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Revised Care Coordination Program for HIV (Human Immunodeficiency Virus) (PROMISE Trial)

N/A
Waitlist Available
Led By Mary Irvine, DrPH
Research Sponsored by City University of New York, School of Public Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up four months after ccp enrollment
Awards & highlights

PROMISE Trial Summary

This trial will test whether a revised HIV Care Coordination Program (CCP) is more effective than the original program in New York City. The goal is to estimate the effect of the revised CCP on timely viral suppression (within 4 months of enrollment).

PROMISE Trial Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Timely Viral Suppression (TVS)

PROMISE Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Revised Care Coordination ProgramExperimental Treatment1 Intervention
The revised model includes the original intervention components without program track assignments or the three-month induction period of weekly visits. Program additions include a set of tools for assessment and counseling around client HIV self-management capacity; allowance of video chat for delivery of some services; and optional "immediate" antiretroviral therapy (iART: ensuring the client has a filled prescription within 4 days of enrollment or diagnosis). Other changes include greater guidance on recruiting individuals with unsuppressed VL and a switch from per-member-per-day reimbursement to fee-for-service reimbursement that accounts for resource demands, such as staff travel to clients' homes, and offers higher rates for meeting performance standards.
Group II: Original Care Coordination ProgramActive Control1 Intervention
Specific intervention components include: 1) outreach for initial case finding and after any missed appointment; 2) case management, including social services and benefits assessments; 3) multidisciplinary care team communication and decision-making via case conferences; 4) patient navigation, including appointment reminders, assistance with scheduling appointments, transportation resources, and accompaniment to primary care visits; 5) antiretroviral treatment adherence support, including directly observed therapy for individuals with greatest need; and 6) structured health promotion, for which clients are assigned to program tracks (determining their frequency of health promotion visits: weekly, monthly or quarterly), depending on their level of assessed need.

Find a Location

Who is running the clinical trial?

New York City Department of Health and Mental HygieneOTHER_GOV
18 Previous Clinical Trials
17,573 Total Patients Enrolled
City University of New York, School of Public HealthLead Sponsor
25 Previous Clinical Trials
37,176 Total Patients Enrolled
Mary Irvine, DrPHPrincipal InvestigatorNew York City Department of Health and Mental Hygiene

Frequently Asked Questions

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

How many distinct venues are hosting this research project?

"For this clinical trial, 17 different medical sites are currently recruiting. These include APICHA Community Health Center in New york, Callen Lorde Community Health Center in Brooklyn, and Wyckoff Heights Medical Center in Elmhurst; as well as 14 other locations."

Answered by AI

Are any individuals currently enlisting in this research?

"As attested to by clinicaltrials.gov, this research project inaugurated on August 1st 2018 and was recently updated on February 4th 2021 is not presently looking for participants. However, 83 other medical trials are actively recruiting volunteers."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
Mount Sinai- Beth Israel Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
BMJ OpenJournal
PROMISE (program Refinements to Optimize Model Impact and Scalability Based on Evidence): A Cluster-randomised, Stepped-wedge Trial Assessing Effectiveness of the Revised Versus Original Ryan White Part A HIV Care Coordination Programme for Patients with Barriers to Treatment in the USA
Irvine, Mary K, Bruce Levin, McKaylee M Robertson, Katherine Penrose, Jennifer Carmona, Graham Harriman, Sarah L Braunstein, and Denis Nash. 2020. “PROMISE (program Refinements to Optimize Model Impact and Scalability Based on Evidence): A Cluster-randomised, Stepped-wedge Trial Assessing Effectiveness of the Revised Versus Original Ryan White Part A HIV Care Coordination Programme for Patients with Barriers to Treatment in the USA”. BMJ Open. BMJ. doi:10.1136/bmjopen-2019-034624.
Stigma and HealthJournal
Social Vulnerabilities and Reported Discrimination in Health Care Among Hiv-positive Medical Case Management Clients in New York City.
Penrose, Katherine, McKaylee Robertson, Denis Nash, Graham Harriman, and Mary Irvine. 2020. “Social Vulnerabilities and Reported Discrimination in Health Care Among Hiv-positive Medical Case Management Clients in New York City.”. Stigma and Health. American Psychological Association (APA). doi:10.1037/sah0000187.
Plos OneJournal
Short-term Effectiveness of HIV Care Coordination Among Persons with Recent HIV Diagnosis or History of Poor HIV Outcomes
Nash, Denis, McKaylee M. Robertson, Kate Penrose, Stephanie Chamberlin, Rebekkah S. Robbins, Sarah L. Braunstein, Julie E. Myers, et al.. 2018. “Short-term Effectiveness of HIV Care Coordination Among Persons with Recent HIV Diagnosis or History of Poor HIV Outcomes”. Edited by Nades Palaniyar. Plos One. Public Library of Science (PLoS). doi:10.1371/journal.pone.0204017.
AIDS and BehaviorJournal
Come as You Are: Improving Care Engagement and Viral Load Suppression Among HIV Care Coordination Clients with Lower Mental Health Functioning, Unstable Housing, and Hard Drug Use
Irvine, Mary K., Stephanie A. Chamberlin, Rebekkah S. Robbins, Sarah G. Kulkarni, McKaylee M. Robertson, and Denis Nash. 2016. “Come as You Are: Improving Care Engagement and Viral Load Suppression Among HIV Care Coordination Clients with Lower Mental Health Functioning, Unstable Housing, and Hard Drug Use”. AIDS and Behavior. Springer Science and Business Media LLC. doi:10.1007/s10461-016-1460-4.
~144 spots leftby Apr 2025
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