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Behavioral Intervention

Intervention for Case Management (CM2 Trial)

N/A
Recruiting
Led By John Schneider, MD
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights

CM2 Trial Summary

This trial will test whether case management can help people living with HIV/on PrEP improve financial wellbeing, access food, and stay linked to care for better viral suppression.

Who is the study for?
This trial is for Black/African American individuals who are either living with HIV or vulnerable to it, have had a gap in HIV or PrEP care, and face financial or food insecurity. Eligible participants include cis-gender men with male partners in the past year, gender-diverse persons, and cis-gender women prescribed PrEP or with an STI history.Check my eligibility
What is being tested?
The study aims to see if focused dyadic case management can improve financial wellbeing, access to food, retention rates for those living with HIV or on PrEP (PrEP persistence), and increase viral suppression compared to standard non-medical case management.See study design
What are the potential side effects?
Since this trial involves case management rather than medication interventions directly, side effects are not typical as seen in drug trials. However, there may be indirect impacts on stress levels due to changes in care management.

CM2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I've had a gap in my HIV or PrEP care for over 6 months or had a detectable viral load in the past 2 years.

CM2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Financial wellbeing
Food Security
Secondary outcome measures
PrEP Persistence
Viral Suppression

CM2 Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 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.
Group II: Treatment as usualActive Control1 Intervention
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.

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Who is running the clinical trial?

National Institute of Mental Health (NIMH)NIH
2,786 Previous Clinical Trials
2,689,519 Total Patients Enrolled
University of ChicagoLead Sponsor
1,004 Previous Clinical Trials
819,597 Total Patients Enrolled
John Schneider, MDPrincipal InvestigatorUniversity of Chicago
2 Previous Clinical Trials
2,128 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are involved with this experiment?

"Affirmative. Clinicaltrials.gov data suggests that this medical trial, which was posted on September 9th 2022, is currently recruiting patients. Approximately 180 individuals are needed from one location to complete the study."

Answered by AI

What criteria must applicants meet in order to be accepted into this trial?

"The prerequisites for joining this clinical trial are to be under 40 years old and have received Pre-Exposure Prophylaxis (Prep). Approximately 180 participants must join the study."

Answered by AI

Are there available vacancies for enrolment in this clinical experiment?

"Clinicaltrials.gov discloses that this clinical trial is still enrolling, beginning on September 9th 2022 and the last record of edits was made on November 30th 2023."

Answered by AI

Is the elderly population being included in this research trial?

"This trial sets the minimum age of entry at 18 and the maximum at 40 in accordance with set eligibility parameters."

Answered by AI
~104 spots leftby Jun 2026