We Are Here Now: a Multi-level, Multicomponent Sexual and Reproductive Health Intervention for American Indian Youth
追踪信息 | |||
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首次提交日期 ICMJE | September 28, 2018 | ||
首次发布日期e ICMJE | October 3, 2018 | ||
最后更新发布日期 | October 3, 2018 | ||
预计研究开始日期 ICMJE | March 1, 2019 | ||
预计主要完成日期 | November 30, 2021 (主要结果测量的最终数据收集日期) | ||
目前主要观察指标 ICMJE |
Change in condom use during sexual intercourse at 3 months, 9 months and 12 months[ Time Frame: 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). |
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原始主要观察测量 ICMJE | 与当前相同 | ||
目前的二级观察 ICMJE |
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描述性信息 | |||
简略标题 ICMJE | We Are Here Now: a Multi-level, Multicomponent Sexual and Reproductive Health Intervention for American Indian Youth | ||
正式标题 ICMJE | We Are Here Now: a Multi-level, Multicomponent Sexual and Reproductive Health Intervention for American Indian Youth | ||
简要概况 | 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 15- to 18-year-old AI youth. |
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详细说明 | 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 15- to 18-year-old AI youth. Our specific aims are: AIM 1: Refine, tailor, and finalize the components of N/E. Our community advisory board and the Fort Peck-based and MSU-based research team will design culturally appropriate adaptations for N/E's 4 levels during the first year of the study, based on the analysis of our recently completed qualitative and quantitative research (focus groups, interviews, and surveys), as well as discussions with elders and community stakeholders. AIM 2: Test the efficacy of N/E for 15- to 18-year-old AI youth. Our hypotheses are: H1: AI youth who participate in N/E will demonstrate increased condom use at 3, 9, and 12 months. (12 months will be used in the Primary Outcome analysis; 3 and 9 months will be used in the Secondary Outcomes analysis.) H2: AI youth who participate in N/E will demonstrate increased use of other birth control at 3, 9, and 12 months. They also will demonstrate a decrease in sexual risk behaviors as measured by reduced number of sex partners, delayed onset of sexual intercourse, and decreased substance use during sex, at 3, 9, and 12 months. (Secondary Outcomes) H3: N/E parents/legal guardians and youth will demonstrate significantly increased communication about topics related to SRH at 3, 9, and 12 months. AI youth who participate in the cultural mentoring program will demonstrate significantly increased understanding of cultural values related to traditional AI beliefs regarding SRH at 3, 9, and 12 months. And AI youth who participate in N/E will report significantly increased use of SRH services at 3, 9, and 12 months as a result of improved coordination among education, health care, and social service agencies on the Fort Peck Reservation. (Tertiary Outcomes) AIM 3: Evaluate the fidelity and acceptability of N/E. N/E's fidelity and acceptability will be evaluated using qualitative methods, including focus groups, activity logs, and staff field notes and meetings. | ||
研究类型 ICMJE | Interventional | ||
研究阶段 | N/A | ||
研究设计 ICMJE | 分配: Randomized 干预模型: Sequential Assignment 干预模型描述: Stepped Wedge Design 盲法: Interventional 盲法描述: 主要目的: Prevention |
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适用条件 ICMJE | |||
干预项目 ICMJE |
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研究工具 |
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招募信息 | |||
招募状态 ICMJE | Not yet recruiting | ||
预计入组 ICMJE |
1008 | ||
原始预计入组 ICMJE | 与当前相同 | ||
预计研究完成日期 | November 30, 2022 | ||
预计主要完成日期 | November 30, 2021 (主要结果测量的最终数据收集日期) | ||
合格标准 ICMJE | Inclusion Criteria: - 15 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. | ||
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年龄 | 最小年龄:15 Years ,最大年龄:18 Years | ||
接受健康的志愿者 | 没有 | ||
可入组国家 ICMJE | United States | ||
管理信息 | 数据检测委员会 | Yes | |
研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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IPD 共享声明 |
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责任方 | Elizabeth Rink,Montana State University | ||
研究赞助商 ICMJE | Montana State University | ||
合作者 ICMJE | |||
研究员 ICMJE |
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PRS 账户 | Montana State University | ||
验证日期 | October 2018 | ||
ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |