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| ID | Type | Description | Link |
|---|---|---|---|
| R01MD012761 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Northern Arizona University | OTHER |
| Fort Peck Community College | UNKNOWN |
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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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.
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.
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 American Indian youth. Our hypotheses are:
H1: American Indian 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: American Indian 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. American Indian youth who participate in the cultural mentoring program will demonstrate significantly increased understanding of cultural values related to traditional American Indian beliefs regarding SRH at 3, 9, and 12 months. And American Indian 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cluster 1 | Other | 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. |
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| Cluster 2 | Other | Cluster 2 includes 1 school 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. |
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| Cluster 3 | Other | Cluster 3 includes 1 school 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| We are here now: a multi-level, multi-component sexual and reproductive health intervention for American Indian youth | Behavioral | 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 Epidemiology Team to enhance the coordination and implementation of SRH services at Fort Peck. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Number of Protected Acts Using a Condom During Vaginal and/or Anal Sex in the Past 30 Days. | Number of protected acts of sex using a condom during vaginal and/or anal sex in the past 30 days is measured as proportion of condom use during vaginal/anal sex using 2 items (number of times condom used relative to number of times had vaginal/anal sex). | Outcome measure time frame was 30 days from survey completion at 3 months post intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Number of Participants Reporting "Yes" to Having Engaged in Sexual Intercourse | Participants reported whether they ever had sex by responding to the question, "Have you ever had sexual intercourse?", with response options of "Yes" or "No". Answers of "Yes" were coded to "1" and answers of "No" were coded to "0". | From enrollment (baseline) to 3 months post-intervention (i.e., 12 months after enrollment) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Score of Parent/Legal Guardian-child Communication About Sexual and Reproductive Health Topics | Parent/legal-child communication about sexual and reproductive health topics was measured using a 24-item communication scale. Each item asked participants if they had discussed a certain topic with their parents, with possible responses of "Yes" and "No". Answers of "Yes" were coded to 1 and "No" coded to 0. All 24 answers were summed to create a communication score with a minimum of 0 and a maximum of 24. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth L Rink, PhD | Montana State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montana State University | Bozeman | Montana | 59715 | United States | ||
| Fort PeckCommunity College |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37004106 | Derived | Anastario M, Rink E, Firemoon P, Carnegie N, Johnson O, Peterson M, Rodriguez AM. Evidence of secular trends during the COVID-19 pandemic in a stepped wedge cluster randomized trial examining sexual and reproductive health outcomes among Indigenous youth. Trials. 2023 Apr 1;24(1):248. doi: 10.1186/s13063-023-07223-1. | |
| 36890753 | Derived | Rink E, Anastario M, Peterson M, FireMoon P, Johnson O, GrowingThunder R, Ricker A, Cox G, Holder S, Baldwin JA. Baseline results from NenUnkUmbi/EdaHiYedo: A randomized clinical trial to improve sexual and reproductive health among American Indian adolescents. J Adolesc. 2023 Jun;95(4):844-859. doi: 10.1002/jad.12158. Epub 2023 Mar 8. |
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There is no plan to have an IPD sharing plan at this point in time.
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Recruitment took place from January 2019 to May 2019. Recruitment included meetings with tribal and school leadership and letters to caregivers who had a child 14- to 18 years old and was attending school.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cluster 1: Baseline, Then 12 Months NE Intervention | Cluster 1 was implemented from September 2019 to September 2020. The Cluster 1 NE intervention took place from September 2019 to March 2020. The NE intervention was severely impacted by the COVID-19 pandemic and not implemented from March 2020 to May 2020. 12 month data was collected in September 2020. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 1, 2019 |
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Stepped Wedge Design
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| Cluster 4 | Other | Cluster 4 includes 1 school on the Fort Peck reservation that will be randomized into the intervention in 2020-2021. Cluster 4 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. |
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| Cluster 5 | Other | Cluster 5 includes 1 school on the Fort Peck reservation that will be randomized into the intervention in 2020-2021. Cluster 4 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. |
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| Change in Mean Number of Lifetime Sex Partners. | The mean number of lifetime sex partners (i.e., the total number of people with whom a participant had sex in their lifetime) was assessed by asking participants, "During your life, with how many people have you had sexual intercourse?" with responses of "1 person", "2 people", "3 people", "4 people", "5 people", and "6 or more people". Responses were treated as integer values from 1-6, where the change in mean number of lifetime sex partners was assessed at 3-months post-intervention (12-months post-baseline) compared to baseline. | From enrollment (baseline) to 3 months post-intervention (i.e., 12 months after enrollment) |
| Change in Mean Number of Vaginal and/or Anal Sex Acts in the Past 30 Days. | Participants reported the number of times they had vaginal and/or anal sex in the past 30 days as an integer value (i.e., 0, 1, 2, 3, etc. times), where answers could be at a minimum of 0 times with no maximum limit. The change in mean number of sex acts was calculated from baseline to 3-months post-intervention. | From baseline to 3-months post-intervention (i.e., 12 months post-baseline) |
| Change in Mean Number of Times Non-condom Birth Control Was Used During Sex in the Past 30 Days. | The number of times non-condom birth control was used during sex in the past 30 days was assessed by asking participants, "Of the times you had sex over the past month, how many TIMES did you use birth control other than a condom, like birth control pills or having a deprova shot?". Responses ranged from 0 (minimum) to any positive integer value, where the maximum was limited by the number of times they had sex in the past month. | From baseline to 3 months post-intervention (i.e., 12 months post-baseline) |
| Change in Mean Number of Pregnancies | Number of times participants reported that they had been pregnant or gotten someone pregnant | Baseline to 3 months post-intervention (i.e., 12 months post-baseline) |
| Change in Number of Participants Reporting "Yes" to Having Used Substances During Sex | Participants reported "Yes" or "No" to the question, "Did you drink alcohol or use drugs before you had sexual intercourse the last time?" | Baseline to 3 months post-intervention (i.e., 12 months post-baseline) |
| Baseline to 3 months post-intervention (i.e., 12 months post-baseline) |
| Change in Number of Participants Reporting "Yes" to Having Used Sexual and Reproductive Health Services From Indian Health Service (IHS) | Use of sexual and reproductive health services from IHS was measured with one question that asked participants, "Have you ever been to Indian Health Services or Fort Peck Tribal Health for things like condoms, birth control, a pregnancy test, or STD test?", where responses were either "Yes" or "No". Responses of "Yes" were coded to 1 and "No" to 0. | From baseline to 3 months post-intervention (i.e., 12 months post-baseline) |
| Poplar |
| Montana |
| 59255 |
| United States |
| 35910931 | Derived | Rink E, Firemoon P, Anastario M, Johnson O, GrowingThunder R, Ricker A, Peterson M, Baldwin J. Rationale, Design, and Methods for Nen Unkumbi/Edahiyedo ("We Are Here Now"): A Multi-Level Randomized Controlled Trial to Improve Sexual and Reproductive Health Outcomes in a Northern Plains American Indian Reservation Community. Front Public Health. 2022 Jul 13;10:823228. doi: 10.3389/fpubh.2022.823228. eCollection 2022. |
| 33180688 | Derived | 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. |
| FG001 |
| Cluster 2: 12 Months Baseline, Then 12 Months NE Intervention |
Cluster 2 was implemented from January 2021 to September 2021. Cluster 2 started 4 months later than planned due to the COVID-19 pandemic and the school being closed. In Cluster 2 the NE intervention was implemented from January 2021 to May 2021. 12 month data collection took place in September 2021. Although Cluster 2 had a late start date the intervention was completed as planned. |
| FG002 | Cluster 3: 24 Months Baseline, Then 12 Months NE Intervention | Cluster 3 was implemented from September 2021 to September 2022. The NE intervention in Cluster 3 was implemented from September 2021 to May 2022. 12 month data collection was completed in September 2022. |
| FG003 | Cluster 4: 24 Months Baseline, Then 12 Months NE Intervention | Cluster 4 was implemented from September 2021 to September 2022. Cluster 4 was implemented simultaneously with Cluster 3. The NE intervention was implemented from September 2021 to May 2022, at the same time as Cluster 3. 12 month collection was completed in September 2022. |
| FG004 | Cluster 5: 36 Months Baseline, Then 12 Months NE Intervention | Cluster 5 was implemented from September 2022 to September 2023. The NE intervention was implemented from September 2022 to May 2023. 12 month data collection was completed in September 2023. |
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| NOT COMPLETED |
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Participants contributed behavioral data on variables related to sexual risk taking.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cluster 1 | Cluster 1 took place from September 2019 to September 2020. Baseline, mid-intervention, and 3 month post intervention data was collected. The Covid-19 pandemic prevented the collection of of the post intervention data. |
| BG001 | Cluster 2 | Cluster 2 took place from January 2021 to September 2021. Baseline, mid-intervention, post-intervention, and 3 month post intervention were collected. However, data collection was truncated due to the school in cluster 2 being closed because of the COVID-19 pandemic. Data was collected from January 2021 to September 2021. |
| BG002 | Cluster 3 | Cluster 3 took place from September 2021 to September 2022. Baseline, mid-intervention, post-intervention, and 3 month post intervention were collected as planned. |
| BG003 | Cluster 4 | Cluster 4 took place from September 2021 to September 2022 simultaneously with Cluster 3. Baseline, mid-intervention, post-intervention, and 3 month post intervention were collected as planned. |
| BG004 | Cluster 5 | Cluster 5 took place from September 2022 to September 2023. Baseline, mid-intervention, post-intervention, and 3 month post intervention were collected as planned. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Mean | Standard Deviation | years |
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| Sex/Gender, Customized | Gender was measured as a binary variable 1 = male, 0 = female. | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Participants in study are American Indian. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Number of protected anal or vaginal intercourse acts in past 30 days | Mean | Full Range | proportion of protected sex acts |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change in Number of Protected Acts Using a Condom During Vaginal and/or Anal Sex in the Past 30 Days. | Number of protected acts of sex using a condom during vaginal and/or anal sex in the past 30 days is measured as proportion of condom use during vaginal/anal sex using 2 items (number of times condom used relative to number of times had vaginal/anal sex). | American Indian youth ages 14 - 18 years who are enrolled in a federally recognized tribe and living on the Fort Peck Reservation in Montana. | Posted | Mean | 95% Confidence Interval | proportion | Outcome measure time frame was 30 days from survey completion at 3 months post intervention. |
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| Secondary | Change in Number of Participants Reporting "Yes" to Having Engaged in Sexual Intercourse | Participants reported whether they ever had sex by responding to the question, "Have you ever had sexual intercourse?", with response options of "Yes" or "No". Answers of "Yes" were coded to "1" and answers of "No" were coded to "0". | Posted | Count of Participants | Participants | From enrollment (baseline) to 3 months post-intervention (i.e., 12 months after enrollment) |
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| Secondary | Change in Mean Number of Lifetime Sex Partners. | The mean number of lifetime sex partners (i.e., the total number of people with whom a participant had sex in their lifetime) was assessed by asking participants, "During your life, with how many people have you had sexual intercourse?" with responses of "1 person", "2 people", "3 people", "4 people", "5 people", and "6 or more people". Responses were treated as integer values from 1-6, where the change in mean number of lifetime sex partners was assessed at 3-months post-intervention (12-months post-baseline) compared to baseline. | Posted | Mean | Standard Deviation | number of sex partners | From enrollment (baseline) to 3 months post-intervention (i.e., 12 months after enrollment) |
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| Secondary | Change in Mean Number of Vaginal and/or Anal Sex Acts in the Past 30 Days. | Participants reported the number of times they had vaginal and/or anal sex in the past 30 days as an integer value (i.e., 0, 1, 2, 3, etc. times), where answers could be at a minimum of 0 times with no maximum limit. The change in mean number of sex acts was calculated from baseline to 3-months post-intervention. | Posted | Mean | Standard Deviation | Number of anal/vaginal sex acts | From baseline to 3-months post-intervention (i.e., 12 months post-baseline) |
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| Secondary | Change in Mean Number of Times Non-condom Birth Control Was Used During Sex in the Past 30 Days. | The number of times non-condom birth control was used during sex in the past 30 days was assessed by asking participants, "Of the times you had sex over the past month, how many TIMES did you use birth control other than a condom, like birth control pills or having a deprova shot?". Responses ranged from 0 (minimum) to any positive integer value, where the maximum was limited by the number of times they had sex in the past month. | Posted | Mean | Standard Deviation | number of times birth control used | From baseline to 3 months post-intervention (i.e., 12 months post-baseline) |
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| Other Pre-specified | Change in Mean Score of Parent/Legal Guardian-child Communication About Sexual and Reproductive Health Topics | Parent/legal-child communication about sexual and reproductive health topics was measured using a 24-item communication scale. Each item asked participants if they had discussed a certain topic with their parents, with possible responses of "Yes" and "No". Answers of "Yes" were coded to 1 and "No" coded to 0. All 24 answers were summed to create a communication score with a minimum of 0 and a maximum of 24. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 3 months post-intervention (i.e., 12 months post-baseline) |
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| Other Pre-specified | Change in Number of Participants Reporting "Yes" to Having Used Sexual and Reproductive Health Services From Indian Health Service (IHS) | Use of sexual and reproductive health services from IHS was measured with one question that asked participants, "Have you ever been to Indian Health Services or Fort Peck Tribal Health for things like condoms, birth control, a pregnancy test, or STD test?", where responses were either "Yes" or "No". Responses of "Yes" were coded to 1 and "No" to 0. | Posted | Count of Participants | Participants | From baseline to 3 months post-intervention (i.e., 12 months post-baseline) |
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| Secondary | Change in Mean Number of Pregnancies | Number of times participants reported that they had been pregnant or gotten someone pregnant | Posted | Mean | Standard Deviation | pregnancies | Baseline to 3 months post-intervention (i.e., 12 months post-baseline) |
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| Secondary | Change in Number of Participants Reporting "Yes" to Having Used Substances During Sex | Participants reported "Yes" or "No" to the question, "Did you drink alcohol or use drugs before you had sexual intercourse the last time?" | Posted | Count of Participants | Participants | Baseline to 3 months post-intervention (i.e., 12 months post-baseline) |
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Adverse events were assessed at baseline, 3 months, 9 months, and 12 months for participants in NE. Cluster 1 adverse events were assessed September 2019-September 2020; Cluster 2 adverse events were assessed September 2020-September 2021; Cluster 3 & Cluster 4 adverse events were assessed September 2021-September 2022; Cluster 5 adverse events were assessed September 2022-September 2023. No adverse events were reported during NE.
There were approximately 453 participants at risk for serious adverse events and all-cause mortality.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
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| EG000 | Cluster 1 | Cluster 1 adverse event data was collected over a 12 month period between September 2019 - September 2020. | 0 | 210 | 0 | 210 | 0 | 210 |
| EG001 | Cluster 2 | Cluster 2 adverse event data was collected over a 12 month period between September 2020 - September 2021. | 0 | 41 | 0 | 41 | 0 | 41 |
| EG002 | Cluster 3 | Cluster 3 adverse event data was collected over a 12 month period between September 2021 - September 2022. | 0 | 23 | 0 | 23 | 0 | 23 |
| EG003 | Cluster 4 | Cluster 4 adverse event data was collected over a 12 month period between September 2021 - September 2022. | 0 | 29 | 0 | 29 | 0 | 29 |
| EG004 | Cluster 5 | Cluster 5 adverse event data was collected over a 12 month period between September 2022 - September 2023. | 0 | 150 | 0 | 150 | 0 | 150 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Elizabeth Rink | Montana State University | 4066000297 | elizabeth.rink@montana.edu |
| Sep 25, 2024 |
| Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 1, 2019 | Sep 25, 2024 | ICF_003.pdf |
| ID | Term |
|---|---|
| D043762 | Reproductive Behavior |
| D012725 | Sexual Behavior |
| ID | Term |
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| D001519 | Behavior |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| More than one race |
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| Unknown or Not Reported |
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