Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT05516069 |
Other study ID # |
22-062 |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
January 23, 2023 |
Est. completion date |
June 30, 2026 |
Study information
Verified date |
June 2023 |
Source |
Unity Health Toronto |
Contact |
Sean B Rourke, PhD |
Phone |
(416) 878-2779 |
Email |
sean.rourke[@]utoronto.ca |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical 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. 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.
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:
1. 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;
2. reach a significant proportion of first-time testers for HIV and subsequently link them
to prevention care; and
3. provide access to harm reduction supplies to reduce harms for people who have systemic
and structural barriers to accessing testing, prevention, care and treatment.