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| ID | Type | Description | Link |
|---|---|---|---|
| H25EJ9047 | Other Grant/Funding Number | California HIV/AIDS Research Program |
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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:
Participants will:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lump sum | Experimental | Participants receive the full guaranteed income amount ($6,750) as one lump sum payment at the beginning of the study. |
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| Monthly Installments | Experimental | Participants receive the guaranteed income intervention split into 9-monthly installments of $750/month |
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| Choice | Experimental | Participants choose which method of Guaranteed Income disbursement they will receive (either lump sum or monthly installments). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lump sum | Other | Participants receive guaranteed income (GI) to the amount of $6,750 as a one-time lump sum payment. |
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| Measure | Description | Time Frame |
|---|---|---|
| HIV viral suppression | Percent of participants (total and by randomization arm) that are HIV virally suppressed at 9 months | From enrollment to end of the intervention at 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From enrollment to one month after enrollment |
| Retention in HIV care |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul D Wesson, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94158 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31372909 | Background | 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. | |
| 37037977 | Background | 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. |
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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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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| Monthly installments | Other | Participants receive guaranteed income (GI) to the total amount of $6,750 as 9-monthly installments of $750 per month |
|
| Choice | Other | Participants choose which method of guaranteed income disbursement they will receive (lump sum or monthly installment) |
|
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
| From enrollment to end of intervention at 9 months |
| 34705154 | Background | 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. |
| 25973818 | Background | 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. |
| 35447035 | Background | 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. |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |