HIVNCT07502365
BIG Chicago: A Trial of Basic Income Guarantee for Young People Living With HIV
A study testing Treatment As Usual and BIG + Treatment As Usual in people with HIV and Financial Stress, run by University of Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- HIV, Financial Stress
- What is being tested?
- Treatment As Usual and BIG + Treatment As Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 304 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jul 2026to Jul 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- Unwilling/unable to provide informed consent
- Unable to confirm HIV status
- Unable to conduct the study in English
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jade Pagkas-Bather contact
United States1 site, 1 recruiting
- Recruiting
University of Chicago
Chicago, Illinois, 60637
Jordan Victorian, 773-702-5915, jordan.victorian@bsd.uchicago.edu
Jade Pagkas-Bather, jpagkasbather@bsd.uchicago.edu
About this study
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:
Read more
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.
Read the 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.
- Conditions
- HIV, Financial Stress
- Being tested
- Treatment As Usual, BIG + Treatment As Usual
- Keywords
- HIV, Financial Stress
- Medical subject headings
- Financial Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment As UsualBehavioural
Participants will go through a baseline survey. Participants will go through a follow-up survey every six months.
BIG + Treatment As UsualBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment As Usual | Active comparator | Baseline survey Receives: Behavioral: Treatment As Usual |
| Treatment As Usual plus Basic Income Guaranteed (BIG) Intervention | Experimental | Baseline survey and BIG intervention Receives: Behavioral: BIG + Treatment As Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention in HIV care
Number of participants who do not experience gaps in care >4 months
Measured: 18 months prior to baseline, to 36 months after baseline
HIV Viral Suppression
Number of participants with an HIV viral load <200 copies/mL
Measured: 18 months prior to baseline, to 36 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start29 Jul 2026
- Primary completionJul 2030 (estimated)
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 304 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Jade Pagkas-Bather, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07502365
- Sponsor's protocol ID
- IRB25-0785
- Other IDs
- 1R01MH140688
- Status last verified
- Aug 2026
- First submitted
- 25 Mar 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BIG Chicago: A Trial of Basic Income Guarantee for Young People Living With HIV
- ClinicalTrials.gov ID
- NCT07502365
- Acronym / sponsor ID
- IRB25-0785
- Conditions
- HIV, Financial Stress
- Keywords
- HIV, Financial Stress
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 304 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 29 Jul 2026 (actual)
- Primary completion
- Jul 2030 (estimated)
- Study completion
- Jul 2030 (estimated)
- First posted
- 31 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment As Usual | Active comparator | Behavioral: Treatment As UsualBaseline survey |
| Treatment As Usual plus Basic Income Guaranteed (BIG) Intervention | Experimental | Behavioral: BIG + Treatment As UsualBaseline survey and BIG intervention |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Living with HIV for 24 months or longer;
- Ages 18-35;
- English-speaking;
- One or both of the following:
- Household income at or below 250% of the Federal Poverty Level; and
Key exclusion criteria (3 listed)
- Unwilling/unable to provide informed consent
- Unable to confirm HIV status
- Unable to conduct the study in English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment As UsualParticipants will go through a baseline survey. Participants will go through a follow-up survey every six months. | Behavioural | Treatment As Usual |
| BIG + Treatment As UsualParticipants 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. | Behavioural | Treatment As Usual plus Basic Income Guaranteed (BIG) Intervention |
Primary outcome
Retention in HIV care
Time frame: 18 months prior to baseline, to 36 months after baseline
Number of participants who do not experience gaps in care >4 months
HIV Viral Suppression
Time frame: 18 months prior to baseline, to 36 months after baseline
Number of participants with an HIV viral load <200 copies/mL
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jade Pagkas-Bather contact
Jade Pagkas-Bather principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment As Usual and BIG + Treatment As Usual in people with HIV and Financial Stress, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jordan Victorian (773-702-5915, jordan.victorian@bsd.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention in HIV care (time frame: 18 months prior to baseline, to 36 months after baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.