APPROACH 2.0: HIV, HCV and Syphilis Testing Through Pharmacies

Sponsor

Memorial University of Newfoundland (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05534633

Collaborator

(none)

1,000

Enrollment

Location

Arm

Anticipated Duration (Months)

83.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
HIV Infections HCV Infection Syphilis Infection	Other: Choice of STBBI test(s)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1000 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

APPROACH 2.0: HIV, HCV and Syphilis Testing Through Pharmacies

Anticipated Study Start Date :

Dec 1, 2022

Anticipated Primary Completion Date :

Nov 30, 2023

Anticipated Study Completion Date :

Nov 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: Participants requesting test(s) for HIV, HCV, and/or syphilis	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.

Arm

Intervention/Treatment

Other: Participants requesting test(s) for HIV, HCV, and/or syphilis

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.

Outcome Measures

Primary Outcome Measures

Number and proportion of new HIV infections found through pharmacy testing in each province [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 [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 [Collected at the end of the study period (approximately one year)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memorial University of Newfoundland	St. John's	Newfoundland & Labrador	Canada	A1A 0L1

Sponsors and Collaborators

Memorial University of Newfoundland

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Deborah Kelly, Professor, Memorial University of Newfoundland

ClinicalTrials.gov Identifier:

NCT05534633

Other Study ID Numbers:

HREB-2022.060

First Posted:

Sep 9, 2022

Last Update Posted:

Sep 9, 2022

Last Verified:

Sep 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Infections

Communicable Diseases

Hepatitis C

Syphilis

Study Results

No Results Posted as of Sep 9, 2022