Case Management Dyad

Not Applicable

Recruiting

• Conditions: HIV; Pre-exposure Prophylaxis; Case Management
• Interventions: Behavioral: Dyadic Case Management

• Registration Number: NCT06162897
• Lead Sponsor: University of Chicago

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.

Study Timeline

• Study Start: 2022-09-09
• Study First Submitted: 2023-11-30
• Study First Submitted QC: 2023-11-30
• Study First Posted: 2023-12-08
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-24
• Last Update Posted: 2025-04-29
• Primary Completion: 2026-06-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• Cis-gender men who have had attraction or sexual activity with a male partner in the past 12 months
• Cis-gender women who are living with HIV or vulnerable to HIV (prescribed PrEP or previous sexually transmitted infection (STI) diagnosis)
• Gender-diverse persons
• 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

Exclusion Criteria

• Cis-gender men without attraction or sexual activity with a male partner in the past 12 months
• Cis-gender women who are not living with or vulnerable to HIV (prescribed PrEP or previous STI diagnosis)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dyadic Case Management	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.

Primary Outcome Measures

Name	Time	Method
Financial wellbeing	18 months	Proportion of subjects who report improved financial wellbeing (e.g. consistent income, ability to pay bills).
Food Security	18 months	Proportion of individuals who report improved access to food (e.g. fewer gaps in access to food, reduced concern about access to food).

Secondary Outcome Measures

Name	Time	Method
PrEP Persistence	18 months	Proportion of individuals who have engaged in PrEP care regularly (beyond 6 months).
Viral Suppression	18 months	Proportion of individuals who have a viral load below 200 copies/mL

Trial Locations

Locations (1)

University of Chicago; 🇺🇸 Chicago, Illinois, United States