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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07115901
Acronym
GI-BOOST
Enrollment
33
Registered
2025-08-11
Start date
2025-12-01
Completion date
2027-02-25
Last updated
2026-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV (Human Immunodeficiency Virus)

Keywords

HIV, Guaranteed Income, Criminal Legal Involvement

Brief 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). 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.

Interventions

OTHERLump sum

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

OTHERMonthly installments

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

OTHERChoice

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

Sponsors

University of California, San Francisco
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
HIV viral suppressionFrom enrollment to end of the intervention at 9 monthsPercent of participants (total and by randomization arm) that are HIV virally suppressed at 9 months

Secondary

MeasureTime frameDescription
Linkage to HIV careFrom enrollment to one month after enrollmentPercentage of participants (in total and by randomization arm) that have linked to an HIV care provider within one month of study enrollment
Retention in HIV careFrom enrollment to end of intervention at 9 monthsPercent 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

Countries

United States

Contacts

CONTACTPaul D Wesson, PhD
paul.wesson@ucsf.edu415-476-2300
CONTACTGraham Hinchcliffe, MS
Graham.Hinchcliffe@ucsf.edu
PRINCIPAL_INVESTIGATORPaul D Wesson, PhD

University of California, San Francisco

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026