We Are Here Now: a Multi-level, Multicomponent Sexual and Reproductive Health Intervention for American Indian Youth (NE)

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 American Indian 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 American Indian youth with adults and elders to discuss traditional American Indian 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 American Indian 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 American Indian 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 14- to 18-year-old American Indian youth.

Study Overview

• Status: Completed
• Conditions: Sexual Behavior; Reproductive Behavior
• Intervention / Treatment: Behavioral: We are here now: a multi-level, multi-component sexual and reproductive health intervention for American Indian 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 American Indian 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 American Indian youth with adults and elders to discuss traditional American Indian 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 American Indian 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 American Indian 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 14- to 18-year-old American Indian 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 14- to 18-year-old American Indian youth. Our hypotheses are:

H1: American Indian 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: American Indian 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. American Indian youth who participate in the cultural mentoring program will demonstrate significantly increased understanding of cultural values related to traditional American Indian beliefs regarding SRH at 3, 9, and 12 months. And American Indian 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.

• Study Type: Interventional
• Enrollment (Actual): 453
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Montana
    • Bozeman, Montana, United States, 59715
      • Montana State University
    • Poplar, Montana, United States, 59255
      • Fort PeckCommunity College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 14 to 18 years old
• a registered member of a federally recognized tribe or an associate tribal member
• a resident of Fort Peck with a parent/legal 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.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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 pairs AI youth with adults and elders to discuss traditional AI 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 AI 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 Epidemiology Team to enhance the coordination and implementation of SRH services at Fort Peck.
Other: Cluster 2; Cluster 2 includes 1 school 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 AI youth with adults and elders to discuss traditional AI 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 AI 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 Epidemiology Team to enhance the coordination and implementation of SRH services at Fort Peck.
Other: Cluster 3; Cluster 3 includes 1 school 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 AI youth with adults and elders to discuss traditional AI 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 AI 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 Epidemiology Team to enhance the coordination and implementation of SRH services at Fort Peck.
Other: Cluster 4; Cluster 4 includes 1 school on the Fort Peck reservation that will be randomized into the intervention in 2020-2021. Cluster 4 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 AI youth with adults and elders to discuss traditional AI 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 AI 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 Epidemiology Team to enhance the coordination and implementation of SRH services at Fort Peck.
Other: Cluster 5; Cluster 5 includes 1 school on the Fort Peck reservation that will be randomized into the intervention in 2020-2021. Cluster 4 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 AI youth with adults and elders to discuss traditional AI 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 AI 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 Epidemiology Team to enhance the coordination and implementation of SRH services at Fort Peck.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Number of Protected Acts Using a Condom During Vaginal and/or Anal Sex in the Past 30 Days.	Number of protected acts of sex using a condom during vaginal and/or anal sex in the past 30 days is measured as proportion of condom use during vaginal/anal sex using 2 items (number of times condom used relative to number of times had vaginal/anal sex).	Outcome measure time frame was 30 days from survey completion at 3 months post intervention.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Number of Participants Reporting "Yes" to Having Engaged in Sexual Intercourse	Participants reported whether they ever had sex by responding to the question, "Have you ever had sexual intercourse?", with response options of "Yes" or "No". Answers of "Yes" were coded to "1" and answers of "No" were coded to "0".	From enrollment (baseline) to 3 months post-intervention (i.e., 12 months after enrollment)
Change in Mean Number of Lifetime Sex Partners.	The mean number of lifetime sex partners (i.e., the total number of people with whom a participant had sex in their lifetime) was assessed by asking participants, "During your life, with how many people have you had sexual intercourse?" with responses of "1 person", "2 people", "3 people", "4 people", "5 people", and "6 or more people". Responses were treated as integer values from 1-6, where the change in mean number of lifetime sex partners was assessed at 3-months post-intervention (12-months post-baseline) compared to baseline.	From enrollment (baseline) to 3 months post-intervention (i.e., 12 months after enrollment)
Change in Mean Number of Vaginal and/or Anal Sex Acts in the Past 30 Days.	Participants reported the number of times they had vaginal and/or anal sex in the past 30 days as an integer value (i.e., 0, 1, 2, 3, etc. times), where answers could be at a minimum of 0 times with no maximum limit. The change in mean number of sex acts was calculated from baseline to 3-months post-intervention.	From baseline to 3-months post-intervention (i.e., 12 months post-baseline)
Change in Mean Number of Times Non-condom Birth Control Was Used During Sex in the Past 30 Days.	The number of times non-condom birth control was used during sex in the past 30 days was assessed by asking participants, "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?". Responses ranged from 0 (minimum) to any positive integer value, where the maximum was limited by the number of times they had sex in the past month.	From baseline to 3 months post-intervention (i.e., 12 months post-baseline)
Change in Mean Number of Pregnancies	Number of times participants reported that they had been pregnant or gotten someone pregnant	Baseline to 3 months post-intervention (i.e., 12 months post-baseline)
Change in Number of Participants Reporting "Yes" to Having Used Substances During Sex	Participants reported "Yes" or "No" to the question, "Did you drink alcohol or use drugs before you had sexual intercourse the last time?"	Baseline to 3 months post-intervention (i.e., 12 months post-baseline)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Mean Score of Parent/Legal Guardian-child Communication About Sexual and Reproductive Health Topics	Parent/legal-child communication about sexual and reproductive health topics was measured using a 24-item communication scale. Each item asked participants if they had discussed a certain topic with their parents, with possible responses of "Yes" and "No". Answers of "Yes" were coded to 1 and "No" coded to 0. All 24 answers were summed to create a communication score with a minimum of 0 and a maximum of 24.	Baseline to 3 months post-intervention (i.e., 12 months post-baseline)
Change in Number of Participants Reporting "Yes" to Having Used Sexual and Reproductive Health Services From Indian Health Service (IHS)	Use of sexual and reproductive health services from IHS was measured with one question that asked participants, "Have you ever been to Indian Health Services or Fort Peck Tribal Health for things like condoms, birth control, a pregnancy test, or STD test?", where responses were either "Yes" or "No". Responses of "Yes" were coded to 1 and "No" to 0.	From baseline to 3 months post-intervention (i.e., 12 months post-baseline)

