Clinical trial NCT06829394: Transitional Housing and HIV Health
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HIV
HIV Antiretroviral Therapy (ART) Adherence
Housing Instability
Keywords: HIV
Housing
Structural Interventions
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Philadelphia Department of Public Health
First posted: 2025-02-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People living with HIV in Priority Group 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.

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, 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.

Eligibility criteria: Inclusion Criteria: Inclusion criteria for the Lottery Population will be all PWH in priority group 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 2 with anticipated inclusion in the inital 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.

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Exclusion Criteria: Does not meet the above inclusion criteria.

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Primary outcomes:
measure: HIV viral suppression - defined as HIV RNA < 200 copies/mL
timeFrame: From lottery to 12 months after the lottery
measure: ART adherence
timeFrame: During discrete 3-month periods up to 12 months after the lottery
Secondary outcomes:
measure: Engagement in HIV care
timeFrame: From lottery to 12 months after the lottery
measure: Health Related Quality of Life
timeFrame: 6, 12, 24 and 36 months after assignment to the lottery
measure: Alcohol use
timeFrame: 6, 12, 24 and 36 months after assignment to the lottery
measure: Cigarette Dependence
timeFrame: 6, 12, 24 and 36 months after assignment to the lottery
measure: Recent Substance Use
timeFrame: 6, 12, 24 and 36 months after assignment to the lottery
measure: ED visits and reason for most recent visit
timeFrame: 6, 12, 24 and 36 months after assignment to the lottery
measure: Hospitalizations
timeFrame: 6, 12, 24 and 36 months after assignment to the lottery
measure: Out of pocket health costs
timeFrame: 6, 12, 24 and 36 months after assignment to the lottery
measure: HIV Transmission risk behaviors
timeFrame: 6, 12, 24 and 36 months after assignment to the lottery
measure: Housing security
timeFrame: 6, 12, 24 and 36 months after assignment to the lottery
measure: Perceived Housing Quality
timeFrame: 6, 12, 24 and 36 months after assignment to the lottery
measure: Neighborhood safety scale
timeFrame: 6, 12, 24 and 36 months after assignment to the lottery
measure: Income as % federal poverty level
timeFrame: 6, 12, 24 and 36 months after assignment to the lottery
measure: Current employment status
timeFrame: 6, 12, 24 and 36 months after assignment to the lottery
measure: Participation in other public programs (e.g. SNAP, Medicaid)
timeFrame: 6, 12, 24 and 36 months after assignment to the lottery
measure: Financial Stress
timeFrame: 6, 12, 24 and 36 months after assignment to the lottery
measure: Food Security
timeFrame: 6, 12, 24 and 36 months after assignment to the lottery
measure: Stress
timeFrame: 6, 12, 24 and 36 months after assignment to the lottery
measure: Psychological Distress
timeFrame: 6, 12, 24 and 36 months after assignment to the lottery
measure: Hope
timeFrame: 6, 12, 24 and 36 months after assignment to the lottery
measure: Preferences survey
timeFrame: 6, 12, 24 and 36 months after assignment to the lottery
measure: Time preference: Hyperbolicity
timeFrame: 6, 12, 24 and 36 months after assignment to the lottery
measure: Time Preferences: Patience
timeFrame: 6, 12, 24 and 36 months after assignment to the lottery
measure: Time Horizon
timeFrame: 6, 12, 24 and 36 months after assignment to the lottery
measure: HIV Stigma
timeFrame: 6, 12, 24 and 36 months after assignment to the lottery
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References: