HIVNCT06829394
Transitional Housing and HIV Health
An observational study of HIV and HIV Antiretroviral Therapy (ART) Adherence, run by University of Pennsylvania at 2 sites in United States.
Trial summary
The goal of this pilot study is to evaluate the implementation and outcomes of the Arms Around You (AAY) program, a supportive housing initiative launched by the Philadelphia Department of Public Health (PDPH) in 2024. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, HIV Antiretroviral Therapy (ART) Adherence, Housing Instability
- What is being tested?
- Program Assignment
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Feb 2025to Aug 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: People living with HIV in Priority Group 1 (currently experiencing sheltered or unsheltered homelessness) or 2 (at high risk for eviction/homelessness) who participate in the lottery, and a smaller sub-population of PWH who participate in the study surveys.
Inclusion Criteria: Inclusion criteria for the Lottery Population will be all PWH in priority groups 1 or 2 included in the initial lottery for access to the AAY program.
Inclusion criteria for the Survey population is (1) eligible for the HIV transitional housing program (2) priority group 1 or 2 with anticipated inclusion in the initial lottery (3) no plans to leave Philadelphia in the next year (4) regular access to a telephone to be able to complete phone surveys (5) able to provide informed consent.
-
Exclusion Criteria: Does not meet the above inclusion criteria.
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Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Eva Fabian, MPH, 760-791-2633, eva.fabian@pennmedicine.upenn.edu
About this study
Official title: A Type 1 Hybrid Effectiveness-Implementation Evaluation of a City-Level Transitional Housing Program's Effects on Health, Economic, and Psychologic Outcomes Among People With HIV
The goal of this pilot study is to evaluate the implementation and outcomes of the Arms Around You (AAY) program, a supportive housing initiative launched by the Philadelphia Department of Public Health (PDPH) in 2024. The program aims to address housing instability among people with HIV (PWH) using a Housing First model. The main questions it seeks to answer are:
- How does AAY affect HIV-related outcomes, particularly viral suppression and antiretroviral therapy (ART) adherence?
- What are the program's effects on economic, psychological, and secondary health outcomes?
- How feasible, acceptable, and scalable is the program for broader implementation? Participants will be assigned to immediate program access or a waitlist using a random lottery system, creating treatment and control groups, respectively. Surveys and health data will be collected at baseline and over 36 months to assess changes in outcomes such as viral suppression, housing security, mental health, and financial well-being. Qualitative interviews with participants and stakeholders will complement quantitative findings to explore mechanisms of change and guide program optimization.
Read the detailed description
Housing instability significantly impedes HIV-related outcomes, such as engagement in care, ART adherence, and viral suppression. Structural racism and poverty exacerbate these disparities, particularly for racial and sexual minorities. To address this, the PDPH developed the AAY program, which combines rent support (up to 48 months), housing medical case management (MCM), and intensive housing counseling, following client-centered, harm-reduction principles.
This hybrid type 1 effectiveness-implementation study will evaluate the effects of the AAY intervention on health, economic, and psychological outcomes. PWH experiencing homelessness or severe housing instability will be prioritized for the program. The lottery-based design will allow researchers to observe differences between those granted immediate program access and those on the waitlist (who will receive standard of care treatment and serve as the control group). The primary outcomes of interest are HIV viral suppression (defined as <200 copies/mL) and ART adherence, measured via pharmacy refill data. Secondary outcomes include housing security, food security, financial stress, psychological distress, and health-related quality of life.
Researchers will use mixed methods to collect data over 36 months. Quantitative data will include pre- and post-program surveys, pharmacy refill records, and PDPH surveillance data. Qualitative data will be gathered through semi-structured interviews with key stakeholders, including program participants, waitlisted individuals, referral case managers, implementing case managers and housing MCMs, and city leaders. These interviews will explore the program's acceptability, implementation challenges, and pathways through which housing support influences HIV outcomes.
