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 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

453

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started May 2019

Longer than P75 for not_applicable

Geographic Reach

1 country

2 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.6 years study duration

First Submitted

Initial submission to the registry

September 28, 2018

Completed

5 days until next milestone

First Posted

Study publicly available on registry

October 3, 2018

Completed

7 months until next milestone

Study Start

First participant enrolled

May 1, 2019

Completed

4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed

1.2 years until next milestone

Results Posted

Study results publicly available

February 10, 2025

Completed

Last Updated

February 27, 2026

Status Verified

December 1, 2025

Enrollment Period

4.6 years

First QC Date

September 28, 2018

Results QC Date

November 20, 2024

Last Update Submit

February 24, 2026

Conditions

Reproductive Behavior Sexual Behavior

Outcome Measures

Primary Outcomes (1)

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 Outcomes (6)

Change in Number of Participants Reporting "Yes" to Having Engaged in Sexual Intercourse
From enrollment (baseline) to 3 months post-intervention (i.e., 12 months after enrollment)
Change in Mean Number of Lifetime Sex Partners.
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.
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.
From baseline to 3 months post-intervention (i.e., 12 months post-baseline)
Change in Mean Number of Pregnancies
Baseline to 3 months post-intervention (i.e., 12 months post-baseline)
+1 more secondary outcomes

Other Outcomes (2)

Change in Mean Score of Parent/Legal Guardian-child Communication About Sexual and Reproductive Health Topics
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)
From baseline to 3 months post-intervention (i.e., 12 months post-baseline)

Study Arms (5)

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.