TY - JOUR
T1 - Protecting our future generation
T2 - Study protocol for a randomized controlled trial evaluating a sexual health self-care intervention with Native American youth and young adults
AU - Lauren, Tingey
AU - Catherine, Sutcliffe
AU - Rachel, Chambers
AU - Hima, Patel
AU - Angelita, Lee
AU - Shauntel, Lee
AU - Laura, Melgar
AU - Anna, Slimp
AU - Anne, Rompalo
AU - Mariddie, Craig
AU - Charlotte, Gaydos
N1 - Funding Information:
This research is supported by grant #1S06GM123547–01 from the National Institutes of Health: Office of the Director, National Institutes of Health (OD), National Institute Of General Medical Sciences (NIGMS), National Institute Of Allergy and Infectious Diseases (NIAID), and National Institute On Minority Health And Health Disparities (NIMHD). The funding body had no role in designing the study; data collection, analysis, or interpretation of the data; and no role in writing the manuscript.
Funding Information:
Ethics approval for this research was obtained by the Johns Hopkins University Bloomberg School of Public Health and Phoenix Area Indian Health Service Institutional Review Boards. The study was also reviewed and approved by the participating Tribe’s governing Tribal Council and Health Advisory Board. The relevant Institutional Review Boards (IRB) approved for minors ages 14–17 to consent to study participation as adults in lieu of requiring parental permission. This decision is based on state law that allows individuals ages 14 and older to consent to STI screening without parental permission. Thus, the IRBs believed requiring parental permission could potentially act as a barrier to study participation, and preclude access to STI screening. Written consent to study participation was obtained from all individuals; this method of consent was approved by the aforementioned entities.
Publisher Copyright:
© 2019 The Author(s).
PY - 2019/12/2
Y1 - 2019/12/2
N2 - 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.
AB - 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.
KW - Native American
KW - Risk and protective factors
KW - Screening
KW - Self-care
KW - Sexually transmitted infection
KW - Young adults
KW - Youth
UR - http://www.scopus.com/inward/record.url?scp=85075948927&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85075948927&partnerID=8YFLogxK
U2 - 10.1186/s12889-019-7956-x
DO - 10.1186/s12889-019-7956-x
M3 - Article
C2 - 31791323
AN - SCOPUS:85075948927
SN - 1471-2458
VL - 19
JO - BMC public health
JF - BMC public health
IS - 1
M1 - 1614
ER -