NCT03694418: NE

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

Completed NA Results posted Last updated 27 February 2026

What this trial tests

NA trial testing We are here now: a multi-level, multi-component sexual and reproductive health intervention for American Indian youth in Reproductive Behavior in 453 participants. Completed in 30 November 2023.

Timeline

1 May 2019

Primary endpoint
30 November 2023

30 November 2023

Quick facts

Lead sponsor	Montana State University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	none
Primary purpose	prevention
Enrollment	453
Start date	1 May 2019
Primary completion	30 November 2023
Estimated completion	30 November 2023
Sites	2 locations across United States

Drugs / interventions tested

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

Conditions studied

• Reproductive Behavior — all drugs for Reproductive Behavior →
• Sexual Behavior — all drugs for Sexual Behavior →

Sponsor

Montana State University

Who can join

Adults 14 to 18, any sex, with Reproductive Behavior or Sexual Behavior. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Number of Protected Acts Using a Condom During Vaginal and/or Anal Sex in the Past 30 Days. Primary · 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).

Group	Value	95% CI
NE Intervention	0.31	0.15 – 0.47

Change in Number of Participants Reporting "Yes" to Having Engaged in Sexual Intercourse Secondary · From enrollment (baseline) to 3 months post-intervention (i.e., 12 months after enrollment)

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".

Group	Value	95% CI
NE Intervention	179

Change in Mean Number of Lifetime Sex Partners. Secondary · From enrollment (baseline) to 3 months post-intervention (i.e., 12 months after enrollment)

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.

Group	Value	95% CI
NE Intervention	2.66	-0.469 – 1.704

Change in Mean Number of Vaginal and/or Anal Sex Acts in the Past 30 Days. Secondary · From baseline to 3-months post-intervention (i.e., 12 months post-baseline)

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.

Group	Value	95% CI
NE Intervention	2.07	1.40 – 13.77

Change in Mean Number of Times Non-condom Birth Control Was Used During Sex in the Past 30 Days. Secondary · From baseline to 3 months post-intervention (i.e., 12 months post-baseline)

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.

Group	Value	95% CI
NE Intervention	0.99	-6.062 – 1.076

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

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.

Group	Value	95% CI
NE Intervention	9.42	0.27 – 4.01

Change in Number of Participants Reporting "Yes" to Having Used Sexual and Reproductive Health Services From Indian Health Service (IHS) Secondary · From baseline to 3 months post-intervention (i.e., 12 months post-baseline)

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.

Group	Value	95% CI
NE Intervention	115	1.69 – 37.15

Change in Mean Number of Pregnancies Secondary · Baseline to 3 months post-intervention (i.e., 12 months post-baseline)

Number of times participants reported that they had been pregnant or gotten someone pregnant

Group	Value	95% CI
NE Intervention	0.09	± 0.34

Change in Number of Participants Reporting "Yes" to Having Used Substances During Sex Secondary · Baseline to 3 months post-intervention (i.e., 12 months post-baseline)

Participants reported "Yes" or "No" to the question, "Did you drink alcohol or use drugs before you had sexual intercourse the last time?"

Group	Value	95% CI
NE Intervention	9

Sponsor's own 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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Using Community-Based Participatory Research to Design, Conduct, and Evaluate Randomized Controlled Trials with American Indian Communities.
   Rink E, Knight K, Ellis C, McCormick A, et al · · 2020 · cited 14× · PMID 33180688 · DOI 10.5888/pcd17.200099
2. Rationale, Design, and Methods for <i>Nen Unkumbi/Edahiyedo (</i>"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.
   Rink E, Firemoon P, Anastario M, Johnson O, et al · · 2022 · cited 6× · PMID 35910931 · DOI 10.3389/fpubh.2022.823228
3. 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.
   Anastario M, Rink E, Firemoon P, Carnegie N, et al · · 2023 · cited 5× · PMID 37004106 · DOI 10.1186/s13063-023-07223-1
4. Baseline results from NenŨnkUmbi/EdaHiYedo: A randomized clinical trial to improve sexual and reproductive health among American Indian adolescents.
   Rink E, Anastario M, Peterson M, FireMoon P, et al · · 2023 · cited 2× · PMID 36890753 · DOI 10.1002/jad.12158
5. Adaptations Due to the COVID-19 Pandemic in a Community-Based Participatory Research Randomized Control Trial Examining Sexual and Reproductive Health Outcomes among American Indian Youth.
   Rink E, Johnson O, Anastario M, Firemoon P, et al · · 2022 · cited 2× · PMID 35881980 · DOI 10.5820/aian.2902.2022.32