NCT06483152

Brief Summary

The goal of this trial is to learn if providing an unlimited transit pass will improve the health of people living with HIV that are experiencing unstable housing. The main questions it aims to answer are:

  1. 1.Do participants who are provided the transit pass manage their HIV better?
  2. 2.Do participants who are provided the transit pass use other social services more that could improve their health and quality of life?

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
146

participants targeted

Target at P25-P50 for not_applicable hiv

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable hiv

Geographic Reach
1 country

1 active site

Status
not yet 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

First Submitted

Initial submission to the registry

June 12, 2024

Completed
19 days until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 3, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

July 3, 2024

Status Verified

June 1, 2024

Enrollment Period

7 months

First QC Date

June 12, 2024

Last Update Submit

June 25, 2024

Conditions

Keywords

transportationtransit passundetectableHIVunstable housing

Outcome Measures

Primary Outcomes (2)

  • Number of Participants with HIV Viral Suppression

    Number of participants with a quantitative HIV Viral RNA test with a concentration under 200 copies of HIV per mL (viral suppression) within the last 12 months.

    12 months

  • Number of Participants with an HIV related Medical Visit

    Number of participants who have received a HIV viral RNA test during a medical visit within the last 12 months.

    12 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

The intervention group will be provided a transit pass for the Minneapolis Metro transit system that will be paid for by the study for 6 months.

Other: Metro Transit Pass

Control

ACTIVE COMPARATOR

The control group will receive the current standard of care, in which people are eligible to receive up to two $10 bus cards from their case manager per month.

Other: Standard of Care

Interventions

A transit pass that enables riders to use the Minneapolis Metro Transit system that will paid for by the study for 6 months

Intervention Group

The current standard of care for Ryan White eligible clients is to receive two $10 bus cards a month from a case manager

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Member of The Aliveness Project
  • Live, reside, or stay regularly outside within the 13 county area surrounding the Twin Cities known in the Ryan White system as the MINNEAPOLIS ST. PAUL TRANSITIONAL GRANT AREA or TGA. This is the same general area as the area where Metro Transit serves, which makes it a convenient reference.
  • Be a person experiencing unstable housing or homelessness
  • Because the residence and housing status of this group rapidly shifts -hence unstable--the following definition of unstable housing was developed in collaboration with Aliveness\'s housing stabilization team, which serves this population:
  • Meet one of three criteria:
  • Currently reports living in one of the following housing conditions:
  • Outside, in a car, or another space unfit for human habitation
  • A homeless shelter
  • Temporary housing with a friend or relative (couch hopping) to which they do not have long-term stable access.
  • Currently lives in a temporary group home or substance abuse treatment program, but lived in one of the above housing conditions prior to entry within the last three months.
  • Is listed in the CAREWare database system as being homeless or having temporary or unstable housing.

You may not qualify if:

  • Inability to provide informed consent
  • Inability to communicate in English
  • Not an Aliveness member in good standing: Some Aliveness members have been banned from the space because of behavioral or safety concerns. Aliveness\'s Member Advisory Committee reviews all such expulsions on a case-by-case basis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Aliveness Project

Minneapolis, Minnesota, 55409, United States

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Jay Orne, PhD

    The Aliveness Project

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jay Orne, PhD

CONTACT

Executive Director

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist

Study Record Dates

First Submitted

June 12, 2024

First Posted

July 3, 2024

Study Start

July 1, 2024

Primary Completion

February 1, 2025

Study Completion

February 1, 2025

Last Updated

July 3, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

The information of the study contains protected health information about participants HIV status

Locations