Personalized Care for Prenatal Stress Reduction & Prevention of Preterm Birth (PTB) Disparities
PTBCARE+
Personalized Toolkit Building a Comprehensive Approach to Resource Optimization and Empowerment in Pregnancy & Beyond (PTBCARE+) A Randomized Controlled Trial (RCT) of Personalized Care for Prenatal Stress Reduction and Preterm Birth Disparities Prevention
2 other identifiers
interventional
1,228
1 country
1
Brief Summary
The goal of this clinical trial is to learn if a personalized prenatal support program \[(Personalized Toolkit Building a Comprehensive Approach to Resource optimization and Empowerment in Pregnancy \& Beyond, (PTBCARE+)\] works to lower stress and lower the risk of early delivery in pregnant individuals at high-risk for delivering preterm. The main question\[s\] it aims to answer are:
- Does the PTBCARE+ patient support program lower patient-reported stress levels during pregnancy?
- Does the PTBCARE+ patient support program improve biologic measures of stress during pregnancy?
- Does the PTBCARE+ patient support program result in a higher chance of delivering a healthy baby at or close to full term? Researchers will compare people who participate in the PTBCARE+ patient support program to those receive usual care to see if the PTBCARE+ patient support program lowers patient-reported stress, improves biologic measures of stress, and increases the chance of delivering a healthy baby at or close to full term. Participants will be randomly assigned to receive the PTBCARE+ patient support program or usual prenatal care. All participants will be asked to:
- complete 2 study visits during pregnancy - including completing electronic surveys, providing a blood and urine sample, measuring the heart rate variability by a clip or the ear or finger, and body composition evaluation using a simple scale-like device.
- complete one study visit postpartum that includes completing electronic surveys, and measuring heart rate variability. Blood and urine sample collection and body composition evaluation via InBody scale are optional at the postpartum visit. People who are randomly assigned to receive the PTBCARE+ support program will receive several resources to help them during pregnancy. These things include items such as:
- a stress reduction toolkit;
- access to an online website that can also be downloaded as a smart phone app;
- the option to receive an electronic massage while in clinic, and more.
- additional support gifts provided at routine clinical appointments People who are randomly assigned to receive usual prenatal care will not receive any additional support resources from the study during pregnancy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 25, 2025
CompletedFirst Posted
Study publicly available on registry
April 8, 2025
CompletedStudy Start
First participant enrolled
February 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2029
January 21, 2026
January 1, 2026
2.5 years
February 25, 2025
January 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Self-reported Perceived Stress Scores
Perceived Stress Scale participant survey * Scores range 0-40 * Higher scores = higher stress
Baseline (Visit 1 - 8+0 to 19+6 weeks) and mid-pregnancy followup (Visit 2 - 22+0 to 29+6 week), a period of up to 22 weeks from enrollment
Self-reported resilience scores
Brief Resilience Scale validated participant survey * score range = 1-5 * higher scores = higher resilience
Baseline (Visit 1 - 8+0 to 19+6 weeks) and mid-pregnancy followup (Visit 2 - 22+0 to 29+6 week), a period of up to 22 weeks from enrollment
Maternal blood-based stress-related gene transcript levels
Each participant's fold change in blood-based stress-related gene transcript levels during pregnancy, calculated as a ratio: (visit 2 gene expression - visit 1 gene expression) divided by visit 1 gene expression.
Baseline (Visit 1 - 8+0 to 19+6 weeks) and mid-pregnancy followup (Visit 2 - 22+0 to 29+6 week), a period of up to 22 weeks from enrollment
Number of participants with preterm birth or fetal death at 14 weeks 0 days or greater and less than 35 weeks gestation
Number of participants who either delivered or experienced a fetal death at a gestational age between 14 weeks 0 days and 35 weeks 0 days gestation. Pregnancies that are lost in the first trimester (prior to 14 weeks of gestation) are excluded from analysis.
Between 14 weeks 0 days and 35 weeks 0 days gestation (delivery at 34 weeks 6 days gestation meets the primary outcome; delivery at 35 weeks 0 days gestation does not) , a period of up to 27 weeks from enrollment.
Secondary Outcomes (25)
Self-reported (subjective) allostatic load
Baseline (Visit 1 - 8+0 to 19+6 weeks) and mid-pregnancy followup (Visit 2 - 22+0 to 29+6 week), a period of up to 22 weeks from enrollment
Self-reported composite "negative" stress
Baseline (Visit 1 - 8+0 to 19+6 weeks) and mid-pregnancy followup (Visit 2 - 22+0 to 29+6 week), a period of up to 22 weeks from enrollment
Number of participants with composite severe maternal morbidity
Enrollment through the postpartum followup period of 10 weeks after delivery, a period of up to 45 weeks from enrollment (assuming latest possible delivery gestational age is 43 weeks)
Perceived Social Support scores
Baseline (Visit 1 - 8+0 to 19+6 weeks) and mid-pregnancy followup (Visit 2 - 22+0 to 29+6 week), a period of up to 22 weeks from enrollment
Satisfaction with medical care
Baseline (Visit 1 - 8+0 to 19+6 weeks) and mid-pregnancy followup (Visit 2 - 22+0 to 29+6 week), a period of up to 22 weeks from enrollment
- +20 more secondary outcomes
Other Outcomes (6)
Level of engagement with PTBCARE+ intervention
Baseline (Visit 1 - 8+0 to 19+6 weeks) until delivery (may occur as late as 43+0 weeks), a period of up to 35 weeks from enrollment
Autonomic function evaluation
Baseline (Visit 1 - 8+0 to 19+6 weeks) and mid-pregnancy followup (Visit 2 - 22+0 to 29+6 week), a period of up to 22 weeks from enrollment
Interval between study enrollment and delivery or in-utero fetal death.
From the time of enrollment to delivery (may occur as late as 43+0 weeks), a period of up to 35 weeks from enrollment
- +3 more other outcomes
Study Arms (2)
Personalized Toolkit Building a Comprehensive Approach to Resource (PTBCARE+) Support Program
ACTIVE COMPARATORThe UNC Personalized Toolkit Building a Comprehensive Approach to Resource optimization and Empowerment in Pregnancy \& Beyond (PTBCARE+) program is a multifaceted, personalized support program designed to help pregnant people at high risk for preterm birth. It enhances the prenatal care experience by adding extensive support resources.
Usual Prenatal Care
NO INTERVENTIONParticipants who are randomized to receive usual care will not receive the PTBCARE+ program. Research team members may contact participants only to remind them of study activities, and will conduct standard in-person follow-up visits per study protocol, but will not provide any additional information or support. Usual care participants will receive standardized resources offered to all prenatal patients in clinic per clinical provider discretion.
Interventions
Research team members will serve as research assistants and will also function as perinatal care coordinators. In the care coordination role, team members will provide emotional support, liaise with clinical staff, and execute regularly scheduled check-ins with each study participant. Team members also assist with helping participants with logistics, obtaining and remembering to take prescribed medications, and other similar related activities. Participants receive access to contact the research assistant / care coordinator by text, email, phone, or through the electronic medical record participant portal. \- Per protocol, the research staff will meet in person with participants at least twice (visit 1, visit 2) during pregnancy and once postpartum (0-10 weeks after delivery, for most participants). Research staff may also meet in person with participants prior to visit 1 for recruitment/enrollment purposes.
Participant is given the option to receive a 15-minute electronic massage / relaxation session in clinic via (a) a specialized massage chair or (b) a massage pad that is placed on top of a standard recliner chair. * the electronic massages provide gentle massages and are safe for most people to use throughout pregnancy. * participants are always be in control of the massage experience and will be given instructions on how to stop the massage at any time. * participants are advised to consult the primary obstetric provider before using the massage chair regarding any specific concerns or questions * during the session, participants may view relaxation videos (from free, publicly available sites online). * participants may choose to sign up for massage(s) at any obstetric visit in the clinic between visit 1 and delivery.
* Small gift packet with encouraging items (example of items = coloring kit, tea lights, stickers, bookmarks, keychain fidget toy, printed support index cards, and other similar items). * Given between 14+0 and 23+6 weeks gestation at time of routine prenatal appointment
* Small gift packet with encouraging items (example of items = coloring kit, tea lights, stickers, bookmarks, keychain fidget toy, printed support index cards, and other similar items). * Given between 18+0 and 27+6 weeks gestation at time of routine prenatal appointment
* Small gift packet with encouraging items (example of items = coloring kit, tea lights, stickers, bookmarks, keychain fidget toy, printed support index cards, and other similar items). * Given between 22+0 and 29+6 weeks gestation at time of routine prenatal appointment
* Small gift packet with encouraging items (example of items = coloring kit, tea lights, stickers, bookmarks, keychain fidget toy, printed support index cards, and other similar items). * Given between 26+0 and 33+6 weeks gestation at time of routine prenatal appointment
Additional benefits / support items and support elements are provided to some participants on an "as needed" basis, per study protocol. * Information / details intentionally withheld and not made public in order to preserve the scientific validity of the study and protect the rights of the research participants * participant eligibility for additional resources as a part of the PTBCARE+ program will be determined by the research staff on the day of Visit 1 after initial set of surveys are completed, and is per protocol
In person check-in with research team member re: participant's needs; research team member provides support. Physical items that are included as part of this visit include: Tote bag with the following stress reduction items or similar: * eye mask * set of pocket index cards, printed back and front, on a variety of topics that influence pregnancy health, ranging from physical to emotional/mental * water bottles * small notebook * pill minder case * magnet and business card for Health Resources and Services Administration (HRSA) national maternal mental health hotline * log in codes for electronic resources * initial handouts with self care plan, introduction to stress reduction toolkit, etc.
Comprehensive, study-specific app that is available as a website or as a downloadable application that includes personalized, interactive modules and resources * no study related materials are available without a password * goal is to collate reputable sources of information to make investigating things online easier * includes optional educational modules for participants * also includes option of entering stress, well-being, blood sugar, blood pressure, etc. values with option to easily download recorded values for patient's clinical team * available online (computer/laptop), tablet, or smart phone. can be downloaded as a progressive web application (PWA) to a local device and used without internet access * Electronic access to the PTBCARE+ website will continue through 10 weeks postpartum unless the participant delivered \<16+0 weeks gestation in which case access will continue through 4 weeks postpartum
* complimentary one-year subscription to Aura - an 'all-in-one' wellbeing app that contains an enormous library of meditations, stories, breath work, work wellness, music, sounds, and more! * Participants can access this app as needed throughout pregnancy and beyond, for up to one year after the date of enrollment
Pouch contains: * printed index card with information about signs and symptoms of low blood sugar * printed index card with information about what to do if blood sugar is low * 2-3 non-perishable, individually wrapped over the counter candy / glucose-raising options; use for low blood sugar treatment is described on the card Only participants who have a diagnosis of diabetes mellitus or glucose intolerance AND have been prescribed an oral medication for blood sugar control or have been prescribed insulin are eligible to receive this. Each participant can receive a maximum of two kits during pregnancy; first at enrollment, and the other at visit 2 or until delivery
* Bottle of 90-100 pills (depending on manufacturer) * Provided at Visit 1 (after randomization) * Patients who received a bottle of low-dose aspirin at Visit 1 are offered a 2nd bottle at Visit 2. All patients whose provider recommends or prescribes either 81mg or 162mg of LDA during pregnancy are offered LDA as described herein. LDA must be on the patient's med list or specific notes from the patient's prenatal provider must explicitly note that it is recommended the patient take LDA in pregnancy for it to be offered. Individuals who are receiving LDA due to participation in another study are not eligible to receive LDA from PTBCARE+ Please note that this is listed as a "behavioral" intervention rather than "drug" intervention because the rational behind providing this over the counter medication is to help make the participant's life easier, and the focus is not on the efficacy of LDA. As such, it is being provided as a behavioral intervention.
In person check-in with research team member re: participant's needs; research team member provides support. Physical items that are included as part of this visit include the following stress reduction items or similar: 1. Frame + ultrasound photo + certificate of achievement! * Picture from anatomy ultrasound (or other subsequent ultrasound) is downloaded, printed, and placed in frame. * Certificate of achievement is printed and placed on other side of frame with ultrasound photo 2. other small items including stickers, printed index cards with supportive messaging, etc.
Eligibility Criteria
You may qualify if:
- Viable, singleton pregnancy, 8+0 to 19+6 weeks, dated by last menstrual period ± ultrasound using standard obstetric criteria per American College of Obstetricians and Gynecologists.
- Gestational age at first ultrasound by last menstrual period (LMP) / Ultrasound method / Measurement agreement with LMP required • Up to 8 weeks 6 days / crown rump length / ± 5 days
- weeks 0 days to 13 weeks 6 days / crown rump length / ± 7 days
- weeks 0 days to 15 weeks 6 days / standard fetal biometry / ± 7 days
- weeks 0 days to 19 weeks 6 days / standard fetal biometry / ± 10 days
- Gestational dating / fetal viability must be confirmed by ultrasound prior to enrollment / randomization.
- Ultrasound report must include documentation of normal fetal heart rate of ≥ 120 beats per minute, or subsequent medical record documentation of auscultation of fetal heart rate ≥ 120 beats per minute.
- Viability must be confirmed / re-confirmed within 7 days of randomization.
- If initial consent occurs early in pregnancy and V1/randomization occur later, viability must be reconfirmed to ensure ongoing eligibility prior to initiating V1 activities (including surveys) and proceeding with randomization.
- No signs or symptoms of, or clinical diagnosis of, evolving miscarriage, active preterm labor, preterm prelabor rupture of membranes at the time of enrollment.
- (3a) High a priori risk for medically indicated preterm birth - must meet at least one of the following 3 criteria (maternal medical history, prior pregnancy history, or moderate risk factor history)
- miPTB criteria #1: Maternal Medical History - any one of the following:
- o Known chronic hypertension requiring medications in the 3 months prior to conception or prior to 22 weeks gestation.
- o At least 2 blood pressure readings 6 hours apart, \<20 weeks gestation, with systolic ≥ 130 mmHg or diastolic ≥ 80 mmHg \*regardless of need for medication or formal diagnosis of hypertension in chart\*
- o Pre-gestational diabetes mellitus.
- +31 more criteria
You may not qualify if:
- Participation in another intervention based clinical trial during pregnancy that is deemed, at the discretion of the investigative team for the current study or the other concurrent study, to conflict with this research and/or confound the study results.
- o There are some concurrent studies, even those designed to test an intervention, which may be compatible with the current study; this will be reviewed by the investigative leadership team on a case-by-case basis.
- Previous participation in the PTBCARE+ program in another pregnancy, with randomization to the PTBCARE+ (active intervention) group.
- Current, ongoing, illicit drug use ≥ 12 weeks gestation.
- History of radical trachelectomy
- Planned voluntary termination of pregnancy.
- Heavy vaginal bleeding or large subchorionic hemorrhage - defined as:
- Bleeding as primary reason for unplanned clinic evaluation or emergency room visit within 14 days of potential enrollment
- Subjective bleeding accompanied by ≥ 4 point drop in the hematocrit within 14 days of potential enrollment
- Subchorionic hemorrhage or abruption on formal ultrasound with a volume ≥ 64 cubic cm (4cm x 4cm x 4cm) within 14 days of potential enrollment
- Major congenital anomaly such as major structural deficit of the heart, lungs, brain, or other major organ system
- If a major congenital anomaly is diagnosed \*after\* enrollment, the patient will continue to participate in the study, however, the investigators will plan to analyze the study results with and without these individuals included.
- Positive aneuploidy screening test (traditional biochemical assay, e.g., quad screen - risk of aneuploidy of 1:25 or higher or cell free deoxynucleic acid (DNA) test result that is screen positive for trisomy 13, trisomy 18, trisomy 21, or sex chromosome abnormality) in the absence of definitive fetal karyotype evaluation.
- Definitive fetal karyotype evaluation can only be obtained through direct testing of the tissue from the conceptus - by chorionic villus sampling or amniocentesis during pregnancy.
- Cystic hygroma or abnormally thickened nuchal translucency ≥ 3 mm at any time in the current gestation, regardless of subsequent diagnostic testing results.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of North Carolina School of Medicine - Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Related Publications (19)
Park S, Marcotte R, Staudenmayer J, Sirard J, VanKim N, Pekow P, Strath S, Freedson P, Chasan-Taber L. Validity of the Pregnancy Physical Activity Questionnaire Short Form (PPAQ-SF). Am J Epidemiol. 2024 Oct 2:kwae382. doi: 10.1093/aje/kwae382. Online ahead of print.
PMID: 39359005BACKGROUNDHeart rate variability: standards of measurement, physiological interpretation and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Circulation. 1996 Mar 1;93(5):1043-65. No abstract available.
PMID: 8598068BACKGROUNDHux VJ, Roberts JM. A potential role for allostatic load in preeclampsia. Matern Child Health J. 2015 Mar;19(3):591-7. doi: 10.1007/s10995-014-1543-7.
PMID: 24939173BACKGROUNDHeshmati S, Kibrislioglu Uysal N, Kim SH, Oravecz Z, Donaldson SI. Momentary PERMA: An Adapted Measurement Tool for Studying Well-Being in Daily Life. J Happiness Stud. 2023;24(8):2441-2472. doi: 10.1007/s10902-023-00684-w. Epub 2023 Sep 22.
PMID: 38130904BACKGROUNDAddison C, Jenkins B, White M. User Manual for Coping Strategies Inventory Short Form (CSI-SF)-The Jackson Heart Study. Int J Environ Res Public Health. 2024 Apr 4;21(4):443. doi: 10.3390/ijerph21040443.
PMID: 38673353BACKGROUNDLuszczynska A, Scholz U, Schwarzer R. The general self-efficacy scale: multicultural validation studies. J Psychol. 2005 Sep;139(5):439-57. doi: 10.3200/JRLP.139.5.439-457.
PMID: 16285214BACKGROUNDSmith BW, Dalen J, Wiggins K, Tooley E, Christopher P, Bernard J. The brief resilience scale: assessing the ability to bounce back. Int J Behav Med. 2008;15(3):194-200. doi: 10.1080/10705500802222972.
PMID: 18696313BACKGROUNDMoser A, Stuck AE, Silliman RA, Ganz PA, Clough-Gorr KM. The eight-item modified Medical Outcomes Study Social Support Survey: psychometric evaluation showed excellent performance. J Clin Epidemiol. 2012 Oct;65(10):1107-16. doi: 10.1016/j.jclinepi.2012.04.007. Epub 2012 Jul 20.
PMID: 22818947BACKGROUNDMustillo S, Krieger N, Gunderson EP, Sidney S, McCreath H, Kiefe CI. Self-reported experiences of racial discrimination and Black-White differences in preterm and low-birthweight deliveries: the CARDIA Study. Am J Public Health. 2004 Dec;94(12):2125-31. doi: 10.2105/ajph.94.12.2125.
PMID: 15569964BACKGROUNDHall LA, Williams CA, Greenberg RS. Supports, stressors, and depressive symptoms in low-income mothers of young children. Am J Public Health. 1985 May;75(5):518-22. doi: 10.2105/ajph.75.5.518.
PMID: 3985241BACKGROUNDDeFranco EA, Hall ES, Muglia LJ. Racial disparity in previable birth. Am J Obstet Gynecol. 2016 Mar;214(3):394.e1-7. doi: 10.1016/j.ajog.2015.12.034. Epub 2015 Dec 22.
PMID: 26721776BACKGROUNDHamilton BE, Martin JA, Osterman MJ, Curtin SC, Matthews TJ. Births: Final Data for 2014. Natl Vital Stat Rep. 2015 Dec;64(12):1-64.
PMID: 26727629BACKGROUNDVianna P, Bauer ME, Dornfeld D, Chies JA. Distress conditions during pregnancy may lead to pre-eclampsia by increasing cortisol levels and altering lymphocyte sensitivity to glucocorticoids. Med Hypotheses. 2011 Aug;77(2):188-91. doi: 10.1016/j.mehy.2011.04.007. Epub 2011 May 6.
PMID: 21550175BACKGROUNDWadhwa PD, Entringer S, Buss C, Lu MC. The contribution of maternal stress to preterm birth: issues and considerations. Clin Perinatol. 2011 Sep;38(3):351-84. doi: 10.1016/j.clp.2011.06.007.
PMID: 21890014BACKGROUNDVohr B. Long-term outcomes of moderately preterm, late preterm, and early term infants. Clin Perinatol. 2013 Dec;40(4):739-51. doi: 10.1016/j.clp.2013.07.006. Epub 2013 Sep 20.
PMID: 24182959BACKGROUNDBodeau-Livinec F, Marlow N, Ancel PY, Kurinczuk JJ, Costeloe K, Kaminski M. Impact of intensive care practices on short-term and long-term outcomes for extremely preterm infants: comparison between the British Isles and France. Pediatrics. 2008 Nov;122(5):e1014-21. doi: 10.1542/peds.2007-2976.
PMID: 18977951BACKGROUNDManuck TA, Sheng X, Yoder BA, Varner MW. Correlation between initial neonatal and early childhood outcomes following preterm birth. Am J Obstet Gynecol. 2014 May;210(5):426.e1-9. doi: 10.1016/j.ajog.2014.01.046.
PMID: 24793722BACKGROUNDManuck TA, Rice MM, Bailit JL, Grobman WA, Reddy UM, Wapner RJ, Thorp JM, Caritis SN, Prasad M, Tita AT, Saade GR, Sorokin Y, Rouse DJ, Blackwell SC, Tolosa JE; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Preterm neonatal morbidity and mortality by gestational age: a contemporary cohort. Am J Obstet Gynecol. 2016 Jul;215(1):103.e1-103.e14. doi: 10.1016/j.ajog.2016.01.004. Epub 2016 Jan 7.
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PMID: 17606536BACKGROUND
Related Links
- Contains study brochure, provided to potentially interested participants
- Health-related social determinants of health including financial stress, as per the NC Department of Health and Human Services consensus
- information regarding heart rate variability and health and regarding software for heart rate variability analysis
- information regarding heartmath sensor and application for heart rate variability data capture and analysis
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tracy Manuck, MD
University of North Carolina, Chapel Hill
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- Lab personnel who receive, process, and analyze study samples are blinded to the study group assignments of participants. They will receive samples labeled only with study identification (ID) number and no participant identifiers, ensuring they remain unaware of which participants belong to which study groups. This blinding helps maintain the integrity of the trial by preventing any potential bias in the handling and analysis of the samples or the reporting of the results of biologic assays.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2025
First Posted
April 8, 2025
Study Start
February 1, 2026
Primary Completion (Estimated)
August 1, 2028
Study Completion (Estimated)
January 1, 2029
Last Updated
January 21, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- 1. De-identified individual data that supports the results will be shared beginning 9 to 36 months following publication of initial results provided the investigator who proposes to use the data in accordance with the guidelines outlined above in the plan description. 2. The study protocol, statistical analysis plan, and informed consent forms will be shared beginning 3 months following delivery of the final study participant, given the importance that several study details are redacted during the study to preserve study integrity and protect research subjects.
- Access Criteria
- Who will have access? * Researchers \& Investigators: Qualified researchers/investigators with legitimate scientific requests. * Public: Data may be made available to the public, depending on the ethical considerations and the purpose of data request. * Access requests will be reviewed by the investigative team to ensure protection of participant privacy is maintained as per the consent form(s) and IRB. What will they be able to access? * A subset of the "minimum necessary" de-identified data to fulfill the objectives outlined in the requestor's proposal * Access to study protocols, statistical analysis plans, and informed consent documents. How will they access it? \- Researchers must submit a formal data access request, similar to request forms that are required to access data through dbGAP and other similar online data repositories. Approved individuals will be able to download de-identified data and supporting documentation from a secure online portal.
De-identified individual data that supports the results will be shared beginning 9 to 36 months following publication of initial results provided the investigator who proposes to use the data: 1. submits a proposal to the study investigative team regarding the planned use of the data, and: 2. the data analysis plans fall under the scope of written, informed consent as per the participant consent form; 3. the proposed analysis does not directly conflict with a pre-specified analysis planned by the primary investigative team at UNC; 4. (as applicable, based on the request) the proposed individual patient data (IPD) request involves a sufficient number of individuals within individual subgroups such that individual participants cannot be readily identified by review of the IPD. 5. has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable; and 6. executes a data use/sharing agreement with UNC.