Nurse-Family Partnership Impact Evaluation in South Carolina (NFP)

This study evaluates the effects of the Nurse Family Partnership (NFP), an established home-visiting program, using a scientifically rigorous individual-level randomized controlled trial. The study will be based in South Carolina, where a Medicaid waiver in combination with a pay-for-success contract will allow expansion of the program to women on Medicaid. The study plans to enroll 4000 low-income, first time mothers and their children into the intervention group, and another 2000 into the control group. The study will evaluate the program's impacts on outcomes using administrative records. This study aims to yield new evidence on the effect of NFP in a modern context, applied to a new population, across a broad range of outcomes, and financed by a novel public-private partnership based on accountability for outcomes.

Study Overview

• Status: Active, not recruiting
• Conditions: Preterm Birth; Injuries; Maternal Behavior
• Intervention / Treatment: Behavioral: Nurse-Family Partnership

Detailed Description

This study is an individual-level randomized controlled trial, with randomization post-consent. The study will enroll pregnant women who are income-eligible for Medicaid, less than 28 weeks pregnant, and have not had a previous live birth. All eligible applicants who provide written consent will be randomly assigned either to a treatment group that is offered access to NFP or to a control group that is not. Two-thirds of those recruited will be randomized to the treatment group and one-third to the control group. Control group members will have access to the standard of care and whatever other programs and services are available in the community.

The investigators will assess the effect of NFP on a range of short- and long-run maternal and child outcomes using administrative data that will be available for all members of both treatment and control groups. Several of the outcomes the investigators will evaluate are required as part of the Medicaid waiver and pay-for-success financing model.

• Study Type: Interventional
• Enrollment (Actual): 5670
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Anderson, South Carolina, United States, 29625
      • Nurse-Family Partnership of Anderson County
    • Charleston, South Carolina, United States, 29405
      • NFP of Berkeley/Charleston/Dorchester Counties
    • Columbia, South Carolina, United States, 29204
      • Nurse-Family Partnership of Lexington-Richland Co.
    • Conway, South Carolina, United States, 29526
      • Nurse-Family Partnership of Horry County
    • Florence, South Carolina, United States, 29506
      • McLeod Health NFP
    • Greenville, South Carolina, United States, 29605
      • Nurse-Family Partnership of Greenville County
    • Greenwood, South Carolina, United States, 29646
      • Carolina Health Centers NFP
    • Orangeburg, South Carolina, United States, 29118
      • Family Solutions of the Lowcountry NFP
    • Spartanburg, South Carolina, United States, 29303
      • Spartanburg Regional Hospital NFP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 55 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Female
• No previous live births
• Currently pregnant
• Gestation period less than 28 weeks (i.e. less than or equal to 27 weeks, 6 days) at time of recruitment
• Ages 15-55
• Income level meets Medicaid eligibility criteria
• Live within an area serviced by a NFP Implementing Agency
• Not currently enrolled in the study
• Not incarcerated or living in lock down facilities

Exclusion Criteria:

• Men
• Women who have had a previous live birth
• Women who are not currently pregnant
• Women who are past their 28th week of gestation (i.e. greater than or equal to 28 weeks, 0 days) at time of recruitment
• Women who are younger than 15 or older than 55 years of age
• Women whose income level does not meet Medicaid eligibility criteria
• Women who live outside of an area serviced by a NFP Implementing Agency
• Women who are currently enrolled in the study
• Women who are currently incarcerated or living in a lock down facility

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment-NFP; NFP is a prenatal and infancy home visiting program for low-income, first-time mothers and their families. Registered nurses begin visiting their clients as early in the pregnancy as possible, helping the mother-to-be make informed choices. The nurses continue visiting regularly until the child is two years old.	Behavioral: Nurse-Family Partnership
No Intervention: Control; Control group members have access to the standard of care and whatever other programs and services are available in the community.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With a Composite Birth Outcome	Composite of at least one of: small for gestational (SGA), or low birth weight (LBW) less than 2500 grams, preterm birth (PTB) less than 37 weeks' gestation (obstetric estimate), or perinatal mortality (fetal death at or after 20 weeks of gestation or mortality in the first 7 days of life).	0-7 days after index birth; vital records, mortality records, and fetal death records
Number of Participants Whose Child Experienced a Major Injury or Concern for Abuse or Neglect	Composite of at least one health care encounter or mortality associated with International Classification of Diseases (ICD) codes indicating either major injury, or, concern for abuse or neglect for the participant's index child(ren).	within 24 months after index birth; Medicaid claims or hospital discharge data
Number of Participants With an Inter-birth Interval of < 21 Months	Having a subsequent birth within the first 21 months of the index birth	within 21 months after index birth; vital records

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With an Infant Born Small for Gestational Age (SGA)	Infant birth weight below the 10th percentile for infants of the same gestational age	At index birth; vital records
Number of Participants With an Infant Born Large for Gestational Age (LGA)	Infant birth weight above the 90th percentile for infants of the same gestational age	At index birth birth; vital records
Number of Participants With an Infant Born With Low Birth Weight (LBW)	Number of participants with an infant born with a birth weight of less than 2500 grams.	At index birth; vital records
Number of Participants With an Infant With Very Low Birth Weight	Number of participants with an infant born with a birth weight of less than 1500 grams.	At index birth; vital records
Birth Weight (Continuous)	A continuous measure of infant birth weight (grams)	At index birth; vital records
Number of Participants With a Preterm Birth	Infant born before 37 weeks' gestation (obstetric estimate)	At index birth; vital records
Number of Participants With an Extremely Preterm Birth	Number of participants with an infant born before 28 weeks' gestation.	At index birth; vital records
Gestational Age at Birth	Gestational age at birth in weeks (continuous)	At index birth; vital records
Number of Participants Experiencing Perinatal Mortality	Fetal death at or after 20 weeks of gestation or mortality in the first 7 days of life	Within 1 week after index birth; mortality records and fetal death records
Number of Participants With a NICU Admission of at Least Overnight	Infant admitted to the neonatal intensive care unit (NICU) for at least one night	At index birth; hospital discharge
Number of Participants Experiencing Neonatal Morbidity	Assisted ventilation immediately after delivery, assisted ventilation for more than six hours, seizure, receipt of surfactant replacement therapy, and receipt of antibiotics for suspected sepsis.	At index birth; hospital discharge
Number of Participants Experiencing Cesarean Delivery	Number of participants experiencing a cesarean delivery for their index birth.	At index birth; vital records
Number of Participants Experiencing Severe Acute Maternal Morbidity	Severe acute maternal morbidity as defined by the Centers for Disease Control and Prevention (CDC).	At index birth; hospital discharge
Number of Participants Experiencing Maternal Mortality	Number of participants experiencing all-cause mortality within one year postpartum.	Within one year after index birth; mortality records
Number of Participants Experiencing Neonatal Abstinence Disorder (NAS) or Maternal Drug/Substance Abuse	Number of participants experiencing neonatal abstinence disorder (NAS) or maternal drug/substance abuse in the first two years postpartum.	Within two years after index birth; Medicaid claims, hospital discharge
Number of Participants Experiencing Violence or Homicide	Includes any ICD code for healthcare encounter associated with experiencing violence or mortality associated with homicide based on ICD code	Within 2 years after index birth; Medicaid claims, mortality records
Number of Participants With a Postpartum Visit	Number of participants with a postpartum visit in first 12 weeks after an index birth.	Within 12 weeks after index birth; Medicaid claims
Number of Participants Who Received Adequate Prenatal Care	With adequacy defined using the Adequacy of Prenatal Care Utilization Index (APNCU), where prenatal care began by the 4th month and at least 80% of recommended visits were attended	At index birth; vital records
Number of Emergency Department Visits During Pregnancy	Number of emergency department visits during pregnancy.	At index birth; hospital discharge
Number of Participants With a Dental Visit During Pregnancy	Number of participants with a dental visit during pregnancy (preventive or treatment).	At index birth; Medicaid claims and dental records
Number of Participants With an Ultrasound at 18-22 Weeks	Number of participants with an ultrasound (anatomy scan) at 18-22 weeks.	18-22 weeks gestation during index pregnancy. Assessed at index birth using Medicaid claims.
Number of Participants Who Received Prenatal Screens	Our original prenatal screening outcome variable included the obstetric panel: Rhesus-D (DRh), red blood cell (RBC) antibody screen, complete blood count (CBC), urine culture, urinalysis; sexually transmitted infection (STI) screenings (HIV, syphilis, hepatitis B, chlamydia if <25, gonorrhea if <25); Group B strep screening, and glucose screening. However, since most participants had already completed their first prenatal visit prior to enrolling in the trial (when many of these tests are performed), it was not appropriate to include first-visit tests as outcomes. We therefore modified the outcome to instead use three clinically relevant measures that could occur after enrollment: glucose screening, Group B strep screening, and Tdap vaccination. These outcomes are reported as they appear in the published papers.	At index birth; Medicaid claims
Number of Participants Who Received a Gestational Diabetes Test (24-28 Weeks)	Received a glucose screen at 24-28 weeks' gestation. Note: Our original prenatal screening outcome variable included the obstetric panel (D [Rh], RBC antibody screen, CBC, urine culture, urinalysis), STI screenings (HIV, syphilis, hepatitis B, chlamydia if <25, gonorrhea if <25), Group B strep screening, and glucose screening. However, since most participants had already completed their first prenatal visit prior to enrolling in the trial (when many of these tests are performed), it was not appropriate to include first-visit tests as outcomes. We therefore modified the outcome to instead use three clinically relevant measures that could occur after enrollment: glucose screening, Group B strep screening, and Tdap vaccination. These outcomes are reported as they appear in the published papers.	At 24-28 weeks' gestation of index pregnancy; Medicaid claims
Number of Participants With a Tdap Vaccination (27-36 Weeks)	Received Tdap vaccination at 27-36 weeks' gestation. Our original prenatal screening outcome variable included the obstetric panel (D [Rh], RBC antibody screen, CBC, urine culture, urinalysis), STI screenings (HIV, syphilis, hepatitis B, chlamydia if <25, gonorrhea if <25), Group B strep screening, and glucose screening. However, since most participants had already completed their first prenatal visit prior to enrolling in the trial (when many of these tests are performed), it was not appropriate to include first-visit tests as outcomes. We therefore modified the outcome to instead use three clinically relevant measures that could occur after enrollment: glucose screening, Group B strep screening, and Tdap vaccination. These outcomes are reported as they appear in the published papers.	At 27-36 weeks' gestation of index pregnancy; Medicaid claims
Number of Participants With a Group B Streptococcus Test (35-37 Weeks)	Received Group B streptococcus test at 35-37 weeks' gestation. Note: Our original prenatal screening outcome variable included the obstetric panel (D [Rh], RBC antibody screen, CBC, urine culture, urinalysis), STI screenings (HIV, syphilis, hepatitis B, chlamydia if <25, gonorrhea if <25), Group B strep screening, and glucose screening. However, since most participants had already completed their first prenatal visit prior to enrolling in the trial (when many of these tests are performed), it was not appropriate to include first-visit tests as outcomes. We therefore modified the outcome to instead use three clinically relevant measures that could occur after enrollment: glucose screening, Group B strep screening, and Tdap vaccination. These outcomes are reported as they appear in the published papers.	At 35-37 weeks' gestation of index pregnancy; Medicaid claims
Number of Participants With a Mental Health Diagnosis or Outpatient Treatment	Diagnosis for depression/anxiety/stress reaction or antidepressant prescription or outpatient mental health visit	During index pregnancy or 60 days postpartum; Medicaid claims
Number of Participants With a Diagnosis of Depression/Anxiety/Stress Reaction	Number of participants with a diagnosis of depression/anxiety/stress reaction.	During index pregnancy or 60 days postpartum; Medicaid claims
Number of Participants With an Antidepressant Prescription	Number of participants with an antidepressant prescription.	During index pregnancy or 60 days postpartum; Medicaid claims
Number of Participants With an Outpatient Mental Health Visit	Number of participants with at least one outpatient mental health visit.	During index pregnancy or 60 days postpartum; Medicaid claims
Number of Participants With a Mental Health Treatment Follow up	Second antidepressant prescription or outpatient mental health visit within 120 days of treatment initiation ("acute phase")	Within 120 days of treatment initiation; Medicaid claims
Number of Participants With a Mental Health Related Emergency/Inpatient Visit	Based on all-listed diagnoses (i.e. primary or secondary) for depression/anxiety/stress reaction	During index pregnancy or 12 months postpartum; Hospital discharge
Number of Mental Health Related Emergency/Inpatient Visits	Based on all-listed diagnoses (i.e. primary or secondary) for depression/anxiety/stress reaction	During index pregnancy or 12 months postpartum; Hospital discharge
Number of Participants Whose Child Experienced a Major Injury	Health care encounter or mortality associated with ICD codes indicating major injury	Within 24 months after index birth; Medicaid claims, hospital discharge, mortality records
Number of Participants Whose Child Experienced Concern for Abuse or Neglect	Health care encounter or mortality associated with ICD codes indicating concern for abuse or neglect	Within 24 months after index birth; Medicaid claims, hospital discharge, mortality records
Number of Injuries	Number of injuries for child	Within 24 months after index birth; hospital discharge
Number of Participants Whose Child Had an Emergency Department Visit	Number of participants whose child had at least one visit to the emergency department.	Within 24 months after index birth; hospital discharge
Number of Child Emergency Department Visits	Total number of child visits to the emergency department (without admission)	Within 24 months after index birth; hospital discharge
Number of Participants Experiencing Child Mortality	All-cause child mortality in first 24 months of life	Within 24 months after index birth; Mortality records
Number of Participants With Recommended Number of Well-child Visits	Number of participants that received the recommended number of well-child visits.	At 15 months after index birth; Medicaid claims
Number of Participants With Lead Screening	Number of participants whose child received at least one lead screening.	At 15 months after index birth; Medicaid claims
Number of Participants With Developmental Screening	Number of participants whose child received at least one developmental screening.	At 12 months after index birth; Medicaid claims
Number of Participants With a Dental Visit	Child receives a dental screen at least once in first 24 months	Within 24 months after index birth; Medicaid claims and dental records
Number of Participants With Fluoride Treatment	Share with recommended fluoride treatments received by child	Within 24 months after index birth; Medicaid claims and dental records
Number of Participants With an Inter-birth Interval of < 24 Months	Having a subsequent birth within the first 24 months of the index birth	Within 24 months after index birth; vital records
Number of Participants With an Inter-birth Interval of < 15 Months	Having a subsequent birth within the first 15 months of the index birth	Within 15 months after index birth; vital records
Inter-birth Interval	Continuous measure of inter-birth interval	60 months after index birth; vital records
Number of Participants With a Family Planning Visit (6 Weeks)	Number of participants who received any family planning-related counseling or service.	Within 6 weeks after index birth; Medicaid claims, hospital discharge
Number of Participants Who Received a Highly or Moderately Effective Method of Contraception (6 Weeks)	Received implant, immediate postpartum long-acting reversible contraception (IPP-LARC), long-acting reversible contraception (LARC), or sterilization and moderately effective contraception to include path, ring, diaphragm, injectables and contraceptive pills	Within 6 weeks after index birth; Medicaid claims, hospital discharge
Number of Participants Who Received Immediate Postpartum Long-acting Reversible Contraception (6 Weeks)	Number of participants who received immediate postpartum long-acting reversible contraception in first 6 weeks postpartum.	Within 6 weeks after index birth; Medicaid claims, hospital discharge
Number of Participants With a Family Planning Visit (1 Year)	Number of participants who received any family planning-related counseling or service in the first year postpartum.	Within 12 months after index birth; Medicaid claims, hospital discharge
Number of Participants Who Received a Highly or Moderately Effective Method of Contraception (1 Year)	Received implant, IPP-LARC, LARC, or sterilization and moderately effective contraception to include path, ring, diaphragm, injectables and contraceptive pills	Within 12 months after index birth; Medicaid claims, hospital discharge
Number of Participants Who Received a Postpartum Intrauterine Device Insertion (1 Year)	Number of participants who received a postpartum intrauterine device insertion in first 12 months postpartum.	Within 12 months after index birth; Medicaid claims, hospital discharge
Time to First Take-up of Family Planning Counseling or Service	Months from pregnancy to first take up of family planning counseling or service	Within 24 months after index birth; Medicaid claims, hospital discharge
Time to First Take-up of Highly Effective Contraceptive Method	Months from discharge to first take up of highly effective contraceptive method (include implant, IPP-LARC, LARC, or sterilization)	Within 24 months after index birth; Medicaid claims, hospital discharge
Number of Participants Who Received Supplemental Nutrition Assistance Program (SNAP) or Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) Benefits	Number of participants who received Supplemental Nutrition Assistance Program (SNAP) or Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) benefits during pregnancy.	During index pregnancy, assessed up to 42 weeks; South Carolina Department of Social Services data and birth certificate data respectively
Number of Months Receiving SNAP or Temporary Assistance for Needy Families (TANF) Benefits	Total months receiving Supplemental Nutrition Assistance Program or Temporary Assistance for Needy Families	Within 24 months after index birth; South Carolina Department of Social Services data
Number of Participants With SNAP or TANF Benefit Churn	Receiving Supplemental Nutrition Assistance Program or Temporary Assistance for Needy Families at any time during a given year and having experienced at least one break in participation of four months or less that started and/or ended during the year	Within 24 months after index birth; South Carolina Department of Social Services data

Collaborators and Investigators

• Sponsor: Harvard School of Public Health (HSPH)
• Collaborators: University of Chicago; Abdul Latif Jameel Poverty Action Lab
• Investigators: Principal Investigator: Margaret McConnell, PhD, Harvard School of Public Health (HSPH)

Publications and helpful links

General Publications

• McConnell MA, Rokicki S, Ayers S, Allouch F, Perreault N, Gourevitch RA, Martin MW, Zhou RA, Zera C, Hacker MR, Chien A, Bates MA, Baicker K. Effect of an Intensive Nurse Home Visiting Program on Adverse Birth Outcomes in a Medicaid-Eligible Population: A Randomized Clinical Trial. JAMA. 2022 Jul 5;328(1):27-37. doi: 10.1001/jama.2022.9703.
• McConnell MA, Zhou RA, Martin MW, Gourevitch RA, Steenland M, Bates MA, Zera C, Hacker M, Chien A, Baicker K. Protocol for a randomized controlled trial evaluating the impact of the Nurse-Family Partnership's home visiting program in South Carolina on maternal and child health outcomes. Trials. 2020 Dec 4;21(1):997. doi: 10.1186/s13063-020-04916-9.
• Swanson K, Ayers S, Oviedo D, Zhou RA, Bates MA, Baicker K, Chien AT, McConnell M. Intensive Nurse Home Visiting and Early Childhood Outcomes: A Randomized Clinical Trial. JAMA Pediatr. 2025 Aug 1;179(8):857-866. doi: 10.1001/jamapediatrics.2025.1600.
• Rokicki S, Oviedo D, Perreault N, Bates MA, Zhou RA, Baicker K, McConnell MA. Impact of nurse home visiting on take-up of social safety net programs in a Medicaid population. Health Aff Sch. 2025 Apr 2;3(4):qxaf038. doi: 10.1093/haschl/qxaf038. eCollection 2025 Apr.
• Rokicki S, Oviedo D, Perreault N, Zera C, McGregor AJ, Bates MA, Zhou RA, Baicker K, McConnell MA. Home Visits and the Use of Routine and Emergency Postpartum Care Among Low-Income People: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2024 Dec 2;7(12):e2451605. doi: 10.1001/jamanetworkopen.2024.51605.
• Steenland MW, Oviedo D, Bates MA, Zhou A, Zera C, Baicker K, McConnell MA. Effect of an Intensive Nurse Home Visiting Program on Postpartum Contraceptive Use and Birth Spacing: A Randomized Controlled Trial. Obstet Gynecol. 2025 Jan 1;145(1):3-12. doi: 10.1097/AOG.0000000000005786. Epub 2024 Nov 14.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): April 1, 2023
• Study Completion (Estimated): April 1, 2046

Study Registration Dates

• First Submitted: November 28, 2017
• First Submitted That Met QC Criteria: November 28, 2017
• First Posted (Actual): December 4, 2017

Study Record Updates

• Last Update Posted (Estimated): December 12, 2025
• Last Update Submitted That Met QC Criteria: December 10, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Premature Birth; Wounds and Injuries
• Other Study ID Numbers: IRB15-2939

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
• product manufactured in and exported from the U.S.: No