HealthyNCT05632575
The Virtual Promotoras Study: eHealth Intervention to Promote Sexual Health Among Young Latina Women in the US South
A study testing Virtual Promotoras Program in people with Healthy, run by University of Alabama, Tuscaloosa at 1 site in United States.
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)… Read more about this study
- Who is it for?
- Ages 16 to 21 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Virtual Promotoras Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2024to 30 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 21 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Non-English or Spanish Speaking. (At this time, we are unable to accommodate Latinas who only speak indigenous languages.)
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Alabama
Tuscaloosa, Alabama, 35209
About this study
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
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".
Read the 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.
- Conditions
- Healthy
- Being tested
- Virtual Promotoras Program
- Keywords
- Latinas, U.S. South, sexual health, healthcare access, mHealth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Promotoras ProgramBehavioural
Participants will receive a unique participant code from the virtual promotoras (i.e., patient educators and navigators), to access the VIP mobile phone app intervention. This will give them access to the three main components of the VIP intervention:
- Educational Modules (8 evidence-based educational modules made by the VPs),
- Sexual and Reproductive Health Plan (SRHP): Quiz-style instrument to help the participant set goals for her sexual health and develop a set of questions to ask her provider.
- Virtual Promotora's (VP) chat room.: Opportunity for participant to ask any questions that she may have about sexual health (SH) or sexual healthcare access (SHCA), refine her SRHP. The VP will also help her make her appointment for her clinical visit with one of the local free clinics which do not require insurance and are youth-friendly, and practice having the conversation that she wants to have with her clinical provider.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm: Virtual Promotoras Intervention | Other | Single-arm study. Pre and post intervention. Observational. Behavioral Receives: Behavioral: Virtual Promotoras Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
sexual health and healthcare access empowerment
The main goal of the proposed intervention is to develop and evaluate the feasibility of a culturally relevant, evidence based sexual health education (knowledge and skill building) and healthcare intervention to empower YLW to care for their SH and make informed reproductive health choices9. This is a development and feasibility study; therefore an evaluation of effectiveness of the intervention will not take place at this point. However, the key outcomes of the intervention are SH empowerment and SHCA empowerment.
The Sexual and Reproductive Empowerment (SRE) for Adolescents and Young Adults Scale, developed by Upadhyay and colleagues (2021) will be utilized to measure this outcome. The scale includes 95 items in 3 subscales: Access to sexual and reproductive information; Access to sexual and reproductive health services; and use of Desired contraceptive method. Items are measured on a 5-point Likert scale from "not at all true" to "extremely true".
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start11 Nov 2024
- Primary completion30 May 2025
- Study completion30 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Observational, single group, pre-post test design.
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama, Tuscaloosa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05632575
- Sponsor's protocol ID
- 19-08-2646
- Status last verified
- Jan 2026
- First submitted
- 4 Nov 2022
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05632575
- Acronym / sponsor ID
- 19-08-2646
- Conditions
- Healthy
- Keywords
- Latinas, U.S. South, sexual health, healthcare access, mHealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of Alabama, TuscaloosaUniversity, hospital or other
- Study start
- 11 Nov 2024 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 Aug 2025 (actual)
- First posted
- 30 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Observational, single group, pre-post test design.
| Arm | Type | Receives |
|---|---|---|
| Single Arm: Virtual Promotoras Intervention | Other | Behavioral: Virtual Promotoras ProgramSingle-arm study. Pre and post intervention. Observational. Behavioral |
Who may qualify
- Ages
- 16 to 21 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Non-English or Spanish Speaking. (At this time, we are unable to accommodate Latinas who only speak indigenous languages.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Promotoras ProgramParticipants will receive a unique participant code from the virtual promotoras (i.e., patient educators and navigators), to access the VIP mobile phone app intervention. This will give them access to the three main components of the VIP intervention: 1. Educational Modules (8 evidence-based educational modules made by the VPs), 2. Sexual and Reproductive Health Plan (SRHP): Quiz-style instrument to help the participant set goals for her sexual health and develop a set of questions to ask her provider. 3. Virtual Promotora's (VP) chat room.: Opportunity for participant to ask any questions that she may have about sexual health (SH) or sexual healthcare access (SHCA), refine her SRHP. The VP will also help her make her appointment for her clinical visit with one of the local free clinics which do not require insurance and are youth-friendly, and practice having the conversation that she wants to have with her clinical provider. | