Reproductive BehaviorNENCT03694418
We Are Here Now: a Multi-level, Multicomponent Sexual and Reproductive Health Intervention for American Indian Youth
A study testing We are here now: a multi-level, multi-component sexual and reproductive health intervention for American Indian youth in people with Reproductive Behavior and Sexual Behavior, run by Montana State University at 2 sites in United States.
Trial 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 American Indian youth. Read more about this study
- Who is it for?
- Ages 14 to 18 years
- Conditions the study is for
- Reproductive Behavior, Sexual Behavior
- What is being tested?
- We are here now: a multi-level, multi-component sexual and reproductive health intervention for American Indian youth
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 453 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 May 2019to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Montana State University
Bozeman, Montana, 59715
Fort PeckCommunity College
Poplar, Montana, 59255
About this study
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.
Read the 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.
- Conditions
- Reproductive Behavior, Sexual Behavior
- Being tested
- We are here now: a multi-level, multi-component sexual and reproductive health intervention for American Indian youth
- Medical subject headings
- Reproductive Behavior, Sexual Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
We are here now: a multi-level, multi-component sexual and reproductive health intervention for American Indian youthBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Cluster 1 | Other | 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. Receives: Behavioral: We are here now: a multi-level, multi-component sexual and reproductive health intervention for American Indian youth |
| Cluster 2 | Other | 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. Receives: Behavioral: We are here now: a multi-level, multi-component sexual and reproductive health intervention for American Indian youth |
| Cluster 3 | Other | 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. Receives: Behavioral: We are here now: a multi-level, multi-component sexual and reproductive health intervention for American Indian youth |
| Cluster 4 | Other | 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. Receives: Behavioral: We are here now: a multi-level, multi-component sexual and reproductive health intervention for American Indian youth |
| Cluster 5 | Other | 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. Receives: Behavioral: We are here now: a multi-level, multi-component sexual and reproductive health intervention for American Indian youth |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Outcome measure time frame was 30 days from survey completion at 3 months post intervention.
Secondary outcomes (6)
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".
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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?"
Measured: Baseline to 3 months post-intervention (i.e., 12 months post-baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2018
- Study start1 May 2019
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Reproductive BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Stepped Wedge Design
- Masking
- None (open label)
- Enrolment
- 453 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montana State University
- Sponsor type
- University, hospital or other
- Collaborators
- Northern Arizona University, Fort Peck Community College, National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Elizabeth Rink, Montana State University
- Investigators
- Elizabeth L Rink, PhD, Principal investigator, Montana State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03694418
- Sponsor's protocol ID
- R01MD012761
- Other IDs
- R01MD012761
- Acronym
- NE
- Status last verified
- Dec 2025
- First submitted
- 28 Sep 2018
- Last updated
- 27 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to have an IPD sharing plan at this point in time.
Publications
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.
PubMed 37004106Rink 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.
PubMed 36890753Rink 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.
PubMed 35910931Rink 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.
PubMed 33180688
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- We Are Here Now: a Multi-level, Multicomponent Sexual and Reproductive Health Intervention for American Indian Youth
- ClinicalTrials.gov ID
- NCT03694418
- Acronym / sponsor ID
- NE / R01MD012761
- Conditions
- Reproductive Behavior, Sexual Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 453 participants (actual)
- Lead sponsor
- Montana State UniversityUniversity, hospital or other
- Collaborators
- Northern Arizona University, Fort Peck Community College, National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 1 May 2019 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 3 Oct 2018 (actual)
- Results
- Posted 10 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Stepped Wedge Design
| Arm | Type | Receives |
|---|---|---|
| Cluster 1 | Other | Behavioral: We are here now: a multi-level, multi-component sexual and reproductive health intervention for American Indian youthCluster 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. |
| Cluster 2 | Other | Behavioral: We are here now: a multi-level, multi-component sexual and reproductive health intervention for American Indian youthCluster 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. |
| Cluster 3 | Other | Behavioral: We are here now: a multi-level, multi-component sexual and reproductive health intervention for American Indian youthCluster 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. |
| Cluster 4 | Other | Behavioral: We are here now: a multi-level, multi-component sexual and reproductive health intervention for American Indian youthCluster 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. |
| Cluster 5 | Other | Behavioral: We are here now: a multi-level, multi-component sexual and reproductive health intervention for American Indian youthCluster 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. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| We are here now: a multi-level, multi-component sexual and reproductive health intervention for American Indian youthN/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. | Behavioural | Cluster 1, Cluster 2, Cluster 3, Cluster 4, Cluster 5 |
Primary outcome
Change in Number of Protected Acts Using a Condom During Vaginal and/or Anal Sex in the Past 30 Days.
Time frame: Outcome measure time frame was 30 days from survey completion at 3 months post intervention.
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).
6 secondary outcomes
Change in Number of Participants Reporting "Yes" to Having Engaged in Sexual Intercourse
Time frame: From enrollment (baseline) to 3 months post-intervention (i.e., 12 months after enrollment)
Change in Mean Number of Lifetime Sex Partners.
Time frame: 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.
Time frame: 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.
Time frame: From baseline to 3 months post-intervention (i.e., 12 months post-baseline)
Change in Mean Number of Pregnancies
Time frame: 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
Time frame: Baseline to 3 months post-intervention (i.e., 12 months post-baseline)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37004106Anastario 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.
- Derived from this study: PubMed 36890753Rink 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.
- Derived from this study: PubMed 35910931Rink 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.
- Derived from this study: PubMed 33180688Rink 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.
- Individual participant dataSharing planned: No. There is no plan to have an IPD sharing plan at this point in time.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth L Rink, PhD principal investigator
Montana State University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing We are here now: a multi-level, multi-component sexual and reproductive health intervention for American Indian youth in people with Reproductive Behavior and Sexual Behavior, run by Montana State University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Number of Protected Acts Using a Condom During Vaginal and/or Anal Sex in the Past 30 Days. (time frame: Outcome measure time frame was 30 days from survey completion at 3 months post intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03694418, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.