SuicideNCT05541926
Scaling up e-Connect in Juvenile Probation Settings
A study testing e-Connect in people with Suicide, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
We propose to conduct research on strategies that support the successful scale-up of an evidence-based, suicidal risk and behavior identification and cross-system linkage programs for justice-involved youth (e-Connect), and to rigorously evaluate the implementation activities and associated costs that support that… Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Suicide
- What is being tested?
- e-Connect
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,629 participants
- Where
- 1 siteUnited States
- Study dates
- 2 May 2023to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All probation agency leadership and officers employed by the partnering sites who are (a) at least 18 years of age and (b) conversant in English in participating study counties are eligible
- All treatment staff (agency directors, supervisors and clinical line staff) employed by participating treatment agencies who are at least 18 years of age and conversant in English in participating study counties will be asked to participate
- All county/local Justice Diversion Alternatives Initiative (JDAI) representatives that work with partnering sites who (a) are at least 18 years of age and (b) conversant in English in participating study counties are eligible
- All youth who are on probation who are (a) 10-18 years of age and (b) conversant in English in participating study counties are eligible;
Who cannot join
- There are no exclusionary criteria and no special classes of participants.
- Sample: County Treatment Staff
- There are no exclusionary criteria and no special classes of participants.
- Sample: Local Facilitators
- There are no exclusionary criteria and no special classes of participants.
- Sample: Probation Youth
- There are no exclusionary criteria and no special classes of participants.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Columbia University and New York State Psychiatric Instititute
New York, New York, 10032
Katherine Elkington, PhD, 646-774-6965, ke2143@cumc.columbia.edu
About this study
Official title: Scaling up eConnect in Juvenile Probation Settings: a Hybrid Implementation Effectiveness Trial of a Digital Suicide Risk/Behavior Identification and linkage-to Treatment System
We propose to conduct research on strategies that support the successful scale-up of an evidence-based, suicidal risk and behavior identification and cross-system linkage programs for justice-involved youth (e-Connect), and to rigorously evaluate the implementation activities and associated costs that support that scale-up of e-Connect within 9 Indiana counties. Guided by the GPM and EPIS frameworks, this 4-year study will comprise 3 project phases: (1) Scale-Up Strategy Efforts, focused on preparing for scale-up; (2) e-Connect-scaleup implementation (2a Exploration and Preparation and 2b Implementation and Sustainment); and (3) Scale-Up Effectiveness Trial/Outcome Evaluation. The current project draws on lessons learned from the e-Connect efficacy trial in NYS and research team leadership will serve as External Facilitators to support 9 Local Facilitators to ensure the successful transfer of knowledge, skill and expertise in delivering e-Connect in a new JJ system and geographic context, utilizing implementation strategies to support the more widespread, sustained and rigorous adoption of e-Connect. The study will include a learning community created by External Facilitators for Local Facilitators to provide support, to exchange strategies to handle implementation issues, to develop competencies in facilitation, and to guide implementation throughout the program. The learning community will help Local Facilitators navigate through the implementation stages of the study.
Read the detailed description
The proposed study will examine strategies to bolster the successful scale-up of e-Connect, one of the few evidence-based suicide behavior identification and cross-system linkage programs for youth on under community supervision. This proposal is from two PIs with complimentary expertise in the justice system, implementation science, clinical decision support systems, and use of large administrative data sets, and is supported by a strong multi-disciplinary team to achieve study aims. Guided by the gateway provider model (GPM) and the Exploration, Preparation, Implementation Sustainment (EPIS) implementation framework, we now propose to extend our work of e-Connect, to develop and test a "purveyor model" of implementation scale-up (i.e. e-Connect-scaleup). In e-Connect-scaleup, research team leadership will serve as External Facilitators to support Local Facilitators to ensure the successful transfer of knowledge, skill and expertise in delivering e-Connect in a new JJ system and geographic context, utilizing implementation strategies to support the more widespread, sustained and rigorous adoption of e-Connect. Working in 9 Indiana counties, randomly assigned to one of three waves in a stepped-wedge, implementation-effectiveness hybrid type-2 design, the specific aims are to examine the clinical and cost-effectiveness of e-Connect-scaleup on (i) identification of youth service need (SB and BH correlates) in juvenile probationers; (ii) cross-system (probation-BH agency) referral; and (iii) youth BH service use (initial BH contact; primary outcome) by comparing the performance of e-Connect to (a) standard probation officer practice (baseline) and (b) to rates achieved in the prior efficacy trial of e-Connect (Aim 1). We will examine potential mediating or moderating effects of EPIS/GPM inner and outer context factors We will also determine whether, at scale, e-Connect promotes SB/BH service need identification, cross-system referral and youth SB/BH service use as compared with standard probation practice (baseline), for all youth on probation, regardless of youth clinical need or demographic characteristics, which would replicate previous performance of e-Connect in NYS (Aim 2). Finally, we will examine the implementation of e-Connect-scaleup in terms of fidelity and acceptability and compare advancement through the stages of implementation through to sustainment across the 9 counties in order to demonstrate the feasibility of scaling-up e-Connect in probation settings beyond NYS (Aim 3). We will elucidate the inner- and outer-level EPIS- and GPM- derived factors that promote or hinder delivery of implementation strategies and practice change to inform scale up across a variety of contexts.
Settings. The sample for the proposed study will be recruited from probation staff, partnering treatment agency staff, and probation youth from 9 counties in Indiana, which are distributed across the state geographically. The counties range in population density, with 5 qualifying as Rural/Mixed and 4 as Urban. Each county participating in the proposed study is also a member of the Indiana Juvenile Detention Alternatives Initiative, a nationwide juvenile justice reform effort funded by the Annie E. Casey Foundation and adopted in nearly a third of Indiana counties. The focus of JDAI is to limit the unnecessary detainment of low-risk probation youth. Each JDAI county has developed committees of staff and community members that use a data-driven process, one of the JDAI core strategies, to identify targets of intervention, assess effectiveness of the interventions, and continue monitoring progress to develop future interventions. Recognizing the benefits of JDAI, Indiana was the second state to institute a central JDAI office to support statewide expansion. Each JDAI county has a dedicated coordinator who will also act as Local Facilitator for e-Connect. See the map indicating the location of participating sites relative to other JDAI counties and juvenile detention centers.
Design, Sample Size and Randomization. In the proposed cluster randomized stepped-wedge design, 9 Indiana counties will be randomized - stratified by population density/urbanicity (as a proxy for staffing and resource availability) - to one of 3 waves of e-Connect-scale-up at 3-month intervals.
We will examine the clinical and cost-effectiveness of e-Connect-scaleup on (i) identification of youth service need (SB and BH correlates) in juvenile probationers; (ii) cross-system (probation-BH agency) referral; and (iii) youth BH service use (initial BH contact; primary outcome) by comparing the performance of e-Connect to (a) standard probation officer practice (baseline) and (b) to rates achieved in the prior efficacy trial of e-Connect (Aim 1). We will examine potential mediating or moderating effects of EPIS/GPM inner (e.g. staff knowledge, organizational functioning) and outer context factors (e.g. youth age, county rate of SB) on e-Connect-scaleup outcomes. We will also determine whether, at scale, e-Connect promotes SB/BH service need identification, cross-system referral and youth SB/BH service use as compared with standard probation practice (baseline), for all youth on probation, regardless of youth clinical need or demographic characteristics, which would replicate previous performance of e-Connect in NYS (Aim 2). Finally, we will evaluate the implementation of e-Connect-scaleup in two ways (Aim 3). First, we will examine the fidelity and acceptability of e-Connect-scaleup, including facilitation strategies. Second, we will document processes of scaling up e-Connect, comparing advancement through the stages of implementation through to sustainment across the 9 counties in order to demonstrate the feasibility of scaling-up e-Connect in probation settings beyond NYS; we will explore the role of site differences and other EPIS and GPM factors on implementation completion (Aim 3). By randomizing sites to e-Connect-scaleup across time, the control group (which is changing over time) is taken to be the sites that have not yet rolled out e-Connect-scaleup by a particular time, treatment as usual (TAU). Data on these behavioral health care cascade outcomes are collected in each county pre and post randomization to e-Connect-scaleup allowing for within site estimates of change while controlling for secular changes over time. We will also examine potential effect modifiers of e-Connect by youth, staff and county level inner and outer setting factors. To examine impact and success of implementation strategies, we will compare stages of implementation completion as well as feasibility and acceptability cross the 9 new counties, exploring the role of site differences as well as other EPIS factors (outer-, inner-context level) on implementation completion. There are two limitations to cluster randomized deigns: potential of uneven distribution of potentially confounding variables within a cluster (i.e. county) as well as interrelationship between variables. Our proposed stratification plan and use of propensity matching will address issues related to confounding. We calculated our ability to detect an effect of e-Connect-scaleup (i.e. power) using a conservative intraclass correlation coefficient (ICC) of .65, denoting a moderate-large positive correlation between outcomes within a county to address issues of interrelationship between variables at the county level.
- Conditions
- Suicide
- Being tested
- e-Connect
- Medical subject headings
- Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
e-ConnectBehavioural
Implementation of the e-Connect system
| Study group | Role | What they receive |
|---|---|---|
| e-Connect | Experimental | County receives training and materials and subsequently begins the e-Connect intervention Receives: Behavioral: e-Connect |
| Standard of Care | No intervention | Standard of care practice in counties prior to the implementation of e-Connect |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment initiation
Date of first behavioral health appointment/contact; extracted from Indiana Probation management information system (MIS)
Measured: 3 years
Secondary outcomes (10)
Treatment engagement
# of weeks in treatment, via termination date; extracted from MIS, Medicaid data
Measured: 3 years
Screen/Identify Youth Service Need
Via e-Connect system and recorded in Caseload Explorer: YASI Orbis, Chestnut Information indicates whether screening has occurred; Extracted from MIS
Measured: 3 years
Cross-system Referral
Indicated by Referral Date; extracted from MIS
Measured: 3 years
Uptake Adoption of e-Connect system
Acceptability, uptake and sustainability of e-Connect (BH and JJ staff; External and Local facilitators
Measured: 6 months
Uptake Adoption - MIS
Number of eligible youth screened via e-Connect
Measured: 3 years
Fidelity to use of e-Connect system
Measured by Stages of Implementation Completion (SIC) tool. indicated by implementation stages complete; time to stage completion; activities completed w/in each stage)
Measured: 3 years
Fidelity of Facilitation
Checklists (self and observer) documenting completeness of activities; External/Local Facilitation activity tracker
Measured: 3 years
Acceptability of e-Connect by the family
PO completes family debriefing checklist: family receptivity to screening results and referral plan
Measured: 3 years
Sustainability of e-Connect protocol
Measured using MIS
Measured: 1 year, 4 months
Sustainability achieved in implementation process
Stages of Implementation Completion (SIC) tool measures - Implementation stages complete; time to stage completion; activities completed within each stage measured by the SIC tool
Measured: 1 year, 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start2 May 2023
- Primary completion30 Apr 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SuicideStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Stepped-wedge design
- Masking
- None (open label)
- Enrolment
- 3,629 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Indiana University, George Mason University, Chestnut Health Systems, National Institute of Mental Health (NIMH), Columbia University
- Responsible party
- Principal investigator, Katherine Elkington, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05541926
- Sponsor's protocol ID
- 8359
- Other IDs
- R01MH130845
- Status last verified
- Jun 2026
- First submitted
- 9 Sep 2022
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scaling up eConnect in Juvenile Probation Settings: a Hybrid Implementation Effectiveness Trial of a Digital Suicide Risk/Behavior Identification and linkage-to Treatment System
- ClinicalTrials.gov ID
- NCT05541926
- Acronym / sponsor ID
- 8359
- Conditions
- Suicide
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,629 participants (estimated)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- Indiana University, George Mason University, Chestnut Health Systems, National Institute of Mental Health (NIMH), Columbia University
- Study start
- 2 May 2023 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 15 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We propose to conduct research on strategies that support the successful scale-up of an evidence-based, suicidal risk and behavior identification and cross-system linkage programs for justice-involved youth (e-Connect), and to rigorously evaluate the implementation activities and associated costs that support that scale-up of e-Connect within 9 Indiana counties. Guided by the GPM and EPIS frameworks, this 4-year study will comprise 3 project phases: (1) Scale-Up Strategy Efforts, focused on preparing for scale-up; (2) e-Connect-scaleup implementation (2a Exploration and Preparation and 2b Implementation and Sustainment); and (3) Scale-Up Effectiveness Trial/Outcome Evaluation. The current project draws on lessons learned from the e-Connect efficacy trial in NYS and research team leadership will serve as External Facilitators to support 9 Local Facilitators to ensure the successful transfer of knowledge, skill and expertise in delivering e-Connect in a new JJ system and geographic context, utilizing implementation strategies to support the more widespread, sustained and rigorous adoption of e-Connect. The study will include a learning community created by External Facilitators for Local Facilitators to provide support, to exchange strategies to handle implementation issues, to develop competencies in facilitation, and to guide implementation throughout the program. The learning community will help Local Facilitators navigate through the implementation stages of the study.
Detailed description
The proposed study will examine strategies to bolster the successful scale-up of e-Connect, one of the few evidence-based suicide behavior identification and cross-system linkage programs for youth on under community supervision. This proposal is from two PIs with complimentary expertise in the justice system, implementation science, clinical decision support systems, and use of large administrative data sets, and is supported by a strong multi-disciplinary team to achieve study aims. Guided by the gateway provider model (GPM) and the Exploration, Preparation, Implementation Sustainment (EPIS) implementation framework, we now propose to extend our work of e-Connect, to develop and test a "purveyor model" of implementation scale-up (i.e. e-Connect-scaleup). In e-Connect-scaleup, research team leadership will serve as External Facilitators to support Local Facilitators to ensure the successful transfer of knowledge, skill and expertise in delivering e-Connect in a new JJ system and geographic context, utilizing implementation strategies to support the more widespread, sustained and rigorous adoption of e-Connect. Working in 9 Indiana counties, randomly assigned to one of three waves in a stepped-wedge, implementation-effectiveness hybrid type-2 design, the specific aims are to examine the clinical and cost-effectiveness of e-Connect-scaleup on (i) identification of youth service need (SB and BH correlates) in juvenile probationers; (ii) cross-system (probation-BH agency) referral; and (iii) youth BH service use (initial BH contact; primary outcome) by comparing the performance of e-Connect to (a) standard probation officer practice (baseline) and (b) to rates achieved in the prior efficacy trial of e-Connect (Aim 1). We will examine potential mediating or moderating effects of EPIS/GPM inner and outer context factors We will also determine whether, at scale, e-Connect promotes SB/BH service need identification, cross-system referral and youth SB/BH service use as compared with standard probation practice (baseline), for all youth on probation, regardless of youth clinical need or demographic characteristics, which would replicate previous performance of e-Connect in NYS (Aim 2). Finally, we will examine the implementation of e-Connect-scaleup in terms of fidelity and acceptability and compare advancement through the stages of implementation through to sustainment across the 9 counties in order to demonstrate the feasibility of scaling-up e-Connect in probation settings beyond NYS (Aim 3). We will elucidate the inner- and outer-level EPIS- and GPM- derived factors that promote or hinder delivery of implementation strategies and practice change to inform scale up across a variety of contexts.
Settings. The sample for the proposed study will be recruited from probation staff, partnering treatment agency staff, and probation youth from 9 counties in Indiana, which are distributed across the state geographically. The counties range in population density, with 5 qualifying as Rural/Mixed and 4 as Urban. Each county participating in the proposed study is also a member of the Indiana Juvenile Detention Alternatives Initiative, a nationwide juvenile justice reform effort funded by the Annie E. Casey Foundation and adopted in nearly a third of Indiana counties. The focus of JDAI is to limit the unnecessary detainment of low-risk probation youth. Each JDAI county has developed committees of staff and community members that use a data-driven process, one of the JDAI core strategies, to identify targets of intervention, assess effectiveness of the interventions, and continue monitoring progress to develop future interventions. Recognizing the benefits of JDAI, Indiana was the second state to institute a central JDAI office to support statewide expansion. Each JDAI county has a dedicated coordinator who will also act as Local Facilitator for e-Connect. See the map indicating the location of participating sites relative to other JDAI counties and juvenile detention centers.
Design, Sample Size and Randomization. In the proposed cluster randomized stepped-wedge design, 9 Indiana counties will be randomized - stratified by population density/urbanicity (as a proxy for staffing and resource availability) - to one of 3 waves of e-Connect-scale-up at 3-month intervals.
We will examine the clinical and cost-effectiveness of e-Connect-scaleup on (i) identification of youth service need (SB and BH correlates) in juvenile probationers; (ii) cross-system (probation-BH agency) referral; and (iii) youth BH service use (initial BH contact; primary outcome) by comparing the performance of e-Connect to (a) standard probation officer practice (baseline) and (b) to rates achieved in the prior efficacy trial of e-Connect (Aim 1). We will examine potential mediating or moderating effects of EPIS/GPM inner (e.g. staff knowledge, organizational functioning) and outer context factors (e.g. youth age, county rate of SB) on e-Connect-scaleup outcomes. We will also determine whether, at scale, e-Connect promotes SB/BH service need identification, cross-system referral and youth SB/BH service use as compared with standard probation practice (baseline), for all youth on probation, regardless of youth clinical need or demographic characteristics, which would replicate previous performance of e-Connect in NYS (Aim 2). Finally, we will evaluate the implementation of e-Connect-scaleup in two ways (Aim 3). First, we will examine the fidelity and acceptability of e-Connect-scaleup, including facilitation strategies. Second, we will document processes of scaling up e-Connect, comparing advancement through the stages of implementation through to sustainment across the 9 counties in order to demonstrate the feasibility of scaling-up e-Connect in probation settings beyond NYS; we will explore the role of site differences and other EPIS and GPM factors on implementation completion (Aim 3). By randomizing sites to e-Connect-scaleup across time, the control group (which is changing over time) is taken to be the sites that have not yet rolled out e-Connect-scaleup by a particular time, treatment as usual (TAU). Data on these behavioral health care cascade outcomes are collected in each county pre and post randomization to e-Connect-scaleup allowing for within site estimates of change while controlling for secular changes over time. We will also examine potential effect modifiers of e-Connect by youth, staff and county level inner and outer setting factors. To examine impact and success of implementation strategies, we will compare stages of implementation completion as well as feasibility and acceptability cross the 9 new counties, exploring the role of site differences as well as other EPIS factors (outer-, inner-context level) on implementation completion. There are two limitations to cluster randomized deigns: potential of uneven distribution of potentially confounding variables within a cluster (i.e. county) as well as interrelationship between variables. Our proposed stratification plan and use of propensity matching will address issues related to confounding. We calculated our ability to detect an effect of e-Connect-scaleup (i.e. power) using a conservative intraclass correlation coefficient (ICC) of .65, denoting a moderate-large positive correlation between outcomes within a county to address issues of interrelationship between variables at the county level.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stepped-wedge design
| Arm | Type | Receives |
|---|---|---|
| e-Connect | Experimental | Behavioral: e-ConnectCounty receives training and materials and subsequently begins the e-Connect intervention |
| Standard of Care | No intervention | –Standard of care practice in counties prior to the implementation of e-Connect |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- All probation agency leadership and officers employed by the partnering sites who are (a) at least 18 years of age and (b) conversant in English in participating study counties are eligible
- All treatment staff (agency directors, supervisors and clinical line staff) employed by participating treatment agencies who are at least 18 years of age and conversant in English in participating study counties will be asked to participate
- All county/local Justice Diversion Alternatives Initiative (JDAI) representatives that work with partnering sites who (a) are at least 18 years of age and (b) conversant in English in participating study counties are eligible
- All youth who are on probation who are (a) 10-18 years of age and (b) conversant in English in participating study counties are eligible;
Key exclusion criteria (7 listed)
- There are no exclusionary criteria and no special classes of participants.
- Sample: County Treatment Staff
- There are no exclusionary criteria and no special classes of participants.
- Sample: Local Facilitators
- There are no exclusionary criteria and no special classes of participants.
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 |
|---|---|---|
| e-ConnectImplementation of the e-Connect system | Behavioural | e-Connect |
Primary outcome
Treatment initiation
Time frame: 3 years
Date of first behavioral health appointment/contact; extracted from Indiana Probation management information system (MIS)
10 secondary outcomes
Treatment engagement
Time frame: 3 years
Screen/Identify Youth Service Need
Time frame: 3 years
Cross-system Referral
Time frame: 3 years
Uptake Adoption of e-Connect system
Time frame: 6 months
Uptake Adoption - MIS
Time frame: 3 years
Fidelity to use of e-Connect system
Time frame: 3 years
Fidelity of Facilitation
Time frame: 3 years
Acceptability of e-Connect by the family
Time frame: 3 years
Sustainability of e-Connect protocol
Time frame: 1 year, 4 months
Sustainability achieved in implementation process
Time frame: 1 year, 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing e-Connect in people with Suicide, run by New York State Psychiatric Institute at 1 site 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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katherine S Elkington, Ph.D. (646-774-6965, ke2143@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment initiation (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jun 2026.