Transitional Housing and HIV Health
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Pennsylvania
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Program Assignment
Other interventionThe intervention group will include People living with HIV who were assigned to the Arms Around You Program in the lottery.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Arms Around You Program Waitlist0 interventions
Group B: Arms Around You Program Recipients1 intervention
Trial outcomes
Primary outcomes
1
HIV viral suppression - defined as HIV RNA < 200 copies/mL
HIV viral suppression during two discrete 6-month periods after the lottery for access to the AAY program. (Lottery population)
Time frame
From lottery to 12 months after the lottery2
ART adherence
ART adherence (survey population)
Time frame
During discrete 3-month periods up to 12 months after the lotterySecondary outcomes
1
Engagement in HIV care
Engagement in HIV care (defined as having an HIV viral load or CD4 count measured within a 6-month period). (Lottery Population)
Time frame
From lottery to 12 months after the lottery2
Health Related Quality of Life
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.
Time frame
6, 12, 24 and 36 months after assignment to the lottery3
Alcohol use
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.
Time frame
6, 12, 24 and 36 months after assignment to the lottery4
Cigarette Dependence
Cigarette Dependence Scale: CDS-5 (Survey Population). Scored on a scale 1-5
Time frame
6, 12, 24 and 36 months after assignment to the lotterySponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Pennsylvania
Lead sponsor
Philadelphia Department of Public Health
Collaborator
Source ClinicalTrials.gov