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

NCT03210701 | Completed Results

• 1 other identifier: HREB-2016.178
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Keywords

pharmacy; pharmacist; POCT; Implementation science

Outcome Measures

Primary Outcomes (5)

• Patients Requesting a Rapid HIV Test at a Community Pharmacy Study Site

  Number of patients who presented to a community pharmacy test site and requested a rapid HIV test.

  Collected at the end of the study period (6-8 months)

• Number of Reactive Test Results

  Number of patients who requested a rapid HIV test at a community pharmacy and received a reactive test result

  Collected at the end of the study period (6-8 months)

• Total Time Required for the HIV Testing Process

  This was the time of the total patient pharmacist interaction, which began with the pharmacist explaining the study and ended with referring the patient for additional sexually transmitted blood borne infections (STBBI) counselling. The entire testing process included time spent explaining the study and consenting the participant, providing pre-test counselling, administering the test and explaining the result, post-test counselling, and referring the participant for additional STBBI testing as indicated.

  From time of participant consenting through to providing pre-test counseling, administering the test & explaining the result, post-test counseling, & referring the participant for additional STBBI testing as indicated, 30-40 minutes on average

• Participant Satisfaction With Testing Experience

  Once the testing was completed (see Outcome 3) prior to leaving, participants were asked to complete a de-identified, blinded questionnaire which assessed perception of the testing experience including factors that influenced their decision to be tested at the pharmacy \& whether they would have sought HIV testing elsewhere if not at the pharmacy. Information was captured using a percentage continuous response scale from 0 to 100%. Participants were instructed to answer the questions by marking an "x" on the line at the point which represented their experience. For example, in response to the question "How likely are you to buy a lottery ticket today?", the participant was instructed that if they were 50% certain, they would mark an "x" at the 50% notch on the line. Questions were positively worded, with higher scores indicating higher agreement. Not all patients answered all questions; reported data is based on the number of respondents for each question.

  Completed immediately after each individual participants testing process was completed, approximately 10 minutes on average

• Participants Self-identified HIV Risk Behaviours

  Prior to initiating the testing process participants were asked to complete a de-identified, blinded questionnaire that 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. Pre-testing questionnaire data on HIV risk factors was used to calculate a Denver HIV Risk Score (www.denverptc.org/resource.php?id=33) for each participant, as a means to predict their probability of having an undiagnosed HIV infection. Patients who score 30 points or greater on the Denver HIV Risk Score are considered at increased risk of undiagnosed HIV infection and should be offered routine screening. Not all patients answered all questions; numbers of respondents for each question is provided.

  Immediately prior to testing process, participant completed the survey, approximately 5 - 10 minutes on average

Study Arms (1)

Patients requesting a HIV screening test

OTHER

Other: A HIV POCT program adapted for & provided by community pharmacists

Interventions

A HIV POCT program adapted for & provided by community pharmacists 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.

Patients requesting a HIV screening test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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+.

You may not qualify if:

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

Sponsors & Collaborators

• Memorial University of Newfoundland: lead

Study Sites (1)

School of Pharmacy, Memorial University

St. John's, Newfoundland and Labrador, A1A 0L1, Canada

Location

Related Publications (2)

• 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.

  PMID: 32380978 DERIVED

• 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.

  PMID: 30788134 DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Dr. Debbie Kelly
• Organization: School of Pharmacy, Memorial University

dvkelly@mun.ca

709 864 7805

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor and Special Advisor of Innovation

Study Record Dates

• First Submitted: June 29, 2017
• First Posted: July 7, 2017
• Study Start: February 14, 2017
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: May 19, 2020
• Results First Posted: May 19, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)