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.
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
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.
- Conditions
- HIV (Human Immunodeficiency Virus)
- 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 group | Role | What they receive |
|---|---|---|
| Lump sum | Experimental | Participants receive the full guaranteed income amount ($6,750) as one lump sum payment at the beginning of the study. Receives: Other: Lump sum |
| Monthly Installments | Experimental | Participants receive the guaranteed income intervention split into 9-monthly installments of $750/month Receives: Other: Monthly installments |
| Choice | Experimental | Participants 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.
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)
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
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.
- First posted11 Aug 2025
- Study start1 Dec 2025
- Primary completion25 Feb 2027 (estimated)
- Study completion25 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HIV (Human Immunodeficiency Virus)Studies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul D Wesson, PhD, Principal investigator, University of California, San Francisco
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 31372909West 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 37037977Moher 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 34705154Iroh 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 25973818Badowski 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
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guaranteed Income to Boost HIV Care Continuity and Suppression Post-Jail Release
- ClinicalTrials.gov ID
- NCT07115901
- Acronym / sponsor ID
- GI-BOOST / 25-43573
- Conditions
- HIV (Human Immunodeficiency Virus)
- Keywords
- HIV, Guaranteed Income, Criminal Legal Involvement
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 25 Feb 2027 (estimated)
- Study completion
- 25 Feb 2027 (estimated)
- First posted
- 11 Aug 2025 (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 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.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lump sum | Experimental | Other: Lump sumParticipants receive the full guaranteed income amount ($6,750) as one lump sum payment at the beginning of the study. |
| Monthly Installments | Experimental | Other: Monthly installmentsParticipants receive the guaranteed income intervention split into 9-monthly installments of $750/month |
| Choice | Experimental | Other: ChoiceParticipants choose which method of Guaranteed Income disbursement they will receive (either lump sum or monthly installments). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Individuals with an active psychosis who are not on treatment
- individuals who do not have a social security number or individual tax ID number
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 |
|---|---|---|
| Lump sumParticipants receive guaranteed income (GI) to the amount of $6,750 as a one-time lump sum payment. | Other | Lump sum |
| Monthly installmentsParticipants receive guaranteed income (GI) to the total amount of $6,750 as 9-monthly installments of $750 per month | Other | Monthly Installments |
| ChoiceParticipants choose which method of guaranteed income disbursement they will receive (lump sum or monthly installment) | Other | Choice |
Primary outcome
HIV viral suppression
Time frame: From enrollment to end of the intervention at 9 months
Percent of participants (total and by randomization arm) that are HIV virally suppressed at 9 months
2 secondary outcomes
Linkage to HIV care
Time frame: From enrollment to one month after enrollment
Retention in HIV care
Time frame: From enrollment to end of intervention at 9 months
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 9 Jun 2026.
- Background: PubMed 31372909Delevry 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.
- Background: PubMed 37037977West 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.
- Background: PubMed 34705154Moher 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.
- Background: PubMed 25973818Iroh 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.
- Background: PubMed 35447035Badowski 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.
- Individual participant dataSharing planned: 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.
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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. This study is not recruiting at the moment.
Paul D Wesson, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
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.