Approximately 200 participants will be enrolled in the survey study, with data collected at baseline and at 6, 12, 24, and 36 months. Key implementation outcomes, such as the program's reach, sustainment, and costs, will also be analyzed to inform scalability. This study will provide critical evidence on how housing interventions can reduce health inequities and improve HIV-related outcomes, offering actionable insights for policymakers and public health leaders in Philadelphia and beyond.
- Being tested
- Program Assignment
- Keywords
- HIV, Housing, Structural Interventions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Program AssignmentOther
The intervention group will include People living with HIV who were assigned to the Arms Around You Program in the lottery.
| Study group | Role | What they receive |
|---|---|---|
| Arms Around You Program Waitlist | These are individuals that are part of the lottery but not yet assigned to the program. | |
| Arms Around You Program Recipients | These are individuals that were part of the lottery AND assigned to the program Receives: Other: Program Assignment |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV viral suppression - defined as HIV RNA < 200 copies/mL
HIV viral suppression during two discrete 6-month periods after the lottery for access to the AAY program. (Lottery population)
Measured: From lottery to 12 months after the lottery
ART adherence
ART adherence (survey population)
Measured: During discrete 3-month periods up to 12 months after the lottery
Secondary outcomes (25)
Engagement in HIV care
Engagement in HIV care (defined as having an HIV viral load or CD4 count measured within a 6-month period). (Lottery Population)
Measured: From lottery to 12 months after the lottery
Health Related Quality of Life
CDC HRQOL-4 (Survey Population). A 4-question scale that assesses four key domains: self-rated general health, physical health, mental health, and activity limitations. Higher score is better outcome.
Measured: 6, 12, 24 and 36 months after assignment to the lottery
Alcohol use
Alcohol Use Disorders Identification Test-Concise: AUDIT-C (Survey Population). Scored on a scale 0-12 with a higher score indicative of a worse outcome.
Measured: 6, 12, 24 and 36 months after assignment to the lottery
Cigarette Dependence
Cigarette Dependence Scale: CDS-5 (Survey Population). Scored on a scale 1-5
Measured: 6, 12, 24 and 36 months after assignment to the lottery
Recent Substance Use
National Institute on Drug Abuse. Screening for Drug Abuse in General Medical Settings. (Survey Population)
Measured: 6, 12, 24 and 36 months after assignment to the lottery
ED visits and reason for most recent visit
(Survey Population)
Measured: 6, 12, 24 and 36 months after assignment to the lottery
Hospitalizations
(Survey Population)
Measured: 6, 12, 24 and 36 months after assignment to the lottery
Out of pocket health costs
Outpatient, ED/inpatient, prescription, other (survey population)
Measured: 6, 12, 24 and 36 months after assignment to the lottery
HIV Transmission risk behaviors
(survey population)
Measured: 6, 12, 24 and 36 months after assignment to the lottery
Housing security
US Census Bureau. 2019 American Housing Survey Instrument Items. (Survey population)
Measured: 6, 12, 24 and 36 months after assignment to the lottery
Perceived Housing Quality
Cerin E, Saelens BE, Sallis JF, Frank LD. Neighborhood Environment Walkability Scale (survey population)
Measured: 6, 12, 24 and 36 months after assignment to the lottery
Neighborhood safety scale
Housing Satisfaction for Persons with Psychiatric Disabilities (survey population)
Measured: 6, 12, 24 and 36 months after assignment to the lottery
Income as % federal poverty level
(survey population)
Measured: 6, 12, 24 and 36 months after assignment to the lottery
Current employment status
(survey population)
Measured: 6, 12, 24 and 36 months after assignment to the lottery
Participation in other public programs (e.g. SNAP, Medicaid)
(survey population)
Measured: 6, 12, 24 and 36 months after assignment to the lottery
Financial Stress
CFPB (survey population)
Measured: 6, 12, 24 and 36 months after assignment to the lottery
Food Security
USDA (survey population)
Measured: 6, 12, 24 and 36 months after assignment to the lottery
Stress
Perceived Stress Scale (survey population)
Measured: 6, 12, 24 and 36 months after assignment to the lottery
Psychological Distress
Kessler 6+ (survey population)
Measured: 6, 12, 24 and 36 months after assignment to the lottery
Hope
State Hope Scale (Survey population). 8-item scale
Measured: 6, 12, 24 and 36 months after assignment to the lottery
Preferences survey
Preference Survey Probabilistic Scale (survey population). Scale 0-10 with higher number indicating better outcome.
Measured: 6, 12, 24 and 36 months after assignment to the lottery
Time preference: Hyperbolicity
Brownback incentivized questions (survey population)
Measured: 6, 12, 24 and 36 months after assignment to the lottery
Time Preferences: Patience
Brownback incentivized questions (survey population)
Measured: 6, 12, 24 and 36 months after assignment to the lottery
Time Horizon
Laajaj (survey population)
Measured: 6, 12, 24 and 36 months after assignment to the lottery
HIV Stigma
HIV stigma scale, short form (survey population)
Measured: 6, 12, 24 and 36 months after assignment to the lottery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start25 Feb 2025
- Primary completionJan 2028 (estimated)
- Study completionAug 2028 (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.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Philadelphia Department of Public Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06829394
- Sponsor's protocol ID
- 855009
- Status last verified
- Mar 2026
- First submitted
- 28 Jan 2025
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Type 1 Hybrid Effectiveness-Implementation Evaluation of a City-Level Transitional Housing Program's Effects on Health, Economic, and Psychologic Outcomes Among People With HIV
- ClinicalTrials.gov ID
- NCT06829394
- Acronym / sponsor ID
- 855009
- Keywords
- HIV, Housing, Structural Interventions
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Philadelphia Department of Public Health
- Study start
- 25 Feb 2025 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 17 Feb 2025 (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 pilot study is to evaluate the implementation and outcomes of the Arms Around You (AAY) program, a supportive housing initiative launched by the Philadelphia Department of Public Health (PDPH) in 2024. The program aims to address housing instability among people with HIV (PWH) using a Housing First model. The main questions it seeks to answer are:
- How does AAY affect HIV-related outcomes, particularly viral suppression and antiretroviral therapy (ART) adherence?
- What are the program's effects on economic, psychological, and secondary health outcomes?
- How feasible, acceptable, and scalable is the program for broader implementation? Participants will be assigned to immediate program access or a waitlist using a random lottery system, creating treatment and control groups, respectively. Surveys and health data will be collected at baseline and over 36 months to assess changes in outcomes such as viral suppression, housing security, mental health, and financial well-being. Qualitative interviews with participants and stakeholders will complement quantitative findings to explore mechanisms of change and guide program optimization.
Detailed description
Housing instability significantly impedes HIV-related outcomes, such as engagement in care, ART adherence, and viral suppression. Structural racism and poverty exacerbate these disparities, particularly for racial and sexual minorities. To address this, the PDPH developed the AAY program, which combines rent support (up to 48 months), housing medical case management (MCM), and intensive housing counseling, following client-centered, harm-reduction principles.
This hybrid type 1 effectiveness-implementation study will evaluate the effects of the AAY intervention on health, economic, and psychological outcomes. PWH experiencing homelessness or severe housing instability will be prioritized for the program. The lottery-based design will allow researchers to observe differences between those granted immediate program access and those on the waitlist (who will receive standard of care treatment and serve as the control group). The primary outcomes of interest are HIV viral suppression (defined as <200 copies/mL) and ART adherence, measured via pharmacy refill data. Secondary outcomes include housing security, food security, financial stress, psychological distress, and health-related quality of life.
Researchers will use mixed methods to collect data over 36 months. Quantitative data will include pre- and post-program surveys, pharmacy refill records, and PDPH surveillance data. Qualitative data will be gathered through semi-structured interviews with key stakeholders, including program participants, waitlisted individuals, referral case managers, implementing case managers and housing MCMs, and city leaders. These interviews will explore the program's acceptability, implementation challenges, and pathways through which housing support influences HIV outcomes.
Approximately 200 participants will be enrolled in the survey study, with data collected at baseline and at 6, 12, 24, and 36 months. Key implementation outcomes, such as the program's reach, sustainment, and costs, will also be analyzed to inform scalability. This study will provide critical evidence on how housing interventions can reduce health inequities and improve HIV-related outcomes, offering actionable insights for policymakers and public health leaders in Philadelphia and beyond.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arms Around You Program Waitlist | – | –These are individuals that are part of the lottery but not yet assigned to the program. |
| Arms Around You Program Recipients | – | Other: Program AssignmentThese are individuals that were part of the lottery AND assigned to the program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People living with HIV in Priority Group 1 (currently experiencing sheltered or unsheltered homelessness) or 2 (at high risk for eviction/homelessness) who participate in the lottery, and a smaller sub-population of PWH who participate in the study surveys.
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 |
|---|---|---|
| Program AssignmentThe intervention group will include People living with HIV who were assigned to the Arms Around You Program in the lottery. | Other | Arms Around You Program Recipients |
Primary outcome
HIV viral suppression - defined as HIV RNA < 200 copies/mL
Time frame: From lottery to 12 months after the lottery
HIV viral suppression during two discrete 6-month periods after the lottery for access to the AAY program. (Lottery population)
ART adherence
Time frame: During discrete 3-month periods up to 12 months after the lottery
ART adherence (survey population)
25 secondary outcomes
Engagement in HIV care
Time frame: From lottery to 12 months after the lottery
Health Related Quality of Life
Time frame: 6, 12, 24 and 36 months after assignment to the lottery
Alcohol use
Time frame: 6, 12, 24 and 36 months after assignment to the lottery
Cigarette Dependence
Time frame: 6, 12, 24 and 36 months after assignment to the lottery
Recent Substance Use
Time frame: 6, 12, 24 and 36 months after assignment to the lottery
ED visits and reason for most recent visit
Time frame: 6, 12, 24 and 36 months after assignment to the lottery
Hospitalizations
Time frame: 6, 12, 24 and 36 months after assignment to the lottery
Out of pocket health costs
Time frame: 6, 12, 24 and 36 months after assignment to the lottery
HIV Transmission risk behaviors
Time frame: 6, 12, 24 and 36 months after assignment to the lottery
Housing security
Time frame: 6, 12, 24 and 36 months after assignment to the lottery
Perceived Housing Quality
Time frame: 6, 12, 24 and 36 months after assignment to the lottery
Neighborhood safety scale
Time frame: 6, 12, 24 and 36 months after assignment to the lottery
Income as % federal poverty level
Time frame: 6, 12, 24 and 36 months after assignment to the lottery
Current employment status
Time frame: 6, 12, 24 and 36 months after assignment to the lottery
Participation in other public programs (e.g. SNAP, Medicaid)
Time frame: 6, 12, 24 and 36 months after assignment to the lottery
Financial Stress
Time frame: 6, 12, 24 and 36 months after assignment to the lottery
Food Security
Time frame: 6, 12, 24 and 36 months after assignment to the lottery
Stress
Time frame: 6, 12, 24 and 36 months after assignment to the lottery
Psychological Distress
Time frame: 6, 12, 24 and 36 months after assignment to the lottery
Hope
Time frame: 6, 12, 24 and 36 months after assignment to the lottery
Preferences survey
Time frame: 6, 12, 24 and 36 months after assignment to the lottery
Time preference: Hyperbolicity
Time frame: 6, 12, 24 and 36 months after assignment to the lottery
Time Preferences: Patience
Time frame: 6, 12, 24 and 36 months after assignment to the lottery
Time Horizon
Time frame: 6, 12, 24 and 36 months after assignment to the lottery
HIV Stigma
Time frame: 6, 12, 24 and 36 months after assignment to the lottery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV and HIV Antiretroviral Therapy (ART) Adherence, run by University of Pennsylvania at 2 sites 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?
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: looking for participants now, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aaron Richterman, MD, MPH (267-441-7915, Aaron.Richterman@Pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV viral suppression - defined as HIV RNA < 200 copies/mL (time frame: From lottery to 12 months after the lottery). 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 23 Mar 2026.