coding individually, the RAs met several times to discuss the coding process and 
propose themes, with disagreements discussed in detail until consensus was reached. Emerging 
themes were grouped and triangulated with the members of the research team (DK, JK, CH) to 
determine final themes and important considerations emerging from the data. Themes from the 
pharmacist focus groups were considered according to the COM-B model8 to understand behaviour 
change, which considers opportunities and challenges in the context of professional capability, 
opportunity, and motivation to offer the HIV POCT program. 
Ethical considerations 
This study was approved by the human research ethics boards in each province. All participants and 
pharmacists signed study consent forms in keeping with the ethics protocol. Identifiable participant 
information was stored separately from trial data, and participants were encouraged to provide 
pseudonyms or false names if they wished for the purposes of being contacted by the RA for their 
telephone interviews. No identifying information was kept by the study team. 
 
 
 

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2 Kielly J, Kelly DV, Hughes C et al. Adaptation of POCT for pharmacies to reduce risk and optimize 
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3 Grindr. https://www.grindr.com/about/ (2019). Accessed 5 March 2019. 
 
4 Health Agency of Canada.  Human immunodeficiency virus HIV Screening and Testing Guide.  
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6 Haukoos JS, Hopkins E, Bender B et al. Comparison of enhanced targeted rapid HIV screening using 
the Denver HIV risk score to nontargeted rapid HIV screening in the emergency department. Ann 
Emerg Med 2013;61(3):353-361. 
 

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