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HIV (Human Immunodeficiency Virus)GI-BOOSTNCT07115901

Guaranteed Income to Boost HIV Care Continuity and Suppression Post-Jail Release

A study testing Lump sum, Monthly installments and Choice in people with HIV (Human Immunodeficiency Virus), run by University of California, San Francisco at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The goal of this clinical trial is to understand the implementation requirements and potential health impacts of a guaranteed income (GI) intervention targeting people living with HIV with criminal legal involvement (PWH-CLI). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV (Human Immunodeficiency Virus)
What is being tested?
Lump sum, Monthly installments and Choice
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
1 siteUnited States
Study dates
1 Dec 2025to 25 Feb 2027
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 years of age or older,
  • Living with an HIV diagnosis
  • Have a recent incarceration in the San Francisco County Jail (within three months of study enrollment)
  • Qualify as very low income (for example, currently experiencing homelessness or having an income less than 30% of the area median income).
  • English literate.

Who cannot join

  • Individuals with an active psychosis who are not on treatment
  • individuals who do not have a social security number or individual tax ID number

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of California, San Francisco

    San Francisco, California, 94158

Other trials in United States

About this study

The goal of this clinical trial is to understand the implementation requirements and potential health impacts of a guaranteed income (GI) intervention targeting people living with HIV with criminal legal involvement (PWH-CLI). The main questions it aims to answer are:

  • How acceptable is a GI intervention, and its intervention components, among PWH-CLI participants and stakeholders?
  • How feasible is a GI intervention for PWH-CLI? What are the implementation barriers and opportunities for this intervention?
  • What is the preliminary efficacy of the GI intervention on improving HIV care outcomes for PWH-CLI? Researches will compare study engagement and study outcomes across three randomization arms (A: receive full GI amount as one lump sum payment; B: receive full GI amount split over nine monthly installments; C: participant chooses whether to receive GI as lump sum payment or monthly installments). HIV care outcomes will be compared against a retrospective cohort of PWH-CLI patients as historical controls.
Read more

Participants will:

  • Be randomized to receive GI intervention as a lump sum payment or monthly installment (over nine months) or choose their preference.
  • Complete 3 surveys throughout study follow up to assess experience with the intervention, experience with social services and benefits programs, experience with the criminal legal system, and HIV care outcomes.
  • Be interviewed by the research team to further understand the experience with the intervention.
Read the detailed description

One-in-seven people living with HIV (PWH) experience incarceration annually. HIV prevalence among those with criminal legal involvement (CLI) is 3x higher than the general population. Upon release, PWH-CLI encounter competing priorities and structural barriers to addressing unmet basic needs, resulting in suboptimal care cascade outcomes. Guaranteed income (GI) through unconditional cash transfers can improve mental health, meet basic needs, and boost employment prospects. However, its effects on PWH-CLI, who face unique post-release challenges affecting HIV treatment retention and viral suppression, remain uncharacterized.

This three-arm pilot study will assess the feasibility, acceptability, implementation requirements, and preliminary efficacy of a GI intervention to improve HIV care in PWH-CLI released from the San Francisco County (SFC) jail. The investigators will randomize up to 33 very low-income patients discharged to a SFDPH network HIV clinic to 1 of 3 arms: A) one lump-sum payment of $6,750; B) 9-monthly installments of $750; or C) "preference" (patient chooses either A or B). The investigators will offer opt-in financial mentoring (FM) sessions during the pilot to bolster GI impacts. Clinical appointment and viral load outcome data will be collected from medical records. All patients will complete quantitative surveys (1 baseline, 2 follow-up) to assess GI experience, patient context, and acceptability. Baseline and endline qualitative interviews with patients (n=12; 4/arm) will explore the GI experience, impacts on HIV treatment, and critical implementation questions to inform future research and policy. Qualitative interviews with system partners (n=10) will explore community perceptions of GI and opportunities to integrate GI in HIV programming and policy.

Given PWH-CLI's economic and social marginalization, the investigators will leverage an existing retrospective cohort of PWH-CLI released from SFC jail as historical controls to test preliminary efficacy against pilot participants - comparing clinical appointments and viral load - instead of utilizing a concurrent no-GI control group. Variation in GI disbursement will provide needed data on acceptability and preliminary efficacy of distribution modes and the role of patient agency in pilot outcomes and overall engagement.

The investigators will pilot a GI intervention for PWH-CLI leaving SFC jail, aiming to reduce structural barriers to care and improve HIV care cascade engagement. The specific aims are to:

(Aim 1) Determine GI intervention acceptability among PWH-CLI and stakeholders. The investigators will explore patient preference for GI disbursement and if GI mode impacts successful HIV care engagement and study procedures through longitudinal qualitative interviews. Thematic analysis will elucidate individual impacts of GI amidst contextual facilitators and barriers to care. Qualitative interviews with system partners will gauge community and policy perceptions of GI intervention acceptability and optimal means to integrate.

(Aim 2) Assess GI intervention feasibility and implementation barriers/opportunities for PWH-CLI. Feasibility measures include differences in study engagement (FM uptake, surveys) by randomization arm. The investigators will assess reported GI receipt experience for PWH-CLI who do/not access other safety net programs and for those experiencing unstable housing, residential treatment programs, and re-incarceration to understand overlap and benefit combinations with other state/county programs to optimize future implementation.

(Aim 3) Test preliminary efficacy of the GI intervention on improving HIV care outcomes. By randomization arm, the investigators will compare the percentage linked to an HIV care provider within 30 days of jail release, retained in HIV care (>= 2 visit >=90 days apart), and virally suppressed at 9 months. GI pilot HIV cascade outcomes will be compared to propensity-matched historical controls from our retrospective cohort of PWH-CLI. The investigators will also assess group differences in re-incarceration rates.

A significant subset of PWH, PWH-CLI are among the least retained in HIV care and adherent to ART. This research will bridge current knowledge gaps by testing GI implementation strategies, assessing community support and integration opportunities, and testing preliminary efficacy in HIV care outcomes to inform a large-scale trial.

Being tested
Lump sum, Monthly installments, Choice
Keywords
HIV, Guaranteed Income, Criminal Legal Involvement
Medical subject headings
Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lump sumOther

    Participants receive guaranteed income (GI) to the amount of $6,750 as a one-time lump sum payment.

  • Monthly installmentsOther

    Participants receive guaranteed income (GI) to the total amount of $6,750 as 9-monthly installments of $750 per month

  • ChoiceOther

    Participants choose which method of guaranteed income disbursement they will receive (lump sum or monthly installment)

Study groups in NCT07115901
Study groupRoleWhat they receive
Lump sumExperimentalParticipants receive the full guaranteed income amount ($6,750) as one lump sum payment at the beginning of the study.
Receives: Other: Lump sum
Monthly InstallmentsExperimentalParticipants receive the guaranteed income intervention split into 9-monthly installments of $750/month
Receives: Other: Monthly installments
ChoiceExperimentalParticipants choose which method of Guaranteed Income disbursement they will receive (either lump sum or monthly installments).
Receives: Other: Choice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HIV viral suppression

    Percent of participants (total and by randomization arm) that are HIV virally suppressed at 9 months

    Measured: From enrollment to end of the intervention at 9 months

Secondary outcomes (2)
  1. Linkage to HIV care

    Percentage of participants (in total and by randomization arm) that have linked to an HIV care provider within one month of study enrollment

    Measured: From enrollment to one month after enrollment

  2. Retention in HIV care

    Percent of participants (in total and by randomization arm) that are retained in HIV care (defined as two or more HIV care visits and/or viral load measurements at least 90 days apart from each other) at 9 months

    Measured: From enrollment to end of intervention at 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2025
  2. Study start1 Dec 2025
  3. Primary completion25 Feb 2027 (estimated)
  4. Study completion25 Feb 2027 (estimated)

Resources

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
33 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07115901
Sponsor's protocol ID
25-43573
Other IDs
H25EJ9047
Acronym
GI-BOOST
Status last verified
Jun 2026
First submitted
4 Aug 2025
Last updated
9 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Given the small projected sample size for this pilot study (n=33) and the vulnerable nature of the study population (people living with HIV with recent criminal legal involvement), we do not have plans to share IPD in order to protect participant anonymity.

Publications

  • Delevry D, Le QA. Effect of Treatment Preference in Randomized Controlled Trials: Systematic Review of the Literature and Meta-Analysis. Patient. 2019 Dec;12(6):593-609. doi: 10.1007/s40271-019-00379-6.

    PubMed 31372909
  • West S, Castro A. Impact of Guaranteed Income on Health, Finances, and Agency: Findings from the Stockton Randomized Controlled Trial. J Urban Health. 2023 Apr;100(2):227-244. doi: 10.1007/s11524-023-00723-0. Epub 2023 Apr 10.

    PubMed 37037977
  • Moher M, Erickson M, Black P, Price M, Fraser C, Norman WV, Guillemi S, Pick N, Elwood Martin R. Improving Post-Release Care Engagement for People Living with HIV Involved in the Criminal Justice System: A Systematic Review. AIDS Behav. 2022 May;26(5):1607-1617. doi: 10.1007/s10461-021-03513-4. Epub 2021 Oct 27.

    PubMed 34705154
  • Iroh PA, Mayo H, Nijhawan AE. The HIV Care Cascade Before, During, and After Incarceration: A Systematic Review and Data Synthesis. Am J Public Health. 2015 Jul;105(7):e5-16. doi: 10.2105/AJPH.2015.302635. Epub 2015 May 14.

    PubMed 25973818
  • Badowski ME, Patel M. Evaluation of Immunologic and Virologic Function in Reincarcerated Patients Living With HIV or AIDS. J Correct Health Care. 2022 Jun;28(3):203-206. doi: 10.1089/jchc.20.07.0055. Epub 2022 Apr 21.

    PubMed 35447035

Questions about this trial

What is this clinical trial studying?

A study testing Lump sum, Monthly installments and Choice in people with HIV (Human Immunodeficiency Virus), run by University of California, San Francisco 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 5 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 9 Jun 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HIV viral suppression (time frame: From enrollment to end of the intervention at 9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07115901, which also lists 5 linked publications.

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 9 Jun 2026.

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