HIVNCT06483152
Unlimited Transportation Passes for Unstable Housed People Living With HIV Trial
A study testing Metro Transit Pass in people with HIV, run by The Aliveness Project at 1 site in United States.
Trial 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. Do participants who are provided the transit pass manage their HIV better? 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- What is being tested?
- Metro Transit Pass
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2024to Feb 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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:
Show all 11Show fewer
- 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.
Who cannot join
- • 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Aliveness Project
Minneapolis, Minnesota, 55409
Jay Orne, PhD, 612-824-5433, Jay@aliveness.org
Executive Director, 612-824-5433, matt@aliveness.org
About this study
Official title: Getting to Zero: Resolving Transportation Barriers to Participation in Services Among Unstably Housed PLWH
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:
Read more
- Do participants who are provided the transit pass manage their HIV better?
- Do participants who are provided the transit pass use other social services more that could improve their health and quality of life?
Researchers will compare the group that is provided with the transit pass to a control group that is not provided with the pass.
Participants will fill out a baseline survey and a follow-up survey after 6 months. Researchers will also look at participant's HIV lab tests to see how well their HIV is being managed.
Read the detailed description
People living with HIV who are homeless or unstably housed often face significant barriers to accessing essential health services, including regular medical appointments critical for managing their condition. The current standard of care provides these individuals with limited transportation support - specifically, two $10 bus cards per month - which are quickly expended and often insufficient to meet their basic needs.
The proposed trial aims to address this gap by assessing whether providing unlimited transit passes can enhance health outcomes compared to the current standard. The intervention hypothesizes that removing transportation barriers will increase attendance at medical appointments and utilization of supportive services at The Aliveness Project, a community center offering meals and social services to people living with HIV. By enabling consistent access to public transit, the intervention targets behavioral changes - specifically, the ability of participants to reliably attend health care appointments - and fosters greater engagement with community support resources.
The clinical outcomes of interest in this trial are increased rates of viral suppression, which is a direct indicator of effective HIV management, improved attendance at healthcare appointments, and increased engagement with supportive services at The Aliveness Project. These outcomes not only measure the efficacy of the intervention in improving health management among unstably housed individuals living with HIV but also provide insights into the broader implications of transportation accessibility on public health. By alleviating a fundamental barrier to care, the intervention aims to demonstrate a superior approach to supporting this vulnerable population in achieving and maintaining viral suppression.
- Conditions
- HIV
- Being tested
- Metro Transit Pass, Standard of Care
- Keywords
- transportation, transit pass, undetectable, HIV, unstable housing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metro Transit PassOther
A transit pass that enables riders to use the Minneapolis Metro Transit system that will paid for by the study for 6 months
Standard of CareOther
The current standard of care for Ryan White eligible clients is to receive two $10 bus cards a month from a case manager
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study startJul 2024 (estimated)
- Primary completionFeb 2025 (estimated)
- Study completionFeb 2025 (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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Aliveness Project
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jay Orne, PhD, The Aliveness Project
- Investigators
- Jay Orne, PhD, Principal investigator, The Aliveness Project
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06483152
- Sponsor's protocol ID
- IN-US-985-7161
- Status last verified
- Jun 2024
- First submitted
- 12 Jun 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The information of the study contains protected health information about participants HIV status
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Getting to Zero: Resolving Transportation Barriers to Participation in Services Among Unstably Housed PLWH
- ClinicalTrials.gov ID
- NCT06483152
- Acronym / sponsor ID
- IN-US-985-7161
- Conditions
- HIV
- Keywords
- transportation, transit pass, undetectable, HIV, unstable housing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- The Aliveness ProjectUniversity, hospital or other
- Study start
- Jul 2024 (estimated)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 3 Jul 2024 (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.
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:
- Do participants who are provided the transit pass manage their HIV better?
- Do participants who are provided the transit pass use other social services more that could improve their health and quality of life?
Researchers will compare the group that is provided with the transit pass to a control group that is not provided with the pass.
Participants will fill out a baseline survey and a follow-up survey after 6 months. Researchers will also look at participant's HIV lab tests to see how well their HIV is being managed.
Detailed description
People living with HIV who are homeless or unstably housed often face significant barriers to accessing essential health services, including regular medical appointments critical for managing their condition. The current standard of care provides these individuals with limited transportation support - specifically, two $10 bus cards per month - which are quickly expended and often insufficient to meet their basic needs.
The proposed trial aims to address this gap by assessing whether providing unlimited transit passes can enhance health outcomes compared to the current standard. The intervention hypothesizes that removing transportation barriers will increase attendance at medical appointments and utilization of supportive services at The Aliveness Project, a community center offering meals and social services to people living with HIV. By enabling consistent access to public transit, the intervention targets behavioral changes - specifically, the ability of participants to reliably attend health care appointments - and fosters greater engagement with community support resources.
The clinical outcomes of interest in this trial are increased rates of viral suppression, which is a direct indicator of effective HIV management, improved attendance at healthcare appointments, and increased engagement with supportive services at The Aliveness Project. These outcomes not only measure the efficacy of the intervention in improving health management among unstably housed individuals living with HIV but also provide insights into the broader implications of transportation accessibility on public health. By alleviating a fundamental barrier to care, the intervention aims to demonstrate a superior approach to supporting this vulnerable population in achieving and maintaining viral suppression.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Metro Transit PassThe 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. |
| Control | Active comparator | Other: Standard of CareThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- • 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
- Currently reports living in one of the following housing conditions:
- 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.
Key exclusion criteria (3 listed)
- • Inability to provide informed consent
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 |
|---|---|---|
| Metro Transit PassA transit pass that enables riders to use the Minneapolis Metro Transit system that will paid for by the study for 6 months | Other | Intervention Group |
| Standard of CareThe current standard of care for Ryan White eligible clients is to receive two $10 bus cards a month from a case manager | Other | Control |
Primary outcome
Number of Participants with HIV Viral Suppression
Time frame: 12 months
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.
Number of Participants with an HIV related Medical Visit
Time frame: 12 months
Number of participants who have received a HIV viral RNA test during a medical visit within the last 12 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: No. The information of the study contains protected health information about participants HIV status
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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.
Jay Orne, PhD principal investigator
The Aliveness Project
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metro Transit Pass in people with HIV, run by The Aliveness Project at 1 site in United States.
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 11 inclusion and 3 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 3 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 United States. 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 Jay Orne, PhD (612-824-5433, Jay@aliveness.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with HIV Viral Suppression (time frame: 12 months). The study lists 2 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 3 Jul 2024.