Ignite Creation Date:
2024-05-06 @ 6:22 PM
Last Modification Date:
2024-10-26 @ 2:46 PM
Study NCT ID:
NCT05632575
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-05
First Post:
2022-11-04
Brief Title:
The Virtual Promotoras Study eHealth Intervention to Promote Sexual Health Among Young Latina Women in the US South
Sponsor:
University of Alabama Tuscaloosa
Organization:
University of Alabama Tuscaloosa
Study Overview
Official Title:
The Virtual Promotoras VIP Program for Young Latina Women Testing the Feasibility of an eHealth Intervention to Promote Sexual Health Among Young Latina Women in the US South
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Young Latina women face significant barriers to sexual health and healthcare access particularly in emerging Latino states like Alabama The goals of the proposed study are to develop and examine the feasibility of an innovative scalable mHealth safe space intervention for Young Latina Women YLW in Alabama AL and to stimulate the conduct of behavioral research at the University of Alabama This work is consistent with the National Institute of Nursing Researchs goals of Enhancing wellness by understanding the physical behavioral cultural and environmental influences on health status and developing culturally tailored interventions to prevent illness and promote health and Using innovative technologies to develop novel interventions that deliver personalized care and real-time health information to patients families and healthcare providers
Detailed Description:
The goals of the proposed study are to develop and examine the feasibility of an innovative scalable mHealth safe space intervention for Young Latina Women YLW in Alabama AL and to stimulate the conduct of behavioral research at the University of Alabama UA YLW are disproportionately affected by sexual health SH disparities compared to their non-Hispanic White counterparts In 2017 the birth rate for AL Latinas 15-19 years of age was 5251000 population compared to 229 among their non-Hispanic white counterparts In 2016 the estimated rate of Hispanics living with diagnosed HIV infection in AL was 2850100000 compared to 1249100000 for non-Hispanic Whites Forty-six percent of AL youth in grades 9-12th report having initiated sexual intercourse Sexually active adolescents 15 years and older should be regularly screened for sexually transmitted infections STI and therefore must have access to healthcare services timely screenings and when desired contraception to adequately care for their SH and make informed SH choices However Hispanic youth are significantly less likely than their non-Hispanic Black and non-Hispanic white counterparts to have a usual place for preventive care Additionally evidence-based culturally relevant SH education programming is largely unavailable AL There is a need for accessible effective and scalable SH and sexual healthcare access SHCA interventions for YLW The Virtual Promotoras Program VIP seeks to address this need
The VIP is centered on the principle that creating a virtual safe space for YLW to learn about SH and SHCA can help them become more empowered to effectively care for their SH ie develop reproductive health goals and plans engage with the healthcare system ie make and keep medical appointments effectively communicate with provider etc and acquire needed preventive services These strategies have been shown to improve health outcomes and reduce health disparities among adolescents including Latinoax youth
Extensive formative work conducted in 2017-2018 44 semi-structured qualitative interviews with YLW Latinoax parents sexual healthcare providers and other key stakeholders with active engagement of the Latinoax community and guided by a Community Based Participatory Research CBPR philosophical framework identified the following themes lack of SH education in schools lack of awareness of available sexual healthcare services and how to navigate them embarrassment or lack of confidence in accessing sexual healthcare and a desire to learn about SH and healthcare access through technology This intervention development study is based on that research Intervention mapping was used to create a detailed intervention outline for the VIP and design a promotoras peer navigator capacity building training and manual
This study includes the development and feasibility of the proposed mHealth VIP Program which if successful will inform a large-scale randomized trial Social Cognitive Theory which postulates that cognitive behavioral and environmental factors determine human behavior guides this work The mHealth VIP tool mobile app will create a virtual safe space where YLW can learn about SH and SHCA educational modules connect with virtual promotoras who can provide guidance and advice on how to navigate the healthcare system eg where to get services if you are uninsured and create a SH plan ie a goal setting and patientprovider communication tool mHealth interventions show great promise toward increasing health-seeking behaviors including SHCA among young populations A majority of YLW have smartphones and half report being online almost constantly making mHealth