Recruiting

HIV Health

Sponsor:

University of Pennsylvania

Code:

NCT06829394

Conditions

HIV

HIV Antiretroviral Therapy (ART) Adherence

Housing Instability

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Program Assignment

Study Details

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. 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.

Conditions

HIV

HIV Antiretroviral Therapy (ART) Adherence

Housing Instability

Study ID

NCT06829394

Start date

Feb 25, 2025

Status verified date

Mar, 2026

Completion date

Aug, 2028

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

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Exclusion Criteria: Does not meet the above inclusion criteria.

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Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Interventions

Program Assignment

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

Primary outcome measure

  • HIV viral suppression - defined as HIV RNA < 200 copies/mL [ Time Frame: From lottery to 12 months after the lottery ]
  • ART adherence [ Time Frame: During discrete 3-month periods up to 12 months after the lottery ]

Central Contacts and Locations

Central contacts

Aaron Richterman, MD, MPH

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

Eva Fabian, MPH

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

Locations

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Eva Fabian, MPH

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

More Information

Sponsor

University of Pennsylvania

Last update posted

Mar 23, 2026

Last verified

Mar, 2026

Keywords

  • HIV
  • Housing
  • Structural Interventions

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2026-03-23.