Clinical trial NCT05632575: The Virtual Promotoras Study: eHealth Intervention to Promote Sexual Health Among Young Latina Women in the US South
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
Keywords: Latinas
U.S. South
sexual health
healthcare access
mHealth
Lead sponsor: University of Alabama, Tuscaloosa
Sponsor class: OTHER
First posted: 2022-11-30
Enrollment: 52
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Observational, single group, pre-post test design.
Primary purpose: PREVENTION

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 Research's 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 52.5/1,000 population compared to 22.9 among their non-Hispanic white counterparts. In 2016, the estimated rate of Hispanics living with diagnosed HIV infection in AL was 285.0/100,000 compared to 124.9/100,000 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 (i.e., develop reproductive health goals and plans), engage with the healthcare system (i.e., 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 Latino/a/x youth.

Extensive formative work conducted in 2017-2018 (44 semi-structured qualitative interviews with YLW, Latino/a/x parents, sexual healthcare providers and other key stakeholders) with active engagement of the Latino/a/x 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 (e.g. where to get services if you are uninsured); and create a SH plan (i.e., a goal setting and patient/provider 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. Reproductive/SH 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 Research's 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.

Eligibility criteria: Inclusion Criteria:

* Potential participants will be eligible to participate if they self-identify as Latina, are 16-21 years of age, self-report not having had a preventive care or sexual healthcare visit in the last 18 months, and have lived in AL for at least 5 years.

Exclusion Criteria:

* Non-English or Spanish Speaking. (At this time, we are unable to accommodate Latinas who only speak indigenous languages.)

Primary outcomes:
measure: sexual health and healthcare access empowerment
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tuscaloosa
country: United States
facility: The University of Alabama
state: Alabama
Study officials:
References: