Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05632575 |
| Other study ID # |
19-08-2646 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 2024 |
| Est. completion date |
August 2024 |
Study information
| Verified date |
January 2024 |
| Source |
University of Alabama, Tuscaloosa |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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".
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.
