NCT05516069

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for not_applicable hiv

Timeline
2mo left

Started Jan 2023

Typical duration for not_applicable hiv

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Jan 2023Jun 2026

First Submitted

Initial submission to the registry

August 17, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 25, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

January 23, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

July 19, 2024

Status Verified

July 1, 2024

Enrollment Period

2.9 years

First QC Date

August 17, 2022

Last Update Submit

July 17, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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).

    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).

    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).

    36 months

Study Arms (1)

Intervention

EXPERIMENTAL

All participants

Other: Our Healthbox (smart vending machine or interactive dispensing system)

Interventions

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.

Intervention

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ensemble

Moncton, New Brunswick, Canada

RECRUITING

Related Links

MeSH Terms

Conditions

Harm ReductionSexually Transmitted DiseasesBlood-Borne Infections

Condition Hierarchy (Ancestors)

BehaviorCommunicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sean B Rourke, PhD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Implementation science research: Cross-sectional, prospective, field trial.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2022

First Posted

August 25, 2022

Study Start

January 23, 2023

Primary Completion

December 30, 2025

Study Completion (Estimated)

June 30, 2026

Last Updated

July 19, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

De-identified aggregate data can be provided upon reasonbale request.

Locations