Reproductive Behavior, Sexual Behavior
Conditions
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 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.
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 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.
Interventions
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.
Sponsors
Study design
Intervention model description
Stepped Wedge Design
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Number of Protected Acts Using a Condom During Vaginal and/or Anal Sex in the Past 30 Days. | Outcome measure time frame was 30 days from survey completion at 3 months post intervention. | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Number of Participants Reporting "Yes" to Having Engaged in Sexual Intercourse | From enrollment (baseline) to 3 months post-intervention (i.e., 12 months after enrollment) | 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". |
| Change in Mean Number of Lifetime Sex Partners. | From enrollment (baseline) to 3 months post-intervention (i.e., 12 months after enrollment) | 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. |
| Change in Mean Number of Vaginal and/or Anal Sex Acts in the Past 30 Days. | From baseline to 3-months post-intervention (i.e., 12 months post-baseline) | 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. |
| Change in Mean Number of Times Non-condom Birth Control Was Used During Sex in the Past 30 Days. | From baseline to 3 months post-intervention (i.e., 12 months post-baseline) | 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. |
| Change in Mean Number of Pregnancies | Baseline to 3 months post-intervention (i.e., 12 months post-baseline) | Number of times participants reported that they had been pregnant or gotten someone pregnant |
| Change in Number of Participants Reporting "Yes" to Having Used Substances During Sex | Baseline to 3 months post-intervention (i.e., 12 months post-baseline) | Participants reported "Yes" or "No" to the question, "Did you drink alcohol or use drugs before you had sexual intercourse the last time?" |
Countries
United States
Contacts
Montana State University
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 210 |
| 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. | 41 |
| 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. | 23 |
| 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. | 29 |
| 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. | 150 |
| Total | 453 |
Baseline characteristics
| Characteristic | Cluster 2 | Cluster 1 | Cluster 3 | Cluster 4 | Cluster 5 | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 15.9 years STANDARD_DEVIATION 1.8 | 15.7 years STANDARD_DEVIATION 1.5 | 15.5 years STANDARD_DEVIATION 1.4 | 15.0 years STANDARD_DEVIATION 1.5 | 15.6 years STANDARD_DEVIATION 1.4 | 15.6 years STANDARD_DEVIATION 1.5 |
| Age, Customized Age of participants | 15.9 years STANDARD_DEVIATION 1.8 | 15.7 years STANDARD_DEVIATION 1.5 | 15.5 years STANDARD_DEVIATION 1.4 | 15.0 years STANDARD_DEVIATION 1.5 | 15.6 years STANDARD_DEVIATION 1.4 | 15.5 years STANDARD_DEVIATION 1.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 41 Participants | 210 Participants | 23 Participants | 29 Participants | 150 Participants | 453 Participants |
| Number of protected anal or vaginal intercourse acts in past 30 days | 0.40 proportion of protected sex acts | 0.40 proportion of protected sex acts | 0.40 proportion of protected sex acts | 0.40 proportion of protected sex acts | 0.40 proportion of protected sex acts | 0.40 proportion of protected sex acts |
| Race (NIH/OMB) American Indian or Alaska Native | 41 Participants | 210 Participants | 23 Participants | 29 Participants | 150 Participants | 453 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 41 Participants | 210 Participants | 23 participants | 29 Participants | 150 Participants | 453 Participants |
| Sex: Female, Male Female | 28 Participants | 103 Participants | 14 Participants | 16 Participants | 68 Participants | 229 Participants |
| Sex: Female, Male Male | 13 Participants | 107 Participants | 9 Participants | 13 Participants | 82 Participants | 224 Participants |
| Sex/Gender, Customized Student gender (number that are male) by cluster. | 14 participants | 107 participants | 9 participants | 13 participants | 82 participants | 225 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 210 | 0 / 41 | 0 / 23 | 0 / 29 | 0 / 150 |
| other Total, other adverse events | 0 / 210 | 0 / 41 | 0 / 23 | 0 / 29 | 0 / 150 |
| serious Total, serious adverse events | 0 / 210 | 0 / 41 | 0 / 23 | 0 / 29 | 0 / 150 |
Outcome results
Number of Protected Acts of 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).
Time frame: Measure for within the past 30 days from completing survey at 3 months, 9 months, 12 months; data at 12 months reported.
Population: American Indian youth ages 14 - 18 years who are enrolled in a federally recognized tribe and living on the Fort Peck Reservation in Montana.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| NE Intervention | Number of Protected Acts of Vaginal and/or Anal Sex in the Past 30 Days. | 0.31 proportion |
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)
Time frame: 3 months, 9 months and 12 months
Ever Had Vaginal and/or Sexual Intercourse.
Measured as a binary yes/no variable. 1 = yes, 0 = no.
Time frame: Measured at time of survey
Frequency of Birth Control Use.
Number of times used birth control during vaginal sex.
Time frame: Time frame is measured as the past year.
Frequency of Vaginal and/or Anal Sex in the Past 30 Days.
Frequency of vaginal and/or anal sex in the past 30 days is measured as an integer with no upper limit.
Time frame: Time frame is assessed as within the past 30 days from survey completion.
Number of Sex Partners in the Past 30 Days.
Number of sex partners in the past 30 days is measured as an integer with no upper limit.
Time frame: Measured at time of survey completion.
Substance Use During Sex.
Substance use during sex is measured as a binary variable 1 = yes, 0 = no.
Time frame: Time frame is the past 30 days.
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
Time frame: 3 months, 9 months and 12 months
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)
Time frame: 3 months, 9 months and 12 months