interventions a natural choice for health promotion among this group ReproductiveSH plans and patient-provider communication checklists are cost-effective but underutilized tools with potential to improve SH outcomes among YLW Additionally the literature on adult Latinas shows that patient navigation is effective at linking Latinas to healthcare services However no other researchers in the US South are working with YLW to develop evidence-based SH education and peer navigator model to increase SH and SHCA empowerment and decrease SH disparities in this group The specific aims of this study are 1 Develop and examine the feasibility of a theory-based culturally relevant SH and SHCA intervention for YLW and 2 Estimate the parameters required to size a group randomized trial for the evaluation of efficacy of the VIP program This work is consistent with the National Institute of Nursing Researchs goals of Enhancing wellness by understanding the physical behavioral cultural and environmental influences on health status and developing culturally tailored interventions to prevent illness and promote health and Using innovative technologies to develop novel interventions that deliver personalized care and real-time health information to patients families and healthcare providers This R15 will help grow the research enterprise at UA and provide unique and previously unavailable research opportunities to UA undergraduate graduate and medical education students
The VIP is centered on the principle that creating a virtual safe space for YLW to learn about SH and SHCA can help them become more empowered to effectively care for their SH ie develop reproductive health goals and plans engage with the healthcare system ie make and keep medical appointments effectively communicate with provider etc and acquire needed preventive services These strategies have been shown to improve health outcomes and reduce health disparities among adolescents including Latinoax youth
Extensive formative work conducted in 2017-2018 44 semi-structured qualitative interviews with YLW Latinoax parents sexual healthcare providers and other key stakeholders with active engagement of the Latinoax community and guided by a Community Based Participatory Research CBPR philosophical framework identified the following themes lack of SH education in schools lack of awareness of available sexual healthcare services and how to navigate them embarrassment or lack of confidence in accessing sexual healthcare and a desire to learn about SH and healthcare access through technology This intervention development study is based on that research Intervention mapping was used to create a detailed intervention outline for the VIP and design a promotoras peer navigator capacity building training and manual
This study includes the development and feasibility of the proposed mHealth VIP Program which if successful will inform a large-scale randomized trial Social Cognitive Theory which postulates that cognitive behavioral and environmental factors determine human behavior guides this work The mHealth VIP tool mobile app will create a virtual safe space where YLW can learn about SH and SHCA educational modules connect with virtual promotoras who can provide guidance and advice on how to navigate the healthcare system eg where to get services if you are uninsured and create a SH plan ie a goal setting and patientprovider communication tool mHealth interventions show great promise toward increasing health-seeking behaviors including SHCA among young populations A majority of YLW have smartphones and half report being online almost constantly making mHealth interventions a natural choice for health promotion among this group ReproductiveSH plans and patient-provider communication checklists are cost-effective but underutilized tools with potential to improve SH outcomes among YLW Additionally the literature on adult Latinas shows that patient navigation is effective at linking Latinas to healthcare services However no other researchers in the US South are working with YLW to develop evidence-based SH education and peer navigator model to increase SH and SHCA empowerment and decrease SH disparities in this group The specific aims of this study are 1 Develop and examine the feasibility of a theory-based culturally relevant SH and SHCA intervention for YLW and 2 Estimate the parameters required to size a group randomized trial for the evaluation of efficacy of the VIP program This work is consistent with the National Institute of Nursing Researchs goals of Enhancing wellness by understanding the physical behavioral cultural and environmental influences on health status and developing culturally tailored interventions to prevent illness and promote health and Using innovative technologies to develop novel interventions that deliver personalized care and real-time health information to patients families and healthcare providers This R15 will help grow the research enterprise at UA and provide unique and previously unavailable research opportunities to UA undergraduate graduate and medical education students
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None