HivPROMISENCT03628287
Program Refinements to Optimize Model Impact and Scalability Based on Evidence
A study testing Revised Care Coordination Program and Original Care Coordination Program in people with Hiv, run by City University of New York, School of Public Health at 17 sites in United States.
Trial summary
In New York, the achievement of 90-90-90 goals is jeopardized not by limited access to affordable care and treatment, but by persistent disparities in HIV viral suppression (VS). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hiv
- What is being tested?
- Revised Care Coordination Program and Original Care Coordination Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 960 participants
- Where
- 17 sitesUnited States
- Study dates
- 1 Aug 2018to 31 Jan 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The original CCP permits enrollment of HIV-infected adults or emancipated minors who are eligible for local Ryan White Part A services (based on residence in the NYC grant area and a household income <435% of federal poverty level) and are 1) newly HIV-diagnosed; 2) out of care >9 months or never in care; 3) missing visits or irregularly in care; 4) exhibiting high VL, VL rebound, or antiretroviral therapy (ART) resistance; 5) new to ART; 6) incompletely adherent to ART; or 7) facing a potential barrier to adherence
- The revised CCP permits enrollment of HIV-infected adults or emancipated minors who are eligible for local Ryan White Part A services (based on residence in the NYC grant area and a household income <435% of federal poverty level) and are 1) newly HIV-diagnosed; 2) out of care >9 months or never in care; 3) virally unsuppressed at the most recent known viral load test in the past 12 months; 4) living with untreated hepatitis C; 5) pregnant; 6)undergoing a change in ART regimen or 7)experiencing other high risk for falling out of medical care or becoming unsuppressed. For criteria (6) and (7), eligibility is conditional upon Self-management Assessment results, unless additional criteria are met.
Who cannot join
- The stepped-wedge experiment is limited to HIV patients who are virally unsuppressed at the time of program enrollment. Individuals with VL <200 copies/mL at last test before or on the day of program enrollment will be excluded from the comparison of model effects on timely viral suppression (TVS).
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
HHC Kings County Hospital Center
Brooklyn, New York, 11203
SUNY Downstate Medical Center - STAR Health Center
Brooklyn, New York, 11203
Sunset Park Health Council, Inc.
Brooklyn, New York, 11220
Wyckoff Heights Medical Center
Brooklyn, New York, 11237
HHC Elmhurst Hospital Center
Elmhurst, New York, 11373
Mount Sinai- Beth Israel Medical Center
New York, New York, 10003
Housing Works Inc
New York, New York, 10009
Callen Lorde Community Health Center
New York, New York, 10011
APICHA Community Health Center
New York, New York, 10013
Mount Sinai-St. Luke's - Roosevelt Hospital
New York, New York, 10025
Mount Sinai Medical Center
New York, New York, 10029
The Institute for Family Health
New York, New York, 10035
Services for the Underserved, Inc.
New York, New York, 10452
Community Health Action Of Staten Island
Staten Island, New York, 10302
Bronx Lebanon Hospital Center
The Bronx, New York, 10453
Argus Community Inc
The Bronx, New York, 10456
HHC Jacobi Medical Center
The Bronx, New York, 10461
About this study
In New York, the achievement of 90-90-90 goals is jeopardized not by limited access to affordable care and treatment, but by persistent disparities in HIV viral suppression (VS). Complex behavioral and structural barriers to achieving and maintaining VS require coordinated, combination approaches to meet medical and social service needs. In 2009, at 28 Ryan White Part A (RWPA)-funded agencies, the New York City (NYC) Department of Health and Mental Hygiene (DOHMH) launched a multi-component HIV Care Coordination Program (CCP) directed toward the most vulnerable persons living with HIV (PLWH) in NYC. A systematic CCP effectiveness study began in 2013 (R01 MH101028; PIs: Irvine, Nash). Findings to date suggest that the CCP is superior to usual care for vulnerable subgroups of PLWH, but there remains substantial room for improvement in short- and long-term VS. In an immediate evidence-to-practice feedback loop, the DOHMH is implementing a refined CCP model in 2018. Greater focusing, tailoring and cues for delivery of key components are expected to increase CCP engagement, reach, fidelity, scalability, effectiveness and impact. The aim of the proposed study is to estimate the effect of the revised (vs. original) CCP on timely VS (within 4 months of enrollment), using experimental methods.
Read the detailed description
Stepped-wedge design. The 17 veteran CCP implementers re-awarded to provide RWPA Care Coordination services in 2018 will be randomized to immediate or delayed implementation of the revised CCP model, with delayed implementers continuing to provide services under the original model until their assigned start date 9 months later, so that we can rigorously and contemporaneously compare effects of the original and revised CCP for the outcome of timely VS. The outcome measure will be derived from the New York City HIV surveillance registry, a population-based data source of longitudinal laboratory (VL, CD4) testing records on all diagnosed NYC PLWH, regardless of medical provider within NYC, and for periods extending before and after program enrollment or discontinuation.
- Conditions
- Hiv
- Being tested
- Revised Care Coordination Program, Original Care Coordination Program
- Keywords
- viral load suppression, medical case management
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Revised Care Coordination ProgramOther
Greater focusing, tailoring and cues for delivery of key components of Care Coordination
Original Care Coordination ProgramOther
Original Care Coordination
| Study group | Role | What they receive |
|---|---|---|
| Original Care Coordination Program | Active comparator | 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. Receives: Other: Original Care Coordination Program |
| Revised Care Coordination Program | Experimental | 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. Receives: Other: Revised Care Coordination Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timely Viral Suppression (TVS)
TVS defined as achieving viral suppression (VL <200 copies/mL) on the last VL test in the four months following CCP enrollment.
Measured: Four months after CCP enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start1 Aug 2018
- Primary completion30 Jan 2020
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for HivStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Stepped-wedge design: To compare effects of the original and revised CCP contemporaneously for timely viral suppression, we will randomize (within matched pairs and one trio) 17 veteran CCP-implementing agencies to immediate or delayed implementation of the revised model, with delayed implementers providing services under the original model until their assigned start date 9 months later.
- Masking
- None (open label)
- Enrolment
- 960 participants (actual)
Sponsor and investigators
- Lead sponsor
- City University of New York, School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- New York City Department of Health and Mental Hygiene
- Responsible party
- Principal investigator, Denis Nash, City University of New York, School of Public Health
- Investigators
- Denis Nash, PhD, Principal investigator, CUNY School of Public Health and Health PolicyMary Irvine, DrPH, Principal investigator, New York City Department of Health and Mental Hygiene
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03628287
- Sponsor's protocol ID
- R01MH117793
- Acronym
- PROMISE
- Status last verified
- Aug 2024
- First submitted
- 9 Aug 2018
- Last updated
- 30 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to the legal restrictions (New York Public Health Law Article 21, Title III) and the confidential nature of HIV surveillance data in New York, public health authorities in New York City cannot release individual-level data on reported HIV cases for purposes other than ensuring appropriate HIV care. The NYC DOHMH staff are available to assist external researchers who may have further specific data questions or uses. Please send an email to hivreport@health.nyc.gov with questions or requests for additional information.
Publications
Robertson MM, Waldron L, Robbins RS, Chamberlin S, Penrose K, Levin B, Kulkarni S, Braunstein SL, Irvine MK, Nash D. Using Registry Data to Construct a Comparison Group for Programmatic Effectiveness Evaluation: The New York City HIV Care Coordination Program. Am J Epidemiol. 2018 Sep 1;187(9):1980-1989. doi: 10.1093/aje/kwy103.
PubMed 29788080Irvine MK, Chamberlin SA, Robbins RS, Kulkarni SG, Robertson MM, Nash D. 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 Behav. 2017 Jun;21(6):1572-1579. doi: 10.1007/s10461-016-1460-4.
PubMed 27342990Irvine MK, Chamberlin SA, Robbins RS, Myers JE, Braunstein SL, Mitts BJ, Harriman GA, Laraque F, Nash D. Improvements in HIV care engagement and viral load suppression following enrollment in a comprehensive HIV care coordination program. Clin Infect Dis. 2015 Jan 15;60(2):298-310. doi: 10.1093/cid/ciu783. Epub 2014 Oct 9.
PubMed 25301208Robertson MM, Penrose K, Irvine MK, Robbins RS, Kulkarni S, Braunstein SL, Waldron L, Harriman G, Nash D. Impact of an HIV Care Coordination Program on Durable Viral Suppression. J Acquir Immune Defic Syndr. 2019 Jan 1;80(1):46-55. doi: 10.1097/QAI.0000000000001877.
PubMed 30299346Nash D, Robertson MM, Penrose K, Chamberlin S, Robbins RS, Braunstein SL, Myers JE, Abraham B, Kulkarni S, Waldron L, Levin B, Irvine MK. Short-term effectiveness of HIV care coordination among persons with recent HIV diagnosis or history of poor HIV outcomes. PLoS One. 2018 Sep 24;13(9):e0204017. doi: 10.1371/journal.pone.0204017. eCollection 2018.
PubMed 30248136Penrose K, Robertson M, Nash D, Harriman G, Irvine M. Social Vulnerabilities and Reported Discrimination in Health Care Among HIV-Positive Medical Case Management Clients in New York City. Stigma Health. 2020 May;5(2):179-187. doi: 10.1037/sah0000187. Epub 2019 Aug 12.
PubMed 32432165Stevens ER, Nucifora KA, Irvine MK, Penrose K, Robertson M, Kulkarni S, Robbins R, Abraham B, Nash D, Braithwaite RS. Cost-effectiveness of HIV care coordination scale-up among persons at high risk for sub-optimal HIV care outcomes. PLoS One. 2019 Apr 25;14(4):e0215965. doi: 10.1371/journal.pone.0215965. eCollection 2019.
PubMed 31022280Hernandez M, Guarino H, Kozlowski S, Srivastava A, Schenkel R, Tapia T, Seabrook TB, Nash D, Irvine MK. Addressing Mental Health Barriers in HIV Care Coordination Is Crucial to Providing Optimal HIV/AIDS Care. AIDS Patient Care STDS. 2024 Mar;38(3):107-114. doi: 10.1089/apc.2023.0240.
PubMed 38471091Irvine MK, Levin B, Abdelqader F, Carmona J, Avoundjian T, Thomas J, Braunstein SL, Robertson M, Nash D. Evaluation of the Revised Versus Original Ryan White Part A HIV Care Coordination Program in a Cluster-Randomized, Stepped-Wedge Trial. J Acquir Immune Defic Syndr. 2023 Apr 1;92(4):325-333. doi: 10.1097/QAI.0000000000003139. Epub 2022 Dec 22.
PubMed 36729538Irvine MK, Levin B, Robertson MM, Penrose K, Carmona J, Harriman G, Braunstein SL, Nash D. 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. 2020 Jul 27;10(7):e034624. doi: 10.1136/bmjopen-2019-034624.
PubMed 32718922
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Program Refinements to Optimize Model Impact and Scalability Based on Evidence
- ClinicalTrials.gov ID
- NCT03628287
- Acronym / sponsor ID
- PROMISE / R01MH117793
- Conditions
- Hiv
- Keywords
- viral load suppression, medical case management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 960 participants (actual)
- Lead sponsor
- City University of New York, School of Public HealthUniversity, hospital or other
- Collaborators
- New York City Department of Health and Mental Hygiene
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 30 Jan 2020 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 14 Aug 2018 (actual)
- Results
- Posted 23 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In New York, the achievement of 90-90-90 goals is jeopardized not by limited access to affordable care and treatment, but by persistent disparities in HIV viral suppression (VS). Complex behavioral and structural barriers to achieving and maintaining VS require coordinated, combination approaches to meet medical and social service needs. In 2009, at 28 Ryan White Part A (RWPA)-funded agencies, the New York City (NYC) Department of Health and Mental Hygiene (DOHMH) launched a multi-component HIV Care Coordination Program (CCP) directed toward the most vulnerable persons living with HIV (PLWH) in NYC. A systematic CCP effectiveness study began in 2013 (R01 MH101028; PIs: Irvine, Nash). Findings to date suggest that the CCP is superior to usual care for vulnerable subgroups of PLWH, but there remains substantial room for improvement in short- and long-term VS. In an immediate evidence-to-practice feedback loop, the DOHMH is implementing a refined CCP model in 2018. Greater focusing, tailoring and cues for delivery of key components are expected to increase CCP engagement, reach, fidelity, scalability, effectiveness and impact. The aim of the proposed study is to estimate the effect of the revised (vs. original) CCP on timely VS (within 4 months of enrollment), using experimental methods.
Detailed description
Stepped-wedge design. The 17 veteran CCP implementers re-awarded to provide RWPA Care Coordination services in 2018 will be randomized to immediate or delayed implementation of the revised CCP model, with delayed implementers continuing to provide services under the original model until their assigned start date 9 months later, so that we can rigorously and contemporaneously compare effects of the original and revised CCP for the outcome of timely VS. The outcome measure will be derived from the New York City HIV surveillance registry, a population-based data source of longitudinal laboratory (VL, CD4) testing records on all diagnosed NYC PLWH, regardless of medical provider within NYC, and for periods extending before and after program enrollment or discontinuation.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stepped-wedge design: To compare effects of the original and revised CCP contemporaneously for timely viral suppression, we will randomize (within matched pairs and one trio) 17 veteran CCP-implementing agencies to immediate or delayed implementation of the revised model, with delayed implementers providing services under the original model until their assigned start date 9 months later.
| Arm | Type | Receives |
|---|---|---|
| Original Care Coordination Program | Active comparator | Other: Original Care Coordination ProgramSpecific 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. |
| Revised Care Coordination Program | Experimental | Other: Revised Care Coordination ProgramThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The original CCP permits enrollment of HIV-infected adults or emancipated minors who are eligible for local Ryan White Part A services (based on residence in the NYC grant area and a household income <435% of federal poverty level) and are 1) newly HIV-diagnosed; 2) out of care >9 months or never in care; 3) missing visits or irregularly in care; 4) exhibiting high VL, VL rebound, or antiretroviral therapy (ART) resistance; 5) new to ART; 6) incompletely adherent to ART; or 7) facing a potential barrier to adherence
- The revised CCP permits enrollment of HIV-infected adults or emancipated minors who are eligible for local Ryan White Part A services (based on residence in the NYC grant area and a household income <435% of federal poverty level) and are 1) newly HIV-diagnosed; 2) out of care >9 months or never in care; 3) virally unsuppressed at the most recent known viral load test in the past 12 months; 4) living with untreated hepatitis C; 5) pregnant; 6)undergoing a change in ART regimen or 7)experiencing other high risk for falling out of medical care or becoming unsuppressed. For criteria (6) and (7), eligibility is conditional upon Self-management Assessment results, unless additional criteria are met.
Key exclusion criteria (1 listed)
- The stepped-wedge experiment is limited to HIV patients who are virally unsuppressed at the time of program enrollment. Individuals with VL <200 copies/mL at last test before or on the day of program enrollment will be excluded from the comparison of model effects on timely viral suppression (TVS).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Revised Care Coordination ProgramGreater focusing, tailoring and cues for delivery of key components of Care Coordination | Other | Revised Care Coordination Program |
| Original Care Coordination ProgramOriginal Care Coordination | Other | Original Care Coordination Program |
Primary outcome
Timely Viral Suppression (TVS)
Time frame: Four months after CCP enrollment
TVS defined as achieving viral suppression (VL <200 copies/mL) on the last VL test in the four months following CCP enrollment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29788080Robertson MM, Waldron L, Robbins RS, Chamberlin S, Penrose K, Levin B, Kulkarni S, Braunstein SL, Irvine MK, Nash D. Using Registry Data to Construct a Comparison Group for Programmatic Effectiveness Evaluation: The New York City HIV Care Coordination Program. Am J Epidemiol. 2018 Sep 1;187(9):1980-1989. doi: 10.1093/aje/kwy103.
- Background: PubMed 27342990Irvine MK, Chamberlin SA, Robbins RS, Kulkarni SG, Robertson MM, Nash D. 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 Behav. 2017 Jun;21(6):1572-1579. doi: 10.1007/s10461-016-1460-4.
- Background: PubMed 25301208Irvine MK, Chamberlin SA, Robbins RS, Myers JE, Braunstein SL, Mitts BJ, Harriman GA, Laraque F, Nash D. Improvements in HIV care engagement and viral load suppression following enrollment in a comprehensive HIV care coordination program. Clin Infect Dis. 2015 Jan 15;60(2):298-310. doi: 10.1093/cid/ciu783. Epub 2014 Oct 9.
- Background: PubMed 30299346Robertson MM, Penrose K, Irvine MK, Robbins RS, Kulkarni S, Braunstein SL, Waldron L, Harriman G, Nash D. Impact of an HIV Care Coordination Program on Durable Viral Suppression. J Acquir Immune Defic Syndr. 2019 Jan 1;80(1):46-55. doi: 10.1097/QAI.0000000000001877.
- Background: PubMed 30248136Nash D, Robertson MM, Penrose K, Chamberlin S, Robbins RS, Braunstein SL, Myers JE, Abraham B, Kulkarni S, Waldron L, Levin B, Irvine MK. Short-term effectiveness of HIV care coordination among persons with recent HIV diagnosis or history of poor HIV outcomes. PLoS One. 2018 Sep 24;13(9):e0204017. doi: 10.1371/journal.pone.0204017. eCollection 2018.
- Background: PubMed 32432165Penrose K, Robertson M, Nash D, Harriman G, Irvine M. Social Vulnerabilities and Reported Discrimination in Health Care Among HIV-Positive Medical Case Management Clients in New York City. Stigma Health. 2020 May;5(2):179-187. doi: 10.1037/sah0000187. Epub 2019 Aug 12.
- Background: PubMed 31022280Stevens ER, Nucifora KA, Irvine MK, Penrose K, Robertson M, Kulkarni S, Robbins R, Abraham B, Nash D, Braithwaite RS. Cost-effectiveness of HIV care coordination scale-up among persons at high risk for sub-optimal HIV care outcomes. PLoS One. 2019 Apr 25;14(4):e0215965. doi: 10.1371/journal.pone.0215965. eCollection 2019.
- Derived from this study: PubMed 38471091Hernandez M, Guarino H, Kozlowski S, Srivastava A, Schenkel R, Tapia T, Seabrook TB, Nash D, Irvine MK. Addressing Mental Health Barriers in HIV Care Coordination Is Crucial to Providing Optimal HIV/AIDS Care. AIDS Patient Care STDS. 2024 Mar;38(3):107-114. doi: 10.1089/apc.2023.0240.
- Derived from this study: PubMed 36729538Irvine MK, Levin B, Abdelqader F, Carmona J, Avoundjian T, Thomas J, Braunstein SL, Robertson M, Nash D. Evaluation of the Revised Versus Original Ryan White Part A HIV Care Coordination Program in a Cluster-Randomized, Stepped-Wedge Trial. J Acquir Immune Defic Syndr. 2023 Apr 1;92(4):325-333. doi: 10.1097/QAI.0000000000003139. Epub 2022 Dec 22.
- Derived from this study: PubMed 32718922Irvine MK, Levin B, Robertson MM, Penrose K, Carmona J, Harriman G, Braunstein SL, Nash D. 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. 2020 Jul 27;10(7):e034624. doi: 10.1136/bmjopen-2019-034624.
- Individual participant dataSharing planned: No. Due to the legal restrictions (New York Public Health Law Article 21, Title III) and the confidential nature of HIV surveillance data in New York, public health authorities in New York City cannot release individual-level data on reported HIV cases for purposes other than ensuring appropriate HIV care. The NYC DOHMH staff are available to assist external researchers who may have further specific data questions or uses. Please send an email to hivreport@health.nyc.gov with questions or requests for additional information.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Denis Nash, PhD principal investigator
CUNY School of Public Health and Health Policy
Mary Irvine, DrPH principal investigator
New York City Department of Health and Mental Hygiene
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Revised Care Coordination Program and Original Care Coordination Program in people with Hiv, run by City University of New York, School of Public Health at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timely Viral Suppression (TVS) (time frame: Four months after CCP enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03628287, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2024.