Implementation Fidelity and Theory-Informed Dose Effects of a Teen Pregnancy Prevention Program for Native American Youth.

In 2019, Native youth had the highest rate of teen pregnancy of all racial/ethnic groups. "Respecting the Circle of Life" (RCL) is one of the first evidence-based teen pregnancy prevention programs for Native teens and there is interest in replicating the program across tribal communities. To inform replication, it is important to consider process data including quality, fidelity, and dosage as these may all moderate impact of the program. Participants were Native youth aged 11-19 and a trusted adult. This study includes participants randomized to the RCL program only (N = 266). Data sources include independent observations, facilitator self-assessments, attendance logs, and self-report assessments completed by enrolled youth at baseline and 3 months post assessment. Data was compiled and summed by cohort. Dosage was number of minutes participating in activities separated by theoretical constructs. Linear regression models were utilized to assess moderation of the effects of the intervention dosage on outcomes of interest. Eighteen facilitators delivered RCL. One hundred eighteen independent observations and 320 facilitator self-assessments were collected and entered. Findings indicate RCL was implemented with high fidelity and quality (4.40 to 4.82 out of a 5-point Likert scale; 96.6% of planned activities completed). Dosage was high with an average completion of 7 out of 9 lessons. There was no association between theoretical construct dosage and outcomes of interest. Overall, this study indicates RCL was delivered with high fidelity, quality, and dosage in this trial. This paper informs future replication of RCL and provides support for hiring paraprofessionals from the local community as facilitators, delivering the RCL to peer groups of the same age and sex, delivering the RCL with short duration and high frequency, and encouraging youth to attend all RCL lessons, but continue to serve youth who have missed one or more lessons.

Evaluation of the Risk Identification for Suicide and Enhanced Care Model in a Native American Community.

Importance: There are many prognostic models of suicide risk, but few have been prospectively evaluated, and none has been developed specifically for Native American populations. Objective: To prospectively validate a statistical risk model implemented in a community setting and evaluate whether use of this model was associated with improved reach of evidence-based care and reduced subsequent suicide-related behavior among high-risk individuals. Design, Setting, and Participants: This prognostic study, done in partnership with the White Mountain Apache Tribe, used data collected by the Apache Celebrating Life program for adults aged 25 years or older identified as at risk for suicide and/or self-harm from January 1, 2017, through August 31, 2022. Data were divided into 2 cohorts: (1) individuals and suicide-related events from the period prior to suicide risk alerts being active (February 29, 2020) and (2) individuals and events from the time after alerts were activated. Main Outcomes and Measures: Aim 1 focused on a prospective validation of the risk model in cohort 1. Aim 2 compared the odds of repeated suicide-related events and the reach of brief contact interventions among high-risk cases between cohort 2 and cohort 1. Results: Across both cohorts, a total of 400 individuals identified as at risk for suicide and/or self-harm (mean [SD] age, 36.5 [10.3] years; 210 females [52.5%]) had 781 suicide-related events. Cohort 1 included 256 individuals with index events prior to active notifications. Most index events (134 [52.5%]) were for binge substance use, followed by 101 (39.6%) for suicidal ideation, 28 (11.0%) for a suicide attempt, and 10 (3.9%) for self-injury. Among these individuals, 102 (39.5%) had subsequent suicidal behaviors. In cohort 1, the majority (220 [86.3%]) were classified as low risk, and 35 individuals (13.3%) were classified as high risk for suicidal attempt or death in the 12 months after their index event. Cohort 2 included 144 individuals with index events after notifications were activated. For aim 1, those classified as high risk had a greater odds of subsequent suicide-related events compared with those classified as low risk (odds ratio [OR], 3.47; 95% CI, 1.53-7.86; P = .003; area under the receiver operating characteristic curve, 0.65). For aim 2, which included 57 individuals classified as high risk across both cohorts, during the time when alerts were inactive, high-risk individuals were more likely to have subsequent suicidal behaviors compared with when alerts were active (OR, 9.14; 95% CI, 1.85-45.29; P = .007). Before the active alerts, only 1 of 35 (2.9%) individuals classified as high risk received a wellness check; after the alerts were activated, 11 of 22 (50.0%) individuals classified as high risk received 1 or more wellness checks. Conclusions and Relevance: This study showed that a statistical model and associated care system developed in partnership with the White Mountain Apache Tribe enhanced identification of individuals at high risk for suicide and was associated with a reduced risk for subsequent suicidal behaviors and increased reach of care.

Predictors of STD Screening From the Indigenist Stress-Coping Model Among Native Adults With Binge Substance Use.

Objective: The American Indian/Alaska Native (AI/AN) population in the U.S. is thriving in spite of settler colonialist efforts of erasure. AI/AN people, however, continue to experience persistent health disparities including a disproportionate burden of substance use and sexually transmitted diseases/infections (STDs/STIs), as well as a disproportionate lack of public health STD screening services and STD prevention interventions grounded in AI/AN social contexts, experiences, and epistemologies. The present study explored how stressors and protective factors based on the Indigenist Stress Coping framework predict STD screening outcomes among Native adults. Methods: We analyzed baseline self-report data from 254 Native adults ages 18-55 years with recent binge substance use who were enrolled in an evaluation of "EMPWR," a two-session STD risk reduction program in a rural, reservation-based community in the U.S. Southwest. Logistic regression models with robust variance were used to estimate odds ratios of lifetime STD testing for the theoretical stressors and cultural buffers. Results: A little over half the sample were males (52.5%, n = 136), with a mean age of 33.6 years (SD = 8.8). The majority (76.7%, n = 195) reported having ever been screened for STD in their life. Discrimination score were significantly associated with lifetime STD testing: The higher discrimination was associated with lower odds of STD testing in the fully adjusted model (aOR = 0.40, 95%CI: 0.18, 0.92). The effects of AI/AN-specific cultural buffer such as participation in traditional practices on STD testing outcomes was in the expected positive direction, even though the association was not statistically significant. Household size was significantly associated with STD screening: The higher the number of people lived together in the house, the higher the odds of STD testing in the fully adjusted model (aOR = 1.19, 95%CI: 1.04, 1.38). Conclusion: Our findings suggest that STD prevention programs should take into consideration AI/AN-specific historical traumatic stressors such as lifetime discrimination encounters and how these interact to drive or discourage sexual health services at local clinics. In addition, larger household size may be a protective factor functioning as a form of social support, and the extended family's role should be taken into consideration. Future research should consider improvement in measurements of AI/AN enculturation constructs.

Measuring the effects of the COVID-19 pandemic on Diné and White Mountain Apache school personnel, families, and students: protocol for a prospective longitudinal cohort study.

BACKGROUND: This paper describes the protocol for a longitudinal cohort study, "Project SafeSchools" (PSS), which focuses on measuring the effects of COVID-19 and the return to in-person learning on Diné (Navajo) and White Mountain Apache (Apache) youth, parents, and educators. The early surges of the COVID-19 pandemic led to the closure of most reservation and border town schools serving Diné and Apache communities. This study aims to: (1) understand the barriers and facilitators to school re-opening and in-person school attendance from the perspective of multiple stakeholders in Diné and Apache communities; and (2) evaluate the educational, social, emotional, physical, and mental health impacts of returning to in-person learning for caregivers and youth ages 4-16 who reside or work on the Diné Nation and the White Mountain Apache Tribal lands. METHODS: We aim to recruit up to N = 200 primary caregivers of Diné and Apache youth ages 4-16 and up to N = 120 school personnel. In addition, up to n = 120 of these primary caregivers and their children, ages 11-16, will be selected to participate in qualitative interviews to learn more about the effects of the pandemic on their health and wellbeing. Data from caregiver and school personnel participants will be collected in three waves via self-report surveys that measure COVID-19 related behaviors and attitudes, mental health, educational attitudes, and cultural practices and beliefs for both themselves and their child (caregiver participants only). We hypothesize that an individual's engagement with a variety of cultural activities during school closures and as school re-opened will have a protective effect on adult and youth mental health as they return to in-person learning. DISCUSSION: The results of this study will inform the development or implementation of preventative interventions that may help Diné and Apache youth and their families recover from the negative impact of the COVID-19 pandemic, and positively impact their health and wellness.

Empowering Our People: Syndemic Moderators and Effects of a Culturally Adapted, Evidence-Based Intervention for Sexual Risk Reduction among Native Americans with Binge Substance Use.

Native American (NA) communities are disproportionately affected by the intersecting, synergistic epidemics of sexually transmitted infections (STIs) and substance use. Targeted approaches to addressing these syndemics are critical given the relative scarcity of mental health and behavioral specialists in NA communities. We conducted a series of moderation analyses using data from a randomized controlled trial of the EMPWR (Educate, Motivate, Protect, Wellness, Respect) intervention for reducing sexual risk behaviors, culturally adapted for NA adults with recent binge substance use living on rural reservations. We considered several potential moderators and substance use and sexual risk outcomes at 6- and 12-months post-baseline. Three hundred and one people participated in the study. Age, marital status, educational attainment, employment, and depressive symptoms were differentially associated with intervention effects. EMPWR could be strengthened with the incorporation of additional skills-building related to condom use negotiation with casual partners. For individuals with lower educational attainment or without employment, additional supports and approaches to intervention may be needed. Importantly, this study did not identify intersecting sexual risk and substance use behaviors as moderators of EMPWR effectiveness, suggesting that NA adults with varying levels of risk behavior may be equally likely to benefit from this intervention.

Improving communication between American Indian youth and caregivers to prevent teenage pregnancy.

American Indian (AI) youth are at increased risk for poor reproductive health outcomes. Parental communication and monitoring are established predictors of sexual risk-taking among adolescents. No program evaluations of sexual risk avoidance programs have focused exclusively on AI youth and parents. This study assesses the impact of the Respecting the Circle of Life (RCL) Teenage Pregnancy Prevention program on parent-youth communication and parental monitoring through a randomized controlled trial with AI youth ages 11-19 and their trusted adults (parents/caregivers) (N = 518). RCL consists of 8-peer group and one parent-youth session. Trusted adult participants completed the Parental Monitoring Scale and the Parent Adolescent Communication Scale at baseline and 3 and 9 months post-intervention via self-report. Intervention impact was evaluated using linear regression models, which included an indicator for study group. At 3 months post, trusted adults in the intervention reported significantly higher levels of sexual health communication (P = 0.042) and spoke to their child more often about how to get condoms (P = 0.001), get birth control (P = 0.014) and protect themselves from human immunodeficiency virus (P = 0.005) compared with trusted adults in the control condition. Program impact varied by age and sex. This study adds to literature and extends findings on RCL impact.

Mobilizing Established School Partnerships to Reach Underserved Children During a Global Pandemic.

The coronavirus disease 2019 pandemic has led to drastic public health measures, including school closures to slow the spread of severe acute respiratory syndrome coronavirus 2 infection. Reopening educational settings by using diagnostic testing approaches in schools can help accelerate the safe return of students and staff to on-site learning by quickly and accurately identifying cases, limiting the spread of severe acute respiratory syndrome coronavirus 2, and ultimately preventing unnecessary school and work absenteeism. Although the National Institutes of Health has identified community partnerships as the foundation for reducing health disparities, we found limited application of a community-based participatory research (CBPR) approach in school engagement. Guided by the CBPR conceptual model, we provide case studies of 2 established and long-standing school-academic partnerships built on CBPR processes and practices that have served as a research infrastructure to reach underserved children and families during the coronavirus disease 2019 pandemic. The process described in this article can serve as an initial platform to continue to build capacity toward increasing health equity.

Native Youth Participating in the Together on Diabetes 12-Month Home-Visiting Program Reported Improvements in Alternative Healthy Eating Index-2010 Diet Quality Domains Likely to Be Associated With Blood Pressure and Glycemic Control.

BACKGROUND: The Together on Diabetes (TOD) intervention was a home-visiting diabetes prevention and management program for Native youth. OBJECTIVES: (1) Examine the impact of the TOD program on diet quality using the Alternative Healthy Eating Index (AHEI-2010); (2) determine association between diet quality and cardiometabolic health. DESIGN: The TOD program was conducted from October 2012 to June 2014 and was evaluated using a pretest-posttest study design from baseline to 12 months. Dietary intake was assessed using a food frequency questionnaire. PARTICIPANTS/SETTING: There were 240 participants between 10 and 19 years of age from 4 reservation-based, rural tribal communities in the southwestern United States that had been diagnosed with T2DM or prediabetes or were identified as at risk based on body mass index and a qualifying laboratory test. INTERVENTION: Youth were taught a 12-lesson curriculum on goal setting, nutrition, and life skills education. MAIN OUTCOME MEASURES: Behavioral and physiologic outcomes related to diabetes. STATISTICAL ANALYSIS: Changes in AHEI-2010 score and associations with cardiometabolic measures were tested, over time, using adjusted longitudinal linear mixed-effects models. RESULTS: The study sample reported an average energy intake of 2016 kcal/d (±1260) and AHEI-2010 score of 47.4 (±7.4) (range: 0-110, higher = better diet quality), indicating low diet quality at baseline. At 12 months' follow-up, there was a reduction in kilocalories (mean = -346 kcal/d; P < .001), sugar-sweetened beverages (mean = -2 fluid oz/d; P = .032), red/processed meat (mean = -1.5 oz/d; P = .008), and sodium (mean = -650 mg/d; P < .001) but no change in AHEI-2010 score (P = .600). The change in systolic blood pressure from baseline to 12 months for participants within the highest AHEI-2010 quartile group was significantly larger than the change in participants within the lowest quartile group (mean = -5.90 mm Hg; P = .036). CONCLUSIONS: Despite stable AHEI-2010 scores during follow-up, there were improvements in diet quality domains likely to be associated with cardiometabolic health. Home-visiting programs like TOD are promising interventions for decreasing dietary intake of poor-quality foods.

Centering the Strengths of American Indian Culture, Families and Communities to Overcome Type 2 Diabetes.

Type 2 diabetes (T2D) is a critical Indigenous health inequity rooted in experiences of colonization and marginalization including disproportionate exposure to stressors, disruption of traditional family and food systems, and attacks on cultural practices that have led to more sedentary lifestyles. Thus, an important step in redressing inequities is building awareness of and interventions attuned to unique Indigenous contexts influencing T2D and Indigenous culture as a pathway to community wellbeing. Using a dynamic, stage-based model of intervention development and evaluation, we detail the creation and evolution of a family-based, culturally centered T2D preventive intervention: Together on Diabetes (later Together Overcoming Diabetes) (TOD). The TOD program was built by and for Indigenous communities via community-based participatory research and has been implemented across diverse cultural contexts. The TOD curriculum approaches health through a holistic lens of spiritual, mental, physical and emotional wellness. Preliminary evidence suggests TOD is effective in reducing diabetes risk factors including lowering BMI and depressive symptoms, and the program is viewed favorably by participants and community members. We discuss lessons learned regarding collaborative intervention development and adaptation across Indigenous cultures, as well as future directions for TOD.

Entrepreneurial, Economic, and Social Well-Being Outcomes from an RCT of a Youth Entrepreneurship Education Intervention among Native American Adolescents.

Background: Entrepreneurship education has demonstrated positive impacts in low-resource contexts. However, there is limited evidence of such programs evaluated among Native American (NA) youth in a rural reservation. Methods: A 2:1 randomized controlled trial evaluated the impact of the Arrowhead Business Group (ABG) entrepreneurship education program on entrepreneurship knowledge, economic empowerment, and social well-being among 394 NA youth. An intent to treat analysis using mixed effects regression models examined within and between study group differences from baseline to 24 months. An interaction term measured change in the intervention relative to change in the control. ABG participants were purposively sampled to conduct focus groups and in-depth interviews. Results: Significant intervention vs. control group improvements were sustained at 12 months for entrepreneurship knowledge and economic confidence/security. Significant within-group improvements were sustained for ABG participants at 24 months for connectedness to parents, school, and awareness of connectedness. Qualitative data endorses positive impacts on social well-being among ABG participants. Conclusion: Observed effects on entrepreneurship knowledge, economic empowerment, and connectedness, supplemented by the experiences and changes as described by the youth themselves, demonstrates how a strength-based youth entrepreneurship intervention focused on developing assets and resources may be an innovative approach to dually address health and economic disparities endured in Native American communities.

Predictors of Responsiveness Among American Indian Adolescents to a Community-Based HIV-Risk Reduction Intervention Over 12 Months.

This analysis explored predictors of responsiveness to the Respecting the Circle of Life (RCL) intervention, a sexual and reproductive health program for American Indian (AI) youth. Data were collected over 12-month follow-up with 267 AI youth aged 13-19. We used mixed effects regression models to examine: (1) whether trajectory patterns of HIV/AIDS knowledge, condom beliefs, condom use self-efficacy, condom use intention and partner negotiation skills differed by baseline levels categorized into low, medium, and high scorers, and (2) the characteristics of youth who made no improvement over the post-intervention period. Results indicate the RCL intervention had greater longitudinal impact among subgroups with low and medium initial scores. High initial scores in knowledge, beliefs, efficacy, intention and skills predicted unresponsiveness to the RCL intervention. Youth differences in age, gender and school truancy (skipping/suspension) did not predict responsiveness to RCL. Results have important prevention science implications: (1) AI youth at greater risk (i.e., those with low initial levels of knowledge, beliefs, self-efficacy, intention and skills) are likely to respond to RCL and should be the target of replication and dissemination efforts. (2) Responsiveness analyses can guide adaptation of RCL and other sexual and reproductive health programs for AI youth to improve efficacy among unresponsive subgroups (i.e., high initial scorers). (3) RCL is equally likely to impact AI youth across different ages, genders and school status, thus validating population-wide implementation strategies.

Self-efficacy and response-efficacy: critical components of sexual and reproductive health interventions targeting condom use intention among American Indian adolescents.

The Respecting the Circle of Life (RCL) intervention is a comprehensive, skills-based sexual/reproductive health program shown to be effective for reducing sexual risk among American Indian (AI) adolescents (13-19 years of age). This paper seeks to identify critical program components of the RCL intervention for replication of impacts on condom use intention (CUI) when scaling to additional communities. RCL was tested among AI adolescents through a cluster randomized controlled trial (N = 267) embedded in an 8-day basketball camp. Data were collected at baseline, immediately post-camp, at 6 and 12 months post-camp. Previously established predictors of CUI that were statistically significantly impacted by RCL at the post-camp time point were tested as mediators of RCL impact on CUI. Condom use self-efficacy and response efficacy fully mediated the effect of RCL on CUI. The indirect path through condom use self-efficacy had the greatest effect on CUI, explaining 79% of the direct effect. When stratified by gender, there was only evidence of mediation among girls. Results indicate condom use self-efficacy and response efficacy are critical components of the RCL intervention for AI girls, and sexual/reproductive health programs should include practical skills training to improve these constructs to maximize intervention impact on CUI.

Evaluation of an Entrepreneurship Education Intervention for American Indian Adolescents: Trial Design and Baseline Sample Characteristics.

Entrepreneurship education is a strength-based approach and holds promise for promoting health equity for American Indian youth. Arrowhead Business Group (ABG) was developed by a tribal-academic research partnership and is being rigorously evaluated for impacts on psychosocial, behavioral, educational, and economic outcomes. This article describes: 1) the trial design and conceptual model under-girding the ABG program; 2) the sociodemographic, sociocultural, and family/household characteristics of participants at baseline; and 3) the baseline differences in key outcome indicators between study groups. Results demonstrate participants have baseline characteristics appropriate for study aims and are compared and contrasted with other youth from the participating tribal community and state in which the tribe resides. Findings inform future analyses to explore how baseline characteristics are associated with primary and secondary outcomes of the evaluation.

Unintentional injury deaths among American Indian residents of the Fort Apache Indian Reservation, 2006-2012.

This study aims to describe the epidemiology of unintentional injury deaths among American Indian residents of the Fort Apache Indian Reservation between 2006 and 2012. Unintentional injury death data were obtained from the Arizona Department of Health Services and death rates were calculated per 100 000 people per year and age adjusted using data obtained from Indian Health Service and the age distribution of the 2010 US Census. Rate ratios were calculated using the comparison data obtained through CDC's Web-based Injury Statistics Query and Reporting System. The overall unintentional injury mortality rate among American Indians residing on the Fort Apache Indian Reservation between 2006 and 2012 was 107.0 per 100 000. When stratified by age, White Mountain Apache Tribe (WMAT) mortality rates for all unintentional injuries exceed the US all races rate except for ages 10-14 for which there were no deaths due to unintentional injury during this period. The leading causes of unintentional injury deaths were MVCs and poisonings. Unintentional injuries are a significant public health problem in the American Indian and Alaska Native communities. Tribal-specific analyses are critical to inform targeted prevention and priority setting.

Exploring the Role of Sex and Sexual Experience in Predicting American Indian Adolescent Condom Use Intention Using Protection Motivation Theory.

Introduction: American Indian (AI) youth experience poor sexual health outcomes. Research indicates the Protection Motivation Theory (PMT) is a robust model for understanding how sexual risk and protective behaviors are associated with condom use intention (CUI). Studies indicate the constructs of the PMT which influence CUI vary by sex and sexual experience. This analysis explores associations between PMT constructs and CUI by sex and sexual experience among AI youth who participated in the Respecting the Circle of Life (RCL) trial, a sexual and reproductive health intervention. Methods: We analyzed baseline data from the sample of 267 AIs, ages 13-19, who participated in the evaluation. We examined CUI and PMT construct scores by sex and sexual experience utilizing generalized estimated equations and multiple regression models to test which PMT constructs were associated with CUI across sex and sexual experience. Results: Twenty-two percentage of participants were sexually experienced; 56.8% reported CUI at baseline. We found several differences in scores in PMT constructs by sex and sexual experience including self-efficacy, response efficacy, vulnerability, severity, and extrinsic rewards. We also found constructs varied that were associated with CUI varied across sex and sexual experience. No PMT constructs were associated with CUI among sexually experienced youth. Conclusion: Results provide support for developing, selecting and delivering sexual health programs by sex and sexual experience in American Indian communities. Girls programs should focus on internal satisfaction and self-worth while boys should focus on negative impacts of not using condoms. Programs for youth who are not sexually active should focus on negative impacts of not using condoms. Programs for sexually inactive youth should work to change peer norms around condom use and improve knowledge about the efficacy of condom use.

Risk and Protective Factors Associated With Lifetime Sexual Experience Among Rural, Reservation-Based American Indian Youth.

Early sexual initiation is a catalyst for sexually transmitted infection and unintended pregnancy. American Indian/Alaska Native (AI/AN) youth initiate sex prior to age 13 more often than other U.S. youth, contributing to current inequalities in sexual health. Identifying what factors were associated with lifetime sexual experience among AI/AN youth can inform the development of primary prevention programming to delay sexual initiation, alleviate the costs of early sexual activity, and improve sexual health outcomes in this population. We analyzed cross-sectional data from 267 AI youth ages 13-19, recruited from a rural, reservation-based community. We used multivariate logistic regression models to estimate associations between independent variables and lifetime sexual experience (vaginal and/or anal sex) across the following categories: sociodemographic, knowledge, attitudes/perceptions, beliefs, intentions, skills, behaviors, and theoretical constructs. The sample was 56.2% female, mean age 15.1 years (SD = 1.7), and 22.5% were sexually experienced. In our final model, condom use self-efficacy (attitude/perception factor) and intentions to remain abstinent until marriage (intention factor) were associated with lower odds of lifetime sexual experience. Age (sociodemographic factor), intention to have sex (intention factor), use of any contraception (behavior factor), and higher response efficacy (theoretical construct) were associated with lifetime sexual experience. Of these, intention to have sex was the strongest indicator. These results both corroborate and contrast with other research conducted among rural, reservation-based AI/AN youth. Our findings show programs targeting intentions may have the greatest impact among reservation-based AI youth, and justify program delivery stratified by age group in this setting.

Characteristics of Substance Abuse and Self-Injury among American Indian Adolescents Who Have Engaged in Binge Drinking.

Binge drinking appears to be a risk factor, facilitator, and method of suicidal and non-suicidal self-injury for some American Indian (AI) youth. We examined characteristics, patterns, and motivations for binge use among AI adolescents (N = 69; 10-19 years-old) who recently engaged in binge drinking. The majority used alcohol alone (53.7%) or a combination of alcohol and marijuana (31.3%) for their binge event. Gender differences emerged with boys more severely affected than girls. Forty-seven percent reported lifetime suicidal thoughts. This study represents one of the first in-depth examinations of substance use and related behaviors among AI adolescents who have engaged in recent binge use.

Rigorous evaluation of a pregnancy prevention program for American Indian youth and adolescents: study protocol for a randomized controlled trial.

BACKGROUND: American Indian adolescents have one of the highest rates of teen pregnancy and repeat teen births in the US. Substance use is a significant risk factor for unprotected sex, and American Indian adolescents have the highest substance use-related morbidity and mortality of any US racial group. Despite these disparities, there are no existing, evidence-based programs for pregnancy prevention that have been rigorously evaluated among American Indian teens. METHODS: The proposed study is a randomized controlled trial to test the efficacy of a comprehensive sexual and reproductive health program developed in partnership with an American Indian community. Participants will be American Indians ages 11-19 and their parent or trusted adult, randomized to receive the control condition or intervention called Respecting the Circle of Life: Mind, Body and Spirit. The intervention includes eight lessons delivered to self-selected peer groups during a summer basketball camp and one lesson delivered to the youth and parent/trusted adult together within 3 months after camp. All lessons are administered by trained community health workers from the participating American Indian community. Youth and parent/trusted adult participants will complete assessments at baseline, 3, 9, 12, 24 and 36 months post-intervention completion. The primary outcome variables are sexual/reproductive health knowledge, sexual initiation, condom use self-efficacy and intent to use a condom at next sex as changed from baseline to post-intervention between intervention and control participants. Selected primary outcomes are applicable to all study participants. DISCUSSION: Currently there are no sexual and reproductive health programs designed specifically for American Indian youth that have been rigorously evaluated and found to have an evidence base. Respecting the Circle of Life is highly innovative by incorporating lesson delivery into a summer basketball camp and involving parents or other trusted adults in curriculum administration. If found successful, it will be the first evidence-based program for teen pregnancy prevention for American Indian youth and adolescents. TRIAL REGISTRATION: Clinicaltrials.gov, NCT02904629 . Retrospectively registered on 23 September 2016.

The Impact of a Sexual and Reproductive Health Intervention for American Indian Adolescents on Predictors of Condom Use Intention.

PURPOSE: American Indian (AI) adolescents experience inequalities in sexual health, in particular, early sexual initiation. Condom use intention is an established predictor of condom use and is an important construct for evaluating interventions among adolescents who are not yet sexually active. This analysis evaluated the impact of Respecting the Circle of Life (RCL), a sexual and reproductive health intervention for AI adolescents, on predictors of condom use intention. METHODS: We utilized a cluster randomized controlled trial design to evaluate RCL among 267 AIs ages 13-19. We examined baseline psychosocial and theoretical variables associated with condom use intention. Generalized estimating equation regression models determined which baseline variables predictive of condom use intention were impacted. RESULTS: Mean sample age was 15.1 years (standard deviation 1.7) and 56% were female; 22% had initiated sex. A larger proportion of RCL versus control participants had condom use intention post intervention (relative risk [RR] = 1.39, p = .008), especially younger (ages 13-15; RR = 1.42, p = .007) and sexually inexperienced adolescents (RR = 1.44, p = .01); these differences attenuated at additional follow-up. Baseline predictors of condom use intention included being sexually experienced, having condom use self-efficacy, as well as response efficacy and severity (both theoretical constructs). Of these, the RCL intervention significantly impacted condom use self-efficacy and response efficacy. CONCLUSIONS: Results demonstrate RCL intervention efficacy impacting variables predictive of condom use intention at baseline, with greater differences among younger, sexually inexperienced adolescents. To sustain intervention impact, future RCL implementation should reinforce education and training in condom use self-efficacy and response efficacy and recruit younger, sexually inexperienced AI adolescents.