Transitional Housing and HIV Health

March 18, 2026 updated by: University of Pennsylvania

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:

  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.

Study Overview

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 Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
      • Philadelphia, Pennsylvania, United States, 19104
        • Not yet recruiting
        • University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

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.

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
From lottery to 12 months after the lottery
ART adherence
Time Frame: During discrete 3-month periods up to 12 months after the lottery
ART adherence (survey population)
During discrete 3-month periods up to 12 months after the lottery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Engagement in HIV care
Time Frame: From lottery to 12 months after the lottery
Engagement in HIV care (defined as having an HIV viral load or CD4 count measured within a 6-month period). (Lottery Population)
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
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.
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
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.
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
Cigarette Dependence Scale: CDS-5 (Survey Population). Scored on a scale 1-5
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
National Institute on Drug Abuse. Screening for Drug Abuse in General Medical Settings. (Survey Population)
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
(Survey Population)
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
(Survey Population)
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
Outpatient, ED/inpatient, prescription, other (survey population)
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
(survey population)
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
US Census Bureau. 2019 American Housing Survey Instrument Items. (Survey population)
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
Cerin E, Saelens BE, Sallis JF, Frank LD. Neighborhood Environment Walkability Scale (survey population)
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
Housing Satisfaction for Persons with Psychiatric Disabilities (survey population)
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
(survey population)
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
(survey population)
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
(survey population)
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
CFPB (survey population)
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
USDA (survey population)
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
Perceived Stress Scale (survey population)
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
Kessler 6+ (survey population)
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
State Hope Scale (Survey population). 8-item scale
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
Preference Survey Probabilistic Scale (survey population). Scale 0-10 with higher number indicating better outcome.
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
Brownback incentivized questions (survey population)
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
Brownback incentivized questions (survey population)
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
Laajaj (survey population)
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
HIV stigma scale, short form (survey population)
6, 12, 24 and 36 months after assignment to the lottery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 25, 2025

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

August 1, 2028

Study Registration Dates

First Submitted

January 28, 2025

First Submitted That Met QC Criteria

February 10, 2025

First Posted (Actual)

February 17, 2025

Study Record Updates

Last Update Posted (Actual)

March 23, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 855009

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe