Case Management Dyad

NCT ID: NCT06162897

Last Updated: 2025-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-09

Study Completion Date

2027-06-30

Brief Summary

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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.

Detailed Description

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The purpose of this research is to test the impact of dyadic, focused case management on financial well-being, access to food, linkage to and retention in care outcomes for individuals living with or vulnerable to HIV. The study population is men who have sex with men (MSM) or same-sex attraction, gender-diverse persons, and cis-gender women living with or at increased vulnerability to HIV.

The study team will be testing the hypotheses that dyadic case management that is focused on financial wellness, will have better outcomes for folks living with or vulnerable to HIV. Analyses will be used to assess the efficacy of the intervention as an emerging practice.

Conditions

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HIV Pre-exposure Prophylaxis Case Management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Treatment as usual

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Dyadic Case Management

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.

Group Type EXPERIMENTAL

Dyadic Case Management

Intervention Type BEHAVIORAL

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.

Interventions

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Dyadic Case Management

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John Schneider, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

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University of Chicago

Chicago, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Rebecca Eavou

Role: CONTACT

773-834-233

Facility Contacts

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Rebecca Eavou, AM

Role: primary

231-357-5995

References

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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.

Reference Type BACKGROUND
PMID: 27516600 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28402827 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25096896 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30768776 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31768689 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29079949 (View on PubMed)

Related Links

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https://catholiccharitiesfortworth.org/new-research-on-why-padua-works/

This is the link to the project this study is based on.

Other Identifiers

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5R01MH131476-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB23-0938

Identifier Type: -

Identifier Source: org_study_id

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