Trial Outcomes & Findings for Testing a Novel Data-to-Suppression (D2S) Intervention Strategy in the Ryan White HIV/AIDS Program (NCT NCT05140421)
NCT ID: NCT05140421
Last Updated: 2026-03-19
Results Overview
Registry-reported VL \<200 copies/mL on any VL test dated in the six months after the client first appeared as unsuppressed on a D2S report for the period
ACTIVE_NOT_RECRUITING
NA
1494 participants
6 months
2026-03-19
Participant Flow
There is no client recruitment for this trial, which relies on data collected as part of surveillance and routine Ryan White HIV/AIDS Program (RWHAP) Part A reporting. The settings are 20 NYC community-based organizations and 7 hospitals funded through the RWHAP Part A grant to provide housing and behavioral health services. The 27 sites were matched in pairs (in one case, two smaller sites were matched to one larger one), and then randomized within pairs to early or delayed implementation.
We excluded 6 RWHAP Part A sites with \<5 eligible individuals (clients in HIV care but virally unsuppressed) in any period, based on simulated D2S reports from 2018-2021. Those sites were not enrolled in the trial at all. The small numbers of potentially eligible individuals disqualified them. In addition, 386 clients from the 27 sites were excluded from the trial based on more mature surveillance data indicating they had not been eligible at the time that they were listed on a D2S report.
Unit of analysis: Sites were assigned to arms
Participant milestones
| Measure |
Early Implementation: UC First, Then D2S, Then D2S Again
Early implementation sites received the Data to Suppression (D2S) intervention components in this sequence: 12 months of no D2S (usual practice only), December 2020-November 2021 (Period 0, months 1-12), followed by 24 months of the D2S intervention, December 2021-November 2023 (Period 1, months 13-24 and Period 2, months 25-36). Viral suppression status was followed for 6 months from each client's appearance on a D2S report, and the last 6-month follow-up period extended through November 2023 (end of Period 2).
|
Delayed Implementation: UC First, Then UC Again, Then D2S
Delayed implementation sites received the Data to Suppression (D2S) intervention in this sequence: 24 months of no D2S (usual practice only), December 2020-November 2022 (Period 0, months 1-12 and Period 1, months 13-24), followed by 12 months of the D2S intervention, December 2022-November 2023 (Period 2, months 25-36). Viral suppression status was followed for 6 months from each client's appearance on a D2S report, and the last 6-month follow-up period extended through November 2023 (end of Period 2).
|
|---|---|---|
|
Period 0: Months 1-12/Dec 2020-Nov 2021
STARTED
|
292 13
|
322 14
|
|
Period 0: Months 1-12/Dec 2020-Nov 2021
COMPLETED
|
292 13
|
322 14
|
|
Period 0: Months 1-12/Dec 2020-Nov 2021
NOT COMPLETED
|
0 0
|
0 0
|
|
Period 1: Months 13-24/Dec 2021-Nov 2022
STARTED
|
209 13
|
279 14
|
|
Period 1: Months 13-24/Dec 2021-Nov 2022
COMPLETED
|
209 13
|
279 14
|
|
Period 1: Months 13-24/Dec 2021-Nov 2022
NOT COMPLETED
|
0 0
|
0 0
|
|
Period 2: Months 25-36/Dec 2022-Nov 2023
STARTED
|
197 13
|
195 14
|
|
Period 2: Months 25-36/Dec 2022-Nov 2023
COMPLETED
|
197 13
|
195 14
|
|
Period 2: Months 25-36/Dec 2022-Nov 2023
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Testing a Novel Data-to-Suppression (D2S) Intervention Strategy in the Ryan White HIV/AIDS Program
Baseline characteristics by cohort
| Measure |
Early Implementation: UC First, Then D2S, Then D2S Again
n=698 Participants
Early Implementation sites received the Data to Suppression (D2S) intervention components December 2021-November 2023 (Period 1, months 13-24, and Period 2, months 25-36).
|
Delayed Implementation: UC First, Then UC Again, Then D2S
n=796 Participants
Delayed Implementation sites received the Data to Suppression (D2S) intervention components December 2022-November 2023 (Period 2, months 25-36) only.
|
Total
n=1494 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
1 Participants
n=224 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
628 Participants
n=110 Participants
|
743 Participants
n=114 Participants
|
1371 Participants
n=224 Participants
|
|
Age, Categorical
>=65 years
|
69 Participants
n=110 Participants
|
53 Participants
n=114 Participants
|
122 Participants
n=224 Participants
|
|
Sex/Gender, Customized
Cisgender man or boy
|
460 Participants
n=110 Participants
|
500 Participants
n=114 Participants
|
960 Participants
n=224 Participants
|
|
Sex/Gender, Customized
Cisgender woman or girl
|
200 Participants
n=110 Participants
|
225 Participants
n=114 Participants
|
425 Participants
n=224 Participants
|
|
Sex/Gender, Customized
TGNCNB* individual
|
38 Participants
n=110 Participants
|
71 Participants
n=114 Participants
|
109 Participants
n=224 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
200 Participants
n=110 Participants
|
235 Participants
n=114 Participants
|
435 Participants
n=224 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
497 Participants
n=110 Participants
|
556 Participants
n=114 Participants
|
1053 Participants
n=224 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=110 Participants
|
5 Participants
n=114 Participants
|
6 Participants
n=224 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=110 Participants
|
5 Participants
n=114 Participants
|
8 Participants
n=224 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=110 Participants
|
3 Participants
n=114 Participants
|
3 Participants
n=224 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
1 Participants
n=224 Participants
|
|
Race (NIH/OMB)
Black or African American
|
526 Participants
n=110 Participants
|
573 Participants
n=114 Participants
|
1099 Participants
n=224 Participants
|
|
Race (NIH/OMB)
White
|
108 Participants
n=110 Participants
|
140 Participants
n=114 Participants
|
248 Participants
n=224 Participants
|
|
Race (NIH/OMB)
More than one race
|
13 Participants
n=110 Participants
|
11 Participants
n=114 Participants
|
24 Participants
n=224 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
47 Participants
n=110 Participants
|
64 Participants
n=114 Participants
|
111 Participants
n=224 Participants
|
|
Region of Enrollment
United States
|
698 Participants
n=110 Participants
|
796 Participants
n=114 Participants
|
1494 Participants
n=224 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: The analysis population includes those who were included on a D2S report (whether delivered or not delivered to their service site) as requiring follow-up for viral suppression, and who were later confirmed through updated surveillance data to have still been alive and virally unsuppressed at the time of report issue.
Registry-reported VL \<200 copies/mL on any VL test dated in the six months after the client first appeared as unsuppressed on a D2S report for the period
Outcome measures
| Measure |
D2S Intervention
n=601 Participants
Sites received the Data to Suppression (D2S) intervention components
|
Usual Care
n=893 Participants
Sites received usual quality management supports (usual practice) from the NYC Health Department
|
|---|---|---|
|
Timely Viral Suppression
|
309 Participants
|
352 Participants
|
SECONDARY outcome
Timeframe: 12 monthsTime to first VL \<200 copies/mL after client's first appearance on a D2S report for the period
Outcome measures
Outcome data not reported
Adverse Events
D2S Intervention
Usual Care
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Mary Irvine, NYC Health Department PI
New York City Department of Health and Mental Hygiene
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place