Case Management Dyad (CM2)

The University of Chicago

Status: Enrolling

Conditions: Pre-exposure Prophylaxis; Case Management; HIV

Treatments: Behavioral: Dyadic Case Management

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06162897

IRB23-0938

5R01MH131476-02 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

180 participants in 2 patient groups

Treatment as usual

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Behavioral: Dyadic Case Management