Case Management Dyad (CM2)

November 30, 2023 updated by: University of Chicago

Implementation of a Triadic Network Case Management Intervention for Younger Black Sexual Minority Men

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Black men who have sex with men (MSM) or same-sex attraction, Black gender-diverse persons, and Black 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 Type

Interventional

Enrollment (Estimated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago
        • Contact:
        • Principal Investigator:
          • John A Schneider, MD, MPH
        • Sub-Investigator:
          • Alida Bouris, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 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.
Experimental: Intervention
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Financial wellbeing
Time Frame: 18 months
Proportion of subjects who report improved financial wellbeing (e.g. consistent income, ability to pay bills).
18 months
Food Security
Time Frame: 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).
18 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: John Schneider, MD, University of Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 9, 2022

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

November 30, 2023

First Submitted That Met QC Criteria

November 30, 2023

First Posted (Estimated)

December 8, 2023

Study Record Updates

Last Update Posted (Estimated)

December 8, 2023

Last Update Submitted That Met QC Criteria

November 30, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB23-0938
  • 5R01MH131476-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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