NCT06829394

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. 1.How does AAY affect HIV-related outcomes, particularly viral suppression and antiretroviral therapy (ART) adherence?
  2. 2.What are the program's effects on economic, psychological, and secondary health outcomes?
  3. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
27mo left

Started Feb 2025

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress35%
Feb 2025Aug 2028

First Submitted

Initial submission to the registry

January 28, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 17, 2025

Completed
8 days until next milestone

Study Start

First participant enrolled

February 25, 2025

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Last Updated

March 23, 2026

Status Verified

March 1, 2026

Enrollment Period

2.8 years

First QC Date

January 28, 2025

Last Update Submit

March 18, 2026

Conditions

Housing InstabilityHIVHIV Antiretroviral Therapy (ART) Adherence

Keywords

HIVHousingStructural Interventions

Outcome Measures

Primary Outcomes (2)

  • 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)

    From lottery to 12 months after the lottery

  • ART adherence

    ART adherence (survey population)

    During discrete 3-month periods up to 12 months after the lottery

Secondary Outcomes (25)

  • Engagement in HIV care

    From lottery to 12 months after the lottery

  • Health Related Quality of Life

    6, 12, 24 and 36 months after assignment to the lottery

  • Alcohol use

    6, 12, 24 and 36 months after assignment to the lottery

  • Cigarette Dependence

    6, 12, 24 and 36 months after assignment to the lottery

  • Recent Substance Use

    6, 12, 24 and 36 months after assignment to the lottery

  • +20 more secondary outcomes

Study Arms (2)

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

Other: Program Assignment

Interventions

Program AssignmentOTHER

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

Arms Around You Program Recipients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

NOT YET RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Central Study Contacts

Aaron Richterman, MD, MPH

CONTACT

267-441-7915Aaron.Richterman@Pennmedicine.upenn.edu

Eva Fabian, MPH

CONTACT

760-791-2633eva.fabian@pennmedicine.upenn.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2025

First Posted

February 17, 2025

Study Start

February 25, 2025

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

August 1, 2028

Last Updated

March 23, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(2)