Pharmacy-Based STBBI Testing for HIV, Hepatitis C, and Syphilis

Overseen By Amanda Butt

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Memorial University of Newfoundland

Disqualifiers: HIV, HCV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of pharmacy-based testing for detecting HIV, hepatitis C, and syphilis. These infections are common and often undiagnosed, so the trial seeks to determine if offering tests at pharmacies can identify more cases and connect individuals to care. Participants receive quick test results, and those with positive results receive guidance for further testing and treatment. The trial seeks individuals living in Newfoundland & Labrador, Alberta, and Nova Scotia who have not been previously diagnosed with these infections. It suits those who can easily visit a pharmacy for testing and have not yet been diagnosed with HIV or hepatitis C. As an unphased trial, this study offers a unique opportunity to enhance public health by improving access to testing and care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on testing for infections, so it's unlikely that you would need to change your medication routine.

What prior data suggests that this pharmacy-based testing program is safe?

Research has shown that testing for HIV, hepatitis C, and syphilis at pharmacies is safe and well-received. Studies have found that self-testing for these infections is not only safe but also makes testing more accessible.

Pharmacists and pharmacy technicians conduct these tests, and past research indicates they can do so safely. No major reports of problems with these pharmacy-based tests have emerged. The tests are simple to use and provide quick results, making them a convenient choice for many.

Overall, evidence supports that testing at pharmacies is a safe way for people to learn their health status and connect to care if needed. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new and convenient way for people to get tested for HIV, Hepatitis C, and syphilis directly at their local pharmacies. Unlike traditional testing methods that usually require a visit to a clinic or a doctor's office, this approach offers easy access and potentially faster results, making it more accessible to a wider population. This pharmacy-based testing could lead to earlier detection and treatment, helping to reduce the spread of these infections in the community.

What evidence suggests that this pharmacy-based testing program is effective for diagnosing HIV, hepatitis C, and syphilis?

This trial will evaluate the effectiveness of pharmacy-based testing for HIV, hepatitis C (HCV), and syphilis. Research has shown that testing for these infections in pharmacies can effectively identify cases. In one study, pharmacies conducted 612 HIV tests, and 0.8% likely identified new cases. For HCV, about 9.5% of the tests returned positive results, and most of these individuals received treatment. Many people who use drugs are willing to undergo these pharmacy tests, with 75% interested in HIV testing and 80% in HCV testing. Overall, pharmacists conducting these tests help discover new cases and connect people to necessary care, which is crucial for controlling these infections. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

The APPROACH 2.0 study is for English-speaking adults (18+) in Canada with a provincial health card who can consent to participate. It's not for those already diagnosed with HIV or HCV, but they may still get certain tests.

Inclusion Criteria

Is able and willing to provide informed consent

Speaks English

Has provincial health card number

Exclusion Criteria

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)

Unwilling or unable to provide informed consent

I have been diagnosed with hepatitis C before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Testing

Participants are offered point of care tests for HIV, HCV, and syphilis at participating pharmacies. Results from point of care tests are available immediately, while dried blood spot test results are available in approximately 2 weeks.

2 weeks

1 visit (in-person)

Follow-up

Participants with reactive tests are linked with confirmatory testing and care, and those with non-reactive results are offered preventative services including HIV PrEP and counselling.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Choice of STBBI test(s)

Trial Overview This trial offers pharmacy-based testing for HIV, hepatitis C, and syphilis using point of care tests or dry blood spot tests. The goal is to see if this approach helps find new cases and connect people to care.

How Is the Trial Designed?

Group I: Participants requesting test(s) for HIV, HCV, and/or syphilis Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Memorial University of Newfoundland

Lead Sponsor

Trials

73

Recruited

1,836,000+

Citations

1. cdc.gov cdc.gov/pcd/issues/2022/22_0129.htm

Implementation and Evaluation of a Collaborative, ... Pharmacists conducted 1,479 HIV or HCV tests among the 1,164 patients. Five of 612 (0.8%) HIV tests yielded a reactive result, and 181 of 867 ( ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8418619/

Attitudes Toward Pharmacy-based HCV/HIV Testing Among ... Findings: Seventy-five percent of PWUD reported being “very likely” to participate in free pharmacy-based HIV testing and 80% for HCV testing.

3. japha.org japha.org/article/S1544-3191(23)00352-7/fulltext

Pharmacy-based sexually transmitted infection service ... Test positivity rate of 9.5% (n=8). -. 87.5% (n=7) of positive cases with documented treatment, of which 62.5% (n= ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S266727662100007X

Pharmacist-led HIV and hepatitis C point-of-care testing ... This research looks to assess the health impacts associated with pharmacist-led HIV and HCV screening coupled with comprehensive education and risk mitigation ...

5. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(24)00068-3/fulltext

Viral hepatitis testing and treatment in community pharmacies This review and meta-analysis aims to evaluate the effectiveness of programs for hepatitis B and C testing and treatment in community pharmacies.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12019630/

Pilot Findings From the First Legalized Mobile Retail ... Building on this foundation, Senate Bill 133 was passed in CT on 28 May 2024, allowing pharmacy technicians also to conduct HIV testing [23].

7. sciencedirect.com sciencedirect.com/science/article/pii/S1876034125001133

HIV, hepatitis, and syphilis self-testing among adolescents ... Self-testing is a safe, acceptable and effective way to increase access to HIV, hepatitis and syphilis testing in AYA. Given these features of self-testing, ...

8. academic.oup.com academic.oup.com/ijpp/article/33/4/369/8161154

Pharmacists' acceptability of provision of sexually transmitted ... Pharmacists accepted the idea of pharmacy-based HIV testing as a service that pharmacies could offer to the public. Santella, 2016 [34], AUS ...

9. pharmacytimes.com pharmacytimes.com/view/pharmacist-led-hcv-program-uncovers-syndemic-risks-supports-expanded-screening

Pharmacist-Led HCV Program Uncovers Syndemic Risks ... The findings revealed significant rates of coinfection with HIV, hepatitis B virus (HBV), and syphilis—highlighting opportunities for ...