NCT06162897

Brief Summary

The overall goal of this study is to test whether dyadic and focused case management will (1) improve financial wellbeing, (2) improve access to food, (3) increase linkage and retention rates for individuals living with HIV or those taking PrEP (PrEP persistence), and (4) increase the proportion of individuals living with HIV who are virally suppressed (viral suppression) when compared to routine Ryan White Non-Medical Case Management.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P25-P50 for not_applicable hiv

Timeline
13mo left

Started Sep 2022

Longer than P75 for not_applicable hiv

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 Progress78%
Sep 2022Jun 2027

Study Start

First participant enrolled

September 9, 2022

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 30, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 8, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

July 11, 2025

Status Verified

May 1, 2025

Enrollment Period

4.2 years

First QC Date

November 30, 2023

Last Update Submit

July 9, 2025

Conditions

HIVPre-exposure ProphylaxisCase Management

Keywords

linkage to careviral suppressioncase managementretention in carefinancial wellbeingfood security

Outcome Measures

Primary Outcomes (2)

  • Financial wellbeing

    Proportion of subjects who report improved financial wellbeing (e.g. consistent income, ability to pay bills).

    18 months

  • Food Security

    Proportion of individuals who report improved access to food (e.g. fewer gaps in access to food, reduced concern about access to food).

    18 months

Secondary Outcomes (2)

  • PrEP Persistence

    18 months

  • Viral Suppression

    18 months

Study Arms (2)

Treatment as usual

NO INTERVENTION

Participants will be offered the current standard of care, Ryan White Non-Medical Case Management. Case management services are need focused and contact is client initiated.

Dyadic Case Management

EXPERIMENTAL

Participants will receive dyadic case management, specifically they will have two case managers assigned to their case. Case management services will be goal focused and will utilize components from Appreciative Inquiry to orient work to future planning, goals, and financial stability.

Behavioral: Dyadic Case Management

Interventions

Dyadic Case ManagementBEHAVIORAL

Subjects enrolled in the intervention arm will be offered focused case management centered around goal setting and future orientation. Subjects will be assigned two case managers to support their goals.

Dyadic Case Management

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Gap in HIV or PrEP care access in the past 24 months, defined as a gap greater than 6 months or detectable viral load at least one time in the past 24 months Self-reported financial or food insecurity

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

Related Publications (6)

  • Evans WN, Sullivan JX, Wallskog M. The impact of homelessness prevention programs on homelessness. Science. 2016 Aug 12;353(6300):694-9. doi: 10.1126/science.aag0833. Epub 2016 Aug 11.

    PMID: 27516600BACKGROUND

  • Bailey ZD, Krieger N, Agenor M, Graves J, Linos N, Bassett MT. Structural racism and health inequities in the USA: evidence and interventions. Lancet. 2017 Apr 8;389(10077):1453-1463. doi: 10.1016/S0140-6736(17)30569-X.

    PMID: 28402827BACKGROUND

  • Singer AW, Weiser SD, McCoy SI. Does Food Insecurity Undermine Adherence to Antiretroviral Therapy? A Systematic Review. AIDS Behav. 2015 Aug;19(8):1510-26. doi: 10.1007/s10461-014-0873-1.

    PMID: 25096896BACKGROUND

  • Wheeler DP, Fields SD, Beauchamp G, Chen YQ, Emel LM, Hightow-Weidman L, Hucks-Ortiz C, Kuo I, Lucas J, Magnus M, Mayer KH, Nelson LE, Hendrix CW, Piwowar-Manning E, Shoptaw S, Watkins P, Watson CC, Wilton L. Pre-exposure prophylaxis initiation and adherence among Black men who have sex with men (MSM) in three US cities: results from the HPTN 073 study. J Int AIDS Soc. 2019 Feb;22(2):e25223. doi: 10.1002/jia2.25223.

    PMID: 30768776BACKGROUND

  • Lopez JD, Shacham E, Brown T. The Impact of Clinic Policy Attendance and the Ryan White HIV/AIDS Medical Case Management Program on HIV Clinical Outcomes: A Retrospective Longitudinal Study. AIDS Behav. 2020 Apr;24(4):1161-1169. doi: 10.1007/s10461-019-02738-8.

    PMID: 31768689BACKGROUND

  • Bouris A, Jaffe K, Eavou R, Liao C, Kuhns L, Voisin D, Schneider JA. Project nGage: Results of a Randomized Controlled Trial of a Dyadic Network Support Intervention to Retain Young Black Men Who Have Sex With Men in HIV Care. AIDS Behav. 2017 Dec;21(12):3618-3629. doi: 10.1007/s10461-017-1954-8.

    PMID: 29079949BACKGROUND

Related Links

Study Officials

  • John Schneider, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca Eavou

CONTACT

773-834-233reavou@bsd.uchicago.edu

Study Design

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

Study Record Dates

First Submitted

November 30, 2023

First Posted

December 8, 2023

Study Start

September 9, 2022

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

June 30, 2027

Last Updated

July 11, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)