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临床试验/NCT07115901
NCT07115901进行中(未招募)不适用

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

University of California, San Francisco2 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2025年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
33
试验地点
2
主要终点
HIV viral suppression

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

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

研究组 & 干预措施

Lump sum

Experimental

Participants receive the full guaranteed income amount ($6,750) as one lump sum payment at the beginning of the study.

干预措施: Lump sum (Other)

Monthly Installments

Experimental

Participants receive the guaranteed income intervention split into 9-monthly installments of $750/month

干预措施: Monthly installments (Other)

Choice

Experimental

Participants choose which method of Guaranteed Income disbursement they will receive (either lump sum or monthly installments).

干预措施: Choice (Other)

结局指标

主要结局

HIV viral suppression

时间窗: 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

HIV viral suppression

时间窗: 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

次要结局

  • Linkage to HIV care(From enrollment to one month after enrollment)
  • Retention in HIV care(From enrollment to end of intervention at 9 months)
  • Linkage to HIV care(From enrollment to one month after enrollment)
  • Retention in HIV care(From enrollment to end of intervention at 9 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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