HIVNCT05516069
Our Healthbox - Evaluating Interactive Dispensing Systems for Low-Barrier Access to HIV Testing and Harm Reduction.
A study testing Our Healthbox (smart vending machine or interactive dispensing system) in people with HIV and HIV Self-testing, run by Unity Health Toronto at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV, HIV Self-testing, Harm Reduction
- What is being tested?
- Our Healthbox (smart vending machine or interactive dispensing system)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,000 participants
- Where
- 1 siteCanada
- Study dates
- 23 Jan 2023to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Age 16 years or older (except for Quebec: age 18 years or older)
- Person living in Canada (Canadian resident)
- Able to provide consent in English or French (via the machine screen)
Who cannot join
- Does not meet all inclusion criteria
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Ensemble
Moncton, New Brunswick
Debbie Warren
About this study
Official title: Reaching HIV Undiagnosed: Implementation and Evaluation of Interactive Dispensing Systems for Low-barrier Access to Rapid Testing and Harm Reduction Supplies With Linkage to Care for Marginalized and Hard-to-reach Populations in Canada.
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.
Read 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.
Read the detailed description
Our Healthbox is a national research program led by REACH Nexus part of MAP Centre for Urban Health Studies at St. Michael's Hospital, Unity Health Toronto that is rolling out "smart" vending machines across Canada. Our Healthbox provides low barrier access, connecting individuals with complex health and social needs to harm reduction materials, HIV Self-Tests and sexual health supplies.
The goal of the Our Healthbox program is to investigate whether strategically placed "smart" interactive vending machines improve access to HIV self-testing, in addition to harm reduction materials, for people who have systemic and structural barriers to accessing testing, treatment, care and prevention.
REACH Nexus is planning to launch 25-30 vending machines nationally in the first year with a goal of 100 vending machines deployed over the next 3 years. REACH is working with local community-based organizations to host and maintain the program for a minimum of 3 years.
REACH Nexus wants to reach everyone in Canada, including key populations, regardless of who they are or where they live - and to help to support them in their connection to care. There is a focus on reaching people with complex health and social needs and people who have systemic and structural barriers to accessing testing, harm reduction materials, treatment, care and prevention. Key populations include gay and bisexual men who have sex with men, African, Caribbean and Black populations, people who use substances as well as Indigenous, First Nations and Metis people.
Participants will self-recruit to the selected Our Healthbox vending machine locations. At Our Healthbox, services such as product dispensing, education information and location services information will be available to the user. Persons can view supplies and individual products to determine which items (i.e. HIV self-tests, harm reduction supplies, sexual health and wellness supplies) without registration. A location services directory is available for users to identify any nearby community based agency services near Our Healthbox.
As this is a research program, in order to dispense products (except for Naloxone for emergency use) from the machine, users will be asked to consent to the program, create a user profile and answer a few demographic questions. All information collected is anonymous, private and confidential. All products are available to the participant free of charge. For every return visit, users will sign in and answer additional survey questions prior to dispensing product. All information collected remains anonymous.
Investigators will use the RE-AIM Implementation Science Framework to outline our research objectives, questions and intended outcomes. We will evaluate if our program can:
- reach people who are undiagnosed with HIV who have complex health, social and substance use to know their status and link to the care they need;
- reach a significant proportion of first-time testers for HIV and subsequently link them to prevention care; and
- provide access to harm reduction supplies to reduce harms for people who have systemic and structural barriers to accessing testing, prevention, care and treatment.
- Conditions
- HIV, HIV Self-testing, Harm Reduction, Sexually Transmitted Diseases, Blood-Borne Infections
- Being tested
- Our Healthbox (smart vending machine or interactive dispensing system)
- Medical subject headings
- Harm Reduction, Sexually Transmitted Diseases, Blood-Borne Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Our Healthbox (smart vending machine or interactive dispensing system)Other
Our Healthboxes or interactive dispensing systems (IDS) will be placed in various locations across Canada and will house HIV self-test kits (provided by REACH), harm reduction supplies (provided by the provincial governments / local community based organizations; e.g. sterile drug use kits for safer injection, naloxone kits, syringes), other community determined needs (including but not limited to hats, mittens and/or socks, rapid Covid-19 antigen kits, KN95 masks). Individuals will be able to access the HIV self-test kits and harm reduction and other materials directly from the machine. Our Healthbox will also provide health information, and a support services directory for people to find the health care they need - in their community.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | All participants Receives: Other: Our Healthbox (smart vending machine or interactive dispensing system) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reaching the undiagnosed and connecting them to care
Number of participants who have used an HIV self test and have accessed a confirmitory HIV test (i.e. those who were undiagnosed, have tested positive for HIV and connected to care).
Measured: 36 months
Reaching first time testers
Number of participants who report that have never tested for HIV and have accessed and used an HIV self test (i.e. first time testers).
Measured: 36 months
Providing access to harm reduction supplies
Number of participants who access (dispense) vaious types of harm reduction supplies (e.g. injectible and non-injectible products).
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study start23 Jan 2023
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Implementation science research: Cross-sectional, prospective, field trial.
- Masking
- None (open label)
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Public Health Agency of Canada (PHAC), Canadian Foundation for AIDS Research (CANFAR)
- Responsible party
- Sponsor
- Investigators
- Sean B Rourke, PhD, Principal investigator, MAP Centre for Urban Health Solutions, St. Micheal's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05516069
- Sponsor's protocol ID
- 22-062
- Status last verified
- Jul 2024
- First submitted
- 17 Aug 2022
- Last updated
- 19 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified aggregate data can be provided upon reasonbale request.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reaching HIV Undiagnosed: Implementation and Evaluation of Interactive Dispensing Systems for Low-barrier Access to Rapid Testing and Harm Reduction Supplies With Linkage to Care for Marginalized and Hard-to-reach Populations in Canada.
- ClinicalTrials.gov ID
- NCT05516069
- Acronym / sponsor ID
- 22-062
- Conditions
- HIV, HIV Self-testing, Harm Reduction, Sexually Transmitted Diseases, Blood-Borne Infections
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Public Health Agency of Canada (PHAC), Canadian Foundation for AIDS Research (CANFAR)
- Study start
- 23 Jan 2023 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 25 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Our Healthbox is a national research program led by REACH Nexus part of MAP Centre for Urban Health Studies at St. Michael's Hospital, Unity Health Toronto that is rolling out "smart" vending machines across Canada. Our Healthbox provides low barrier access, connecting individuals with complex health and social needs to harm reduction materials, HIV Self-Tests and sexual health supplies.
The goal of the Our Healthbox program is to investigate whether strategically placed "smart" interactive vending machines improve access to HIV self-testing, in addition to harm reduction materials, for people who have systemic and structural barriers to accessing testing, treatment, care and prevention.
REACH Nexus is planning to launch 25-30 vending machines nationally in the first year with a goal of 100 vending machines deployed over the next 3 years. REACH is working with local community-based organizations to host and maintain the program for a minimum of 3 years.
REACH Nexus wants to reach everyone in Canada, including key populations, regardless of who they are or where they live - and to help to support them in their connection to care. There is a focus on reaching people with complex health and social needs and people who have systemic and structural barriers to accessing testing, harm reduction materials, treatment, care and prevention. Key populations include gay and bisexual men who have sex with men, African, Caribbean and Black populations, people who use substances as well as Indigenous, First Nations and Metis people.
Participants will self-recruit to the selected Our Healthbox vending machine locations. At Our Healthbox, services such as product dispensing, education information and location services information will be available to the user. Persons can view supplies and individual products to determine which items (i.e. HIV self-tests, harm reduction supplies, sexual health and wellness supplies) without registration. A location services directory is available for users to identify any nearby community based agency services near Our Healthbox.
As this is a research program, in order to dispense products (except for Naloxone for emergency use) from the machine, users will be asked to consent to the program, create a user profile and answer a few demographic questions. All information collected is anonymous, private and confidential. All products are available to the participant free of charge. For every return visit, users will sign in and answer additional survey questions prior to dispensing product. All information collected remains anonymous.
Investigators will use the RE-AIM Implementation Science Framework to outline our research objectives, questions and intended outcomes. We will evaluate if our program can:
- reach people who are undiagnosed with HIV who have complex health, social and substance use to know their status and link to the care they need;
- reach a significant proportion of first-time testers for HIV and subsequently link them to prevention care; and
- provide access to harm reduction supplies to reduce harms for people who have systemic and structural barriers to accessing testing, prevention, care and treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Implementation science research: Cross-sectional, prospective, field trial.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Our Healthbox (smart vending machine or interactive dispensing system)All participants |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Age 16 years or older (except for Quebec: age 18 years or older)
- Person living in Canada (Canadian resident)
- Able to provide consent in English or French (via the machine screen)
Key exclusion criteria (1 listed)
- Does not meet all inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Our Healthbox (smart vending machine or interactive dispensing system)Our Healthboxes or interactive dispensing systems (IDS) will be placed in various locations across Canada and will house HIV self-test kits (provided by REACH), harm reduction supplies (provided by the provincial governments / local community based organizations; e.g. sterile drug use kits for safer injection, naloxone kits, syringes), other community determined needs (including but not limited to hats, mittens and/or socks, rapid Covid-19 antigen kits, KN95 masks). Individuals will be able to access the HIV self-test kits and harm reduction and other materials directly from the machine. Our Healthbox will also provide health information, and a support services directory for people to find the health care they need - in their community. | Other | Intervention |
Primary outcome
Reaching the undiagnosed and connecting them to care
Time frame: 36 months
Number of participants who have used an HIV self test and have accessed a confirmitory HIV test (i.e. those who were undiagnosed, have tested positive for HIV and connected to care).
Reaching first time testers
Time frame: 36 months
Number of participants who report that have never tested for HIV and have accessed and used an HIV self test (i.e. first time testers).
Providing access to harm reduction supplies
Time frame: 36 months
Number of participants who access (dispense) vaious types of harm reduction supplies (e.g. injectible and non-injectible products).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
- Program websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. De-identified aggregate data can be provided upon reasonbale request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sean B Rourke, PhD principal investigator
MAP Centre for Urban Health Solutions, St. Micheal's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Our Healthbox (smart vending machine or interactive dispensing system) in people with HIV and HIV Self-testing, run by Unity Health Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sean B Rourke, PhD ((416) 878-2779, sean.rourke@utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reaching the undiagnosed and connecting them to care (time frame: 36 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2024.