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

Trial Summary

What is the purpose of this trial?

When REACH Nexus at MAP Centre for Urban Solutions out of St. Michael's Hospital launched its signature program, I'm Ready in 2021, our goal was to democratize access to free HIV self-testing to reach the undiagnosed in Canada. The program, the first of its kind in Canada has been successfully rolling out 50,000 free, HIV self-tests and connecting participants via a mobile app on an iOS or Android smart phone to care. While this is an important milestone in improving access, REACH knows that more needs to be done. An estimated 20-30% of undiagnosed individuals do not have access to a phone to order the HIV self-tests, and many face multiple barriers to accessing healthcare and harm reduction support: chaotic life circumstances, addiction challenges, stigma and more. Everyone in Canada should have equitable access to the health care they need. But REACH knows that this is not the case.So, REACH is working hard to change this. hese ongoing barriers inspired us to continue creating innovative solutions, and launch our second signature program, Our Healthbox. Our Healthbox meets people where they are, with what they need for their health and well-being. This program is scaling up innovations in health technologies to reach undiagnosed individuals with HIV. These smart interactive vending machines will be strategically located across Canada. The goal is to reach people where they live to provide free and low barrier access to HIV self-testing kits, STBBI testing and other harm reduction supplies. Participation in Our Healthbox, as with I'm Ready, also gives us the opportunity to collect important data that will continue to inform and guide REACH Nexus' work to grow and scale innovative health solutions across the country.

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 data supports the effectiveness of the treatment Our Healthbox, INSTI HIV Self Test?

Research shows that HIV self-testing devices, like the INSTI HIV Self Test, are effective in providing convenient and accurate results, with studies reporting high usability and performance. For example, a study in South Africa found that similar self-test devices had a sensitivity of 94.7% and specificity of 99.8%, indicating they are reliable for detecting HIV. ^{1 2 3 4 5}

Is the HIV self-test safe for humans?

The studies reviewed focus on the usability and effectiveness of HIV self-tests, but they do not report any specific safety concerns for humans. However, some tests did not meet regulatory standards, indicating a need for caution when selecting a test. ^{5 6 7 8 9}

How does the Smart Vending Machines for HIV Self-Testing treatment differ from other treatments for HIV?

The Smart Vending Machines for HIV Self-Testing offer a unique approach by providing easy access to HIV self-test kits through vending machines, making it more convenient and private for individuals to test themselves. This method differs from traditional testing as it increases accessibility and privacy, especially for high-risk populations, without the need for a healthcare provider's involvement. ^{1 8 10 11 12}

Research Team

Sean B Rourke, PhD

Principal Investigator

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

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]

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]

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]

References

1. Uganda 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. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

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

3. Switzerland pubmed.ncbi.nlm.nih.gov

HIV self-test reporting using mHealth platforms: A pilot study in Johannesburg, South Africa. [2023]

4. Canada 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. [2022]

5. Switzerland 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. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Implications of the on-line market for regulation and uptake of HIV self-testing in Australia. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

User acceptability and feasibility of self-testing with HIV rapid tests. [2022]

8. United States 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. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Usability Evaluation of the mLab App for Improving Home HIV Testing Behaviors in Youth at Risk of HIV Infection. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Electronic vending machines for dispensing rapid HIV self-testing kits: a case study. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Fingerpick Blood-Based Nucleic Acid Testing on A USB Interfaced Device towards HIV self-testing. [2023]

12. England 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. [2020]