Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2025-02-25
2028-08-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Arms Around You Program Waitlist
These are individuals that are part of the lottery but not yet assigned to the program.
No interventions assigned to this group
Arms Around You Program Recipients
These are individuals that were part of the lottery AND assigned to the program
Program Assignment
The intervention group will include People living with HIV who were assigned to the Arms Around You Program in the lottery.
Interventions
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Program Assignment
The intervention group will include People living with HIV who were assigned to the Arms Around You Program in the lottery.
Eligibility Criteria
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Inclusion Criteria
\-
18 Years
ALL
No
Sponsors
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Philadelphia Department of Public Health
OTHER_GOV
University of Pennsylvania
OTHER
Responsible Party
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Locations
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University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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855009
Identifier Type: -
Identifier Source: org_study_id
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