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Protecting our future generation: study protocol for a randomized controlled trial evaluating a sexual health self-care intervention with Native American youth and young adults.

ABSTRACT: BACKGROUND:Disparities in sexually transmitted infections (STI) are an urgent problem among Native American youth and young adults which are not fully explained by different sexual or related behaviors. These sexual health disparities are more likely attributed to social environments and structural determinants such as a shortage of sexual healthcare providers, lower socioeconomic status, and access barriers to STI screening and treatment, including geographic isolation and confidentiality concerns. Innovative, non-clinic based alternatives to promote STI screening and treatment are essential for alleviating these disparities. Self-care, or the care taken by individuals towards their own health and well-being may be such a strategy. This study will assess the efficacy of a self-care intervention, called Protecting Our Future Generation, for increasing uptake of STI screening and impacting sexual risk and protective behaviors among Native American youth and young adults living in a reservation-based community in the Southwestern United States. METHODS:The proposed study is a randomized controlled trial to test the efficacy of a self-care intervention compared to a control condition. Participants will be Native Americans ages 14-26?years old who have had vaginal or anal sex at least once in their lifetime. Participants will be randomized to the intervention which includes: 1) a sexual health self-assessment with embedded clinical prediction tool predicting STI positivity, and 2) personalized messaging with key steps to lower risk for STIs, or the control condition which includes: 1) a self-assessment about water, soda and sugar sweetened beverage consumption, and 2) personalized messaging to meet recommended daily intake. All participants will be offered a self-administered STI test. Participants will complete assessments at baseline, 3- and 6-months follow-up. The primary outcome measure is completion of STI screening. DISCUSSION:Protecting Our Future Generation is among the first self-care interventions uniquely focused on sexual health among a Native American population, who endure significant sexual health disparities and are under-represented in research. If efficacious, the intervention will be a model of sexual health self-care for Native American youth and young adults adaptable for use in healthcare and community-based settings. TRIAL REGISTRATION:Clinical Trials: http://clinicaltrials.gov; NCT03895320; Registered 03/28/2019.

SUBMITTER: Lauren T

PROVIDER: S-EPMC6888928 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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Protecting our future generation: study protocol for a randomized controlled trial evaluating a sexual health self-care intervention with Native American youth and young adults.

Lauren Tingey T Catherine Sutcliffe S Rachel Chambers C Hima Patel P Angelita Lee L Shauntel Lee L Laura Melgar M Anna Slimp S Anne Rompalo R Mariddie Craig C Charlotte Gaydos G

BMC public health 20191202 1

<h4>Background</h4>Disparities in sexually transmitted infections (STI) are an urgent problem among Native American youth and young adults which are not fully explained by different sexual or related behaviors. These sexual health disparities are more likely attributed to social environments and structural determinants such as a shortage of sexual healthcare providers, lower socioeconomic status, and access barriers to STI screening and treatment, including geographic isolation and confidentiali ...[more]

PMID: 31791323

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Project description:BackgroundIn 1999, type 2 diabetes mellitus (T2DM) was identified as an emerging epidemic in youth, and racial and ethnic minority youth were identified with high risk. Two decades later, no gold standard T2DM prevention intervention has been established for this population.ObjectiveThis study tests the efficacy of a telehealth diabetes prevention intervention for African American (AA) families with children with risk for T2DM. Concurrently, investigators aim to evaluate an implementation strategy for the uptake of the intervention by the University of Mississippi Medical Center's (UMMC) pediatric weight management clinic.MethodsThis single-arm trial will enroll 20 parents with overweight or obesity of children (8-11 years) with overweight or obesity, both of whom are at risk for T2DM. Parents will meet in small groups (5 parents per group) weekly for 11 weeks and then monthly for 4 monthly maintenance sessions via videoconference using Wi-Fi-enabled iPads with cellular connectivity. The intervention will be adapted from the National Diabetes Prevention Program and Power to Prevent, a diabetes prevention program tailored for AA families. The same lifestyle intervention facilitated by a racially concordant lifestyle coach trained in the Diabetes Prevention Program will be delivered to all groups (n=4). Participants will be recruited in-person during patient encounters at the UMMC's pediatric weight management clinic. Sessions will consist of dietary and physical activity behavior change strategies facilitated using problem-solving and goal-setting skills. The implementation strategy has 2 targets: the pediatric weight management clinic site and clinical team and parents of children at risk for T2DM engaged in intensive obesity treatment to prevent T2DM. The multifaceted implementation protocol includes 4 discrete strategies: creating a new clinical team, changing the service site, intervening with families, and promoting organizational readiness for change.ResultsRecruitment and enrollment began in December 2020, and the intervention is scheduled to be delivered to the first cohort of parents in March 2021. The results are expected to be submitted for publication beginning in November 2021 through 2022. The primary outcome measure for the pilot trial will include changes from baseline to 12 and 30 weeks in the child BMI z score and parent BMI. The implementation evaluation will include multiple measures of feasibility, acceptability, appropriateness, fidelity, and efficacy. This protocol was approved by the UMMC's Institutional Review Board (#2020V0249).ConclusionsThe proposed intervention approach is supported by the scientific literature and is scalable given the current and future health care subsidies for telehealth. Findings from this pilot trial will begin to address critical barriers to defining a gold standard lifestyle intervention for AA families with children at risk for T2DM. If effective, the intervention could be feasibly disseminated to treat obesity and prevent T2DM in high-risk AA pediatric populations.International registered report identifier (irrid)PRR1-10.2196/25699.

Project description:BackgroundRegarding health technologies, African American young adults have low rates of uptake, ongoing usage, and engagement, which may widen sexual health inequalities.ObjectiveWe aimed to examine rates of uptake and ongoing usage, and factors influencing uptake, ongoing usage, and engagement for a consumer health informatics (CHI) intervention for HIV/sexually transmitted infection (STI) prevention among African American young adults, using the diffusion of innovation theory, trust-centered design framework, and O'Brien and Toms' model of engagement.MethodsThis community-based participatory mixed methods study included surveys at four time points (n=315; 280 African American participants) among young adults aged 18 to 24 years involved in a blended offline/online HIV/STI prevention intervention (HIV Outreach, Prevention, and Education [HOPE] eIntervention), which was described as a "HOPE party." Qualitative interviews were conducted with a subset of participants (n=19) after initial surveys and website server logs indicated low uptake and ongoing usage. A generalized linear mixed-effects model identified predictors of eIntervention uptake, server logs were summarized to describe use over time, and interview transcripts were coded and thematically analyzed to identify factors affecting uptake and engagement.ResultsParticipants' initial self-reported eIntervention uptake was low, but increased significantly over time, although uptake never reached expectations. The most frequent activity was visiting the website. Demographic factors and HOPE party social network characteristics were not significantly correlated with uptake, although participant education and party network gender homophily approached significance. According to interviews, one factor driving uptake was the desire to share HIV/STI prevention information with others. Survey and interview results showed that technology access, perceived time, and institutional and technological trust were necessary conditions for uptake. Interviews revealed that factors undermining uptake were insufficient promotion and awareness building, and the platform of the intervention, with social media being less appealing due to previous negative experiences concerning discussion of sexuality on social media. During the interaction with the eIntervention, interview data showed that factors driving initial engagement were audience-targeted website esthetics and appealing visuals. Ongoing usage was impeded by insufficiently frequent updates. Similarly, lack of novelty drove disengagement, although a social media contest for sharing intervention content resulted in some re-engagement.ConclusionsTo encourage uptake, CHI interventions for African American young adults can better leverage users' desires to share information about HIV/STI prevention with others. Ensuring implementation through trusted organizations is also important, though vigorous promotion is needed. Visual appeal and targeted content foster engagement at first, but ongoing usage may require continual content changes. A thorough analysis of CHI intervention use can inform the development of future interventions to promote uptake and engagement. To guide future analyses, we present an expanded uptake and engagement model for CHI interventions targeting African American young adults based on our empirical results.

Project description:BackgroundCulturally relevant interventions are needed to help American Indian and Alaska Native (AI/AN) teenagers and young adults navigate common risky situations involving family and friends, including drug and alcohol misuse, dating violence, and suicidality. Leveraging We R Native, a multimedia health resource for Native teenagers and young adults, staff of the Northwest Portland Area Indian Health Board designed the BRAVE intervention for Native youth. The program is delivered via SMS text messaging and includes role model videos, mental wellness strategies, links to culturally relevant resources, and social support from family and friends.ObjectiveWe aim to conduct a randomized controlled trial of the BRAVE intervention among AI/AN teenagers and young adults (aged 15-24 years) to assess its impact on their physical, mental, and spiritual health; their resilience and self-esteem; and their coping and help-seeking skills.MethodsFrom October to December 2019, we recruited 2334 AI/AN teenagers and young adults nationwide via social media channels and SMS text messages and enrolled 1044 participants. AI/AN teenagers and young adults enrolled in the study received either BRAVE SMS text messages, designed to improve mental health, help-seeking skills, and cultural resilience, or 8 weeks of science, technology, engineering, and math (STEM) SMS text messages, designed to elevate and reaffirm Native voices in STEM and medicine and then received the BRAVE SMS text messages. The impacts of the BRAVE intervention were tested using linear mixed-effect models and linear regressions.ResultsA total of 833 AI/AN teenagers and young adults were included in the analysis. Individuals in the BRAVE and STEM arms showed significant positive trends over the course of the study for all outcomes, except cultural identity and help-seeking behavior. Mean scores were significantly different for health (P<.001), resilience (P<.001), negative coping (P=.03), positive coping (P<.001), self-efficacy (P=.02), and self-esteem (P<.001). Changes in help-seeking self-efficacy were significant in those exhibiting risky behaviors at baseline to exit (P=.01). Those who reported positive coping scores at baseline also reported better health on average; however, no difference was found in risky drug and alcohol use (P<.001). The number of participants who used SMS text messages to help themselves increased from 69.1% (427/618) at 3 months to 76% (381/501; P<.001) at 8 months. Similarly, the number of participants who used SMS text messages to help friends or family members increased from 22.4% (138/616) at 3 months to 54.6% (272/498) at 8 months.ConclusionsThis is the first national randomized controlled trial of a mobile health intervention among AI/AN teenagers and young adults to test the efficacy of a mental wellness intervention in relation to STEM career messages. This study provides new insights for supporting the next generation of AI/AN changemakers.Trial registrationClinicalTrials.gov NCT04979481; https://clinicaltrials.gov/ct2/show/NCT04979481.

Dataset Information

Protecting our future generation: study protocol for a randomized controlled trial evaluating a sexual health self-care intervention with Native American youth and young adults.

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Protecting our future generation: study protocol for a randomized controlled trial evaluating a sexual health self-care intervention with Native American youth and young adults.

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