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Program Refinements to Optimize Model Impact and Scalability Based on Evidence

Program Refinements to Optimize Model Impact and Scalability Based on Evidence

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03628287
Acronym
PROMISE
Enrollment
960
Registered
2018-08-14
Start date
2018-08-01
Completion date
2023-01-31
Last updated
2024-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hiv

Keywords

viral load suppression, medical case management

Brief 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). 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.

Interventions

OTHERRevised Care Coordination Program

Greater focusing, tailoring and cues for delivery of key components of Care Coordination

OTHEROriginal Care Coordination Program

Original Care Coordination

Sponsors

New York City Department of Health and Mental Hygiene
CollaboratorOTHER_GOV
City University of New York, School of Public Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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).

Design outcomes

Primary

MeasureTime frameDescription
Timely Viral Suppression (TVS)Four months after CCP enrollmentTVS defined as achieving viral suppression (VL \<200 copies/mL) on the last VL test in the four months following CCP enrollment.

Countries

United States

Participant flow

Pre-assignment details

Older New York City HIV surveillance registry datasets were used to determine trial eligibility for the original protocol, excluding clients who died during follow-up. 16 clients who died within 4 months of Care Coordination Program (CCP) or revised-CCP enrollment were added as eligible for trial outcome analyses. Updated surveillance and match datasets identified additional eligible individuals based on latest reported viral load at time of CCP or revised-CCP enrollment, who were also included.

Participants by arm

ArmCount
Early-implementation
Early-implementing sites received the revised intervention starting in August 2018 (start of Period 1), with follow-up through January 2020 (end of Period 2).
531
Later-implementation
Later-implementing sites received the revised intervention starting in May 2019 (start of Period 2), with follow-up through January 2020 (end of Period 2).
429
Total960

Baseline characteristics

CharacteristicLater-implementationTotalEarly-implementation
Age, Customized
<25 years
32 Participants56 Participants24 Participants
Age, Customized
>=55 years
102 Participants267 Participants165 Participants
Age, Customized
Between 25 and 44 years
205 Participants399 Participants194 Participants
Age, Customized
Between 45 and 54 years
90 Participants238 Participants148 Participants
Antiretroviral Therapy (ART) Status
Not on ART
48 Participants100 Participants52 Participants
Antiretroviral Therapy (ART) Status
On ART
381 Participants860 Participants479 Participants
Cluster of differentiation 4 (CD4) Count
<200
188 Participants422 Participants234 Participants
Cluster of differentiation 4 (CD4) Count
200-499
156 Participants352 Participants196 Participants
Cluster of differentiation 4 (CD4) Count
500+
76 Participants170 Participants94 Participants
Cluster of differentiation 4 (CD4) Count
No CD4 at enrollment
9 Participants16 Participants7 Participants
Country of Birth
Other country
192 Participants290 Participants98 Participants
Country of Birth
US/US territory
237 Participants670 Participants433 Participants
Educational Level
>High school/GED
124 Participants254 Participants130 Participants
Educational Level
≤High school/GED or equivalent
302 Participants700 Participants398 Participants
Educational Level
Unknown
3 Participants6 Participants3 Participants
Employment Status
Any paid employment
134 Participants210 Participants76 Participants
Employment Status
No paid employment
283 Participants734 Participants451 Participants
Employment Status
Unknown
12 Participants16 Participants4 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
146 Participants329 Participants183 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
283 Participants630 Participants347 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants1 Participants1 Participants
Federal Poverty Level (FPL)
100%-200% of FPL
78 Participants132 Participants54 Participants
Federal Poverty Level (FPL)
<100% of FPL
324 Participants780 Participants456 Participants
Federal Poverty Level (FPL)
>200% of FPL
27 Participants48 Participants21 Participants
Housing Status
Stably housed
351 Participants729 Participants378 Participants
Housing Status
Unstably housed or unhoused
78 Participants231 Participants153 Participants
Incarceration History
>12 months ago
61 Participants208 Participants147 Participants
Incarceration History
Last 12 months
10 Participants35 Participants25 Participants
Incarceration History
Never
355 Participants707 Participants352 Participants
Incarceration History
Unknown
3 Participants10 Participants7 Participants
Insurance Status
Insured
299 Participants775 Participants476 Participants
Insurance Status
Uninsured
130 Participants185 Participants55 Participants
Lifetime Hard Drug Use
No
309 Participants652 Participants343 Participants
Lifetime Hard Drug Use
Unknown
4 Participants14 Participants10 Participants
Lifetime Hard Drug Use
Yes
116 Participants294 Participants178 Participants
Mental Health Diagnosis/Condition
No
259 Participants481 Participants222 Participants
Mental Health Diagnosis/Condition
Unknown
23 Participants46 Participants23 Participants
Mental Health Diagnosis/Condition
Yes
147 Participants433 Participants286 Participants
Primary Language
English
304 Participants741 Participants437 Participants
Primary Language
Other
124 Participants218 Participants94 Participants
Primary Language
Unknown
1 Participants1 Participants0 Participants
Race/Ethnicity, Customized
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race/Ethnicity, Customized
Asian/Pacific Islander
15 Participants15 Participants0 Participants
Race/Ethnicity, Customized
Black or African American
230 Participants548 Participants318 Participants
Race/Ethnicity, Customized
Hispanic or Latino
146 Participants329 Participants183 Participants
Race/Ethnicity, Customized
More than one race/Other
13 Participants18 Participants5 Participants
Race/Ethnicity, Customized
Unknown or Not Reported
0 Participants1 Participants1 Participants
Race/Ethnicity, Customized
White
25 Participants49 Participants24 Participants
Recent Hard Drug Use
No
354 Participants761 Participants407 Participants
Recent Hard Drug Use
Unknown
5 Participants16 Participants11 Participants
Recent Hard Drug Use
Yes
70 Participants183 Participants113 Participants
Region of Enrollment
United States
Bronx
97 Participants341 Participants244 Participants
Region of Enrollment
United States
Brooklyn
173 Participants320 Participants147 Participants
Region of Enrollment
United States
Manhattan
72 Participants154 Participants82 Participants
Region of Enrollment
United States
Outside NYC but within NY EMA
5 Participants7 Participants2 Participants
Region of Enrollment
United States
Queens
71 Participants95 Participants24 Participants
Region of Enrollment
United States
Staten Island
7 Participants29 Participants22 Participants
Region of Enrollment
United States
Unknown
4 Participants14 Participants10 Participants
Sex/Gender, Customized
Cisgender man or boy
295 Participants626 Participants331 Participants
Sex/Gender, Customized
Cisgender woman or girl
112 Participants297 Participants185 Participants
Sex/Gender, Customized
Identified as transgender, gender nonconforming, non-binary, or not sure/questioning (TGNCNB)
22 Participants37 Participants15 Participants
Sexual Orientation
Bisexual
31 Participants64 Participants33 Participants
Sexual Orientation
Gay or Lesbian
141 Participants266 Participants125 Participants
Sexual Orientation
Other/Unknown
17 Participants51 Participants34 Participants
Sexual Orientation
Straight or Heterosexual
240 Participants579 Participants339 Participants
Time Since Diagnosis
>10 to 20 years pre-enrollment
114 Participants313 Participants199 Participants
Time Since Diagnosis
>1 to 10 years pre-enrollment
110 Participants221 Participants111 Participants
Time Since Diagnosis
≤1 year pre-enrollment
103 Participants154 Participants51 Participants
Time Since Diagnosis
>20 years pre-enrollment
102 Participants272 Participants170 Participants
Transmission Risk
Heterosexual
207 Participants505 Participants298 Participants
Transmission Risk
Injection drug users (IDU)
18 Participants50 Participants32 Participants
Transmission Risk
Men who have sex with men (MSM)
172 Participants321 Participants149 Participants
Transmission Risk
MSM/IDU
5 Participants8 Participants3 Participants
Transmission Risk
Other/Unknown
7 Participants24 Participants17 Participants
Transmission Risk
Perinatal
20 Participants52 Participants32 Participants
Viral Load
10,000+
264 Participants603 Participants339 Participants
Viral Load
1,500-9,999
74 Participants159 Participants85 Participants
Viral Load
200-1,499
80 Participants181 Participants101 Participants
Viral Load
No viral load at enrollment
11 Participants17 Participants6 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
9 / 5317 / 429
other
Total, other adverse events
0 / 5310 / 429
serious
Total, serious adverse events
0 / 5310 / 429

Outcome results

Primary

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.

Time frame: Four months after CCP enrollment

Population: The final analysis used an intention-to-treat design and included all 960 participants recruited at baseline. No participants were lost to follow-up.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Early-implementationTimely Viral Suppression (TVS)Achieved TVS (suppressed within four months)254 Participants
Early-implementationTimely Viral Suppression (TVS)Did not achieve TVS (unsuppressed)277 Participants
Later-implementationTimely Viral Suppression (TVS)Achieved TVS (suppressed within four months)261 Participants
Later-implementationTimely Viral Suppression (TVS)Did not achieve TVS (unsuppressed)168 Participants

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026