Nurse-Family Partnership Impact Evaluation in South Carolina
Phase: NA
Conditions: Preterm Birth, Injuries, Maternal Behavior
Sponsor: Harvard School of Public Health (HSPH)

 
HLMA Research Protocol  
For use by HMS, HSDM and HSPH Investigators 
 
Research Protocol Template | HRP-503 | Version date: April 10, 2014 | Page 1 of 29 
Longwood Medical Area IRB http://www.hsph.harvard.edu/ohra/ 
Instructions: The purpose of this research protocol is to provide IRB members and reviewers with sufficient 
information to conduct a substantive review.  If a separate sponsor’s protocol exists, please submit it in addition 
to this document. 
 
Complete all of the sections below.  For more detailed instructions, please consult the Investigator’s Manual or 
IRB website (links provided below).  
 
GENERAL INFORMATION 
Protocol # (if assigned): IRB15-2939 
Version Date: 08/04/2022 
Version Number: 20 
Principal Investigator: Margaret McConnell, PhD 
Faculty Advisor (if PI is a student):  
Protocol Title: Randomized Evaluation of Nurse Family Partnership in South Carolina 
 
1. Specific Aims 
Objective 
To evaluate the Nurse Family Partnership (NFP), an existing home-visiting program in South Carolina, 
using a scientifically rigorous individual-level randomized controlled trial.   The evaluation will be 
conducted in partnership with the NFP program and the South Carolina Department of Health and 
Human Services. Additional statewide partners include: The Duke Endowment, South Carolina First 
Steps to School Readiness, BlueCross BlueShield of South Carolina Foundation, Children’s Trust of 
South Carolina and the South Carolina Department of Health and Environmental Control (DHEC). 
 
Research questions 
What is the average impact of NFP on 1) pre-term birth, 2) birth spacing, 3) child injury, and 4) long-
term health, education, and economic self sufficiency of the family? What proportion of study 
participants in the treatment group reside in low-income zip codes (LIZCs) at the time of study 
enrollment?  
 
2. Background 
2.1 
Provide the scientific background and rationale for the study 
Prior Evidence 
Nurse Family Partnership (NFP) is a long-standing 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 for herself and 
her baby. The nurses continue visiting the mothers after their baby is born; meeting weekly or bi-
weekly, until the child reaches two years of age.  
 
From 1978 to 1994, three modest-scale randomized evaluations were conducted in Elmira, NY, 
Memphis, TN, and Denver, CO to estimate the impact of NFP on first-time, low-income mothers and 
their children. Follow-up research on these three study samples continues today, to examine the 
impact of NFP on long-term outcomes for mothers and children.  Across the three trials, evidence 
suggests that NFP improves pre-natal health, reduces childhood injuries, increases the spacing 
between subsequent pregnancies, increases maternal employment, and improves school readiness for 
the children of mothers who participated in the program.  
 
However, there are a number of reasons that the impact of NFP in South Carolina today may differ 
from the impacts detected in previous trials. First, the socio-economic composition of the mothers and 
children may differ from those in the previous study samples. Second, the standard of care that all 
Medicaid-eligible mothers and children receive now may be better than that in the previous trials. 

 
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Third, many of the long-term outcomes in previous trials were based on self-reported survey data, 
which may be less accurate than the administrative data on which we will rely for both short- and 
long-term outcomes.   
 
Unmet Need 
South Carolina ranks 45th in the country for child well-being, according to the Annie E. Casey 
Foundation’s analysis of data on health, education, economic well-being, and family and community.1 
In particular, the need for home-visiting services in South Carolina currently exceeds the capacity of 
local programs. For example, NFP currently serves only about 800 of 11,500 eligible high-risk 
mothers each year.  
 
To improve maternal and child health outcomes, the South Carolina Department of Health and Human 
Services (SCDHHS) is utilizing a Medicaid waiver to help cover the costs of NFP home visits and 
establishing a Pay-for-Success (PFS) contract to expand the Nurse Family Partnership home-visiting 
program statewide, with a focus on underserved rural areas. This expansion will not be able to cover 
all eligible women, however.  Given, that the program has limited capacity, a lottery was seen as a fair 
way to allocate slots in the program. This provides a valuable opportunity to learn about the effects of 
the NFP program on mothers and children through a randomized controlled trial, and indeed the 
expansion is predicated on just such an evaluation being conducted.  
 
2.2 
Describe the significance of the research, and how it will add to existing knowledge 
President Obama’s Budget requests $500 million for fiscal year 2016 and $15 billion over the next 10 
years to expand Home Visiting for families.2 This research is important because it will strengthen the 
evidence base for home-visiting programs, help government officials and philanthropists assess the 
value of programs like NFP, and inform future decisions about funding and expanding such programs. 
Part of the state and federal government’s willingness to fund the expansion of the NFP program is 
contingent on an evaluation of its effects. This research will thus not only add to our understanding of 
how the NFP program impacts mothers and children when NFP is brought to scale in the current 
economic and health care environment, but can also help inform the allocation of billions of dollars 
meant to improve health and well-being in fiscally sustainable programs.   
 
3. Study Setting  
3.1. Identify the sites or locations where the research will be conducted.  
NFP is currently implemented through nine health care centers in South Carolina, and all nine will 
participate in the study: 
• Department of Health and Environmental Control (four sites: Upstate, Pee Dee, Lowcountry 
and Midlands) 
• McLeod Health System 
• Greenville Health System 
• Spartanburg Regional Health System 
• Carolina Health Centers 
• Family Solutions of the Lowcountry 
 
NFP program staff, trained in human subjects’ protections and the study protocol, will conduct study 
enrollment (including informed consent, baseline survey administration, and randomization).  They 
will enroll mothers in the study in-person, in a private setting that is convenient and comfortable for 
 
1 KIDS COUNT Databook, 2013. 
2 http://www.hhs.gov/news/press/2015pres/02/20150219a.html 

 
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the mother.  These locations may include a private room at a clinic, the study participant’s home, or 
another neutral, private location of the mother’s choice. Due to COVID-19, nurses will enroll mothers 
in the study virtually. NFP is set up to provide home visiting services via Telehealth and has provided 
additional guidance to nurses about how to ensure similar service delivery with Telehealth which 
includes: planning logistics and expectations of a telehealth encounter, discussing how silence may be 
difficult to interpret and encourage both parties to discuss any concerns, and keeping in mind and 
discussing safety concerns and plan signals that can be made during a telehealth encounter if the client 
needs to end the call with non-verbal communication.  
 
 
Additional sites of research include: 
• Rutgers School of Public Health 
• Brown University 
• RAND Corporation 
 
Research team staff members at these sites include Slawa Rokicki at Rutgers School of Public Health, 
Maria Steenland at Brown University, and Annetta Zhou at RAND Corporation. Each team member is 
required to have completed human subject training via the CITI Program.  
 
 
3.2. Describe the Principal Investigator’s experience conducting research at study site(s) and 
familiarity with local culture 
Dr. Margaret McConnell’s research combines behavioral economics with field and laboratory 
experiments to understand and evaluate policies designed to change health behaviors, with a specific 
focus on maternal and child health. Her work among low-income populations in Boston examines the 
impact of cash assistance on the amount of time that families spend engaging in Kangaroo Mother 
Care with babies born prematurely.  Her ongoing research in Kenya examines the effect of cash 
transfers incorporating pre-commitment on the choice of a high quality maternal delivery facility and 
the impact of vouchers with and without deadlines on the uptake of postpartum family planning.   Her 
work focuses largely on urban areas with poor populations. 
3.3. Is the research conducted outside the United States?  
No 
Yes:  If yes; describe site-specific regulations or customs affecting the research, local 
scientific and ethical review structure 
 
3.4 
Are there any permissions that have been or will be obtained from cooperating institutions, 
community leaders, or individuals, including approval of an IRB or research ethics committee? 
No 
Yes:  If yes; provide a list of the permissions (also include copies with the application, if 
available) 
This project is being conducted in cooperation with the state of South Carolina’s Department of 
Health and Human Services as well as the NFP program. Statewide partners include: The Duke 
Endowment, South Carolina First Steps to School Readiness, BlueCross BlueShield of South Carolina 
Foundation, Children’s Trust of South Carolina and the South Carolina Department of Health and 
Environmental Control (DHEC).  Expansion of the NFP program is predicated on an evaluation of its 
effects, which we will be conducting in cooperation with these public and private partners. 
 
The following IRBs have been invited to rely on Harvard’s IRB for review, approval, and continuing 
oversight of this research study: 
Research team: 
• MIT (Co-Investigator’s affiliation) 
• Rutgers School of Public Health 
• Brown University 

 
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• RAND Corporation 
 
Staff members at these locations will participate in data analysis with access to the study’s L4 server. 
None of these participating locations will receive or store any data. Each location has completed their 
respective reliance agreement with Harvard T.H. Chan School of Public Health, with all participating 
institutions relying on IRB15-2939 (updated on 05/10/2022 to IRB22-0644). 
 
   Health Care Centers: 
• South Carolina Department of Health and Environmental Control (includes sites at Upstate, Pee 
Dee, Lowcountry and Midlands) 
• McLeod Health System 
• Greenville Health System 
• Spartanburg Regional Health System 
 
Two health care centers, Carolina Health Centers & Family Solutions of the Lowcounty, do not have 
institutional review boards.  Each staff person at these agencies who will conduct study enrollment 
will first complete the CITI Training and sign an Individual Investigator’s Agreement before the 
research starts.  
 
If the institutions listed above do not agree to rely on Harvard’s IRB, we will cooperate with their 
review boards to obtain approval. We will submit any external permissions to the Harvard IRB.  
 
We have also requested approval for this research project from NFP’s National Service Office. A 
copy of their approval is attached.  
 
4. Study Design 
4.1. Describe the study design type  
This study is an individual-level randomized controlled trial where 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 offered the opportunity to enroll in NFP. 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. 
 
Prior to randomization, eligible applicants who provide written consent will be asked to complete a 
brief 30 minute baseline interview.  Using encrypted tablets and Computer Assisted Personal 
Interview (CAPI) software, the NFP program staff will ask the participant questions about her health, 
feelings, use of social services, and what she hopes to get from the home visiting program. For 
completing the baseline interview, each participant will receive a $25 gift card as compensation for 
her time. Data collected at baseline will be used to describe the characteristics of the study sample and 
to assess the baseline equivalence of the treatment and control groups post-randomization.  
 
Receiving the data file for all program participants from our partner is necessary to correctly identify 
study participants and match them to program data. We use this data to identify and correct data entry 
errors in either our survey data or our partner's program data. Disagreements between our study data 
and the NSO program data can take time to reconcile. This necessitates keeping the full set of NSO 
program for 1 year in order to ensure that all study participants have been accurately identified. For 
example, an individual in the NSO program data may initially appear to not be a study participant. 
However, due to data entry errors, it may be found that this individual is indeed a study participant 
after multiple iterations of data cleaning. Without keeping the full set of NSO program data for one 

 
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year, we would not be able to reconcile and ensure high quality matched data across these two 
sources.  
 
After the 1 year study period, data on any individuals in the NSO program data who have not been 
identified as study participants will be deleted. All NSO program data is kept on a Harvard Level Four 
server. Access to the Server is restricted, two-factor authentication is required for all users, and 
compliance with Harvard's level four protocol is review quarterly. 
 
Receiving this data is part of the contract we have signed as evaluators of this project.  Specifically, 
the contract requires that NSO provides data on all potential clients (not just those consented to the 
study).    
 
To assess the impact of offering NFP, we will collect administrative data for both treatment and 
control group members from various state agencies. Data for pre-term birth and birth spacing will be 
obtained from Vital Records, collected and maintained by the South Carolina Department of Health 
and Environmental Control. Data on child injuries will be obtained from an all-payer encounter 
database overseen by the South Carolina Data Oversight Council.  These three outcomes are of 
primary interest to the public and private partners in formally evaluating the effects of NFP (as part of 
the conditions for paying for the expansion), and the relevant state offices are committed to 
facilitating this data collection. 
 
We will also collect administrative data on additional outcomes such as health care utilization, 
mortality, education attainment, abuse and neglect, employment/earnings, use of government services, 
credit, and crime. This broader evaluation will provide a more comprehensive assessment of the 
impact of the NFP program, both on additional outcomes beyond the outcomes used for program 
payments and over a longer time period. This will yield useful specific evidence for the State of South 
Carolina, and for policy makers nationally, who are interested in comprehensive analyses on the social 
and economic impact of the NFP program. We will use an instrumental variable approach to measure 
program impacts.  
 
4.1.1 Nurse survey 
 
To support our understanding of the findings from this RCT, we will also administer a survey to all 
nursing staff who have delivered services throughout the time period of study enrollment. The 
purpose of this survey is to understand the implementation of home visiting services during the study 
period and to explore heterogeneity in impact based on nurses’ and implementing agencies’ 
characteristics.   
 
Prior to completing the survey, nurses will be asked to provide consent. After providing consent, 
nurses will be asked to complete a 30 minute survey. Nurses will be asked a series of questions about 
their demographics, prior employment and educational history, as well as about their current 
experiences working at the Nurse Family Partnership in South Carolina. Nurses who complete the 
survey will receive a $25 gift card. Data collected will be used to describe the characteristics of nurses 
and agencies that are implementing the home visiting services that are being studied. This information 
will also be matched to the NSO programmatic records to understand heterogeneity in program 
effects.  
 
4.2. Indicate the study’s duration - and the estimated date of study completion 
Study enrollment will take place over a four year period between January, 2016 and July, 2020. Each 
mother and child will be enrolled in the NFP program until the child is 2 years old, at which point 
their interaction with the program and the study will end. The initial impact will be estimated using 

 
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administrative data around January, 2023. The long-term outcomes will be gathered from 
administrative data for up to thirty years, but will not involve direct contact with the mothers or 
children.  
 
4.2.1 Duration of the nurse survey 
The survey will be administered over a 8 month period between March 2020 and October 2020. This 
information will be stored and matched with administrative data for up to thirty years, but will not 
involve any additional follow-up with the nurses. 
 
4.3. Indicate the total number of participants (if applicable, distinguish between the number of 
participants who are expected to be screened and enrolled, and the number of enrolled 
participants needed) 
Over the four year period, NFP expects to screen 26,000 applicants for eligibility and enroll 6,000 of 
those into the study; approximately 4,000 will be randomly assigned to the treatment group and 2,000 
to the control group. 
 
4.3.1. Total number of participants in the nurse survey. 
Over the 6 month period we plan to survey up to 200 nurses.  
 
4.4. List inclusion criteria  
Eligibility Criteria 
Process for assessing criteria 
Female 
Applicant’s self-report 
No previous live births 
Applicant’s self-report 
Currently pregnant 
Applicant’s self-report of having received a positive 
pregnancy test  
Gestation period less than 28 
weeks (i.e. less than or equal to 
27 weeks, 6 days) 
Estimated due date; best guess of practitioner and  applicant 
Ages 15-55 
Applicant’s self-reported date of birth 
Income level meets Medicaid 
eligibility criteria 
Applicant’s self-report, verify enrollment and/or eligibility 
in QuickChecks (State eligibility determination program) 
Live within an area serviced by 
a NFP Implementing Agency 
 
Applicant’s self-report of current mailing address 
Not currently enrolled in the 
study 
Search for matches by last name & DOB in the study 
database 
Not incarcerated or living in 
lock down facilities 
Applicant’s self-report or as reported by the relevant agency 
or facility 
 
4.4.1 List inclusion criteria for the nurse survey 
• Any nurse home visitor or nurse supervisor who delivered NFP services during the study 
enrollment period 2016 – 2020. 

 
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4.5. List 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) 
• 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 
 
4.5.1 List exclusion criteria for the nurse survey 
• 
Any nurse home visitor or nurse supervisor who has not provided any home visiting services 
during the study enrollment period. 
 
4.6. Describe study procedures  
NFP program staff will determine if program applicants are eligible for the study using the eligibly 
criteria and processes specified above.  If NFP program staff determine that the applicant is not 
eligible for the study, they will provide the applicant a list of other available resources in the 
community, and their interaction will end there. If the applicant is eligible, the program staff will 
review the consent form with her and will explain verbally to her: 
• what it means to be in the study 
• the associated risks and benefits of participating in the study 
• that being in the study is voluntary 
• that she may or may not be randomly selected to participate in NFP 
• that being in the study will not affect any benefits that she and her children are otherwise 
entitled 
• that she is free to stop taking part in the study at any time 
• that she can refuse to answer any questions in the interview 
• that any information that can be used to identify her will be kept private, unless there is concern 
that she or someone else may be harmed 
• that she will be asked to provide her contact information 
• that the research team may obtain information from the state or federal government, from home 
visiting programs, and from her family’s health care providers. 
• that she is free to ask questions about the research now or at any time in the future 
 
The program staff will check the applicant’s understanding of what it means to be in the study, and will 
ask the applicant if she has any questions. Once the applicant is fully informed, the program staff will 
ask the applicant to electronically sign and date the informed consent form if she agrees to participate in 
the study. The program staff conducting study enrollment also will sign and date the consent form 
electronically. If she does not agree to participate in the study, the program staff will document her 
refusal on a referral tracking form. In response to COVID-19, written consent will be waived. Verbal 
consent will be obtained until in person study visits are possible.  
 
Each applicant who agrees to participate in the study will then be asked to complete a short, 30 minute 
interview about her background, relationships, health and use of social services. The applicant will be 
reminded that she may refuse to answer questions at any time. The program staff will verbally ask the 
applicant questions, and will enter the applicants’ responses into an encrypted survey form. The 

 
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applicant will be informed during the consent process that the interview may also be recorded for 
quality assurance purposes.   
 
All eligible program applicants who provide their written consent and complete the baseline interview 
will be randomly assigned “on-the-spot” to a treatment group that is offered access to the NFP program 
or to a control group that is not offered the opportunity to enroll in NFP.  Program staff will use a pre-
programed randomization function on their tablets to conduct the random assignment.  Program staff 
will explain to the participant that the computer chooses which study group she will be assigned to, and 
that her assignment is not dependent on any personal traits or characteristics.  
 
If the applicant is assigned to the control group, the program staff will explain that she was not chosen 
by the computer to receive NFP services, but that she may continue to seek care at the health care center 
as she normally would.  The program staff will also provide a list of other resources and programs that 
are available in the community.  
 
If the applicant is assigned to the treatment group, the program staff will proceed to schedule her first 
home-visiting appointment.  The program staff will also provide treatment group members with a list of 
other resources and programs that are available in the community. In response to COVID-19, the 
materials the applicant would have otherwise received in person (copy of the consent form, $25 gift 
card, and list of community resources) will be mailed to the address the applicant provides. 
 
4.6.1. Describe study procedures for the nurse survey 
 
Nurses will receive an email with a link to complete an online survey at a time that is convenient for 
them. Nurses will read the consent form and have an opportunity to email or call research staff 
regarding any questions before consenting to the survey. Everyone who consents to the survey will then 
be asked to complete the online survey. 
 
Former NFP nurses who delivered NFP services at some point during the 2016-2020 period will receive 
a subset of questions to answer from the full survey. 
 
4.7. Does the study involve the collection of data/specimens (including the use of existing 
data/specimens)?  
No 
Yes:  If yes; indicate how, when, where and from whom specimens or data will be 
obtained 
NFP program staff will collect identifying information (including name, date of birth, social security 
number, address, and Medicare and Medicaid IDs (if applicable)) and baseline data (see draft baseline 
survey instrument attached) from study participants at intake, prior to randomization. The identifying 
information will be kept separate from the baseline survey responses. A unique code, not containing 
any identifying information, will be used to analyze participants’ baseline responses.  
 
As explained to subjects in the Informed Consent documents, identifying information will be used to 
access historical and future administrative records that relate to the health and wellbeing of the mother 
and her children. This could include data on the birth of the mother’s children, health care use (such as 
how many times she or her children visit a health facility), government records, interaction with 
government services (such as cash assistance, food stamps, or child welfare), or from her children’s 
school after they start going to school.  All of the information listed above is already collected about 
the mother and her children, even if they are not in the study. Taking part in the study means that the 
mother will allow our research team to use this existing secondary information for research purposes.  
 

 
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If a consented study participant is later discovered to be ineligible for the study/program (e.g. because 
she is over-income, not pregnant, or farther along in her pregnancy than she initially reported at study 
intake), the study team will continue to track and analyze administrative data for the participant and 
her children. 
 
4.7.1 Data collection for nurse survey 
For the nurse survey, the research team will collect nurse name. Nurse name will be collected and 
nurse responses will be merged into the administrative datasets. The identifying information will be 
kept separate from the survey responses. A unique code, not containing any identifying information, 
will be used to analyze nurses’ responses.  
 
The Evaluation team has executed data use agreements with the following agencies: 
• BAA with Nurse Family Partnership, for implementation data. These data will be used to 
describe the implementation of Nurse Family Partnership in South Carolina during the study 
period, its adherence to program fidelity standards, the dosage received by treatment group 
participants and the exposure of control group members to NFP services. 
• BAA with South Carolina Department of Health and Human Services, for individually 
identified health data.  These data will be used to measure the effects of NFP on maternal 
and child health outcomes. 
• BAA with South Carolina Revenue and Fiscal Affairs Office, for individually identified 
health data. These data will be used to measure the effects of NFP on maternal and child 
health outcomes. 
• DUA with South Carolina Revenue and Fiscal Affairs Office, for Public Use Encounter 
Data. These data include encounter level Inpatient, Outpatient Surgery, Emergency 
Department, and Imaging records from 2010-2014. Analysis will focus on women with at 
least one childbirth (from diagnosis and procedure codes) whose primary payer is Medicaid 
and children whose primary payer is Medicaid, but records for other individuals will be used 
to conduct comparison analyses. These data will be used to design the analysis plan for this 
study.  
• DUA with South Carolina Revenue and Fiscal Affairs Office, for Encounter Data with 
Restricted Elements. Records (any inpatient, outpatient surgery, emergency department 
discharge records or imaging records) will be matched to a master list of study subjects using 
First Name, Middle Name, Last Name, Social Security Number, and Date of Birth. These data 
will be used to measure the effects of NFP on child injury.  
• DUA with South Carolina Department of Health and Environmental Control, for 
historical birth certificate data. Historical Vital Statistics data will aid the understanding of 
the study population. Our research team will use the data to conduct power calculations for 
various outcomes, to explore the predictive strength of potential control variables, and to 
understand determinants of maternal and child health in the Medicaid population. These data 
will be used to design the analysis plan for this study.  
• DUA with South Carolina Department of Health and Environmental Control, for matched 
birth certificate data, including child’s name and date of birth.  These data will be used to 
measure the impact of NFP on pre-term birth and birth spacing for study participants.  
• DUA with The University of South Carolina, for matched data on MIECHV-funded home 
visiting programs.  These data will be used to assess the proportion of study participants who 
receive other home-visiting services funded by the Maternal, Infant, and Early Childhood 
Home Visiting (MIECHV) program. 
• DUA with First Steps, for matched data on study participants’ participation in home-
visiting programs affiliated with First Steps. These data will be used to assess the 
proportion of study participants who receive other home-visiting services. 

 
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• DUA with South Carolina State Law Enforcement Division, for matched data on arrests, 
custody, offense, and judicial outcomes. Records will be matched to a master list of study 
subjects using First Name, Middle Name, Last Name, Social Security Number, and Date of 
Birth. These data will be used to measure the effects of NFP on criminal behavior. 
• DUA with South Carolina State Law Enforcement Division, for historical and current de-
identified data for the entire state of South Carolina on arrests, custody, offense, and 
judicial outcomes. These data will be used to improve our understanding of the study 
population. It will be used to conduct power calculations for various outcomes, to explore the 
predictive strength of potential control variables, and to understand determinants of maternal 
and child mental health. 
• DUA with South Carolina Department of Mental Health, for matched data on mental 
health diagnoses and services. Records will be matched to a master list of study subjects 
using First Name, Middle Name, Last Name, Social Security Number, and Date of Birth. 
These data will be used to measure the effects of NFP on mental health. 
• DUA with South Carolina Department of Mental Health, for historical and current de-
identified data on mental health diagnoses and services. These data will be used to 
improve our understanding of the study population. It will be used to conduct power 
calculations for various outcomes, to explore the predictive strength of potential control 
variables, and to understand determinants of maternal and child health. 
• DUA with South Carolina Department of Education, for matched data on test scores, 
enrollment, attendance, and disciplinary action. Records will be matched to a master list of 
study subjects using First Name, Middle Name, Last Name, Social Security Number, and 
Date of Birth. These data will be used to measure the effects of NFP on education. 
• DUA with South Carolina Department of Education, for historical and current de-
identified data on test scores, enrollment, attendance, and disciplinary action. These data 
will be used to improve our understanding of the study population. It will be used to conduct 
power calculation for various outcomes, to explore the predictive strength of potential control 
variables, and to understand determinants of maternal and child health. 
• DUA with South Carolina Department of Corrections, for matched data on incarceration. 
Records will be matched to a master list of study subjects using First Name, Middle Name, 
Last Name, Social Security Number, and Date of Birth. These data will be used to measure 
the effects of NFP on incarceration. 
• DUA with South Carolina Department of Corrections, for historical and current de-
identified data on incarceration. These data will be used to improve our understanding of 
the study population. It will be used to conduct power calculation for various outcomes, to 
explore the predictive strength of potential control variables, and to understand determinants 
of maternal and child health. 
• DUA with South Carolina Department of Social Services, for matched data on the use of 
social services and human services. Records will be matched to a master list of study 
subjects using First Name, Middle Name, Last Name, Social Security Number, Date of Birth, 
and Medicaid number. These data will be used to measure the effects of NFP on use of social 
services and human services. 
• DUA with South Carolina Department of Social Services, for historical and current de-
identified data on the use of social services and human services. These data will be used to 
improve our understanding of the study population. It will be used to conduct power 
calculation for various outcomes, to explore the predictive strength of potential control 
variables, and to understand determinants of maternal and child health. 
 
 
 

 
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4.8. Is there a data and safety monitoring plan (required for greater than minimal risk studies)? 
No 
Yes:  If yes; describe the plan 
 
4.9. Are there any anticipated circumstances under which participants will be withdrawn from the 
research without their consent? 
No 
Yes:  If yes; describe the circumstances as well any associated procedures to ensure 
orderly termination 
 
5. Data/Statistical Analyses Plan 
5.1. Briefly describe the plan for data analysis (including the statistical method if applicable) 
To answer the research questions, we will use an instrumental variable (IV) approach and 
administrative data to estimate the local average treatment effect of NFP on intervention group 
members who actually participate in NFP relative to the services consumed by the control group. This 
estimated effect of NFP is of policy interest because it represents the impact of NFP on those moms 
who are likely to participate in NFP were the program to expand and offer additional program slots 
through a lottery. The source of non-compliance that it explicitly captures is that some mothers 
randomized into the intervention group may never receive NFP services (i.e. the “enrollment rate” is 
less than 1). According to the enrollment protocol, no mothers in the control group should be enrolled 
in NFP services. To the extent that some sample members in the control group receive services from 
similar home visiting programs that may also affect outcomes, this model estimates the effect of NFP 
relative to the mix of other home-visiting programs that the control group receives, rather than relative 
to no home-visiting service at all. 
 
The impact estimate is the regression-adjusted difference between the average outcomes of treatment 
group participants and control group participants. Impact estimates with p-values less than 0.05 (two-
tailed test) will be considered statistically significant and provide evidence that there are likely true 
differences between the groups as a result of NFP.  
 
In addition to these impact estimates, we will also report the percentage of treatment group 
participants who reported living in a low-income zip code (LIZC) at the time of study enrollment. 
(LIZC is defined as a zip code in which fifteen percent (15%) or more of households have incomes 
below the federal poverty guidelines according to 2012 Census Bureau Data.)  Before reporting this 
percentage, we will use Google Map’s Application Programming Interface (API) to confirm that the 
participant’s self-reported zip code corresponds with their self-reported street address. To do this, we 
will send a file of unformatted, raw street addresses, cities, and states to Google’s API to return 
formatted addresses, including zip code.  We will then compare these formatted zip codes to the zip 
codes reported by each study participant. The file we send to Google Map’s API will include a greater 
number of ‘fake’ (i.e. non-study participant) addresses than actual addresses, to maintain study 
participants’ confidentiality.  
 
We will also analyze how the main impact estimates vary within our sample. In particular some 
mothers and their children may be at higher risk for adverse outcomes such as preterm birth or 
childhood injury. We will define “risk” based on poverty rate in the census tract in which a mother is 
enrolled. In order to perform this analysis, we will match participants’ self-reported addresses to 
census tracts in two ways. First, we will send a de-identified file that will only include a randomly 
generated ID number and the following address information of unformatted, raw street addresses, 
cities, states, and zip codes to the United States Census Bureau’s Geocoder tool as well as to the 
geocoding service, Geocodio. We will match addresses to census tracts using both the Census Bureau 
Geocoder tool as well as Geocodio in order to be able to cross validate the accuracy of the census tract 
mapping. Mapping to the wrong census tract or failing to map to a census tract will reduce the 
accuracy of our analysis. The randomly generated ID number will allow for linking census tract 

 
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information back to our data.  Second we will check perform a last check of the accuracy of our first 
method of linking to census tracts by retrieving the latitude and longitude of participants’ addresses 
via the Google Maps API in the same procedure described above. We will then use these latitude and 
longitude coordinates to link addresses to census tracts using cartographic boundary files provided by 
the Census Bureau. Once we have matched participants’ addresses to census tracts, we will investigate 
how our main impacts vary by the census tract rate of poverty. The files we send to The Census 
Bureau’s Geocoder tool, to Geocodio, and to Google Map’s API will include a greater number of 
‘fake’ (i.e. non-study participant) addresses than actual addresses, to maintain study participants’ 
confidentiality.  
 
 
5.2. Is there a sample size/power calculation? 
No 
Yes:  If yes; describe the calculation and the scientific rationale, and, if applicable, by 
site and key characteristics such as participant demographics  
NFP plans to serve 4,000 families in South Carolina between January 2016 and January 2020.  Our 
power analysis suggests that with 4,000 families served in the treatment group, we will need a 2:1 T:C 
ratio  (or 2,000 control group families) to achieve 80% or higher chance of detecting statistically 
significant effects on two out of the three primary outcomes (pre-term birth, birth spacing, and 
childhood injury), if the true effect size of the outcomes equals the expected effect size provided by 
NFP. These expected effect sizes are based on analysis of previous NFP trials and baseline knowledge 
on the current population of South Carolina’s Medicaid-eligible first-time mothers and the 
assumptions summarized below.   
 
As of May, 2015, the expected effective sizes, in percentage difference between the treatment group 
and the control groups, is -20% for the measure of pre-term birth, -18% for the measure of birth 
spacing, and -13% for the measure of child injury.  In addition, we need 95% or more of women 
randomized into the treatment group to receive NFP services, and at most 5% of the control group that 
receives a home visiting program that has as much impact as NFP. Furthermore, our power calculation 
is based on the assumption that the distribution of the outcomes variables have the following mean 
(standard deviation) combinations in the absence of NFP intervention:  0.12 (0.32) for the binary 
measure for pre-term birth, 0.14 (0.34) for the binary measure of birth spacing, and  0.18 (0.30) for the 
measure of child injury.  
 
With this set of assumptions, we need to enroll at least 6,000 women into the evaluation with a 2:1 
treatment to control ratio to achieve near 80% or higher power. With these numbers we will have 
roughly 70% power to detect a statistically significant effect on the birth-spacing measure if the true 
effect size is -18%. We will have a nearly 100% chance to detect a statistical significant effect on the 
child injury measure if the true effect size is -13%.  We will not have sufficient statistical power to 
detect the expected effect (-20%) on the pre-term birth measure; the minimum detectable effect size 
with 80% power for the pre-term birth measure is -30%.   
 
6. Recruitment Methods 
6.1. Does the study involve the recruitment of participants? 
No: If no, skip to 7.1 
Yes: If yes; indicate how, when, where, and by whom participants will be recruited  
Recruitment of participants into the study will be conducted by NFP program staff, including 
Outreach Specialists, Nurse Supervisors, and Nurse Home Visitors at the implementing agencies. 
Outreach Specialists are study-specific staff who will conduct outreach with community stakeholders, 
build awareness of the program, assess client eligibility, conduct the informed consent process, 
administer the baseline survey, and randomize participants throughout the study enrollment period. 

 
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Nurse Supervisors & Nurse Home Visitors are program staff that implement NFP and will also 
complete these study activities as they build their caseload.  
 
NFP has existed in South Carolina for 7 years, and has existing relationships with many service 
providers in the community.  Women can be referred to the NFP program through a variety of 
channels including, but not limited to: health care providers, WIC clinics, schools, pregnancy testing 
clinics, other home visiting programs, NFP clients or graduates, and Medicaid. Some clients are also 
“self-referred.” NFP aims to partner with these referral sources, as well as with community-based 
organizations and other agencies serving high-risk pregnant clients, to identify and engage women 
who may be eligible for the program. Methods for recruiting participants broadly fall into one of four 
categories: 
a) Information about a potential participant is submitted to NFP implementing agencies through 
the existing referral process, or she reaches out to NFP.  The NFP Outreach Specialist will 
verbally assess whether the eligibility criteria are met and then schedule an in-person meeting 
for obtaining informed consent and completing study enrollment. 
b) A woman meets with an Outreach Specialist or Nurse Home Visitor who is stationed at a 
referral site (e.g. at a high volume prenatal care or WIC site), and can immediately consent to 
enroll in the study, if eligible. 
c) A potential client submits her information to a centralized website or phone number dedicated 
to the trial. Outreach staff will then contact the woman by phone to determine eligibility, and 
schedules an in-person meeting to obtain informed consent and complete study enrollment.  
d) South Carolina Department of Health & Human Services (SCDHHS) will provide a list of 
women who are newly enrolled in Medicaid and pregnant to NFP on a regular basis.  NFP will 
send one letter to each mom newly enrolled in Medicaid letting her know that she may be 
eligible to participate in a no-cost, confidential study for a chance to receive a home nurse. The 
letter will not disclose that the study is for first-time moms, in case the letter is intercepted by 
someone other than the mom. Outreach staff will then contact these potential clients over the 
phone to describe the study, determine whether these clients are interested in the program, and 
schedule an in-person meeting. During the in-person meeting, a trained nurse will make the 
final eligibility determination and conduct study enrollment. 
 
Throughout the enrollment period, three full-time Outreach Specialists will spend 3- 4 days per week 
at high-volume referral sites engaging clients and conducting study enrollment, as described in b) 
above. Nurse Home Visitors (NHVs) will also spend time at referral sites enrolling clients, while they 
build their caseloads.  
 
6.1.1 Recruitment of nurses for nurse survey 
 
Recruitment of nurses will be conducted by the research team, as well as nurse supervisors and their 
staff.  
 
6.2. Are there any materials that will be used to recruit participants, e.g., emails, posters, and 
scripts? 
No 
Yes:  If yes; provide a list of the materials (also include copies with the application) 
A community outreach campaign will be implemented in South Carolina to raise awareness of NFP 
services. Strategies will include advertisements in social media outlets and local media outlets, such as 
community newspapers. Outreach posters and flyers will also be placed throughout targeted 
neighborhoods in strategic venues (e.g., laundromats, bodegas, markets, etc.). Radio and television 
advertisements (using the same script) will also be utilized to raise awareness of NFP services. These 
advertisements will allow interested applicants to find out more about the study through a centralized 
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An Enrollment Script will be used by NFP program staff to recruit participants for the program, 
explain the study and determine eligibility.   
 
For those prospective study participants who miss their scheduled study enrollment visit, the NFP 
program staff will call the mom to reschedule and send a letter in the mail, as follow-up. (See Survey 
Reschedule Letter).  
 
6.2.1. Strategies will include sending emails to Nurse Supervisors with suggested email templates to 
send to their current and former staff to complete the survey. The research team may also send emails 
to recruit current and former staff.  
 
7. Available Resources 
7.1. Describe the feasibility of recruiting the required number of participants within the recruitment 
period  
NFP currently restricts outreach due to limited slots available for new clients. Once the study starts, 
NFP is confident that the combination of existing referral sources, new outreach strategies, active 
outreach at referral sites, and outreach to recent Medicaid enrollees will enable the project to recruit 
the required number of eligible participants per year (n=1,000).  NFP currently serves about 800 first-
time mothers per year in the same communities that will participate in the study. The study will 
necessitate that NFP scale up by 25%, which NFP is committed to doing by allocating staff 
(leadership and project personnel) and marketing resources to increase referrals.  
 
Community organizations that have existing relationships with target families will introduce clients to 
NFP, acting as a trusted intermediary. Referral networks will also be created through engaging 
managed care organizations (MCOs), hospitals, Federally Qualified Health Centers, and large 
physician groups to ensure a robust referral pipeline. Furthermore, agencies outside of the healthcare 
arena at the local and state level have become referral sources for NFP programs in South Carolina. 
For example, in Anderson, SC, the Office of the Solicitor (District Attorney) is such a partner, as is 
the Office of First Steps to School Readiness, whose board of directors consists of top-level decision-
makers within state departments and agencies (e.g. Department of Health & Human Services, 
Department of Social Services, etc.). 
 
7.2. Describe how the Principal Investigator will ensure that a sufficient amount of time will be 
devoted to conducting and completing the research. 
The Principal Investigator is committed to dedicating a sufficient amount of time to conduct and 
complete the research. She has a demonstrated track-record of conducting and completing large-scale 
research studies, particularly those that have a long time horizon.  The team is actively pursuing 
additional funding to cover a substantial share of the PI’s time. 
 
7.3. Are there research staff members, in addition to the Principal Investigator?  
No: If no, skip to 7.5 
Yes: If yes; outline training plans to ensure that research staff members are adequately 
informed about the protocol and study-related duties 
All research and program staff who will have direct interaction with participants and/or access to 
identifiable information will review Harvard’s Human Research Protection Program Plan as part of 
their initial orientation and will complete (and regularly renew) Harvard’s online training curriculum 
available through the CITI program.  In addition, all program staff who are conducting study 
enrollment will receive a minimum of eight hours of training by evaluation staff on the protection of 
human subjects and the foundations of the experimental design.  Specifically, program staff who are 
responsible for enrolling eligible applicants in the study will be trained in obtaining informed consent, 
administering the baseline survey, explaining random assignment, protecting participants’ privacy and 

 
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confidentiality, and reporting adverse events. We will train the program staff using IRB-approved 
protocols, scripts, consent forms and survey instruments.   
7.4. Describe the minimum qualifications for each research role (e.g., RN, social worker) their 
experience in conducting research, and their knowledge of local study sites and culture  
Outreach Specialists will have at least a high school diploma plus a substantial amount of college 
coursework. Outreach Specialists will receive training in research, ethics and study protocols. These 
individuals will have a strong understanding of the local landscape and culture, customs and norms, 
including how to communicate effectively with formal and informal leaders of the communities being 
served through the project. The Outreach Specialists already on staff have existing relationships in 
local communities, and can activate those relationships for the benefit of the project. They also 
possess the skills to engage new partners and cultivate new relationships. Additionally, many 
Outreach Specialists have backgrounds in community development and community organizing.   
 
Nurse Supervisors will be registered nurses (RNs) who manage the Nurse Home Visitors. At each 
agency, they will play a role in outreach and recruitment, managing referrals, and, in some cases, 
enrollment of subjects. Supervisors will have a deep knowledge of the agency they work for and the 
community served. Ten such supervisors already have experience managing NFP at their agency. One 
new supervisor will be hired for this project. This role requires a minimum BSN and preferred 
master’s preparation in nursing or a related field. 
 
Nurse Home Visitors will also be RNs with a Bachelor of Science Degree in Nursing who have a very 
strong knowledge of the study sites. The majority of the nurses already on staff have prior experience 
implementing the NFP program at the study sites, and several of them have been implementing the 
program since 2008 when NFP began implementation in South Carolina. Seventeen new nurses will 
also be hired for this project. These individuals will receive training in research, ethics and study 
protocols and may have past experience conducting research. A majority of the nurses are residents of 
the communities being served, and have a background in serving those communities prior to coming 
to NFP. 
 
Nurse Supervisors and Nurse Home Visitors are trained to screen for various abuses (including 
substance abuse and domestic violence) and to make referrals to local support services. They are 
also mandated reporters in the state of South Carolina. As mandated reporters, they must report to the 
appropriate authorities when they have reason to believe, in their professional capacity, that a child 
has been abused or neglected.  
 
7.5. Briefly describe how the research facilities and equipment at the research site(s) support the 
protocol’s aims, e.g., private rooms available for interviews, etc. 
NFP program staff who are conducting study enrollment at the NFP implementing agencies will be 
provided private rooms to conduct interviews, and secure tablets with encrypted survey forms to 
collect baseline data and randomize participants.  
 
For clients who are approached at referral sites, NFP staff may initially engage clients in a public 
space (e.g. the waiting room at a health clinic or a table at a WIC clinic). Study staff will secure 
private space for obtaining informed consent and conducting interviews. In some instances, the study 
consent process and baseline interview may be completed in a follow-up meeting at an agreed upon 
location, such as the woman’s home or another neutral, private location. 
 
NFP staff will be provided with a toll-free number that they can call to reach the core research team to 
ask questions or report adverse events. This toll-free number will be monitored during standard 

 
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business hours. NFP staff will also be provided with an email address (nfpstudy@povertyactionlab.org) 
that is dedicated to this study and monitored on a regular basis.  
 
7.6. Are there provisions for medical and/or psychological support resources (e.g., in the event of 
incidental findings, research-related stress)? 
No 
Yes:  If yes; describe the provisions and their availability 
There is limited risk of research-related stress. However, NFP program staff are registered nurses 
trained to provide resources/referrals to help pregnant women deal with stress.  
 
 
7.6.1 Nurse survey: Are there provisions for medical and/or psychological support resources 
(e.g., in the event of incidental findings, research-related stress)? Yes, for nurses who are currently 
employed by NFP.  
There is limited risk of research-related stress. However, if current NFP nurses experience stress as a result of 
the survey, their organizations already have systems in place for nurses to bring any thoughts, questions, or 
concerns that may come about by the research. These resources and support systems include, but are not limited 
to, case conferences, reflective supervision, team meeting education modules, and employee assistant programs 
which are available at many sites. We provide information about resources and support systems in the consent 
form and encourage nurses to reach out to their nurse supervisors and colleagues if they need information on 
how to access these services. We also inform nurses that they can contact the research team directly if they do 
not know who to contact, or do not feel comfortable contacting someone at their site directly.  
 
These resources and supports are not necessarily available to former NFP nurses and are not included in the 
consent form for former NFP nurses.  
 
 
2. Vulnerable Populations 
2.1. Are there any potentially vulnerable populations (e.g., children, pregnant women, human 
fetuses, neonates, prisoners, elderly, economically disadvantaged, employees or students of the 
investigator or sponsor, undocumented, terminally ill, cognitively impaired or mentally ill, etc.)? 
No: If no, skip to 3.1 
Yes: If yes; identify all vulnerable populations 
 
Pregnant women, neonates, children 
 
2.2. Describe safeguards to protect their rights and welfare  
This research study involves no more than minimal risk to pregnant women and their children.  The 
research is designed to evaluate a service program that is designed specifically to provide additional 
resources to these populations, which is why enrollment focuses on them. Information on children will 
be obtained from administrative data and only with their mother’s written informed consent.  
 
Nurse Supervisors and Nurse Home Visitors are trained to screen for various abuses (including 
substance abuse and domestic violence) and to make referrals to local support services. They are 
also mandated reporters in the state of South Carolina. As mandated reporters, they must report to the 
appropriate authorities when they have reason to believe, in their professional capacity, that a child 
has been abused or neglected.  
 
If the mandated reporter has reason to believe that a child is being abused or neglected by a parent, 
guardian or person responsible for a child’s welfare, reports must be made to the Department of Social 
Services (DSS) office or law enforcement agency in the county in which the child resides. 
 

 
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If the mandated reporter has reason to believe that a child is being abused or neglected by someone 
other than a parent, guardian or person responsible for a child’s welfare, reports must be made to a 
law enforcement agency in the county in which the child resides.  
 
The nurses will comply with state laws that require them to report if they have reason to believe a 
child is being abused or neglected.  
 
 
3. Consent Process 
3.1. Will consent to participate be obtained? 
No: If no, skip to 3.5 
Yes: If yes; describe the setting, role of individuals involved, timeframe(s), and steps to 
minimize coercion/undue influence during the consent process (at the time of initial consent and 
throughout the study) 
NFP program staff will be trained by the study team about how to implement the informed consent 
process. To minimize coercion/undue influence, program staff will allow the participant as much time 
as she needs to read through the consent form and will also review the consent form with her verbally 
(estimated time: 10-15 minutes). The program staff will emphasize that participation in the study is 
voluntary, and that participants may refuse to answer questions or may choose to stop participating in 
the study at any time. Program staff will be trained to check for participant’s comprehension of what it 
means to be in the study (particularly their understanding of the random assignment process) and will 
encourage study participants to ask questions now and in the future, if they have them.  
 
Based on the local population in South Carolina, the majority of participants will speak English as 
their primary language.  The consent materials will also be translated into Spanish (see Translation 
Attestation Form attached).  Occasionally, participants may speak another language besides English or 
Spanish, but based on existing enrollment patterns we expect this to be less than 0.5% of cases. In 
those rare cases, NFP program staff will utilize an interpreter service through the health care center 
where they work to facilitate the informed consent process.   
 
Due to COVID-19, informed consent will be obtained virtually over the phone. Nurses are trained in 
motivational interviewing and will continue to check for participant’s comprehension of what it means 
to be in the study, the understanding of the randomization process, and encourage questions. Written 
informed consent will be waived during this period and up until in person study visits are possible.  
 
3.2. Are there any special populations?  
No 
Yes:  If yes; describe the process to obtain consent, permission or assent   
NFP currently targets its services to vulnerable young mothers, including pregnant minors (under 18 
years old), who have the highest need of support during their pregnancy and first years as a parent.  
The use of Medicaid funds to cover NFP for the expansion population in South Carolina is predicated 
on an evaluation of its effects using this randomized controlled design. The study is the only pathway 
through which anyone who meets the inclusion criteria in South Carolina, including pregnant minors, 
can access NFP.  
 
South Carolina law does not require parental consent for minors to seek healthcare services, including 
reproductive healthcare services. In accordance with this law, and to protect the well-being of the 
young mothers who may be endangered if they are required but not able to obtain parental permission, 
it is necessary to allow an avenue for pregnant minors to provide their own consent to participate in 
the study. If pregnant minors were not allowed to provide their own consent, and were thus excluded 
from study enrollment if they could not practicably obtain parental consent, this would deny them 
access to Medicaid-funded NFP services – which would be inconsistent both with the goals of 

 
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providing additional resources to this vulnerable population and with the laws and regulations in 
South Carolina. (Currently, the median age of pregnant women who receive NFP services in South 
Carolina is 19, meaning that a substantial share of those served are minors.3) 
 
NFP staff are trained to communicate and provide care to this special population of pregnant minors, 
and will be implementing the informed consent process with them.  During the consent process, NFP 
staff will take special care to make sure that each pregnant minor understands that her participation in 
the research study is voluntary and that she can quit at any time without penalty.  
 
NFP staff will invite each pregnant minor to provide an electronic signature if she wishes to 
participate in the study.  The pregnant minor’s electronic signature will provide a permanent record of 
1) the information conveyed to the mother about the study, 2) the fact that the consent process 
occurred, and 3) the mother’s willingness to participate.  By default, NFP staff will not provide 
pregnant minors (under 18) with a copy of the unsigned consent form, in case her family does not yet 
know she is pregnant. Instead, NFP staff will provide pregnant minors with the Principal 
Investigator’s email address (mmcconne@hsph.harvard.edu) and/or the IRB’s toll-free number (1-
866-606-0573) in case she later has questions, concerns or complaints about this research study. 
 
However, if a participant under 18 years old actively asks for a copy of the unsigned consent form, or 
if a guardian who is present at the time of study enrollment actively asks to keep a copy of the 
unsigned consent form, a copy of the consent form will be provided. In these situations, it is implied 
that the minor is willing to share the information about her pregnancy with her family. During the 
consent process, the nurse will remind the minor that she is free to discuss her decision to participate 
in the research with her family, friends, or doctors, but that she does not need her guardian’s 
permission to participate in the study. 
 
NFP nurses will comply with state laws that require them to report if they have reason to believe a 
child is being abused or neglected. During the informed consent process, NFP staff will make the 
participant aware that they are mandated reporters who are required to report to the appropriate 
authorities if they have reason to believe a child is being abused or neglected. They will explain to the 
participant that it is their legal and ethical responsibility to report situations of child abuse, child 
neglect, or any life-threatening situation to appropriate authorities.  
 
3.3. Will consent of the participants be documented in writing?  
Yes 
No:  If no; describe the rationale for requesting a waiver or alteration of 
documentation of consent (and/or parental permission) 
We will obtain an electronic signature from subjects who consent to participate. Due to COVID-19 we 
will waive written consent and only obtain verbal consent until in person study visits are possible.  
 
3.4. Will participants be provided with a copy of their signed consent form or information sheet 
(when a consent form is not signed)? 
Yes 
No:  If no; explain any extenuating circumstances that make it impossible or 
inappropriate to meet this requirement, i.e., doing so may place participants at increased risk, if 
inadvertently disclosed 
Participants 18 years or older will be provided a copy of the unsigned consent form/information sheet 
to take home that is identical to the one she signed, but does not include her signature.  This will be 
done to protect the participant’s privacy in the case where she inadvertently loses or misplaces the 
information sheet (because the version she has will not contain her name).  
 
3 http://www.nursefamilypartnership.org/assets/PDF/Communities/State-profiles/SC_State_Profile.aspx 

 
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Participants under 18 years old will not be provided a copy of the unsigned consent form by default, 
to protect their privacy, safety and well-being. Providing information sheets to pregnant minors may 
put them at increased risk, particularly in cases where her family does not yet know she is pregnant. 
Instead, NFP staff will provide pregnant minors with the Principal Investigator’s email address 
(mmcconne@hsph.harvard.edu) and/or the IRB’s toll-free number (1-866-606-0573) in case she later 
has questions, concerns or complaints about this research study. However, if a participant under 18 
years old actively asks for a copy of the unsigned consent form, or if a guardian who is present at the 
time of study enrollment actively asks to keep a copy of the unsigned consent form, a copy of the 
consent form will be provided. In these situations, it is implied that the minor is willing to share the 
information about her pregnancy with her family. During the consent process, the nurse will remind 
the minor that she is free to discuss her decision to participate in the research with her family, friends, 
or doctors, but that she does not need her guardian’s permission to participate in the study.  
 
Due to COVID-19, a copy of the unsigned consent form//information sheet will be mailed to clients. 
 
 
3.5. Is a waiver or alteration of consent (and/or parental permission) being requested?  
No 
Yes:  If yes; describe the rationale for the request. If the alteration is because of 
deception or incomplete disclosure, explain whether and how participants will be debriefed 
(include any debriefing materials with the application) 
NFP currently targets its services to vulnerable young mothers, including pregnant minors (under 18 
years old), who have the highest need of support during their pregnancy and first years as a parent.  
The use of Medicaid funds to cover NFP for the expansion population in South Carolina is predicated 
on an evaluation of its effects using this randomized controlled design. The study is the only pathway 
through which anyone who meets the inclusion criteria in South Carolina, including pregnant minors, 
can access NFP.  
 
South Carolina law does not require parental consent for minors to seek healthcare services, including 
reproductive healthcare services. In accordance with this law, and to protect the well-being of the 
young mothers who may be endangered if they are required but not able to obtain parental permission, 
it is necessary to allow an avenue for pregnant minors to provide their own consent to participate in 
the study. If pregnant minors were not allowed to provide their own consent, and were thus excluded 
from study enrollment if they could not practicably obtain parental consent, this would deny them 
access to Medicaid-funded NFP services – which would be inconsistent both with the goals of 
providing additional resources to this vulnerable population and with the laws and regulations in 
South Carolina. (Currently, the median age of pregnant women who receive NFP services in South 
Carolina is 19, meaning that a substantial share of those served are minors.4) 
 
NFP staff are trained to communicate and provide care to this special population of pregnant minors, 
and will be implementing the informed consent process with them.  During the consent process, NFP 
staff will take special care to make sure that each pregnant minor understands that her participation in 
the research study is voluntary and that she can quit at any time without penalty.  
 
NFP staff will invite each pregnant minor to provide an electronic signature if she wishes to 
participate in the study.  The pregnant minor’s electronic signature will provide a permanent record of 
1) the information conveyed to the mother about the study, 2) the fact that the consent process 
occurred, and 3) the mother’s willingness to participate.  By default, NFP staff will not provide 
 
4 http://www.nursefamilypartnership.org/assets/PDF/Communities/State-profiles/SC_State_Profile.aspx 

 
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pregnant minors (under 18) with a copy of the unsigned consent form, in case her family does not yet 
know she is pregnant. Instead, NFP staff will provide pregnant minors with the Principal 
Investigator’s email address (mmcconne@hsph.harvard.edu ) and/or the IRB’s toll-free number (1-
866-606-0573) in case she later has questions, concerns or complaints about this research study. 
 
However, if a participant under 18 years old actively asks for a copy of the unsigned consent form, or 
if a guardian who is present at the time of study enrollment actively asks to keep a copy of the 
unsigned consent form, a copy of the consent form will be provided. In these situations, it is implied 
that the minor is willing to share the information about her pregnancy with her family. During the 
consent process, the nurse will remind the minor that she is free to discuss her decision to participate 
in the research with her family, friends, or doctors, but that she does not need her guardian’s 
permission to participate in the study. 
 
 
4. Risks  
4.1. Are there any reasonably foreseeable risks, discomforts, and inconveniences to participants 
and/or groups/communities? 
No 
Yes:  If yes; indicate probability, magnitude, and duration of each (note that risks may 
be physical, psychological, social, legal, and/or economic) 
Taking part in this research involves minimal risk. There is always a small risk that the mother or 
children’s Protected Health Information (PHI) will be seen by someone who is not on the study team. 
However, the study team will follow strict rules to protect the mother and children’s privacy and 
confidentiality.  The study team will adhere to Harvard’s Level 4 data security requirements to protect 
participants’ PHI.  
 
There is one exception to privacy/confidentiality that we will make participants aware of during the 
informed consent process: NFP staff are mandated reporters and will comply with state laws that 
require them to report to authorities if they have reason to believe a child is being abused or neglected. 
It is their legal responsibility to report situations of child abuse, child neglect, or any life-threatening 
situation to appropriate authorities.  
 
 
4.2. Identify whether any of the information collected, if it were to be disclosed outside of the research, 
could reasonably place the participant at risk of criminal or civil liability or be damaging to the 
participant’s financial standing, employability or reputation. 
We are not collecting any sensitive information (e.g. illegal drug use) in the baseline survey such that 
if it were to be disclosed outside of the research team, the participant could reasonably be placed at 
risk.  For the analysis of the outcome measures, we are using administrative databases already in 
possession of the state, so there is also minimal risk that if this information were disclosed, it could 
reasonably be damaging to the participant’s financial standing, employability, or reputation. If PHI 
were disclosed, the participant could experience emotional or financial distress. However, the study 
team will follow strict data security requirements to protect this information from being released, as 
discussed below. 
 
There is one exception to privacy/confidentiality that we will make participants aware of during the 
informed consent process: NFP staff are mandated reporters and will comply with state laws that 
require them to report to authorities if they have reason to believe a child is being abused or neglected. 
It is their legal responsibility to report situations of child abuse, child neglect, or any life-threatening 
situation to appropriate authorities.  
 
 

 
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4.3. Outline provisions in place to minimize risk 
All study team members will access to confidential information will both acknowledge a 
confidentiality agreement and be appropriately trained. 
 
Identifying information will always be kept separate from the datasets that will be used for analysis. 
The datasets used for analysis will be stripped of personal identifiers such as name, address, record 
number, and replaced with a unique, scrambled study identifier.  Indirect identification may be 
possible, but no attempts will be made to identify individual study participants, and the study team 
will adhere to strict data security protocols to protect participants’ confidentiality.  
 
Confidential information will never be sent via email except in encrypted files. Designated study staff 
will use encrypted files and/or a secure File Transfer Portal (FTP) to transfer personal identifiers to 
the data agencies for selecting administrative records.  After the data agency staff-person selects the 
administrative records for the study participants, he will strip off any personal identifiers, keep the 
study ID, and send back a limited dataset to the study team through the secure FTP.  
For cases in which the study team needs to go “onsite” to conduct a match with administrative data, 
study staff will follow the procedures below which have been approved by the HSPH Information 
Security Specialist, Ingrid Skoog: 
 
1. On the Level 4 Server, study staff will create a “finder file” that includes the study participants’ 
unique study ID and personal identifiers.  This file will be saved as an encrypted .7z file.  
2. This “finder file” will be transferred securely via VPN to an encrypted, external hard-drive. 
3. Study staff will bring the encrypted hard-drive to the partner’s site, transfer the partners’ 
administrative database (including identifiers) to the external hard-drive, and then connect the 
hard-drive to a laptop that (1) doesn't connect to the internet (2) is full disk encrypted and (3) 
gets reimaged/wiped after each use. 
4. Study staff will conduct the match on the laptop, using the personal identifiers. 
5. After the study staff has selected the administrative records for study participants, she will 
create three de-identified files to bring back to Cambridge on the encrypted, external hard-
drive: 
a. A cross-walk that includes only the unique study ID and the ID from the administrative 
data 
b. A file that includes only the administrative outcomes data and the ID from the 
administrative data.  (This file will include no personal identifiers.)    
c. The code used to generate these two files. (The code will include no personal 
identifiers). 
6. All other files, besides the three de-identified files mentioned above, will be deleted from both 
the external hard-drive and the laptop while on-site.  
7. Upon return to Cambridge, the three de-identified files will be securely transferred from the 
encrypted hard-drive to the Level 4 server via VPN, and the laptop will get re-imaged/wiped 
by IT, so that all of the files on the laptop are permanently deleted. 
 
All data will be stored on an institutional stationary server that only designated study staff will have 
access to. A written list of those designated study staff will be disclosed to the IRB. Each study staff-
person who has access to the Level 4 server will be given an individually assigned (non-shared) user 
account. Their access to the Level 4 data or servers will be removed if they no longer have a reason 
under the access policy to access the information (e.g., they change jobs or leave the university).  
 
In addition, a qualified Server Administer will maintain the Level 4 server at Harvard where the data 
will be stored. The server administrator will: 
• require complex passwords from individual users (no shared access); 

 
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• permit access to only those users for whom access has been established; 
• inhibit password guessing attacks; 
• not be allowed to retrieve user passwords; 
• use a secure mechanism to update and/or change passwords; 
• keep the operating system and application patches current; 
• use the applicable malware detection software will be run with up-to-date signature files; 
• force re-authentication to user accounts after an idle period; 
• protect from improper network-based access, physical theft and loss; 
• log user and administrator access to servers; and 
• review logs periodically for anomalous behavior. 
 
Limited data sets extracted from the Level 4 server will be stored on MIT Dropbox Enterprise for 
collaboration and analysis. These data sets will not contain any individual identifiers such as name, 
contact information, address, SSN, or any account number. However, they may contain individually 
relevant dates such as date of admissions and date of discharge. Such external collaboration and 
analysis may include but is not exclusive to extracting deidentified data for analysis on external web 
applications which is not possible from the Level 4 server. The sole purpose being to generate new 
variables such as growth Z-Scores standardized to National benchmarks which will enhance our 
analysis. Only the designated study staff will have access to the limited data sets on Dropbox. All 
local copies of data will be deleted upon project completion.  
 
All electronic records containing confidential information will be properly disposed of by overwriting 
the information. Any publications of analysis will include only aggregated data not linked to any 
individual. 
 
5. Benefits  
5.1. Describe potential benefits of study participation (indicate if there is no direct benefit) 
For participating in the study, participants gain the opportunity to have access to additional 
information and support through NFP, which may improve their and their children’s outcomes. 
 
5.2. Describe potential benefits of the research to the local community and/or society 
The study will provide information to help improve services for pregnant women and parents with 
young children.  Programs like NFP have the potential to substantially improve long-run outcomes 
including maternal and child health, and are of substantial interest to local and national policy-makers 
and stakeholders. 
 
6. Reportable Events 
6.1. Outline plans for communicating reportable events (e.g., adverse events, unanticipated problems 
involving risks to participants or others, breach of confidentiality) 
All NFP program staff who are conducting study enrollment will be trained to report protocol 
violations or unanticipated problems involving risk to participants or others to the Principal 
Investigator within 24 hours of the specific event. The Principal Investigator will communicate 
adverse events, including any potential breaches of confidentiality, within 5 business days to the IRB, 
who will make the final determination as to whether a particular event constitutes an unanticipated 
problem involving risks to participants or others. 
 
NFP staff are mandated reporters and will comply with state laws that require them to report to 
authorities if they have reason to believe a child is being abused or neglected. It is their legal 
responsibility to report situations of child abuse, child neglect, or any life-threatening situation to 
appropriate authorities.  

 
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If the mandated reporter has reason to believe that a child is being abused or neglected by a parent, 
guardian or person responsible for a child’s welfare, reports must be made to the Department of Social 
Services (DSS) office or law enforcement agency in the county in which the child resides. 
 
7. Research Related Injuries (this section must be completed for any greater than minimal risk 
research) 
13.1  Are there provisions for medical care and compensation for research-related injuries? 
No 
Yes:  If yes; outline these provisions (Please note that although Harvard’s policy is not 
to provide compensation for physical injuries that result from study participation, medical 
treatment should be available including first aid, emergency treatment and follow-up care as 
needed. If the research plan deviates from this policy, provide appropriate justification.) 
 
8. Participant Privacy 
8.1. Describe provisions to protect participants’ privacy (their desire to control access of others to 
themselves, e.g., the use of a private interview room) and to minimize any sense of intrusiveness 
that may be caused by study questions or procedures 
All study staff will be trained to protect participants’ privacy. Study enrollment and surveys will be 
completed in private settings and will not be shared with anyone beyond the study staff. All 
information about individual participants will be marked with a unique code number, not with the 
participant’s name or any other identifying information. No reports will describe participants in a way 
that would allow any individual participant to be identified.   
 
There is one exception to privacy/confidentiality that we will make participants aware of during the 
informed consent process: NFP staff are mandated reporters and will comply with state laws that 
require them to report to authorities if they have reason to believe a child is being abused or neglected. 
It is their legal responsibility to report situations of child abuse, child neglect, or any life-threatening 
situation to appropriate authorities.  
 
 
9. Data Confidentiality 
9.1. Will the information that is obtained be recorded in such a manner that participants can be 
identified, directly or through identifiers linked to the participants?  
No: If no, skip to 10.1 
Yes: If yes; either state that participants will be told that their data will be public or describe 
provisions to maintain the confidentiality of identifiable data, e.g., use of password protections  
(please refer to the Harvard Research Data Security Policy Protection Memo, at 
http://www.security.harvard.edu/harvard-research-data-security-policy-protection-memo, for 
additional information about required data security measures) [NOTE: Harvard Research Data 
Security Policy does not always apply if data are not being stored at Harvard facilities.  Please 
consult the Data Security Policy for additional information.] 
Identifying information will always be kept separate from the datasets that will be used for analysis. 
As discussed below, the datasets used for analysis will be stripped of personal identifiers such as 
name, address, record number, and replaced with a unique, scrambled study identifier.  Indirect 
identification may be possible, but no attempts will be made to identify individual study participants, 
and the study team will adhere to strict data security protocols, described below, to protect 
participants’ confidentiality.  
 
Confidential information will never be sent via email except in encrypted files. Designated study staff 
will use encrypted files and/or a secure File Transfer Portal (FTP) to transfer personal identifiers to 
the data agencies for selecting administrative records.  After the data agency staff-person selects the 

 
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administrative records for the study participants, he will strip off any personal identifiers, keep the 
study ID, and send back a limited dataset to the study team through the secure FTP.  
 
For cases in which the study team needs to go “onsite” to conduct a match with administrative data, 
study staff will follow the procedures below which have been approved by the HSPH Information 
Security Specialist, Ingrid Skoog: 
 
1. On the Level 4 Server, study staff will create a “finder file” that includes the study participants’ 
unique study ID and personal identifiers.  This file will be saved as an encrypted .7z file.  
2. This “finder file” will be transferred securely via VPN to an encrypted, external hard-drive. 
3. Study staff will bring the encrypted hard-drive to the partner’s site, transfer the partners’ 
administrative database (including identifiers) to the external hard-drive, and then connect the 
hard-drive to a laptop that (1) doesn't connect to the internet (2) is full disk encrypted and (3) 
gets reimaged/wiped after each use. 
4. Study staff will conduct the match on the laptop, using the personal identifiers. 
5. After the study staff has selected the administrative records for study participants, she will 
create three de-identified files to bring back to Cambridge on the encrypted, external hard-
drive: 
a. A cross-walk that includes only the unique study ID and the ID from the administrative 
data 
b. A file that includes only the administrative outcomes data and the ID from the 
administrative data.  (This file will include no personal identifiers.)    
c. The code used to generate these two files. (The code will include no personal 
identifiers). 
6. All other files, besides the three de-identified files mentioned above, will be deleted from both 
the external hard-drive and the laptop while on-site.  
7. Upon return to Cambridge, the three de-identified files will be securely transferred from the 
encrypted hard-drive to the Level 4 server via VPN, and the laptop will get re-imaged/wiped 
by IT, so that all of the files on the laptop are permanently deleted. 
 
 
All data will be stored on an institutional stationary server that only designated study staff will have 
access to. A written list of those designated study staff will be disclosed to the IRB. Each study staff-
person who has access to the Level 4 server will be given an individually assigned (non-shared) user 
account. Their access to the Level 4 data or servers will be removed if they no longer have a reason 
under the access policy to access the information (e.g., they change jobs or leave the university). A 
locking screen-saver will be in place on the server to block staff’s access to idle sessions.  
 
All electronic records containing confidential information will be properly disposed of by overwriting 
the information. Any publications of analysis will include only aggregated data not linked to any 
individual. 
 
There is one exception to privacy/confidentiality that we will make participants aware of during the 
informed consent process: NFP staff are mandated reporters and will comply with state laws that 
require them to report to authorities if they have reason to believe a child is being abused or neglected. 
It is their legal responsibility to report situations of child abuse, child neglect, or any life-threatening 
situation to appropriate authorities.  
 
 

 
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9.2. Describe i) whether data will be transmitted, and if so how; ii) how long it will be stored; and iii) 
plans for the data at the end of the storage period (how will it be destroyed, or will it be 
returned to data provider) 
At study enrollment, program staff (trained in human subjects protections) will collect personal 
identifiers from each participant including first name, last name, date of birth, social security number, 
address, Medicare Health Insurance Claim Number (HICN) (if applicable), and Medicaid Statistical 
Information System ID (if applicable).  Each study participant will be assigned a unique study ID that 
does not contain any identifying information (e.g. will not contain the participant’s initials or last four 
digits of Social Security Number).  This information will be collected in an encrypted survey form, 
and will be transferred securely to a Level 4 Server at Harvard through a File Transfer Portal (FTP).   
 
The personal identifiers and unique study IDs will be stored in a ‘crosswalk’ file, separate from all 
other data used for analysis.  The crosswalk file will meet Harvard’s Level 4 data security 
requirements.  For example, only designated research staff will have access to the crosswalk file on a 
secure server at Harvard.  A qualified Server Administer will maintain the server at Harvard where 
this cross-walk file will be stored. The server administrator will: 
• require complex passwords from individual users (no shared access); 
• permit access to only those users for whom access has been established; 
• inhibit password guessing attacks; 
• not be allowed to retrieve user passwords; 
• use a secure mechanism to update and/or change passwords; 
• keep the operating system and application patches current; 
• use the applicable malware detection software will be run with up-to-date signature files; 
• force re-authentication to user accounts after an idle period; 
• protect from improper network-based access, physical theft and loss; 
• log user and administrator access to servers; and 
• review logs periodically for anomalous behavior 
 
A backup copy of data collected at study enrollment will be downloaded to an encrypted external hard 
drive that only designated study staff will have access to. A written list of those designated staff will 
be disclosed to the IRB. Due to Covid-19 Professor McConnell will keep the external hard drive at her 
home. The hard drive will remain in her locked office at the conclusion of the pandemic.  
 
At agreed-upon time intervals, designated research staff will use a secure File Transfer Portal (FTP) to 
transfer the “crosswalk” file (with study IDs and personal identifiers) to the state data agency. The 
data agency will use the personal identifiers in the crosswalk to match administrative records to our 
list of study participants.  The data agency will then send back the matched data, but strip off all 
personal identifiers (leaving study IDs).  This limited data file will be stored on the Level 4 server, as 
well, since it may considered individually identifiable per HIPAA regulations. The limited data file 
will be used for analysis and will never be matched to the crosswalk file that contains the personal 
identifiers. A copy of the limited data set may be kept on MIT Dropbox Enterprise for analysis and 
collaboration. MIT Dropbox, unless otherwise specified in a DUA.  
 
For cases in which the study team needs to go “onsite” to conduct a match with administrative data, 
study staff will follow the procedures below which have been approved by the HSPH Information 
Security Specialist, Ingrid Skoog: 
 
1. On the Level 4 Server, study staff will create a “finder file” that includes the study participants’ 
unique study ID and personal identifiers.  This file will be saved as an encrypted .7z file.  
2. This “finder file” will be transferred securely via VPN to an encrypted, external hard-drive. 

 
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3. Study staff will bring the encrypted hard-drive to the partner’s site, transfer the partners’ 
administrative database (including identifiers) to the external hard-drive, and then connect the 
hard-drive to a laptop that (1) doesn't connect to the internet (2) is full disk encrypted and (3) 
gets reimaged/wiped after each use. 
4. Study staff will conduct the match on the laptop, using the personal identifiers. 
5. After the study staff has selected the administrative records for study participants, she will 
create three de-identified files to bring back to Cambridge on the encrypted, external hard-
drive: 
a. A cross-walk that includes only the unique study ID and the ID from the administrative 
data 
b. A file that includes only the administrative outcomes data and the ID from the 
administrative data.  (This file will include no personal identifiers.)    
c. The code used to generate these two files. (The code will include no personal 
identifiers). 
6. All other files, besides the three de-identified files mentioned above, will be deleted from both 
the external hard-drive and the laptop while on-site.  
7. Upon return to Cambridge, the three de-identified files will be securely transferred from the 
encrypted hard-drive to the Level 4 server via VPN, and the laptop will get re-imaged/wiped 
by IT, so that all of the files on the laptop are permanently deleted. 
 
 
9.3. Indicate how research team members and/or other collaborators are permitted access to 
information about study participants  
Only designated research team members will be permitted access to information about study 
participants.  Each team member who is designated access will be required to have individual 
credentials and a protected password that will never be shared; the password must be different from 
any other password used for another Harvard or personal accounts, must be of sufficient length and 
complexity to reasonably protect it from being guessed by humans or computers, and must be changed 
immediately if there is suspicion of compromise. Confidential information will only be accessed for 
authorized purposes and never shared with someone who is not authorized to receive it.  
 
9.4. If future open access, i.e., free availability and unrestricted use, of data is planned or likely, 
indicate how data will be released.  
The creation of a public-use de-identified data set is planned for the end of the study period (subject to 
data use agreements).  This data set will be purged of any small cell values that might permit indirect 
identification of participants or any proprietary information. 
 
10. Costs and Payments  
10.1. Identify any costs that participants may incur during the study, including transportation costs, 
childcare, or other out-of-pocket expenses. 
Participants will not incur any costs for participating in the study.  
 
10.2. Is there any payment or reimbursement that participants may receive during the study?  
No 
Yes:  If yes; specify the amount, method and timing of disbursement. (Please refer to 
Harvard University Financial Policy on Human Subject Payments at 
http://vpr.harvard.edu/sites/vpr.harvard.edu/files/news/Human%20Subject%20Payments%20P
olicy%20Final_0.pdf) 
Participants who enroll in the study will be provided with a $25 gift card to compensate them for their 
time in completing the baseline survey, regardless of whether they are randomized to the treatment 
group or the control group. Due to COVID-19, gift cards will be mailed to clients to compensate them 
for their time for both treatment and control group. 

 
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11. Multi-site Study Management  
11.1. Is this a multi-site study? 
No 
Yes:  If yes; describe plans for communication among sites regarding adverse events, 
interim results, protocol modifications, monitoring of data, etc. 
The NFP program has a long-standing, centralized National Service Office that oversees 
communication with NFP implementing agencies.  The study team has regular communication with 
the National Service Office, and will keep them abreast throughout the study period of any adverse 
events, interim results, or protocol modifications that should be shared with NFP implementing 
agencies.  In consultation with the National Service Office, the study team will determine the best way 
to communicate these updates to the NFP implementing agencies, depending on the content and 
urgency of the message (e.g. via email, phone, etc.).  
 
12. Investigational Drug/Biologic/Device 
12.1. Does this study involve an Investigational Drug/Biologic/Device? 
No: If no; skip to 13.1 
Yes: If yes; identify and describe the drug/biologic/device (e.g., marketing status: Is there an 
IND/IDE, classification of a device as significant vs. non-significant risk) 
 
12.2. Describe its administration or use 
 
12.3. Compare the research drug/biologic/device to the local standard of care 
 
12.4. Describe plans for receiving, storage, dispensing and return (to ensure that they will be used 
only for participants and only by authorized investigators) 
 
12.5. If proven beneficial, describe anticipated availability and cost to participants post-study; plans 
(if applicable) to make available 
 
 
13. HIPAA Privacy Protections 
13.1. Are HIPAA privacy protections required? Please note that only Harvard University Health 
Services and Harvard School of Dental Medicine are covered entities at Harvard.  Harvard is 
otherwise not a HIPAA covered entity.  If, however, data is derived from a Covered Entity (e.g. 
a hospital or community health center), mark ‘yes’ and address the items below. 
No: If no; skip to 14.1 
Yes: If yes; include at least one of the following: 
Describe plans for obtaining authorization to access protected health information 
Provide the rationale for a waiver of authorization or limited waiver of authorization 
request  
We used Harvard’s approved template for ‘Consent at HIPAA covered entities.’  This template provides 
clear language about” 
• 
The privacy rules of the HIPAA law, including a definition of PHI, and participants’ rights 
under the law 
• 
Who will be able to see the PHI for research purposes 
• 
What types of PHI will be collected 
• 
Where the PHI will be collected from 
• 
How the PHI will be protected to maintain each participant’s privacy and confidentiality 
• 
How the PHI will used 
 

 
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The consent form and the NFP staff who will be conducting the informed consent process will make it 
clear to the participant that by signing the consent form, she is authorizing the study team to use her and 
her children’s PHI. The participant will also be informed that she may cancel this authorization at any 
time by contacting the study team, in writing, at the address on the consent form. If she decides not to 
authorize the investigators to use her PHI or she cancels this authorization, she and her children will no 
longer be able to participate in this research study, and the use or sharing of future PHI will be stopped. 
However, the PHI that has already been collected may still be used. 
 
14. Data and Specimen Banking 
14.1. Does the study include Data and Specimen Banking?  
No: If no; skip to 15.1 
Yes: If yes; identify what will be collected and stored, and what information will be 
associated with the specimens 
 
14.2. Describe where and how long the data/specimens will be stored and whether participants’ 
permission will be obtained to use the data/specimens in other future research projects 
 
14.3. Identify who may access data/specimens and how 
 
14.4. Will specimens and/or data be sent to research collaborators outside of Harvard? 
No 
Yes:  If yes; describe the plan 
 
20.5 Will specimens and/or data be received from collaborators outside of Harvard? 
No 
Yes:  If yes; describe the plan 
 
 
15. Sharing Study Results 
15.1. Is there a plan to share study results with individual participants? 
No 
Yes:  If yes; describe the plan 
 
15.2. Is there a plan to disseminate aggregate results to the community where the research is 
conducted? 
No 
Yes:  If yes; describe the plan 
Results from the study will be disseminated to academics, the public, and the policy community. The 
study can provide state and federal policy-makers much needed information about the effect of 
expanding or implementing home visiting programs, taxpayers and voters information about the use of 
public resources to subsidize such programs, and participants information about the efficacy of such 
interventions. 
 
16. Regulatory Compliance 
16.1. Describe plan for monitoring regulatory compliance, in order to ensure proper record keeping 
and retention of required regulatory documents 
The software (SurveyCTO) will time and date stamp the recording of informed consent, the baseline 
survey, and the randomization. The study team will monitor the data from this in real time to ensure that 
protocol is followed (including that consent, survey, and randomization were done in the proper order) 
and that the clients, the field offices, and the recruiters did not tamper with the randomization. 
Additionally, we will work with NFP administrators to ensure the overall fidelity of the implementation 
to the evaluation plan through random back checks, site visits, and monitoring of other data.  
 

 
HLMA Research Protocol  
For use by HMS, HSDM and HSPH Investigators 
 
Research Protocol Template | HRP-503 | Version date: April 10, 2014 | Page 29 of 29 
Longwood Medical Area IRB http://www.hsph.harvard.edu/ohra/ 
The PI will make sure that all investigators and study staff have up-to-date Human Research Training 
certificates on file. The PI will also ensure that her CV, as well as the CVs of the other co-investigators, 
have been updated within the past 2 years, and that they are signed and dated and centrally stored. 
 
The study team will also keep any grant progress reports, correspondence to and from funding agencies, 
signed agreements/contracts, external IRB approvals, and a roster of members with documentation of 
HSPH’s Federalwide Assurance (FWA) Number on file throughout the course of the study.