A New APPROACH to HIV Testing: Adaptation of POCT for Pharmacies to Reduce Risk and Optimize Access to Care in HIV

NCT ID: NCT03210701

Last Updated: 2020-05-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 123 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-14
• Study Completion Date: 2017-09-01

Brief Summary

An estimated 21% of Canadians with HIV are unaware of their infection. There is a need to improve access to HIV testing to detect infections earlier so individuals can access care early and take steps to prevent transmission to others. Barriers to HIV testing include limited access or reluctance to go to traditional testing sites (doctor's offices and sexually transmitted infection clinics), and the lengthy wait time to receive test results from standard laboratory-based HIV testing (usually 1-2 weeks). These deterrents are particularly significant for those at highest risk of infection, who may be socially marginalized or stigmatized. In rural areas, HIV testing may only be available through doctor's offices and hospitals, yet many Canadians do not have access to a family physician. Pharmacists are among the most trusted and accessible healthcare providers, and are well positioned to improve access to HIV testing. Point of care tests for HIV are easy to administer and results are available within minutes, making them ideal for use in the community pharmacy setting. Point of care testing (POCT) by pharmacists can ensure individuals receive their test results, and facilitate timely linkages to care and treatment. This adaptation grant will look at factors influencing the acceptability and feasibility of pharmacist-provided rapid POCT for HIV in two Canadian provinces, including pharmacies in both urban and rural areas. The effectiveness of pharmacist-delivered POCT will be considered from a variety of perspectives including people living with or at risk of HIV, as well as pharmacists as the service providers.

Detailed Description

Background: There is a need to improve access to HIV testing to detect infections earlier so individuals can access care and prevent transmission. Barriers to testing include limited access or reluctance to go to traditional testing sites, and the lengthy wait time to receive results. Pharmacists are trusted, accessible health providers and are well positioned to offer HIV testing. Point of care tests (POCT) for HIV are easy to administer and results available within minutes, making them ideal for use in the pharmacy setting. HIV POCT may overcome barriers to standard testing for those at high risk and in healthcare resource-limited settings. Preliminary data suggest pharmacist-administered POCT can reach those who have never had an HIV test. Implementation and effectiveness of pharmacist-delivered POCT is the focus of this study. Study goals: To determine whether a multi-faceted HIV POCT program adapted for community pharmacies in two Canadian provinces is acceptable, feasible and effective in reaching those at high risk and those who have never been tested. Implementation and effectiveness of an integrated, contextualized model of HIV POCT in urban and rural pharmacies in Newfoundland (NL) and Alberta (AB) will be assessed. 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 Score for each participant, as a means to predict their probability of having an undiagnosed HIV infection. 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. Qualitative data were analysed using a thematic analysis approach. 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. Themes from the pharmacist focus groups were considered according to the Capability, Opportunity, Motivation, Behaviour (COM-B) model to understand behaviour change, which considers opportunities and challenges in the context of professional capability, opportunity, and motivation to offer the HIV POCT program. Impact: This study will inform further modifications to the pharmacy HIV POCT model to optimize effectiveness and increase scalability prior to full adoption and implementation. This will form the basis for a subsequent grant application. Knowledge gained can be used to scale up effective testing programs to increase the number of high risk individuals getting tested. The pharmacy is a novel venue to offer HIV testing, and if successful could be a widely accessible option applicable to other provinces and other countries. This study will provide proof of concept for pharmacy based POCT for other sexually transmitted and blood-borne infections (STBBI) (once tests become available) and successful implementation may also lead to pharmacist-delivered pre-exposure prophylaxis (PrEP) programs, to further reduce HIV infection rates.

Conditions

HIV Infections

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Patients requesting a HIV screening test

Group Type: OTHER

A HIV POCT program adapted for & provided by community pharmacists

Intervention Type: OTHER

Using a Type II hybrid Implementation-Effectiveness study design investigators will assess the implementation and effectiveness of a multi-faceted, integrated, contextualized model of HIV POCT in pharmacies in urban and rural settings in NL and AB, Canada. This design will be flexible, responsive and capable of capturing changing elements at multiple points in time. A mixed methods approach will be used to assess Implementation and Effectiveness aims.

Interventions

A HIV POCT program adapted for & provided by community pharmacists

Using a Type II hybrid Implementation-Effectiveness study design investigators will assess the implementation and effectiveness of a multi-faceted, integrated, contextualized model of HIV POCT in pharmacies in urban and rural settings in NL and AB, Canada. This design will be flexible, responsive and capable of capturing changing elements at multiple points in time. A mixed methods approach will be used to assess Implementation and Effectiveness aims.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Consistent with current testing guidelines and the National HIV POCT Action Plan HIV testing will be offered to anyone age 18+ who requests a test and is not known to be HIV+.

Exclusion Criteria

• Anyone unwilling to sign the consent form will be unable to participate in the study or receive HIV POCT.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Memorial University of Newfoundland

OTHER

Sponsor Role: lead

Responsible Party

Deborah Kelly

Associate Professor and Special Advisor of Innovation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

School of Pharmacy, Memorial University

St. John's, Newfoundland and Labrador, Canada

Countries

Canada

References

Kelly DV, Kielly J, Hughes C, Gahagan J, Asghari S, Hancock S, Burt K, Smyczek P, Charlton C, Nguyen H. Expanding access to HIV testing through Canadian community pharmacies: findings from the APPROACH study. BMC Public Health. 2020 May 7;20(1):639. doi: 10.1186/s12889-020-08719-0.

Reference Type: DERIVED

PMID: 32380978 (View on PubMed)

Kielly J, Kelly DV, Hughes C, Day K, Hancock S, Asghari S, Gahagan J, Marra C, Nguyen H. Adaptation of POCT for pharmacies to reduce risk and optimize access to care in HIV, the APPROACH study protocol: examining acceptability and feasibility. Pilot Feasibility Stud. 2018 Feb 27;4:59. doi: 10.1186/s40814-018-0252-1. eCollection 2018.

Reference Type: DERIVED

PMID: 30788134 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HREB-2016.178

Identifier Type: -

Identifier Source: org_study_id