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NCT Number: NCT06162897

Case Management Dyad

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.

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Key information

Conditions

HIV Case Management Pre-exposure Prophylaxis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Chicago

Chicago, Illinois, 60637, United States

Location status: Recruiting

Location contact

Alida Bouris, PhD

SUB_INVESTIGATOR

John A Schneider, MD, MPH

PRINCIPAL_INVESTIGATOR

Rebecca Eavou, AM

CONTACT

[email protected]

2313575995

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dyadic Case Management

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.

Primary outcomes

  1. Financial wellbeing

    Time frame: 18 months

    Proportion of subjects who report improved financial wellbeing (e.g. consistent income, ability to pay bills).

  2. 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).

Secondary outcomes

  1. PrEP Persistence

    Time frame: 18 months

    Proportion of individuals who have engaged in PrEP care regularly (beyond 6 months).

  2. Viral Suppression

    Time frame: 18 months

    Proportion of individuals who have a viral load below 200 copies/mL

Study contacts

Contact information is provided by the study sponsor or research team.

Rebecca Eavou

CONTACT

[email protected]

773-834-2336

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Acronym: CM2

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Dec 8, 2023
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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