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Transitional Housing and HIV Health

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06829394
Enrollment
200
Registered
2025-02-17
Start date
2025-02-25
Completion date
2028-08-01
Last updated
2026-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV, HIV Antiretroviral Therapy (ART) Adherence, Housing Instability

Keywords

HIV, Housing, Structural Interventions

Brief 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. 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: 1. How does AAY affect HIV-related outcomes, particularly viral suppression and antiretroviral therapy (ART) adherence? 2. What are the program's effects on economic, psychological, and secondary health outcomes? 3. 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.

Interventions

OTHERProgram Assignment

The intervention group will include People living with HIV who were assigned to the Arms Around You Program in the lottery.

Sponsors

University of Pennsylvania
Lead SponsorOTHER
Philadelphia Department of Public Health
CollaboratorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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. \-

Design outcomes

Primary

MeasureTime frameDescription
HIV viral suppression - defined as HIV RNA < 200 copies/mLFrom lottery to 12 months after the lotteryHIV viral suppression during two discrete 6-month periods after the lottery for access to the AAY program. (Lottery population)
ART adherenceDuring discrete 3-month periods up to 12 months after the lotteryART adherence (survey population)

Secondary

MeasureTime frameDescription
Engagement in HIV careFrom lottery to 12 months after the lotteryEngagement in HIV care (defined as having an HIV viral load or CD4 count measured within a 6-month period). (Lottery Population)
Health Related Quality of Life6, 12, 24 and 36 months after assignment to the lotteryCDC 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.
Alcohol use6, 12, 24 and 36 months after assignment to the lotteryAlcohol Use Disorders Identification Test-Concise: AUDIT-C (Survey Population). Scored on a scale 0-12 with a higher score indicative of a worse outcome.
Cigarette Dependence6, 12, 24 and 36 months after assignment to the lotteryCigarette Dependence Scale: CDS-5 (Survey Population). Scored on a scale 1-5
Recent Substance Use6, 12, 24 and 36 months after assignment to the lotteryNational Institute on Drug Abuse. Screening for Drug Abuse in General Medical Settings. (Survey Population)
ED visits and reason for most recent visit6, 12, 24 and 36 months after assignment to the lottery(Survey Population)
Hospitalizations6, 12, 24 and 36 months after assignment to the lottery(Survey Population)
Out of pocket health costs6, 12, 24 and 36 months after assignment to the lotteryOutpatient, ED/inpatient, prescription, other (survey population)
HIV Transmission risk behaviors6, 12, 24 and 36 months after assignment to the lottery(survey population)
Housing security6, 12, 24 and 36 months after assignment to the lotteryUS Census Bureau. 2019 American Housing Survey Instrument Items. (Survey population)
Perceived Housing Quality6, 12, 24 and 36 months after assignment to the lotteryCerin E, Saelens BE, Sallis JF, Frank LD. Neighborhood Environment Walkability Scale (survey population)
Neighborhood safety scale6, 12, 24 and 36 months after assignment to the lotteryHousing Satisfaction for Persons with Psychiatric Disabilities (survey population)
Income as % federal poverty level6, 12, 24 and 36 months after assignment to the lottery(survey population)
Current employment status6, 12, 24 and 36 months after assignment to the lottery(survey population)
Participation in other public programs (e.g. SNAP, Medicaid)6, 12, 24 and 36 months after assignment to the lottery(survey population)
Financial Stress6, 12, 24 and 36 months after assignment to the lotteryCFPB (survey population)
Food Security6, 12, 24 and 36 months after assignment to the lotteryUSDA (survey population)
Stress6, 12, 24 and 36 months after assignment to the lotteryPerceived Stress Scale (survey population)
Psychological Distress6, 12, 24 and 36 months after assignment to the lotteryKessler 6+ (survey population)
Hope6, 12, 24 and 36 months after assignment to the lotteryState Hope Scale (Survey population). 8-item scale
Preferences survey6, 12, 24 and 36 months after assignment to the lotteryPreference Survey Probabilistic Scale (survey population). Scale 0-10 with higher number indicating better outcome.
Time preference: Hyperbolicity6, 12, 24 and 36 months after assignment to the lotteryBrownback incentivized questions (survey population)
Time Preferences: Patience6, 12, 24 and 36 months after assignment to the lotteryBrownback incentivized questions (survey population)
Time Horizon6, 12, 24 and 36 months after assignment to the lotteryLaajaj (survey population)
HIV Stigma6, 12, 24 and 36 months after assignment to the lotteryHIV stigma scale, short form (survey population)

Countries

United States

Contacts

CONTACTAaron Richterman, MD, MPH
Aaron.Richterman@Pennmedicine.upenn.edu267-441-7915
CONTACTEva Fabian, MPH
eva.fabian@pennmedicine.upenn.edu760-791-2633

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026