NCT07115901

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
10mo left

Started Dec 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress35%
Dec 2025Feb 2027

First Submitted

Initial submission to the registry

August 4, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 11, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2027

Last Updated

March 13, 2026

Status Verified

March 1, 2026

Enrollment Period

1.2 years

First QC Date

August 4, 2025

Last Update Submit

March 10, 2026

Conditions

Keywords

HIVGuaranteed IncomeCriminal Legal Involvement

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Linkage to HIV care

    From enrollment to one month after enrollment

  • Retention in HIV care

    From enrollment to end of intervention at 9 months

Study Arms (3)

Lump sum

EXPERIMENTAL

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

Other: Lump sum

Monthly Installments

EXPERIMENTAL

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

Other: Monthly installments

Choice

EXPERIMENTAL

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

Other: Choice

Interventions

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

Lump sum

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

Monthly Installments
ChoiceOTHER

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

Choice

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94158, United States

RECRUITING

Related Publications (5)

  • 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.

    PMID: 31372909BACKGROUND
  • 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.

    PMID: 37037977BACKGROUND
  • 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.

    PMID: 34705154BACKGROUND
  • 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.

    PMID: 25973818BACKGROUND
  • 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.

    PMID: 35447035BACKGROUND

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Paul D Wesson, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul D Wesson, PhD

CONTACT

Graham Hinchcliffe, MS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2025

First Posted

August 11, 2025

Study Start

December 1, 2025

Primary Completion (Estimated)

February 25, 2027

Study Completion (Estimated)

February 25, 2027

Last Updated

March 13, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

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.

Locations