NCT07502365

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.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
304

participants targeted

Target at P50-P75 for not_applicable hiv

Timeline
49mo left

Started Apr 2026

Longer than P75 for not_applicable hiv

Status
not yet 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 Progress5%
Apr 2026Jul 2030

First Submitted

Initial submission to the registry

March 25, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 31, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2030

Last Updated

April 13, 2026

Status Verified

March 1, 2026

Enrollment Period

4.3 years

First QC Date

March 25, 2026

Last Update Submit

April 6, 2026

Conditions

HIVFinancial Stress

Keywords

HIVFinancial Stress

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Treatment As Usual

ACTIVE COMPARATOR

Baseline survey

Behavioral: Treatment As Usual

Treatment As Usual plus Basic Income Guaranteed (BIG) Intervention

EXPERIMENTAL

Baseline survey and BIG intervention

Behavioral: BIG + Treatment As Usual

Interventions

Treatment As UsualBEHAVIORAL

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

Treatment As Usual
BIG + Treatment As UsualBEHAVIORAL

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.

Treatment As Usual plus Basic Income Guaranteed (BIG) Intervention

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Living with HIV for 24 months or longer;
  • Ages 18-35;
  • English-speaking;
  • One or both of the following:
  • Experienced a gap in HIV provider care of 6 or greater months during the prior 12-month period;
  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Financial Stress

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Jade Pagkas-Bather

    University of Chicago

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jordan Victorian

CONTACT

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

Jade Pagkas-Bather

CONTACT

jpagkasbather@bsd.uchicago.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2026

First Posted

March 31, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

July 1, 2030

Study Completion (Estimated)

July 1, 2030

Last Updated

April 13, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share