Navigation Study: Durham

August 19, 2026 updated by: Duke University

Evaluation of the Navigation Prevention Program: Durham

The purpose of this RCT is to evaluate the implementation and impact of a new, community-wide prevention program, "Community Navigation", on maternal and child health and well-being. This program recruits mothers at the OB/GYN or pediatrician's office prenatally and provides up to six Navigation visits (prenatally, and at child ages 12, 24, 36, 48, and 60 months) to assess family strengths and needs, establish connections between the family and primary health care or other community providers based on identified needs and family preference, and then follows up one month later to confirm these referrals.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Note: 400 families were enrolled in this RCT under Navigation 1.0. However, their data will not be included in any analysis due to changes to the Navigation intervention design resulting in Navigation 2.0. The final RCT sample includes of 815 participants enrolled during the implementation of Navigation 2.0.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
815

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27708
        • Duke University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 second and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Pregnant individuals residing in Durham County, NC who are receiving prenatal care from a Duke University OB/GYN clinic, the Durham County Health Department, or the local Fetal Diagnostic Center.
  2. Primary language is English or Spanish
  3. Recruited into the study at or before 28 weeks gestation.

Exclusion Criteria:

  • Families residing outside of Durham County
  • Families that are planning to move out of either county within the next 2 months at the time of recruitment
  • Families will also be ineligible if the parent has a cognitive impairment that impairs their ability to consent/participate.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Navigation Version 1.0 (discontinued, modified to Version 2.0. Data will not be used)
Navigation 1.0 recruits mothers in OB/GYN (prenatal) offices, provides up to three Navigation visits, establishes connections between the family and primary health care or other community providers, and then follows up one month later to confirm these referrals. Navigators will assess and support family needs across multiple developmentally-appropriate domains at each age. Prenatally, the domains include support for (1) health and access to healthcare, (2) adjustments to pregnancy, (3) household and material needs, and (4) family safety. At 12, 24, and 36 months, the domains include support for (1) child basic needs, (2) parenting and child behavior, (3) child health and development, and (4) parent health and well-being.
Behavioral: Navigation Intervention Version 1.0 (discontinued, modified to Version 2.0. Data will not be used)
Navigation 1.0 recruits mothers in OB/GYN (prenatal) offices, provides up to three Navigation visits, establishes connections between the family and primary health care or other community providers, and then follows up one month later to confirm these referrals. Navigators will assess and support family needs across multiple developmentally-appropriate domains at each age. Prenatally, the domains include support for (1) health and access to healthcare, (2) adjustments to pregnancy, (3) household and material needs, and (4) family safety. At 12, 24, and 36 months, the domains include support for (1) child basic needs, (2) parenting and child behavior, (3) child health and development, and (4) parent health and well-being.
Other: Control Intervention
Brief educational information will be provided about pregnancy (provided prenatally) and child development when the child is approximately 12, 24, 36, 48, and 60 months old.
Behavioral: Control Intervention
Brief educational information will be provided about pregnancy (provided prenatally) and child development when the child is approximately 12, 24, 36, 48, and 60 months old.
Experimental: Navigation Intervention Version 2.0

Navigation 2.0 recruits mothers in OB/GYN offices. Mothers are offered visits from a Navigator prenatally and postnatally (at child ages 12, 24, 36, 48, and 60 months). During visits, the Navigator works with the mother/caregiver to identify family needs, establishes connections between the family and community providers, and follows up one month later to confirm these referrals.

At all touch points, Navigators assess and support family needs in four domains. For the prenatal, 12, and 24 month Navigation visits, the domains include (1) Health Care; (2) Caring for the Infant; (3) A Safe Home; and (4) Parent Well-Being. At the 36, 48, and 60 month Navigation visits, the domains include: (1) Health Care; (2) Caring for the Child; (3) Child Development; and (4) Family Interactions. Families are also invited at all visits to nominate other needs not related to these four domains.
Behavioral: Navigation Intervention Version 2.0

Navigation 2.0 recruits mothers in OB/GYN offices. Mothers are offered visits from a Navigator prenatally and postnatally (at child ages 12, 24, 36, 48, and 60 months). During visits, the Navigator works with the mother/caregiver to identify family needs, establishes connections between the family and community providers, and follows up one month later to confirm these referrals.

At all touch points, Navigators assess and support family needs in four domains. For the prenatal, 12, and 24 month Navigation visits, the domains include (1) Health Care; (2) Caring for the Infant; (3) A Safe Home; and (4) Parent Well-Being. At the 36, 48, and 60 month Navigation visits, the domains include: (1) Health Care; (2) Caring for the Child; (3) Child Development; and (4) Family Interactions. Families are also invited at all visits to nominate other needs not related to these four domains.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Evaluate the implementation by the families' satisfaction with the Navigation program.
Time Frame: 3 months
This will be measured via participant self-reports as the percentage of families that rate themselves as satisfied or very satisfied with their Navigation experience and the percentage of families that would recommend the program to other families.
3 months
Evaluate the impact of the Navigation program by reviewing maternal health.
Time Frame: 3 months
This will be measured from participant self-reports via a comparison of Navigation and control groups' mean scores of their ratings of their overall health, depression symptoms, anxiety symptoms, and substance abuse symptoms.
3 months
Evaluate the impact of the Navigation program by reviewing child health and development.
Time Frame: 3 months
This will be measured from parent reports via a comparison of the Navigation and control groups' mean scores on ratings of their overall health, social-emotional development, and cognitive development.
3 months
Evaluate the impact of the Navigation program by reviewing parent and parent-child relationships.
Time Frame: 3 months
This will be measured from participant self-reports via a comparison of Navigation and control groups' mean scores on ratings of their knowledge of child development, parenting self-efficacy, parenting stress, parent discipline behavior, and parent attributions of child behavior.
3 months
Evaluate the impact of the Navigation program by reviewing family service receipt and children's connection to medical home.
Time Frame: 3 months
Family services receipt will be measured from parent reports via a comparison of the Navigation and control groups' mean number of community services they have accessed since receiving Navigation/the control intervention. Connection to a medical home will be measured from parent report via a comparison of the Navigation and control groups' likelihood of having a primary care physician for their child.
3 months
Evaluate the implementation by the rate of enrollment in the Navigation program.
Time Frame: Prenatally (up until delivery of target child)
Proportion of participants in the Navigation group who agree to schedule a prenatal Navigation visit, which will be collected from enrollment logs.
Prenatally (up until delivery of target child)
Evaluate the implementation by the rate of retention in the Navigation program.
Time Frame: 12 months
This will be collected from participant tracking logs completed by the navigators (i.e., whether they completed the 12-month Navigation visit with the participant).
12 months
Evaluate the implementation by the rate of retention in the Navigation program.
Time Frame: 24 months
This will be collected from participant tracking logs completed by the navigators (i.e., whether they completed the 24-month Navigation visit with the participant).
24 months
Evaluate the implementation by the rate of retention in the Navigation program.
Time Frame: 36 months
This will be collected from participant tracking logs completed by the navigators (i.e., whether they completed the 36-month Navigation visit with the participant).
36 months
Evaluate the implementation by the fidelity of implementation of the Navigation manual by Navigators.
Time Frame: 12 months
For 10% of the Navigation visits, a second Navigator will observe the primary Navigator. The second Navigator will check using a list of program elements from the program manual to assess whether the primary Navigator adheres to each program element. In addition, the second Navigator will score the family on each of the Navigation domains. Fidelity of implementation will be measure by the percent adherence to the program manual and the inter-rater reliability on the domain scores using Cohen's kappa statistic.
12 months
Evaluate the implementation by the fidelity of implementation of the Navigation manual by Navigators.
Time Frame: 24 months
For 10% of the Navigation visits, a second Navigator will observe the primary Navigator. The second Navigator will check using a list of program elements from the program manual to assess whether the primary Navigator adheres to each program element. In addition, the second Navigator will score the family on each of the Navigation domains. Fidelity of implementation will be measure by the percent adherence to the program manual and the inter-rater reliability on the domain scores using Cohen's kappa statistic.
24 months
Evaluate the implementation by the fidelity of implementation of the Navigation manual by Navigators.
Time Frame: 36 months
For 10% of the Navigation visits, a second Navigator will observe the primary Navigator. The second Navigator will check using a list of program elements from the program manual to assess whether the primary Navigator adheres to each program element. In addition, the second Navigator will score the family on each of the Navigation domains. Fidelity of implementation will be measure by the percent adherence to the program manual and the inter-rater reliability on the domain scores using Cohen's kappa statistic.
36 months
Evaluate the implementation by the proportion of families receiving screening scores that indicate risk for negative child and/or family outcomes.
Time Frame: Prenatal (before delivery of target child)
This will be collected from case report forms completed by the Navigators. For each intervention domain of interest, Navigators will rate family needs on a 1-4 scale with scores of 3 and 4 indicating a need for referral to community resources. This outcome will be measured as the proportion of families receiving at least one score of 3 or 4.
Prenatal (before delivery of target child)
Evaluate the implementation by the proportion of families receiving screening scores that indicate risk for negative child and/or family outcomes.
Time Frame: 12 months
This will be collected from case report forms completed by the Navigators. For each intervention domain of interest, Navigators will rate family needs on a 1-4 scale with scores of 3 and 4 indicating a need for referral to community resources. This outcome will be measured as the proportion of families receiving at least one score of 3 or 4.
12 months
Evaluate the implementation by the proportion of families receiving screening scores that indicate risk for negative child and/or family outcomes.
Time Frame: 24 months
This will be collected from case report forms completed by the Navigators. For each intervention domain of interest, Navigators will rate family needs on a 1-4 scale with scores of 3 and 4 indicating a need for referral to community resources. This outcome will be measured as the proportion of families receiving at least one score of 3 or 4.
24 months
Evaluate the implementation by the proportion of families receiving screening scores that indicate risk for negative child and/or family outcomes.
Time Frame: 36 months
This will be collected from case report forms completed by the Navigators. For each intervention domain of interest, Navigators will rate family needs on a 1-4 scale with scores of 3 and 4 indicating a need for referral to community resources. This outcome will be measured as the proportion of families receiving at least one score of 3 or 4.
36 months
Evaluate the implementation by the proportion of families referred to community resources.
Time Frame: Prenatally (before delivery of target child)
This will be collected from case report forms completed by the Navigators. On the CRFs, Navigators will indicate any community resources to which they refer families. This outcome will be measured as the proportion of families that are referred to one or more community resources by the Navigator.
Prenatally (before delivery of target child)
Evaluate the implementation by the proportion of families referred to community resources.
Time Frame: 12 months
This will be collected from case report forms completed by the Navigators. On the CRFs, Navigators will indicate any community resources to which they refer families. This outcome will be measured as the proportion of families that are referred to one or more community resources by the Navigator.
12 months
Evaluate the implementation by the proportion of families referred to community resources.
Time Frame: 24 months
This will be collected from case report forms completed by the Navigators. On the CRFs, Navigators will indicate any community resources to which they refer families. This outcome will be measured as the proportion of families that are referred to one or more community resources by the Navigator.
24 months
Evaluate the implementation by the proportion of families referred to community resources.
Time Frame: 36 months
This will be collected from case report forms completed by the Navigators. On the CRFs, Navigators will indicate any community resources to which they refer families. This outcome will be measured as the proportion of families that are referred to one or more community resources by the Navigator.
36 months
Evaluate the implementation by the proportion of families that initiate community services.
Time Frame: Prenatally (before delivery of target child)
This will be collected from case report forms completed by the Navigators. On the CRFs, Navigators will indicate whether families initiated participation in the community services to which they were referred, if any. This outcome will be measured as the proportion of families referred to community services that initiate participation in at lease one community service.
Prenatally (before delivery of target child)
Evaluate the implementation by the proportion of families that initiate community services.
Time Frame: 12 months
This will be collected from case report forms completed by the Navigators. On the CRFs, Navigators will indicate whether families initiated participation in the community services to which they were referred, if any. This outcome will be measured as the proportion of families referred to community services that initiate participation in at lease one community service.
12 months
Evaluate the implementation by the proportion of families that initiate community services.
Time Frame: 24 months
This will be collected from case report forms completed by the Navigators. On the CRFs, Navigators will indicate whether families initiated participation in the community services to which they were referred, if any. This outcome will be measured as the proportion of families referred to community services that initiate participation in at lease one community service.
24 months
Evaluate the implementation by the proportion of families that initiate community services.
Time Frame: 36 months
This will be collected from case report forms completed by the Navigators. On the CRFs, Navigators will indicate whether families initiated participation in the community services to which they were referred, if any. This outcome will be measured as the proportion of families referred to community services that initiate participation in at lease one community service.
36 months
Evaluate the implementation by the families' satisfaction with the Navigation program.
Time Frame: 15 months
This will be measured via participant self-reports as the percentage of families that rate themselves as satisfied or very satisfied with their Navigation experience and the percentage of families that would recommend the program to other families.
15 months
Evaluate the implementation by the families' satisfaction with the Navigation program.
Time Frame: 27 months
This will be measured via participant self-reports as the percentage of families that rate themselves as satisfied or very satisfied with their Navigation experience and the percentage of families that would recommend the program to other families.
27 months
Evaluate the implementation by the families' satisfaction with the Navigation program.
Time Frame: 39 months
This will be measured via participant self-reports as the percentage of families that rate themselves as satisfied or very satisfied with their Navigation experience and the percentage of families that would recommend the program to other families.
39 months
Evaluate the impact of the Navigation program by reviewing child maltreatment.
Time Frame: 12 months
This will be measured through Child Protective Services records via a comparison of the Navigation group and control group in their likelihood of having a substantiated or "services needed" case of maltreatment.
12 months
Evaluate the impact of the Navigation program by reviewing child maltreatment.
Time Frame: 24 months
This will be measured through Child Protective Services records via a comparison of the Navigation group and control group in their likelihood of having a substantiated or "services needed" case of maltreatment.
24 months
Evaluate the impact of the Navigation program by reviewing child maltreatment.
Time Frame: 36 months
This will be measured through Child Protective Services records via a comparison of the Navigation group and control group in their likelihood of having a substantiated or "services needed" case of maltreatment.
36 months
Evaluate the impact of the Navigation program by reviewing child maltreatment.
Time Frame: 48 months
This will be measured through Child Protective Services records via a comparison of the Navigation group and control group in their likelihood of having a substantiated or "services needed" case of maltreatment.
48 months
Evaluate the impact of the Navigation program by reviewing child maltreatment.
Time Frame: 60 months
This will be measured through Child Protective Services records via a comparison of the Navigation group and control group in their likelihood of having a substantiated or "services needed" case of maltreatment.
60 months
Evaluate the impact of the Navigation program by reviewing maternal health.
Time Frame: 15 months
This will be measured from participant self-reports via a comparison of Navigation and control groups' mean scores of their ratings of their overall health, depression symptoms, anxiety symptoms, and substance abuse symptoms.
15 months
Evaluate the impact of the Navigation program by reviewing maternal health.
Time Frame: 27 months
This will be measured from participant self-reports via a comparison of Navigation and control groups' mean scores of their ratings of their overall health, depression symptoms, anxiety symptoms, and substance abuse symptoms.
27 months
Evaluate the impact of the Navigation program by reviewing maternal health.
Time Frame: 39 months
This will be measured from participant self-reports via a comparison of Navigation and control groups' mean scores of their ratings of their overall health, depression symptoms, anxiety symptoms, and substance abuse symptoms.
39 months
Evaluate the impact of the Navigation program by reviewing maternal health.
Time Frame: 51 months
This will be measured from participant self-reports via a comparison of Navigation and control groups' mean scores of their ratings of their overall health, depression symptoms, anxiety symptoms, and substance abuse symptoms.
51 months
Evaluate the impact of the Navigation program by reviewing maternal health.
Time Frame: 63 months
This will be measured from participant self-reports via a comparison of Navigation and control groups' mean scores of their ratings of their overall health, depression symptoms, anxiety symptoms, and substance abuse symptoms.
63 months
Evaluate the impact of the Navigation program by reviewing child health and development.
Time Frame: 15 months
This will be measured from parent reports via a comparison of the Navigation and control groups' mean scores on ratings of their overall health, social-emotional development, and cognitive development.
15 months
Evaluate the impact of the Navigation program by reviewing child health and development.
Time Frame: 27 months
This will be measured from parent reports via a comparison of the Navigation and control groups' mean scores on ratings of their overall health, social-emotional development, and cognitive development.
27 months
Evaluate the impact of the Navigation program by reviewing child health and development.
Time Frame: 39 months
This will be measured from parent reports via a comparison of the Navigation and control groups' mean scores on ratings of their overall health, social-emotional development, and cognitive development.
39 months
Evaluate the impact of the Navigation program by reviewing child health and development.
Time Frame: 51 months
This will be measured from parent reports via a comparison of the Navigation and control groups' mean scores on ratings of their overall health, social-emotional development, and cognitive development.
51 months
Evaluate the impact of the Navigation program by reviewing child health and development.
Time Frame: 63 months
