Preventing Alcohol Exposed Pregnancy Among Urban Native Young Women: Mobile CHOICES
Phase: NA
Conditions: Alcohol Exposed Pregnancy
Sponsor: University of Colorado, Denver

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Cover Page 
 
Protocol and Statistical Analysis Plan 
 
Project Title: Preventing Alcohol Exposed Pregnancy among Urban Native Young Women: Mobile 
CHOICES 
 
 
 
 
Principal Investigator: Carol E. Kaufman and Michelle Sarche (MPI) 
Version Date: 11.17.21 
 
NCT Number:  NCT04376346 
Unique Protocol Id 18-0574 / 20-3122 
 
 
 
 

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W 
COMIRB Protocol 
COLORADO MULTIPLE INSTITUTIONAL REVIEW BOARD 
CAMPUS BOX F-490    TELEPHONE:  303-724-1055  Fax:  303-724-0990 
 
 
 
Protocol #: 
20-3122 
Project Title: Preventing Alcohol Exposed Pregnancy among Urban Native Young Women: Mobile 
CHOICES 
 
 
 
 
Principal Investigator: Carol E. Kaufman and Michelle Sarche (MPI) 
Version Date: 11.17.21 
 
 
 
 
 
 
  
 
I. Hypotheses and Specific Aims:      
Fetal Alcohol Spectrum Disorders (FASD) result in neurodevelopmental deficits and lifelong disability; they 
are a leading cause of preventable birth defects in the U.S.1,2 According to the CDC, any sexually active 
woman of reproductive age who drinks alcohol and does not use effective contraception is at risk for an 
alcohol exposed pregnancy (AEP) that could cause FASD.2 By this definition, American Indian and Alaska 
Native (AIAN) young women are especially vulnerable. AIAN girls initiate alcohol use earlier than their non-
AIAN peers;3-6 they are also more likely to have used alcohol in their lifetimes, in the last 30 days, and on a 
daily basis.7 Concomitantly, compared to all other race groups, high school-aged AIAN girls report the 
highest levels of ever having had sex (69%), and having had sex in the last 3 months (50%). Across all 
AIAN youth, 32% reported using alcohol or drugs before last sex, the highest rate across all race groups, 
and 80% reported not using effective contraception at last sex.8,9 Unsurprisingly, the birth rate for AIAN 
women ages 15-19 is 27 per 1000—the third highest rate after non-Hispanic Blacks and Hispanics.10 One 
study estimates that 25% of these teen births are substance involved, with the most common substance, 
alcohol, accounting for more than half of these.11 While an estimated 72% of AIAN young women live in 
urban areas,12 research relevant to AEP is largely based on reservation samples.13-15 With rare 
exceptions,16-20 the research base for urban AIAN youth and young adults remains thin. Urban AIANs tend 
to live not in concentrated neighborhoods but rather dispersed across the urban landscape; thus, common 
community-based recruitment and intervention strategies are expensive or rarely applicable for research 
engagement of urban AIANs.21 Consequently, urban AIAN needs are often ignored in research aimed at 
developing, implementing, and evaluating culturally appropriate services. Recent research indicates that 
mobile health (mHealth) interventions are promising for delivering effective interventions to hard-to-reach 
populations.22-24 The goal of this project is thus to expand reach and services to urban AIAN young women 
through mHealth technology to prevent AEP and FASD.  
 
The proposed project builds directly on the work of an earlier NIAAA-funded project (R21AA17596; 
Sarche, PI {Ojibwe, MPI on this project}). Using intensive community-based participatory research (CBPR) 
methods,25,26 tribal community and AEP prevention experts guided the adaptation of CHOICES (Changing 
High-risk alcohOl use and Increasing Contraception Effectiveness Study),27 an evidence-based brief AEP 
intervention supported by the CDC, for use with young American Indian women age 16-20. CHOICES 
relies on motivational interviewing (MI) to increase contraceptive use and decrease drinking among adult 
women at risk for an AEP.27 The adapted version, American Indian Youth CHOICES (AIY-C) preserves the 
brief MI format and focus on AEP prevention through increased contraceptive use and decreased drinking. 
AIY-C diverges from CHOICES in its cultural content, its universal approach, and its youthful age range. 
AIY-C supports all young AIAN women in making current (for sexually active or drinking youth) or future 
(among abstinent youth) healthy choices about contraception and drinking. AIY-C contains features that 
make it highly amenable to mHealth approaches, including a framework for integrating diverse cultural 
teachings, few modules of short duration, and concrete opportunities for goal-setting and achievement. This 
proposed project is innovative in its plan to recruit AIAN young women from major urban areas in the US 
through social media and to deliver AIY-C via mobile devices—both of which are increasingly ubiquitous 
among AIAN young adults.28,29 While social media recruitment and mHealth interventions are not new, 

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including for adult AEP prevention,30-33 only very recently have they been used with AIAN populations.34-36 
Appropriate partnership with urban AIAN organizations is foundational to the project’s success.37 We have 
engaged strong collaborators to guide us through social media recruitment strategies, mHealth intervention 
translation and implementation, and evaluation processes in urban AIAN settings. Engaging with cultural 
and intervention expert guidance, we propose the following specific aims: 
SA1: Develop social-media-based recruitment strategies for urban AIAN young 
women; we will pilot and refine these strategies. 
SA2: Translate AIY-C for mHealth delivery through an iterative and theoretically driven 
process, integrating urban AIAN young women’s input to enhance cultural and 
health engagement content and responsiveness; we will pilot and refine the 
translated mHealth AIY-C intervention. 
SA3:  Recruit 700 (final N=525) urban AIAN young women using the refined social media 
strategies, and conduct an RCT to rigorously evaluate the effectiveness of the 
mHealth translation of AIY-C for preventing AEP and FASD.  
 
SAs 1 and 2 were conducted under a separate COMIRB protocol (#18-0574) as preparatory to research 
efforts.  For this protocol, we focus only on SA 3.  
 
II. Background and Significance:  
 
In the US, an estimated 1 in 8 pregnancies are exposed to alcohol.38 In any given month, 2 million 
women, about 1 in 30, are at risk of AEP that could result in FASD.39 FASD include FAS, partial FAS, 
alcohol-related birth defects, and alcohol-related neurodevelopmental disorders.40 Children born with FASD 
suffer cognitive, physical, and social-emotional consequences throughout life; social and financial costs are 
enormous to individuals and society41-46 Rates of drinking among pregnant AIAN women exceed those of 
other groups,47-49 with rates of 30%15-43%50 in some samples. Prevalence estimates for FASD in AIAN 
communities are limited and often dated but exceed other groups by at least 2 or more times.48,51,52  
 
 
Given these data as well as a strong commitment to the health of future generations, tribal 
communities prioritize youth AEP prevention.11,53,54 AIAN youth are at-risk for initiating alcohol use at 
younger ages relative to their non-AIAN peers9 while patterns of use among AIAN youth who drink are 
more likely to put their own health and that of an unborn child at risk. High school AIAN girls are more likely 
to have drunk alcohol prior to age 13, currently drink, and drink 5+ drinks at a time compared to those in all 
other race groups.8 AEP data for AIANs are limited due to insufficient sample sizes in large national 
studies;55 however, the rates cited here confer risk for AEP when coupled with the early and unprotected 
sexual activity documented for AIAN youth.9,53,56  While over 70% of AIANs live in urban areas, little 
research exists on patterns of AEP among urban AIAN young women in particular. What does exist 
indicates that they may be at the same or greater risk for alcohol use and sexual risk compared to their 
non-AIAN counterparts.9,17,57 
In part, the lack of research reflects the research challenges of a small population overall (<2% of 
the US population), widely dispersed across urban centers (i.e., few AIAN neighborhoods exist in most 
urban settings). New recruitment and intervention implementation strategies to reach this population are 
critical.  While social media recruitment is not new,87-89 it has rarely been used among AIAN participants;34 
yet, this approach may hold substantial promise. Moreover, the potential for mobile health (mHealth) -
delivered youth interventions, including AIANs, is growing. The Pew Research Center estimates that, in 
2015, 86% of adults aged 18-29 owned a smart phone and 50% owned a tablet,90 while almost 76% of 
teens aged 15-17 owned smart phones and 56% owned a tablet.91 While the “technology divide” still exists, 
it is fast disappearing among teens and, perhaps, among AIAN populations in particular. A survey of adults 
from 128 tribal communities found AIANs were more connected to the internet than the general population, 
perhaps because mobile technology and the access it provides to email, texting, social media, and websites 
can virtually diminish large distances or isolation. 29,92 

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We have selected one intervention that has had demonstrated impact in preventing AEP, CHOICES 
(Changing High-risk alcohOl use and Increasing Contraception Effectiveness Study),27 an evidence-based 
brief AEP intervention supported by the CDC to implement with urban AIAN young women.  In earlier work, 
Dr. Sarche (MPI; Ojibwa), using intensive community-based participatory research (CBPR) methods,25,26 
along with tribal community and AEP prevention experts, guided the adaptation of CHOICES for use with 
young American Indian women age 16-20 (American Indian Youth-CHOICES, or AIY-C).  Based on this 
work (R21AA17596; Sarche, PI) and our formative work, we developed an mHealth version for smart phone 
use that we have named Native WYSE (women young strong empowered) making CHOICES (NWC). In 
this way, in tandem with social media and other recruitment, we will offer a culturally tailored intervention 
that this population can access at their convenience.  
To assess the effectiveness of NWC to encourage urban AIAN young women to make and sustain 
healthy decisions related to alcohol use and sexual risk taking, we will conduct a randomized controlled 
trial.   
 
III. Preliminary 
Studies/Progress Report:   
Adapted AIY-C intervention 
content. AIY-C integrates 
tribal values with guidance 
about young women’s 
sexual health along with 
core messages about 
alcohol use and effective 
contraception from the 
original CHOICES 
curriculum. Given its 
applicability and relevance 
for all young women 
regardless of alcohol use or 
sexual activity, AIY-C adds 
messages to support young 
women who may choose to 
abstain from sex. Given 
AIY-C’s focus on young 
women, messages about 
alcohol convey that no safe 
level of drinking exists for 
those under 21. In Table 3 
we outline the AIY-C 
components (CHOICES 
core components) and their 
cultural, developmental, 
and universal adaptations 
that the CBPR methodology 
produced. We worked 
closely with our advisory 
board of cultural and scientific experts to translate AIY-C to an mHealth format.  
 
Formative research (accomplished under protocol #18-0574) 
 
In-depth interviews. We conducted 32 in-depth interviews (IDIs) to inform both methodology and content in 
Table 3.  AIY-C Selected components and adaptations 
 
AIY-C Components 
Cultural/ Developmental/Universal Adaptations 
Session 1  
Introduction: What is it? How does it 
work? How does it help? 
Relevance for young Native women, simplified 
language, scope of intervention broadened  
Reflection on 7 Teachings of Anishinaabe: 
Love, honesty, respect, kindness, humility, 
bravery, wisdom 
AIY-C specific cultural teachings emphasizing 
wellness and balance; reflections on 
presence/absence/relevance of teachings 
Reflection on Medicine Wheel: Spiritual 
(North); Emotional (South), Physical (East), 
Mental (West) 
AIY-C cultural heuristic emphasizing spiritual 
wholeness and balance; participants asked to 
reflect on alcohol's impact in key spiritual realms. 
Important Facts for Young Women: Safer 
sex, birth control, and pregnancy 
Simplified language, universal language about 
sex, condom use, safer sex practices, STD risks 
Daily Journaling: Instructions.  
Online for security.  added questions: offered 
drink/sex, safer sex practices, thoughts/feelings 
Session 2  
Personal Feedback: Alcohol risk, cost, and 
calories 
Review of offers to drink, alcohol risk assessment 
based on any drinking 
Personal Feedback: Birth control & safer 
sex, pregnancy, AEP, and STD Risk 
Review of offers to have sex, STD risk assessment 
Personal Goals: Alcohol 
Continuing NOT to drink as goal for those who do 
not drink; cultural supports for goal attainment 
Change Ruler: Birth control & Safer sex 
Added safer sex practices 
Personal Goals: Birth control & Safer sex 
Continue NOT to have sex a goal for not sexually 
active, safer sex goals, cultural supports for goals  
Optional:  Contraceptive Visit with Healthcare Provider (recommended after session 2) 
Session 3  
Birth Control Visit Review, if applicable 
Core CHOICES exercise 
Discuss changes in alcohol use, birth 
control use, and safer sex practices 
Continuing not to drink/have sex as goals; safer 
sex practices 
Review goals and change plans  
Continuing not to drink/have sex as goals; safer 
sex practices 
Session 4  
Discuss changes in alcohol use, birth 
control use, and safer sex practices 
Continuing not to drink/have sex as goals; safer 
sex practices 
Final Goals: Birth Control & Safer Sex 
Continuing NOT to have sex as goal for those not 
sexually active, safer sex goals, cultural supports 
for goal attainment 
My AIY-C Story Review 
Core CHOICES exercise 

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our mobile health adaptation of NWC. We recruited AIAN young women nationally through carefully 
designed social media advertisements. We conducted three iterative rounds of IDIs to hone ideas and 
preferences on platform use, types of technology engagement, and content on alcohol, contraception, and 
culture. Findings from these IDIs were critical to ensuring relevance and acceptance of our intervention for 
young Native women. The data revealed that an intervention that addresses alcohol and contraceptive use 
rather than as AEP prevention was preferred. Participants suggested that cultural symbols such as 
medicine wheel, Sun and Moon and Sacred Mountains should be considered when conveying information 
about AEP. Participants also mentioned traditional ceremonies and the arts could be used to highlight the 
message of wellbeing and health. Most participants indicated that they would be able to relate to most of 
the alcohol mentioned in the CHOICES curriculum, excluding wine. In regards to conveying information 
about alcohol and contraceptive use most of the participants stated they preferred the quizzes with visuals 
over the ones without since those were more engaging. All participants felt the online journaling would be 
received well and recommended its use.  
 
NWC mobile app. Findings from our IDIs informed the content to include in our mobile app.  The app 
contains six sessions; these sessions include content on alcohol use, birth control and safer sex, and facts 
of AEP and FASD.  The app also includes culturally relevant imagery such as the medicine wheel and 
connections across generation.  Motivational interview elements of tone, assessment of personal risk, 
decisional balance exercises, and goal setting are also included. Participant knowledge of alcohol and birth 
control methods, including condoms, is assessed through the app.  See Appendix A for a selection of 
images from the App. 
 
IV. Research Methods 
We propose using an RCT with a baseline sample n=700 urban AIAN young women aged 16 to 20 to 
evaluate NWC for its effectiveness in AEP prevention.  
 
 
Figure 1. NWC Conceptual Model 
 
Outcome Measure(s):  Figure 1 
depicts the measures used the 
assess the impact of NWC.  These 
measures include demographics, 
such as age, education level, and 
income, measures of social risk; 
environmental support; and cultural 
identity.  Theoretical mediators 
include knowledge of effective 
contraception and alcohol use during 
pregnancy and self-efficacy related 
to sexual activity and contraceptive 
and alcohol use. Our primary 
outcomes include sexual activity, 
abstinence, effective contraceptive 
use, and alcohol and other substance consumption—AEP protective and risk factors.  With the pandemic, 
we have also added measures on experiences with COVID-19 to capture appropriate context. 
 
B. Description of Population to be Enrolled:   
Our population of focus will be AIAN women, ages 16-20, who live in urban areas (50,000 people or more), 
and who are not pregnant or breastfeeding at the time of enrollment.  Currently, we are awaiting approval 
from the Southcentral Foundation of Alaska, a research review IRB for Alaska Native healthcare in 
Native WYSE 
CHOICES
Cultural
Identiﬁcation
Knowledge
• Contraception 
eﬀectiveness
• Alcohol use during 
pregnancy
Self-eﬃcacy
• Sexual activity
• Contraceptive use
• Alcohol use
Alcohol 
Consumption 
(+other 
substances)
Sexual Risk: 
Activity and 
Abstinence
Theoretical 
Mediators
Primary Outcomes
Eﬀective 
Contraceptive 
Use (among 
those sexually 
active)
Demographics 
+ social 
risk/support 
environment
AEP Risk

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Anchorage (the only urban area in Alaska with population > 50,000). Until we receive this approval, we will 
exclude residents from Alaska. 
 
C. Study Design and Research Methods   
 
Screening 
We will screen each participant for eligibility before enrolling them into the study. The questions are 
administered by Qualtrics (accessed by URL from a recruitment flyer or social media post). These 
questions include items not on the recruitment advertisements as a way to screen out frauds - those who 
try to game the screening criteria to collect compensation. Each potential participant will provide answers to 
the following questions within the Qualtrics screening survey: 
1. What is your assigned sex at birth? 
(if "other": What gender do you identify as?) 
2. How old are you in years? 
3. What is your race/ethnicity? Please select all that apply. 
4. Are you currently pregnant? 
5. Are you currently breastfeeding? 
6. Do you currently live on an American Indian reservation or in an Alaska Native village? 
7. What city do you live in? 
9. In what state do you currently reside? 
To be eligible for Native WYSE CHOICES, they must be: Biologically female, 16-20 years old, American 
Indian or Alaska Native (may identify with other races), not pregnant or breastfeeding, not living on a 
reservation, and living in an urban area (population >= 50,000). Because we do not yet have approval from 
the Native Alaska organization with oversight in Anchorage (the only Alaskan city to meet population size 
requirements), we will exclude Alaskan residents. Once a participant meets all eligibility criteria in the first 
part of the screener questions, they will be asked to enter their first name, cell phone number, email 
address, a second email address (optional) and birth month and year. The completed eligibility data are 
reviewed by a team member who will also check city population size. If all appropriate eligibility data 
are selected and the city named has a population of 50,000 or more, the participant is identified as 
“tentatively eligible.” At this point, a member of the research team will reach out up to 4 times to confirm 
eligibility through a phone call or a text (for those youth uncomfortable with a phone call) by asking the 
respondent to confirm their name, birth month and year, city and state, and email address. This 
confirmation is short but provides an important opportunity to screen out frauds.  
 
Obtaining informed consent. Preliminary conversations with our university IRB have confirmed that, like our 
other projects, this project will also likely qualify for a waiver of parental consent for minors, based on minor 
participants’ ages (16-17) and the sensitive nature of the topic wherein participants may incur risk if 
participation is disclosed to a parent. Participants will be asked to consent to project participation as adults. 
During the consent process, participants can contact the project team with any questions or concerns. The 
consent process will describe the 2 arms of the study and let them know that after they complete the 
baseline survey, their assignment to a particular arm will be random.  After reading the consent, 
participants will be asked follow-up questions to verify comprehension. 
 
Consent 
Once the identity is confirmed, the respondent will be sent a unique link (exclusive to that participant) to the 
consent. Once they have read the consent (which they can scroll up or down for review) they will be asked 
to electronically sign the form in a signature box if they consent. The participant can take as long as they 
would like to review the consent or discuss with others. They are able to click on the consent link at a later 
time if they want to think about their participation. If they consent, we will ask them to write or type their 
name indicating they agree to an electronic signature and that they consent. We include as a part of the 
consent that they can take a screenshot or video screen recording of the signed consent form for their 

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records, or they can request a copy be sent to them by email or USPS. We will ask them for a mailing 
address (optional, unless they request a USPS-delivered signed consent), and social media handles. 
These latter contact data are helpful as backup for multiple options to contact participants over the course 
of the 12 month study should cell number and email no longer work. If they do not consent, they will not be 
able to participate in the study. 
The contact information and consenting signature will be stored in a secured database separate from 
survey data, and accessible only by project staff. 
 
 
Assignment methods. Once recruited and consented, 
eligible AIAN young women will complete the 
baseline survey, and asked to download the NWC 
app.  Once they have done this, the app will 
immediately electronically randomize the participant 
to either NWC or the comparison condition. That is, 
the two interventions are accessed through the same 
app – once the participant registers to download the 
app, she will be randomly assigned one arm or the 
other. Figure 2 shows participant flow through the 
proposed project. 
 
Progression of NWC. Because of the electronic mode of administration, participants can progress through 
each session at their own pace. We will provide electronic reminders if timely progression of the app has 
not been demonstrated.  
 
Counterfactual intervention. We will provide young women in the comparison arm an engaging online 
intervention which is independent of our outcomes of interest.  The focus will be on life skills including 
social media safety, budgeting, resume building, and career development.   
 
Participant tracking methods.  Participant tracking involves two sets of processes.  The first is through 
screening and enrollment and then survey completion.  The second centers on downloading the app and 
progression through the other surveys in a timely way.  1) On the screening survey, once participants are 
considered eligible, they will be required to provide their name, phone number, birth month and year, email 
address, and a second email address (optional).  A second email is useful to keep in contact participants in 
case a primary email is closed.  Once a participant has been determined eligible and has read and signed 
the consent form, we also request mailing address and social media handles, again, useful contact 
information to track participants over time since at this young age, contact information can change 
frequently. 2) During the registration process for the app, participants use an email address to register (the 
registration email is the link to the survey data, to track which participants downloaded and engaged in the 
app).  Through the intervention stage, progress in NWC will be tracked electronically. We will send 
reminders to young women who have not completed a survey in a timely way (we allow 2 weeks).  We will 
follow up with personal texts, emails, phone calls, or private social media contacts provided, up to 4 times, 
as necessary. 
 
Fidelity. Since intervention content will be administered electronically, we anticipate full fidelity. We expect 
full adherence, and we will be able to monitor closely progress towards this goal. However, we will track 
occurrences of technological challenges (e.g., lost devices, or navigational issues), or other unanticipated 
events with respect to the intervention content delivery.  
 
Post-intervention follow-up retention plans. After the intervention, when surveys are months apart and risk 
of attrition is high, we have integrated additional retention plans. Every two months, we will offer a small 

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incentive (e.g., $10 gift card) to participants who confirm their contact information.  
 
Throughout the project, we will use electronic data to monitor study participation. As data are accrued 
across the rolling sample, we will use electronic data to monitor sample intake, responses rates, and 
baseline equivalency.  
 
RCT timing. Recruitment will begin PY3 (see “Timeline,” below). We anticipate a rolling recruitment across 
2 years. This roll-out will allow sampling strategy adjustment as needed.  
 
Procedures/modes of data collection. Once IRB approvals are obtained, we will begin implementation. We 
will use the University’s Qualtrics survey system, a HIPAA-compliant and secured software for research 
which can be optimized for smartphones or other devices. As noted above, eligible participants who provide 
consent will be sent a unique URL to complete a baseline survey. Through the tracking software, we will 
issue additional URLs for follow-up surveys at the appropriate time. Participants will be compensated $25 
for baseline and the first post-intervention survey, increasing to $35, $40, and $50, respectively, for each of 
the 3 follow-up surveys. Participants will not be re-consented at each survey point; still, at each survey, 
participants will be reminded that participation is voluntary, and they can decline participation at any time. 
 
Intervention and survey progression. After the baseline survey, participants will be asked to download the 
app using their email and a password, so we can track their registration and ultimately link app use with 
survey data (e.g., to check number of sessions responded engaged in).  We will incentivize the app 
download with a small e-gift card ($10).  Once registered, the app will randomize participants and they can 
immediately begin their first intervention sessions (NWC or counterfactual). Once participants have 
progressed through their respective programs, each will be given an additional small e-gift card ($10), and, 
2 months later, a URL for the first posttest. Similarly, at 6 and 12 months after program completion, each 
will be sent URLs to complete a survey.  
 
We will regularly monitor electronic reports of progress through the intervention (for NWC), and survey 
completion progress for follow-up (both arms). Survey data will be routinely checked by the Data 
Management team for any problems, inconsistencies, or missing data. They will routinely summarize 
response rates for each survey, and by arm. If response rates are low, or unbalanced by arm, Drs. 
Kaufman and Sarche will identify possible causes, their solutions, and quickly implement changes to rectify 
deficiencies.  
 
D. Recruitment 
The primary method of recruitment will be through multiple social media platforms. Specific recruitment 
activities will vary across the platforms, but will typically include posts to promote the program and study. 
We will also use seed recruitment, and encourage AIAN young women participants to invite their peers and 
family members to sign up for the program (i.e., chain referral, up to 3). 
 
We will ask the participants enrolled in the study to follow our page on Instagram, share our recruitment 
post on their Instagram page and tag us in that post. This strategy will amplify our recruitment post among 
their followers (who may be similarly eligible) and encourage participation in our study (as the recruitment 
post will have come from a trusted source). This is completely voluntary and the recruitment post does not 
require participants to disclose any personal health information. 
 
We will also recruit by posting flyers and information throughout locations including AIAN-serving youth 
facilities and college centers (if pandemic conditions allow for this). We also will disseminate recruitment 
flyers via listservs and email networks. Finally, if pandemic conditions allow, we will attend community 
events (e.g., powwows, health fairs), to invite potentially eligible women to enroll by giving them a 

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recruitment flyer with a link to the screener. Recruitment will continue until we have 700 participants 
enrolled. 
 
E. Description, Risks and Justification of Procedures and Data Collection Tools: 
Description Risks and justification:   
As with any electronically based system, our electronic data could be hacked. Thus, potentially 
compromising confidentiality and privacy.  However, we have a strong system in place to guard against 
such possibilities, including the use of University-sanctioned electronic data collection systems.  Further, 
any data stored on university servers (in locked rooms) will be accessible only by password and 
usernames, and only by research staff.  The justification for using this system is immense.  It offers an 
innovative way to increase research participation by a vastly under-represented population, while also 
providing services that are culturally tailored to individuals who may not otherwise have access to such 
services. 
 
    
F. Potential Scientific Problems:   
The innovative aspects of this project necessitate some uncertainty. The proposed social media recruitment 
and mHealth intervention strategy for AEP have not been used with urban AIAN young women before, 
although similar approaches have been successful with other populations nationally and appear promising 
for adult AIAN women. We do not yet fully know the parameters for targeted recruitment of AIANs in urban 
areas or their engagement with electronically administered interventions, but this study will provide an 
important opportunity to understand them. Other more common caveats also apply. All measures will be 
self-reported without independent verification. Although we will strive for broad national representation and 
cultural diversity of AIAN young women, we cannot guarantee that. Our project is technologically based. 
While this provides great reach and accessibility, we do not yet know if the loss of direct human guidance 
will critically hamper outcomes for this population. We also know that not all urban AIAN young women 
have access to technology. 
 
G. Data Analysis Plan:   
All intervention effectiveness analyses will be based on an intention-to-treat approach. For continuous 
outcomes (frequency/quantity indices of alcohol) and mediational outcomes (alcohol and contraceptive self-
efficacy), we will estimate a series of latent growth curve models (LGCM) in Mplus to assess the effect of 
intervention exposure on the trajectories of those outcomes over the study period.165 The “normative” 
trajectory of an outcome is estimated for the comparison group before estimating the same trajectory 
among those exposed to the intervention. The third step estimates the degree to which the normative 
growth trajectory is altered by intervention exposure. On the fourth and final step, the interaction between 
intervention exposure and pre-intervention status on the outcome is tested. This permits an assessment of 
the differential effectiveness of the intervention as a function of baseline levels of the outcome variable.  
 
For dichotomous outcomes, Latent Markov Models (LMM) will be used to evaluate transitions between 
behavioral states (e.g., sexually active to abstinent) throughout follow-up.166,167 Intervention status is 
modeled as a time-invariant covariate; its effect on the transition probabilities is estimated freely. 
Effectiveness is indicated if those in the intervention have significantly lower probabilities than the controls 
of transitioning out of the abstinence state and significantly higher probabilities of transitioning out of the 
sexually active state. LMM may also reveal that early sexual experience among control group participants 
predicts sexual activity across the course of the study but that this relationship is interrupted among 
intervention participants. Other moderators of intervention effectiveness will also be explored (e.g., 
enculturation). 
 
H. Summarize Knowledge to be Gained:   
If successful, the overall study will generate evidence of NWC effectiveness for AEP prevention by 
demonstrating: 1) increased effective contraceptive use or sexual abstinence among urban AIAN young 

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women; 2) decreased or eliminated alcohol use in urban AIAN young women who drink; and 3) maintained 
abstinence (sexual or alcohol) among those who have this as their goal. If successful, the project will also 
provide vital information about the feasibility of mHealth interventions for reaching urban AIAN young 
women or other urban AIAN populations who might otherwise not access health information or 
interventions 
 
I. Supplement Award 
 
At the end of July, 2021, we were awarded NIAA supplemental funds to the current grant to conduct 
qualitative interviews with participants enrolling in our ongoing social/behavioral RCT. The supplement 
funds us to conduct phone or video (i.e., Zoom or similar) interviews with a sub-sample of enrolled 
participants about the impact of COVID on behaviors related to alcohol exposed pregnancies.  We will not 
be conducting the interviews at this time; instead, with this consent change requested in this amendment, 
we aim to grow the pool of potential respondents immediately. 
 
J. Background and Specific Aim 
 
The devastating impact of COVID-19 on American Indian and Alaska Native (AIAN) communities has been 
well-documented,168-170 with substantial focus on reservation or other tribal land-based communities, often 
rural and remote.171,172 However, more than 72% of AIANs reside in urban settings,173 a majority of the 
racial group, but a small fraction – often less than 1% - of most urban communities.  Many urban AIANs are 
tightly connected to tribal communities and cultural practices,174 commonly traveling between urban areas 
and tribal reservation communities to participate in family events or important cultural celebrations and 
ceremonies.  However, urban AIANs are likely to experience different cultural, social, and economic 
impacts of the pandemic compared to AIANs living in tribal reservation settings175– and those differences 
may be critical to alcohol-exposed pregnancy (AEP) risk.  Early pandemic-related data in the general 
population indicate increased alcohol use by youth176,177 and decreased access to effective contraception 
among women.178  This combination is likely to increase AEP risk, and for urban AIAN young women – 
often with limited local resources – that risk may be especially elevated.  Yet, as research moves quickly to 
monitor pandemic-related risk among the most vulnerable, this small demographic is rarely considered.179  
We know little about the impact of COVID-19, the changes in alcohol use, sexual activity, or contraceptive 
use to assess AEP risk among young urban Native women.  Similarly, we know little about the ways in 
which they find resilience and strength in their communities to overcome pandemic hardships or to engage 
in the promise of vaccines. 
 
We will conduct in-depth interviews with participants purposively selected based on baseline survey 
responses.  To maximize insights in the diversity of experience of the pandemic and gain timely, in-the-
moment, insights, we will recruit and interview young women from our RCT sample (n=32) over 2 years. 
We will also interview selected participants (n=8) at regular intervals over 2 years to capture their 
experiences longitudinally as circumstances of the pandemic shift. With this qualitative design – i.e. cross-
sectional insights complemented by a longitudinal view of urban AIAN young women’s journey through the 
changing circumstances – we will be able to integrate our statistical findings within an agile interpretive 
frame.  Across two years of data collection and analysis, we propose the following supplemental aims to 
the parent grant: 
 
 
Supp SA:  Contextualize patterns of drinking, sexual activity, and contraceptive use among urban 
AIAN young women during the evolving pandemic through cross-sectional and longitudinal in-
depth interviews.   
 
 

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Completion of the supplemental aim will provide critical insights to inform policies and interventions to 
address AEP risk in this vulnerable yet resilient population under evolving pandemic conditions – including 
an unfolding recovery from the pandemic.  Incorporating this work into a randomized trial will amplify 
evidence of vulnerability and resilience, and provide context for the efficacy of the culturally tailored 
intervention we are testing.  As repercussions of the pandemic persist, we will need more than just 
behavioral assessments; appropriate strategies to prevent AEP will require contextual and pandemic-
specific parameters.   
 
K. Supplement Study Design and Research Methods 
We will conduct both longitudinal and cross-sectional In-Depth Interviews (IDIs) to capture the depth and 
breadth of urban AIAN young women’s behavior, experience and perceptions during the next phases of the 
pandemic. Longitudinal IDIs will be conducted with the same 8 participants every 6 months over a 24-
month period (i.e. 4 interviews per participant) to allow for an in-depth exploration of pandemic response 
and recovery and implications for AEP risk. While these longitudinal IDIs will provide a depth of 
understanding, cross-sectional interviews with different participants each time will increase the breadth of 
understanding. Cross-sectional IDIs will therefore be conducted with 8 different participants every 6 months 
over a 24-month period for a total of 32 unique interviews (i.e. 8 interviews per period).        
 
IDI participants will be invited to reflect on questions about the family, peer, and/or partner influence on, as 
well as the broader environmental context of, their drinking, sexual activity and contraceptive access and 
use.  Participants will be asked how they perceived changes in their personal choices in these areas over 
the course of the pandemic, including pandemic conditions at the time of the interview. In addition, 
participants will also be asked about their community’s and their own pandemic-related safety practices 
(mask wearing, social distancing, vaccination interest), and how the pandemic has shaped their 
employment and educational opportunities or aspirations.  Finally, participants will be invited to talk about 
resources, including cultural ones, that were instrumental in supporting them through the pandemic.   
 
The IDIs will last approximately 1 hour. All the interviews will be conducted over phone or video (over 
Zoom) depending on the technological bandwidth of participants and will be recorded.  
The recording will be safely stored in the University's password protected server. Only Native WYSE 
CHOICES project staff will have access to the audio file. The audio recordings will be destroyed on a 
timeline in accordance with NIH policy on data destruction. 
 
L. Supplement Recruitment 
IDI participants will be sampled purposively from our pool of existing RCT participants. Through this 
amendment our consent form will allow participants to endorse interest in an IDI; for those endorsing 
interest, we will invite participants based on their baseline answers to questions on drinking, sexual activity 
and contraceptive use, but also other experiences in the pandemic – for example, housing, work, or 
educational experience, vaccine beliefs and experiences, or personal experience of the disease. 
 
Our project staff will send out a Qualtrics survey asking interested participants if they would like to 
participate in the IDIs. Participants will be randomly selected and will be given an option to either participate 
in cross-sectional or longitudinal IDIs.  This process will continue until we meet the threshold of 8 
participants for each format of IDIs. Once this process is completed, our project staff will set up time for the 
IDIs. Participants will have an option for conducting interviews over telephone or over zoom depending on 
their technological bandwidth. The IDIs will be audio recorded. At the end of the interview, participants in 
the longitudinal interviews will be asked to set up a time/date for the next interview. Cross-sectional IDI 
participants will be thanked for their participation. Additionally, we will resume the same recruitment 
process for cross-sectional IDIs every 6 months for next 24 months. Participants will receive $40 in amazon 
gift card at the completion of each interview.   
 

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M. Supplement Data Analysis 
IDI recordings will be deidentified, transcribed, and analyzed using NVivo.  Two coders familiar with the 
study will code the data to maintain reliability and methodological coherence of the qualitative data. We will 
use a combination of inductive and deductive coding approaches. The primary coder will begin by carefully 
analyzing the transcripts through the process of inductive or open coding. This process allows the primary 
coder to code data, categorize the codes, and reorganize the categories thematically. Next, the secondary 
coder will code the transcripts utilizing the major themes. In addition, the secondary coder will also look for 
additional emergent themes. To ensure the reliability of the findings of the study, both coders will discuss 
emergent themes with the study lead. Kappa scores for each theme will be calculated to assess interrater 
reliability. 
 
N. Supplement Description, Risks and Justification of Procedures and Data Collection Tools: 
Description Risks and justification:   
As with any electronically based system, our electronic data could be hacked. Thus, potentially 
compromising confidentiality and privacy.  However, we have a strong system in place to guard against 
such possibilities, including the use of University-sanctioned electronic data collection systems.  Further, 
any data stored on university servers (in locked rooms) will be accessible only by password and 
usernames, and only by research staff.  The justification for using this system is immense.  It offers an 
innovative way to increase research participation by a vastly under-represented population, while also 
providing services that are culturally tailored to individuals who may not otherwise have access to such 
services. 
 
O. Supplement Potential Scientific Problem 
For the IDIs, we are drawing participants from the existing pool of RCT participants. While the IDIs focus on 
participants who are at-risk for AEP, the RCT includes participants who are not at-risk for AEP. Therefore, it 
is possible to not have a sufficient number of participants who are at-risk for AEP in our pool of RCT 
participants limiting our chance of adequately recruiting enough participants for the IDIs. 
 
P. Supplement Summarize Knowledge to be Gained: 
If successful, the supplement will provide us with a greater contextual understanding around patterns of 
drinking, sexual activity and contraceptive use among urban AIAN young women during the evolving 
COVID-19 pandemic. 
 
 
References: 
 
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