N/A
Completed N=453
We Are Here Now: a Multi-level, Multicomponent Sexual and Reproductive Health Intervention for American Indian Youth
Reproductive Behavior · Sexual Behavior
Source: ClinicalTrials.gov NCT03694418 ↗
Enrolled (actual)
453
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcomePrimary: Change in Number of Protected Acts Using a Condom During Vaginal and/or Anal Sex in the Past 30 Days. — 0.31 proportion — p=<0.05
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Number of Protected Acts Using a Condom During Vaginal and/or Anal Sex in the Past 30 Days. |
0.31 | <0.05 sig |
| SECONDARY Change in Number of Participants Reporting "Yes" to Having Engaged in Sexual Intercourse |
179 | <0.01 sig |
| SECONDARY Change in Mean Number of Lifetime Sex Partners. |
2.66 | 0.265 |
| SECONDARY Change in Mean Number of Vaginal and/or Anal Sex Acts in the Past 30 Days. |
2.07 | <0.05 sig |
| SECONDARY Change in Mean Number of Times Non-condom Birth Control Was Used During Sex in the Past 30 Days. |
0.99 | 0.05 |
| SECONDARY Change in Mean Number of Pregnancies |
0.09 | 0.026 sig |
| SECONDARY Change in Number of Participants Reporting "Yes" to Having Used Substances During Sex |
9 | 0.038 sig |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03694418). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.