We Are Here Now: a Multi-level, Multicomponent Sexual and Reproductive Health Intervention for American Indian Youth
Phase: NA
Conditions: Reproductive Behavior, Sexual Behavior
Sponsor: Montana State University

 
 
 
 
 
 
 
 
 
 
COVER LETTER 
 
 
 
Official Title of Study: Nenunkumbi/Edahiyedo ("We Are Here Now"): A Mult-level, Multi-component 
Sexual and Reproductive Health Intervention for American Indian Youth 
 
NCT number: 03694418. 
 
This manual of operations was created on February 1, 2019.  
 
Nenunkumbi/Edahiyedo ("We Are Here Now"): A Mult-level, Multi-component Sexual and Reproductive 
Health Intervention for American Indian Youth was funded by the National Institute of Minority Health 
and Health Disparities, Grant Number R01MD01271. Our NCT number is: 03694418.  
 
This document contains the following: 1) study summary; 2) study protocol; 3) analysis plan; 4) study 
intervention administration of data collection; 5) selection and enrollment of participants; 6) human 
subjects; 7) data safety monitoring plan; 8) revision history; and 9) appendices.  
 
Institutional Review Board Approval was received from Montana State University on February 5, 2018 
and from the Fort Peck Tribes on October 29, 2018. These IRB approvals as well as subsequent IRB 
modification requests due to the COVID 19 pandemic are in the appendices. Updated IRB approvals 
from Montana State University (11.06.20- 5-year renewal timeline) and the Fort Peck Tribes (11.02.23 -
yearly renewal timeline) were included in the appendices on 9.25.24.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
Nenunkumbi/Edahiyedo ("We Are Here Now"): A Mult-level, Multi-
component Sexual and Reproductive Health Intervention for American Indian 
Youth 
 
 
Principal Investigator 
 
Elizabeth Rink PhD, MSW 
Associate Professor 
Department of Health and Health Development 
Montana State University 
Bozeman, Montana 
Email: elizabeth.rink@montana.edu 
 
 
Supported by: 
 
The National Institute of Minority Health and Health Disparities 
National Institute of Health 
Grant Number: R01 MD012701 
 
 
Study Intervention Provided by: 
 
Nenunkumbi/Edahiyedo ("We Are Here Now") is an equitable collaborative community- 
academic partnership grounded in trust, respect, mutual understanding and a commitment to 
improving the lives of young people and their families on the Fort Peck Indian Reservation. 
Nenunkumbi/Edahiyedo ("We Are Here Now") is implemented by: Fort Peck Community 
College, the Fort Peck Tribes Language and Cultural Department, the Fort Peck Tribal Health 
Department, the school districts of Frazer, Wolf Point, Poplar, Brockton and Culbertson and 
Montana State University. 

TABLE OF CONTENTS 
 
 
SECTION 1: STUDY SUMMARY 
Page 2 
 
 
 
SECTION  2: STUDY PROTOCOL 
Page 2 
 
 
 
 
SECTION 3: ANALYSIS PLAN 
Page 8 
 
 
 
 
SECTION 4: STUDY INTERVENTION ADMINISTRATION 
OF DATA COLLECTION 
 
 
 
 
SECTION 5: SELECTION AND ENROLLMENT OF PARTICIPANTS 
 
 
 
 
SECTION 6: HUMAN SUBJECTS 
 
 
 
 
 
SECTION 7: DATA SAFETY MONITORING PLAN 
 
 
 
 
SECTION 8: TOOL REVISION HISTORY 
 
Page 10 
 
 
 
 
Page 13 
 
 
 
 
Page 14 
 
 
 
 
 
Page 20 
 
 
 
 
Page 25 
 
 
 
 
SECTION 9: APPENDICES 
Page 26 

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SECTION 1: STUDY SUMMARY 
 
American Indian (Al) communities in the United States (US) are disproportionately affected by sexual and 
reproductive health disparities, compared to other populations, placing current and future generations of Al 
societies in jeopardy. Our study, "Nen OnkUmbi/EdaHiYedo (NIE - "We are Here Now")", utilizes a culturally 
tailored ecological intervention in which the prevention of sexual-risk behaviors among Al youth that lead to 
STls, HIV, HCV, and teen pregnancy are addressed. N/E takes place on the Fort Peck Reservation in 
northeastern Montana. N/E is a community-based participatory research sexual and reproductive health (SRH) 
intervention, constructed on Ecological Systems Theory. Based on Fort Peck tribal members' desire to 
implement a holistic SRH intervention for the tribes' youth, N/E includes: 1) A school-based SRH curriculum 
called Native Stand, designed to address individual-level factors that lead to risky behaviors; 2) a family-level 
curriculum called Native Voices, tailored to increase communication between adult family members and youth 
about SRH topics; 3) a cultural mentoring component at the community-level that pairs Al youth with adults and 
elders to discuss traditional Al beliefs and practices about SRH; and 4) a systems-level strategy to activate a 
multi-sectoral network of local youth servicing organizations to coordinate SRH services. The overarching aim 
of this proposal is to refine and tailor the components of N/E and evaluate its efficacy. N/E is a 5-year study 
involving 456 15- to 18-year-old Al youth and their parent/legal guardian. 
 
SECTION 2: STUDY PROTOCOL 
 
2.1 Study Team Roster. NIE's tribal community and academic study team combines Indigenous expertise in 
traditional knowledge, contemporary reservation culture, and local tribal resources and skills with Westernized 
research experience in SRH interventions among Indigenous populations and qualitative and quantitative 
research methodologies. The study team members are listed below. 
 
• 
Elizabeth Rink, Ph.D., MSW, at Montana State University (MSU) is the principal investigator (Pl) for 
NIE. Dr. Rink will be responsible for the overall research and fiscal administration, implementation, and 
evaluation of NIE. 
Email: elizabeth.rink@montana.edu 
• 
Paula FireMoon (Sioux), M.A., is NIE's Fort Peck-based Project Director. Ms. FireMoon will oversee 
community participation, including implementation of NIE, and coordination of NIE's research activities 
with tribal schools, health care facilities, and other youth-servicing agencies on the Fort Peck 
Reservation. 
Email: PFiremoon@fpcc.edu. 
• 
Ramey Growing Thunder (Sioux/Navajo), M.Ed., is director of the Fort Peck Tribes' Language and 
Culture Department. Mrs. Growing Thunder will lead the implementation of NIE's cultural mentoring 
program. 
Email: rgrowingthunder@gmail.com. 
• 
Adriann Ricker (Assiniboine), MPH, CHES, is associate director of the Fort Peck Tribes' Health 
Promotion and Disease Prevention Program. Ms. Ricker will increase coordination among, and access 
to, SRH services for Al youth in schools, health care facilities, and youth-servicing agencies at Fort 
Peck. 
Email: adricker@gmail.com. 
• 
Community Advisory Board (CAB) that includes five tribal members. CAB members are: Ingrid 
FireMoon - Email: IFiremoon@fortpecktribes.net, Bruce Bauer- Email: bwbauer@yahoo.com, Olivia 
Johnson - Email: ojohnson@brockton.k12.mt.us; Martel Reum - Email: MReum@fpcc.edu; and 
Alexandria Herrald - Email: alexandria.herrald26@gmail.com. 
• 
Julie Baldwin (Cherokee), Ph.D., director of The Center for Health Equity Research at Northern 
Arizona University, with over 20 years of research expertise in the design, implementation, and 

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evaluation of HIV and substance abuse prevention interventions for Al youth is the study's Co- 
Investigator and senior research mentor to Dr. Rink. 
Email: Julie.Baldwin@nau.edu. 
• 
Mike Anastario, Ph.D., is Co-Investigator and statistician for the study. 
Email: manastar@fiu.edu. 
• 
Rachel Hallum-Montes, Ph.D., an independent contractor who has worked on a variety of national 
teen pregnancy-prevention studies with the CDC will consult on the assessment of the coordination 
and implementation of SRH services for Al youth. 
Email: rhallum.montes@gmail.com. 
• 
Genevieve Cox, Ph.D., NIE's MSU-based research program manager. 
Email: genevieve.cox@montana.edu. 
 
2.2 Study Sites. NIE is implemented on the Fort Peck Reservation in Northeastern Montana. Fort Peck is 
located in a Northern Plains frontier environment and spans 2.1 million acres. It borders the 47½ parallel to the 
north Uust south of the border with Canada), with Big Muddy Creek to the east, the Missouri River to the south, 
and Big Porcupine Creek to the west. Approximately 8,000 enrolled tribal members, predominately from the 
Assiniboine and Sioux Nations, live on the reservation. The Assiniboine and Sioux are descendants of the 
Nakada, Nakata, Nakona, Lakota, and Dakota Nations. The Assiniboine comprise Wadopana (Canoe Paddlers 
Who Live on the Prairie) and Hudashana (Red Bottom) bands, and the Sioux comprise Sisseton/Wahpetons, 
the Yanktonais, and the Teton Hunkpapa bands. NIE will be implemented in the communities of Frazer, Wolf 
Point, Poplar, Brockton, and Culbertson. These 5 communities have public high schools that serve Al students. 
Frazer, Wolf Point, Poplar, and Brockton are on the reservation, and Culbertson is a border town on the east 
end of the reservation that Al youth from the reservation community of Fort Kipp attend (See Figure 1 for map 
of reservation and high schools).
Collaborating entities in NIE are:  
 
• 
Montana State University, 318 Herrick Hall, 
Bozeman, MT. 59715, phone: 406.994.3833, 
Fax: 406.994.2013 
 
 
  
• 
Fort Peck Community College, PO Box 398 
Poplar, MT. 59255, phone: (406) 768-6300, Fax:L
 
768.6301
• 
The Fort Peck Tribes Language and Cultural 
Department, 603 Court Avenue, PO Box 1027, 
 
 
Poplar, MT. 59255, phone: 406.768.3520, Fax: 
406.768.3531. 
. 
• 
The Fort Peck Tribal Health Department, 107 H Street East, PO Box 1027, Poplar, MT. 59255, Phone: 
406. 653.1191, Fax: 406. 768.5780. 
• 
Frazer Public School, 325 6th Street, Frazer, MT. 59225, Phone: 406.695.2241, Fax: 406. 695.2243. 
• 
Wolf Point School District, 213 6th Ave. South, Wolf Point, MT. 59201, Phone: 406.653.2361, Fax: 406. 
653.3405. 
• 
Poplar School District, 400 4th Avenue West, Poplar, MT. 59255, Phone: 406.768.6600, Fax: 
406.768.6800. 
• 
Brockton School District, 215 North 5th Street, Brockton, MT. 59213, Phone: 406.768.3311, Fax: 406. 
786.3377. 
• 
Culbertson School, 423 1st Avenue West, P.O. Box 459, Culbertson, MT. 59218, Phone: 

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406.787.6241, Fax: 406.787.62

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2.3 RESEARCH DESIGN OVERVIEW 
 
2.3.1 Study Title. Nenunkumbi/Edahiyedo ("We Are Here Now"): A Mult-level, Multi-component Sexual and 
Reproductive Health Intervention for American Indian Youth 
 
2.3.2 Study_ Aims. 
 
• 
AIM 1 begins with a year of formative work to refine and tailor the components of N/E. Our community 
advisory board and the Fort Peck-based and MSU-based research team will design culturally 
appropriate adaptations for N/E's 4 levels. 
• 
AIM 2 tests the efficacy of N/E using a cluster-randomized stepped-wedge design (SWD), in which the 
5 high schools that Fort Peck youth attend are randomized into the intervention 1 at a time. N/E's 
primary outcome is increased condom use during sexual intercourse. Secondary outcomes are delayed 
onset of sexual intercourse, number of sex partners, frequency of sexual intercourse, pregnancy 
history, consistent use of birth control during sexual intercourse, and whether alcohol and/or other 
drugs are used during sexual intercourse. Tertiary outcomes are increased parent/legal guardian-child 
communication about SRH topics, increased understanding of cultural values related to traditional Al 
beliefs regarding SRH, and increased use of SRH services. Quantitative data collection includes: 
student surveys at baseline, 3, 9 and 12 months; parent/legal guardian surveys at baseline, 9 and 12 
months. Qualitative data collection includes SRH service provider discussion groups at baseline and 
thereafter once a year over the 5-year study, with logs to track coordination and implementation at 
baseline and 3, 6, 9 and 12 months. 
• 
AIM 3 will evaluate the fidelity and acceptability of N/E with focus groups, activity logs, and staff 
meeting notes and staff field notes. 
 
Our long-term goal is to produce a toolkit, including curriculum manuals, an SRH cultural mentoring program, 
and specific systems-level actions suitable for replication in other tribal communities. The public health 
impact is the prevention of STls, HIV, HCV, and teen pregnancies in Al youth resulting in reduced sexual and 
reproductive health disparities and improved health in Al families and communities. 
 
2.3.3 Design Overview. NIE is a community-based participatory research (CBPR) multi-level, multi- 
component sexual and reproductive health (SRH) intervention, constructed on Ecological Systems Theory. NIE 
is based on Fort Peck tribal members' desire to implement a holistic SRH intervention for Al youth. NIE 
includes: 1) A school-based SRH curriculum called Native Stand, designed to address individual-level factors 
that lead to sexual risk behaviors; 2) a family-level curriculum called Native Voices, tailored to increase 
communication between adult family members and youth about SRH topics; 3) a cultural mentoring component 
at the community level that pairs Al youth with adults and elders to discuss traditional Al beliefs and practices 
about SRH; and 4) a mobilizing strategy to activate a multi-sectoral network of youth-servicing organizations at 
the systems level in Fort Peck to coordinate SRH services for Al youth. The overarching aim of this study is to 
refine, tailor, and finalize the components of NIE and evaluate its efficacy. We will use a cluster-randomized 
stepped-wedge design (SWD), in which 5 schools that Al youth from Fort Peck attend are the clusters to be 
randomized into the intervention 1 at a time, with all schools eventually being randomized to the intervention. 
The 5 schools are located in separate communities, mitigating the potential for cross-contamination. NIE is a 5- 
year study involving 456 15- to 18-year-old Al youth. 

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2.3.4 Intervention Design. NIE is a 5-year CBPR ecological intervention for 456 15- to 18-year-old Al youth 
living on the Fort Peck Reservation. Nen OnkUmbilEdaHiYedo ("We Are Here Now") derives from the 
Assiniboine (Nen OnkUmbt) and Sioux (EdaHiYedo) names for their traditional coming-of-age ceremonies, 
when, at the age of 15 and over, young tribal members are believed to be ready for integrated education and 
training on sex, what it means to be a man or a woman, relationships, having children, and being a parent. NIE 
is guided by a 5-member CAB. The primary institutional partners responsible for the implementation of NIE are 
Fort Peck Community College (FPCC), the Fort Peck Tribes Language and Culture Program, the Fort Peck 
Tribal Health Department (Epi Team)1, and MSU. 
 
NIE will be implemented simultaneously over the 9-month school year (Table 1). Components include: 1) 
Individual Level. Native Stand is a school-based, 27-module STI-, HIV-, and teen pregnancy-prevention 
curriculum, originally developed for rural white youth and adapted in 2008 as a stand-alone SRH curriculum for 
Al youth. For NIE, an adaptation of Native Stand will be implemented in the study's 5 high schools to educate 
Al youth on sexual risk behavior prevention strategies. The tailoring of Native Stand will reduce its 27 modules 
to 18 modules and will include specific community-relevant traditional and contemporary cultural lesson plans. 
Native Stand will be integrated into each of the 5 schools' established curriculum and will be delivered by the 
NIE School Coordinator in a classroom setting as part of the students' regular class schedule. 2) Family Level. 
Native Voices is a video-based HIV/STl-prevention intervention designed for Al youth to address condom use, 
negotiation skills, group discussion, and role playing. Native Voices will be adapted from 1 module into 4 
modules to involve parents/legal guardians, as recommended by the CDC. Our adaptation of Native Voices 
involves students with one of their parents/legal guardians to promote parent/legal guardian/youth discussions 
about preventing STls, HIV, HCV, and teen pregnancy. The NIE School Coordinator will present Native Voices 
to groups of students and their parents/legal guardians at the study's high schools for 2 hours in the evening. 
3) Community Level. The third level of NIE is a cultural mentoring component that pairs Al youth with older 
adults and elders to discuss traditional Al beliefs and practices about reproductive health. The mentoring 
program is based on Assiniboine and Sioux traditional knowledge and the National Mentoring Partnership 
standards for mentoring. The mentoring program was designed specifically for Fort Peck youth by the Fort 
Peck Tribes' Language and Culture Department and has been in existence for 5 years. NIE integrates this 
cultural mentoring program into NIE's overall framework with an emphasis on addressing traditional topics 
related to SRH, such as overall information on cultural beliefs, values, and ceremonies, and more specific 
information on cultural beliefs and values regarding sex, having children, parenting, and relationships. Our 
cultural mentoring program will include older male and female tribal members who will be paired with the youth 
by gender and tribal affiliation. Al youth will meet one-on-one with their mentors each month and also monthly 
in mentor-mentee small groups. Depending on the purpose of the cultural mentoring sessions, the sessions will 
take place at either the study's high schools, the Fort Peck Language and Culture Department's main office in 
Poplar, community centers on the reservation, or at the Buffalo Ranch. Ramey Growing Thunder will oversee 
the implementation of the cultural mentoring program. 4) Systems Level. The fourth level of NIE mobilizes the 
existing Epi Team to enhance the coordination and implementation of SRH services at Fort Peck. The 
members of the Epi Team will utilize the recommendations in the CDC's Contraceptive and Reproductive 
Health Services for Teens: Evidence-based Clinical Best Practices Guide to enhance the coordination and 
implementation of SRH services for Al youth. This enhancement process will take place during the Epi Team's 
monthly meetings at the Fort Peck Tribal Headquarters in Poplar by developing a coordination and monitoring 
plan that can be tracked over time to address the barriers, facilitators, and solutions to increase access to SRH 
 
1 Fort Peck Tribal Epidemiology Team (Epi Team), which is a local committee that has been in existence for 15 years to monitor 
diseases on the reservation and the health status of tribal members. The Epi Team is comprised of the Fort Peck Tribal Health  
Department; the Indian Health Service (Poplar Service Unit and Wolf Point Service Unit); the Roosevelt County Health Department; 
school nurses from the Fort Peck Health Promotion and Disease Prevention Program; the high schools of Frazer, Wolf Point, Poplar, 
Brockton, and Culbertson; and the Fort Peck Tribal Executive Board. 

 
Nenunkumbi/Edahiyedo ("We Are Here Now''): A Mult-level, Mu/ti-component Sexual and Reproductive Health 
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•
services for Al youth at Fort Peck. Dr. Rink, Ms. FireMoon, Ms. Ricker and Dr. Cox will attend the Epi Team's 
monthly meetings to work in partnership to implement NIE's systems-level component. 
 
 
2.3.5 
Trial Design. 
Our selection of an SWD to 
evaluate NIE is consistent 
with tribal members' desires 
that all 15- to 18-year-old Al 
youth receive the 
intervention. The SWD is  a 
cluster-randomized trial,  
which  involves random and 
sequential crossover of 
clusters from control to 
intervention until all clusters 
are exposed to the 
intervention. 5 29
l . The first 
observation period 
corresponds to a baseline 
measurement observation, 
in which none of the 
clusters have been 
randomized to NIE. 
Clusters are randomized to  
NIE at subsequent  steps  
until all clusters have 
completed treatment. Following randomization of the schools to the intervention, there will be three 
waves of implementation: Wave 1 (1 school in 2019), Wave 2 (2 schools in 2019-2020), and Wave 3 (2 
schools in 2020-2021). The 5 schools on the Fort Peck Reservation will be the clusters that are randomized to 
NIE. NIE will take approximately 40 weeks, or 3 quarters, to implement. The first observation period (Q4 of Year 2) 
provides baseline measurements for all respondents drawn from every cluster.  The cluster is then surveyed at 3, 9, 
and 12 months for the  students  in the  cluster  once  they  have  begun participation in the intervention, and at 9 
and 12 months for the parents/legal guardians in the cluster once they have begun participation in the intervention. 
Following completion of the intervention across all clusters, we will conduct the quantitative analysis. The SWD 
allows us to control for the effect of time and ensure that the full Al population of schools at Fort Peck receives NIE. 
The systems-level component of NIE will be implemented reservation-wide rather than school-wide during Years 2 
to 4 of NIE as the SWD is rolled out. The systems level component will be measured and analyzed qualitatively. 
 
2.3.6 Trial Timeline. The timeline for NIE is: Year 1-Refine, tailor, and finalize the components of NIE with 
the CAB by reviewing our current quantitative and qualitative data from Fort Peck and by talking with elders 

 
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and community stakeholders. We will have monthly team meetings and quarterly CAB meetings. When 
necessary, we will meet with CAB members individually. We will also recruit, hire, and train staff in Native 
Stand and Native Voices; identify the cultural mentors; purchase all necessary materials and supplies; finalize 
research protocols and IRB approvals. Years 2, 3, and 4- Collect baseline data; Implement NIE; conduct 
quantitative and qualitative data collection; conduct ongoing fidelity and acceptability data collection; and 
continue monthly team meetings and quarterly CAB meetings. Year 5-Finish data collection; conduct data 
analysis; work with CAB on interpretation of data analysis; develop sustainability plan; develop intervention 
toolkit; and disseminate results to scientific, professional, and Fort Peck communities. See Appendices for NIE 
timeline. 
 
2.3. 7 Sample Size and Population. NIE's sample size is 456 Al male and female youth ages 15 to 18 years 
old. The population of Al youth 15 to 18-year-old attending the five schools participating in the study is 
approximately 617. 
 
2.3.8 Study Background and Rationale. Comprehensive national surveillance data on SRH among Als is 
difficult to assess due to the underrepresentation of Als in national surveys. The data on Al SRH in the United 
States that are available demonstrate that Als are disproportionately affected by adverse conditions 
attributable to SRH, compared to other populations. Al youth report earlier onset of sexual intercourse than 
other adolescent populations in the U.S. The teen birth rate among Als is 2 to 3 times higher than that among 
Caucasians. In addition, the rates of pre-term birth and low birth weight are much higher in Als compared to 
Caucasians. STls are up to 4.6 times higher for Al males and females compared to Caucasians, with young Al 
males having the highest chlamydia rates of any racial- and age-specific population in the U.S. As a result, Al 
females have higher rates of miscarriages and ectopic pregnancies than Caucasian females and are at risk for 
infertility. For Al males, STls can lead to urethritis, epididymitis, and prostate cancer, which is higher in Al men 
than all other racial and ethnic males in the U.S. In addition, the costly and burdensome health consequences 
of Al youths' high STI rates include infection with HIV and HCV. The incidence of HIV in Al males and females 
is 30% higher than in Caucasian males and females, and in recent years Als are the only racial and ethnic 
group in which the incidence of HIV continues to rise. Furthermore, of all population subgroups in t he U.S., the 
incidence of HCV is highest in Als. At present no extant multi-level, multi-component intervention has been 
shown to be efficacious in addressing SRH among Al youth. The majority of Al interventions appearing in the 
peer-reviewed literature instead focus on alcohol and substance use reduction. Thus, a critical need exists to 
address the SRH disparities among Al youth, which place current and future generations of Al societies in 
jeopardy. 
 
The literature related to SRH among Al youth identifies poverty, isolation, alcohol and other drug use, physical 
and sexual victimization, and lack of comprehensive and coordinated SRH education and clinical services as 
factors that influence unintended pregnancies and STls. Evidence also suggests that ambivalence toward sex, 
social pressures, depression, anxiety, and experiences of historical trauma and loss influences sexual risk 
behavior among Als. Mistrust of research and researchers continues in Al communities due to a legacy of 
neglect and betrayal by the U.S. government and by researchers from outside their communities. This mistrust 
impedes the cooperation between tribal communities and academics to design, implement, and evaluate 
effective interventions to address SRH disparities among Al youth. 
 
The complex factors that influence sexual risk behaviors among Al youth warrant novel Al community-specific 
interventions. Previous research with Al youth on SRH has lacked an ecological design and implementation, 
and it has neither addressed nor leveraged the interconnectedness of the individual, family, community, and 
larger systems in preventing STls, HIV, HCV, and teen pregnancy. Furthermore, CBPR, which has become an 
established methodological framework for partnering with Al communities to conduct research, has been 
sparsely applied to understanding and addressing Indigenous SRH. CBPR has the potential to facilitate the  

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implementation and evaluation of an ecological intervention in Al communities, particularly given its amenability 
to multi-sectoral and multi-level stakeholder involvement in the research process. 
 
SECTION 3: ANALYSIS PLAN 
 
3.1.1 Power analysis. Sample size requirements were calculated taking into account a unique design effect 
for the SWD,2 such that Nsw = Nu x DEsw (where Nu is the total number of students needed to detect the 
treatment effect with a power of 80% and a significance level of 0.05, uncorrected for cluster and repeated 
measurements). The design effect was calculated as: 
 
𝐷𝐸𝑠𝑤= 1 + 𝜌(𝑘𝑡𝑛+ 𝑏𝑛−1)
1 + 𝜌(1
2 𝑘𝑡𝑛+ 𝑏𝑛−1)
× 3(1 −𝜌)
2𝑡(𝑘−1
𝑘)
 
 
where k is the number of steps, n is the expected number of students per cluster, b is the number of baseline 
measurements, t is the number of measurements after each step, and p is the intra-class correlation 
coefficient, estimated to be 0.016 based on findings reported by Kaufman et al. 3 With anρ of 0.05, power of 
0.8, Nu = 292, DEsw = 1.3273, and the expectation of 15% attrition during the study, a sample size of 456 will 
allow the detection of a 0.14 increase in the proportion of condom use relative to the frequency of sexual 
intercourse from baseline to the 12-month observation period hypothesized under Aim 2. 
 
3.1.2 Missing data. Attrition is likely to covary with truancy, suggesting a missing data mechanism that is not 
missing at random (NMAR). To address this, a dropout variable Di will be developed for each individual across 
the 4 observation periods, where Di=k for dropout between the (k-1/hand kth occasion. A model of th 
log {
(Pr⁡(𝐷𝑖=𝑘
(Pr⁡(𝐷𝑖>𝑘|
𝐷𝑖≥𝑘,𝑌𝑖1,…,𝑌𝑖𝑘)
𝐷𝑖>𝑘,𝑌𝑖1,…,𝑌𝑖𝑘)}= 𝜃1 + 𝜃2𝑌𝑖𝑘−1 + 𝜃3𝑌𝑖𝑘 presumes that 𝜃3 ≠0⁡for the NMAR mechanism. Missing data 
will be examined using multiple imputation, where missing values are replaced by a set of m plausible values 
using a propensity scoring sequence to generate a single estimate of the parameters of interest. 4 
Observations will first be grouped on the basis of propensity score similarity, then individuals with missing 
values will be randomly matched to those with observed values, and finally missing values will be randomly 
selected with replacement from the random sample of observed values. This sequence will be repeated 
sequentially starting at the 3-month follow-up observation through the 12-month follow-up observation, and the 
entire propensity scoring and time imputation sequence(s) will be repeated at minimum across 2::5 datasets (m) 
to estimate 𝛽̅ =
1
𝑚∑
𝛽̂(𝑘)
𝑚
𝑘=1
. Sensitivity analyses will also be used to assess the robustness of primary results 
attributable to missing data by examining imputed and nonimputed data. 
 
3.1.3 Dose. The treatment dose is the number of intervention components delivered to the individual student, 
accounting for individual students' attendance and participation. This will be tracked using the fidelity log, staff 
field notes, and the CAB meeting. A count, nominal, or weighted percentage will be used to represent dose 
pending analysis of the dose frequency distribution. 
 
3.1.4 Baseline data analysis. Baseline data will first be analyzed to determine whether demographic and SRH 
variables vary relative to school (cluster). The psychometric properties of scales will be explored, and 
confirmatory factor analyses (CFA) for scales will be conducted. Finally, structural equation models (SEM) will 
 
2Woertman W et al. Stepped wedge designs could reduce the required sample size in cluster randomized trials. J Clin Epidemiol. July 2013;66(7):752-758. 
3 Kaufman C et al. Effectiveness of Circle of Life, an HIV-preventive intervention for American Indian middle school youths. Am J Public Health. June 2014; 104(6):e106-e112. 
4 Fitzmaurice G, Laird N, Ware J. Generalized Linear mixed effects Models in Applied Longitudinal Analysis. Hoboken, NJ: John Wiley & Sons Inc.; 2004. 
 
 
 
be developed based on the multi-level components derived from the Ecological Systems Theory model 
probability of dropout, where 

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upon with the N/E was built. CFAs and SEMs will be conducted using Mplus software. 
 
3.1.5 Randomization of schools. The 5 schools that Al youth from Fort Peck attend are the clusters to be 
randomized into the intervention, with all schools eventually being randomized to the intervention. Students 
and their parents/legal guardians will be recruited for baseline participation prior to randomization of the sites. 
Schools will be randomized to the intervention following baseline data collection using a single sequence 
random assignment to clusters that will determine order of intervention receipt.5 
3.1.5 Generalized linear mixed-effects models. To test for effectiveness of the NIE intervention across all 
hypotheses under Aim 2, the generalized linear mixed-effects models (GLMM) will be used to model binary 
primary and secondary outcomes (condom use under H1, condom use and other sexual risks under H2) and 
continuous tertiary outcomes (H3) in the data. The GLMM allows for individual-level binary and continuous 
responses to be modeled, key covariates to be controlled for, the specification of autocorrelation within 
individuals, and clustering by school. The GLMM is also the most frequently employed analytic method to 
adjust for the longitudinal nature of SWDs,6 and it was chosen over the Generalized Estimating Equations 
(GEEs) because GEEs show inflated Type 1 error rates when the number of clusters is small, as is the case 
with the number of schools at Fort Peck. Hussey and Hughes proposed a mixed-effects regression approach 
for the SWD-CRT design,7 where: 
Yijl = 𝜇+ 𝛽𝑗+ 𝜃𝑋𝑖𝑗+ 𝑢𝑖+ 𝑒𝑖𝑗𝑙, and where 𝑢𝑖~𝑁(0, 𝜎𝑢2);⁡𝑒𝑖𝑗𝑙~𝑁(0, 𝜎𝑒2),⁡ with 𝛽𝑗=the fixed effect of time, 
𝑋𝑖𝑗=intervention (0,1 or dose representation), 𝜃 =intervention effect, 𝑢𝑖=random effect for cluster, and 𝑒𝑖𝑗𝑙=residual 
for i clusters, j time periods, and l adolescents. Yijl will be modeled for SRH outcomes and interpreted in terms of a 
contrast of the log odds of response relative to AI youths with similar values for unobserved random effects. In order 
to test for changes in the tertiary outcomes, we will specify Yijl as continuous response outcomes. STATA statistical 
software will be used to conduct GLMMs. However, SAS will be used if more complex specification of the intraclass 
correlation becomes necessary. 
 
3.1.6 7 Analysis of focus group data. Focus group data will be transcribed and coded using a partially 
inductive procedure. First, all transcript data will be open coded (line-by-line coding). The open codes will be 
pre-sorted based on whether participants are responding to acceptability or fidelity prompts. Within each 
implementation domain, axial codes will be developed to group the open codes, and the team will meet to 
discuss how axial codes saturate the pre-defined acceptability and fidelity categories. Transcripts will be coded 
using Atlas.ti software. 
 
