Sexual Behavior Clinical Trial
— NEOfficial title:
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 AI 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 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. 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 AI 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 AI youth.
Status | Recruiting |
Enrollment | 1008 |
Est. completion date | November 30, 2022 |
Est. primary completion date | November 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 14 Years to 18 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Montana State University | Bozeman | Montana |
United States | Fort PeckCommunity College | Poplar | Montana |
Lead Sponsor | Collaborator |
---|---|
Montana State University | Florida International University, Northern Arizona University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in increased parent/legal guardian-child communication about sexual and reproductive health topics at 3 months, 9 months and 12 months | Change in increased parent/legal-child communication about sexual and reproductive health topics will be measured using a 24 item Likert scale, higher score = higher communication | 3 months, 9 months and 12 months | |
Other | Change in increased usage of sexual and reproductive health services at 3 months, 9 months and 12 months | Change in increased usage of sexual and reproductive health services will be measured with 9 items ( frequency, type and follow up of sexual and reproductive health services used) | 3 months, 9 months and 12 months | |
Primary | Change in condom use during sexual intercourse at 3 months, 9 months and 12 months | Change in condom use during sexual intercourse will be measured as proportion of condom use during sexual intercourse will be measured using 2 items (number of times condom used relative to number of times had sexual intercourse). | 3 months, 9 months and 12 months | |
Secondary | Change in delayed onset of sexual intercourse at 3 months, 9 months and 12 months | Changes in delayed onset of sexual intercourse will be measured intercourse with 2 items (ever had sexual intercourse and age at first sexual intercourse) | 3 months, 9 months and 12 months | |
Secondary | Change in decreased number of sex partners at 3 months, 9 months and 12 months | Change in decreased number of sex partners will be measured by 2 items ( lifetime of sex partners and the number of sex partners in the past month) | 3 months, 9 months and 12 months | |
Secondary | Change in frequency of sexual intercourse at 3 months, 9 months and 12 months | Change in frequency of sexual intercourse will be measured with 1 time ( frequency of sexual intercourse in the past month) | 3 months, 9 months and 12 months | |
Secondary | Change in number of pregnancies at 3 months, 9 months and 12 months | Change in number of pregnancies will be measure with 1 item (number of pregnancies) | 3 months, 9 months and 12 months | |
Secondary | Change in increased use of birth control during sexual intercourse at 3 months, 9 months and 12 months | Change in the increased use of birth control during sexual intercourse will be measured with 3 items (type of birth control used and number of times birth control was sued during sexual intercourse) | 3 months, 9 months and 12 months | |
Secondary | Change in decreased alcohol/drug use concurrently sexual intercourse at 3 months, 9 months and 12 months | Change in decreased alcohol/drugs used concurrently with sexual intercourse will be measured with 1 item ( substance use with sexual intercourse) | 3 months, 9 months and 12 months |
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