An interventional study of Choice of STBBI test(s) in HIV Infections, HCV Infection and Syphilis Infection, sponsored by Memorial University of Newfoundland. Active, not recruiting at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-02.
Sponsored by Memorial University of Newfoundland · Not applicable, Interventional, and Screening
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).
4,340 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 407 is above the median of 83 across 3,312 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →Memorial University of Newfoundland is the lead sponsor of 49 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Other: Choice of STBBI test(s)
Participants may receive a point of care HIV test, and/or point of care HCV test, and/or dry blood spot test, which can test for HIV, HCV, and syphilis, at the participants' choice.
Number and proportion of new HIV infections found through pharmacy testing in each province
Time frame: Collected at the end of the study period (approximately one year)
Number and proportion of new HCV infections found through pharmacy testing in each province
Time frame: Collected at the end of the study period (approximately one year)
Number and proportion of new syphilis infections found through pharmacy testing in each province
Time frame: Collected at the end of the study period (approximately one year)
Plan to share: No
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This study is active, not recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Memorial University of Newfoundland