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临床试验/NCT07502365
NCT07502365招募中不适用

BIG Chicago: A Trial of Basic Income Guarantee for Young People Living With HIV

University of Chicago1 个研究点 分布在 1 个国家目标入组 304 人开始时间: 2026年7月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
304
试验地点
1
主要终点
Retention in HIV care

研究概览

简要总结

The goal of this clinical trial is to compare two interventions - Basic Income Guarantee (BIG) + Treatment as Usual and Treatment as Usual among individuals living with HIV who have experienced financial hardships.

The main question it aims to answer is:

Compared with the Treatment as Usual group, will participants in the BIG + Treatment as Usual group be more likely to improve care engagement and viral suppression?

Participants on the study will be:

  • Randomly assigned (like the flip of a coin) to participate in either BIG + Treatment as Usual or Treatment as Usual. Participants will have an equal chance of being placed in either group.
  • Complete 9 surveys over a 36 month period.
  • Complete a release of information so electronic medical record data can be accessed for the 18 months prior to treatment engagement and for 36 months from program enrollment.
  • Participants in the Treatment as Usual group will not receive any intervention.
  • HIV viral load testing will be confirmed at 3 timepoints (baseline, 12 months, and 18 months).
  • Participants in the BIG + Treatment as Usual group will receive $500 monthly income for 18 months.
  • Participants in the BIG + Treatment as Usual group will complete 3 social network surveys to assess how receiving BIG impacts their social networks.
  • A subset of participants in the BIG + Treatment as Usual group (30 participants) will complete 5 individual interviews over the course of receiving BIG and the 18 months after.

详细描述

For this randomized controlled trial, the study will recruit, screen, and enroll a total sample of 304 adults aged 18-35 years living with HIV. Participants will be recruited through networks of community-based organizations, HIV care providers, and other community partners. Eligible participants will include individuals who have experienced interruptions in HIV care, defined as being out of HIV care for more than six months within the past 24 months and/or having a detectable HIV viral load (≥200 copies/mL). Eligibility screening and enrollment will be conducted by University of Chicago research staff. Following eligibility confirmation, research staff will explain the scope of the study, the basic income intervention, and participant expectations. All participants will complete informed consent procedures prior to study enrollment. Participants will also complete a release of information authorizing access to electronic medical record data for the purposes of assessing HIV viral load and HIV care engagement throughout the study period.

Randomization and Study Conditions After completion of baseline procedures, participants will be randomized in a 1:1 ratio to either the Basic Income Guarantee (BIG) intervention arm (n=152) or a treatment-as-usual control arm (n=152). Participants randomized to treatment as usual will continue to receive any services and supports they would otherwise access in the community, without receipt of study-provided cash transfers.

Basic Income Guarantee Intervention Participants assigned to the BIG intervention will receive unconditional cash transfers of $500 per month for a total duration of 18 months. Payments will be delivered via reloadable gift cards. The first payment will be issued within the first 10 days of the month following study enrollment and completion of the baseline assessment. No conditions or behavioral requirements are attached to receipt of the cash transfers. All participants, regardless of study arm, will be offered optional financial counseling resources; participation in financial counseling is not required to receive study payments.

Data Collection Procedures Baseline (T1). At enrollment, all participants will complete a baseline survey assessing domains including financial security, employment, housing stability, physical health, mental health, and access to public benefits and social services. Baseline procedures will be completed prior to randomization.

HIV viral load testing. The study will collect HIV viral loads for all participants at baseline and 12 and 18 months. Participants may either: (1) complete a lab blood draw test performed by UChicago testing services staff at the Chicago Center for HIV Elimination (CCHE), or (2) provide study staff with recent test results or documentation of viral load (dated within the prior 30 days of viral load timepoint).

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 35 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Living with HIV for 24 months or longer;
  • •Ages 18-35;
  • •English-speaking;
  • •One or both of the following:
  • •Experienced a gap in HIV provider care of 6 or greater months during the prior 12-month period;
  • •Had an unsuppressed viral load at any point within the prior 12-month period (unsuppressed meaning a viral load of 200 copies/mL or higher);
  • •Household income at or below 250% of the Federal Poverty Level; and
  • •Experiencing financial distress, as based on a financial well-being score of 1-4 (high financial distress).

排除标准

  • •Unwilling/unable to provide informed consent
  • •Unable to confirm HIV status
  • •Unable to conduct the study in English

研究组 & 干预措施

Treatment As Usual

Active Comparator

Baseline survey

干预措施: Treatment As Usual (Behavioral)

Treatment As Usual plus Basic Income Guaranteed (BIG) Intervention

Experimental

Baseline survey and BIG intervention

干预措施: BIG + Treatment As Usual (Behavioral)

结局指标

主要结局

Retention in HIV care

时间窗: 18 months prior to baseline, to 36 months after baseline

Number of participants who do not experience gaps in care \>4 months

HIV Viral Suppression

时间窗: 18 months prior to baseline, to 36 months after baseline

Number of participants with an HIV viral load \<200 copies/mL

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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