NCT03210701: APPROACH

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

Completed NA Results posted Last updated 19 May 2020

What this trial tests

NA trial testing A HIV POCT program adapted for & provided by community pharmacists in HIV Infections in 123 participants. Completed in 1 September 2017.

Timeline

14 February 2017

Primary endpoint
1 September 2017

1 September 2017

Quick facts

Lead sponsor	Memorial University of Newfoundland
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	screening
Enrollment	123
Start date	14 February 2017
Primary completion	1 September 2017
Estimated completion	1 September 2017
Sites	1 location across Canada

Drugs / interventions tested

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

Conditions studied

• HIV Infections — all drugs for HIV Infections →

Sponsor

Memorial University of Newfoundland

Who can join

18 and older, any sex, with HIV Infections. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Patients Requesting a Rapid HIV Test at a Community Pharmacy Study Site Primary · Collected at the end of the study period (6-8 months)

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

Group	Value	95% CI
Study Participants	123

Number of Reactive Test Results Primary · Collected at the end of the study period (6-8 months)

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

Group	Value	95% CI
Study Participants	1

Total Time Required for the HIV Testing Process Primary · 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

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.

Group	Value	95% CI
Study Participants	30.4	± 6.95

Participant Satisfaction With Testing Experience Primary · Completed immediately after each individual participants testing process was completed, approximately 10 minutes on average

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

Comfort with testing at pharmacy

Group	Value	95% CI
Study Participants	88.66	0 – 100

Confidence PhC did a good job administering test

Group	Value	95% CI
Study Participants	96.93	0 – 100

Likelihood to get tested for other STBBI

Group	Value	95% CI
Study Participants	83.14	0 – 100

Importance of privacy at pharmacy site

Group	Value	95% CI
Study Participants	89.42	0 – 100

Importance of finger prick blood sample

Group	Value	95% CI
Study Participants	80.35	0 – 100

Importance of immediate test results

Group	Value	95% CI
Study Participants	94.87	0 – 100

Importance of private room for testing and consult

Group	Value	95% CI
Study Participants	94.87	0 – 100

Importance of free testing

Group	Value	95% CI
Study Participants	88.78	0 – 100

Participants Self-identified HIV Risk Behaviours Primary · Immediately prior to testing process, participant completed the survey, approximately 5 - 10 minutes on average

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

Men who have sex with men

Group	Value	95% CI
Study Participants	56

History of IV drug use

Group	Value	95% CI
Study Participants	6

Previously exchanged sex for money or drugs

Group	Value	95% CI
Study Participants	8

Prior blood transfusion

Group	Value	95% CI
Study Participants	2

Denver HIV risk score >/= 30

Group	Value	95% CI
Study Participants	89

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Expanding access to HIV testing through Canadian community pharmacies: findings from the APPROACH study.
   Kelly DV, Kielly J, Hughes C, Gahagan J, et al · · 2020 · cited 26× · PMID 32380978 · DOI 10.1186/s12889-020-08719-0
2. Adaptation of POCT for pharmacies to reduce risk and optimize access to care in HIV, the APPROACH study protocol: examining acceptability and feasibility.
   Kielly J, Kelly DV, Hughes C, Day K, et al · · 2018 · cited 5× · PMID 30788134 · DOI 10.1186/s40814-018-0252-1