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APPROACH 2.0: HIV, HCV and Syphilis Testing Through Pharmacies

Primary Purpose

HIV Infections, HCV Infection, Syphilis Infection

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Choice of STBBI test(s)
Sponsored by
Memorial University of Newfoundland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for HIV Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Memorial University of NewfoundlandRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

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

Arm Description

Outcomes

Primary Outcome Measures

Number and proportion of new HIV infections found through pharmacy testing in each province
Number and proportion of new HCV infections found through pharmacy testing in each province
Number and proportion of new syphilis infections found through pharmacy testing in each province

Secondary Outcome Measures

Full Information

First Posted
September 6, 2022
Last Updated
October 17, 2023
Sponsor
Memorial University of Newfoundland
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1. Study Identification

Unique Protocol Identification Number
NCT05534633
Brief Title
APPROACH 2.0: HIV, HCV and Syphilis Testing Through Pharmacies
Official Title
APPROACH 2.0: HIV, HCV and Syphilis Testing Through Pharmacies
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Memorial University of Newfoundland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, HCV Infection, Syphilis Infection

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Participants requesting test(s) for HIV, HCV, and/or syphilis
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Choice of STBBI test(s)
Intervention Description
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 Outcome Measure Information:
Title
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)
Title
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)
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Debbie V Kelly
Phone
709-864-7805
Email
dvkelly@mun.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Amanda Butt
Phone
709-864-8732
Email
amandab@mun.ca
Facility Information:
Facility Name
Memorial University of Newfoundland
City
St. John's
State/Province
Newfoundland & Labrador
ZIP/Postal Code
A1A 0L1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Debbie V Kelly
Phone
709-864-7805
Email
dvkelly@mun.ca
First Name & Middle Initial & Last Name & Degree
Amanda Butt
Phone
709-864-8732
Email
amandab@mun.ca

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

APPROACH 2.0: HIV, HCV and Syphilis Testing Through Pharmacies

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