407 Participants Needed

Pharmacy-Based STBBI Testing for HIV, Hepatitis C, and Syphilis

DV
AB
Overseen ByAmanda Butt
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Memorial University of Newfoundland
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

Human Immunodeficiency Virus (HIV), hepatitis C (HCV), and syphilis are sexually transmitted and blood borne infections (STBBI) that affect millions of people worldwide and rates are rising in Canada. HCV and syphilis are curable, and HIV is treatable with virtually no risk of transmission to sexual partners when the infection is controlled, however, these outcomes require adequate testing. Unfortunately, an estimated 44% of Canadians living with HCV and 13% living with HIV are not diagnosed. These undiagnosed cases are the source of over half of new HIV infections. Furthermore, HIV-syphilis coinfection is common. Accessible testing forms a key pillar of an elimination strategy and acts as an access point for linking people to care. Community pharmacies are more accessible site for STBBI testing, compared to hospitals and doctors' offices. This is especially true for members of marginalized communities, some of whom are at higher risk of infection. The COVID-19 pandemic highlighted the need for low-barrier STBBI testing, as in-person healthcare services at doctors' offices and traditional screening clinics were scaled back. Pharmacies remained open throughout the pandemic.The APPROACH 2.0 study will assess the impact of a pharmacy-based testing program for HIV, hepatitis C, and syphilis in participating pharmacies in three Canadian provinces: Newfoundland \& Labrador, Alberta, and Nova Scotia on finding new diagnoses and linkages with care. Participants will be offered point of care tests for HIV and/or HCV and/or a dry blood spot test which will test for HIV, HCV, and syphilis. These tests are easy to administer. Results from the point of care tests are available immediately during the pharmacy visit while participants will be contacted with dried blood spot test results when available (approximately 2 weeks). Participants with reactive tests are linked with confirmatory testing and care, and those with non-reactive results are offered preventative services including HIV PrEP (as indicated) and counselling.This study builds on a pilot study completed in 2017 (www.APPROACHstudy.ca).

Eligibility Criteria

The APPROACH 2.0 study is for English-speaking adults (18+) in Canada with a provincial health card who can consent to participate. It's not for those already diagnosed with HIV or HCV, but they may still get certain tests.

Inclusion Criteria

Is able and willing to provide informed consent
Speaks English
Has provincial health card number

Exclusion Criteria

Participants who have been previously diagnosed with HIV infection will not be eligible for HIV testing (point of care test or dry blood spot test)
Unwilling or unable to provide informed consent
I have been diagnosed with hepatitis C before.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Testing

Participants are offered point of care tests for HIV, HCV, and syphilis at participating pharmacies. Results from point of care tests are available immediately, while dried blood spot test results are available in approximately 2 weeks.

2 weeks
1 visit (in-person)

Follow-up

Participants with reactive tests are linked with confirmatory testing and care, and those with non-reactive results are offered preventative services including HIV PrEP and counselling.

4 weeks

Treatment Details

Interventions

  • Choice of STBBI test(s)
Trial Overview This trial offers pharmacy-based testing for HIV, hepatitis C, and syphilis using point of care tests or dry blood spot tests. The goal is to see if this approach helps find new cases and connect people to care.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Participants requesting test(s) for HIV, HCV, and/or syphilisExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Memorial University of Newfoundland

Lead Sponsor

Trials
73
Recruited
1,836,000+
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