APPROACH 2.0: HIV, HCV and Syphilis Testing Through Pharmacies

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Genital Diseases HCV Infection Hepatitis Hepatitis C Hepatitis, Viral, Human Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Liver Diseases RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Syphilis Infection Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Memorial University of Newfoundland

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Ages 18 years and older, speaks English, has provincial health card number, and is able and willing to provide informed consent.

Exclusion criteria

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.

Treatment and study plan

Choice of STBBI test(s)

Other

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.

Primary outcomes

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)

Sponsors and collaborators

Lead sponsor

Memorial University of Newfoundland

Other

Registry information

Important dates

Study start: 2022
Primary completion: 2024
Study completion: 2025
First posted: Sep 9, 2022
Registry last updated: Dec 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed