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

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ClinicalTrials.gov Identifier: NCT03694418
Recruitment Status : Recruiting
First Posted : October 3, 2018
Last Update Posted : October 14, 2021
Sponsor:
Collaborators:
Florida International University
Northern Arizona University
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 14, 2021
Actual Study Start Date  ICMJE May 1, 2019
Estimated Primary Completion Date November 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 1, 2018)
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 1, 2018)
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 1, 2018)
  • Change in increased parent/legal guardian-child communication about sexual and reproductive health topics at 3 months, 9 months and 12 months [ Time Frame: 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
  • Change in increased usage of sexual and reproductive health services at 3 months, 9 months and 12 months [ Time Frame: 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)
Original Other Pre-specified Outcome Measures Same as current
 
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 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.
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 14- 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 14- 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  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
Stepped Wedge Design
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Reproductive Behavior
  • Sexual Behavior
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  ICMJE
  • 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.
    Intervention: Behavioral: We are here now: a multi-level, multi-component sexual and reproductive health intervention for American Indian youth
  • 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.
    Intervention: Behavioral: We are here now: a multi-level, multi-component sexual and reproductive health intervention for American Indian youth
  • 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.
    Intervention: Behavioral: We are here now: a multi-level, multi-component sexual and reproductive health intervention for American Indian youth
Publications * Rink E, Knight K, Ellis C, McCormick A, FireMoon P, Held S, Webber E, Adams A. Using Community-Based Participatory Research to Design, Conduct, and Evaluate Randomized Controlled Trials with American Indian Communities. Prev Chronic Dis. 2020 Nov 12;17:E143. doi: 10.5888/pcd17.200099.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 1, 2018)
1008
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 30, 2022
Estimated Primary Completion Date November 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Elizabeth Rink, PhD 406-994-3833 elizabeth.rink@montana.edu
Contact: Marissa Cheplick, MPH 406-994-6890 marissa.cheplick@montana.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03694418
Other Study ID Numbers  ICMJE R01MD012761( U.S. NIH Grant/Contract )
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  ICMJE
Plan to Share IPD: No
Plan Description: There is no plan to have an IPD sharing plan at this point in time.
Responsible Party Elizabeth Rink, Montana State University
Study Sponsor  ICMJE Montana State University
Collaborators  ICMJE
  • Florida International University
  • Northern Arizona University
Investigators  ICMJE Not Provided
PRS Account Montana State University
Verification Date October 2021

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