Hair Care Product Use Among Women Of Color: A Northern Manhattan Intervention
Phase: NA
Conditions: Breast Cancer, Pregnancy Related, Exposure During Pregnancy
Sponsor: Columbia University

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Hair Care Product Use Among Women Of Color 
 
 
 
 
Hair Care Product Use Among Women Of Color: A Northern 
Manhattan Intervention 
 
NCT04493892 
 
 
09/21/2022 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Hair Care Product Use Among Women Of Color 
Background  
Recent trends suggest a convergence in breast cancer (BC) incidence rates in black and white 
women due to the stability in incidence trends in white women compared to the steady annual 
increase in black women (0.3% per year) (1,2). These changing incidence patterns over a short 
time period cannot be attributed to changing genetic factors. While reproductive trends have 
been proposed to drive some of the health disparities,(3) endocrine disruptor chemical (EDC) 
exposures during BC susceptibility windows may also play a role in breast cancer health 
disparities (4,5) as EDC exposure patterns differ by race and ethnicity (6,7).EDCs disrupt 
reproductive development and increase cancer risk through their ability to have a direct, indirect, 
or interactive action on cellular processes within the mammary tissues. These actions include, but 
are not limited to, acting upon hormone receptors, the ability to behave agonistically or 
antagonistically on nuclear receptors, and confer epigenetic changes that increase oncogenic 
susceptibility (8-11). EDCs may have the most influence during periods of dynamic structural 
and functional changes in the mammary glands, (4,5,12) such as during pregnancy and the 
postpartum windows (5,13).  
Hair care products (HCPs) are a class of personal care products (PCPs) that contain EDCs; there 
are stark differences in HCP use by race (6,14-17). In a group of racially and ethnically diverse 
women (n=301), compared to non-Hispanic white women, women of African descent were more 
frequent users of hair oils, lotions, leave-in conditioner, root stimulator and perm/relaxers (14). 
The Sister Study has also shown where 67% of Black women were users of hair pomades and 
straighteners, only 3% of White women were users (7). Differences in hair texture may explain 
differences in use. Nevertheless, of major concern, clinical, epidemiological, and laboratory 
studies have suggested HCPs are associated with earlier pubertal events, (6,18-21) where the 
timing of pubertal maturation is an established risk factor for BC risk (22-24). Additional studies 
have shown that compared to infrequent users, women classified as moderate or frequent users of 
PCPs had a 10-15% higher BC risk,(25) dark hair dye is associated with a 52-72% increased BC 
risk, (17,26) a history of chemical relaxer or straightener use is associated with a 64-74% 
increase in BC risk, (17,27) and in 454 Mexican women (233 cases) urinary concentrations of 
monoethyl phthalate (MEP) were positively associated with BC [OR 2.2. (1.33, 3.63)], with 
stronger associations observed for pre-menopausal women [OR 4.1. (1.6, 10.7)] (28).  
Evidence is emerging on EDC exposures across the pregnancy/postpartum periods. This is of 
importance because while pregnancy is associated with a long-term reduced risk of BC, it also 
confers an increased risk of BC for at least a decade after birth (1,2,8,9). EDC exposure during 
this period of increased risk could promote ‘activation’ effects for BC following pregnancy. In 
pregnant women, PCP use is correlated with higher concentrations of urinary phthalates, (29-31) 
urinary metabolite concentrations vary by PCP type,(32,33) and urinary metabolite 
concentrations differ by sociodemographic factors and across racial and ethnic populations (34). 
For example, a multiethnic cohort of 446 pregnant women found that urinary phthalate 
metabolites were significantly higher among WOC (34). However, while studies assess 
knowledge and attitudes of PCPs during the pregnancy/postpartum periods, no study has 
implemented a behavioral intervention. Five cross-sectional studies have examined knowledge, 

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Hair Care Product Use Among Women Of Color 
attitudes, and prevention behaviors in pregnant women. Four studies with women of 
Frenchdescent focused on intent to change cosmetic use during pregnancy (32,35-37) and 
TIDES, a US based pregnancy cohort (n=894), surveyed health attitudes around PCP use (38).  
These studies are not reflective of PCP practices among pregnant WOC. An intervention to 
reduce phthalate exposures during the pregnancy/postpartum window would have both 
fetal/early and maternal health implications. First, behavioral changes during pregnancy could 
mitigate EDC exposures that exert in utero effects that may program long term risk for hormone-
related disease for the child. Second, behavioral changes could reduce ‘activation’ effects for BC 
following pregnancy (12). Pregnant women are primed to change behaviors for their babies’ 
health. Therefore, we propose an educational intervention during pregnancy to promote reduced 
use of phthalate-containing HCPs. We focus on phthalates because of the well documented 
animal (39,40) and human (41-45) evidence on their effects on reproductive health and 
development, (11,41) they are ubiquitous46 and added to HCPs to provide scent, (6,19) detected 
in human breast milk, urine, amniotic fluid and placenta (suggesting fetal exposure), (11,41) and 
phthalate interventions have proven successful (47-49). 
Study Design 
Objective:  
To reduce use of personal care products that contain endocrine disrupting chemicals among 
women. For this pilot intervention, we focus on the hair care product class of personal care 
products, the reduction in use of phthalate-containing Hair Care Products (HCPs) and use among 
pregnant Women of Color (WOC).  
Study Aims:  
This pilot interventional study will include prospective data collection, including questionnaire 
data and urinary metabolite measures. We will also conduct key informant sessions and 
interviews and focus groups. This pilot proposal will apply the Precaution Adoption Process 
Model (PAPM), a 7-stage theoretical model for health behavior change that attempts to explain 
how an individual comes to decisions to take action and how the individual then translates that 
decision into action (Glanz K, et al. Health Behavior and Health Education: 4th Ed.; 2008).  
Therefore, among WOC, defined as Black or Hispanic women, residing in Manhattan, Bronx, 
Queens, Brooklyn, and Staten Island and in the 3rd trimester of pregnancy, we propose the 
following:  
Specific Aims: 
1. Qualitative Approaches across 5-10 groups (n=50-100 total participants), we will:  
a. Deliver an educational intervention on harmful chemical exposures, such as phthalates, 
found i hair care products, developed by the research team using empirical evidence with 
key informant feedback. 

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Hair Care Product Use Among Women Of Color 
b. Through focus groups gather participant feedback on content and questions pertaining 
to intervention and attributes women of color consider when deciding on Hair Care 
Product use, using a semi-structured guide. 
2. Quantitative Approaches using repeat measures, we will: 
a. Using repeated questionnaires to assess PAPM stages, we will assess self-reported 
behavioral changes in the use of phthalate-free hair care products comparing stage at 
enrollment to  
• Stage after the intervention (post-test1),  
• Stage at 1- month post-intervention (post-test2), and  
• Stage at 1-month postpartum (post-test3).  
 
b. Examine the correlation between self-reported behavioral change assessed by the PAPM 
questionnaire and  
• Change in self-reported Hair Care Product exposure measured via questionnaire 
(n=50),  
• Change in internal dose of urinary phthalate metabolites (targeted gas 
chromatography/high resolution mass spectrometry (known as GC/HRMS) 
Orbitrap; n=25 with 3-repeat samples),  
•  (Exploratory) change in internal dose of all-other detectable urinary metabolites 
(untargeted GC/HRMS-Orbitrap; n=25 with 3-repeat samples). 
Remote Option for Study Aims:  
We have included a description of how each element of the protocol will be administered if 
remote is necessary.  
Hypothesis: We hypothesize that the pilot intervention will increase awareness of phthalate 
chemicals in hair care products and women progressing across the PAPM stages. We expect an 
inverse association between participants who adopt the use of phthalate-free hair care products 
and self-reported phthalate-containing hair care products and urinary phthalate concentrations. 
We compare phthalate concentrations in the 3rd trimester when catabolic activity peaks (Zeng et 
al. Annals of Nutrition and Metabolism. 2017;70(1):59-65) and subsequently measure sustained 
behavioral changes 1-month postpartum. We will explore metabolite concentrations across the 
whole period recognizing the possible limitation of changes in metabolism across the follow-up 
period. 
Potential Risks 
This is a minimum risk protocol. Participants will receive the following information about 
potential risks on the consent form:  
Participants may feel uncomfortable answering some of the questions on the questionnaires, but 
they have been informed that they have the right to refuse to respond to any questions they do not 
wish to answer. They are informed that the information they provide on the questionnaire will be 

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Hair Care Product Use Among Women Of Color 
kept entirely confidential. However, any time personal information is released, there is a 
possibility of confidentiality being compromised. 
 We have provided participants with the following information about the potential for a breach in 
confidentiality on the consent form:  
Despite all of our efforts, unanticipated problems, such as a stolen computer may occur, 
although highly unlikely. Please note the following process will be adhered to for ANY and ALL 
aspects of the study in which your research data is labeled with your unique code number (aka 
study ID): Your unique code number (aka study ID) will be separated from your name or any of 
your information that could identify you. The research file that links your name to the code 
number will be kept in a locked file cabinet and / or an encrypted data file and only the 
investigator and study staff will have access to the file. Your name or any of your information 
that can identify you will not be used in any reporting of the study results. 
Potential Benefits 
There are no direct benefits to participation. The consent form states, “You may or may not 
receive personal benefit from taking place in this study.” 
Participants can choose not to participate in any parts of the study or can choose to withdraw 
from the study at any time. This study does not present greater than minimal risk. 
Subject Population Justification 
This study concerns health risks for pregnant women associated with increased levels of EDC 
chemicals through the use of personal care products that contain EDCs. EDCs may have the most 
influence during periods of dynamic structural and functional changes in the mammary glands 
(4,5,12) such as during pregnancy and the postpartum windows (5,13). This is import because 
pregnancy confers an increased risk of breast cancer for at least a decade after birth (1,2,8,9). 
EDC exposure during this period of increased risk could affect the fetus and promote ‘activation’ 
effects for BC following pregnancy. An intervention during pregnancy on EDC exposures and 
HCPs could have intergenerational health implications for mother and child, which is why we are 
targeting pregnant women. We are obtaining remote e-consent from this vulnerable population 
due to restrictions posed by the COVID-19 pandemic.  
Statistical Procedures 
For the Pilot Intervention: 
Aim 1 Analysis. All sessions (whether conducted in person or remote via Zoom) will be recorded 
and transcribed verbatim by a professional transcription service. We will use Dedoose to code 
using grounded theory and qualitative content analysis focusing on the questions and content 
feedback of the educational intervention and attributes pertaining to PCP use. Dr. Lauren 
Houghton will oversee the creation of the codebook and train the research staff involved in 
coding transcripts. We believe with n=50-100, we will meet our goal of saturation and finalized 
thematic codes will aid in improving the educational intervention and provide an exhaustive 
categorization of attributes WOC consider for HCP product selection. 

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Hair Care Product Use Among Women Of Color 
Aim 2b Analysis:  Please see Study Procedures section (under ‘Metabolomics’ heading) for an 
explanation of Kurt Pennell and his team at Brown University’s involvement in the analysis 
portion of this study. In brief, this exploratory analysis, performed by our partner collaborators at 
Brown University, will conduct Hair Care Product descriptive analyses, including the frequency 
of phthalate-containing products, by category and overall. They will conduct urinary phthalate 
descriptive analyses (log transformed concentrations) comparing detectable ranges for each of 
the urinary phthalate exposure constructs and comparing with national levels from biomonitoring 
reports. They will also conduct untargeted descriptive analyses by characterizing the patterns in 
chemical exposures over time through principle component analyses (PCA) (Gibson et al. 
Current environ health reports. 2019;6(2):53-61). Using spearman correlations, they will 
independently examine the correlation between PAPM and a) change in phthalate containing 
PCPs, and b) change in PCA patterns. Results: We expect the intervention will result in an 
association between PAPM progresses and a decreased use of phthalate-containing HCPs and 
lower concentration levels of MEP (and LMW metabolites). 
Privacy and Data Security  
In Person: All hard copy questionnaires will be stored in locked cabinets in the Epidemiology 
department at CUIMC. Only personnel who have completed human subjects training and are on 
this protocol have access to these files. No names or other personal- identifying information will 
be attached to any computerized data.  
Remote Option: In the event that the consent process (remote e-consent) and questionnaires are 
administered to participants remotely (sent to participants via email or text message), we will use 
Columbia's Qualtrics site to obtain e-consent and collect questionnaire data directly from 
participants. The data generated from the electronically administered questionnaires will be 
coded and a key will be kept separately on encrypted computers. Only Columbia investigators 
will have access to the key code. Access to the surveys is available exclusively through an 
anonymous online link, which is sent directly from Columbia research staff to participants. 
Access to aggregate data is granted solely to authorized staff via password-protected accounts. 
All respondent data is saved as a downloadable CSV file in Qualtrics, with information on 
whether a participant has started, is completing, or has finished the questionnaire, as well as start 
and end date information. Once data is entered into Qualtrics, data will be downloaded from 
Qualtrics by Columbia staff and saved on an encrypted endpoint (desktop or laptop computer).  
Please note the following process will be adhered to for ANY and ALL aspects of the study in 
which participant research data is labeled with either their study ID and specimen ID:  
Overall: The research file that links any information that can identify the participant to the code 
number will be kept in a locked file cabinet, an encrypted data file, and/or CUIMC IRB approved 
and encrypted hard or shared drives. Questionnaires and biospecimens will be stored using 
participants’ unique code number and will not be directly linked to any information that can 
identify the participant to the code number. Questionnaires, biospecimens, and recorded sessions 
will be kept in a locked file cabinet, an encrypted data file, and/or CUIMC IRB approved and 
encrypted shared drives. Only the principal investigator and study staff who have CUIMC IRB 

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Hair Care Product Use Among Women Of Color 
approval for this study will have access to these files. Participant names or any of your 
information that can identify them will not be used in any reporting of the study results. Transfer 
of Biospecimen to Collaborators: The urine collection receptacles will have labels with a 
prepopulated participant specimen ID. Dr. Kurt Pennell, study collaborator and director of the 
231 Engineering Research Center at Brown University and his team will analyze the 
biospecimens. We will deidentify the specimen before our collaborators at Brown receive them. 
Any unused samples will be destroyed by Brown University or mailed back to CUIMC. We are 
not collecting any genomic data and biospecimens will not be used for whole genome 
sequencing in this study.  
All computers have been updated by the MSPH IT staff to comply with all university standards 
for encryption. All human subject data that is stored on an End User Devices is always protected 
by a strong password with the data encrypted at all times. Columbia University will not share or 
offer the raw data to any third party and we will not publish or disclose confidential data nor 
infringe on any privacy rights when processing the raw data.  
Remote Option: Should the consent (remote e-consent) and questionnaires be administered 
remotely, information is collected online through Columbia's Qualtrics site. All staff interacting 
with participants are IRB approved and have completed the required HIPAA and Human 
Subjects training.  
Recording of Group Sessions— We are asking for participants to allow us to record (both audio 
and video) the key informant and educational intervention sessions. The key informant sessions 
will not be transcribed.  
Specific identifiers that will be recorded: The recordings will include full facial features and 
participants’ first name. We are including this identifiable information in the recording so that we 
can keep track of what each participant says throughout the discussion. Participants will have the 
option to turn off their camera on the Zoom app if they prefer not to show their face, in which 
case they will be identified by their Zoom username that they register with.  
People who will have access to the recordings: The transcription company, a registered vendor 
with Columbia University, will have access to the recording so that they can transcribe what is 
said during the discussion. We will provide the name of the transcription company and a Service 
Agreement in upcoming modifications. The key informant sessions will not be provided to the 
company for transcription.  
Clear indication that recording(s) will be kept indefinitely: Identifiers might be removed from the 
identifiable information and, after such removal, the information or biospecimens could be used 
for future research studies without additional consent from the participant. Participants are 
informed in the consent process that their authorization to use and share their research 
information does not have an expiration (ending) date. They are told that they may revoke 
consent and authorization at any time and for any reason, and are provided with instructions and 
contact information for doing so. 

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Hair Care Product Use Among Women Of Color 
Use(s) of the recording(s): The recordings will be used by the research team only for the 
purposes of analyzing the discussion and not for commercial or educational purposes. 
Compensation: Participants will not be provided additional compensation for being recorded; 
please see the Compensation field of the Subjects section of the protocol for more details on 
compensation for overall participation. 
Mechanisms in place to protect confidentiality of those being recorded: In order to protect 
participant privacy, the transcription company, FlatWorld Solutions, will only receive a recording 
of the session that includes the image of their face (should they choose to keep the camera on) 
and the name the participant provides when they register for the session (their Zoom user name). 
This is so they can create a “script” of the conversations that take place during the recorded 
group sessions and keep track of who said what. The transcription company will receive the 
recording through a secure file transfer system. The image of participants’ face and / or Zoom 
user name will be attached to their study ID, but, only the CUIMC study team will have access to 
the file that links the information in the recording to their study ID and that file will be saved on 
an encrypted computer. Only the transcription company and the study team at Columbia will 
have access to the recording; study collaborators will only have access to the ‘script’ of the 
discussion after it has been transcribed by the transcription company. Our contract with the 
transcription company requires that they destroy the recordings as soon as the script of the 
session is submitted to and approved by the Columbia research team. After this point, recordings 
will be stored on an encrypted hard drive that only CUIMC staff has access to. 
Clear indication that recording(s) will be kept indefinitely- Identifiers might be removed from 
the identifiable private information or identifiable biospecimens and, after such removal, the 
information or biospecimens could be used for future research studies without additional consent 
from the participant. Participants are informed in the consent process that their authorization to 
use and share your research information does not have an expiration (ending) date. They are told 
that they may revoke consent and authorization at any time and for any reason and are provided 
with instructions and contact information for doing so. 
De-identified data will be shared with Rutgers University and WE ACT for Environmental 
Justice (partners) through an encrypted file sharing service. 
Data is collected in private CUIMC offices by phone or mail or in person in the clinical research 
space provided through CUIMC and the CTSA. Data is only collected by staff members who 
have completed human subjects training and are approved as part of this protocol. Mechanisms 
in place to protect confidentiality of those being recorded: In order to protect participant privacy, 
the transcription company will only receive a recording of the session that includes the image of 
their face (should they choose to keep the camera on) and the name the participant provides 
when they register for the session (their Zoom user name). This is so they can create a “script” of 
the conversations that take place during the recorded group sessions and keep track of who said 
what. The transcription company will receive the recording through a secure file transfer system. 
The image of participants’ face and / or Zoom user name will be attached to their study ID, but, 
only the CUIMC study team will have access to the file that links the information in the 

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Hair Care Product Use Among Women Of Color 
recording to their study ID and that file will be saved on an encrypted computer. Only the 
transcription company and the study team at Columbia will have access to the recording; study 
collaborators will only have access to the ‘script’ of the discussion after it has been transcribed 
by the transcription company. Our contract with the transcription company requires that they 
destroy the recordings as soon as the script of the session is submitted to and approved by the 
Columbia research team. After this point, recordings will be stored on an encrypted hard drive 
that only CUIMC staff has access to. 
Procedures 
Objective: To reduce use of personal care products that contain endocrine disruptor chemicals 
among women.  
The below details the Pilot Intervention  
Study Overview: To reduce use of phthalate-containing hair care products among women of 
color. We will apply the Precaution Adoption Process Model (PAPM).  
All activities will be performed remote or in person based on IRB mandates. We will submit 
Questionnaires and Facilitator Forms after initial IRB protocol approval.  
Specific Aims:  
1. Qualitative Approaches across 5 groups (n=50-100 total participants), we will:  
a. Deliver an educational intervention on harmful chemical exposures, such as phthalates, 
found in hair care products, developed by the research team using empirical evidence 
with key informant feedback.  
b. Through focus groups gather participant feedback on content and questions pertaining 
to intervention and attributes women of color consider when deciding on hair care 
product use, using a semi-structured guide.  
2. Quantitative Approaches using repeat measures, we will:  
a. Using repeated questionnaires to assess PAPM stages, we will assess self-reported 
behavioral changes in the use of phthalate-free hair care products comparing stage at 
enrollment to: 
• Stage after the intervention (post-test1),  
• Stage at 1-month post-intervention (post-test2), and  
• Stage at 1-month postpartum (post-test3).  
b. Examine the correlation between self-reported behavioral change assessed by the 
PAPM questionnaire and  
• Change in self-reported HCP exposure measured via questionnaire (n=50), 
• Change in internal dose of urinary phthalate metabolites (targeted gas 
chromatography/high resolution mass spectrometry (GC/HRMS) Orbitrap; 
n=25 with 3-repeat samples), 

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Hair Care Product Use Among Women Of Color 
• (Exploratory) change in internal dose of all-other detectable urinary 
metabolites (untargeted GC/HRMS-Orbitrap; n=25 with 3-repeat 
samples). 
 
Questionnaire Constructs : All who wish to enroll and who enroll in the study will be asked to 
complete the following questionnaires which will be administered preferably via Qualtrix but in 
paper format if requested.  
Eligibility Questionnaire: Confirm that potential participants meet the eligibility requirements 
(Black or Hispanic women, residing in Northern Manhattan and in the 3rd trimester of 
pregnancy). 
 Sociodemographic Questionnaire: Information that includes maternal age, gestational age, 
race/ethnicity, occupation and educational attainment, and reproductive characteristics and 
pregnancy details.  
Hair Care Product Questionnaire: Asking participants to take stock of current / recent and past 
hair care product use. This questionnaire was developed by our colleagues at the Rutgers Center 
for Environmental Exposures and Disease based on / modified from the Women’s Circle of 
Health Study questionnaire that captured a detailed list (including brand name and product) of 
each hair product each participant used in the last 24-48 hours. This questionnaire is best 
completed in the space where the woman conducts her everyday hair care routine as she will 
need to recall product type and name. Therefore, we are sending the questionnaire to be 
completed at home prior to the educational intervention.  
Precaution Adoption Process Model Questionnaire: A 7-stage theoretical model for health 
behavior change that attempts to explain how an individual comes to decisions to act and how 
the individual then translates that decision into action. The ‘change in PAPM variable’ (PAPM) 
will illustrate how the intervention moves people across staging. Given movement can be fluid, 
(Rouillon et al. Int J Environ Res Public Health. 2018;15(10), participants will be categorized as 
progresses (i.e. advancing stage(s) from last reported stage), regresses (i.e. regressing stage(s) 
from last reported stage), or stagnant (i.e. not moving from last reported step), comparing: pre-
test to post-test1, post-test1 to post-test2, and post-test2 to post-test3, and post-test1 to post-test3. 
Those who progress to Stage 4 will be labeled as negative progresses. We will provide 
descriptive statistics by pre-test, post-tests, and by the PAPM variable at each time point (when 
relevant). Using spearman correlations, we will examine independent correlations between 
PAPM stage at pre-test with each post-test (post-tests1-3). While PAPM staging is not a 
continuous parameter but ordinal,( Glanz et al. Health Behavior and Health Education: Theory, 
Research and Practice 4th Edition; 2008) correlations will inform how the intervention moves 
people across staging.  
The PAPM stages for this study are described as follows:  
Stage 1: Never heard of endocrine disrupting chemicals (EDCs), nor EDCs in hair care products 
(HCPs) 

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Hair Care Product Use Among Women Of Color 
Stage 2: Never thought about using phthalate-free HCPs  
Stage 3: Undecided about phthalate-free HCPs  
Stage 4: Decided not to use phthalate-free HCPs  
Stage 5: Decided to use phthalate-free HCPs  
Stage 6: Procured and has used (at least once) phthalate-free HCPs  
Stage 7: Use phthalate-free HCPs regularly  
 
Research Guides – The Education Intervention Guide and the Focus Group Guide will be 
developed with the Key Informants and will be submitted for IRB review prior to administration. 
Biospecimen Collection, Processing, and Analysis Urine is the preferred biomarker matrix for 
the hydrophilic phthalate metabolites, whose clearance time is a matter of days and is temporally 
stable in stored urine samples in spite of their relatively rapid clearance, urine phthalate 
biomarker measurements are relatively stable over time (days to months); this is likely because 
exposure sources and patterns of product use are common and fairly consistent. Thus, any 
changes observed in the urinary metabolites will most likely be due to changes in hair care 
product practices rather than within-individual variability.  
For urine collection, we will follow the CDC urine collection protocol for processing phthalates, 
and we are asking participants for their first morning urine. Research staff will review the 
collection procedures with the participants over the phone. Participants will be asked to record 
date and time of their sample. Urine samples will be stored at or below -20 °C (per the CDC’s 
phthalates urine protocol) within the Biomarkers Core Shared Resource Lab, affiliated with 
Herbert Irving Comprehensive Cancer Center (Directed by Dr. Regina Santella). The urine 
sample will be assessed for specific gravity to adjust for urine dilution using a refractometer 
(Adibi JJ, et al. Environ Health Perspect. 2008;116(4):467-473).  
Metabolomics: The Biomarkers Core Lab, HICCC (Directed by Dr. Santella) will ship to the 
Kurt Pennell Lab at Brown University urine samples in cryovials that are packed securely in dry 
ice. The receiving lab at Brown University will conduct Gas Chromatography / High Resolution 
Mass Spectrometry-Orbitrap analyses (henceforth GC/HRMS)- Orbitrap analyses) on a random 
sample of 25 participants, prioritizing participants who have 3 repeat urinary measures and are 
categorized as progresses or stagnant between PAPM post-test1 to post-test3 (see the study 
procedure section for this definition). Kurt Pennell and team (Brown University) will follow an 
extensive and detailed standardized protocol from Pennell for sample preparation and for 
GC/HRMS for Targeted and Non-targeted Analyses within the HRMS facility located in the new 
Engineering Research Center at Brown University. In brief, urine samples will be extracted 
based on EPA Method 8016A for phthalates and phthalate esters (Silva MJ, et al. J Anal Toxicol. 
2005;29(8):819-824). Plastics will be strictly avoided to prevent phthalate contamination. The 
team will assess at minimum 20 LMW phthalates that have been associated with healthier PCP 

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Hair Care Product Use Among Women Of Color 
practices. Sample extracts will be analyzed by Pennell and team using a Thermo GC-Orbitrap Q 
Exactive mass spectrometer analysis performed using Thermo TraceFinder software.  
 Pennell and team will NOT seek to determine genetic predisposition of disease in subjects who 
are asymptomatic. Pennell and team will NOT be conducting any sequencing (whole 
genome/exome or RNA), nor will they be using any assay/platforms. 
 Phase I: Key Informant Session We will be conducting at least one Key Informant session with 
our collaborators and partners to design the group educational intervention and focus group 
session. The Key Informant session will take place via Zoom Webinar or an in-person meeting 
(dependent on current IRB regulations) and last about 2 hours. Sessions will be recorded. 
Discussions will include the questionnaire constructs, the content of the educational intervention 
and script, the message of the intervention and script, and the content of the semi-structured 
focus group and script. We will also seek feedback from collaborators and partners through 
Zoom or in-person meetings (dependent on current IRB regulations).  
Phase II: Recruitment, Enrollment, Consent, and Retention Please see the “Recruitment and 
Consent” section of the protocol for details. In brief, we will check for participant eligibility, 
enroll, and consent 50-100 women of color within Northern Manhattan who are early in their 3rd 
trimester of pregnancy and speak English and/or Spanish. 
Confidentiality:  
All confidential information will remain strictly confidential. The information participants 
provide in the questionnaires (completed on paper, in person) as well as urine collection 
receptacles will be assigned a study ID. The urine collection receptacles will have labels with a 
prepopulated study ID. Each participant study ID will be separated from participant names or 
any identifiable information. The file that links participant names to Study IDs will be kept in a 
locked file cabinet and only the investigator and study staff will have access to the file.  
The following people and/or agencies will be able to look at, copy, use and share participant 
research information:  
-The principal investigator, Columbia University Medical Center and New York-
Presbyterian Hospital study staff and other medical professionals who may be evaluating 
the study.  
-Authorities from Columbia University and New York-Presbyterian Hospital, including 
the Institutional Review Board ('IRB'). An IRB is a committee organized to protect the 
rights and welfare of people involved in research.  
-The Federal Office of Human Research Protections ('OHRP')  
Identifiers might be removed from the identifiable private information or identifiable 
biospecimens and, after such removal, the information or biospecimens could be used for future 
research studies without additional consent from participants. Authorization to use and share 
participant research information does not have an expiration date. Participants have been told 
that they may change their mind and revoke consent and authorization at any time and for any 

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Hair Care Product Use Among Women Of Color 
reason. They have been instructed to contact the Principal Investigator, whose contact 
information they have been given, should they decide at any point to revoke consent and 
authorization.  
Benefit: There are no direct benefits to participating in this study. Risk: This is a minimum risk 
protocol. Participants may feel anxious by answering some of the questions but they do not have 
to answer any question that make them feel uncomfortable.  
Retention: At enrollment, the research staff will complete a participant contact sheet, which 
includes the subjects’ address, home number, cell number, e-mail address, social media 
information (e.g., Instagram, Facebook), and at least one contact through which the participant 
can be reached. Additionally, the contact sheet allows documentation of all phone, mail and in-
person communication with the study participant. We will also discuss participants’ follow-up 
preferences and safety issues with e-mail or postal mail. For every participant not successfully 
reached by phone or email, we will mail a letter to her last known address. Even if a participant 
has moved, mail is often forwarded to the new address.  
Participants will be contacted via phone (call or text) and/or e-mail two to four days prior to the 
educational intervention/focus group session. Should a participant miss their session, we will 
follow-up via phone, mail, or email. If unable to contact during the follow-up period, we will 
also additionally contact participants through social media (direct message) (with permission) or 
through the alternative contact the participant provided upon enrollment. In addition, participants 
will have monthly check-ins through phone, mail, and/or e-mail.  
Incentives: We will provide study participants a $40 Target gift card incentive per session ($20 
Target gift card for urine sample submission and $20 Target gift card per questionnaire 
completed) and have budgeted an additional $20 per attendee to cover the cost of refreshments 
served at the educational intervention and to reimburse for up to $20 worth of travel to and from 
Columbia University (if in-person). If sessions are conducted remotely, participants will not be 
reimbursed for travel expenses. Additionally, we are looking to acquire free hair product samples 
from Shea Moisture, but in case they are not available, we will provide everyone with $10 Target 
gift cards to purchase a phthalate-free product from Target.  
The Target Gift Card incentive structure will be a phased-out incentive system that will no longer 
be used where the new CUIMC Human Subject Clinical Trial participants Prepaid Visa Debit 
Cards will now be the default for providing compensation. Each participant will receive one card 
through the mail. Once the participant verifies that they have received the card, they can activate 
the card. Once the card is activated, each participant will begin to access funds that are pushed to 
their visa card as an incentive to study participation. The same amount of incentive per study part 
completion as described above will be provided. The participants will now have the flexibility of 
use outside of Target and eliminates multiple transactions per participant follow-up. If a visa card 
is lost, the card will be deactivated. If the visa card is lost with funds remaining on the visa card, 
the participant will contact the bank and study staff to go through the process of issuing a new 
card. We will abide by all policies that are in accordance with this CUIMC Incentive system.  

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Hair Care Product Use Among Women Of Color 
We aim to make the Prepaid Visa incentive system the default incentive system beginning 
October 2021. The Prepaid Visa Registration System is an approved system for research 
participants through CUIMC. All currently enrolled participants will be re-consented using the 
updated consent form to this payment structure.  
Phase III: Sending Study Materials Prior to the In-Person or Remote Session We are asking 
enrolled participants to consent to send the following items to their mailing address, email 
address, and text message link to cell phone prior to their in-person session (when applicable): 
the consent form, the Hair Care Product Questionnaire, and the urine sample collection kit (with 
icepack). Please see Consent Form for more details. In brief, once determined eligible, a trained 
study team member will email or text a link to the remote e-consent process and review the 
information with the participant over the phone to answer any questions they may have. Part of 
this process includes asking the participant for verbal consent to send the aforementioned items 
to a mail and email address of the participants choosing, as well as text message links. The 
participant will complete the remote e-consent process this same way. The Hair Care Product 
Questionnaire provided via Qualtrix is best to be completed in the space where the woman 
conducts her everyday hair care routine as she will need to recall product type and name. We are 
also asking for first morning urine to standardize collection of all urine samples over time.  
In the case we do not get verbal consent to provide study materials using any of these methods, it 
will be difficult for them to participate in this study remotely. Therefore, we will then say during 
the consent process “If and when this study has an in-person component, could we contact you in 
the future?” and provide Yes and No options.  
Phase IV: Educational Intervention and Focus Group Sessions – IN PERSON OR REMOTE 
Participants will be asked in the welcome letter and reminded during ‘reminder’ calls, emails, 
and text messages to:  
1.Submit completed remote e-consent process to research staff at CUIMC or bring their 
consent form to an in person session or complete the paper consent form (once received 
in the mail) and send back to research staff within the prepaid return envelope.  
2.Mail in the provided envelope the completed urine kit to the Biomarkers Shared 
Resource Lab, affiliated with Herbert Irving Comprehensive Cancer Center (Santella) or 
bring them to an in person meeting.  
3.Have completed, via Qualtrics, the questionnaires before the educational intervention.  
Based on discussion with the Key Informants, we will do one or a combination of the following 
for administering the Intervention and Focus Groups REMOTELY:  
1.Sessions will be administered consecutively or in two separate sessions to the same 
group of women. n~50 women with groups of 8-12. Session lasting 1-1.5 hours or 2-2.5 
hours, respectively.  

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Hair Care Product Use Among Women Of Color 
2.The intervention session will be administered to n~50 women with groups of 8-12 and 
the Focus Group Session will be administered to a separate group of n~50 women with 
groups of 8-12 with each session lasting 1-1.5 hours. 
 
The Educational Intervention:  
The intervention will be followed by a question and answer session. The intervention will focus 
on phthalate reducing behaviors because of the well documented animal and human evidence on 
their effects on reproductive health and development, they are ubiquitous and added to HCPs to 
provide scent, detected in human breast milk, urine, amniotic fluid and placenta (suggesting fetal 
exposure) and phthalate interventions have proven successful. At the end of the intervention, we 
will also administer a similar Precaution Adoption Process Model Questionnaire to assess the 
impact of the intervention.  
A trained staff member will prior to the start of the educational intervention if taking place in-
person: 
1.review the consent form with the participant and obtain written consent before the 
intervention begins  
2.Administer the Sociodemographic Questionnaire (participant self-completes or if 
preferred, completed with interviewer) before the intervention begins.  
3.Administer the Precaution Adoption Process Model Questionnaire (participant self-
completes) before the intervention begins.  
4.Provide the Hair Care Product Questionnaire to be self-completed if they did not 
complete the questionnaire prior to the session. Or, provide a return envelope if the 
participant forgot to bring the completed questionnaire with them.  
Remote Option: A trained staff member will have gone over the consent process remotely and 
will send them links from Qualtrix to complete the Sociodemographic Questionnaire and the 
Precaution Adoption Process Model Questionnaire prior to the educational intervention.  
 
The Focus Groups:  
From consumer theory, when a rational consumer is faced with a set of options, the consumer 
will place values or preferences to each option, and then choose the preferred. However, 
consumers are making decisions based on multiple attributes that determine the hair care 
products’ utility and therefore the purchase. Therefore, while we hypothesize that our educational 
intervention will make participants more aware of the importance of ingredients as an HCP 
attribute, women will unlikely make maintainable HCP use decisions based on ingredients alone. 
Thus, pulling from consumer discrete decision making, we will determine what attributes WOC 
apply when making decisions about HCPs. Factors identified will inform a behavioral 

16 
Hair Care Product Use Among Women Of Color 
intervention that targets educational awareness plus other attributes that participants apply to 
HCP use decisions.  
Phase V: Follow-Up – ALL REMOTE There will be two follow-up sessions conducted over the 
phone that will take place about Mid-Late 3rd trimester (Follow-Up 1) and 1-month postpartum 
(Follow-Up 2). At each follow-up, the following will be collected: repeat Hair Care Product 
Questionnaire, repeat Precaution Adoption Process Model Questionnaire, and first morning urine 
collection. 
Recruitment and Consent 
We will enroll n=50-100 adult pregnant women (18 years or older), who are within 0-4 weeks of 
the 3rd trimester of their pregnancy, speaks English and/or Spanish, and lives within Manhattan, 
Bronx, Queens, Brooklyn, Staten Island. We will recruit through (1) Instagram advertisements 
and (2) the OBGYN clinic. We have experience recruiting pregnant women through the 
Columbia Ambulatory Care Network for the Milk-Associated Markers And Breast Optical 
Spectroscopy Study (MAMA BOSS) pilot study (PI: McDonald, IRB# AAAR4711) which is a 
study designed to understand postpartum breast biology. We will be working alongside Dr. 
Ashanda Saint Jean who is the OB/GYN director of the Ambulatory Care Network, the site 
director at the Rangel Community Health Center, and an admitting physician at the New York 
Presbyterian/Allen Hospital to recruit participants. Dr. Saint Jean will approach potentially 
eligible or soon to be eligible mothers being seen at the ACN and provide them with a packet 
comprised of the study Consent Form and a Welcome Letter. Dr. Saint Jean will then allow the 
mother time to review the packet privately and will thereafter answer any questions and obtain 
the name and contact information of those who might be interested in being contacted. Dr. Saint 
Jean will provide the PI and research staff with the name and contact number of pregnant women 
who have expressed interest in the study and who have provided verbal permission to be 
approached by the study team for participation. The research team will then follow-up with the 
interested individual either by phone or by email and conduct the eligibility and enrollment 
process. If eligibility is confirmed, the participant will be scheduled to attend the educational 
intervention. Our current location for the intervention is the Community Engagement Core 
Community Space (affiliated with the Irving Medical Center) in Washington Heights. 
We will also use the CCPH Columbia Community Partnership for Health and Community 
Engagement Core Resource based out of the Irving Medical Center to assist with recruitment. 
Additional recruitment strategies will include:  
1.We will contact the Directors and Chiefs of other Ambulatory Care Networks and Obstetrics & 
Gynecology Divisions here at Columbia Presbyterian and local facilities (e.g., Allen Hospital) in 
the CUIMC catchment area to see if we can leave fliers in the waiting areas.  
2. Research flyer that will be distributed in locations throughout Manhattan, Bronx, Queens, 
Brooklyn, Staten Island, including but not limited to, public libraries, health food stores, coffee 
shops, and hospitals.  

17 
Hair Care Product Use Among Women Of Color 
3. We also will have a short post for online local parent groups that allow postings. The post will 
include language as written on the flier and within the consent. Interested parties will be able to 
call or email us to get more information.  
4.We will post the electronic version of the study flyer or a short post that includes language as 
written on the flyer on Craigslist, community websites, and other websites where research 
studies are appropriate for posting. Interested parties will be able to call or email us to get more 
information. For any referrals, the study coordinator will confirm eligibility by administering a 
short eligibility questionnaire over the phone or in-person. If eligible, a study coordinator will 
proceed with the consent process.  
Consent: Once a woman has been identified as a potential participant by one of our recruitment 
partners, or if they reach out to us after having seen recruitment materials, they will be 
administered the eligibility screener questionnaire by a trained study team member (over the 
phone). If the participant is determined eligible, the study team member will email or text 
message the participant a link that takes them to the Remote Electronic Consent process on 
Qualtrics. The study team member will initiate the Informed Consent Process, which will begin 
with a concise and focused presentation of the key information about the research study. This 
will be accomplished by verbally reviewing the complete consent form with the participant (25-
30 minutes) on the phone. In the beginning of the Informed Consent Process, the study team 
member will obtain verbal consent to share the study materials with the participant, either mailed 
or electronic. Mailed study materials would include a urine collection kit with instructions. 
Electronic study materials would include a link to the electronic version of this consent form, 
questionnaires, biospecimen collection forms, and study reminders. The participant can select 
from one of the following options:  
1. Consent to having the study materials mailed to the address the participant provides  
2. Consent to having the study materials e-mailed to the email address the participant provides  
3. Consent to having the study materials texted to the cell phone number the participant provides  
4. Not consenting to having study materials mailed or electronically sent. In the case of option 4, 
the study personnel will explain to them that it will be difficult for them to participate in this 
study remotely. Study personnel then read the participant the following, “If, and when, this study 
has an in-person component, may we contact you in the future? This will be the end of the 
consent process for this study. Thank you!” and the participant can answer “yes” or “no.” This 
will be the end of the consent process for this study.  
The verbal consent obtained by the study staff from the participant is only so they can send the 
participant the study materials. They will also receive (via text or email) a link to the remote e-
consent process administered on Qualtrics. They will provide written consent that applies to the 
entire study via the e-consent process administered on Qualtrics. Please note- the urine collection 
(biospecimen) process is not part of the screening process; participants are only asked to provide 
urine samples once they have consented to participate in the study.  

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Hair Care Product Use Among Women Of Color 
In the case verbal consent is granted, the following options will ensue: If the study takes place in-
person for the intervention or focus group, we will have obtained verbal consent, but will also 
obtain written consent at that time. We will provide the participant a copy of the signed consent 
form in person. 
If the entire study takes place remotely, and the participant completes the remote E-Consent 
process at the time of consenting, a copy of the consent will be generated and emailed to the 
participant and available to them for the duration of the study. We will also, upon request, send a 
hard copy to the participants address.  
In both cases, written consent will be obtained for the entirety of the study.  
If the entire study takes place remotely, and the participant was unable to complete the E-
Consent at the time of the phone call, we will ask the participant to e-consent at a later date and 
send reminders up until the day of the session. If the participant has chosen to consent through a 
hard copy, we will send the consent to an email address and to the provided address with a return 
email address and a pre-paid envelope to return via mail. If the participant does not econsent or 
provide written consent via email or mail, they will not be permitted to participate in the session.  
Emails/texts will be sent by a Columbia Research team member through Outlook, Mailchimp or 
Qualtrics (or SMS if using study cellphone to text) and will include a link to a Qualtrics survey, 
which includes the e-Consent form. Written consent for the entire study will be obtained. 
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