3.2 Qualitative Data Analysis. The systems level component and the FAS evaluation component of N/E will 
be analyzed using content analysis. Common themes will be identified from the two respective sets of data 
collection instruments. Coding will proceed in stages. A topical indexing scheme will be developed with input from 
the community advisory board members to identify the text pertaining to particular topics relevant to the systems 
level and FAS components of N/E. The software program, Atlis.ti will be used to construct and organize a topical 
indexing system of codes identifying sections of text that capture the central concepts of interests. Then, content 
coding will be developed by the research team with advice from the community 
5 Esserman D, Allore HG, Travison TG. The Method of Randomization for Cluster-Randomized Trials: Challenges of Including Patients with 
Multiple Chronic Conditions. International journal of statistics in medical research. 2016;5(1):2-7. doi:10.6000/1929-6029.2016.05.01.1. 
6 Barker D, McElduff P, D'Este C, Campbell MJ. Stepped wedge cluster randomized trials: A review of the statistical methodology used and available. 
BMC Med Res Methodol. 2016;16:69. 
7 Hussey M, Hughes J. Design and analysis of stepped wedge cluster randomized trials. Contemp Clin Trials. February 2007;28(2):182-191 

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advisory board to capture the content, themes, or sentiment of responses within topics. The community 
advisory board members will receive copies of the content coding and the content, themes, and sentiment of 
responses for each of the themes identified in the qualitative data collection forms. Members of the research 
team, including the community advisory board, will individually identify themes from all text pertaining to a 
specific topic are related to N/E's AIMS 2 and 3 in order to then assist the research team in developing codes 
to be analyzed using Atlis.ti. The codes will be reviewed and approved of by the community advisory board 
prior to analysis. The coding reliability for the content coding will be determined through check coding of at 
least 20% of the randomly chosen text within major topical categories. Once the data are coded, the themes 
and patterns will be summarized and interpreted. Coded text will be used to identify illustrative quotes from the 
qualitative data collection materials. 
 
SECTION 4: STUDY INTERVENTION ADMINISTRATION OF DATA COLLECTION 
 
NIE is a mixed methods study involving quantitative and qualitative methodology. There are four data collection 
components to NIE: 1) student survey (quantitative); 2) parent survey (quantitative); 3) systems level tracking 
(qualitative); and 4) fidelity, acceptability and sustainability evaluation (qualitative). The student survey, parent 
survey and systems level tracking data collection are described in section 4.1. The fidelity, acceptability and 
sustainability evaluation data collection is described in section 4.2. 
 
4.1. NIE Intervention Components: The intervention components  and corresponding  modes of data collection 
to test efficacy of the four aspects  of our intervention  are  shown  in the  table below.  The  left column  indicates 
the intervention component, while the right column indicates the type of data collection and the timeline of data 
collection. 
 
Intervention Component 
Types of Data Collection and Timeline 
Individual level: Native Stand 
• Student Surveys: baseline, 3 months, 9 
months, 12 months 
• Parent Surveys: baseline, 9 months, 12 
months 
Family level: Native Voices 
Community level: Cultural Mentoring 
Systems level: Enhancement of the 
coordination and implementation of SRH 
services at Fort with the Fort Peck Epi Team 
• Barriers and Facilitators Discussion 
Group: yearly 
• Coordination & Implementing Monitoring 
Plan Trackinq Loq: quarterly 
 
 
Subsequent to randomization of the 5 area schools to the intervention, there will be a baseline data 
collection from the middle of March to June 2019, followed by three waves of implementation and concurrent 
data collection over the next 3 years. For a visual picture of how these intervention components and methods 
of data collection fit into an overall Timeline, please see our Trial Timeline in the appendix.  
 
 
 
For the student and parent/legal guardian participating  in  NIE, there are 2 forms of data collection: a student 
survey and a parent/legal guardian survey. Ms. FireMoon, a part-time  assistant,  and the N/E school outreach 
coordinator will oversee  both surveys'  administration. The  student  surveys  and parent/legal guardian surveys will be 
completed  using Research Electronic  Data  Capture  or "REDCap." REDCap is a secure web application for building 
and managing surveys and databases.

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The students and parents will take the survey on iPads that have the mobile application version  of REDCap  installed  
on the tablets. The mobile app version of REDCap collects data offline to be uploaded to an online, secure database 
once a secure wifi location is reached. Deidentified data will be stored virtually on the REDCap server and available 
for download to Genevieve Cox, Paula Firemoon, Michael Anastario, Rachel Hallum-Montes and Beth Rink. Only 
Paula Firemoon, the NIE outreach coordinator, and Genevieve Cox will have access to names linking students 
and parents to their records during data collection and intervention implementation. These files will be kept in a 
locked file cabinet by Genevieve Cox at MSU after data collection. 
 
From Years 2-4, 456 students and one of their parents/legal guardians will participate in NIE's data collection. 
Student surveys for baseline, 3, and 9 months will be administered during regularly scheduled classes in an 
assigned classroom by Ms. FireMoon, the assistant, and N/E's outreach coordinator. Baseline data collection 
will begin in March 2019 for all schools and parents included in the intervention. Groups of 20 students at a 
time will be appropriately spaced in the classroom in order to ensure privacy, and survey instructions will be 
presented to students prior to REDCap administration. Ms. FireMoon, the assistant, and the NIE outreach 
coordinator will thoroughly review the assent form with the students, which will include a description of NIE, 
types of questions that will be asked, and potential risks and benefits of participating in NIE. All students will be 
reminded that they can withdraw at any time without consequences. Prior similar procedures have been 
successfully used by Dr. Rink and Ms. FireMoon for data collection in the Fort Peck schools with Al youth. For 
students who graduate from high school prior to the 12-month follow-up, they and their parent/legal guardian 
will be contacted by Ms. FireMoon to complete the 12-month follow-up (during evening hours) at the high 
school from which they graduated following the same procedure described above. Although data collection for 
the students has been designed to coincide with the school year, the same procedures will be followed if the 
data collection occurs when school is not in session. 
 
Wave 1 data collection will commence in December 2019 with 1 school after students have begun receiving the 
Native Stand and Cultural Mentoring components of the intervention during the school year.  
 
Wave 1 9- month follow-up will take place at the end of the school year in May/June 2020 as the intervention is 
completed. The Wave 1 12-month follow-up will take place at the beginning of the next school year in 
September 2020. 
 
Wave 2 (2 schools) and Wave 3 (schools) will follow the same procedures and pattern of timeline of data 
collection. The parent survey will be administered during evening hours at the high school by Ms. FireMoon, 
the assistant, and N/E's outreach coordinator. All baseline parent data will be collected in Fall 2019. We will 
use the same REDCap administration procedures for parents/legal guardians that are described for students 
above. Ms. FireMoon, the assistant, and the N/E outreach coordinator will review the consent forms with the 
parents/legal guardians to ensure their understanding of the purpose of N/E, types of questions they will be 
asked, and the study's potential risks and benefits. All parents/legal guardians will be reminded that they can 
withdraw themselves and/or their child at any time without consequences.  
 
Wave 1 (parents of first school) parent 9- month follow up will take place in spring of 2020. Wave 1 parent 12-
month follow-up will take place in Fall 2020. Wave 2 (parents of schools 2 and 3) and Wave 3 (parents of 
schools 4 and 5) will follow the same procedures and pattern of timeline of data collection. Data Safety & 
Monitoring Plan describes participant safety and support plans 
 
 

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4.1.2 For the systems-level component of N/E, there are 2 forms of data collection: a barriers/ 
facilitators discussion guide, and a coordination and implementation monitoring plan tracking log. 
These 2 forms of data collection span the 8 service domains relative to improving SRH services for 
adolescents as outlined by the CDC. The barriers/facilitators discussion guide will be administered in a group 
discussion format to the Epi Team at baseline and at 12 months during a standing monthly meeting held at the 
Fort Peck Tribal Headquarters to assess the factors that impede or strengthen the provision of SRH services 
for Al youth at Fort Peck. The Epi Team's discussion of the barriers/facilitators will be recorded and 
transcribed. Based on findings from the barriers/facilitators guide, a coordination and implementation 
monitoring plan will be developed in the form of a tracking log, in order to monitor improved coordination and 
provision of SRH services. The coordination and implementation monitoring plan tracking log will be completed 
as part of the baseline data collection and tracked quarterly during a regular monthly meeting of the Epi 
Team. Dr. Rink and Ms. FireMoon will be the primary research staff-with assistance from two of N/E's 
consultants, Ms. Adriann Ricker and Dr. Rachel Hallum-Montes-to collaborate with the Epi Team in 
completing the barriers/facilitators discussion guide, developing the implementation monitoring plan, and 
tracking the plan's progress toward increasing access to SRH services for Al youth. No identifying data or 
participants will be collected. 
 
4.1.3 Incentives: Incentives for the students and parents/legal guardians are based on discussions with N/E's 
Community Advisory Board and members of the FPCC research team, as well as Dr. Rink's prior experience 
with research studies involving Indigenous communities. Students will receive $10 at the baseline, 3-month, 
and 9-month data collections and $20 at the 12-month data collection. Parents/legal guardians will receive $10 
at the baseline and 9-month data collections and at each of the 4 sessions of Native Voices, plus $20 at the 
12-month data collection. Similar incentives for students and parents have been previously successful. Epi 
Team members will not receive incentives for participation in N/E, as it is part of their tribal employment 
responsibilities. 
 
4.2 Fidelity, Acceptability and Sustainability Data Collection. Fidelity recommendations from the National 
Institutes of Health Behavior Change Consortium will be implemented across the 5 areas of study design, 
component leader training, delivery of treatment, receipt of treatment, and enactment of treatment skills. The 
Fidelity, Acceptability, and Sustainability (FAS) of the N/E intervention will be emphasized with a variety of 
internal processes and data collection methods. The left column describes the FAS component, while the right 
column describes the corresponding type of data collection and timeline of data collection. 

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. 
 
 
 
Fidelity, Acceptability, and Sustainability 
Component 
Types of Data Collection and Timeline 
Community Advisory Board (CAB) meetings 
• CAB FAS Meeting Form: quarterly 
• 
CAB meeting notes: quarterly 
Team-wide meetings 
• Team-wide meetings FAS Form: bi- 
monthly 
Consistency of staff training 
• Staff training evaluation log: yearly 
FAS of coordination/implementation 
enhancement of Epi Team 
• 
Fidelity Reach Log/Staff Field notes: 
monthly 
Intervention implementation of Native Stand, 
Native Voice, and Cultural Mentoring 
• Fidelity Reach Log/Staff Field notes: each 
day of intervention 
Community level FAS 
• 8 Focus Groups (2 youth, 2 parent, 2 
regarding Cultural mentoring, 2 
professionals): yearly beginning in Year 3 
(Total of 24 Focus Groups) 
 
4.2.1 FAS Data Collection: In consultation with Dr. Hallum-Montes, Dr. Rink, Dr. Cox, and Ms. Firemoon 
developed four forms to collect FAS data during the implementation of the intervention. 
 
Forms: 
1.) The "Community Advisory Board Meeting Form" will be collected once per quarter after each meeting of the 
CAB. It will document the barriers and facilitators to intervention implementation discussed at CAB meetings, 
any social, environmental, political, or bureaucratic contextual factors such as the death of an elder or Tribal 
Council election year, that may have inhibited or facilitated intervention implementation, and any suggestions to 
mitigate these barriers the CAB discusses. CAB meeting notes will also be taken during each 
meeting. 
2.) The "Whole Team Meeting Form" will document bi-monthly meetings that include Paula Firemoon, Beth 
Rink, Adriann Ricker, Ramey Growing Thunder, the N/E outreach coordinator, the Cultural Mentor outreach 
coordinator, and Genevieve Cox. This form will include any barriers and facilitators to intervention 
implementation discussed, contextual factors (social, environmental, political, or bureaucratic) discussed, 
suggestions, and who will be responsible for implementing these suggestions. 
 3.) The "Staff Training Evaluation Log" will be collected yearly and documents who has been trained, what 
procedures were followed during training, problems encountered during trainings, and any feedback from the 
trainings. 
4.) The "Fidelity Reach Log and Field Notes" form includes documenting the delivery of the intervention and 
any field observations study staff note. It will document the date of the intervention, the length of time the 
intervention was delivered, specific modules delivered, and any barriers and facilitators to the delivery of the 
intervention. 
 

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The outreach coordinator will also document any environmental, social, political, or bureaucratic barriers or 
facilitators and suggested solutions to the intervention delivery. With the exception of names of staff trained, no 
identifying data will be collected. These files will be kept in a locked file cabinet by Genevieve Cox at MSU after 
data collection. 
 
In addition to the 4 FAS forms, we will implement 8 focus groups at 12 months from inception of the 
intervention for each year of the 3 years of planned intervention implementation (a total of 24 focus groups). 
The focus groups will include 6 to 8 individuals per group. The 8 focus groups will consist of 2 focus groups 
with youth, 2 focus groups with parents, 2 focus groups with the cultural mentors, and 2 focus groups with 
professionals from schools, agencies, and health care organizations that a·re involved in N/E. The focus groups 
will be recorded and transcribed. Written consent will be obtained from the adults participating in the fidelity 
and acceptability focus groups. Written consent and assent will be obtained from the parents/legal guardians 
and their child, respectively, in order for the child to participate in the focus groups. Focus group participants 
will receive a $20 incentive. No identifying data will be collected. 
 
SECTION 5: SELECTION AND ENROLLMENT OF PARTICIPANTS 
 
4.1 lnclusion Criteria. To be eligible for inclusion in NIE, students must be: 1) 15 to 18 years old; 2) a 
registered member of a federally recognized tribe or an associate tribal member; and 3) a resident of Fort Peck 
with a parent/legal guardian. For inclusion in the systems-level component of NIE, only those staff members 
who sit on the Epi Team as representatives of their respective agencies are eligible. Written informed consent 
will be obtained from the head of each agency represented on the Epi Team and the staff member participating 
in the Epi Team. 
 
4.2 Exclusion Criteria. Exclusion criteria are minimal due to the CAB's value of inclusion in NIE. Exclusion 
criteria include: 1) not meeting the aforementioned inclusion criteria; and 2) having a medically identified 
physical or cognitive impairment that would impede their understanding of and participation in the educational 
content and activities of Native Stand, Native Voices, and the cultural mentoring program. 
 
4.3 Study Enrollment Procedures. Students and their parent/legal guardian will be recruited from each of the 
study's 5 schools. Based on discussions with school personnel and our previously successful recruitment 
strategies, recruitment will occur via flyers posted in the schools, letters to the parents, parent-teacher 
meetings, and word of mouth. Additionally, a parent/legal guardian session that provides an overview of NIE, 
the content and format of the intervention components, and risks and benefits of participation will be held at 
each of the study's 5 schools. Students and their parents/legal guardians, and students from each cluster, will 
be recruited for participation at baseline. Students and their parents/legal guardians will be recruited for 
baseline participation prior to randomization of the sites. Students and parents/legal guardians will be 
assigned unique study identification numbers. No persons who refuse to participate in the study, in whole or in 
part, will be coerced to engage in any study activity. After written consent and assent is obtained from the 
parent/legal guardian and child, respectively, they will be enrolled in the study.

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SECTION 6: HUMAN SUBJECTS 
 
6.1 Institutional Review Board Approvals. The study has approval from the Fort Peck Institutional Review 
Board and the Montana State University Institutional Review Board. In addition, the study has been registered 
with ClinicalTrials.gov. These aforementioned approvals are in agreement with the conditions for approval to 
conduct human subjects research as outlined in our Notice of Grant Award from the National Institute of 
Minority Health & Health Disparities. See Appendices for research approvals. 
 
5.2. Human Subjects' Characteristics. There three groups participating in the study in which data will be 
collected include: 1) 15 to 18-year-old youth; 2) a parent/legal guardian; and 3) members of the Fort Peck Epi 
Team. 
 
6.3. Data Sources for Human Subjects Based on Intervention Levels. Our study includes four levels of 
intervention: 
 
1) Individual Level. Native Stand is a school-based, 27-module STI-, HIV-, and teen pregnancy-prevention 
curriculum, originally developed for rural white youth and adapted for Native youth in 2008. For our study, an 
adaptation of Native Stand will be implemented over 9 months in the 5 tribal high schools to educate Fort Peck 
tribal youth on sexual risk behavior prevention strategies by tailoring and reducing the 27 modules into 18 
modules, as well as including specific community-relevant traditional and contemporary cultural lesson plans. 
Trained project staff will deliver Native Stand in school classroom settings during the school year as part of 
each school's curriculum. American Indian students only will be recruited for Levels 2 and 3 and for data 
collection. 
 
2) Family Level. Native Voices is a video-based HIV/STI prevention intervention designed for Al adolescents, 
which includes condom use, negotiation skills, group discussion, and role playing. Native Voices will be 
adapted from 1 module into 4 modules, as recommended by the creators of Native Voices for curriculum 
adaptations involving family members, and will involve students and one of their parents/legal guardians. Our 
adaptation of Native Voices promotes discussions between the students and their parent/legal guardian 
regarding STI, HIV, HCV, and pregnancy prevention relevant to the Fort Peck tribal community. Ms. FireMoon 
will implement Native Voices to groups of 10 students and their parents/legal guardians at one time at the local 
high school for 2 hours in the evening. Native Voices' 4 modules will be implemented over 9 months. 
 
3) Community Level. The third level of our study is a cultural mentoring component that pairs Al youth with 
older adults and elders to discuss traditional American Indian beliefs and practices about reproductive health. 
To our knowledge, no mentoring programs have been designed for Al youth that specifically address sexual 
and reproductive health issues. The mentoring program is based on Assiniboine and Sioux traditional 
knowledge and the National Mentoring Partnership standards for mentoring. The mentoring program was 
designed specifically for Fort Peck youth by the Fort Peck Tribes' Language and Cultural Department and has 
been in existence for 5 years. Our study integrates this cultural mentoring program into our study's overall 
framework. Our cultural mentoring program will include older male and female tribal members from the 
Assiniboine and Sioux tribes. The older adults will be paired with the youth participating in the intervention by 
gender and tribal affiliation. Students participating in Native Stand and Native Voices with their parent/legal 
guardian will meet monthly over the course of 9 months one-on-one with their mentor and monthly in mentor 
mentee small groups. Topics addressed in the cultural mentoring program include overall information on 
Assiniboine and Sioux cultural beliefs, values, and ceremonies, as well as more specific information on  
Assiniboine and Sioux cultural beliefs and values regarding sex, having children, parenting, and 
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4) Systems Level. The fourth level of our study is a community-level strategy that involves mobilizing a 
network of education, health care, and social service agencies at Fort Peck to coordinate reproductive health 
services for 15- to 18-year-old Al youth over a 12-month period. The systems-level approach will utilize existing 
tribal infrastructure by enhancing the work of the established Fort Peck Tribal Epidemiology Team (Epi Team). 
The Epi Team is a local committee made up of the Fort Peck Tribal Health Department; Indian Health Service 
(Poplar Service Unit and Wolf Point Service Unit); the Roosevelt County Health Department; and school 
nurses from the Fort Peck Health Promotion and Disease Prevention Program. The Epi Team meets monthly 
and has been in existence for 15 years with the purpose of monitoring diseases on the reservation and the 
health status of the Assiniboine and Sioux tribes. As part of N/E, the Epi Team is tasked with improving the 
coordination and implementation of STI, HIV, and HCV screening, condom distribution, contraceptive services, 
and pregnancy testing on the Fort Peck Reservation. 
 
5.3.1. Data Collection Materials for Human Subjects. For the individual-, family-, and community-level 
components of N/E, there are two forms of data collection: a student survey administered at baseline and at 3, 
9, and 12 months after intervention inception, and a parent/legal guardian survey administered at baseline and 
at 9 and 12 months after intervention inception. The student survey will assess participation in Native Stand, 
Native Voices, and the cultural mentoring program. The parent survey will assess participation in Native 
Voices. Ms. FireMoon and the study's outreach coordinator will oversee the administration of the student 
surveys and the parent/legal guardian surveys. The student surveys and parent/legal guardian surveys will be 
completed utilizing REDCap. Between Years 2-4, 456 students and one of their parents or legal guardians will 
participate in N/E's data collection. Student surveys for baseline, 3 months, and 9 months will be administered 
to groups of 20 students at a time during regularly scheduled classes in an assigned classroom by Ms. 
FireMoon and the study's outreach coordinator. During data collection, groups of 20 students will be 
appropriately spaced in the classroom in order to ensure privacy, and survey instructions will be presented to 
students prior to REDCap administration. Ms. FireMoon and the study's outreach coordinator will thoroughly 
review the assent form with the students at the baseline data collection, which will include a description of N/E, 
types of questions that will be asked, and potential risks and benefits of participating in N/E. All students will be 
reminded that they can withdraw at any time without consequences. For students that graduate from high 
school prior to the 12 months data collection, they will be contacted by Ms. FireMoon directly to complete the 
12 months data collection (during evening hours) at the high school they graduated from following the same 
procedure described above. This same procedure will be followed if the data collection time point occurs for 
some reason when school is not in session. The parent survey will be administered during evening hours at the 
high school in an assigned classroom by Ms. FireMoon and the study's outreach coordinator. We will use the 
same REDCap procedures for parents/legal guardians that are described for youth above. In addition, written 
consent will be obtained from the parents/legal guardians prior to their participation in the study. Ms. Firemoon 
and the study's outreach coordinator will review the informed consent with the parents/legal guardians at the 
time of data collection. 
 
For the systems-level component of N/E, there are two forms of data collection: a barriers/facilitators 
discussion guide and a coordination and implementation monitoring plan tracking log. These two forms of data 
collection span the 8 service domains relative to improving SRH services for adolescents as outlined by the 
Centers for Disease Control and Prevention (CDC). The barriers/facilitators discussion guide will be 
administered in a group discussion format to the Epi Team at baseline and at 12 months during a standing 
monthly meeting held at the Fort Peck Tribal Headquarters to assess the factors that impede or strengthen the 
provision of SRH services for Al youth on the Fort Peck Reservation. The Epi Team's discussion of the 
barriers/facilitators will be recorded and transcribed. Based on findings from the barriers/facilitators guide, a 
coordination and implementation monitoring plan will be developed in the form of a tracking log in order to  

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monitor improved coordination and provision of SRH services. The coordination and implementation monitoring 
plan tracking log will be completed as part of the baseline data collection and tracked at 3, 6, 9, and 12 months 
during a regular monthly meeting of the Epi Team. In collaboration with the Epi Team, Ms. FireMoon,  Ms. 
Adriann Ricker, and Dr. Rink will complete the barriers/facilitators discussion guide, develop the 
implementation monitoring plan, and track the plan's progress toward increasing access to sexual and 
reproductive health services for American Indian youth on the Fort Peck Reservation. 
 
All students attending each school will be eligible to participate in the individual-level Native Stand curriculum, 
as it will be incorporated into that school's regular curriculum. In order to be eligible for inclusion in the family 
and community-level components of N/E and the data collections, students must be: 1) 15 to 18 years old; 2) a 
registered member of a federally recognized tribe or an associate member; 3) a resident of the Fort Peck 
Reservation with a parent/legal guardian; and 4) enrolled at one of the five schools participating in N/E. 
 
Exclusion criteria are minimal due to the value the CAB places on inclusion in N/E's program implementation. 
Exclusion criteria include 1) not meeting the aforementioned inclusion criteria, and 2) having a physical or 
cognitive impairment that would impede the student's understanding of and participation in the content of 
Native Stand, Native Voices, and the cultural mentoring program. Study-enrolled students must agree at the 
outset to participate in Native Stand, Native Voices, and the cultural mentoring program, and agree to complete 
the survey at baseline and at 3, 9, and 12 months during and shortly after their cluster's program. Parents/legal 
guardians must also agree to participate in Native Voices and complete the parent/legal guardian survey at 
baseline and at 9 and 12 months. No persons will be coerced to engage in any study activity, and anyone may 
refuse to participate at any time. After written consent and assent are obtained from the parents/legal 
guardians and their children, respectively, they will be enrolled in the study. For inclusion in the systems -level 
component of the study, only those staff members who sit on the Epi Team as representatives of their 
respective agencies are eligible. Written informed consent will be obtained from the head of each agency 
represented on the Epi Team and the staff member participating in the Epi Team. 
 
If at any point in the study a student discloses abuse, they will be referred to the appropriate person or 
organization. For example, a research participant who is under the age of 18 and in school who discloses that 
he or she is being abused at home will be referred to the counselors in the school for assistance, with the 
possibility of joint reporting to Child Protective Services. Students will be informed during the informed consent 
process that any abuse they may disclose will be reported, since the members of the research team and the 
interviewers are mandated reporters. 
 
Another form of data collection that involves human subjects is related to Aim 3 of our study, which is to 
evaluate the fidelity and acceptability of N/E. As part of Aim 3 we will conduct focus groups. We will implement 
8 focus groups at 12 months from inception of the intervention's curricular components for each year of the 3 
years of planned intervention implementation (a total of 24 focus groups). The focus groups will include 6 to 8 
individuals per group. The 8 focus groups will consist of 2 focus groups with youth, 2 focus groups with 
parents, 2 focus groups with the cultural mentors, and 2 focus groups with professionals from schools, 
agencies, and health care organizations that are involved in N/E. Written consent and assent will be obtained 
from adults, parents/legal guardians, and youth, respectively. Focus groups will be recorded and transcribed. 
No names or other identifying information, such as an address, will be included on the transcripts. However, . 
age and gender will be recorded. After each focus group, the focus group facilitator will check the audiotapes 
for clarity. Clear audiotapes will be transcribed. Audiotapes that are not sufficiently clear, or do not have 
adequate volume to transcribe, will not be transcribed. Instead, responses typed or directly written down by the 
focus group guide during the interview will be used as the transcript for content analysis. Names of students or 
others identified in the transcripts will be blacked out in order to ensure confidentiality. 

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6.3.2. List of Data Source Materials and Measures (Table 2 below). 
 
Student Survey: To assess students' participation in N/E, we draw from several existing measurements 
that have been implemented and validated in research studies with Al youth. Primary outcome measure: 
Condom use will measure frequency of condom use relative to frequency of sex during sexual intercourse 
using questions derived from the Risk Behavior Assessment. Secondary outcome measures: These will 
include the number of sex partners; age of onset of sexual intercourse; frequency of sexual intercourse;  
pregnancy history; frequency and type of birth control used during sexual intercourse relative to the frequency 
of sexual intercourse; and frequency and types of substance use (cigarettes, marijuana, alcohol, and 
methamphetamine). Tertiary outcome measures: Parent/legal guardian communication is measured by the 
frequency and types of SRH topics that parent/legal guardian and child discussed. Cultural identity is 
measured using two established measurements: One measure assesses the extent to which a student 
identifies with his or her American Indian culture and feels cultural pride, and the other measure assesses 
frequency and type of participation in cultural activities. Access to SRH services is measured by frequency and 
type of SRH service used (ever been tested for STls and follow-up, ever been tested for HIV and follow-up, 
ever been tested for HCV and follow-up, ever been pregnant/gotten someone pregnant and follow-up). Other 
variables to be measured in N/E that assess attitudes, intentions, skills, and mental health are: Motivation to 
avoid STls, HIV, HCV, and pregnancy, as measured by asking students how important it is to them to keep 
themselves (or someone else) from getting an STI, HIV, and HCV, and how important it is to them to keep from 
getting pregnant or getting someone pregnant. Intention to use condoms and/or birth control is measured by 
asking students how likely it is they will use condoms and/or birth control the next time they have sexual 
intercourse. Intention to abstain from sex is measured by asking students how likely it is that they will not 
participate in sexual intercourse. Condom and birth control use self-efficacy is measured by assessing 
confidence in one's ability to use condoms and birth control. Refusal skills regarding sex are assessed by how 
strongly students believe they can say no to sex. Knowledge about STls, HIV, HCV, pregnancy, and healthy 
relationship characteristics are measured using true/false/don't know questions. Mental health is assessed 
using two established measures: One measure assesses depression using the C-ESD, and the other 
measurement assesses exposures to stressful life events by assessing lifetime occurrences of a series of 
negative events. Standard demographic measures in the student survey are age, gender, sexual orientation, 
school, and highest grade completed. 
 
Parent/Legal Guardian Survey. The parent/legal guardian survey is based on parents'/legal guardians' 
participation in Native Voices. It includes a list of SRH topics about which the parent/legal guardian has spoken 
to the child and the frequency of times discussed. The parent/legal guardian measures have been validated  
in previous studies evaluating parent/child SRH communication and have been used by Dr. Rink in her 
Greenland studies. The SRH topic list and frequency is the same as in the student survey, only adapted for 
parents/legal guardians. Standard demographic measures included in the parent/legal guardian survey are 
age, gender, marital status, highest grade completed, and occupation. 
 
Barriers/Facilitators Discussion Guide. The barriers/facilitators discussion guide is a qualitative assessment 
using open-ended questions that address the factors impeding and facilitating SRH services for Al youth on the 
Fort Peck Reservation. The guide is based on the 8 service domains for evidence-based clinical practices 
outlined in the CDC's Contraceptive and Reproductive Health Services for Teens: Evidence-based Clinical 
Best Practices Guide(80-82)-namely, contraceptive access; provision of hormonal contraception/IUD; 
emergency contraception; cervical cancer screening; STI/HIV/HCV testing and treatment; cost, confidentiality, 
consent; health center infrastructure; and health center environment. 
 
Coordination and Implementation Monitoring Plan Tracking Log. The tracking log will monitor the 
progress toward completion of the 8 SRH service domains identified from the barriers/facilitators discussion  

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guide and corresponding evidence-based clinical practice elements. 
 
Focus Groups. Data collection related to Aim 3 of our study, which is to evaluate the fidelity and acceptability 
of N/E, includes a focus group guide, as described above. The Aim 3 focus groups will include questions such 
as what experiences/activities they liked and/or did not like about the intervention, what educational information 
they did and/or did not like about the intervention, and what recommendations they have for improving the 
intervention. 
Table 2. NIE Measures. 
 
 
6.4 Potential Risks 
 
There may be minor risks to agreeing to participate in N/E. Student and parent/legal guardian participants may 
be asked some questions that make them feel uncomfortable, sad, or confused (e.g., questions about sexual 
risk behaviors). For participants in the systems-level component of the study that evaluates the enhancement 
of the coordination of SRH services, we anticipate low to no risks, since none of the data being collected will be 
of a personal nature. For Aim 3, which uses focus groups as one method of data collection to evaluate the 
fidelity and acceptability of N/E, we also anticipate low to no risk, since none of the data being collected will be 
of a personal nature. All study participants will be informed that they may choose to stop their participation in 
N/E at any time or decline to answer a particular question asked of them on a data collection instrument or 
during a data collection process. We will inform study participants that the study is voluntary and that they can 
withdraw from the study, by stating that they want to do so, at any time over the course of the study. 
6.4.1. Adequacy of Protection Against Risks 

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A. Recruitment and Informed Consent 
 
The high schools in Frazer, Wolf Point, Poplar, Brockton, and Culbertson will serve as the primary recruitment 
sites for our study. Based on discussions with school personnel and our previously successful recruitment 
strategies, recruitment will occur via flyers posted in the schools, letters to the parents, parent-teacher 
meetings, and word of mouth. Additionally, a parent/legal guardian session that provides an overview of N/E, 
the content and format of the intervention components, and risk and benefits of participation will be held at 
each of the study's 5 schools. Students and their parents/legal guardians from each cluster will be recruited for 
participation at baseline (Q2 of Year 2). At the time of the student data collection at baseline, Paula FireMo on 
and the study's outreach coordinator will thoroughly review the assent form with the students, which will 
include a description of the N/E curricular components, types of questions that will be asked in the data 
collection, and potential risks and benefits of participating in N/E. All attempts will be made to help the students 
understand the nature of the study. Paula FireMoon and the study's outreach coordinator will thoroughly review 
the consent forms with the parents, which will include a description of N/E, types of questions that will be 
asked, and potential risks and benefits of participating in N/E. Parents will provide informed consent for their 
child as well as for themselves prior to their participation in the Native Voices curriculum. For the systems-level 
component, Epi Team members will complete an informed consent at the time of the first barriers and 
facilitators discussions in Year 2. If members change from one such discussion to the next, new informed 
consents will be collected as needed. For the Aim 3 focus groups, informed consent will be obtained from the 
mentors or the professionals representing agencies prior to their participation in the focus groups as key 
stakeholders. Consent and assent will be obtained from parents/legal guardians for their participation in a 
parent group, and from parents/legal guardians and their children, respectively, for the children's participation 
in a children's focus group. All study participants, both adults and children, will be reminded that they can 
withdraw at any time without consequences. No study participant will be coerced to participate in the study, in 
whole or in part. Human subjects approval has been received from the Fort Peck IRB for the Year/Aim 1 
refining, tailoring, and finalizing the intervention design. At that point, new applications to the Fort Peck IRB 
and the MSU IRB will receive approvals prior to study start. 
 
B. Protection Against Risk 
 
Because N/E involves children ages 15 to 18 years old, we will ensure that parents/legal guardians understand 
the research protocol and are able to provide informed consent for themselves and their participating children 
in this minimal-risk intervention study. To preserve confidentiality, all data collection forms will be coded with a 
unique identifier. All of the project data, including the audiotapes and transcripts, will be labeled with study 
identification numbers and stored separately from the informed consent forms. Consent forms will be kept in a 
locked file cabinet in Paula FireMoon's office at Fort Peck Community College, which has a combination lock 
on the door that only Paula FireMoon knows. All survey data will be stored in a password-protected file on a 
password-protected computer at Fort Peck Community College in Paula FireMoon's office. Focus group 
documents will be uploaded onto MSU's Box server, a password-protected cloud data storage system. All of 
the project data-including the audiotapes, transcripts, and interview summaries with study identification 
numbers-will be stored separately from the informed consent  forms in a locked file cabinet in Dr. Rink's  
locked office at Montana State University, to which only Dr. Rink and the MSU-based research program 
manager, Genevieve Cox, will have access. Once the focus groups have been transcribed and checked for 
validation against the audiotapes, the audiotapes will be destroyed in order to ensure no voice recognition. At 
the end of the project, all of the deidentified data files (though not individual surveys) will be returned to Fort 
Peck Community College and stored in the Fort Peck research archives in Poplar, Montana, as is required by 
the Fort Peck IRB. Please note that none of the data returned to Fort Peck Community College will contain a 
study participant's name or contact information to ensure that personal information collected during the study is 
not associated with a study participant's name. Data files at Fort Peck Community College will be kept in 

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accordance with federal law regarding research material. Also, the study participants (completing surveys or 
participating in focus groups) will be informed of where the data will be stored during the informed consent 
process. All data will be kept in accordance with federal law requirements regarding research material. 
 
SECTION 7: DATA SAFETY MONITORING PLAN 
 
This plan describes the general data and safety monitoring procedures for the proposed research activities, 
including the responsibilities of the Pl, Co-Investigators, and the Community Advisory Board, as well as the 
reporting of adverse events. This data safety monitoring plan was submitted with our R01 proposal and 
approved by the review panel, project officer and grants management officer at NIH. Protocols for data safety 
have also been reviewed and approved by the Fort Peck and Montana State University Institutional Review 
Boards. 
 
The principal investigator, Elizabeth Rink, Ph.D., the Fort Peck-based project director Paula FireMoon, M.Ed. 
(co-investigator), and the Fort Peck Tribes' Language and Culture Department director Ramey Growing 
Thunder, MA (co-investigator), will be responsible for knowing and adhering to the cultural protocols and 
official policies of the Fort Peck Tribes and the five participating high schools; the Fort Peck IRB policies and 
procedures; and the MSU IRB policies and procedures. Dr. Rink will be the lead on the Fort Peck and MSU 
IRB correspondences and reports. She will maintain accurate documentation of the Fort Peck and MSU IRB 
correspondences and reports on her password-protected desktop computer in her locked office at MSU. 
The Pl and the local Fort Peck co-investigators (FireMoon and Growing Thunder), who together will oversee 
the intervention at Fort Peck, are responsible for documentation and handling of all possible study-related 
adverse events. They all are experienced in conducting research and implementing and evaluating community 
based programs with American Indian youth. Rink and FireMoon have experience conducting such research 
related to sexual and reproductive health. All will assure that data collection and safety monitoring systems are 
in place and implemented-Mrs. Growing Thunder for the mentoring program and Ms. FireMoon for the other 
intervention components. 
 
The Data and Safety Monitoring Plan includes the following descriptions: 
 
1. Potential adverse events resulting from participation; 
2. Procedures to safeguard against those events; 
3. Response procedures for adverse events; 
4. Reporting procedures for adverse events; 
5. Oversight. 
 
1. Potential Adverse Events Resulting from Participation 
 
A. Possible violation of confidentiality; 
B. Possible violation of cultural protocols or official policies; 
C. Possible discomfort due to completing data collection tools; 
D. Possible embarrassment in disclosing personal sensitive information; 
E. Possible disclosure of information about intended physical harm to victims, or abuse of children, that 
would need to be reported to the child welfare agency, and an investigation of the allegations(s) and 
further action, as indicated, that could ensue; 
F. Possible dissatisfaction with completing the data collection tools; 
G. Possible dissatisfaction with the intervention activities. 
 
2. Procedures to Safeguard Against Adverse Events 

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All data collection protocols include a form on which the research team will record any problems with the data 
collection, concerns about the adolescents, or unusual occurrences during the conduct of the intervention or 
the collection of data. These forms allow the team to quickly review and respond to any possible concerns or 
adverse effects. The form includes contact information for Rink, FireMoon, and Growing Thunder. One or more 
of them will always be available during data collection. During phone conferences and meetings (weekly during 
the intervention periods and monthly otherwise), all problems and concerns will be discussed and processed 
among themselves, and with other project personnel as needed. 
 
A. Informed Consent: Ms. FireMoon and the N/E outreach coordinator will review the consent forms with the 
parents/legal guardians at baseline to ensure their understanding of the purpose of N/E, types of questions 
they will be asked, and the study's potential risks and benefits. They will be reminded that they can withdraw 
themselves or their child at any time without consequences. Likewise, Ms. FireMoon and the study's outreach 
coordinator will thoroughly review the assent form with the 456 students to be enrolled, which will include a 
description of N/E, types of questions that will be asked, and potential risks and benefits of participating in N/E. 
All students will be reminded that they can withdraw at any time without consequences. After written consent 
and assent are obtained from the parents/legal guardians and their child, respectively, they will be enrolled in 
the study. For inclusion in the systems level component of the study, only those staff members who sit on the 
Epi Team as representatives of their respective agencies are eligible. Written informed consent will be 
obtained from the head of each agency represented on the Epi Team and the staff member participating in the 
Epi Team. Written consent and assent will be obtained from the maximum of 192 adult professionals, 
parents/legal guardians, and youth, respectively, for participation in the 24 planned focus groups. All study 
participants will be informed of where and how the data will be stored during the informed consent process. 
 
B. Confidentiality and Data Safeguards: To ensure confidentiality, all information will be coded using a unique 
identification number so that it cannot be associated with any individual. All of the survey data will be labeled 
with study identification numbers and stored separately from the informed consent forms in a locked file 
cabinet in Paula FireMoon's locked office at Fort Peck Community College. A master sheet, with individual 
names and their respective unique study identification numbers, will be kept in a separate locked file that can 
be accessed only under supervision of the Pl or Project Director. The data collection from the student surveys 
and parent/legal guardian surveys will be downloaded using the RedCap software into the MSU Box server, a 
file-sharing cloud server, for storage. This is a password protected virtual storage system for de-identified 
research materials that only specified invited individuals (members of the research team) may view. The 
audiotapes of the focus groups will be stored separately from the informed consent forms in a locked file 
cabinet in Dr. Rink's locked office at Montana State University. All other focus group data including the de- 
identified transcripts, interview summaries, and the results of the content analysis will be stored on the MSU 
Box server. All data entered into Box as part of the project's computerized database will be identified by unique 
identification number only. The entire research team and all other project personnel who come in contact with 
data or with the human subjects of the intervention will sign a formal oath of confidentiality. The information 
gathered will be used only for scientific, program evaluation, or instructional purposes. No information about 
the identities of study participants will be published or presented at conferences. 
 
C. Cultural Protocols and Tribal/Schoo/ Policy Safeguards: Dr. Rink and Ms. FireMoon will be responsible 
for working with the study's CAB, other investigators, and consultants to ensure that the intervention adheres 
to the cultural protocols and official policies of the Fort Peck Tribes; the Fort Peck IRB policies and procedures; 
and the MSU IRB policies and procedures. Tribal elders will be consulted on traditional topics and protocols 
that cannot otherwise be addressed by Ms. FireMoon, the study's CAB members, and Mrs. Growing Thunder. 
Dr. Rink and Ms. FireMoon will hold quarterly meetings with the study's CAB. All documents related to N/E will 
be developed, reviewed, and vetted by the study's CAB members as necessary during the quarterly CAB 

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meetings. Similarly, all data resulting from N/E will be reviewed, interpreted, and approved by the CAB. If 
necessary, Dr. Rink and Ms. FireMoon will also meet individually with CAB members to discuss the study's 
research protocols, data collection instruments, and findings. In addition to the CAB-related meetings, Dr. Rink, 
Ms. FireMoon, and Mrs. Growing Thunder will hold monthly team meetings to discuss the study's research 
protocols, implementation strategies and progress, research-related documents, data collection procedures, 
and analysis. Any concerns brought up by the CAB or other members of the research team will be discussed 
until a resolution is reached. 
 
As part of N/E we will use fidelity and acceptability recommendations from the National Institutes of Health 
Behavior Change Consortium. These recommendations address study design, component leader training, 
delivery of treatment, receipt of treatment, and enactment of treatment skills. In order to assess the fidelity and 
acceptability of N/E, data sources will include: staff training logs, fidelity reach logs, staff field notes, notes from 
discussions at monthly team meetings, and notes from discussions with CAB members and at CAB meetings. 
Focus groups are an additional qualitative measure to assess fidelity and acceptability. These fidelity and 
acceptability data sources will assist the MSU based and FPCC-based research teams and the CAB to monitor 
the enrollment of students and parents/legal guardians into the study, monitor the data submission, quality- 
check the data being reported, avoid potential study related bias or inconsistencies, and prepare interim 
reports when necessary. 
 
D. Mandatory Reporting Safeguards: Procedures to prevent the violation of confidentiality will be limited by 
mandatory reporting requirements. Subjects will be informed in the consent document that the research team 
must report to authorities: (1) physical injury to any child caused by other than accidental means; and (2) 
information from a study participant that leads the research team to believe a person is in imminent danger of 
physical harm. The project personnel will inform parents or guardians if, in the judgment of the research 
team/project personnel, their child (under 18) is in imminent danger of trying to harm him/herself. 
 
E. Research Team Safeguards: All research team/project personnel who interface in any way with intervention 
protocols, data collection, or data analysis are required to complete and be up-to-date with the extensive 
Collaborative Institutional Training Initiative (CITI) training and testing program and the NIH Good Clinical 
Practice Training. Weekly or monthly meetings or phone conferences will occur among the key personnel for 
ongoing training, monitoring of protocols, and problem solving. Questions concerning data collection will be 
processed during this time. The Project Director (Ms. FireMoon) will coordinate and oversee all activities at the 
data collection sites and will report all activities, concerns, and questions to the Pl on an ongoing basis. Prior to 
the start of the intervention cycle, the entire team on the ground in the Fort Peck communities, including 
personnel to be hired, will be trained to identify events that would fall under mandatory reporting guidelines. 
These include physical injury to any child caused by other than accidental means, or information from a 
student participant that leads staff to believe a person is in imminent danger of physical harm. 
 
F. Discomfort with Completing lntetvention Data Collection Instruments or Disclosure Safeguards: During 
the course of participation in the research, a participant may have questions concerning the data collection 
tools. Either the Project Director (Ms. FireMoon) or the Outreach Coordinator (to-be-hired) will be available at 
each school data collection event to answer questions. Likewise, the mentoring program Director (Mrs.  
Growing Thunder) and her Community Mentorship Coordinator (to-be-hiredDo you want to add name?) will be 
available at each group mentoring meeting to answer questions. To prevent discomfort or embarrassment, the 
Project Director (Ms. FireMoon) is trained in counseling and has experience in therapeutic interaction. The Pl 
has training and previous work experience in clinical social work and will be available to all participants via cell 
phone, email, or in person when she is at Fort Peck to address any concerns regarding the data collection 
instruments. The remaining staff will receive specialized training in sexual and reproductive health and will also 
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G. Dissatisfaction Safeguards: Participants will be encouraged to discuss with the Pl or Fort Peck-based 
project personnel any possible dissatisfaction with the data collection tools or intervention activities. 
 
3. Response Procedures for Adverse Events 
 
A. Discomfort with Disclosure: All project personnel working in the reservation communities are under the 
supervision of the Pl, who is highly trained in counseling. Any participant experiencing embarrassment or 
discomfort when completing data collection tools will be responded to in a compassionate and professional 
manner. If a participant experiences any other adverse reactions to the data collection tools or intervention 
activities/sessions, the participant will be referred to IHS Poplar Service Unit, HIS W olf Point Service Unit, or 
the Fort Peck Tribes Health Promotion and Disease Prevention Program (HPDP) on the Fort Peck reservation, 
which all have trained psychotherapists available to tribal members. Participants will also be encouraged to 
contact the research team/project personnel in the event of a late adverse reaction and will receive specific 
written and verbal instructions during the project consent procedures about how to do so if the need arises. 
 
B. Mandatory Reporting: Serious adversities shared by subjects that need to be reported by the research 
team/project personnel include physical abuse and neglect or threat of physical harm to self or others. To 
anticipate these concerns, the research team/project personnel have established procedures and guidelines to 
respond to risk disclosures among participants. 
 
Four types of situations require special procedures: 
 
• 
Suicide thoughts or attempts: Two types of risks will be addressed in the project: (a) ideation or 
presentation of thoughts or interest in suicide, and (b) action, which includes both thoughts of suicide as 
well as the presence of a plan and means to accomplish a suicide act. As participants complete the 
data collection instruments, key personnel will review instruments and items for response values that 
indicate concern. Based on the response values, these key personnel will collectively review disclosed 
information and, if deemed necessary, conduct follow-up inquiry with the participant to further 
determine level of risk. If the participant is determined to present immediate risk, a referral will be made 
to one of the following, depending on which is most appropriate for the situation: IHS Poplar Service 
Unit, IHS Wolf Point Service Unit, or Fort Peck Tribes' Health Promotion and Disease Prevention 
Program, which offers mental health services to youth in schools. If the disclosure is the result of one of 
the written items on the data collection tools, Ms. FireMoon will contact the participant by tele phone. If 
the disclosure occurs during an on-site session, the session leader will follow through with an in-depth 
interview to clarify the presence of suicidal risk and develop a plan of action. Session leaders and 
mentors will be trained and required to identify suicidal risks in both the domains of ideation and action. 
Session leaders will follow up in the same way and inform the Pl. In the most extreme cases of risk, the 
Pl then assumes follow-up responsibility for the plan of action. 
• 
Abuse: Child abuse concerns may arise from any or a combination of the following sources: (a) the 
youth verbally indicates that abuse has occurred or is occurring; (b) the youth answers one or more 
data collection tool items suggesting the possibility of abuse; (c) the youth is observed being treated in 
an abusive manner; (d) the youth is observed with bodily injury (e.g., bruise, burns, black eyes) whose 
origin appears to differ from the explanation given of the injury. At any time during the completion of the 
data collection instruments, or during intervention sessions, if any of the above information leads key 
personnel or mentors to suspect abuse or neglect of children, documented steps will be followed to 
obtain additional information and personnel will contact the Pl. Based on the information, the team will 
determine appropriate further inquiry and follow-up. Based on the information, the team will develop a 
safety plan that may include a participatory report to the Fort Peck Tribes/BIA Child Protective Services 

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agency, and/or possible referral to the Fort Peck Tribes' Family Violence Resource Center based in 
Wolf Point. 
• 
Threat of danger to others: The threat of danger to others includes disclosure of potential physical harm 
by a participant to others, including members of the participant's family or other individuals in the school 
or community. At any time during completion of data collection tools or during intervention sessions, if 
any information emerges suggesting the threat of harm to others, the team will review the information 
and determine next steps in accordance with the law, school policies, and the guidance of the CAB and 
project partners. 
• 
Addiction: Addiction to substances is a condition characterized by compulsive substance intake, 
craving, and seeking, despite negative consequences associated with the substance(s) used. This 
project does not directly address substance abuse and addiction. However, the student survey asks 
about substance use, and some intervention sessions related to substance use occur outside of school 
settings. A situation may occur where a participant reveals information or exhibits characteristics that 
suggest addiction to substances. The key personnel and mentors will be trained to recognize signs and 
symptoms of addiction. Together with the Pl they will determine the best response and plan for referral 
to Spotted Bull Addiction Services based in Poplar on the reservation. 
 
C. SRH Health Risks and Needs: Due to the intervention and research subject matter of sexual and 
reproductive health, participants may reveal information during data collection or intervention sessions 
that suggests either sexually transmitted infections, HIV, HCV, or suspected pregnancy. Key personnel 
and mentors will have received training on the services available through the local IHS Service Units to 
test and treat STls, HIV, HCV, and/or to provide pregnancy testing and prenatal care. Participants who 
present these issues will be referred to the appropriate health practitioners for care, and project personnel will 
follow up with participants as needed to ensure action was taken to address health risks. The intervention 
program itself will encourage youth to access services for disease and pregnancy prevention. 
 
D. Reporting Procedures for Adverse Events 
 
The anticipated potential adversity inherent in the completion of the student survey is limited and will be 
addressed by the timely intervention of the key personnel and mentors, as appropriate-all with prior skills 
and/or training in risk assessment and mandatory reporting requirements. The occurrence of adverse events 
will be reported to the MSU and Fort Peck IRBs, the Data and Safety Monitoring Committee, and others as 
appropriate including the participating schools. 
 
E. Reporting Procedure for Serious Unanticipated Adverse Events: In the event of an unanticipated serious 
adverse event, the Pl and Project Director will ensure that these events are reported to the NIH Program 
Official within hours by phone, fax, and/or email and will submit a written report to the Program Official no 
more than two days later. Project personnel will also utilize the following reporting procedures: 
 
1) When the research team/project personnel become aware of a serious adverse event, reporting 
requirements must be implemented in a timely manner. 
2) The Pl completes an Adverse Event Report and submits it to the MSU and Fort Peck IRB Chairs, to the 
project's Data and Safety Monitoring Committee, and to the project Community Advisory Board. The 
CAB will help identify culturally and socially appropriate ways of remedying adverse events. 
3) The Chairs will convene expedited meetings of their respective IRBs. First the Fort Peck IRB and then 
the MSU IRB, with input from the Pl and the Data and Safety Monitoring Committee, will review the 
study protocol and determine what further action to take based on the best interests of the participants 
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F. Oversight 
 
The boards that provide oversight to NIE are: 
• 
Community Advisory Board 
• 
The Fort Peck Institutional Review Board 
• 
The Fort Peck Tribal Executive Board 
• 
Montana State University Office of Research Compliance 
• 
Montana State University Office of Sponsored Programs 
• 
The Montana State University Institutional Review Board 
• 
Data Safety and Monitoring Board 
 
For the purposes of the Data Safety and Monitoring Plan, the Data Safety and Monitoring Board (DSMB) will 
be chaired by Dr. Jared Jobe, retired NIH program officer, Dr. David Huh, a researcher and statistician, Dr. 
William Lambert, a researcher, and Dr. Cynthia Pearson, a researcher. Meetings of the Committee will occur 
semi-annually by telephone or Zoom, and unless closed by the Chair, will be joined by the Pl (Rink), the 
Project Director (Paula FireMoon), Ramey Growing Thunder, the Director of the Fort Peck Tribes Language 
and Culture Program, the study statistician (Mike Anastario), Dr. Julie Baldwin, the study co-Investigator, and 
the study's research program manager (Genevieve Cox). The DSMB will: a) review the research protocol and 
plans for data and safety monitoring; b) evaluate study progress, including data quality, participant recruitment 
rates, retention rates, outcome and adverse experience data, and risk versus benefit profile; and c) review the 
protocols to protect the confidentiality of the study data and the results of monitoring. 
 
The study's community advisory aboard is updated quarterly on the study progress. The Fort Peck Tribal 
Executive Board, the Fort Peck IRS, the MSU IRB, and MSU's Office of Research Compliance and MSU's 
Office of Sponsored Programs are updated once a year on the study. The DSMB committee also will annually 
review the project's Data and Safety Monitoring Plan regarding: a) Reassessment of the risks and benefits to 
study participants; b) Participant recruitment, accrual, and retention; c) Data quality and confidentiality; d) 
Consideration of external scientific or therapeutic developments with impact on the safety of participants or the 
ethics of the study; e) Any adverse events. 
 
The research team will update the general Data and Safety Monitoring Plan as well as the research protocols 
as needed. Adverse events will be reported to the Tribes, the participating schools, and the IRBs on an annual 
basis. Serious adverse events will be reported immediately to these entities as well as NIH and the DSMB. A 
written report will follow within 3 days of the event. The written report will be in the format required by the 
Tribes, schools, and the IRBs, and will contain information regarding the date of the event, description of the 
event, assessment of cause, whether the event indicates an increased risk for current or future subjects, and 
whether changes to the informed consent are necessary. 

26 
Nenunkumbi/Edahiyedo ("We Are Here Now'?: A Mult-level, Multi-component Sexual and Reproductive Health 
Intervention for American Indian Youth 
Manual of Operations 
Version 1 - 02.01.19 
 
SECTION 8: APPENDICES 
 
The Appendices includes the following documents: 
 
• 
IRB Approvals 
• 
  

'
,._e11t2"  
 
.I
t.< 
Fort Peck Tribal Institutional Review Board  
For the Protection of Human Subjects 
FWA00019355 
 
 
Fort Peck Community College 
Box 398 
Poplar, MT 59255 
406-768-5555 
 
 
 
Chair: 
Robert McAnally 
406-768-8377 
bmcassin.@gma iI.com 
 
Administrator: 
Joy Toavs 
406-768-5555 
jtoavs@fpcc.edu 
 
 
FORT PECK 
 
 
MEMORANDUM 
 
 
 
TO: 
 
FROM: 
Elizabeth Rink, PhD. MSW 
 
Robert McAnally
Chair, Institutional Review Board for the Protection of Human Subjects 
 
DATE: 
SUBJECT: 
October 26, 2018 
 
Nen UnkUmbi/EdaHiYedo ("We Are Here Now") 
The above proposal was reviewed on October 4, 2018 by the Fort Peck Tribal Institutional Review 
Board. This proposal is now approved for a period of one-year. 
 
Please keep track of the number of subjects who participate in the study and of any unexpected or 
adverse consequences of the research. If there are any adverse consequences, please report them to 
the committee as soon as possible. If there are serious adverse consequences, please suspend the 
research until the situation has been reviewed by the Institutional Review Board. 
 
Any changes in the human subjects' aspects of the research should be approved by the committee 
before they are implemented. 
 
It is the investigator's responsibility to inform subjects about the risks and benefits of the research. 
Although the subject's signing of the consent form, documents this process, you, as the investigator 
should be sure that the subject understands it. Please remember that subjects should receive a copy 
of the consent form and that you should keep a signed copy for your records. 
 
In one year, you will be sent a questionnaire asking for information about the progress of the research. 
The information that you provide will be used to determine whether the committee will give continuing 
approval for another year. If the research is still in progress in 5 years, a complete new application will 
be required. 
 
The Fort Peck IRB requests that when you have a manuscript, thesis, or presentation prepared for 
public consumption, that you provide the Fort Peck IRB with an opportunity to review the document 
prior to publication and to make recommendations to ensure that the document appropriately respects 
the Fort Peck peoples. 
 
 

 
 
 
INSTITUTIONAL REVIEW BOARD 
For the Protection of Human Subjects 
FWA 00000165 
MONTANA 
STATE UNIVERSITY 
 
960 Technology Blvd. Room 127 
c/ o Microbiology & Immunology 
Montana State University 
Bozeman, MT 59718 
Telephone: 406-994-6783 
FAX: 406-994-4303 
E-mail: cherylj@montana .edu 
 
Chair: 
Mark Quinn 
406-994-4707 
mquinn@montana.edu 
Administrator: 
Cheryl Johnson 
406-994-4706 
cherylj@montana.edu 
 
 
MEMORANDUM 
 
 
 
TO: 
Elizabeth Rink 
- 
, 
FROM: 
Mark Quinn  
Chair, Institutional Rr   view Board for the Protection of Human Subjects 
 
DATE: 
February 5, 2018 
 
SUBJECT: 
''Nen Onk?umbi/Edahiyedo ("We Are Here Now'J - a Multi-level, Multi-component 
sexual and Reproductive Health Intervention for American Indian Youth" [ER020518] 
 
 
The above proposal was reviewed by expedited review by the Institutional Review Board. This 
proposal is now approved for a period of one-year. 
 
Please keep track of the number of subjects who participate in the study and of any unexpected or 
adverse consequences of the research. If there are any adverse consequences, please report them 
to the committee as soon as possible. If there are serious adverse consequences, please suspend 
the research until the situation has been reviewed by the Institutional Review Board. 
 
Any changes in the human subjects' aspects of the research should be approved by the committee 
before they are implemented. 
 
It is the investigator's responsibility to inform subjects about the risks and benefits of the research. 
Although the subject's signing of the consent form, documents this process, you, as the investigator 
should be sure that the subject understands it. Please remember that subjects should receive a copy 
of the consent form and that you should keep a signed copy for your records. 
 
In one year, you will be sent a questionnaire asking for information about the progress of the 
research. The information that you provide will be used to determine whether the committee will give 
continuing approval for another year. If the research is still in progress in 5 years, a complete new 
application will be required. 

 
Nen OnkUmbi/EdaHiYedo ("We Are Here Now") 
Informed Consent to Participate in Human Subjects Research with Montana State University in 
Partnership with Fort Peck Community College 
What is this project about? 
We Are Here Now is an intervention project with Fort Peck Community College and Montana State University. 
The purpose of this intervention is to teach youth at Fort Peck important things they need to know about sex so 
that they can stay healthy and not get a sexually transmitted disease, HIV, or Hepatitis C, and so that they can 
make healthy decisions about having children, getting pregnant, or getting someone pregnant. We Are Here 
Now teaches parents about how to speak with their child about sensitive topics related to sex. We Are Here 
Now also teaches Assiniboine and Sioux youth about their culture and traditional beliefs and practices about 
what it means to be a young Native person who will soon be an adult. 
Why me? 
You have been selected to participate in this focus group because you participated in We Are Here Now. You 
may choose to participate or not participate in this focus group at any time. 
What happens to me if I decide to participate? 
If you decide to be in this focus group we will be asking you questions about what you liked and did not like 
about We Are Here Now. The focus group will be about 1 hour. We will ask you questions about what you 
thought was good about We Are Here Now and what you did not like so much. We will also ask you what you 
think we need to change to make the program better the next time we do the program here at Fort Peck. We 
will record the focus group and we will not keep track of who is saying what. This means that nothing you say  
will be associated with you. Your responses are anonymous. If you agree to participate in this focus group, you 
will receive a $10 gift card that you can use here at Fort Peck. 
What are the risks? 
There may be very minimal risks to participating in the focus group. We are going to ask you questions about 
what you liked and did not like about We Are Here Now. Maybe you might feel uncomfortable sharing with us 
what you thought about the program. That is okay. It is important that we hear for you about what you liked and 
did not like about We Are Here Now so that we can make it better the next time we implement the program 
here. If there is something you would really like us to know and do not feel comfortable talking about it in the 
focus group you can contact Paula Firemoon at Fort Peck Community College and speak with her. 
What are the benefits? 
The information gathered in this focus group will help the We Are Here Now's research team and members of 
the Fort Peck community to understand how to make this program better for young people on the reservation. 
Who gets access to information from this interview? 
 
The research team has access to the data collected for this project. The We Are Here Now community 
advisory board will also have access to the data collected for this intervention. All responses in this focus group 
are confidential amongst the other people in the focus group. It is important that what we say in the focus 
group stays here. So that we respect what everyone has to say. In the transcripts created from the focus group 
recording none of the responses will be associated with your name. This means that your responses in the 
focus group transcripts are anonymous. Neither the research team nor the community advisory board will know 
who you are in the focus group transcripts. 
 

 
 

 
How am I i nformed about the results of the proje ct, and when will they be released and presented to 
someone else? 
We will publish the intervention results and make presentations on the results from We Are Here Now. Your 
identity will never appear in a publication or in print or be discussed at a presentation. In addition, you will have  
the opportunity to learn about the intervention results by contacting members of the research team, attending 
community meetings where we share the results of the project, and through local (Fort Peck Reservation) 
media. 
Who is involved in We Are Here Now? 
If you have any questions regarding this survey please contact: 
Paula Firemoon,  Fort Peck Community College - Email: PFiremoon@fpcc,edu ; Phone: 406.768.6300 
Ramey Growing Thunder, Fort Peck Tribes Language and Culture Department 
Email:rgrowingthunder@gm ail.com; Phone: 406.768-3520 
Elizabeth Rink, Montana State University- Email: elizabeth.rink@montana.edu; Phone: 406.994.3833 
CONSENT STATEMENT 
If the research participant is a minor: 
If you are 18 years or younger and you agree to participate in this focus group, please read, complete, and 
sign the statement below. By signing this consent form you are giving your verbal and written consent to 
complete this focus group. 
Minor: I have read the above and understand the discomfort, inconvenience, and risks associated with this 
focus group. 
I, ______________________________________ , agree to participate in this focus group. 
Name of Minor 
Minor Participant Signature: _  _  _  _  _  _  _  _  _  _  _  _  _  _  _  _ Date: 
_ 
 
 
Parent/Legal Guardian agreement for minor: 
If as a parent or guardian you do want your child to participate in this focus group, please read, complete, and 
sign the statement below. 
Parent/Legal Guardian for Minor: I have read the above and understand the discomfort, inconvenience, and 
risks associated with this focus group. 
I,   
,do agree to have my child participate in this focus group. 
Name of Parent/Guardian: __________________________________________ Date:  
Parent/Guardian Signature: 
   Date:  
Focus Group Administrator Signature: 
 Date: 
  
 
 

 
Nen OnkUmbi/EdaHiYedo ("We Are Here Now") 
Informed Consent to Participate in Human Subjects Research with Montana State 
University in Partnership with Fort Peck Community College 
What is this project about? 
We Are Here Now is an intervention project with Fort Peck Community College and Montana 
State University. The purpose of this intervention is to teach youth at Fort Peck important things 
they need to know about sex so that they can stay healthy and not get a sexually transmitted 
disease, HIV, or Hepatitis C, and so that they can make healthy decisions about having 
children, getting pregnant, or getting someone pregnant. We Are Here Now teaches parents 
about how to speak with their child about sensitive topics related to sex. We Are Here Now also 
teaches Assiniboine and Sioux youth about their culture and traditional beliefs and practices 
about what it means to be a young Native person who will soon be an adult. 
Why me? 
You have been selected to participate in this focus group because you participated in Native 
Voices which is part of a larger intervention called We Are Here Now. You may choose to 
participate or not participate in this focus group at any time. 
What happens to me if I decide to participate? 
If you decide to be in this focus group we will be asking you questions about what you liked and 
did not like about Native Voices. The focus group will be about 1 hour. We will ask you 
questions about what you thought was good about Native Voices and what you did not like so 
much. We will also ask you what you think we need to change to make the program better the 
next time we do the program here at Fort Peck. We will record the focus group and we will not 
keep track of who is saying what. This means that nothing you say will be associated with you. 
Your responses are anonymous. If you agree to participate in this focus group, you will receive 
a $20 gift card that you can use here at Fort Peck. 
What are the risks? 
There may be very minimal risks to participating in the focus group. We are going to ask you 
questions about what you liked and did not like about Native Voices. Maybe you might feel 
uncomfortable sharing with us what you thought about the program. That is okay. It is important 
that we hear for you about what you liked and did not like about Native Voices so that we can 
make it better the next time we implement the program here. We will also ask you questions 
about what you may have changed about the what and how you speak with your child about sex 
or relationships as a result of participating in Native Voices. If there is something you would 
really like us to know and do not feel comfortable talking about it in the focus group you can 
contact Paula Firemoon at Fort Peck Community College and speak with her. 
What are the benefits? 
The information gathered in this focus group will help the We Are Here Now's research team 
and members of the Fort Peck community to understand how to make this program better for 
young people and their parents and families on the reservation. 
 
 
 
 
  

 
Who gets access to information from this interview? 
The research team has access to the data collected for this project. The We Are Here Now 
community advisory board will also have access to the data collected for this intervention. All 
responses in this focus group are confidential amongst the other people in the focus group. It is 
important that what we say in the focus group stays here. So that we respect what everyone has 
to say. In the transcripts created from the focus group recording none of the responses will be 
associated with your name. This means that your responses in the focus group transcripts are 
anonymous.  Neither the research team nor the community advisory board will know who you 
are in the focus group transcripts. 
How am I informed about the results of the project, and when will they be released and 
presented to someone else? 
We will publish the intervention results and make presentations on the results from We Are Here 
Now. Your identity will never appear in a publication or in print or be discussed at a 
presentation. In addition, you will have the opportunity to learn about the intervention results by 
contacting members of the research team, attending community meetings where we share the 
results of the project, and through local (Fort Peck Reservation) media. 
Who is involved in We Are Here Now? 
If you have any questions regarding this focus group please contact: 
Paula Firemoon, Fort Peck Community College 
Email: PFiremoon@fpcc,edu; Phone: 406.768.6300 
 
Ramey Growing Thunder, Fort Peck Tribes Language and Culture Department 
Email:rgrowingthunder@gmail.com; Phone: 406.768-3520 
 
Elizabeth Rink, Montana State University 
Email: elizabeth.rink@montana.edu; Phone: 406.994.3833 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
CONSENT STATEMENT 
Parent/Legal Guardian: I have read the above and understand the discomfort, inconvenience, 
and risks associated with this focus group. 
 
I, ___________________________________ , do agree to participate in this focus group. 
 
 
Name of Parent/Guardian:   
   
 
Parent/Guardian Signature:-   
Date: 
 
Focus Group Administrator Signature:·  
Date:
 
 
 

                                                                 
 
 
INSTITUTIONAL REVIEW BOARD 
For the Protection of Human Subjects 
FWA 00000165 
 
 
       MONTANA 
STATE UNIVERSITY 
2155 Analysis Drive 
c/o Microbiology & Immunology 
Montana State University 
Bozeman, MT 59718 
Telephone: 406,994-6783 
FAX: 406-994-4303 
E-mail: cherylj@montana.edu 
Chair: 
Mark Quinn 
406-994-4707 
mquinn@montana.edu 
Administrator: 
Cheryl Johnson 
406-994-4706 
cherylj@montana.edu 
 
 
MEMORANDUM 
 
 
 
TO: 
Elizabeth Rink, Genevieve Cox, Paula Firemoon, Mike Anastario 
FROM: 
Mark Quinn  
Chair, Institutional Review Board for the Protection of Human Subjects 
 
DATE: 
October 3, 2018 
 
SUBJECT: 
"Nen unk?umbi/Edahiyedo ("We Are Here Now'? - a Multi-level, Mu/ti-component 
Sexual and Reproductive Health Intervention for American Indian Youth" [ER100318- 
FC] 
 
 
The above proposal was reviewed by the Institutional Review Board. This proposal is now approved 
for a period of one-year. 
 
Please keep track of the number of subjects who participate in the study and of any unexpected or 
adverse consequences of the research. If there are any adverse consequences, please report them 
to the committee within 3 calendar days. If there are serious adverse consequences, please suspend 
the research until the situation has been reviewed by the Institutional Review Board. 
 
Any changes in the human subjects' aspects of the research should be approved by the committee 
before they are implemented. 
 
It is the investigator's responsibility to inform subjects about the risks and benefits of the research. 
Although the subject's signing of the consent form, documents this process, you, as the investigator 
should be sure that the subject understands it. Please remember that subjects should receive a copy 
of the consent form and that you should keep a signed copy for your records. 
 
In one year, you will be sent a questionnaire asking for information about the progress of the 
research. The information that you provide will be used to determine whether the committee will give 
continuing approval for another year. If the research is still in progress in 5 years, a complete new 
application will be required. 

NenUnkUmbi/EdaHiYedo ("We  Are Here Now") 
Waiver of Consent to Participate in Human Subjects Research with Montana State University in 
Partnership with Fort Peck Community College 
 
We Are Here Now is an intervention project with Fort Peck Community College and Montana State University. 
NenUnkUmbi/EdaHiYedo ("We are Here Now," or NIE) derives from the Assiniboine (NenUnkUmbi) and 
Sioux (EdaHiYedo) names for their traditional coming-of-age  ceremonies.  The  purpose  of this  program is to 
teach  youth at Fort  Peck  important  things they need  to know about sex so that they can stay healthy  and not get  
a sexually transmitted disease, HIV, or Hepatitis C, and so that they can make healthy decisions about having 
children, getting pregnant, or getting someone pregnant. We  Are  Here  Now  also  includes  tribal  elders and 
leaders teaching Assiniboine and Sioux youth about  their  culture  and  traditional  beliefs  and  practices  about 
what it means to be a young Native person  who  will soon  be an adult.  In addition  to working  with  youth, We 
Are Here Now also is offering education to parents/legal guardians about how to speak with their children about 
sensitive topics related to sex. 
 
As part ofN/E will be working with the Fort Peck Epi Team to evaluate the reproductive health services 
available to youth on the Fort Peck Indian Reservation. Members of the Montana State University and Fort Peck 
based research team will be attending Epi team meetings to assess the reproductive health services available for 
youth on the reservation. These meetings will include discussions of the barriers and facilitators of reproductive 
health and tracking any changes that the agency you work for makes as result of our discussions. The Montana 
State University and Fort Peck based research team will provide regular feedback to the Epi Team of the 
monitoring we are conducting related to the barriers and facilitators of reproductive health services for tribal 
youth. 
 
Our discussions will be audiotaped and transcribed in order to conduct content analysis of the primary themes 
that emerge related to the barriers and facilitators of our discussions. There is no risk associated with your 
involvement in the discussions; and there is no cost or compensation to you for participation in our discussions. 
 
If you have any questions regarding N/E please contact: 
Paula FireMoon, Fort Peck Community College 
Email: PFiremoon@fpcc,edu; Phone: 406.768.6300 
Elizabeth Rink, Montana State University 
Email: elizabeth.rink@montana.edu; Phone: 406.994.3833 
Mark Quinn, Montana State University Institutional Review Board Chair 
Email: mguinn@montana.edu; Phone: 406.994. 4707 
 
CONSENT STATEMENT 
 
I have read the purpose ofN/E and the role of the Epi Team in this study. 
 
I,   
,do agree to participate in the Epi Team discussions related to 
assessing the barriers and facilitators of reproductive health services of youth on the Fort Peck Indian 
Reservation. 
 
 
Signature:  
Date:  
 
 
 
 

NenUnkUmbi/EdaHiYedo ("We  Are  Here Now") 
Informed Consent to Participate in Human Subjects Research with Montana State University in 
Partnership with Fort Peck Community College 
 
What is this project about? 
We Are Here Now is an intervention project with Fort Peck Community College and Montana State University. 
The purpose of this intervention is to teach youth at Fort Peck important things they need to know about sex so 
that they can stay healthy and not get a sexually transmitted disease, HIV, or Hepatitis C, and so that they can 
make healthy decisions about having children, getting pregnant, or getting someone pregnant. We Are Here 
Now also teaches Assiniboine and Sioux youth about their culture and traditional beliefs and practices about 
what it means to be a young Native person who will soon be an adult. 
 
Why me? 
You have been selected to participate in We Are Here Now because you are a young person at Fort Peck. You 
may choose to participate or not participate at any time. 
 
What happens to me if I decide to participate? 
If you decide to be in We Are Here Now, you will participate in a survey that will take 50 to 60 minutes. You will 
be asked to complete this survey three more times during the next year so that we can keep track of any 
changes you may have in your beliefs and behaviors as a result of participating in We Are Here Now. You will 
be asked several questions about different topics related to sex, having children, and sexually transmitted 
diseases in order to learn about what you think about having children and what you know about sexually 
transmitted diseases. You will also be asked questions about your sexual behavior and experiences with drugs 
and alcohol. You will also be asked questions about your feelings and emotions and your traditional culture. It 
is important that you know that all of your responses on this survey are anonymous. This means that no one 
will know that it is you who answered these questions. Your responses will be kept track of in the computer that 
you are taking the survey on. Your name will be nowhere in the computer or on the survey. There is no cost to 
you if you agree to participate in this study. If you agree to participate in this survey, you will receive a $10 gift 
card that you can use here at Fort Peck. Also by agreeing to participate in We Are Here Now, your parent/legal 
guardian is agreeing to participate in an educational program called Native Voices, and you are agreeing to be 
part of a cultural mentoring program with the Fort Peck Tribes' Language and Culture Department. 
 
What are the risks? 
There may be minor risks to agreeing to participate in the survey. Some of the questions may make you feel 
uncomfortable, sad, or confused. You may choose to stop the survey at any time or decline to answer a 
particular question. The questions will be about your life experiences as they relate to sex, drug and alcohol 
use, having children, sexually transmitted diseases, your feelings and emotions, and your understanding of 
your traditional culture. A list of resources are provided in this consent form if you feel that you would like to 
speak with someone further about your life experiences. None of the things that you say on the survey will be 
connected to your name. 
 
What are the benefits? 
The information gathered in this survey will help the intervention's research team and members of the Fort 
Peck community to understand what kind of impact your participation in We Are Here Now is having on your 
decisions to avoid getting a sexually transmitted disease and your decisions about having children when you 
feel you are ready. We would also like you to know that if you tell us about any abusive situation you are 
experiencing or have experienced, we will need to report that to the appropriate services here at Fort Peck so 
that you can receive assistance. 
 
Who gets access to information from this interview? 
All responses on this survey will be confidential. Only one person, Paula FireMoon, will know that you 
participated. Your personal information such as your name, telephone number and address will be linked to a 
study identification number to track your participation in the study. Your personal information will only be kept 
in order to contact you to participate in the follow up data collection for this study. Your personal information 
will be kept in a locked file cabinet at the Fort Peck Community College Institutional Review Board 
administration office in Poplar. Neither Paula nor the rest of the research team, nor the community advisory  

board, will know what your individual responses to the survey are. The data collected in this study will not be 
associated with your name. The research team and the community advisory board will have access to the data 
collected for this project with no identifying information on it that can be associated with your name.  
 
How am I informed about the results of the project, and when will they be released and presented to 
someone else? 
We will publish the intervention results and make presentations on the results from We Are Here Now. Your 
identity will never appear in a publication or in print or be discussed at a presentation. In addition, you will have 
the opportunity to learn about the intervention results by contacting members of the research team, attending 
community meetings where we share the results of the project, and through local (Fort Peck Reservation) 
media. 
 
Who is involved in We Are Here Now? 
If you have any questions regarding this survey please contact: 
 
Paula FireMoon, Fort Peck Community College 
Email: PFiremoon@fpcc,edu; Phone: 406.768.6300 
Elizabeth Rink, Montana State University 
Email: elizabeth.rink@montana.edu; Phone: 406.994.3833 
Mark Quinn, Montana State University Institutional Review Board Chair 
Email: mquinn@montana.edu; Phone: 406.994. 4707 
 
CONSENT STATEMENT 
 
If the research participant is a minor: 
 
If you are 18 years or younger and you agree to participate in this survey, please read, complete, and sign the 
statement below. By signing this consent form you are giving your verbal and written consent to complete this 
survey. 
 
Minor: I have read the above and understand the discomfort, inconvenience, and risks associated with this 
survey. 
 
I,   
,agree to participate in this survey. 
Name of Minor 
 
Minor Participant Signature:  
Date: ______________ 
 
Parent/Legal Guardian agreement forJnir1or: 
 
If as a parent or guardian you do want your child to participate in this survey, please read, complete, and sign 
the statement below. 
 
Parent/Legal Guardian for Minor: I have read the above and understand the discomfort, inconvenience, and 
risks associated with this survey. 
 
I,  
, do agree to have my child participate in this survey. 
Name of Parent/Guardian 
 
 
Parent/Guardian Signature:  
   Date:  
 
 
  Survey Administrator Signature:  
Date: 
 

We Are Here Now - Pilot Intervention Parent Focus Group Guide 
 
NenUnkUmbi/EdaHiYedo ("We Are Here Now") 
Informed Consent to Participate in Human Subjects Research with Montana State 
University in Partnership with Fort Peck Community College 
 
What is this project about? 
We Are Here Now is an intervention project with Fort Peck Community College and Montana 
State University. NenUnkUmbi/EdaHiYedo ("We are Here Now," or NIE) derives from the 
Assiniboine (NenUnkUmb1) and Sioux (EdaHiYedo) names for their traditional coming-of-age 
ceremonies. The purpose of this program is to teach youth at Fort Peck important things they 
need to know about sex so that they can stay healthy and not get a sexually transmitted disease, 
HIV, or Hepatitis C, and so that they can make healthy decisions about having children, getting 
pregnant, or getting someone pregnant. We Are Here Now also includes tribal elders and leaders 
teaching Assiniboine and Sioux youth about their culture and traditional beliefs and practices 
about what it means to be a young Native person who will soon be an adult. In addition to working 
with youth, We Are Here Now also is offering education to parents/legal guardians about how to 
speak with their children about sensitive topics related to sex. 
 
Why me? 
You and your child have been invited to participate in We Are Here Now and to help gather 
information about the program and its effects. Your participation in this intervention is entirely 
voluntary. You can choose not to participate at any time. You and your child may withdraw from the 
intervention at any time without negative consequences. Your participation in We Are Here Now is 
your choice. 
 
What happens to me if I decide to participate? 
If you agree to participate in We Are Here Now, you will be with other guardians or parents of 
young people who are participating in We Are Here Now, and you will learn about how to talk with 
your child about sex. We Are Here Now is a project that educates youth and their 
guardians/parents about sexual and reproductive health. As a participant in We Are Here Now, you 
will be talking with other guardians/parents about healthy sexual behaviors and about how to talk 
with your children about sex. You will be asked to complete a survey specifically for 
guardians/parents about how you talk to your child about sex and what kinds of things about sex 
you speak with them about. There is no cost to you if you agree to participate in this study. You will 
receive an incentive of $20 for this first survey, and then $10 each time you attend the four Native 
Voices sessions (at 2 of these sessions you will again fill out the survey). Finally, you will receive a 
$25 incentive for completing the final survey after the end of the program. 
 
What are the risks? 
Some of the questions may make you feel a bit uncomfortable. For example, we will ask you about 
what kinds of sexual topics you talk about with your child. A list of community resources is provided 
with this informed consent if you feel you would like to speak with someone further about feelings 
that may have been brought up as a result of your participation in this study. 
 
What are the benefits? 
Through this program you will learn about ways to speak effectively with your child about sex and 
topics related to sexual health. The information gathered in this survey will help the intervention's 
research team and members of the Fort Peck community to understand what kind of impact your 
participation in We Are Here Now is having on your decisions to talk with your child about sensitive 
topics related to sex.  
 

We Are Here Now - Pilot Intervention Parent Focus Group Guide 
 
Who gets access to information from this interview? 
All responses on this survey will be confidential. Only one person, Paula FireMoon, will know 
that you participated. Your personal information such as your name, telephone number and 
address will be linked to a study identification number to track your participation in the study. 
Your personal information will only be kept in order to contact you to participate in the follow 
up data collection for this study. Your personal information will be kept in a locked file cabinet 
at the Fort Peck Community College Institutional Review Board administration office in 
Poplar. Neither Paula nor the rest of the research team, nor the community advisory board, 
will know what your individual responses to the survey are. The data collected in this study 
will not be associated with your name. The research team and the community advisory board 
will have access to the data collected for this project with no identifying information on it that 
can be associated with your name. 
 
How am I informed about the results of the project, and when will they be released and 
presented to someone else? 
We will publish the intervention results and make presentations on the results from We Are 
Here Now. Your identity will never appear in a publication or in print or be discussed at a 
presentation. In addition, you will have the opportunity to learn about the intervention results 
by contacting members of the research team, by attending community meetings where we 
share the results of the project, and through local (Fort Peck Reservation) media. 
 
Who is involved in We Are Here Now? 
If you have any questions regarding this survey please contact: 
 
Paula FireMoon, Fort Peck Community College 
Email: PFiremoon@fpcc,edu; Phone: 406.768.6300 
 
Elizabeth Rink, Montana State University 
Email: elizabeth.rink@montana.edu; Phone: 406.994.3833 
 
Mark Quinn, Montana State University Institutional Review Board Chair 
Email: mquinn@montana.edu; Phone: 406.994. 4707 
 
CONSENT STATEMENT 
 
Parent/Legal Guardian for Minor: I have read the above and understand the discomfort, 
inconvenience, and risks associated with this survey. 
 
I,   
,do agree to participate in this survey. 
Name of Parent/Guardian 
 
 
Parent/Guardian Signature:  
Date: ________ 
 
 
Survey Administrator Signature:  
Date:_________ 
 

We Are Here Now - Pilot Intervention Parent Focus Group Guide 
 
INSTITUTIONAL REVIEW BOARD 
For the Protection of Human Subjects 
FWA 00000165 
 
MONTANA 
STATE UNIVERSITY 
96 0 T echn ology Blvd. Room 127 
c/o Microb io logy & Immun ology 
Mont ana St ate University 
Bozeman, MT 597 18 
Telephone:   406-99 4-678 3 
FAX: 406-99 4 -4303 
E-mail:   cherylj@montana.edu 
Chair: 
Mark Quinn 
406-994-4707 
mquinn @montana .edu 
Administrator: 
Ch eryl Johnson 
406-994-4706 
che rylj@ montan a.edu 
 
 
 
 
MEMORANDUM 
 
 
TO: 
FROM: 
 
DATE: 
SUBJECT: 
Elizabeth Rink 
 
Mark Quinn 
. 
Chair, Institutional Review Board for the Protection of Human Subjects 
August 9, 2019 
''Nen Onk?umbi/Edahiyedo ("We Are Here Now'J - a Multi-level, Multi-component 
sexual and Reproductive Health Intervention for American Indian Youth - Pilot 
Study [ER020518] 
 
 
This is to acknowledge receipt of the request dated August 8, 2019 for a minor modification to 
the above protocol. The request for the following modification is approved: 
 
• 
Increase the incentive for parents to complete the final survey three months after 
finishing Native Voices. 

We Are Here Now - Pilot Intervention Parent Focus Group Guide 
 
NenUnkUmbi/EdaHiYedo ("We Are Here Now") 
Informed Consent to Participate in Human Subjects Research with Montana State 
University in Partnership with Fort Peck Community College 
 
What is this project about? 
We Are Here Now is an intervention project with Fort Peck Community College and Montana 
State University. NenUnkUmbi/EdaHiYedo ("We are Here Now," or NIE) derives from the 
Assiniboine (NenUnkUmb1) and Sioux (EdaHiYedo) names for their traditional coming-of-age 
ceremonies. The purpose of this program is to teach youth at Fort Peck important things they 
need to know about sex so that they can stay healthy and not get a sexually transmitted 
disease, HIV, or Hepatitis C, and so that they can make healthy decisions about having 
children, getting pregnant, or getting someone pregnant. We Are Here Now also includes tribal 
elders and leaders teaching Assiniboine and Sioux youth about their culture and traditional 
beliefs and practices about what it means to be a young Native person who will soon be an 
adult. In addition to working with youth, We Are Here Now also is offering education to 
parents/legal guardians about how to speak with their children about sensitive topics related to 
sex. 
 
Why me? 
You and your child have been invited to participate in We Are Here Now and to help gather 
information about the program and its effects. Your participation in this intervention is entirely 
voluntary. You can choose not to participate at any time. You and your child may withdraw from 
the intervention at any time without negative consequences. Your participation in We Are Here 
Now is your choice. 
 
What happens to me if I decide to participate? 
If you agree to participate in We Are Here Now, you will be with other guardians or parents of 
young people who are participating in We Are Here Now, and you will learn about how to talk 
with your child about sex. We Are Here Now is a project that educates youth and their 
guardians/parents about sexual and reproductive health. As a participant in We Are Here Now, 
you will be talking with other guardians/parents about healthy sexual behaviors and about how 
to talk with your children about sex. You will be asked to complete a survey specifically for 
guardians/parents about how you talk to your child about sex and what kinds of things about sex 
you speak with them about. There is no cost to you if you agree to participate in this study. You 
will receive an incentive of $20 each time you attend the four Native Voices sessions. At 2 of 
these sessions you will fill out a survey. You will also receive a $25 incentive for completing the 
final survey three months after finishing Native Voices . 
 
What are the risks? 
Some of the questions may make you feel a bit uncomfortable. For example, we will ask you 
about what kinds of sexual topics you talk about with your child. 
 
What are the benefits? 
Through this program you will learn about ways to speak effectively with your child about sex 
and topics related to sexual health. The information gathered in this survey will help the 
intervention's research team and members of the Fort Peck community to understand what kind 
of impact your participation in We Are Here Now is having on your decisions to talk with your 
child about sensitive topics related to sex. 
 
APPROVED 

We Are Here Now - Pilot Intervention Parent Focus Group Guide 
 
MSU IRB 

We Are Here Now - Pilot Intervention Parent Focus Group Guide 
 
Who gets access to information from this interview? 
All responses on this survey will be confidential. Only one person, Paula FireMoon, will know that you 
participated. Your personal information such as your name, telephone number and address will be linked to 
a study identification number to track your participation in the study. Your personal information will only be 
kept inorder to contact you to participate in the follow up data collection for this study. Your personal 
information will be kept in a locked file cabinet at the Fort Peck Community College Institutional Review Board 
administration office in Poplar. Neither Paula nor the rest of the research team, nor the community advisory 
board, will know what your individual responses to the survey are. The data collected in this study will not be 
associated with your name. The research team and the community advisory board will have access to the 
data collected for this project with no identifying information on it that can be associated with your name. 
 
How am I informed about the results of the project, and when will they be released and presented to 
someone else? 
We will publish the intervention results and make presentations on the results from We Are Here Now. Your 
identity will never appear in a publication or in print or be discussed at a presentation. In addition, you will 
have the opportunity to learn about the intervention results by contacting members of the research team, by 
attending community meetings where we share 
the results of the project, and through local (Fort Peck Reservation) media. 
 
Who is involved in We Are Here Now? 
If you have any questions regarding this survey please contact: 
 
Paula FireMoon, Fort Peck Community College 
Email: PFiremoon@fpcc,edu; Phone: 406.768.6300 
 
Elizabeth Rink, Montana State University 
Email: elizabeth.rink@montana.edu; Phone: 406.994.3833 
 
Mark Quinn, Montana State University Institutional Review Board Chair 
Email: mquinn@montana.edu; Phone: 406.994. 4707 
 
CONSENT STATEMENT 
 
Parent/Legal Guardian for Minor: I have read the above and understand the discomfort, inconvenience, and risks 
associated with this survey. 
 
I, 
, do agree to participate in this survey. 
Name of Parent/Guardian 
 
 
Parent/Guardian Signature: 
Date:________ 
 
 
Survey Administrator Signature: 
Date:_________ 
 
 
 
APPROVED 

We Are Here Now - Pilot Intervention Parent Focus Group Guide 
 
 MSU IRB 

We Are Here Now - Pilot Intervention Parent Focus Group Guide 
INSTITUTIONAL REVIEW BOARD 
  For the Protection of Human Subjects 
FWA 00000165 
MONTANA 
STATE UNIVERSITY 
 
960 Tedmology Blvd. Room 127 
c/ o Microbiology & Imm u nology 
Montana Srate University 
Bozeman, MT 597 18 
Telephone: 406-994--6783 
FAX: 406-994-4303 
E-mail: cherylj@montana.edu 
 
Chair: 
Mark Quinn 
406-994-4707 
mquinn@montana.edu 
Administrator: 
Cheryl .John so n 
406-9 94-4706 
cherylj@montanaedu 
 
MEMORANDUM 
 
 
TO: 
Elizabeth Rink 
FROM: 
Mark Quinn 
Chair , Institutional Review Board for the Protection of Human Subjects 
 
DATE: 
April 20, 2020 
 
SUBJECT: 
"Nen Onk?umbi/Edahiyedo ("We Are Here Now'? - a Multi-level, Multi-component 
Sexual and Reproductive Health Intervention for American Indian Youth- Pilot 
Study" [ER020518] 
 
 
This is to acknowledge receipt of the request dated April 20, 2020 for minor modifications to the 
above protocol. The request for the following modifications is approved: 
 
• 
Protocol is being changed for parents to read and complete a parent educational packet 
of resources alongside one-on-one meetings with our Native implementors, rather than 
group educational sessions; 
• 
Request to include Focus Groups focused on Fidelity, Acceptability, and Sustainability of 
the project implementation to be conducted in summer 2020. A total of 8 focus groups 
will be conducted including two focus groups with youth participants, two focus groups 
with parents of youth participants, 2 focus groups surrounding the cultural mentoring 
components of the intervention, and 2 focus groups with professionals involved in the 
intervention. 

We Are Here Now - Pilot Intervention Parent Focus Group Guide 
 
 
 
NenUnkUmbi/EdaHiYedo ("We Are Here Now") 
lnformed Consent to Participate in Human Subjects Research with Montana State University in 
Partnership with Fort Peck Community College 
 
We Are Here Now is an intervention project with Fort Peck Community College and Montana State 
University. NenUnkUmbi/EdaHiYedo ("We are Here Now," or NIE) derives from the Assiniboine 
(NenUnkUmb1) and Sioux (EdaHiYedo) names for their traditional coming-of-age ceremonies. The purpose 
of this program is to teach youth at Fort Peck important things they need to know about sex so that they 
can stay healthy and not get a sexually transmitted disease, HIV, or Hepatitis C, and so that they can make 
healthy decisions about having children, getting pregnant, or getting someone pregnant. We Are Here Now 
also includes tribal elders and leaders teaching Assiniboine and Sioux youth about their culture and 
traditional beliefs and practices about what it  means to  be  a  young Native person who will soon be an 
adult. In addition to working with youth, We Are Here Now also is offering education to parents/legal 
guardians about how to speak with their children about sensitive topics related to sex. 
 
You have been chosen to participate in a Focus Group to help us understand the  value and effectiveness 
of We Are Here Now because you are involved in the intervention as a youth participant in the  schools, as 
a parent of a participant, or  as someone who has been helping to facilitate We Are Here Now. We would 
like to better understand your point of view on what has worked best so far with We Are Here Now and 
what might be improved. Specifically,  we would like to understand what experiences  and activities you 
have liked or did not like, what educational information you liked or did not like, and any recommendations 
you might have for improving We Are Here Now. 
 
Our discussions will be audiotaped and transcribed. These transcriptions are anonymous and confidential, 
and we will ask all participants to maintain confidentiality of discussions. However, we cannot guarantee full 
confidentiality because we cannot guarantee that participants involved in this Focus Group will not share 
stories or discussions outside our group. However, in transcriptions, no names will be used. There is no 
risk associated with your involvement in the discussions; and there is no cost to you for your participation in 
our discussions. You will receive $20 for your time. 
 
We will publish the intervention results and make presentations on the results from We Are Here Now. 
Information from the project will also be posted on the U.S. website, https://ClinicalTrials.gov. Your identity 
will never appear in a publication or in print or be discussed at a presentation. In addition, you will have the 
opportunity to learn about the intervention results by contacting members of the research team, attending 
community meetings where we share the results of the project, and through your local community media. 
 
If you have any questions regarding this Focus Group please contact: 
 
Paula FireMoon, Fort Peck Community College 
Email: PFiremoon@fpcc,edu; Phone: 406-768-6300 
 
Olivia Johnson, Fort Peck Community College 
Email: OJohnson@fpcc.edu; Phone: 406-768-6300 
 
Elizabeth Rink, Montana State University 
Email: elizabeth.rink@montana.edu; Phone: 406-994-3833 
 
Mark Quinn, Montana State University Institutional Review Board Chair 
Email: mquinn@montana.edu ; Phone: 406-994-4707 
 
 

We Are Here Now - Pilot Intervention Parent Focus Group Guide 
 
 
 
 
CONSENT STATEMENT: 
 
If the research participant is a minor: 
If you are 18 years or younger and you agree to participate in this focus group, please read, 
complete, and sign the statement below. By signing this consent form you are giving your verbal 
and written consent to complete this focus group. 
 
Minor: I have read the above and understand the discomfort, inconvenience, and risks associated 
with this focus group. 
I, __________________________________ , agree to participate in this focus group. 
Name of Minor 
Minor Participant Signature: _  _  _  _  _  _  _  _  _  _  _  _  _  _  _  _ 
Date: _ _  _  _  _  _ 
 
 
Parent/Legal Guardian agreement for minor: 
If as a parent or guardian you do want your child to participate in this focus group, please read, 
complete, and sign the statement below. 
Parent/Legal Guardian for Minor: I have read the above and understand the discomfort, 
inconvenience, and risks associated with this focus group. 
I, _______________________________ , do agree to have my child participate in this focus 
group. 
Name of Parent/Guardian: _ _  _  _  _  _  _  _  _  _  _  _  _  _  _  _  _  _  _  _ 
 
Parent/Guardian Signature: _ _  _  _  _  _  _  _  _  _  _  _  _  _  _  _  _  _  _  _  Date: _  _  _  _ 
 
Focus Group Administrator Signature: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ .Date_ _   

 
We Are Here Now - Pilot Intervention Parent Focus Group Guide 
 
 
 
INSTITUTIONAL REVIEW BOARD 
For the Protection of Human Subjects 
FWA 00000165 
 
MONTANA 
STATE UNIVERSITY 
960 Technology Blvd. Room 127 
c/o Microbiology & Immunology 
Montana State University 
Bozeman, MT 59718 
Telephone: 406-994-6783 
FAX: 406-994-4303 
E-mail: cherylj@montana.edu 
Chair: 
Mark Quinn 
406-994-4707 
mquinn@montana.edu 
Administrator: 
Cheryl Johnson 
406-994-4706 
cherylj@montana.edu
 
 
MEMORANDUM 
 
 
TO: 
Elizabeth Rink, Genevieve Cox, Paula Firemoon, Mike Anastario 
 
FROM: 
Mark Quinn 
Chair, Institutional Review Board for the Protection of Human Subjects 
DATE: 
September 30, 2020 
SUBJECT: 
''Nen Onk?umbi/Edahiyedo ("We Are Here Now'J - a Multi-level, Multi-component 
sexual and Reproductive Health Intervention for American Indian Youth 
[ER100318-FCJ 
 
 
This is to acknowledge receipt of the request dated September 29, 2020 for minor modifications 
to the above protocol. The request for the following modifications is approved: 
 
• 
Will conduct a within scope data collection of the impact of COVID-19 on their primary 
outcome variables and the study's stepped wedge design. 
• 
Will be collecting data from a subset of the study participants. The data collection will 
include: a chain referral network survey and in-depth interviews. 
• 
Submitted the consent forms and data collection instruments for the two methods of data 
collection. 

Pl: Elizabeth Lynne Rink, PhD MSW 
 
Nen OnkUmbi/EdaHiYedo ("We Are Here Now") 
Informed Consent to Participate in Human Subjects Research with Montana State University in 
Partnership with Fort Peck Community College 
 
What is this project about? 
We Are Here Now is an intervention project with Fort Peck Community College and Montana State 
University. The purpose of this intervention is to teach youth at Fort Peck important things they need to 
know about sex so that they can stay healthy and not get a sexually transmitted disease, HIV, or Hepatitis 
C, and so that they can make healthy decisions about having children, getting pregnant, or getting someone 
pregnant. We Are Here Now also teaches Assiniboine and Sioux youth about their culture and traditional 
beliefs and practices about what it means to be a young Native person who will soon be an adult. For the 
purpose of this interview we would like to learn from you how COVID-19 and the sheltering in place orders 
have impacted your behaviors. 
Why me? 
You have been selected to participate in this survey because you participate in the original data collection 
for We Are Here Now in Spring 2019. You may choose to participate or not participate at any time. 
What happens to me if I decide to participate? 
If you decide to participate in this interview we will ask you a series of questions about how COVID-19 and 
the sheltering in place orders impacted some of your behaviors and your feelings as well as your friends 
and family. The interview that will take about 45 minutes.  You will be asked several questions about 
different topics related to sex, your feelings and what you did during the sheltering in place orders from 
March 2020 to May 2020 and then, you will also be asked questions about what has happened in your life 
more recently. It is important that you know that all of your responses are anonymous. his means that no 
one will know that it is you who answered these questions. We will audio-tape and transcribe your interview. 
Your name will be nowhere in the transcript  of your interview. If you agree to participate in this interview,  
you will receive a $10 gift card that you can use here at Fort Peck. If you would like a copy of your interview 
please let us know and we will make sure that you receive a copy of the transcript from our discussion. 
What are the risks? 
There may be minor risks to agreeing to participate in the interview. Some of the questions may make you 
feel uncomfortable, sad, or confused. You may choose to stop the interview at any time or decline to answer 
a particular question. The questions will be about your perceptions of what was going on in your life during 
the sheltering place orders last Spring, from March 2020 to May 2020 and then now. None of the things that 
you say in the interview will be connected to your name. Although there are minor risks to agreeing to 
participate in the interview, if you feel sad or lonely or anxious you can talk to the person here today who is 
giving you this survey about how you are feeling and they are help you. You are also contact the names on 
this informed consent and we can assist you with finding someone to help you with how you are feeling. 
What are the benefits? 
The information gathered in this interview will help us understand how COVID-19 has impacted young 
people at Fort Peck so that we can help the Tribes, schools and other resources at Fort Peck you and your 
family now and in the future. We would also like you to know that if you tell us about any abusive situation 
you are experiencing or have experienced, we will need to report that to the appropriate services here at 
Fort Peck so that you can receive assistance. 
Who gets access to information from this interview? 
The research team has access to the data collected for this project. The We Are Here Now community 
advisory board will also have access to the data collected for this intervention. All responses on this survey 
will be anonymous. Neither the research team nor the community advisory board will know who you are and 
what your responses to the survey are. 
How am I informed about the results of the project, and when will they be released and presented to 
someone else? 
We will publish the results and make presentations on the results from this survey. Your identity will never 
appear in a publication or in print or be discussed at a presentation. In addition, you will have the 
opportunity to learn about the intervention results by contacting members of the research team, attending 
 
Supplemental Funding Request In-Depth Interview Guide 
9-28-20 
APPROVED 
MSU IRB 

Pl: Elizabeth Lynne Rink, PhD MSW 
 
community meetings where we share the results of the project, and through local (Fort Peck Reservation) 
media. 
 
Who is involved in We Are Here Now? 
If you have any questions regarding this survey please contact: 
 
Paula FireMoon, Fort Peck Community College 
Email: PFiremoon@fpcc,edu; Phone: 406.768.6300 
 
Bob McAnnally, Fort Peck Institutional Review Board Chair 
Email: bmcassin@gmail.co; Phone: 406.768.6300. 
 
Elizabeth Rink, Montana State University 
Email: elizabeth.rink@montana.edu; Phone: 406.994.3833 
 
Mark Quinn, Montana State University Institutional Review Board Chair 
Email: MQuinn@montana.edu; Phone: 406-994-4707 
 
CONSENT STATEMENT 
 
If the research participant is a minor: 
 
If you are 18 years or younger and you agree to participate in this survey, please read, complete, and sign 
the statement below. By signing this consent form you are giving your verbal and written consent to 
complete this survey. 
 
Minor: I have read the above and understand the discomfort, inconvenience, and risks associated with this 
survey. 
 
I,   
,agree to participate in this survey. 
Name of Minor 
 
Minor Participant Signature: 
Date: 
_ 
 
Parent/Legal Guardian agreement for minor: 
 
If as a parent or guardian you do want your child to participate in this survey, please read, complete, and 
sign the statement below. 
 
Parent/Legal Guardian for Minor: I have read the above and understand the discomfort, inconvenience, 
and risks associated with this survey. 
 
I,   
_,do agree to have my child participate in this survey. 
 
Name of Parent/Guardian 
 
Parent/Guardian Signature: ____________________________________________Date: 
 
_ 
 
 
Survey Administrator Signature: 
Date 
 
_ 
 
 
 
 
Supplemental Funding Request In-Depth Interview Guide 
9-28-20 
APPROVED 
MSU IRB 

Date approved 
Nen UnkUmbi/EdaHiYedo ("We Are Here Now") 
Informed Consent to Participate in Human Subjects Research with Montana State University in 
Partnership with Fort Peck Community College 
 
What is this project about? 
We Are Here Now is an intervention project with Fort Peck Community College and Montana State University. 
The purpose of this intervention is to teach youth at Fort Peck important things they need to know about sex so 
that they can stay healthy and not get a sexually transmitted disease, HIV, or Hepatitis C, and so that they can 
make healthy decisions about having children, getting pregnant, or getting someone pregnant. We Are Here 
Now also teaches Assiniboine and Sioux youth about their culture and traditional beliefs and practices about 
what it means to be a young Native person who will soon be an adult. For the purpose of this survey we would 
like to learn from you how COVID-19 and the sheltering in place orders have impacted your behaviors . 
 
Why me? 
You have been selected to participate in this survey because you participate in the original data collection for 
We Are Here Now in Spring 2019. You may choose to participate or not participate at any time. 
 
What happens to me if I decide to participate? 
If you decide to participate in this survey we will ask you a series of questions about how COVID-19 and the 
sheltering in place orders impacted some of your behaviors and your feelings. The survey that will take about 
45 minutes. You will be asked several questions about different topics related to sex, your feelings and what 
you did during the sheltering in place orders from March 2020 to May 2020 and then, you will also be asked 
questions about what you have done over the past month. It is important that you know that all of your 
responses on this survey are anonymous. This means that no one will know that it is you who answered these 
questions. Your responses will be kept track of in the computer that you are taking the survey on. Your name 
will be nowhere in the computer or on the survey. If you agree to participate in this survey, you will receive a 
$10 gift card that you can use here at Fort Peck. Once you have finished the survey, you will be given a 
coupon to give to 2 or 3 of the people that you socialize with so that they can participate in the survey .also. For 
each person you tell to participate in the survey you will receive another $10 gift card. You may also sk you to 
participate in an interview to talk with us further about what you think is important for us to know about how 
COVID 19 influenced your life. 
 
What are the risks? 
There may be minor risks to agreeing to participate in the survey. Some of the questions may make you feel 
uncomfortable, sad, or confused. You may choose to stop the survey at any time or decline to answer a 
particular question. The questions will be about sex, drug and alcohol use, your feelings and emotions, and 
how your life has been impacted by COVID-19 and the sheltering in place orders. None of the things that you 
say on the survey will be connected to your name. Although there are minor risks to agreeing to participate in 
the survey, if you feel sad or lonely or anxious you can talk to the person here today who is giving you this 
survey about how you are feeling and they are help you. You are also contact the names on this informed 
consent and we can assist you with finding someone to help you with how you are feeling. 
 
What are the benefits? 
The information gathered in this survey will help us understand how COVID-19 has impacted young people at 
Fort Peck so that we can help the Tribes, schools and other resources at Fort Peck you and your family now 
and in the future. We would also like you to know that if you tell us about any abusive situation you are 
experiencing or have experienced, we will need to report that to the appropriate services here at Fort Peck so 
that you can receive assistance. 
 
Who gets access to information from this interview? 
The research team has access to the data collected for this project. The We Are Here Now community 
advisory board will also have access to the data collected for this intervention. All responses on this survey will 
be anonymous. Neither the research team nor the community advisory board will know who you are and what 
your responses to the survey are.  
 
APPROVED MSUIRB  

Supplemental Funding Request In-Depth Interview Guide 
9-28-20 
PI: Elizabeth Lynne Rink, PhD MSW 
APPROVED MSU 05/03/2021 
IRB# ER020518 
INSTITUTIONAL REVIEW BOARD 
How am I informed about the results of the project, and when will they be released and presented to 
someone else? 
We will publish the results and make presentations on the results from this survey. Your identity will never appear 
in a publication or in print or be discussed at a presentation. In addition, you will have the opportunity to learn about 
the intervention results by contacting members of the research team, attending community meetings where we 
share the results of the project, and through local (Fort Peck Reservation) media. 
 
Who is involved in We Are Here Now? 
If you have any questions regarding this survey please contact: 
 
Paula FireMoon, Fort Peck Community College 
Email: PFiremoon@fpcc,edu; Phone: 406.768.6300 
 
Bob McAnnally, Fort Peck Institutional Review Board Chair 
Email: bmcassin@gmai l.co; Phone: 406.768.6300. 
 
Elizabeth Rink, Montana State University 
Email: elizabeth.rink@montana.edu; Phone: 406.994.3833 
 
Mark Quinn, Montana State University Institutional Review Board Chair 
Email: MQuinn@montana.edu; Phone: 406-994-4707 
 
CONSENT STATEMENT 
 
If the research participant is a minor: 
 
If you are 18 years or younger and you agree to participate in this survey, please read, complete, and sign the  
statement below. By signing this consent form you are giving your verbal and written consent to complete this  
survey. 
 
Minor: I have read the above and understand the discomfort, inconvenience, and risks associated with this 
survey. 
 
I, _______________________________________ , agree to participate in this survey. 
Name of Minor 
 
Minor Participant Signature: 
Date:· _ _ _ _ _ 
 
Parent/Legal Guardian agreement for minor: 
 
If as a parent or guardian you do want your child to participate in this survey, please read, complete, and sign the 
statement below. 
 
Parent/Legal Guardian for Minor: I have read the above and understand the discomfort, inconvenience, and 
risks associated with this survey. 
 
I, 
, do agree to have my child participate in this survey. 
Name of Parent/Guardian 
 
Parent/Guardian Signature: ___________________________________________ Date: 
 
Survey Administrator Signature  _________________________________________ Da-te 
 
 
 

Supplemental Funding Request In-Depth Interview Guide 
9-28-20 
PI: Elizabeth Lynne Rink, PhD MSW 
APPROVED MSU 05/03/2021 
IRB# ER020518 
Nen ŨnkUmbi/EdaHiYedo (“We Are Here Now”) 
Informed Consent to Participate in Human Subjects Research with 
Montana State University in Partnership with Fort Peck Community 
College 
What is this project about? 
We Are Here Now is an intervention project with Fort Peck Community College and Montana State University. The 
purpose of this intervention is to teach youth at Fort Peck important things they need to know about sex so that they 
can stay healthy and not get a sexually transmitted disease, HIV, or Hepatitis C, and so that they can make healthy 
decisions about having children, getting pregnant, or getting someone pregnant. We Are Here Now also teaches 
Assiniboine and Sioux youth about their culture and traditional beliefs and practices about what it means to be a 
young Native person who will soon be an adult. For the purpose of this interview we would like to learn from you 
how the COVID-19 pandemic over the past year impacted your behaviors. 
Why me? 
You have been selected to participate in this interview because you participate in the original data collection for We 
Are Here Now in Spring 2019. You may choose to participate or not participate at any time. 
What happens to me if I decide to participate? 
If you decide to participate in this interview, we will ask you a series of questions about how COVID-19 and the 
sheltering in place orders impacted some of your behaviors and your feelings as well as your friends and family. 
The interview that will take about 45 minutes. You will be asked several questions about different topics related to 
sex, your feelings and what you did during COVID-19 pandemic when you could not go to school because your 
school was shut down, you will also be asked questions about what has happened in your life more recently. It is 
important that you know that all of your responses are anonymous. This means that no one will know that it is you 
who answered these questions. We will audiotape and transcribe your interview. Your name will be nowhere in the 
transcript of your interview. If you agree to participate in this interview, you will receive a $10 gift card that you can 
use here at Fort Peck. If you would like a copy of your interview please let us know and we will make sure that you 
receive a copy of the transcript from our discussion. 
What are the risks? 
There may be minor risks to agreeing to participate in the interview. Some of the questions may make you feel 
uncomfortable, sad, or confused. You may choose to stop the interview at any time or decline to answer a particular 
question. The questions will be about your perceptions of what was going on in your life over the past year during the 
COVID-19 pandemic. None of the things that you say in the interview will be connected to your name. Although there 
are minor risks to agreeing to participate in the interview, if you feel sad or lonely or anxious you can talk to the 
person here today who is giving you this interview about how you are feeling, and they are help you. You are also 
contact the names on this informed consent and we can assist you with finding someone to help you with how you 
are feeling. 
What are the benefits? 
The information gathered in this interview will help us understand how the COVID-19 pandemic has impacted 
young people at Fort Peck so that we can help the Tribes, schools and other resources at Fort Peck you and your 
family now and in the future. We would also like you to know that if you tell us about any abusive situation you are 
experiencing or have experienced, we will need to report that to the appropriate services here at Fort Peck so that 
you can receive assistance. 
Who gets access to information from this interview? 
The research team has access to the data collected for this project. The We Are Here Now community advisory 
board will also have access to the data collected for this intervention. All responses in this interview are 
anonymous. Neither the research team nor the community advisory board will know who you are and what your 
responses to the interview are. 
How am I informed about the results of the project, and when will they be 
released and presented to someone else? 
We will publish the results and make presentations on the results from the interviews that we conduct to agencies at 
Fort Peck and the Fort Peck Tribal Executive Board. Your identity will never appear in a publication or in print or be 
discussed at a presentation. In addition, you will have the opportunity to learn 

Supplemental Funding Request In-Depth Interview Guide 
9-28-20 
PI: Elizabeth Lynne Rink, PhD MSW 
APPROVED MSU 05/03/2021 
IRB# ER020518 
about the intervention results by contacting members of the research team, attending community meetings where 
we share the results of the project, and through local (Fort Peck Reservation) media. 
 
Who is involved in We Are Here Now? 
If you have any questions regarding this interview, please contact: 
 
Paula FireMoon, Fort Peck Community College 
Email: PFiremoon@fpcc,edu; Phone: 406.768.6300 
 
Bob McAnnally, Fort Peck Institutional Review Board Chair 
Email: bmcassin@gmail.co; Phone: 406.768.6300. 
 
Elizabeth Rink, Montana State University 
Email: elizabeth.rink@montana.edu; Phone: 406.994.3833 
 
Mark Quinn, Montana State University Institutional Review Board Chair 
Email: MQuinn@montana.edu; Phone: 406-994-4707 
 
CONSENT STATEMENT 
 
If the research participant is a minor: 
 
If you are 18 years or younger and you agree to participate in this interview, please read, complete, and sign the 
statement below. By signing this consent form, you are giving your verbal and written consent to complete this 
interview. 
 
Minor: I have read the above and understand the discomfort, inconvenience, and risks associated with this 
interview. 
 
I, 
, agree to participate in this interview. 
Name of Minor 
 
Minor Participant Signature: 
Date:   
 
 
Parent/Legal Guardian agreement for minor: 
 
If as a parent or legal guardian you do want your child to participate in this interview, please read, 
complete, and sign the statement below. 
 
Parent/Legal Guardian for Minor: I have read the above and understand the discomfort, inconvenience, 
and risks associated with this interview. 
 
I, 
, do agree to have my child participate in this interview. 
 
Name of Parent/Legal Guardian 
 
Parent/Legal Guardian Signature: 
Date:   
 
 
 
Interview Administrator Signature: 
Date   
 
 
 
 

- Page 1 of 6 - 
 
ClinicalTrials. gov PRS 
Protocol Registration and Results System 
 
ClinicalTrials.gov Protocol Registration and Results System (PRS) Receipt 
Release Date: October 1, 2018 
 
ClinicalTrials.gov ID: NCT03694418 
 
 
Study Identification 
Unique Protocol ID: R01MD012761 
Brief Title: We Are Here Now: a Multi-level, Multicomponent Sexual and Reproductive 
Health Intervention for American Indian Youth ( NE) 
Official Title: We Are Here Now: a Multi-level, Multicomponent Sexual and Reproductive 
Health Intervention for American Indian Youth 
Secondary IDs: 
 
 
Study Status  
 
Record Verification: October 2018 
Overall Status: Not yet recruiting 
Study Start: March 1, 2019 [Anticipated] 
Primary Completion:  November 30, 2021 [Anticipated] 
Study Completion:  November 30, 2022 [Anticipated] 
 
 
Sponsor/Collaborators  
 
Sponsor: Montana State University 
Responsible Party: Principal Investigator 
Investigator: Elizabeth Rink [erink] 
Official Title: Associate Professor 
Affiliation: Montana State University 
Collaborators: 
 
 
Oversight  
 
U.S. FDA-regulated Drug: No 
U.S. FDA-regulated Device: No 
U.S. FDA IND/IDE:  No 
Human Subjects Review: Board Status: Pending 
Board Name: Montana State University IRB 
Board Affiliation: Mark Quinn 
Phone: 994-4707 
Email: mquinn@montana.edu 
Address: 
 
960 Technology Blvd. Room 127 

- Page 2 of 6 - 
 
Montana State University 
Bozeman, Montana 59718 
Data Monitoring: Yes 
FDA Regulated Intervention: No 
 
Study Description  
 
Brief Summary: N/E is a community-based participatory research (CBPR) multi-level, multi- 
component sexual and reproductive health (SRH) intervention, constructed on 
Ecological Systems Theory. N/E is based on Fort Peck tribal members' desire 
to implement a holistic SRH intervention for Al youth. N/E includes: 1) A school- 
based SRH curriculum called Native Stand, designed to address individual- 
level factors that lead to sexual risk behaviors; 2) a family-level curriculum 
called Native Voices, tailored to increase communication between adult family 
members and youth about SRH topics; 3) a cultural mentoring component 
at the community level that pairs Al youth with adults and elders to discuss 
traditional Al beliefs and practices about SRH; and 4) a mobilizing strategy to 
activate a multi-sectoral network of youth-servicing organizations at the systems 
level in Fort Peck to coordinate SRH services for Al youth. The overarching 
aim of this proposal is to refine, tailor, and finalize the components of N/E and 
evaluate its efficacy. We will use a cluster-randomized stepped-wedge design 
(SWD), in which 5 schools that Al youth from Fort Peck attend are the clusters 
to be randomized into the intervention 1 at a time, with all schools eventually 
being randomized to the intervention. The 5 schools are located in separate 
communities, mitigating the potential for cross-contamination. N/E is a 5-year 
study involving 456 15- to 18-year-old Al youth. 
Detailed Description: N/E is a community-based participatory research (CBPR) multi-level, multi- 
component sexual and reproductive health (SRH) intervention, constructed on 
Ecological Systems Theory. N/E is based on Fort Peck tribal members' desire 
to implement a holistic SRH intervention for Al youth. N/E includes: 1) A school- 
based SRH curriculum called Native Stand, designed to address individual- 
level factors that lead to sexual risk behaviors; 2) a family-level curriculum 
called Native Voices, tailored to increase communication between adult family 
members and youth about SRH topics; 3) a cultural mentoring component 
at the community level that pairs Al youth with adults and elders to discuss 
traditional Al beliefs and practices about SRH; and 4) a mobilizing strategy to 
activate a multi-sectoral network of youth-servicing organizations at the systems 
level in Fort Peck to coordinate SRH services for Al youth. The overarching 
aim of this proposal is to refine, tailor, and finalize the components of N/E and 
evaluate its efficacy. We will use a cluster-randomized stepped-wedge design 
(SWD), in which 5 schools that Al youth from Fort Peck attend are the clusters 
to be randomized into the intervention 1 at a time, with all schools eventually 
being randomized to the intervention. The 5 schools are located in separate 
communities, mitigating the potential for cross-contamination. N/E is a 5-year 
study involving 456 15- to 18-year-old Al youth. 
Our specific aims are: 
AIM 1: Refine, tailor, and finalize the components of N/E. Our community 
advisory board and the Fort Peck-based and MSU-based research team will 
design culturally appropriate adaptations for N/E's 4 levels during the first 
year of the study, based on the analysis of our recently completed qualitative 
and quantitative research (focus groups, interviews, and surveys), as well as 
discussions with elders and community stakeholders. 
AIM 2: Test the efficacy of N/E for 15- to 18-year-old Al youth. Our hypotheses 
are: 

- Page 3 of 6 - 
 
H1: Al youth who participate in N/E will demonstrate increased condom use 
at 3, 9, and 12 months. (12 months will be used in the Primary Outcome 
analysis; 3 and 9 months will be used in the Secondary Outcomes analysis.) 
H2: Al youth who participate in N/E will demonstrate increased use of other 
birth control at 3, 9, and 12 months. They also will demonstrate a decrease 
in sexual risk behaviors as measured by reduced number of sex partners, 
delayed onset of sexual intercourse, and decreased substance use during 
sex, at 3, 9, and 12 months. (Secondary Outcomes) H3: N/E parents/legal 
guardians and youth will demonstrate significantly increased communication 
about topics related to SRH at 3, 9, and 12 months. Al youth who participate 
in the cultural mentoring program will demonstrate significantly increased 
understanding of cultural values related to traditional Al beliefs regarding 
SRH at 3, 9, and 12 months. And Al youth who participate in N/E will report 
significantly increased use of SRH services at 3, 9, and 12 months as a result 
of improved coordination among education, health care, and social service 
agencies on the Fort Peck Reservation. (Tertiary Outcomes) AIM 3: Evaluate 
the fidelity and acceptability of N/E. N/E's fidelity and acceptability will be 
evaluated using qualitative methods, including focus groups, activity logs, and 
staff field notes and meetings.
 
Conditions 
 
 
 
Conditions: Reproductive Behavior 
Sexual Behavior 
Keywords: 
Study Design 
Study Type: lnterventional 
Primary Purpose: Prevention 
Study Phase: N/A 
lnterventional Study Model: Sequential Assignment 
Stepped Wedge Design 
Number of Arms: 3 
Masking: None (Open Label) 
Allocation: Randomized 
Enrollment: 1008 [Anticipated] 
Arms and Interventions 
 
Arms 
Assigned Interventions 
Cluster 1 
Cluster 1 is 1 school on the Fort Peck Reservation 
that will be randomized into the intervention in 2019. 
Cluster 1 will receive all four levels of the intervention 
including: 1) A school-based SRH curriculum called 
Native Stand, designed to address individual-level 
factors that lead to sexual risk behaviors; 2) a family- 
level curriculum called Native Voices, tailored to 
increase communication between adult family 
members and youth about SRH topics; 3) a cultural 
mentoring component at the community level that 
Behavioral: We are here now: a multi-level, multi- 
component sexual and reproductive health intervention 
for American Indian youth 
N/E will be implemented simultaneously over the 9- 
month school year. Components include: 1) Individual 
Level- Native Stand 2) Family Level - Native Voices; 
3) Community Level - Cultural mentoring program; and 
4) Systems Level. The fourth level of N/E mobilizes  
the existing Epi Team to enhance the coordination and 
implementation of SRH services at Fort Peck. 

- Page 4 of 6 - 
 
Arms 
Assigned Interventions 
pairs Al youth with adults and elders to discuss 
traditional Al beliefs and practices about SRH; and 
4) a mobilizing strategy to activate a multi-sectoral 
network of youth-servicing organizations at the 
systems level in Fort Peck to coordinate SRH services 
for Al youth. 
Cluster 2 
Cluster 2 includes 2 schools on the Fort Peck 
Reservation that will be randomized in the intervention 
in 2019-2020. Cluster 2 will receive all four levels 
of the intervention including: 1) A school-based 
SRH curriculum called Native Stand, designed to 
address individual-level factors that lead to sexual risk 
behaviors; 2) a family-level curriculum called Native 
Voices, tailored to increase communication between 
adult family members and youth about SRH topics; 
3) a cultural mentoring component at the community 
level that pairs Al youth with adults and elders to 
discuss traditional Al beliefs and practices about 
SRH; and 4) a mobilizing strategy to activate a multi- 
sectoral network of youth-servicing organizations at 
the systems level in Fort Peck to coordinate SRH 
services for Al youth. 
Behavioral: We are here now: a multi-level, multi- 
component sexual and reproductive health intervention 
for American Indian youth 
N/E will be implemented simultaneously over the 9- 
month school year. Components include: 1) Individual 
Level- Native Stand 2) Family Level - Native Voices; 
3) Community Level - Cultural mentoring program; and 
4) Systems Level. The fourth level of N/E mobilizes  
the existing Epi Team to enhance the coordination and 
implementation of SRH services at Fort Peck. 
Cluster 3 
Cluster 3 are the remaining 2 schools on the Fort 
Peck reservation that will be randomized into the 
intervention in 2020-2021. Cluster 3 will receive all 
four levels of the intervention including: 1) A school- 
based SRH curriculum called Native Stand, designed 
to address individual-level factors that lead to sexual 
risk behaviors; 2) a family-level curriculum called 
Native Voices, tailored to increase communication 
between adult family members and youth about SRH 
topics; 3) a cultural mentoring component at the 
community level that pairs Al youth with adults and 
elders to discuss traditional Al beliefs and practices 
about SRH; and 4) a mobilizing strategy to activate a 
multi-sectoral network of youth-servicing organizations 
at the systems level in Fort Peck to coordinate SRH 
services for Al youth. 
Behavioral: We are here now: a multi-level, multi- 
component sexual and reproductive health intervention 
for American Indian youth 
N/E will be implemented simultaneously over the 9- 
month school year. Components include: 1) Individual 
Level- Native Stand 2) Family Level - Native Voices; 
3) Community Level - Cultural mentoring program; and 
4) Systems  Level. The fourth level of N/E mobilizes 
the existing Epi Team to enhance the coordination and 
implementation of SRH services at Fort Peck. 
 
Outcome Measures 
Primary Outcome Measure: 
1. Change in condom use during sexual intercourse at 3 months, 9 months and 12 months 
Change in condom use during sexual intercourse will be measured as proportion of condom use during sexual 
intercourse will be measured using 2 items (number of times condom used relative to number of times had sexual 
intercourse). 
[Time Frame: 3 months, 9 months and 12 months] 
 
Secondary Outcome Measure: 
2. Change in delayed onset of sexual intercourse at 3 months, 9 months and 12 months 
Changes in delayed onset of sexual intercourse will be measured intercourse with 2 items (ever had sexual intercourse 
and age at first sexual intercourse) 
[Time Frame: 3 months, 9 months and 12 months] 

- Page 5 of 6 - 
 
3. Change in decreased number of sex partners at 3 months, 9 months and 12 months 
Change in decreased number of sex partners will be measured by 2 items ( lifetime of sex partners and the number of 
sex partners in the past month) 
[Time Frame: 3 months, 9 months and 12 months] 
4. Change in frequency of sexual intercourse at 3 months, 9 months and 12 months 
Change in frequency of sexual intercourse will be measured with 1 time ( frequency of sexual intercourse in the past 
month) 
[Time Frame: 3 months, 9 months and 12 months] 
5. Change in number of pregnancies at 3 months, 9 months and 12 months 
Change in number of pregnancies will be measure with 1 item (number of pregnancies) 
[Time Frame: 3 months, 9 months and 12 months] 
6. Change in increased use of birth control during sexual intercourse at 3 months, 9 months and 12 months 
Change in the increased use of birth control during sexual intercourse will be measured with 3 items (type of birth 
control used and number of times birth control was sued during sexual intercourse) 
[Time Frame: 3 months, 9 months and 12 months] 
7. Change in decreased alcohol/drug use concurrently sexual intercourse at 3 months, 9 months and 12 months 
Change in decreased alcohol/drugs used concurrently with sexual intercourse will be measured with 1 item 
( substance use with sexual intercourse) 
[Time Frame: 3 months, 9 months and 12 months] 
 
Other Pre-specified Outcome Measures: 
8. Change in increased parenUlegal guardian-child communication about sexual and reproductive health topics at 3 
months, 9 months and 12 months 
Change in increased parenUlegal-child communication about sexual and reproductive health topics will be measured 
using a 24 item Likert scale, higher score = higher communication 
[Time Frame: 3 months, 9 months and 12 months] 
9. Change in increased usage of sexual and reproductive health services at 3 months, 9 months and 12 months 
Change in increased usage of sexual and reproductive health services will be measured with 9 items ( frequency, type 
and follow up of sexual and reproductive health services used) 
[Time Frame: 3 months, 9 months and 12 months] 
 
Eligibility 
 
 
 
Minimum Age: 15 Years 
Maximum Age: 18 Years 
Sex: All 
Gender Based: No 
Accepts Healthy Volunteers: No 
Criteria: Inclusion Criteria: 
• 15 to 18 years old 
• a registered member of a federally recognized tribe or an associate tribal 
member 
• a resident of Fort Peck with a parenUlegal guardian. Exclusion criteria are 
minimal due to the CAB's value of inclusion in the intervention. 
• For inclusion in the systems-level component of the intervention, only 
those staff members who sit on the Epi Team as representatives of their 
respective agencies are eligible. 

- Page 6 of 6 - 
 
Exclusion Criteria: 
• not meeting the aforementioned inclusion criteria 
• having a medically identified physical or cognitive impairment that would impede 
their understanding of and participation in the educational content and activities of 
Native Stand, Native Voices, and the cultural mentoring program. 
 
Contacts/Locations 
Central Contact Person: Elizabeth Rink, PhD 
Telephone: 406-994-3833 
Email: elizabeth.rink@montana.edu 
Central Contact Backup: Genevieve Cox, PhD 
Telephone: 406-994-4622 
Email: genevieve.cox@motnana.edu 
Study Officials: 
Locations: United States, Montana 
Montana State University 
Bozeman, Montana, United States, 59715 
Contact: Elizabeth Rink, PhD 406-994-3833 elizabeth.rink@montana.edu 
Contact: Genevieve Cox, PhD 406-994-4622 
genevieve.cox@montana.edu 
Sub-Investigator: Paula Brien-Firemoon 
 
Fort PeckCommunity College 
Poplar, Montana, United States, 59255 
Contact: Paula Brien-FireMoon, MA 406-768-7653 PFiremoon@fpcc.edu 
IPDSharing 
 
 
Plan to Share IPD: No 
There is no plan to have an IPD sharing plan at this point in time. 
 
 
References 
 
 
Citations: 
Links: 
Available !PD/Information: 
 
U.S. National Library of Medicine I U.S. National Institutes of Health I U.S. Department of Health & Human Services 

RPPR 
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RPPR 
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A COVER PAGE 
Project Title: We are here now - a multi-level, multi-component sexual and reproductive health intervention for American Indian youth 
Grant Number: 5R01MD012761-02 
Project/Grant Period: 04/01/2018 - 11/30/2022 
Reporting Period: 04/01/2018 - 11/30/2018 
Requested Budget Period: 12/01/2018 -11/30/2019 
Report Term Frequency: Annual 
Date Submitted: 10/03/2018 
Program Director/Principal Investigator Information: 
Recipient Organization: 
ELIZABETH LYNNE RINK, PHO BA 0TH 
Phone number: 406-994-3833 
Email: elizabeth.rink@montana.edu 
MONTANA STATE UNIVERSITY - BOZEMAN 
MONTANA STATE UNIVERSITY-BOZEMAN 
309 Montana Hall 
BOZEMAN, MT 597170000 
DUNS: 625447982 
EIN: 1816010045A1 
RECIPIENT ID: 
Change of Contact PD/Pl: No 
Administrative Official: 
Signing Official: 
TRACI MIYAKAWA 
MONTANA STATE UNIV (BOZEMAN) 
BOZEMAN, MT 59717 
BOZEMAN, MT 59717 
TRACI MIYAKAWA 
MONTANA STATE UNIV (BOZEMAN) 
BOZEMAN, MT 59717 
BOZEMAN, MT 59717 
Phone number: 406-994-2381 
Email: tracim@montana.edu 
Phone number: 406-994-2381 
Email: tracim@montana.edu 
Human Subjects: Yes 
HS Exempt: No 
Exemption Number: 
Phase Ill Clinical Trial: No 
Vertebrate Animals: No 
hESC:No 
Inventions/Patents: No 

RPPR 
Page 2 
 
RPPR 
FINAL 
8. ACCOMPLISHMENTS 
8.1 WHAT ARE THE MAJOR GOALS OF THE PROJECT? 
Our study, Nen OnkUmbi/EdaHiYedo ("We Are Here Now," or N/E), builds on an 11-year collaborative research relationship between the 
Assiniboine and Sioux Tribes of the Fort Peck Reservation and Montana State University (MSU) researchers to prevent STls, HIV, HCV, and 
teen pregnancy among Al youth. 
N/E is a community-based participatory research (CBPR) multi-level, multi-component sexual and reproductive health (SRH) intervention, 
constructed on Ecological Systems Theory. N/E is based on Fort Peck tribal members'  desire to implement  a holistic SRH intervention  for 
Al youth. N/E includes: 1) A school-based SRH curriculum called Native Stand, designed to address individual-level factors that lead to 
sexual risk behaviors; 2) a family-level curriculum called Native Voices,  tailored  to increase  communication  between  adult  family 
members  and youth about SRH topics; 3) a cultural mentoring component  at the community  level that pairs Al youth with adults and   
elders to discuss traditional Al beliefs and practices about SRH; and 4) a mobilizing strategy to activate a multi-sectoral network of youth- 
servicing organizations  at the systems  level in Fort Peck to coordinate SRH services  for Al youth. The overarching  aim of this proposal is 
to refine, tailor, and finalize the components of N/E and evaluate its efficacy. We will use a cluster-randomized stepped-wedge design 
(SWD), in which 5 schools that Al youth from Fort Peck attend are the clusters to be randomized into the intervention 1 at a time, with all 
schools eventually being randomized to the intervention. The 5 schools are located in separate communities, mitigating the potential for 
cross-contamination. N/E is a 5-year study involving 456 15- to 18-year-old Al youth. 
Our specific aims are: 
AIM 1: Refine, tailor, and finalize the components of N/E. Our community advisory board and the Fort Peck-based and MSU-based 
research team will design culturally appropriate adaptations for N/E's 4 levels during the first year of the study, based on the  analysis of 
our recently completed qualitative and quantitative research (focus groups, interviews, and surveys), as well as discussions  with elders 
and community stakeholders. 
AIM 2: Test the efficacy of N/E for 15- to 18-year-old Al youth. Our hypotheses are: 
H1: Al youth who participate in N/E will demonstrate increased condom use at 3, 9, and 12 months. (12 months will be used in the 
Primary Outcome analysis; 3 and 9 months will be used in the Secondary Outcomes analysis.) 
H2: Al youth who participate in N/E will demonstrate increased use of other birth control at 3, 9, and 12 months. They also will 
demonstrate a decrease in sexual risk behaviors as measured by reduced number of sex partners, delayed onset of sexual intercourse, 
and decreased substance use during sex, at 3, 9, and 12 months. (Secondary Outcomes) 
H3: N/E parents/legal guardians and youth will demonstrate significantly increased communication about topics related to SRH at 3, 9, 
and 12 months. Al youth who participate in the cultural mentoring program will demonstrate significantly increased understanding of 
cultural values related to traditional Al beliefs regarding SRH at 3, 9, and 12 months. And Al youth who participate in N/E will report 
significantly increased use of SRH services at 3, 9, and 12 months as a result of improved coordination among education, health care, 
and social service agencies on the Fort Peck Reservation. (Tertiary Outcomes) 
AIM 3: Evaluate the fidelity and acceptability of NIE. N/E's fidelity and acceptability will be evaluated using qualitative methods, including 
focus groups, activity logs, and staff field notes and meetings. 
H4: N/E will result in a viable and sustainable multi-level, multi-component SRH intervention for Al youth. 
Our short-term goal is to integrate N/E into the existing Fort Peck infrastructure to ensure local sustainability. Our long-term goal is to 
produce a toolkit, including curriculum manuals, an SRH cultural mentoring program, and specific systems-level actions suitable for 
replication in other tribal communities. The public health impact is the prevention of STls, HIV, HCV, and teen pregnancies in Al youth 
resulting in reduced sexual and reproductive health disparities and improved health in Al families and communities. 
8.1.a Have the major goals changed since the initial competing award or previous report? 
No 
8.2 WHAT WAS ACCOMPLISHED UNDER THESE GOALS? 
File uploaded: R01MD012761_ YearOneRPPR_Accomplishments_101518.pdf 
8.3 COMPETITIVE REVISIONS/ADMINISTRATIVE SUPPLEMENTS 
For this reporting period, is there one or more Revision/Supplement associated with this award for which reporting is required? 
No 
8.4 WHAT OPPORTUNITIES FOR TRAINING AND PROFESSIONAL DEVELOPMENT HAS THE PROJECT PROVIDED? 
File uploaded: R01MD012761_YearOneRPPR_ Training&ProfessionalDevelopment_Rink_101518.pdf 
8.5 HOW HAVE THE RESULTS BEEN DISSEMINATED TO COMMUNITIES OF INTEREST? 
Dissemination of the notice of award for NE was made through Fort Peck Tribal Council meetings, meetings with Fort Peck Community- 

RPPR 
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RPPR 
FINAL 
 
College faculty, staff and students, and was published on the Montana State University webpage as well as in the Bozeman Chronicle. In 
addition, Dr. Rink was selected to give a Provost Distinguished Lecture at the Museum of the Rockies ( 9/17/18) to the academic and 
public community.  As part of her Distinguished  Lecture Dr. Rink presented on the process of developing NE in which she presented to  
the Although  this dissemination  of NE is not about the results from the study, it does provide information to the Fort Peck tribal   
community and the larger Montana State University and Montanans about the study. 
B.6 WHAT DO YOU PLAN TO DO DURING THE NEXT REPORTING PERIOD TO ACCOMPLISH THE GOALS? 
The following will be completed during the next reporting cycle (12/01/18 to 11/30/19): 
* Implement baseline data collection in the 5 schools at Fort Peck between 3/01/19 to 6/01/19. 
* Begin implementation of Aim 2 to test the efficacy of NIE for 15- to 18-year-old Al youth. Implementation of NE will begin in 9/2019 in 
one school at Fort Peck. The first school to receive NE in 9/2019 has yet to be determined because, as outlined in our proposal and in 
keeping with our study's Stepped Wedge Design, we must collect baseline data first and then randomize the schools into the 
intervention. 
• Implement systems level component of NE. 
* Manage data software REDCap. 
* Convene DMSP committee and 2 hold meetings. 
* Hold 4 community advisory board meetings and meet with community advisory board members individually as needed. 

RPPR 
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B.2 (R01MD01276l_YearOneRPPR_Accomplishments_l01518.pdf) 
 
 
The following accomplishments have been completed during reporting period (4/01/18 -11/30/18) related to 
the study's specific aims (goals): 
 
AIM 1. Refine, tailor, and finalize the components of NIE. Our community advisory board and the Fort Peck- 
based and MSU-based research team will design culturally appropriate adaptations for NIE's 4 levels during 
the first year of the study, based on the analysis of our recently completed qualitative and quantitative research 
(focus groups, interviews, and surveys), as well as discussions with elders and community stakeholders. 
 
• 
3 community advisory board meetings have been held to refine, tailor and finalize the components of 
NIE, including Native Stand, Native Voices, the Cultural Mentoring Program, and the System's Level 
adaptations. 
• 
4 meetings have been held specifically with Paula Firemoon, Ramey GrowingThunder and Elizabeth 
Rink to discuss the integration of the Cultural Mentoring Program with Native Stand and Native Voices. 
• 
2 meetings have been held with members of the Fort Peck Epi Team to discuss the adaptation of 
reproductive health services for 15-18 year old tribal youth. 
• 
2 discussions have been held with elders to talk about NIE. 
• 
Subawards have been established with Fort Peck Community College, the Fort Peck Tribes Language 
and Culture Department, and Northern Arizona University. 
• 
3 meetings (2 conference calls and 1 in-person) with Dr. Julie Baldwin at Northern Arizona University 
who is Dr. Rink's senior research mentor on the study, to discuss tailoring of NIE. 
• 
3 meetings with Adriann Ricker, consultant to discuss adaptation of systems level component of NIE 
including working with the schools to revise their sexual and productive health education policies and 
meetings with the Fort Peck Epi team to tailor their services for 15 - 18 year old tribal youth. 
• 
Hiring of personnel with Fort Peck Community College has begun. 
• 
Hiring of personnel and mentors with the Fort Peck Tribes Language and Cultural Program has  begun. 
• 
Hired research program manager to replace Elizabeth Bird. 
• 
Initiation of ClinicalTrials.gov forms for approval has begun. 
 
AIM 2: Test the efficacy of NIE for 15- to 18-year-old Al youth. 
 
• 
Data collection instruments have been finalized by the community advisory board, Fort Peck based 
research team and the Montana State University (MSU) based research team. 
• 
Participation in 2 REDCap trainings to establish data management systems of NIE. 
• 
Data management systems, REDCap, has been used to create the data management components of 
the study including the development of the data entry systems for the youth and parent surveys. 
• 
Institutional Review Board applications have been submitted to the Fort Peck IRS and the MSU IRS for 
review and approval. 
• 
Study has been registered with ClincialTrials.gov (NCT # 03694418) 
• 
Discussions with school administrators and teachers in each of the 5 schools involved in N/E have 
begun to prepare for the baselines data collection from March 1, 2019 to June 1, 2019. 
 
AIM 3: Evaluate the fidelity and acceptability of NIE. NIE's fidelity and acceptability will be evaluated using 
qualitative methods, including focus groups, activity logs, and staff field notes and meetings. 
 
• 
Aim 3 has not been implemented during this reporting period because the intervention has not started 
yet. However, per AIM 1 and AIM 2, the tailoring of N/E has been complemented, data collection 
instruments have been complemented and the research protocols for N/E are being reviewed and 
approved by the Fort Peck IRS and the MSU IRS. 
• 
2 conference calls have been held with Rachel Hallum-Montes, the study's evaluation consultant, to 
discuss and plan for the evaluation of the fidelity and acceptability of NIE. 
R01 Mnn1?7R1 YA::irOnARPPR Ar.r.nmnli hmP.nt Pl· Fli7::ihP.th I vnnP. Rink 
1 

RPPR 
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B.4 (ROl MOO12761_YearOneRPPR_Training&Professiona!Development_Rink_l O1518.pdf) 
 
Training and Professional Development completed during this reporting period (4/01/18 - 
11/30/18) including the following: 
 
• 
Attendance at 2 REDCap trainings. 
• 
3 meetings with Julie Baldwin, Dr. Rink's senior research mentor. 
• 
Participation in 1 seminar on reproduction and sexuality with underserved 
populations. 
• 
Dr. Rink mentored 1 undergraduate student intern as part of a summer internship 
program from June 2018 to August 2018. 
• 
Research Program Manager (new hire) attended one week NIH training on NIH 
grants management and NIH.gov systems, protocols, policies and procedures in 
San Francisco in October 2018. 
• 
Attendance at 1 seminar through the Center for American Indian and Rural 
Health Equity on quantitative data analysis with small populations. 

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RPPR 
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C. PRODUCTS 
C.1 PUBLICATIONS 
Are there publications or manuscripts accepted for publication In a journal or other publication (e.g., book, one-time publication, 
monograph) during the reporting period resulting directly from this award? 
No 
C.2 WEBSITE(S) OR OTHER INTERNET SITE(S) 
Nothing to report 
C.3 TECHNOLOGIES OR TECHNIQUES 
 
C.4 INVENTIONS, PATENT APPLICATIONS, AND/OR LICENSES 
Have Inventions, patent applications and/or licenses resulted from the award during the reporting period? No 
If yes, has this information been previously provided to the PHS or to the official responsible for patent matters at the grantee 
organization? 
C.5 OTHER PRODUCTS AND RESOURCE SHARING 
Nothing to report 
Survey Instruments 
Survey instruments for youth and parent data collection 
Protocols 
Institutional Review Board Protocols for the MSU and Fort Peck IRBs 
Data or Databases 
REDCap 
Evaluation Instruments 
Evaluation tracking materials for systems level component of intervention 
Educational aids or curricula 
Adaptation of Native Voices for Assiniboine & Sioux Tribes 

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D. PARTICIPANTS 
 
D.1 WHAT INDIVIDUALS HAVE WORKED ON THE PROJECT? 
ELRINK 
IY 
I Rink, 
OTH,BA,P I PD/Pl 
Elizabeth 
HD 
Lynne 
GENEVIEVE.CO Iy 
 
PhD 
Research 
Genevieve, Cox  
Program 
Manager 
JBALDWIN 
y 
Baldwin, Julie I PhD 
Co- 
Ann 
Investigator 
RGROWINGTH 
y 
GrowingThun  I MA 
Co- UNDER
 
 
der, Ramey 
Investigator 
PBRIEN- 
y 
Brien- 
JMA 
Co- 
FIREMOON 
 
Firemoon, 
 
Investigator 
Paula 
Glossary of acronyms: 
S/K - Senior/Key 
DOB - Date of Birth 
Cal - Person Months (Calendar) 
Aca - Person Months (Academic) 
Sum - Person Months (Summer) 
0.0 
3.5 
0.0 
NA 
I 3.o 
0.0 
0.0 
NA 
lo.o 
0.0 
1.0 
NA 
11.0 
0.0 
0.0 
NA 
13.0 
0.0 
0.0 
NA 
Foreign Org - Foreign Organization Affiliation 
SS - Supplement Support 
RE - Reentry Supplement 
DI - Diversity Supplement 
OT - Other 
NA - Not Applicable 
D.2 PERSONNEL UPDATES 
D.2.a Level of Effort 
Will there be, in the next budget period, either (1) a reduction of 25% or more in the level of effort from what was approved by the agency 
for the PD/Pl(s) or other senior/key personnel designated in the Notice of Award, or (2) a reduction in the level of effort below the 
minimum amount of effort required by the Notice of Award? 
No 
D.2.b New Senior/Key Personnel 
Are there, or will there be, new senior/key personnel? 
Yes 
File uploaded: Cox_BioSketch.pdf 
D.2.c Changes In Other Support 
Has there been a change In the active other support of senior/key personnel since the last reporting period? 
No 
D.2.d New Other Significant Contributors 
Are there, or will there be, new other significant contributors? 
No 
D.2.e Multi-Pl (MPI) Leadership Plan 

RPPR 
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RPPR 
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\/Viii there be a change in the MPI Leadership Plan for the next budget period? 
NA 

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D.2.b (Cox_BioSketch.pdf) 
 
 
0MB No. 0925-0001 and 0925-0002 (Rev. 09/17 Approved Through 03/31/2020) 
 
BIOGRAPHICAL SKETCH 
NAME: Cox, Genevieve Ramsey 
 
eRA COMMONS USER NAME: Genevieve.Cox 
POSITION TITLE: Research Program Manager 
EDUCATION/TRAINING 
 
 
 
 
 
 
 
 
 
 
 
 
 
A. Personal Statement 
 
As a community, cultural, and environmental sociologist, I am committed to better understanding how the 
intersection of identities and issues such as race, class, and gender should be considered in tandem with 
geography and context when trying to determine the ways that knowledge, attitudes, perceptions, and 
values inform problems of public health or community development. I completed my Ph.D. as a 
Community, Health, and Environment fellow and I have a broad range of experience working with 
community-based research. I have been involved in all stages of research projects from program 
management to data collection to analysis to program evaluation of applied health care interventions to 
the writing of findings in both scholarly publications and research briefs. I have training in quantitative, 
qualitative, and mixed methodology research design and analysis. My master's thesis and article entitled 
"Poor Women with Sexually Transmitted Infections: Providers' Perspectives on Diagnoses," looked at the 
role that stigma plays as a barrier to health care for low-income women with sexually transmitted 
infections so my applied research interests are directly related to the intervention of this study. 
 
As an Assistant Professor at a community college for three years after graduate school focused on 
teaching, I kept active in the research world by being a member of the Regional Institutional Review Board 
at the University of Southern Maine. I then helped steer a nonprofit organization as it's Program Director. 
My wide-ranging training and experience has helped inculcate a dedication to working with vulnerable and 
underserved populations. I carry this dedication with me in the community-based participatory research 
projects I am a part of. 
 
B. Positions and Honors 
2005-2006 Program Manager, National Visitor Use Monitoring Study of the Pacific Northwest. USDA Forest 
Service and Pennsylvania State University, Portland, Oregon 
2010-2013 Instructor and Lecturer, Department of Sociology, University of New Hampshire, Durham, NH 
2008-2013 Research Assistant, Carsey School of Public Policy, University of New Hampshire, Durham, NH 
INSTITUTION AND LOCATION 
DEGREE 
(if     
applicable) 
Completion 
Date 
MM/YYYY 
FIELD OF STUDY 
University of New Hampshire 
Ph.D. 
06/2012 
Sociology 
West Virginia University 
M.A. 
08/2005 
Applied Social 
Research 
Ohio University 
B.A. 
06/2002 
English and Theater 

RPPR 
Page 10 
 
D.2.b (Cox_BioSketch.pdf) 
 
2013-2016 Assistant Professor of Sociology, Department of Social Sciences, Southern Maine Community 
College, South Portland, ME 
2013-2016 Institutional Review Board Member, University of Southern Maine, Portland, ME 
2016-2017 Program Evaluator, Partnerships for Health, Augusta, ME 
2017-2018 Program Director, Renewal in the Wilderness, Portland, ME 
2018-current Research Program Manager, Center for American Indian and Rural Health Equity, Montana State 
University, Bozeman, MT 
Honors: 
2007-2011 Community, Health, and Environment Fellowship, Departments of Sociology and Psychology, 
University of New Hampshire 
2005 Velma K. Miller Award, Outstanding Graduate Student in Women's Studies, West Virginia University 
C. Contributions to Science 
Mentoring Future Scientists: 
As a former college professor focused on teaching, my main contributions to science have been in working to 
mentor future scientists. In my past classes (which have totaled upwards of 50 classes taught), we have had a 
focus on current social problems through the scientific lens of evidence-based research. This works to expand 
the student's knowledge base beyond the personal and anecdotal to understanding larger structural patterns 
and historical influence. I am extremely proud to have been a part of so many students' understanding of the 
importance of the scientific method and evidence-based research beyond their own personal experience, 
especially at the community college level. 
 
Community Context: 
Much of my past written work has to do with utilizing the community context to better understand behaviors, 
attitudes, and outcomes within communities. My doctoral dissertation was entitled, "Culture, Place, and Identity 
in a Mobile Community" and focused on ways values and place identity combine to create a community cultural 
identity that participants often adhere to. Related articles, briefs, and research presentations: 
Cox, Genevieve R., Corinna Jenkins Tucker, Erin Sharp, Karen Van Gundy, and Cesar Rebellon. 2014. 
"Practical Considerations: Community Context in a Declining Rural Economy and Emerging 
Adults' Educational and Occupational Aspirations." Emerging Adulthood. 2 (3): 173-183. 
Cox, Genevieve R. and Corinna Jenkins Tucker. 2011. "No place like home: Place and community 
identity among North Country youth." New England Issue Brief No. 24. January, 2011. The 
Carsey Institute, University of New Hampshire: Durham, NH. 
March 23, 2013. "Place Identity and Artistic Visual Integration: Burning Man Participants in Portland, 
OR." Presentation at the Annual Meeting of the Eastern Sociological Association. Boston, MA.  
February, 2012. Genevieve Cox. "Urban Mobile Artists: Why Place Still Matters for Burners in Portland, 
Oregon." Presentation at the Annual Meeting of the Eastern Sociological Association. New York, 
NY. 
November, 2011. Erin Sharp, Genevieve Cox, Cesar Rebellion, Corinna Jenkins Tucker, and Karen 
Van Gundy. "The Power of Rural Youth: Findings from the Coos Youth Study." Presentation at 
the New Hampshire Annual Celebration of National Rural Health Day. Meredith, NH. 
 
Familial Relationships: 
My research has also looked at ways that familial context interacts with outcomes for adolescents in terms of 
violence within the family and how larger economic forces affect relationships within the family. 
Tucker, Corinna Jenkins, Genevieve R. Cox, Erin Sharp, Karen Van Gundy, Cesar Rebellon, and Nena 
Stracuzzi. 2013. "Sibling Proactive and Reactive Aggression in Adolescence." Journal of Family 
Violence. 28(3):299-310. 
Tucker, Corinna Jenkins and Genevieve R. Cox. 2011. "Coos teens' view of their family economic 
stress tied to quality of relationships at home." New England Issue Brief No. 28. October, 2011. 
The Carsey Institute, University of New Hampshire: Durham, NH. 

RPPR 
Page 11 
 
D.2.b (Cox_BioSketch.pdf) 
 
Socioeconomic Status and Sexually Transmitted Infection: 
My master's thesis and subsequent manuscript focus on ways that stigma affects the experience of STI 
diagnosis between a provider and a patient. 
Cox, Genevieve R. 2011. "Poor Women with Sexually Transmitted Infections: Providers' Perspectives 
on Diagnoses." Online Journal of Rural Nursing and Health Care. 11(2). 

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E. IMPACT 
E.1 WHAT IS THE IMPACT ON THE DEVELOPMENT OF HUMAN RESOURCES? 
Not Applicable 
E.2 WHAT IS THE IMPACT ON PHYSICAL, INSTITUTIONAL, OR INFORMATION RESOURCES THAT FORM INFRASTRUCTURE? 
NOTHING TO REPORT 
E.3 WHAT IS THE IMPACT ON TECHNOLOGY TRANSFER? 
Not Applicable 
E.4 WHAT DOLLAR AMOUNT OF THE AWARD'S BUDGET IS BEING SPENT IN FOREIGN COUNTRY(IES)? 
NOTHING TO REPORT 

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F. CHANGES 
F.1 CHANGES IN APPROACH AND REASONS FOR CHANGE 
Not Applicable 
F.2 ACTUAL OR ANTICIPATED CHALLENGES OR DELAYS AND ACTIONS OR PLANS TO RESOLVE THEM 
The challenges and delays encountered during this reporting period (4/01/18 to 11/30/18) and related actions/plans to resolve them are 
listed below. 
* Elizabeth Bird resigned from her position in the beginning of the reporting period and new search had to be conducted to replace her. 
The search took several months longer than anticipated and was completed in August 2018. Currently there is a new hire who is working 
as the Research Program Manager for the study. The new hire began work on September 4, 2018. 
* Two prominent elders died at Fort Peck, one in June 2018 and the other in July 2018. Both deaths were unexpected and were felt by all 
Fort Peck Tribal members. As a result several weeks were taken up with grieving and ceremonies to honor the passing of the two elders. 
There is of course no way to plan for these types of sorrowful events in tribal communities. Because of the role that the Fort Peck Tribal 
College and the Fort Peck Tribes Language and Culture Program have in the community  study personnel were attentive to honoring  the  
2 deaths which delayed study activities. 
* In the original proposal ( that was truncated in the NOA by 4 months) the end of Year 1 baseline data collection was to be completed. 
The base line data collection was planned with the 5 schools in the study during the proposal submission process. Thus we could not 
change the base line data collection plans for Spring 2019 as schools have complicated academic schedules. Base line data collection 
will take place during Year 2 in Spring 2019 as initially planned as part of Year 1. 
* All human subjects requirements were to be completed during Year 1 in the original proposal. The truncation of Year 1 in the NOA by 4 
months has delayed this process. At present all the research protocols have been approved by the study's community advisory board;   
and Fort Peck IRB and MSU IRB are reviewing the research protocols for approval. It is anticipated that all human subjects requirements 
will be finalized by December 1, 2018 at the latest. 
* Because of the time taken to recruit and hire a new research program manager and the death of 2 elders at Fort Peck, sub awards to  
Fort Peck Community College, the Fort Peck Tribes Language and Culture Program and Northern Arizona University, were late in getting 
executed. 
F.3 SIGNIFICANT CHANGES TO HUMAN SUBJECTS, VERTEBRATE ANIMALS, BIOHAZARDS, AND/OR SELECT AGENTS 
F.3.a Human Subjects 
No Change 
F.3.b Vertebrate Animals 
No Change 
F.3.c Blohazards 
No Change 
F.3.d Select Agents 
No Change 

RPPR 
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RPPR 
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G. SPECIAL REPORTING REQUIREMENTS 
G.1 SPECIAL NOTICE OF AWARD TERMS AND FUNDING OPPORTUNITIES ANNOUNCEMENT REPORTING REQUIREMENTS 
File(s) uploaded: 
FPIRB_FWA_2018.pdf 
G.2 RESPONSIBLE CONDUCT OF RESEARCH 
Not Applicable 
G.3 MENTOR'S REPORT OR SPONSOR COMMENTS 
Not Applicable 
G.4 HUMAN SUBJECTS 
G.4.a Does the project involve human subjects? 
Yes 
Is the research exempt from Federal regulations? 
No 
Does this project involve a clinical trial? 
Yes 
If yes, is this an NIH-defined Phase Ill Clinical Trial? 
No 
G.4.b Inclusion Enrollment Data 
Report Attached: 'We are here now' - a multi-level, multi-component sexual and reproductive health intervention for American Indian 
youth 
G.4.c ClinlcalTrials.gov 
Does this project include one or more applicable clinical trials that must be registered in ClinicalTrials.gov under FDAAA? 
Yes 
If yes, provide the ClinicalTrials.gov identifier, NCT number (e.g., NCT00654321) for those trials: 
NCT03694418 
G.5 HUMAN SUBJECTS EDUCATION REQUIREMENT 
Are there personnel on this project who are newly involved in the design or conduct of human subjects research? 
No 
G.6 HUMAN EMBRYONIC STEM CELLS (HESCS) 
Does this project involve human embryonic stem cells (only hESC lines listed as approved in the NIH Registry may be used in NIH 
funded research)? 
No 
G.7 VERTEBRATE ANIMALS 

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RPPR 
FINAL 
Does this project Involve vertebrate animals? 
No 
G.8 PROJECT/PERFORMANCE SITES 
 
G.9 FOREIGN COMPONENT 
No foreign component 
G.10 ESTIMATED UNOBLIGATED BALANCE 
G.10.a Is it anticipated that an estimated unobligated balance (including prior year carryover) will be greater than 25% of the current 
year's total approved budget? 
Yes 
Estimated unobligated balance: 666930 
G.10.b Provide an explanation for unobllgated balance: 
The estimate unobligated balance will be greater that 25% because: 1) Year 1 was truncated by 4 months; 2) there was a new hire that had to 
be recruited and hired; 3) the subawards were delayed in getting executed because of the time allocated to getting the new hire and the death 
of 2 elders at Fort Peck during the Summer of 2018. 
G.10.c If authorized to carryover the balance, provide a general description of how it is anticipated that the funds will be spent 
The carryover funds will be used to complete the following: 
* Hold monthly team meetings and quarterly CAB meetings. When necessary, we will meet with CAB members individually. 
* Continue monthly trips to Fort Peck. 
* Recruit, hire, and train staff in Native Stand and Native Voices; identify the cultural mentors; purchase all necessary materials and 
supplies. 
* Collect baseline data from March 1, 2019 to June 1, 2019 as originally planned in Year 1. 
* Upon completion of the baseline data collection randmonize the 5 schools for participation in the intervention. 
* Analyze baseline data collection in collaboration with the CAB. 
* Implement evaluation of the systems level intervention with the Fort Peck Epi  Team. 
* Start the implement of the full intervention in 1 school beginning September 1, 2019. 
* Establish DSM Committee and hold 2 meetings. 
* Establish contracts with study consultants. 
G.11 PROGRAM INCOME 
Is program Income anticipated during the next budget period? 
No 
G.12 F&A COSTS 
Is there a change In performance sites that will affect F&A costs? 
 
 
Primary: MONTANA 
STATE UNIVERSITY - 
BOZEMAN 
I 625447982 
MT-001 
P.O. Box 173540 
318 Herrick Hall 
BOZEMAN MT 597173540 
Fort Peck Community 
College 
I 102366432 
MT-001 
PO Box 398 
Poplar MT 592559398 
Fort Peck Assiniboine & 
Sioux Tribes Language & 
Culture Dept 
\ 106578164 
MT-001 
PO Box 1027 
Poplar MT 592551027 

    RPPR 
FINAL 
 
No 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
RPPR 
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G.1 (FPIRB_FWA_2018.pdf) 
 
 
 
 
FWA#: 
Institution: 
Expires: 
FWA00019355 
Fort Peck Community College 
06/20/2023 
 
 
 
 
Federalwide Assurance (FWA) 
0MB  No. 0990-0278 
Approved for use through July 31, 2020 
for the Protection of Human Subiects 
 
L Institution Filing Assurance 
Legal Name: 
City: 
Poplar 
 
Fort Peck Community College 
 
State/Province:    MT 
Country: 
USA 
 
Institutional Com.u,onents 
List below all components over which the Institution has legal authority that operate under a different name. Also list 
with an asterisk(*) any alternate names under which the Institution operates. 
 
NOTE: The Signatory Official signing this Assurance must be legally authorized to represent the Institution providing 
this Assurance and all components listed below. 
 
Name of Component or 
Alternate Names Used 
Fort Peck Community College !RB 1/ l 
 
City 
Poplar 
State 
(or Country if Outside U.S.) 
MT 
A 
 
3. Statement of Principles 
This Institution assures that all of its activities related to human subjects research, regardless of the source of support,  
will be guided by the following statement of  principles governing the institution  in the discharge of its responsibilities 
for protecting the rights and welfare of human subjects of research conducted at or sponsored by the institution. (indicate 
below) 
 
The Belmont Report 
The Declaration of Helsinki 
 
 
 
 
4, Applicability 

RPPR 
Page 18 
 
 
 
G. l (FPIRB_FW A_2018.pdf) 
 
 
 
 
 
(a) This Assurance applies whenever this Institution becomes engaged in human subjects research conducted or 
supported by any U.S. federal department or agency that has adopted the U.S. Federal Policy for the Protection of 
Human Subjects (also known as the Common Rule), unless the research is otherwise exempt from the requirements of 
the Common Rule or the department or agency conducting or supporting the research determines that the research shall 
be conducted under a separate assurance. 
(b) Optional: This Institution elects to apply the following to all of its human subjects research regardless of the source 
of support, except for research that is covered by a separate assurance: 
 
 
 
 
 
 
The Common Rule and subparts B, C, and D of the HHS regulations at 45 CFR part 46 
 
 
5, Assurance of Compliance with the Terms of the Federalwide Assurance 
 
(a) This Institution assures that whenever it engages in research to which this Assurance applies, it will comply with the 
Terms of the Federalwide Assurance (contained in a separate document on the Office for Human Research Protections 
(OHRP) website). 

RPPR 
Page 19 
 
 
 
G. l (FPIRB_FWA_2018.pdf) 
 
 
 
 
6, Designation of Institutional Review Boards (IRBs) 
This Institution assures that it will rely upon only IRBs registered with OHRP for review of research to which this FWA 
applies. This institution (a) designates the following internal IRB(s) for review of research under this Assurance; or (b) 
does not have an internal IRB and designates the following external IRB for review of all research to which this FWA 
applies or, if multiple external IRBs are relied upon, the following external IRB that reviews the largest percentage of 
research to which this fWA applies. 
NOTE: Institutions designating internal IRBs do not need to designate any of the external IRBs upon which it relies. 
 
 
HHSIRB 
Registration 
Number 
Name of IRB as Registered with HHS 
 
Is the IRB Internal or 
External to the Institution? 
 
 
1, Human Protecti!)ns Administrator (e.g., Human Subjects Administrator or Human Subjects Contact Person) 
 
First Name: 
Joy 
Middle Initial: 
Last Name: Toavs 
Degrees or Suffix: 
Institution: 
BA 
Institutional Title: 
Fort Peck Community College 
Administrative Officer 
Telephone: 406 768-5555 
Address: P.O. Box 398 
605 Indian Avenue 
FAX: 
406 768-3026 
E-Mail: 
jtoavs@fpcc.edu 
City: 
Poplar 
State/Province: MT 
Country: 
USA 

RPPR 
Page 20 
 
 
 
G.1 (FPIRB_FW A_2018.pdf) 
 
 
 
 
Signatory Official (i.e., Official Legally Authorized to Represent the Institution) 
 
I have read and agree to the Terms of the Federalwide Assurance. 
 
I recognize that providing research investigators, /RB members and staff, and other relevant personnel with appropriate 
initial and continuing education and training about human subject protections will help ensure that the requirements of 
this Assurance are satisfied. 
 
Acting officially in an authorized capacity on behalf of this Institution and with an understanding of the Institution's 
responsibilities under this Assurance, I assure protections for human subjects as specified above. The IRB(s) that this 
institution relies upon will comply with the Terms of the Federalwide Assurance when reviewing research covered by 
this Assurance and possess appropriate knowledge of the local context in which this Institution's research will be 
conducted. 
All information provided with this Assurance is up-to-date and accurate. I am aware that false statements could be cause 
for invalidating this Assurance and may lead to other administrative or legal action. 
 
 
Signature: 
Wayne Two Bulls MS Ed. 
Date: 
06/20/2018 
 
First Name: 
Wayne 
Middle Initial: 
Last Name: Two Bulls 
Degrees or Suffix: 
Institution: 
MS Ed. 
Institutional Title: 
Fort Peck Community College 
Vice President of Academics 
Telephone: 406 768-6300 
Address: P.O. Box 398 
605 Indian Avenue 
 
City: 
Poplar 
FAX: 
406 768-6301 
 
 
 
State/Province: MT 
E-Mail: 
WTwoBulls@fpcc.edu 
 
 
 
Country: 
USA 
 
2, FWA AQProval 
 
The Federal wide Assurance for the Protection of Human Subjects for Institutions Within the United States submitted to 
HHS by the above Institution is hereby approved. 
 
Assurance Number: 
FWA00019355 
Signature of HHS Approving Official: Gail Holloway 
Expiration Date:   06/20/2023 
Date:   06/20/2018 

RPPR 
Page 21 
 
 
 
G.1 (FPIRB_FWA_2018.pdf) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid 
0MB control number. The valid 0MB control number for this information collection is 0990-0278 . The time required to complete this 
information collection is estimated to average 30 minutes per response, including the time to review instructions, gather the data needed, and 
complete and review the information collection. If you have comments concerning the accuracy of the time estimate(s) or suggestions for 
improving this form, please write to: U.S. Department of Health & Human Services, OS/OCIO/PRA, 200 Independence Ave., S.W., Suite 336-
E, Washington D.C. 20201, Attention: PRA Reports Clearance 

 
Inclusion Data Record (IDR) #: 200138 
Delayed Onset Study ?: No 
Enrollment Location: Domestic 
Inclusion Enrollment Report  
Using an Existing Dataset or Resource: No 
Clinical Trial: Yes 
NIH Defined Phase Ill Clinical Trial: No 
Study Title: 'We are here now' - a multi-level, multi-component sexual and reproductive health intervention for American Indian youth 
Planned Enrollment 
 
Racial Categories 
Ethnic Gateaories 
Total 
Not Hispanic or Latino 
Hispanic or Latino 
Unknown/Not 
Reported Ethnicitv 
Female 
Male 
Unknown/ 
Not Reported 
Female 
Male 
Unknown/ 
Not Reported 
Female 
Male 
Unknown/ 
Not Reported 
American Indian/Alaska Native 
500 
500 
0 
0 
1000 
Asian 
0 
0 
0 
0 
0 
Native Hawaiian or 
Other Pacific Islander 
0 
0 
0 
0 
0 
Black or African American 
0 
0 
0 
0 
0 
While 
4 
4 
0 
0 
8 
More than One Race 
0 
0 
0 
0 
0 
Unknown or Not Reported 
Total 
504 
504 
0 
0 
1008 
Cumulative Enrollment 
NOTE: No cumulative enrollment data exists. Although prompted to do so, the PD/Pl did not enter information. No data can be displayed. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
Page 1 

Nen OnkUmbi/EdaHiYedo ("We Are Here Now") 
Informed Consent to Participate in Human Subjects Research with Montana State University in 
Partnership with Fort Peck Community College 
 
What is this project about? 
We Are Here Now is an intervention project with Fort Peck Community College and Montana State University. 
The purpose of this intervention is to teach youth at Fort Peck important things they need to know about sex so 
that they can stay healthy and not get a sexually transmitted disease, HIV, or Hepatitis C, and so that they can 
make healthy decisions about having children, getting pregnant, or getting someone pregnant. We Are Here 
Now also teaches Assiniboine and Sioux youth about their culture and traditional beliefs and practices about 
what it means to be a young Native person who will soon be an adult. 
 
Why me? 
You have been selected to participate in We Are Here Now because you are a young person at Fort Peck. You 
may choose to participate or not participate at any time. 
 
What happens to me if I decide to participate? 
If you decide to be in We Are Here Now, you will participate in a survey that will take 50 to 60 minutes. You will 
be asked to complete this survey three more times during the next year so that we can keep track of any 
changes you may have in your beliefs and behaviors as a result of participating in We Are Here Now. You will 
be asked several questions about different topics related to sex, having children, and sexually transmitted 
diseases in order to learn about what you think about having children and what you know about sexually 
transmitted diseases. You will also be asked questions about your sexual behavior and experiences with drugs 
and alcohol. You will also be asked questions about your feelings and emotions and your traditional culture. It 
is important that you know that all of your responses on this survey are anonymous. This means that no one 
will know that it is you who answered these questions. Your responses will be kept track of in the computer that 
you are taking the survey on. Your name will be nowhere in the computer or on the survey. If you agree to 
participate in this survey, you will receive a $10 gift card that you can use here at Fort Peck. Also by agreeing 
to participate in We Are Here Now, your parent/legal guardian is agreeing to participate in an educational 
program called Native Voices, and you are agreeing to be part of a cultural mentoring program with the Fort 
Peck Tribes' Language and Culture Department. 
 
What are the risks? 
There may be minor risks to agreeing to participate in the survey. Some of the questions may make you feel 
uncomfortable, sad, or confused. You may choose to stop the survey at any time or decline to answer a 
particular question. The questions will be about your life experiences as they relate to sex, drug and alcohol 
use, having children, sexually transmitted diseases, your feelings and emotions, and your understanding of 
your traditional culture. None of the things that you say on the survey will be connected to your name. 
 
What are the benefits? 
The information gathered in this survey will help the intervention's research team and members of the Fort 
Peck community to understand what kind of impact your participation in We Are Here Now is having on your 
decisions to avoid getting a sexually transmitted disease and your decisions about having children when you 
feel you are ready. We would also like you to know that if you tell us about any abusive situation you are 
experiencing or have experienced, we will need to report that to the appropriate services here at Fort Peck so 
that you can receive assistance. 
 
Who gets access to information from this interview? 
The research team has access to the data collected for this project. The We Are Here Now community 
advisory board will also have access to the data collected for this intervention. All responses on this survey will 
be anonymous. Neither the research team nor the community advisory board will know who you are and what 
your responses to the survey are. 
 
How am I informed about the results of the project, and when will they be released and presented to 
someone else? 

We will publish the intervention results and make presentations on the results from We Are Here Now. Your 
identity will never appear in a publication or in print or be discussed at a presentation. In addition, you will have 
the opportunity to learn about the intervention results by contacting members of the research team, attending 
community meetings where we share the results of the project, and through local (Fort Peck Reservation) 
media. 
 
Who is involved in We Are Here Now? 
If you have any questions regarding this survey please contact: 
 
Paula FireMoon, Fort Peck Community College 
Email: PFiremoon@fpcc,edu; Phone: 406.768.6300 
 
Elizabeth Rink, Montana State University 
Email: elizabeth.rink@montana.edu; Phone: 406.994.3833 
 
CONSENT STATEMENT 
 
If the research participant is a minor: 
 
If you are 18 years or younger and you agree to participate in this survey, please read, complete, and sign the 
statement below. By signing this consent form you are giving your verbal and written consent to complete this 
survey. 
 
Minor: I have read the above and understand the discomfort, inconvenience, and risks associated with this 
survey. 
 
I,  
, agree to participate in this survey. 
Name of Minor 
 
 
Minor Participant Signature:  
Date:  
_ 
 
Parent/Legal Guardian agreement for minor: 
 
If as a parent or guardian you do want your child to participate in this survey, please read, complete, and sign 
the statement below. 
 
Parent/Legal Guardian for Minor: I have read the above and understand the discomfort, inconvenience, and 
risks associated with this survey. 
 
I,   
,do agree to have my child participate in this survey. 
Name of Parent/Guardian 
 
 
Parent/Guardian Signature:  
Date:  
 
_ 
 
 
Survey Administrator Signature:  
Date  
 
_ 

Introduction 
 
This survey will ask you questions about yourself. Many of the questions are about topics related to sex, 
alcohol and drugs, how you talk to your parents about sex, and your life experiences. Please remember that all 
of your answers to the questions are anonymous. This means that no one will know that it was you who 
answered these questions. No one will know your name and your answers to the questions. Only the answers 
to the questions will be recorded, not your name. 
 
Thank you for taking the time to complete this survey. 
 
SECTION 1: DEMOGRPAHICS 
 
1.1 What is your gender? 
Male 
Female 
 
1.2 How old are you?  
(age in years) 
 
1.3 What town do you live in? 
 
Frazer 
Oswego 
Wolf Point 
Poplar 
Brockton 
Fort Kipp 
Other   
 
 1
.4. What grade are you in? 
gth 
10th 
11th 
12th 
 
SECTION 2: CULTURAL IDENTITY (terliary outcome variable) 
 
The next set of questions are related to your culture and what it means for you to be an American Indian. 
 
2.1 How much do you now live by or follow an American Indian way of life? 
 
a. Not at all 
b. A little 
c. Some 
d. A lot 
 
2.2 How much do you now live by or follow a White or Anglo way of life? 
 
a. Not at all 
b. A little 
c. Some 
d. A lot 
 
2.3 How important is it to you to follow religious or spiritual beliefs which are based on traditional Indian 
beliefs? 
 
a. Not at all important 
b. Not very important 

c. Somewhat important 
d. Very important 
 
2.4 How important is it to you to follow religious or spiritual beliefs that are based on Christian beliefs such as 
Catholic, Baptist, Mormon, etc.? 
 
a. Not at all important 
b. Not very important 
c. Somewhat important 
d. Very important 
 
2.7. How proud are you to be an American Indian? 
 
a. Not at all proud 
b. Not very proud 
c. Somewhat proud 
d. Very proud 
e. I do not consider myself to be an American Indian. 
 
2.8 What kinds of activities have you participated in over the past year? 
□ Gathering traditional foods 
□ Singing and drumming 
□ Beading 
□ Traditional ceremonies 
□ Hand/stick games 
□ Sweats 
□ Hunting 
□ Kinship History 
□ Using sacred medicine 
□ Going to Pow Wows 
□ Dancing at Pow Wows 
□ Learning what it means to be a 
□ Traditional beliefs about sex 
man (if male)/woman(if female) 
□ Learning about what it means to be 
an adult 
□ Sundance/Medicine lodge 
□ Other (please describe): 
 
SECTION 3: COMMUNICATION ABOUT SEX WITH PARENTS/LEGAL GUARDIAN (tertiary outcome 
variable) 
 
Now you are going to be asked questions about what kinds of topics related to sex you do or do not talk with 
your parents/legal guardian about. 
 
3.1. Have you talked with your parent/legal guardian about each of the following topics in the past year?  
 
. 
YES I NO I I DON'T KNOW 
a. What qualities are important in choosinq close friends 
b. What qualities to look for in a boyfriend/girlfriend/life 
bodies ch 
ansmitted infections (STls 
e to have sex 

h. How well birth control can prevent pregnancy 
i. How to choose a method of birth control 
j. How to say no if someone wants to have sex and you 
don't want to 
k. How well condoms can prevent sexually transmitted 
infections (STls) 
I. Menstruation (having menstrual periods) 
m. The importance of not pressuring other people to have 
sex 
n. How you will make decisions about whether or not to 
have sex 
o. Consequences of getting pregnant/getting someone 
preqnant 
p. How to use a condom 
q. Reasons why you should not have sex 
r. Masturbation 
s. What it feels like to have sex 
t. Homosexuality/people beinq qay 
u. Wet dreams fmeasured for boys onlyl 
v. What to do if a partner doesn't want to use a condom 
w. How people can prevent getting sexually transmitted 
infections (STls) 
x. How you will know if you are in love 
 
SECTION 4: ACCESS TO REPRODUCTIVE HEALTH SERVICES(terliary outcome variable) 
This next set of questions is about where you go to get services like getting a pregnancy test, sexually 
transmitted disease test, or birth control. 
 
4.1 Have you ever been to Indian Health Service or Fort Peck Tribal Health for things like condoms, birth 
control, a pregnancy test or a sexually transmitted disease test? 
 
a. yes 
b. no 
 
4.2 If you need to get condoms, birth control, a pregnancy test, or a sexually transmitted disease test, where 
would you go? (Mark all that apply) 
 
a. Indian Health Services 
b. Fort Peck Tribal Health 
c. Roosevelt County Health Department 
d. Somewhere off the reservation 
e. The Hospital 
f. A private doctor 
g. Local stores 
h. School nurse 
i. Teachers or counselors in your school 
j. Elder 
k. Other 
 
4.3 If you had to put your response on a scale, how uncomfortable or comfortable would you say you feel when 
a health care provider talks with you about birth control and STDs? Would you say you are: 
 
a. Very uncomfortable 
b. Slightly uncomfortable 
c. Neither uncomfortable or comfortable 

d. Slightly comfortable 
e. Very comfortable 
 
4.4 In general, how satisfied or dissatisfied would you say you are with the birth control and STD information 
and services you have received from health care providers in the past? 
 
a. Very dissatisfied 
b. Somewhat dissatisfied 
c. Neither satisfied nor dissatisfied 
d. Somewhat satisfied 
e. Very satisfied 
 
4.5 How likely is it that you will seek birth control or STD services from a health care provider in the next year? 
 
a. Not at all likely 
b. A little likely 
c. Moderately likely 
d. Very likely 
e. Extremely likely 
 
Section 5: Sexual Behavior (primary, secondary, tertiary outcome variables) 
 
The next questions ask you about your sexual behavior. 
 
5.1 Have you ever had sexual intercourse? Yes 
No 
 
If you have never had sexual intercourse, skip to Section 6. 
 
5.2 How old were you when you had sexual intercourse for the first time? 
 
a. I have never had sexual intercourse 
b. 11 years old or younger 
c. 12 years old 
d. 13 years old 
e. 14 years old 
f. 15 years old 
g. 16 years old 
h. 17 years old or older 
 
5.3 During your life, with how many people have you had sexual intercourse? 
 
a. 1 person 
b. 2 people 
c. 3 people 
d. 4 people 
e. 5 people 
f. 6 or more people 
 
5.4 During the past month, how many people have you had sex with?  
 
[# of people] 
 
5.5 During the past month, how many TIMES have you had sex?  
times 
 
5.6 Of the times you had sex over the past month, how many TIMES was a condom used? 
  
times 

5.7 Of the times you had sex over the past month, how many TIMES did you use birth control other than a 
condom, like birth control pills or having a deprova shot? 
  
times 
 5
.Over the past month, did you drink alcohol or take any kind of drug and have sex? 
Yes 
No 
 
5.9 Did you drink alcohol or use drugs before you had sexual intercourse the last time? 
 
a. I have never had sexual intercourse 
b. Yes 
c. No 
5.10 The last time you had sexual intercourse, what one method did you or the person you had sex with use to 
prevent pregnancy? (Select only one response.) 
 
a. No method was used to prevent pregnancy 
b. Birth control pills 
c. Condoms 
d. An IUD (such as Mirena or ParaGard) or implant (such as lmplanon or Nexplanon) 
e. A shot (such as Depo-Provera), patch (such as OrthoEvra), or birth control ring (such as NuvaRing) 
f. Withdrawal or some other method 
g. Not sure 
 
5.11 How many times have you been pregnant or gotten someone pregnant? 
 
a. 0 times 
b. 1 time 
c. 2 or more times 
d. Not sure 
 
5.12 Have you ever been tested for HIV, the virus that causes AIDS? 
 
a. Yes 
b. No 
c. Not sure 
 
5.13 Have you ever been tested for other sexually transmitted diseases (STDs), such as genital herpes, 
chlamydia, syphilis, or genital warts? 
 
a. Yes 
b. No 
c. Not sure 
 
5.14 Have you ever been told by a doctor or nurse that you had the HIV infection or any other sexually 
transmitted disease (STD)? 
 
a. Yes 
b. No 
c. Not sure 
 
If yes, did you receive follow-up care? Yes 
No 
Not sure 
 
5.15 Have you ever been tested for HCV (Hepatitis C)? 
 
a. Yes 
b. No 

c. Not sure 
 
5.16 Have you ever been told by a doctor or nurse that you had Hepatitis C? 
 
a. Yes 
b. No 
c. Not sure 
 
If yes, did you receive follow-up care? Yes 
No 
Not sure 
 
Section 6: Substance Use Questions (secondary outcome variables) 
 
These next questions are about alcohol and drug use. 
 
6.1 How old were you when you tried any of the following for the first time? 
 
Alcohol 
I have 
never 
tried 
8 years 
old or 
younger 
9 or 
10 
years 
old 
11 or 
12 
years 
old 
13 or 
14 
years 
old 
15 or 
16 
years 
old 
17 years old or older 
Marijuana 
(grass, pot, 
weed, or reefer) 
I have 
never 
tried 
8 years 
old or 
younger 
9 or 
10 
years 
old 
11 or 
12 
years 
old 
13 or 
14 
years 
old 
15 or 
16 
years 
old 
17 years old or older 
Meth (speed, 
crystal, crank, or 
ice) 
I have 
never 
tried 
8 years 
old or 
younger 
9 or 
10 
years 
old 
11 or 
12 
years 
old 
13 or 
14 
years 
old 
15 or 
16 
years 
old 
17 years old or older 
Cocaine 
(powder, crack, 
or freebase) 
I have 
never 
tried 
8 years 
old or 
younger 
9 or 
10 
years 
old 
11 or 
12 
years 
old 
13 or 
14 
years 
old 
15 or 
16 
years 
old 
17 years old or older 
Ecstasy 
(MOMA) 
I have 
never 
tried 
8 years 
old or 
younger 
9 or 
10 
years 
old 
11 or 
12 
years 
old 
13 or 
14 
years 
old 
15 or 
16 
years 
old 
17 years old or older 
Heroin (smack, 
junk, or diesel) 
I have 
never 
tried 
8 years 
old or 
younger 
9 or 
10 
years 
old 
11 or 
12 
years 
old 
13 or 
14 
years 
old 
15 or 
16 
years 
old 
17 years old or older 
Steroids (pills or 
shots without a 
doctor's 
prescription) 
I have 
never 
tried 
8 years 
old or 
younger 
9 or 
10 
years 
old 
11 or 
12 
years 
old 
13 or 
14 
years 
old 
15 or 
16 
years 
old 
17 years old or older 
Inhalants (sniff 
glue, breathe 
the contents of 
aerosol spray 
cans, or inhale 
any paints or 
sprays to get 
hiQh) 
I have 
never 
tried 
8 years 
old or 
younger 
9 or 
10 
years 
old 
11 or 
12 
years 
old 
13 or 
14 
years 
old 
15 or 
16 
years 
old 
17 years old or older 
 
6.2 During your life, how many times have you used any of the following: 

Alcohol 
0 times 
1-2 
times 
3-9 
times 
10-19 
times 
20-39 
times 
40-99 
times 
100 or 
more 
times 
Marijuana 
(grass, pot, 
weed, or 
reefer) 
0 times 
1-2 
times 
3-9 
times 
10-19 
times 
20-39 
times 
40-99 
times 
100 or 
more 
times 
Meth 
(speed, 
crystal, 
crank, or 
ice) 
0 times 
1-2 
times 
3-9 
times 
10-19 
times 
20-39 
times 
40-99 
times 
100 or 
more 
times 
Cocaine 
(powder, 
crack, or 
0 times 
1-2 
times 
3-9 
times 
10-19 
times 
20-39 
times 
40-99 
times 
100 or 
more 
times 
freebase) 
Ecstasy 
(MOMA) 
0 times 
1-2 
times 
3-9 
times 
10-19 
times 
20-39 
times 
40-99 
times 
100 or 
more 
times 
Heroin 
(smack, 
junk, or 
diesel) 
0 times 
1-2 
times 
3-9 
times 
10-19 
times 
20-39 
times 
40-99 
times 
100 or 
more 
times 
Steroids 
0 times 
1-2 
3-9 
10-19 
20-39 
40-99 
100 or 
(pills or 
shots 
without a 
doctor's 
prescription) 
times 
times 
times 
times 
times 
more 
times 
Inhalants 
(sniff glue, 
breathe the 
0 times 
1-2 
times 
3-9 
times 
10-19 
times 
20-39 
times 
40-99 
times 
100 or 
more 
times 
contents of 
aerosol 
spray cans, 
or inhale 
any paints 
or sprays to 
qet hiqh) 
 
6.3 During the past 30 days, how many times did you use any of the following: 
 
Alcohol 
0 times 
1 time 
2 times 
3 to 5 
times 
6 to 9 
times 
1Oto 19 
times 
20 or more 
times 
Marijuana 
(grass, pot, 
weed, or reefer) 
0 times 
1 time 
2 times 
3 to 5 
times 
6 to 9 
times 
10 to 19 
times 
20 or more 
times 
Meth (speed, 
crystal, crank, 
or ice) 
0 times 
1 time 
2 times 
3 to 5 
times 
6 to 9 
times 
10 to 19 
times 
20 or more 
times 
Cocaine 
(powder, crack, 
or freebase) 
0 times 
1 time 
2 times 
3 to 5 
times 
6 to 9 
times 
1Oto 19 
times 
20 or more 
times 
Ecstasy 
(MOMA) 
0 times 
1 time 
2 times 
3 to 5 
times 
6 to 9 
times 
10 to 19 
times 
20 or more 
times 

Heroin (smack, 
iunk, or diesel) 
0 times 
1 time 
2 times 
3 to 5 
times 
6 to 9 
times 
10 to 19 
times 
20 or more 
times 
Steroids (pills or 
shots without a 
doctor's 
prescription) 
0 times 
1 time 
2 times 
3 to 5 
times 
6 to 9 
times 
10 to 19 
times 
20 or more 
times 
Inhalants (sniff 
glue, breathe 
the contents of 
aerosol spray 
cans, or inhale 
any paints or 
sprays to get 
hiqh) 
0 times 
1 time 
2 times 
3 to 5 
times 
6 to 9 
times 
10 to 19 
times 
20 or more 
times 
 
6.4 During the past 30 days, on how many days did you have 5 or more drinks of alcohol in a row-that is, 
within a couple of hours? 
 
a. 0 days 
b. 1 day 
c. 2 days 
d. 3 to 5 days 
e. 6 to 9 days 
f. 10 to 19 days 
g. 20 or more days 
 
6.5 During your life, how many times have you used a needle to inject any illegal drug into your body? 
 
a. 0 times 
b. 1 time 
c. 2 or more times 
 
SECTION 7: BELIEFS ABOUT PREGNANCY (Other Variables) 
 
These questions are about your beliefs about pregnancy. 
 
7.1. How old do you think a woman should be when she has her first child? 
 
a. 
YEARS OLD 
b. I don't know. 
 
7.2. How old do you think a man should be when he has his first child? 
 
a. 
YEARS OLD 
b. I don't know. 
 
7.3. If you or your partner/boyfriend/girlfriend had a child in the next year, please tell us how having a child 
would affect you. (Even if you don't have a partner right now, tell us what you think you would do if this 
happened.) 
 
a. It would interfere with my relationship with my partner. 
i. Disagree 
ii. Neither agree nor disagree 
iii. Agree 

i. Disagree 
ii. Neither agree nor disagree 
iii. Agree 
m. It would make it difficult to stay in school. 
 
b. It would take away my freedom. 
i. Disagree 
ii. Neither agree nor disagree 
iii. Agree 
 
c. It would interfere with my plans. 
i. Disagree 
ii. Neither agree nor disagree 
iii. Agree 
 
d. It would be a real problem. 
i. Disagree 
ii. Neither agree nor disagree 
iii. Agree 
 
e. It would fit in with my plans. 
i. Disagree 
ii. Neither agree nor disagree 
iii. Agree 
 
f. My family would be upset or disappointed. 
i. Disagree 
ii. Neither agree nor disagree 
iii. Agree 
 
g. My family would kick me out. 
i. Disagree 
ii. Neither agree nor disagree 
iii. Agree 
 
h. It would give my life direction. 
i. Disagree 
ii. Neither agree nor disagree 
iii. Agree 
 
i. It would make it difficult to get or keep a job. 
i. Disagree 
ii. Neither agree nor disagree 
iii. Agree 
 
j. I would consider it a great gift. 
i. Disagree 
ii. Neither agree nor disagree 
iii. Agree 
 
k. It would encourage me to keep my job or look for a better job. 
i. Disagree 
ii. Neither agree nor disagree 
iii. Agree 
 
I. My family would support me. 

i. Disagree 
ii. Neither Disagree nor Agree 
iii. Agree 
d. Talking about birth control methods with your partner will bring the two of you a lot closer. 
 
i. Disagree 
ii. Neither agree nor disagree 
iii. Agree 
 
7.4. If you or your partner got pregnant within the next year or are currently expecting a child, how likely do you 
think it is that you would do any of the following things? (Even if you don't have a partner right now, tell us 
what you think you would do if this happened.) 
 
I WOULD ... 
 
a. Raise the baby. 
i. Not at all likely 
ii. Not very likely 
iii. Somewhat likely 
iv. Very likely 
 
b. Get married or stay married. 
i. Not at all likely 
ii. Not very likely 
iii. Somewhat likely 
iv. Very likely 
 
c. Put the baby up for adoption. 
i. Not at all likely 
ii. Not very likely 
iii. Somewhat likely 
iv. Very likely 
 
d. Give the child to a relative to raise. 
i. Not at all likely 
ii. Not very likely 
iii. Somewhat likely 
iv. Very likely 
 
SECTION 8: BELIEFS ABOUT BIRTH CONTROL METHODS, STls, & HCV (Other Variables) 
 
These next questions are about your beliefs about birth control and sexually transmitted diseases.  
 
8.1 I believe that ... 
 
a. Used correctly, most birth control methods will lower the chances a woman will get pregnant. 
i. Disagree 
ii. Neither Disagree nor Agree 
iii. Agree 
 
b. Talking about birth control methods will make your partner uncomfortable. 
i. Disagree 
ii. Neither Disagree nor Agree 
iii. Agree 
 
c. Using some birth control methods can be dangerous to a woman's health. 

i. Disagree 
ii. Neither Disagree nor Agree 
iii. Agree 
 
e. It is hard for Indian women to accept using birth control methods because at times in the past the 
federal government forced it on them. 
i. Disagree 
ii. Neither Disagree nor Agree 
iii. Agree 
 
f. Some birth control methods are too difficult to use correctly. 
i. Disagree 
ii. Neither Disagree nor Agree 
iii. Agree 
 
g. Most of my friends and same-age relatives who have sexual intercourse use some type of birth 
control method. 
i. Disagree 
ii. Neither Disagree nor Agree 
iii. Agree 
 
h. My friends and same-age relatives encourage me to use some type of birth control method every 
time I have sexual intercourse. 
i. Disagree 
ii. Neither Disagree nor Agree 
iii. Agree 
 
8.2. I believe that ... 
 
a. My parents and most of my older relatives have talked with me about abstinence (not having 
sexual intercourse) as a method of birth control. 
i. Disagree 
ii. Neither Disagree nor Agree 
iii. Agree 
 
b. My parents and most of my older relatives have talked with me about the importance of using some 
type of birth control method. 
i. Disagree 
ii. Neither Disagree nor Agree 
iii. Agree 
 
c. I will insist on using a condom with a new sexual partner, even if my partner doesn't want to. 
i. Disagree 
ii. Neither Disagree nor Agree 
iii. Agree 
 
d. If I were going to have sex in the next year, I would use condoms. 
i. Disagree 
ii. Neither Disagree nor Agree 
iii. Agree 
 
e. I would avoid using condoms if at all possible. 
i. Disagree 
ii. Neither Disagree nor Agree 
iii. Agree 

f. Using condoms makes sex feel unnatural. 
i. Disagree 
ii. Neither Disagree nor Agree 
iii. Agree 
 
g. You feel closer to your partner when you don't use condoms. 
i. Disagree 
ii. Neither Disagree nor Agree 
iii. Agree 
 
h. If I decided to have sexual intercourse with someone, I'm quite certain I could get my partner to 
agree to use condoms. 
i. Disagree 
ii. Neither Disagree nor Agree 
iii. Agree 
 
i. If my partner wanted to use a condom, we could use one correctly. 
i. Disagree 
ii. Neither Disagree nor Agree 
iii. Agree 
 
j. I would never talk to a sex partner about using condoms. 
i. Disagree 
ii. Neither Disagree nor Agree 
iii. Agree 
 
8.3 The next few questions are about Hepatitis C (HCV). Answer True or False. 
 
a. HCV has no long-term effects on your health.................................True 
False 
b. It is possible to be vaccinated against HCV....................................True 
False 
c. People who have injected drugs are not at risk for HCV.................True 
False 
d. HCV can be transmitted by tattooing and body piercing.................True 
False 
e. All people who have HCV can be cured.........................................True 
False 
f. HCV can be transmitted by sharing razors or toothbrushes............True 
False 
g. A person can get HCV by sharing a needle and syringe 
with someone when injecting drugs...............................................True 
False 
h. A woman can get HCV through having sex with a man..................True 
False 
i. A person can get HCV from mosquitos...........................................True 
False 
j. Someone who looks very healthy can pass on HCV.......................True 
False 
 
SECTION 9: CONTRACEPTIVE & CONDOM USE SELF-EFFICACY (Other variables) 
We are now going to ask you some questions about what is important to you when selecting a birth control 
method to use when you have sex. 
 
9.1 Indicate how important or unimportant these things about birth control are to you when selecting a birth 
control method to use to prevent pregnancy. Use this scale for your answers: 
 
1. Not important 
2. Slightly important 
3. Moderately important 
4. Very important 
5. Extremely important 
 
a. Does not require me to touch my partners genitals 
1 
2 
3 
4 
5 

b. Is not messy to use. 
1 
2 
3 
4 
5 
 
c. Does not have to be washed or stored. 
1 
2 
3 
4 
5 
 
d. Can be bought without seeing a health care provider or getting a prescription 
1 
2 
3 
4 
5 
 
e. Can be used without your knowing about it. 
1 
2 
3 
4 
5 
 
f. Only needs to be used when I have sex. 
1 
2 
3 
4 
5 
g. Reduces your chances of getting HIV. 
1 
2 
3 
4 
5 
 
h. Reduces your chances of getting an STD other than HIV. 
1 
2 
3 
4 
5 
 
i. Does not cause side effects like bleeding, cramps, weight gain, or changes in mood in [NAME]. 
1 
2 
3 
4 
5 
 
j. 
Does not cause pain or irritation. 
1 
2 
3 
4 
5 
 
k. Will not decrease sexual pleasure for you or [NAME]. 
1 
2 
3 
4 
5 
 
I. Is effective in preventing pregnancy. 
1 
2 
3 
4 
5 
 
m. It is inexpensive. 
1 
2 
3 
4 
5 
 
n. It is easy to use. 
1 
2 
3 
4 
5 
 
o. It is a method you can control. 
1 
2 
3 
4 
5 
 
p. It is a method your partner likes. 
1 
2 
3 
4 
5 
 
9.2 Next we are going to ask some questions about how confident you are using a condom. Use this scale for 
your answers: 
 
1 Not at all confident 
2 Slightly confident 
3 Moderately confident 
4 Very confident 
5 Extremely confident 

a. How confident are you that you could suggest using a condom even if you were afraid that your 
partner would reject you? 
1 
2 
3 
4 
5 
 
b. How confident are you that you could suggest using a condom even if you were unsure of how your 
partner felt about condoms? 
1 
2 
3 
4 
5 
 
c. How confident are you that you could suggest using a condom even if you were afraid that your 
partner would think that you have had sex with another person before? 
1 
2 
3 
4 
5 
 
d. How confident are you that you could suggest using a condom even if you were afraid that your 
partner would think you have an STD? 
1 
2 
3 
4 
5 
 
e. How confident do you feel in your ability to discuss using condoms with your partner? 
1 
2 
3 
4 
5 
 
f. How confident do you feel in your ability to use a condom correctly? 
1 
2 
3 
4 
5 
 
g. How confident do you feel in your ability to put a condom on without breaking the sexual mood with 
your partner? 
1 
2 
3 
4 
5 
 
h. How confident do you feel in your ability to buy condoms without feeling embarrassed? 
1 
2 
3 
4 
5 
 
i. How confident are you that you could remember to carry a condom with you in case you need one? 
1 
2 
3 
4 
5 
 
j. How confident do you feel in your ability to use a condom with your partner even after drinking? 
1 
2 
3 
4 
5 
 
k. How confident do you feel in your ability to use a condom with your partner even if you are high? 
1 
2 
3 
4 
5 
 
I. How confident do you feel in your ability to use a condom with your partner even if you are sexually 
excited? 
1 
2 
3 
4 
5 
 
Good job! You are doing great so far! Please continue answering the questions. 
 
9.3 The next questions ask about how sure you are that you could say NO to sex, alcohol, drugs, etc.-even if 
you have NEVER done any of these things before. (Choose one answer for each question) 
 
a. How sure are you that you would be able to say NO to having sex with someone you have known for 
a few days or less? 
i. I Definitely Can Say No 
ii. I Can Say No 
iii. I Don't Know 
iv. I Can't Say No 
v. I Definitely Can't Say No 
vi. Refuse to Answer 

b. How sure are you that you would be able to say NO to having sex with someone you want to date 
again? 
i. I Definitely Can Say No 
ii. I Can Say No 
iii. I Don't Know 
iv. I Can't Say No 
v. I Definitely Can't Say No 
vi. Refuse to Answer 
 
c. How sure are you that you would be able to say NO to having sex with someone who you want to fall 
in love with you? 
i. I Definitely Can Say No 
ii. I Can Say No 
iii. I Don't Know 
iv. I Can't Say No 
v. I Definitely Can't Say No 
vi. Refuse to Answer 
 
d. How sure are you that you would be able to say NO to having sex with someone who is pressuring 
you to have sex? 
i. I Definitely Can Say No 
ii. I Can Say No 
iii. I Don't Know 
iv. I Can't Say No 
v. I Definitely Can't Say No 
vi. Refuse to Answer 
 
e. How sure are you that you would be able to say NO to having sex with someone after one or both of 
you have been drinking alcohol, smoking pot, and/or using drugs, etc.? 
i. I Definitely Can Say No 
ii. I Can Say No 
iii. I Don't Know 
iv. I Can't Say No 
v. I Definitely Can't Say No 
vi. Refuse to Answer 
 
f. How sure are you that you would be able to say NO to having sex with someone who refuses to wear 
a condom? 
i. I Definitely Can Say No 
ii. I Can Say No 
iii. I Don't Know 
iv. I Can't Say No 
v. I Definitely Can't Say No 
vi. Refuse to Answer 
 
g. How sure are you that you would be able to say NO to having sex with someone who you have had 
sex with before? 
i. I Definitely Can Say No 
ii. I Can Say No 
iii. I Don't Know 
iv. I Can't Say No 
v. I Definitely Can't Say No 
vi. Refuse to Answer 

SECTION 10: HEALTHY RELATIONSHIPS CHARACTERISTICS (other variables) 
 
Think about a current close relationship (other than with a family member)-it could be a romantic relationship, 
a close friend, or another. (If you don't have a relationship like that right now, think about one you had in the 
past, or think about a relationship that you would like to have in the future.) 
 
10.1 Are the following signs of a healthy relationship? (Choose one answer for each question) 
 
a. One partner acts jealous or possessive. 
i. Yes 
ii. No 
iii. Don't Know 
iv. Refuse to Answer 
 
b. One partner criticizes or puts the other one down. 
i. Yes 
ii. No 
iii. Don't Know 
iv. Refuse to Answer 
 
c. One of you threatens to hurt themselves or the other person if the relationship ever ends. 
i. Yes 
ii. No 
iii. Don't Know 
iv. Refuse to Answer 
 
d. You and your partner feel free to ask honestly for what you want. 
i. Yes 
ii. No 
iii. Don't Know 
iv. Refuse to Answer 
 
e. Your partner tries to change or control you (what you do and where you go). 
i. Yes 
ii. No 
iii. Don't Know 
iv. Refuse to Answer 
 
f. You and your partner are both comfortable with how physical the relationship is (or isn't). 
i. Yes 
ii. No 
iii. Don't Know 
iv. Refuse to Answer 
 
g. You bring out the best qualities in each other. 
i. Yes 
ii. No 
iii. Don't Know 
iv. Refuse to Answer 
 
h. You both feel close to each other (not just physically) and are willing to trust each other with personal 
stuff. 

i. Yes 
ii. No 
iii. Don't Know 
iv. Refuse to Answer 
 
i. You make decisions jointly, with input from each partner. 
i. Yes 
ii. No 
iii. Don't Know 
iv. Refuse to Answer 
 
j. Your partner thinks there are some situations in which it is OK for him or her to hit you. 
i. Yes 
ii. No 
iii. Don't Know 
iv. Refuse to Answer 
 
SECTION 11: LIFE EVENTS (other variables) 
 
11.1 Life Events are the next set of questions. For each life event, answer "No" if the event did not happen to 
you in the past year, or "Yes" if the life event did happen to you in the 12.§.§!_y_ear. 
 
 
I 
 
SECTION 11: FEELINGS AND EMOTIONS (other variables) 
No I Yes 
1. Has a family member called you names, insulted you, or shamed you on a regular 
basis? 
o 
1 
  

You are almost done with the survey. These are the last questions. 
 
11.1 Please mark which best describes how you felt during the past week. 
 
a. I felt that I could not shake off the blues even with help from my family or friends. 
i. None of the time (0 days) 
ii. Rarely or a little of the time (1-2 days) 
iii. Some of the time (3-4 days) 
iv. Most or all of the time (5-7 days) 
 
b. I felt depressed. 
i. None of the time (0 days) 
ii. Rarely or a little of the time (1-2 days) 
iii. Some of the time (3-4 days) 
iv. Most or all of the time (5-7 days) 
 
c. I thought my life had been a failure. 
i. None of the time (0 days) 
ii. Rarely or a little of the time (1-2 days) 
iii. Some of the time (3-4 days) 
iv. Most or all of the time (5-7 days) 
 
d. I felt fearful. 
i. None of the time (0 days) 
ii. Rarely or a little of the time (1-2 days) 
iii. Some of the time (3-4 days) 
iv. Most or all of the time (5-7 days) 
 
e. I felt lonely. 
i. None of the time (0 days) 
ii. Rarely or a little of the time (1-2 days) 
iii. Some of the time (3-4 days) 
iv. Most or all of the time (5-7 days) 
 
f. I had crying spells. 
i. None of the time (0 days) 
ii. Rarely or a little of the time (1-2 days) 
iii. Some of the time (3-4 days) 
iv. Most or all of the time (5-7 days) 
 
g. I felt sad. 
i. None of the time (0 days) 
ii. Rarely or a little of the time (1-2 days) 
iii. Some of the time (3-4 days) 
iv. Most or all of the time (5-7 days) 
 
h. I felt crabby. 
i. None of the time (0 days) 
ii. Rarely or a little of the time (1-2 days) 
iii. Some of the time (3-4 days) 
iv. Most or all of the time (5-7 days) 
 
i. I felt hopeless. 
i. None of the time (0 days) 
ii. Rarely or a little of the time (1-2 days) 

iii. Some of the time (3-4 days) 
iv. Most or all of the time (5-7 days) 
 
j. I felt like no one cared. 
i. None of the time (0 days) 
ii. Rarely or a little of the time (1-2 days) 
iii. Some of the time (3-4 days) 
iv. Most or all of the time (5-7 days) 
 
k. I felt discouraged. 
i. None of the time (0 days) 
ii. Rarely or a little of the time (1-2 days) 
iii. Some of the time (3-4 days) 
iv. Most or all of the time (5-7 days) 
 
11.2. During the past week .... 
 
a. Have you often worried that you have made a fool of yourself in front of other people? 
i. No 
ii. Yes 
 
b. Have you often worried that you have made a mistake or done something the wrong way? 
i. No 
ii. Yes 
 
c. Have you been almost always worried about something? 
i. No 
ii. Yes 
 
d. Have you been very worried about whether other people like you? 
i. No 
ii. Yes 
 
e. Have you often gotten worried or nervous? 
i. No 
ii. Yes 
 
 
YOU ARE FINISHED WITH THE SURVEY! THANK YOU VERY MUCH FOR TAKING THE TIME TO 
COMPLETE THE SURVEY. PLEASE REMEMBER THAT NONE OF YOUR RESPONSES WILL BE 
ASSOCIATED WITH YOUR NAME. IF YOU HAVE ANY QUESTIONS ABOUT THIS SURVEY PLEASE ASK 
US. 

Nen OnkUmbi/EdaHiYedo {"We Are Here Now") 
Informed Consent to Participate in Human Subjects Research with Montana State 
University in Partnership with Fort Peck Community College 
 
What is this project about? 
We Are Here Now is an intervention project with Fort Peck Community College and Montana 
State University. Nen OnkUmbi/EdaHiYedo {"We are Here Now," or NIE) derives from the 
Assiniboine (Nen OnkUmbt) and Sioux (EdaHiYedo) names for their traditional coming-of-age 
ceremonies. The purpose of this program is to teach youth at Fort Peck important things they 
need to know about sex so that they can stay healthy and not get a sexually transmitted 
disease, HIV, or Hepatitis C, and so that they can make healthy decisions about having 
children, getting pregnant, or getting someone pregnant. We Are Here Now also includes tribal 
elders and leaders teaching Assiniboine and Sioux youth about their culture and traditional 
beliefs and practices about what it means to be a young Native person who will soon be an 
adult. In addition to working with youth, We Are Here Now also is offering education to 
parents/legal guardians about how to speak with their children about sensitive topics related to 
sex. 
 
Why me? 
You and your child have been invited to participate in We Are Here Now and to help gather 
information about the program and its effects. Your participation in this intervention is entirely 
voluntary. You can choose not to participate at any time. You and your child may withdraw from 
the intervention at any time without negative consequences. Your participation in We Are Here 
Now is your choice. 
 
What happens to me if I decide to participate? 
If you agree to participate in We Are Here Now, you will be with other guardians or parents of 
young people who are participating in We Are Here Now, and you will learn about how to talk 
with your child about sex. We Are Here Now is a project that educates youth and their 
guardians/parents about sexual and reproductive health. As a participant in We Are Here Now, 
you will be talking with other guardians/parents about healthy sexual behaviors and about how 
to talk with your children about sex. You will be asked to complete a survey specifically for 
guardians/parents about how you talk to your child about sex and what kinds of things about sex 
you speak with them about. You will receive an incentive of $20 for this first survey, and then 
$10 each time you attend the four Native Voices sessions (at 2 of these sessions you will again 
fill out the survey). Finally, you will receive a $25 incentive for completing the final survey after 
the end of the program. 
 
What are the risks? 
Some of the questions may make you feel a bit uncomfortable. For example, we will ask you 
about what kinds of sexual topics you talk about with your child. 
 
What are the benefits? 
Through this program you will learn about ways to speak effectively with your child about sex 
and topics related to sexual health. The information gathered in this survey will help the 
intervention's research team and members of the Fort Peck community to understand what kind 
of impact your participation in We Are Here Now is having on your decisions to talk with your 
child about sensitive topics related to sex. 

Who gets access to information from this interview? 
All responses on this survey will be anonymous. Only one person, Paula FireMoon, will know 
that you participated, because she will keep this signed consent form in a locked file cabinet in 
her locked office. Neither she nor the rest of the research team, nor the community advisory 
board, will know what your individual responses to the survey are. The research team will have 
access to the anonymous data collected for this project. The We Are Here Now community 
advisory board will also have access to the anonymous data collected for this intervention. 
 
How am I informed about the results of the project. and when will they be released and 
presented to someone else? 
We will publish the intervention results and make presentations on the results from We Are Here 
Now. Your identity will never appear in a publication or in print or be discussed at a 
presentation. In addition, you will have the opportunity to learn about the intervention results by 
contacting members of the research team, by attending community meetings where we share 
the results of the project, and through local (Fort Peck Reservation) media. 
 
Who is involved in We Are Here Now? 
If you have any questions regarding this survey please contact: 
 
Paula FireMoon, Fort Peck Community College 
Email: PFiremoon@fpcc,edu; Phone: 406.768.6300 
 
Elizabeth Rink, Montana State University 
Email: elizabeth.rink@montana.edu; Phone: 406.994.3833 
 
CONSENT STATEMENT 
 
Parent/Legal Guardian for Minor: I have read the above and understand the discomfort, 
inconvenience, and risks associated with this survey. 
 
I,   
,do agree to participate in this survey. 
Name of Parent/Guardian 
 
 
Parent/Guardian Signature:  
Date:  
 
_ 
 
 
SuNey Administrator Signature:  
Date  
 
_ 

"NenUnkUmbi/EdaHiYedo" (We Are Here Now) 
 
PARENT SURVEY 
 
We want to learn more about how you discuss sex with your child and what kinds of topics you 
discuss. We will be asking you a series of questions about how you talk to your child about sex 
and how you experience this communication. We thank you for your time. 
 
SECTION 1: DEMOGRAPHICS  
We would like to start by asking you some questions about yourself. 
 
1. How old are you?  
_ 
2. What is the highest grade you have completed?  
_ 
3. What is your occupation?  
_ 
4. What is your martial status? Please circle one. 
a. married 
b. single 
c. living with a boyfriend/girlfriend 
 
 
SECTION 2: COMMUN/CATION WITH CHILD 
Next we are going to ask some questions about how you feel about your ability to talk to your 
child about sex and what kinds of things about sex you specifically talk about. 
 
1. How would you rate your ability to communicate with your child in general? 
a. Difficult 
b. Somewhat Difficult 
c. Neither Difficult or Easy 
d. Somewhat Easy 
e. Easy 
 
2. How would you rate your ability to communicate with your child about sex? 
a. Difficult 
b. Somewhat Difficult 
c. Neither Difficult or Easy 
d. Somewhat Easy 
e. Easy 
 
3. I would like to talk more often with my child about sex and sexuality. 
a. Yes 
b. No 
 
4. Have you ever talked with your child about each of the following topics? 
YES NO I DON'T KNOW 
a. What qualities are important in choosinQ close friends 
b. What qualities to look for in a boyfriend/girlfriend/life 
partner 

 
c. How to ask someone out on a date 
d. How boys' bodies chanqe physically as they qrow up 
e. How qirls' bodies chanqe physically as they qrow up 
f. How women get pregnant and have babies 
g. Symptoms of sexually transmitted infections (STls) 
h. Reasons why people like to have sex 
i. How well birth control can prevent pregnancy 
j, How to choose a method of birth control 
k. How to say no if someone wants to have sex and you 
don't want to 
I. How well condoms can prevent sexually transmitted 
infections (STls) 
m. Menstruation (havinq menstrual periods) 
n. The importance of not pressuring other people to have 
sex 
o. How your child will make decisions about whether or not 
to have sex 
p. Consequences of getting pregnant/getting someone 
preqnant 
q. How to use a condom 
r. Reasons why your child should not have sex at this time 
s. Masturbation 
t. What it feels like to have sex 
u. Homosexuality/people being gay 
v. Wet dreams [measured for parents of boys only] 
w. What to do if a partner doesn't want to use a condom 
x. How people can prevent getting sexually transmitted 
infections (STls) 
v. How your child will know if he/she is in love 
 
CLOSING STATEMENT 
Thank you so much! That is all of our questions. As I said in the beginning, everything you told 
me today will remain private. Your name will not be on any information. 

Nen OnkUmbi/EdaHiYedo (We Are Here Now) 
Systems-Level Intervention Component 
BARRIERS & FACILITATORS DISCUSSION GUIDE 
We Are Here Now is a 5-year  intervention  project  with  Fort  Peck  Community  College 
and Montana State University.  Nen OnkUmbi/EdaHiYedo ("We are Here Now," or 
NIE) derives from the Assiniboine  (NenUnkUmbi)  and Sioux (EdaHiYedo) names  for 
their traditional coming-of-age ceremonies. The overall goal of We Are Here Now is to 
reduce STls, HIV, HCV, and teen pregnancy among American Indian  (Al) youth living on  
the Fort Peck Reservation. There are four levels of We Are Here Now. a school-based 
curriculum called Native Stand; a parent curriculum called Native Voices; a cultural 
mentoring program with the Fort Peck Tribes' Language and Culture Department; and a 
systems-level component that involves increasing  access  to sexual and  reproductive 
health (SRH) services for Al youth here at Fort Peck. As part of the systems-level 
component of We Are Here Now, we are working with the members of the Epi Team to 
identify and track the barriers and facilitators to provision  of SRH  services  for Al  youth 
here at Fort Peck. We would  like to discuss  with  you what is and is not being provided  to 
Al youth in your agencies  and discuss  possible  solutions  and steps to enhancing  what 
and how SRH services are provided to Al youth. Our discussion today is based on the 8 
service domains relative to improving SRH services of adolescents as outlined by the 
Centers for Disease Control and Prevention's (CDC) Contraceptive and  Reproductive 
Health Services for Teens: Evidence-based Clinical Best Practices. We will use the 
results from our annual discussions to develop a monitoring plan tracking log to track our  
efforts to increase access to and utilization of SRH services for Al youth over the 5 years 
of We Are Here Now. As we have discussed, we will audio-tape the annual discussions, 
so please try to talk one person at a time. We would like everyone to be able to express 
their viewpoints without being interrupted. Do you have any questions for me before we 
begin the discussion? [Answer questions, if any] OK, let's get started. 
 
SERVICE DOMAIN #1: CONTRACEPTIVE ACCESS 
 
Discuss the extent to which your agency does or does not provide the services listed 
below. Please address what the barriers are to providing these services and/or what the 
factors are that facilitate the provision of these services. 
 
• Offers same-day appointments 
 
• Offers after-school-hours appointments 
 
• Offers appointments during the weekend 
 
• Takes/updates sexual health history at every visit 
 
• Offers a wide-range of contraception (via prescription and/or dispensed onsite) 
 
• Offers hormonal contraception or IUD at every visit to the clinical provider regardless 
of reason for visit (e.g., urgent, preventive, school health, sports physical, 
pregnancy testing, emergency contraception, sexually transmitted disease [STD] 
testing, HIV testing) to ensure that there are no missed opportunities 

• Prescribes hormonal contraception without prerequisite exams or STI testing (i.e., 
without first requiring any of the following: Pap smear, pelvic examination, breast 
examination, or STD testing) 
 
SERVICE DOMAIN #2: QUICK START PROVISION OF HORMONAL 
CONTRACEPTION/IUD 
Discuss the extent to which your agency does or does not provide the services listed 
below. Please address what the barriers are to providing these services and/or what the 
factors are that facilitate the provision of these services. 
• Initiates hormonal contraception using the Quick Start method1 
• Initiates hormonal contraception after the client has had a negative pregnancy test 
using Quick Start method 
 
• Initiates hormonal contraception using the Quick Start method when an adolescent 
client is provided with emergency contraception where a pregnancy test is 
negative 
 
• Offers Quick Start insertion of IUD 
 
SERVICE DOMAIN #3: EMERGENCY CONTRACEPTION 
 
Discuss the extent to which your agency does or does not provide the services listed 
below. Please address what the barriers are to providing these services and/or what the 
factors are that facilitate the provision of these services. 
 
• Ensures emergency contraception is available to females 
 
• Provides emergency contraception to females for future use 
 
• Provides emergency contraception to males for future use 
 
SERVICE DOMAIN #4: CERVICAL CANCER SCREENING 
Discuss the extent to which your agency does or does not provide the service listed 
below. Please address what the barriers are to providing these services and/or what the 
factors are that facilitate the provision of these services. 
 
• 
Adheres to current cervical cancer screening (Pap Smear) guidelines (i.e., initiate 
pap screening at age 21) 
 
SERY_ICE DOMAl_t-.1 #5: STI/HIV TESTING AND TREATMENT 
 
Discuss the extent to which your agency does or does not provide the services listed 
below. Please address what the barriers are to providing these services and/or what the 
factors are that facilitate the provision of these services. 
 
• Provides Chlamydia screening at least annually, or based on diagnostic criteria, 
consistent with USPSTF and CDC recommendations 

• Offers Chlamydia screening for females using a urine or vaginal swab specimen 
 
• Offers Chlamydia screening for males using a urine specimen 
 
• Offers Gonorrhea screening for both females and males 
 
• Offers HIV rapid testing for females and males as per CDC recommendations 
 
• Offers expedited, patient-delivered partner therapy as an option for the treatment of 
uncomplicated chlamydia! infection 
 
Additional question for HCV testing: Discuss the extent to which your agency does or 
does not provide HCV testing and treatment. In your discussion, address what the 
barriers are to providing HCV testing and treatment and/or what the factors are that 
facilitate the provision of HCV testing and treatment. 
 
SERVICE DOMAIN #6: COST, CONFIDENTIALITY, CONSENT 
 
Discuss the extent to which your agency does or does not provide the services listed 
below. Please address what the barriers are to providing these services and/or what the 
factors are that facilitate the provision of these services. 
 
• Provides low-cost or no-cost contraceptive and reproductive health care services 
 
• Provides confidential contraceptive and reproductive health care to adolescents 
without need for parental or caregiver consent (in accordance with state policy) 
 
SERVICE DOMAIN #7: HEALTH CENTER/AGENCY INFRASTRUCTURE 
 
Discuss the extent to which your agency does or does not provide the services listed 
below. Please address what the barriers are to providing these services and/or what the 
factors are that facilitate the provision of these services. 
 
• Participates in the federal 3408 drug discount purchasing program 
 
• Uses electronic medical records (e.g., eClinical Works, Centricity, Epic, NextGen) 
 
• Has systems in place to facilitate billing third party payers for contraceptive and 
reproductive health care services provided 
 
SERVICE DOMAIN #8: HEALTH CENTER/AGENCY ENVIRONMENT 
 
Discuss the extent to which your agency does or does not provide the services listed 
below. Please address what the barriers are to providing these services and/or what the 
factors are that facilitate the provision of these services. 
 
• Has a counseling area that provides both visual and auditory privacy 
 
• Has an examination room that provides visual and auditory privacy 
 
• Has teen-focused magazines in the waiting room or examination areas 
 
• Displays information on issues related to adolescent sexual and reproductive health 

(e.g., confidentiality, cost, what services are available to adolescents) 
 
• Has brief evidence-based or evidence-informed video or other interventions designed 
for adolescents 
 
THANK YOU! That is it for our discussion today. Are there any questions? Or does 
anyone have anything more you would like to add? 

NenUnkUmbi/EdaHiYedo (We are Here Now): COORDINATION & IMPLEMENTING MONITORING PLAN TRACKING LOG 
 
AGENCY NAME:  
 _ 
AGENCY CONTACT INFORMATION:  
_ 
DATE TRACKING LOG FILLED OUT:  
  
_ 
AGENCY CONTACT NAME:   
 
 
OVERVIEW AND INSTRUCTIONS 
 
The purpose of this assessment is to help your health center identify current services, as well as opportunities for improving the quality of services for adolescent patients. 
Information collected through this assessment will be used to trach health center progress in improving adolescent access to contraceptive and reproductive health services within 
Fort Peck. 
 
This assessment should be completed every 3 months. Please meet with members of your multidisciplinary health care team to co mplete this assessment. This team-based 
approach to completing the assessment is important to ensure the information collected is accurate, and also to ensure that relevant team members are aware of the data being 
collected, and able to work together to identify opportunities for improving the quality of services offered to adolescents. 
 
SERVICE DOMAlt-,1 #1: CONTRA_CEPTIVE ACC_ESS 
 
Evidence Based Clinical Practice 
Service Provided 
(check only one\ 
Barriers/Facilitators Description 
Action Steps 
Required 
Completion 
Timeline 
Responsible 
Party 
Alwavs 
Sometimes 
Never 
Offers same-day appointments 
Offers after-school hours appointments. 
Offers weekend appointments. 
Takes/updates sexual health history at every 
visit 
Offers a wide-range of contraception 
Offers hormonal contraception or IUD at every 
visit to the clinical provider regardless of 
reason for visit 
Prescribes hormonal contraception without 
prerequisite exams or STI testing 

SERVICE DOMAIN #2: qUJCK START PROVISION of HORMONAL CONTRACEPTIQN/IUO 
 
Evidence Based Clinical Practice 
Service Provided 
(check only on ) 
Barriers/Facilitators Description 
Action Steps 
Required 
Completion 
Timeline 
Responsible 
Party 
Alwavs 
Sometimes 
Never 
Initiates hormonal contraception using the 
Quick Start method 
Initiates hormonal contraception after the 
client has had negative pregnancy test using 
Quick Start method 
Initiates hormonal contraception using the 
Quick Start method when an adolescent client 
is provided with emergency contraception 
where a pregnancy test in negative 
Offers Quick Start Insertion of IUD 
 
 
SERVICE DOMAIN #3: EMERGENCY CONTRACEPTION 
 
Evidence Based Clinical Practice 
Service Provided 
{check only one) 
Barriers/Facilitators Description 
Action Steps 
Required 
Completion 
Timeline 
Responsible 
Party 
Alwavs 
Sometimes 
Never 
Ensures emergency contraception is available 
Provides emergency contraception to females 
for future use 
Provides emergency contraception to males 
for future use 
 
 
 
 
 
SERVICE DOMAIN #4: CERVICAJ.. CANCER SCREE; ING 
 
Evidence Based Clinical Practice 
Service Provided 
(check only one\ 
Barriers/Facilitators Description 
Action Steps 
Required 
Completion 
Timeline 
Responsible 
Party 
Atwavs 
Sometimes 
Never 
Adheres to current cervical cancer screening 
(Pap Smear) guidelines (i.e., intiate pap 
screening at age 21) 

SERVICE DOMAIN #5: STI/I-IIV/HCV TESTING AND TREATM_ENT 
 
Evidence Based Clinical Practice 
Service Provided 
(check only on ) 
Barriers/Facilitators Description 
Action Steps 
Required 
Completion 
Timeline 
Responsible 
Party 
Alwavs 
Sometimes 
Never 
Provides Chlamydia screening at least 
annually, or based on diagnostic criteria, 
consistent with USPSTF and CDC 
recommendations 
Offers Chlamydia screening for females using 
a urine or vaginal swab specimen 
Offers Chlamydia screening for males using a 
urine specimen 
Offers Gonorrhea screening for both females 
and males 
Offers HIV rapid testing for females and males 
as per CDC recommendations 
Offers expedited, patient-delivered partner 
therapy as an option for the treatment of 
uncomplicated chlamydia! infection 
Offers HCV testing and treatment 
 
 
SERVICE DOMAIN #6: COST. CONFIDENTIALITY, CONSENT 
 
Evidence Based Clinical Practice 
Service Provided 
(check only one) 
Barriers/Facilitators Description 
Action Steps 
Required 
Completion 
Timeline 
Responsible 
Party 
Alwavs 
Sometimes 
Never 
Provides low-cost or no-cost contraceptive 
and reproductive health care services 
 
Provides confidential contraceptive and 
reproductive health care to adolescents 
without need for parental or caregiver consent 
(in accordance with state policy) 
 

SERVICE DOMAIN #7: HEALTHCARE/AG_f:NCY INFRASTRUCTURE 
 
Evidence Based Clinical Practice 
Service Provided 
(check only one\ 
Barriers/Facilitators Description 
Action Steps 
Required 
Completion 
Timeline 
Responsible 
Party 
Alwavs 
Sometimes 
Never 
Participates in the federal 340B drug discount 
purchasing program 
Uses electronic medical records 
Has systems in place to facilitate billing third 
party payers for contraceptive and 
reproductive health care services provided 
 
 
SERVICE DOMAIN #8:_HEALTI-LCENTER/AGENCY ENVIRONMENT 
 
Evidence Based Clinical Practice 
Service Provided 
(check onlv one) 
Barriers/Facilitators Description 
Action Steps 
Required 
Completion 
Timeline 
Responsible 
Party 
A!wavs 
Sometimes 
Never 
Has a counseling area that provides both 
visual and auditory privacy 
Has an examination room that provides visual 
and auditory privacy 
Has teen-focused magazines in the waiting 
room or examination areas 
Displays information on issues related to 
adolescent sexual and reproductive health 
(e.g., confidentiality, cost, what services area 
available to adolescents) 
Has brief evidence-based or evidence- 
informed video or other interventions 
designed for adolescents 

SERVICE DOMAN #SA: HEALTli CEl'IITER STAFF TRAINING 
 
Please indicate the number and percentage of ALL health center staff (e.g., all clinical and non-clinical staff that have direct contact with adolescent clients) that have received 
training in the following areas in the past two years. 
 
In the past two years, staff received 
trainina on... 
Number of 
staff 
% of staff 
Barriers/Facilitators Description 
Action Steps 
Reauired 
Completion 
Timeline 
Responsible 
Partv 
Stages of adolescent development 
 
State-specific minors' rights to consent and 
confidentiality laws or provisions 
 
Cultural competency, including relevant 
Native beliefs and cultural traditions 
 
Continuous quality improvement (CQI) 
 
Youth-friendly services 
 
Strategies for serving non-English speaking 
populations (inc interoreter) 
 
Addressing the needs of lesbian, gay, 
bisexual, transgender, and queer (LGBTQ) 
youth 
 
 
 
Please indicate the number and percentage of clinical staff (e.g., MDs, advance practice clinicians, nurse-extenders) that have been trained in the following areas in the 
past two years. 
 
In the past two years, clinical staff 
received trainina on... 
Number of 
staff 
% of staff 
Barriers/Facilitators Description 
Action Steps 
Reauired 
Completion 
Timeline 
Responsible 
Party 
Contraceptive Services for Adolescents 
Use of the Quick Start method for initiation of 
hormonal contraception 
Use of Quick Start method for initiation of IUD 
IUDs for Adolescents 
Hormonal Implants 
Emergency Contraception 
Pap Smear Guidelines 
Breast exam guidelines 
Conducting a sexual health 
assessment/history for adolescents 
STI testing for adolescents 
HIV testing for adolescents 
Male sexual and reproductive health services 
Continuous quality improvement (CQI) 
Youth-friendly services 
Cultural competency, including relevant 
Native beliefs and cultural traditions 

SERVICE DOMAN #9: ADOLESCENT PATIENT DEMOGRAPHICS 
 
NOTE: The following data may be collected via billing records, EMRs, and other methods. We are open to suggestions for other data colle ction methods based on your familiarity 
with your health center partners and your ability to collect data from your partners. It is recommended that you collect these data every 3 months. 
 
Please note that by "visits" we mean any visit where an adolescent is seen by a health care team member - not only visits designated as reproductive/sexual health visits. 
 
Please note that by "adolescent visits where contraceptive, reproductive, or sexual health services are provided" we mean any health center visit where contraceptive, reproductive, 
or sexual health services are provided to the adolescent patient, regardless of the primary reason for the visit. 
 
 
 
 
 
 
 
 

Please complete the below table regarding the provision of hormonal contraception and IUD for adolescents in the J:!ast 3 months. 
 

NenUnkUmbi/EdaHiYedo (We are Here Now) 
Community Advisory Board meeting form 
Date of Meeting 
_ 
Date form filled out (todays date): 
_ 
Filled out once per quarter after each Community Advisory Board meeting. 
 
 
 
Barriers or Facilitators to 
Intervention implementation 
discussed: 
Type of contextual factors 
discussed (i.e. Social 
context, Environmental 
context, Political context, 
or Bureaucratic context): 
Suggestions or solutions discussed: 

NenUnkUmbi/EdaHiYedo (We are Here Now) 
Whole Team meeting form 
Date of Meeting 
_ 
Date form filled out (today's date): 
_ 
Filled out once every other month beginning February 2019. 
 
Barriers or Facilitators to 
Type of contextual factors 
Suggestions or solutions 
Action and 
Adherence to 
Intervention 
discussed (i.e. Social 
discussed: 
responsible 
Community- 
implementation 
context, Environmental 
party: 
Based 
discussed: 
context, Political context, 
Participatory 
or Bureaucratic context): 
Research 
Principles? 

NenUnkUmbi/EdaHiYedo (We are Here Now) 
Fidelity Reach Log and Field Notes: 
Date form filled out (today's date}:  
_ 
Filled out each day any component of the Intervention is delivered. 
 
Intervention Delivery 
Intervention 
Component Name 
(i.e. Native Stand, 
Native Voices, 
Date of 
Intervention 
delivery or 
meeting: 
Length of 
time of 
Intervention 
delivery: 
If Native Stand, Native 
Voices, or Cultural 
Mentoring, specific 
modules delivered: 
Barriers to Intervention 
delivery: 
Facilitators to Intervention 
delivery: 
Cultural Mentoring, 
or Systems): 

Field Notes: 
Below to be filled out by the School Coordinator after any component of the Intervention is delivered. 
 
Intervention 
Component Name 
(i.e. Native Stand, 
Native Voices, 
Cultural Mentoring, 
or Systems): 
Environmental 
(weather, travel, 
etc.) barriers or 
facilitators to 
Intervention 
Delivery? 
Social (basketball, 
mood of the group or 
general community 
etc.) barriers or 
facilitators to 
Intervention delivery? 
Political or 
bureaucratic barriers 
or facilitators to 
Intervention delivery? 
Suggestions or solutions?