This will be measured from parent reports via a comparison of the Navigation and control groups' mean scores on ratings of their overall health, social-emotional development, and cognitive development.
63 months
Evaluate the impact of the Navigation program by reviewing parent and parent-child relationships.
Time Frame: 15 months
This will be measured from participant self-reports via a comparison of Navigation and control groups' mean scores on ratings of their knowledge of child development, parenting self-efficacy, parenting stress, parent discipline behavior, and parent attributions of child behavior.
15 months
Evaluate the impact of the Navigation program by reviewing parent and parent-child relationships.
Time Frame: 27 months
This will be measured from participant self-reports via a comparison of Navigation and control groups' mean scores on ratings of their knowledge of child development, parenting self-efficacy, parenting stress, parent discipline behavior, and parent attributions of child behavior.
27 months
Evaluate the impact of the Navigation program by reviewing parent and parent-child relationships.
Time Frame: 39 months
This will be measured from participant self-reports via a comparison of Navigation and control groups' mean scores on ratings of their knowledge of child development, parenting self-efficacy, parenting stress, parent discipline behavior, and parent attributions of child behavior.
39 months
Evaluate the impact of the Navigation program by reviewing parent and parent-child relationships.
Time Frame: 51 months
This will be measured from participant self-reports via a comparison of Navigation and control groups' mean scores on ratings of their knowledge of child development, parenting self-efficacy, parenting stress, parent discipline behavior, and parent attributions of child behavior.
51 months
Evaluate the impact of the Navigation program by reviewing parent and parent-child relationships.
Time Frame: 63 months
This will be measured from participant self-reports via a comparison of Navigation and control groups' mean scores on ratings of their knowledge of child development, parenting self-efficacy, parenting stress, parent discipline behavior, and parent attributions of child behavior.
63 months
Evaluate the impact of the Navigation program by reviewing family service receipt and children's connection to medical home.
Time Frame: 15 months
Family services receipt will be measured from parent reports via a comparison of the Navigation and control groups' mean number of community services they have accessed since receiving Navigation/the control intervention. Connection to a medical home will be measured from parent report via a comparison of the Navigation and control groups' likelihood of having a primary care physician for their child.
15 months
Evaluate the impact of the Navigation program by reviewing family service receipt and children's connection to medical home.
Time Frame: 27 months
Family services receipt will be measured from parent reports via a comparison of the Navigation and control groups' mean number of community services they have accessed since receiving Navigation/the control intervention. Connection to a medical home will be measured from parent report via a comparison of the Navigation and control groups' likelihood of having a primary care physician for their child.
27 months
Evaluate the impact of the Navigation program by reviewing family service receipt and children's connection to medical home.
Time Frame: 39 months
Family services receipt will be measured from parent reports via a comparison of the Navigation and control groups' mean number of community services they have accessed since receiving Navigation/the control intervention. Connection to a medical home will be measured from parent report via a comparison of the Navigation and control groups' likelihood of having a primary care physician for their child.
39 months
Evaluate the impact of the Navigation program by reviewing family service receipt and children's connection to medical home.
Time Frame: 51 months
Family services receipt will be measured from parent reports via a comparison of the Navigation and control groups' mean number of community services they have accessed since receiving Navigation/the control intervention. Connection to a medical home will be measured from parent report via a comparison of the Navigation and control groups' likelihood of having a primary care physician for their child.
51 months
Evaluate the impact of the Navigation program by reviewing family service receipt and children's connection to medical home.
Time Frame: 63 months
Family services receipt will be measured from parent reports via a comparison of the Navigation and control groups' mean number of community services they have accessed since receiving Navigation/the control intervention. Connection to a medical home will be measured from parent report via a comparison of the Navigation and control groups' likelihood of having a primary care physician for their child.
63 months
Evaluate the impact of the Navigation program by assessing child kindergarten readiness
Time Frame: 66 months
This will be measured from North Carolina Department of Public Instruction administrative records via a comparison of Navigation and control groups' mean child achievement scores child reading and math, as well as behavior and discipline records.
66 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Duke University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kenneth Dodge, PhD, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 20, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 16, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 18, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00104042

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings