NCT05534633Active, not recruiting
APPROACH 2.0: HIV, HCV and Syphilis Testing Through Pharmacies
Source: ClinicalTrials.gov · Last updated 2 Dec 2024
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 407 (actual)
- First submitted
- 6 Sept 2022
- Start date
- 1 Dec 2022
- Primary completion date
- 31 Mar 2024
- Lead sponsor
- Memorial University of Newfoundland
- Diseases
- HIV
- NCT number
- NCT05534633
What you commit to
- Study type: Interventional
- Participants enrolled: 407
- From 1 Dec 2022 to the primary completion date, 31 Mar 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Unwilling or unable to provide informed consent. 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). Participants who have previously been diagnosed with HCV are not eligible for HCV point of care test, but may request a dry blood spot test.
Who the study is looking for
- Ages 18 years and older, speaks English, has provincial health card number, and is able and willing to provide informed consent.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Memorial University of Newfoundland Coordinator of this site? Confirm its status | St. John's | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.