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NCT03694418 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by Montana State University.

Completed
Registry status
NA
Development phase
453
Enrollment target

NCT03694418: Completed NA study, sponsored by Montana State University.

NCT03694418 is a NA study that has completed, run by Montana State University. The registered enrollment target is 453 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03694418, a NA study, has completed, sponsored by Montana State University.

COMPLETED
Registry status
NA
Development phase
453 participants
Enrollment target

Study 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.

Primary Outcome

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).

Interventions

  • BEHAVIORAL We are here now: a multi-level, multi-component sexual and reproductive health intervention for American Indian youth

Trial Details

FieldValue
Enrollment Target 453 participants
Start Date 2019-05-01
Est. Completion 2023-11-30
Phase NA
Montana State University

36 total trials

What the finished NCT03694418 record still lists

NCT03694418 is an interventional study that assigns participants to a tested intervention. The registered 453 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (68% lower).

The record links to 0 conditions, and to 1 intervention - of which We are here now: a multi-level, multi-component sexual and reproductive health intervention for American Indian youth is the first listed.

NCT03694418 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03694418 about?

NCT03694418 is a clinical study titled "We Are Here Now: a Multi-level, Multicomponent Sexual and Reproductive Health Intervention for American Indian 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 American Indian youth. N/E in...

What is the current status of trial NCT03694418?

This trial is currently completed. It is a NA study. The enrollment target is 453 participants. The study started on 2019-05-01. Estimated completion is 2023-11-30.

What interventions are being tested in trial NCT03694418?

The interventions under investigation include: We are here now: a multi-level, multi-component sexual and reproductive health intervention for American Indian youth (BEHAVIORAL).

Who is sponsoring clinical trial NCT03694418?

This trial is sponsored by Montana State University, which has 36 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03694418's enrollment target sits among peer trials

453 225th of 2000 higher than 1,776 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03694418, the US trial registry maintained by the National Library of Medicine. NCT03694418 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.