Collaborators and Investigators

• Sponsor: Montana State University
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD); Northern Arizona University; Fort Peck Community College
• Investigators: Principal Investigator: Elizabeth L Rink, PhD, Montana State University

Publications and helpful links

General Publications

• Rink E, Firemoon P, Anastario M, Johnson O, GrowingThunder R, Ricker A, Peterson M, Baldwin J. Rationale, Design, and Methods for Nen Unkumbi/Edahiyedo ("We Are Here Now"): A Multi-Level Randomized Controlled Trial to Improve Sexual and Reproductive Health Outcomes in a Northern Plains American Indian Reservation Community. Front Public Health. 2022 Jul 13;10:823228. doi: 10.3389/fpubh.2022.823228. eCollection 2022.
• Rink E, Knight K, Ellis C, McCormick A, FireMoon P, Held S, Webber E, Adams A. Using Community-Based Participatory Research to Design, Conduct, and Evaluate Randomized Controlled Trials with American Indian Communities. Prev Chronic Dis. 2020 Nov 12;17:E143. doi: 10.5888/pcd17.200099.
• Anastario M, Rink E, Firemoon P, Carnegie N, Johnson O, Peterson M, Rodriguez AM. Evidence of secular trends during the COVID-19 pandemic in a stepped wedge cluster randomized trial examining sexual and reproductive health outcomes among Indigenous youth. Trials. 2023 Apr 1;24(1):248. doi: 10.1186/s13063-023-07223-1.
• Rink E, Anastario M, Peterson M, FireMoon P, Johnson O, GrowingThunder R, Ricker A, Cox G, Holder S, Baldwin JA. Baseline results from NenUnkUmbi/EdaHiYedo: A randomized clinical trial to improve sexual and reproductive health among American Indian adolescents. J Adolesc. 2023 Jun;95(4):844-859. doi: 10.1002/jad.12158. Epub 2023 Mar 8.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Actual): November 30, 2023
• Study Completion (Actual): November 30, 2023

Study Registration Dates

• First Submitted: September 28, 2018
• First Submitted That Met QC Criteria: October 1, 2018
• First Posted (Actual): October 3, 2018

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 24, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior; Reproductive Behavior; Sexual Behavior
• Other Study ID Numbers: R01MD012761 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to have an IPD sharing plan at this point in time.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No