Transitional Housing and HIV Health

University of Pennsylvania

Status: Enrolling

Conditions: HIV Antiretroviral Therapy (ART) Adherence; Housing Instability; HIV

Treatments: Other: Program Assignment

Study type: Observational

Funder types: Other

Identifiers

NCT06829394

855009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Exclusion Criteria: Does not meet the above inclusion criteria.

Trial design

200 participants in 2 patient groups

Arms Around You Program Waitlist

Description:

These are individuals that are part of the lottery but not yet assigned to the program.

Arms Around You Program Recipients

Description:

These are individuals that were part of the lottery AND assigned to the program

Treatment:

Other: Program Assignment