Trial Outcomes & Findings for Program Refinements to Optimize Model Impact and Scalability Based on Evidence (NCT NCT03628287)
NCT ID: NCT03628287
Last Updated: 2024-08-30
Results Overview
TVS defined as achieving viral suppression (VL \<200 copies/mL) on the last VL test in the four months following CCP enrollment.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
960 participants
Primary outcome timeframe
Four months after CCP enrollment
Results posted on
2024-08-30
Participant Flow
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.
Participant milestones
| Measure |
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).
|
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).
|
|---|---|---|
|
Overall Study
STARTED
|
531
|
429
|
|
Overall Study
Period 0: No Revised Program Delivery
|
83
|
93
|
|
Overall Study
Period 1: Revised Program Delivery Only at Sites Assigned to Early Implementation
|
286
|
104
|
|
Overall Study
Period 2: Revised Program Delivery at All Sites
|
162
|
232
|
|
Overall Study
COMPLETED
|
531
|
429
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Program Refinements to Optimize Model Impact and Scalability Based on Evidence
Baseline characteristics by cohort
| Measure |
Early-implementation
n=531 Participants
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).
|
Later-implementation
n=429 Participants
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).
|
Total
n=960 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<25 years
|
24 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Age, Customized
Between 25 and 44 years
|
194 Participants
n=5 Participants
|
205 Participants
n=7 Participants
|
399 Participants
n=5 Participants
|
|
Age, Customized
Between 45 and 54 years
|
148 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
238 Participants
n=5 Participants
|
|
Age, Customized
>=55 years
|
165 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
267 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Cisgender man or boy
|
331 Participants
n=5 Participants
|
295 Participants
n=7 Participants
|
626 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Cisgender woman or girl
|
185 Participants
n=5 Participants
|
112 Participants
n=7 Participants
|
297 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Identified as transgender, gender nonconforming, non-binary, or not sure/questioning (TGNCNB)
|
15 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
183 Participants
n=5 Participants
|
146 Participants
n=7 Participants
|
329 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
347 Participants
n=5 Participants
|
283 Participants
n=7 Participants
|
630 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian/Pacific Islander
|
0 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
318 Participants
n=5 Participants
|
230 Participants
n=7 Participants
|
548 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
24 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than one race/Other
|
5 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
183 Participants
n=5 Participants
|
146 Participants
n=7 Participants
|
329 Participants
n=5 Participants
|
|
Region of Enrollment
United States · Bronx
|
244 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
341 Participants
n=5 Participants
|
|
Region of Enrollment
United States · Brooklyn
|
147 Participants
n=5 Participants
|
173 Participants
n=7 Participants
|
320 Participants
n=5 Participants
|
|
Region of Enrollment
United States · Manhattan
|
82 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
154 Participants
n=5 Participants
|
|
Region of Enrollment
United States · Queens
|
24 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
|
Region of Enrollment
United States · Staten Island
|
22 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Region of Enrollment
United States · Outside NYC but within NY EMA
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States · Unknown
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Primary Language
English
|
437 Participants
n=5 Participants
|
304 Participants
n=7 Participants
|
741 Participants
n=5 Participants
|
|
Primary Language
Other
|
94 Participants
n=5 Participants
|
124 Participants
n=7 Participants
|
218 Participants
n=5 Participants
|
|
Primary Language
Unknown
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Country of Birth
US/US territory
|
433 Participants
n=5 Participants
|
237 Participants
n=7 Participants
|
670 Participants
n=5 Participants
|
|
Country of Birth
Other country
|
98 Participants
n=5 Participants
|
192 Participants
n=7 Participants
|
290 Participants
n=5 Participants
|
|
Transmission Risk
Men who have sex with men (MSM)
|
149 Participants
n=5 Participants
|
172 Participants
n=7 Participants
|
321 Participants
n=5 Participants
|
|
Transmission Risk
Injection drug users (IDU)
|
32 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Transmission Risk
MSM/IDU
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Transmission Risk
Heterosexual
|
298 Participants
n=5 Participants
|
207 Participants
n=7 Participants
|
505 Participants
n=5 Participants
|
|
Transmission Risk
Perinatal
|
32 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Transmission Risk
Other/Unknown
|
17 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Housing Status
Stably housed
|
378 Participants
n=5 Participants
|
351 Participants
n=7 Participants
|
729 Participants
n=5 Participants
|
|
Housing Status
Unstably housed or unhoused
|
153 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
231 Participants
n=5 Participants
|
|
Incarceration History
Never
|
352 Participants
n=5 Participants
|
355 Participants
n=7 Participants
|
707 Participants
n=5 Participants
|
|
Incarceration History
Last 12 months
|
25 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Incarceration History
>12 months ago
|
147 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
208 Participants
n=5 Participants
|
|
Incarceration History
Unknown
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sexual Orientation
Gay or Lesbian
|
125 Participants
n=5 Participants
|
141 Participants
n=7 Participants
|
266 Participants
n=5 Participants
|
|
Sexual Orientation
Straight or Heterosexual
|
339 Participants
n=5 Participants
|
240 Participants
n=7 Participants
|
579 Participants
n=5 Participants
|
|
Sexual Orientation
Bisexual
|
33 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Sexual Orientation
Other/Unknown
|
34 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Mental Health Diagnosis/Condition
Yes
|
286 Participants
n=5 Participants
|
147 Participants
n=7 Participants
|
433 Participants
n=5 Participants
|
|
Mental Health Diagnosis/Condition
No
|
222 Participants
n=5 Participants
|
259 Participants
n=7 Participants
|
481 Participants
n=5 Participants
|
|
Mental Health Diagnosis/Condition
Unknown
|
23 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Recent Hard Drug Use
Yes
|
113 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
183 Participants
n=5 Participants
|
|
Recent Hard Drug Use
No
|
407 Participants
n=5 Participants
|
354 Participants
n=7 Participants
|
761 Participants
n=5 Participants
|
|
Recent Hard Drug Use
Unknown
|
11 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Lifetime Hard Drug Use
Yes
|
178 Participants
n=5 Participants
|
116 Participants
n=7 Participants
|
294 Participants
n=5 Participants
|
|
Lifetime Hard Drug Use
No
|
343 Participants
n=5 Participants
|
309 Participants
n=7 Participants
|
652 Participants
n=5 Participants
|
|
Lifetime Hard Drug Use
Unknown
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Insurance Status
Insured
|
476 Participants
n=5 Participants
|
299 Participants
n=7 Participants
|
775 Participants
n=5 Participants
|
|
Insurance Status
Uninsured
|
55 Participants
n=5 Participants
|
130 Participants
n=7 Participants
|
185 Participants
n=5 Participants
|
|
Employment Status
Any paid employment
|
76 Participants
n=5 Participants
|
134 Participants
n=7 Participants
|
210 Participants
n=5 Participants
|
|
Employment Status
No paid employment
|
451 Participants
n=5 Participants
|
283 Participants
n=7 Participants
|
734 Participants
n=5 Participants
|
|
Employment Status
Unknown
|
4 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Federal Poverty Level (FPL)
<100% of FPL
|
456 Participants
n=5 Participants
|
324 Participants
n=7 Participants
|
780 Participants
n=5 Participants
|
|
Federal Poverty Level (FPL)
100%-200% of FPL
|
54 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
132 Participants
n=5 Participants
|
|
Federal Poverty Level (FPL)
>200% of FPL
|
21 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Educational Level
≤High school/GED or equivalent
|
398 Participants
n=5 Participants
|
302 Participants
n=7 Participants
|
700 Participants
n=5 Participants
|
|
Educational Level
>High school/GED
|
130 Participants
n=5 Participants
|
124 Participants
n=7 Participants
|
254 Participants
n=5 Participants
|
|
Educational Level
Unknown
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Time Since Diagnosis
≤1 year pre-enrollment
|
51 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
154 Participants
n=5 Participants
|
|
Time Since Diagnosis
>1 to 10 years pre-enrollment
|
111 Participants
n=5 Participants
|
110 Participants
n=7 Participants
|
221 Participants
n=5 Participants
|
|
Time Since Diagnosis
>10 to 20 years pre-enrollment
|
199 Participants
n=5 Participants
|
114 Participants
n=7 Participants
|
313 Participants
n=5 Participants
|
|
Time Since Diagnosis
>20 years pre-enrollment
|
170 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
272 Participants
n=5 Participants
|
|
Antiretroviral Therapy (ART) Status
On ART
|
479 Participants
n=5 Participants
|
381 Participants
n=7 Participants
|
860 Participants
n=5 Participants
|
|
Antiretroviral Therapy (ART) Status
Not on ART
|
52 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Viral Load
200-1,499
|
101 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
181 Participants
n=5 Participants
|
|
Viral Load
1,500-9,999
|
85 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
159 Participants
n=5 Participants
|
|
Viral Load
10,000+
|
339 Participants
n=5 Participants
|
264 Participants
n=7 Participants
|
603 Participants
n=5 Participants
|
|
Viral Load
No viral load at enrollment
|
6 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Cluster of differentiation 4 (CD4) Count
<200
|
234 Participants
n=5 Participants
|
188 Participants
n=7 Participants
|
422 Participants
n=5 Participants
|
|
Cluster of differentiation 4 (CD4) Count
200-499
|
196 Participants
n=5 Participants
|
156 Participants
n=7 Participants
|
352 Participants
n=5 Participants
|
|
Cluster of differentiation 4 (CD4) Count
500+
|
94 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
170 Participants
n=5 Participants
|
|
Cluster of differentiation 4 (CD4) Count
No CD4 at enrollment
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Four months after CCP enrollmentPopulation: The final analysis used an intention-to-treat design and included all 960 participants recruited at baseline. No participants were lost to follow-up.
TVS defined as achieving viral suppression (VL \<200 copies/mL) on the last VL test in the four months following CCP enrollment.
Outcome measures
| Measure |
Early-implementation
n=531 Participants
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).
|
Later-implementation
n=429 Participants
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).
|
|---|---|---|
|
Timely Viral Suppression (TVS)
Achieved TVS (suppressed within four months)
|
254 Participants
|
261 Participants
|
|
Timely Viral Suppression (TVS)
Did not achieve TVS (unsuppressed)
|
277 Participants
|
168 Participants
|
Adverse Events
Early-implementation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 9 deaths
Later-implementation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 7 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Denis Nash, PhD
City University of New York, School of Public Health
Phone: 347-331-6554
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place