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

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Elizabeth Rink，Montana State University

Tracking Information

First Submitted Date ^ICMJE

September 28, 2018

First Posted Date ^ICMJE

October 3, 2018

Last Update Posted Date

October 3, 2018

Actual Study Start Date ^ICMJE

March 1, 2019

Estimated Primary Completion Date

November 30, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^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).

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Change in delayed onset of sexual intercourse at 3 months, 9 months and 12 months[ Time Frame: 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)
Change in decreased number of sex partners at 3 months, 9 months and 12 months[ Time Frame: 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)
Change in frequency of sexual intercourse at 3 months, 9 months and 12 months[ Time Frame: 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)
Change in number of pregnancies at 3 months, 9 months and 12 months[ Time Frame: 3 months, 9 months and 12 months ]
Change in number of pregnancies will be measure with 1 item (number of pregnancies)
Change in increased use of birth control during sexual intercourse at 3 months, 9 months and 12 months[ Time Frame: 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)
Change in decreased alcohol/drug use concurrently sexual intercourse at 3 months, 9 months and 12 months[ Time Frame: 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)

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

Detailed 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 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.

Study Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Stepped Wedge Design
Masking: Interventional
Masking Description:
Primary Purpose: Prevention

Condition ^ICMJE

Intervention ^ICMJE

Behavioral: We are here now: a multi-level, multi-component sexual and reproductive health intervention for American Indian youth
N/E will be implemented simultaneously over the 9-month school year. Components include: 1) Individual Level- Native Stand 2) Family Level - Native Voices; 3) Community Level - Cultural mentoring program; and 4) Systems Level. The fourth level of N/E mobilizes the existing Epi Team to enhance the coordination and implementation of SRH services at Fort Peck.

Study Arms

Other: Cluster 1
Cluster 1 is 1 school on the Fort Peck Reservation that will be randomized into the intervention in 2019. Cluster 1 will receive all four levels of the intervention including: 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.
Other: Cluster 2
Cluster 2 includes 2 schools on the Fort Peck Reservation that will be randomized in the intervention in 2019-2020. Cluster 2 will receive all four levels of the intervention including: 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.
Other: Cluster 3
Cluster 3 are the remaining 2 schools on the Fort Peck reservation that will be randomized into the intervention in 2020-2021. Cluster 3 will receive all four levels of the intervention including: 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.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

1008

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

November 30, 2022

Estimated Primary Completion Date

November 30, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria ^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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

15 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

Elizabeth Rink，Montana State University

Study Sponsor ^ICMJE

Montana State University

Collaborators ^ICMJE

Investigators ^ICMJE

PRS Account

Montana State University

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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