Smart Vending Machines for HIV Self-Testing

Overseen By Sean B Rourke, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Unity Health Toronto

Disqualifiers: Does not meet inclusion criteria

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

5000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to make HIV self-testing more accessible by placing smart vending machines in various locations across Canada. The goal is to reach individuals who face barriers to healthcare, such as chaotic life circumstances or lack of a phone. Participants will have easy access to free HIV self-testing kits, like the INSTI HIV Self Test, and other health supplies. The trial seeks Canadian residents aged 16 or older who can read English or French. As an unphased trial, it offers a unique opportunity to contribute to making healthcare more accessible for everyone.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these smart vending machines are safe for distributing HIV self-tests?

Research has shown that the INSTI HIV Self Test, a key component of the Our Healthbox program, is safe for home use. This test is popular due to its quick and easy application. Reports indicate it reliably detects HIV in most cases.

The INSTI test is a one-time, rapid test requiring only a drop of blood, delivering results in just 60 seconds. Studies have found it to be highly accurate, with no major safety issues reported, indicating users generally tolerate it well.

Overall, evidence suggests the INSTI HIV Self Test is a safe choice for those seeking to know their HIV status quickly and privately. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Smart Vending Machines for HIV Self-Testing because they offer a new, convenient way to access HIV tests. Unlike traditional testing options that require a visit to a clinic or healthcare facility, these vending machines provide easy, private access to self-test kits. This innovative delivery method has the potential to increase testing rates, especially among people who may not seek out testing due to stigma or privacy concerns. By making self-testing more accessible, these machines could play a significant role in early diagnosis and treatment, ultimately helping to reduce the spread of HIV.

What evidence suggests that these smart vending machines are effective for improving access to HIV self-testing?

Research has shown that HIV self-testing is highly effective. In this trial, participants will use the INSTI HIV Self Test, one of the quickest and most accurate tests, delivering results in just 60 seconds. Studies have found that people can use these self-test kits correctly and reliably. The test has a CE Mark, indicating it meets European safety and health standards. This fast and private option allows individuals to learn their HIV status without visiting a clinic. Overall, self-testing helps reach more people who might not have access to regular healthcare services. ^{1 3 4 6 7}

Who Is on the Research Team?

Sean B Rourke, PhD

Principal Investigator

MAP Centre for Urban Health Solutions, St. Micheal's Hospital

Are You a Good Fit for This Trial?

This trial is for individuals aged 16 and older (18+ in Quebec) living in Canada who can consent in English or French. It's aimed at those without access to a phone for HIV self-testing, facing healthcare barriers like addiction, stigma, or chaotic lifestyles.

Inclusion Criteria

Person living in Canada (Canadian resident)

I am at least 16 years old, or 18 if living in Quebec.

I can give consent in English or French.

Exclusion Criteria

Does not meet all inclusion criteria

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants access smart vending machines for HIV self-testing and harm reduction supplies

36 months

Multiple visits to vending machines as needed

Follow-up

Participants are monitored for engagement with HIV testing and linkage to care

36 months

What Are the Treatments Tested in This Trial?

Interventions

• Our Healthbox

Trial Overview The 'Our Healthbox' program is being tested; it's an interactive vending machine that provides free HIV self-tests and harm reduction supplies with no need for a smartphone, aiming to reach undiagnosed individuals across Canada.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

All participants

Who Is Running the Clinical Trial?

Unity Health Toronto

Lead Sponsor

Trials

572

Recruited

470,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Canadian Foundation for AIDS Research (CANFAR)

Collaborator

Trials

8

Recruited

7,200+

Public Health Agency of Canada (PHAC)

Collaborator

Trials

51

Recruited

101,000+

Published Research Related to This Trial

The new HIV NAT-on-USB device allows individuals to self-test for HIV using just a finger-prick blood sample, providing a more sensitive method than traditional rapid tests, which can miss asymptomatic carriers.

With a turnaround time of about 60 minutes and a detection limit of 214 viral RNA copies/mL, this device is designed for ease of use and high sensitivity, making it particularly beneficial for high-risk populations seeking private testing during early exposure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fingerpick Blood-Based Nucleic Acid Testing on A USB Interfaced Device towards HIV self-testing. Liu, T., Choi, G., Tang, Z., et al.[2023]

A study evaluated the use of vending machines to distribute HIV self-tests (HIVST) to men who have sex with men at high risk of HIV, finding that 32% of surveyed sauna users had never tested for HIV despite engaging in high-risk behaviors.

The vending machines dispensed 265 testing kits, showing significantly higher uptake (34 tests per month) compared to traditional outreach testing methods (6 tests per month), indicating that this approach is both feasible and well-accepted in the community.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability and feasibility of using digital vending machines to deliver HIV self-tests to men who have sex with men. Vera, JH., Soni, S., Pollard, A., et al.[2020]

In a study involving 150 participants from Kenya, Malawi, and South Africa, it was found that less than 25% of users correctly followed all steps of the HIV self-testing process, highlighting significant usability challenges.

To improve the effectiveness of HIV self-tests, the research suggests that tests should include easy-to-understand pictorial instructions, simplified sample collection, fewer steps, and clearer result interpretation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What should the ideal HIV self-test look like? A usability study of test prototypes in unsupervised HIV self-testing in Kenya, Malawi, and South Africa. Peck, RB., Lim, JM., van Rooyen, H., et al.[2018]

A web-based survey of 692 Chinese men who have sex with men (MSM) revealed that 71.2% were willing to use a smartphone-based electronic reader (SER) for HIV self-testing (HIVST), indicating strong interest in this technology to enhance testing frequency.

Participants who engaged in higher-risk sexual behaviors, such as unprotected anal intercourse, were more likely to express willingness to use an SER, suggesting that this tool could be particularly beneficial for those at greater risk of HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Willingness of Chinese Men Who Have Sex With Men to Use Smartphone-Based Electronic Readers for HIV Self-testing: Web-Based Cross-sectional Study. Marley, G., Fu, G., Zhang, Y., et al.[2022]

A study of eight HIV self-testing kits purchased online in Australia found that none met the Australian Therapeutic Goods Administration (TGA) standards for home use, indicating a significant risk of individuals using sub-standard products during vulnerable times.

The demand for HIV self-testing is evident, highlighting the need for health policies and regulations to ensure access to safe and effective testing devices, particularly for populations at higher risk of HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implications of the on-line market for regulation and uptake of HIV self-testing in Australia. Williams, OD., Dean, JA., Harting, K., et al.[2018]

In a study involving 9,505 participants in Johannesburg, 25.9% engaged with a survey about their HIV self-test results, with 78.4% of those willing to self-report their status, indicating a significant interest in sharing results.

Among those who self-reported, 16.2% tested positive for HIV, and 65.0% of these individuals expressed a willingness to link to care, highlighting the potential of self-testing to facilitate access to treatment for HIV-positive individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HIV self-test reporting using mHealth platforms: A pilot study in Johannesburg, South Africa. Phatsoane Gaven, M., Quaife, M., Majam, M., et al.[2023]

The Asante HIV-1/2 Oral Self-Test demonstrated high usability with an average score of 98.1%, indicating that novice users can effectively operate the device, although some instructions may need revision for clarity.

The test showed strong performance with a sensitivity of 94.7% and specificity of 99.8%, suggesting it is a reliable option for convenient HIV self-testing in South Africa.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of the Sedia HIV Self-Test Device: Usability and Performance in the Hands of Untrained Users in Johannesburg, South Africa. Majam, M., Rhagnath, N., Msolomba, V., et al.[2021]

A study involving 350 participants in Singapore found that while 90% of users found the HIV self-testing kit easy to use, 85% failed to perform all steps correctly, leading to a high rate of invalid results (56%).

The interrater agreement between self-testing and trained personnel testing was low (kappa value of 0.28), indicating that many users struggled to accurately interpret their test results, suggesting that self-testing should not be implemented at this time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

User acceptability and feasibility of self-testing with HIV rapid tests. Lee, VJ., Tan, SC., Earnest, A., et al.[2022]

The study demonstrates that electronic vending machines can feasibly dispense oral, fluid, rapid HIV self-testing kits in Los Angeles County, addressing key logistical and community approval challenges.

By partnering with a local health center for counseling and support, the implementation of these vending machines could enhance access to HIV testing in the community.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic vending machines for dispensing rapid HIV self-testing kits: a case study. Young, SD., Klausner, J., Fynn, R., et al.[2022]

In a study involving 1410 pregnant women and their male partners in Kenya, providing self-testing kits along with an improved invitation letter significantly increased the likelihood of male partners getting tested for HIV, with over 80% participation in the intervention group.

Men who received both the self-testing kits and the improved invitation were twelve times more likely to test for HIV compared to those who received standard care, highlighting the effectiveness of self-testing as a complementary approach to traditional HIV testing methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of HIV self-testing kits in increasing uptake of male partner testing among pregnant women attending antenatal clinics in Kenya: a randomized controlled trial. Marwa, T., Karanja, S., Osero, J., et al.[2022]

HIV self-testing (HIVST) is gaining popularity as a convenient and user-friendly option for individuals to test for HIV at home, which can help reach at-risk populations who may not otherwise seek testing in healthcare settings.

While HIVST offers advantages like ease of use and potential integration with mobile health solutions, it also presents challenges such as lower test performance compared to traditional methods and difficulties in providing proper counseling and linkage to care after testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bringing HIV Self-Testing to Scale in the United States: a Review of Challenges, Potential Solutions, and Future Opportunities. Steehler, K., Siegler, AJ.[2020]

The mLab app, designed to analyze photos of OraQuick HIV self-tests, was found to be useful and user-friendly among youth at high risk for HIV, based on feedback from 20 end-users.

Despite some usability issues, the app's features, including personalized feedback and HIV prevention information, aim to enhance access to HIV testing and support better health outcomes in vulnerable populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usability Evaluation of the mLab App for Improving Home HIV Testing Behaviors in Youth at Risk of HIV Infection. Sanabria, G., Scherr, T., Garofalo, R., et al.[2021]

Citations

1. aidsmap.com aidsmap.com/about-hiv/how-accurate-self-testing-home-testing-hiv

How accurate is self-testing (home testing) for HIV? Studies show that most people can accurately and reliably use self-testing devices. HIV self-testing involves collecting your own specimen (oral ...

2. biolytical.com biolytical.com/rapid-hiv-self-test-kit

INSTI® HIV Self Test | Fast, Private, Reliable Results at ... Discover the INSTI® HIV Self Test, the quickest way to check your HIV status. Get accurate results in just 60 seconds from the comfort of your home.

3. insti.com insti.com/hiv-self-test/?srsltid=AfmBOooQzcYYXr1TE3KAUDClPLOW5tahbOvg2qzAluYuEctPHJWUztO0

World's Fastest HIV Home Test Kit - INSTI INSTI HIV Self Test is the world's fastest HIV home test kit. Highly accurate. CE Marked. One drop of blood. Instant results. No waiting. Learn more here.

4. fda.gov fda.gov/media/189319/download

INSTI® HIV Self Test Device SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED). 1. GENERAL ... The Clinical performance and non-clinical study results support the effectiveness ...

5. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK595333/

Rapid HIV Self-Testing - NCBI Bookshelf - NIH The INSTI HIV-1/2 Antibody Self Test is the first HIV self-testing ... 57.1% (n = 228) reported their HIV self-test results back to GetaKit.ca.

6. fda.gov fda.gov/vaccines-blood-biologics/insti-hiv-self-test

INSTI HIV Self Test The INSTI HIV Self Test is a single use, rapid, in vitro diagnostic qualitative immunoassay for the detection of antibodies to Human ...

7. insti.com insti.com/hiv-self-test/?srsltid=AfmBOopfpz4Ca-3fJiLD5v0yegfuxXtwTbHo_X-WG3DYgbDuwHnWdmE5

World's Fastest HIV Home Test Kit - INSTI INSTI HIV Self Test is the world's fastest HIV home test kit. Highly accurate. CE Marked. One drop of blood. Instant results. No waiting. Learn more here.