Study protocol for data to suppression (D2S) : a cluster-randomised, stepped-wedge effectiveness trial of a reporting and capacity-building intervention to improve HIV viral suppression in housing and behavioural health programmes in New York City
© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ..
INTRODUCTION: With progress in the 'diagnose', 'link' and 'retain' stages of the HIV care continuum, viral suppression (VS) gains increasingly hinge on antiretroviral adherence among people with HIV (PWH) retained in care. The Centers for Disease Control and Prevention estimate that unsuppressed viral load among PWH in care accounts for 20% of onward transmission. HIV intervention strategies include 'data to care' (D2C)-using surveillance to identify out-of-care PWH for follow-up. However, most D2C efforts target care linkage, not antiretroviral adherence, and limit client-level data sharing to medical (versus support-service) providers. Drawing on lessons learnt in D2C and successful local pilots, we designed a 'data-to-suppression' intervention that offers HIV support-service programmes surveillance-based reports listing their virally unsuppressed clients and capacity-building assistance for quality-improvement activities. We aimed to scale and test the intervention in agencies delivering Ryan White HIV/AIDS Programme-funded behavioural health and housing services.
METHODS AND ANALYSIS: To estimate intervention effects, this study applies a cross-sectional, stepped-wedge design to the intervention's rollout to 27 agencies randomised within matched pairs to early or delayed implementation. Data from three 12-month periods (pre-implementation, partial implementation and full implementation) will be examined to assess intervention effects on timely VS (within 6 months of a report listing the client as needing follow-up for VS). Based on projected enrolment (n=1619) and a pre-implementation outcome probability of 0.40-0.45, the detectable effect size with 80% power is an OR of 2.12 (relative risk: 1.41-1.46).
ETHICS AND DISSEMINATION: This study was approved by the New York City Department of Health and Mental Hygiene's institutional review board (protocol: 21-036) with a waiver of informed consent. Findings will be disseminated via publications, conferences and meetings including provider-agency representatives.
TRIAL REGISTRATION NUMBER: NCT05140421.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2023 |
|---|---|
| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:13 |
|---|---|
| Enthalten in: |
BMJ open - 13(2023), 7 vom: 14. Juli, Seite e076716 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Irvine, Mary K [VerfasserIn] |
|---|
| Links: |
|---|
| Anmerkungen: |
Date Completed 17.07.2023 Date Revised 24.11.2023 published: Electronic ClinicalTrials.gov: NCT05140421 Citation Status MEDLINE |
|---|
| doi: |
10.1136/bmjopen-2023-076716 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM359524656 |
|---|
| LEADER | 01000naa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM359524656 | ||
| 003 | DE-627 | ||
| 005 | 20231226210632.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231226s2023 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1136/bmjopen-2023-076716 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1198.xml |
| 035 | |a (DE-627)NLM359524656 | ||
| 035 | |a (NLM)37451738 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Irvine, Mary K |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Study protocol for data to suppression (D2S) |b a cluster-randomised, stepped-wedge effectiveness trial of a reporting and capacity-building intervention to improve HIV viral suppression in housing and behavioural health programmes in New York City |
| 264 | 1 | |c 2023 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 17.07.2023 | ||
| 500 | |a Date Revised 24.11.2023 | ||
| 500 | |a published: Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT05140421 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. | ||
| 520 | |a INTRODUCTION: With progress in the 'diagnose', 'link' and 'retain' stages of the HIV care continuum, viral suppression (VS) gains increasingly hinge on antiretroviral adherence among people with HIV (PWH) retained in care. The Centers for Disease Control and Prevention estimate that unsuppressed viral load among PWH in care accounts for 20% of onward transmission. HIV intervention strategies include 'data to care' (D2C)-using surveillance to identify out-of-care PWH for follow-up. However, most D2C efforts target care linkage, not antiretroviral adherence, and limit client-level data sharing to medical (versus support-service) providers. Drawing on lessons learnt in D2C and successful local pilots, we designed a 'data-to-suppression' intervention that offers HIV support-service programmes surveillance-based reports listing their virally unsuppressed clients and capacity-building assistance for quality-improvement activities. We aimed to scale and test the intervention in agencies delivering Ryan White HIV/AIDS Programme-funded behavioural health and housing services | ||
| 520 | |a METHODS AND ANALYSIS: To estimate intervention effects, this study applies a cross-sectional, stepped-wedge design to the intervention's rollout to 27 agencies randomised within matched pairs to early or delayed implementation. Data from three 12-month periods (pre-implementation, partial implementation and full implementation) will be examined to assess intervention effects on timely VS (within 6 months of a report listing the client as needing follow-up for VS). Based on projected enrolment (n=1619) and a pre-implementation outcome probability of 0.40-0.45, the detectable effect size with 80% power is an OR of 2.12 (relative risk: 1.41-1.46) | ||
| 520 | |a ETHICS AND DISSEMINATION: This study was approved by the New York City Department of Health and Mental Hygiene's institutional review board (protocol: 21-036) with a waiver of informed consent. Findings will be disseminated via publications, conferences and meetings including provider-agency representatives | ||
| 520 | |a TRIAL REGISTRATION NUMBER: NCT05140421 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, U.S. Gov't, P.H.S. | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a HIV & AIDS | |
| 650 | 4 | |a Health informatics | |
| 650 | 4 | |a Patient Navigation | |
| 650 | 4 | |a Public health | |
| 650 | 4 | |a Quality in health care | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 7 | |a Anti-Retroviral Agents |2 NLM | |
| 700 | 1 | |a Abdelqader, Faisal |e verfasserin |4 aut | |
| 700 | 1 | |a Levin, Bruce |e verfasserin |4 aut | |
| 700 | 1 | |a Thomas, Jacinthe |e verfasserin |4 aut | |
| 700 | 1 | |a Avoundjian, Tigran |e verfasserin |4 aut | |
| 700 | 1 | |a Peterson, Meghan |e verfasserin |4 aut | |
| 700 | 1 | |a Zimba, Rebecca |e verfasserin |4 aut | |
| 700 | 1 | |a Braunstein, Sarah L |e verfasserin |4 aut | |
| 700 | 1 | |a Robertson, McKaylee M |e verfasserin |4 aut | |
| 700 | 1 | |a Nash, Denis |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t BMJ open |d 2012 |g 13(2023), 7 vom: 14. Juli, Seite e076716 |w (DE-627)NLM215724372 |x 2044-6055 |7 nnns |
| 773 | 1 | 8 | |g volume:13 |g year:2023 |g number:7 |g day:14 |g month:07 |g pages:e076716 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1136/bmjopen-2023-076716 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 13 |j 2023 |e 7 |b 14 |c 07 |h e076716 | ||