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Case Management Dyad

Implementation of a Triadic Network Case Management Intervention for Along the Status Neutral HIV Care Continuum

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06162897
Acronym
CM2
Enrollment
180
Registered
2023-12-08
Start date
2022-09-09
Completion date
2027-06-30
Last updated
2026-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Case Management, HIV, Pre-exposure Prophylaxis

Keywords

linkage to care, viral suppression, case management, retention in care, financial wellbeing, food security

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.

Detailed description

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.

Interventions

BEHAVIORALDyadic 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.

Sponsors

University of Chicago
Lead SponsorOTHER
National Institute of Mental Health (NIMH)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Financial wellbeing18 monthsProportion of subjects who report improved financial wellbeing (e.g. consistent income, ability to pay bills).
Food Security18 monthsProportion of individuals who report improved access to food (e.g. fewer gaps in access to food, reduced concern about access to food).

Secondary

MeasureTime frameDescription
PrEP Persistence18 monthsProportion of individuals who have engaged in PrEP care regularly (beyond 6 months).
Viral Suppression18 monthsProportion of individuals who have a viral load below 200 copies/mL

Countries

United States

Contacts

CONTACTRebecca Eavou
reavou@bsd.uchicago.edu773-834-2336
PRINCIPAL_INVESTIGATORJohn Schneider, MD

University of Chicago

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 22, 2026