BIG Chicago: A Trial of Basic Income Guarantee for Young People Living With HIV

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.

Study Overview

• Status: Not yet recruiting
• Conditions: HIV; Financial Stress
• Intervention / Treatment: Behavioral: Treatment As Usual; Behavioral: BIG + Treatment As Usual

Detailed Description

For this randomized controlled trial, the study will recruit, screen, and enroll a total sample of 304 adults aged 18-35 years living with HIV. Participants will be recruited through networks of community-based organizations, HIV care providers, and other community partners. Eligible participants will include individuals who have experienced interruptions in HIV care, defined as being out of HIV care for more than six months within the past 24 months and/or having a detectable HIV viral load (≥200 copies/mL). Eligibility screening and enrollment will be conducted by University of Chicago research staff. Following eligibility confirmation, research staff will explain the scope of the study, the basic income intervention, and participant expectations. All participants will complete informed consent procedures prior to study enrollment. Participants will also complete a release of information authorizing access to electronic medical record data for the purposes of assessing HIV viral load and HIV care engagement throughout the study period.

Randomization and Study Conditions After completion of baseline procedures, participants will be randomized in a 1:1 ratio to either the Basic Income Guarantee (BIG) intervention arm (n=152) or a treatment-as-usual control arm (n=152). Participants randomized to treatment as usual will continue to receive any services and supports they would otherwise access in the community, without receipt of study-provided cash transfers.

Basic Income Guarantee Intervention Participants assigned to the BIG intervention will receive unconditional cash transfers of $500 per month for a total duration of 18 months. Payments will be delivered via reloadable gift cards. The first payment will be issued within the first 10 days of the month following study enrollment and completion of the baseline assessment. No conditions or behavioral requirements are attached to receipt of the cash transfers. All participants, regardless of study arm, will be offered optional financial counseling resources; participation in financial counseling is not required to receive study payments.

Data Collection Procedures Baseline (T1). At enrollment, all participants will complete a baseline survey assessing domains including financial security, employment, housing stability, physical health, mental health, and access to public benefits and social services. Baseline procedures will be completed prior to randomization.

HIV viral load testing. The study will collect HIV viral loads for all participants at baseline and 12 and 18 months. Participants may either: (1) complete a lab blood draw test performed by UChicago testing services staff at the Chicago Center for HIV Elimination (CCHE), or (2) provide study staff with recent test results or documentation of viral load (dated within the prior 30 days of viral load timepoint).

Follow-up Surveys. All participants will complete follow-up surveys every six months for a total of 36 months post-enrollment. Follow-up surveys will reassess baseline domains, including financial security, employment, housing, physical and mental health, and benefit access. Surveys will be administered either remotely or in person using secure data collection platforms.

Social Network Surveys (BIG Arm Only). Participants in the BIG intervention arm will complete a social network survey at baseline, 12 months, and 18 months to examine changes in social ties, support, and resource sharing over the course of the cash transfer period.

Qualitative Interviews (BIG Subsample). A purposive subsample of 30 participants from the BIG intervention arm will participate in longitudinal, in-depth qualitative interviews to explore participants' experiences with the basic income intervention and its perceived impacts. Interviews will occur at baseline and at approximately 9, 18, 27, and 36 months post-enrollment.

Clinical Outcomes All participants will provide authorization for research staff to access electronic medical record data. Primary outcomes will include HIV viral load and HIV care engagement, assessed via medical record abstraction at multiple time points throughout the 36-month study period.

• Study Type: Interventional
• Enrollment (Estimated): 304
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jordan Victorian; Phone Number: 773-702-5915; Email: jordan.victorian@bsd.uchicago.edu
• Study Contact Backup: Name: Jade Pagkas-Bather; Email: jpagkasbather@bsd.uchicago.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Treatment As Usual; Baseline survey	Behavioral: Treatment As Usual; Participants will go through a baseline survey. Participants will go through a follow-up survey every six months.
Experimental: Treatment As Usual plus Basic Income Guaranteed (BIG) Intervention; Baseline survey and BIG intervention	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retention in HIV care	Number of participants who do not experience gaps in care >4 months	18 months prior to baseline, to 36 months after baseline
HIV Viral Suppression	Number of participants with an HIV viral load <200 copies/mL	18 months prior to baseline, to 36 months after baseline

Collaborators and Investigators

• Sponsor: University of Chicago
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Jade Pagkas-Bather, University of Chicago

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): July 1, 2030

Study Registration Dates

• First Submitted: March 25, 2026
• First Submitted That Met QC Criteria: March 25, 2026
• First Posted (Actual): March 31, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 6, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: HIV; Financial Stress
• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological; Behavior; Financial Stress; Therapeutics
• Other Study ID Numbers: IRB25-0785; 1R01MH140688 (U.S. NIH Grant/Contract)

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