Recruiting

BIG & Treatment as Usual

Sponsor:

University of Chicago

Code:

NCT07502365

Conditions

HIV

Financial Stress

Eligibility Criteria

Sex: All

Age: 18 - 35

Healthy Volunteers: Not accepted

Interventions

Treatment As Usual

BIG + Treatment As Usual

Study Details

Brief summary:

The goal of this clinical trial is to compare two interventions - Basic Income Guarantee (BIG) + Treatment as Usual and Treatment as Usual among individuals living with HIV who have experienced financial hardships.

The main question it aims to answer is:

Compared with the Treatment as Usual group, will participants in the BIG + Treatment as Usual group be more likely to improve care engagement and viral suppression?

Participants on the study will be:

  • Randomly assigned (like the flip of a coin) to participate in either BIG + Treatment as Usual or Treatment as Usual. Participants will have an equal chance of being placed in either group.
  • Complete 9 surveys over a 36 month period.
  • Complete a release of information so electronic medical record data can be accessed for the 18 months prior to treatment engagement and for 36 months from program enrollment.
  • Participants in the Treatment as Usual group will not receive any intervention.
  • HIV viral load testing will be confirmed at 3 timepoints (baseline, 12 months, and 18 months).
  • Participants in the BIG + Treatment as Usual group will receive $500 monthly income for 18 months.
  • Participants in the BIG + Treatment as Usual group will complete 3 social network surveys to assess how receiving BIG impacts their social networks.
  • A subset of participants in the BIG + Treatment as Usual group (30 participants) will complete 5 individual interviews over the course of receiving BIG and the 18 months after.

Conditions

HIV

Financial Stress

Study ID

NCT07502365

Start date

Jul 29, 2026

Status verified date

Aug, 2026

Completion date

Jul, 2030

Anticipated

Primary completion date

Jul, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 35

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Living with HIV for 24 months or longer;
  • Ages 18-35;
  • English-speaking;
  • One or both of the following:

1. Experienced a gap in HIV provider care of 6 or greater months during the prior 12-month period;
2. Had an unsuppressed viral load at any point within the prior 12-month period (unsuppressed meaning a viral load of 200 copies/mL or higher);
  • Household income at or below 250% of the Federal Poverty Level; and
  • Experiencing financial distress, as based on a financial well-being score of 1-4 (high financial distress).

Exclusion Criteria:

  • Unwilling/unable to provide informed consent
  • Unable to confirm HIV status
  • Unable to conduct the study in English

Study Design

Enrollment

304 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: Treatment As Usual

Baseline survey

experimental: Treatment As Usual plus Basic Income Guaranteed (BIG) Intervention

Baseline survey and BIG intervention

Interventions

Treatment As Usual

Participants will go through a baseline survey. Participants will go through a follow-up survey every six months.

BIG + Treatment As Usual

Participants will go through a baseline survey. Participants will go through a follow-up survey every six months. Participants will also receive a $500 monthly income over an 18-month period.

Primary outcome measure

  • Retention in HIV care [ Time Frame: 18 months prior to baseline, to 36 months after baseline ]
  • HIV Viral Suppression [ Time Frame: 18 months prior to baseline, to 36 months after baseline ]

Central Contacts and Locations

Central contacts

Jordan Victorian

773-702-5915jordan.victorian@bsd.uchicago.edu

Jade Pagkas-Bather

jpagkasbather@bsd.uchicago.edu

Locations

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Jordan Victorian

773-702-5915jordan.victorian@bsd.uchicago.edu

Jade Pagkas-Bather

jpagkasbather@bsd.uchicago.edu

Principal Investigator:

Jade Pagkas-Bather, MD, MPH

More Information

Sponsor

University of Chicago

Last update posted

Aug 6, 2026

Last verified

Aug, 2026

Keywords

  • HIV
  • Financial Stress

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Chicago on 2026-08-06.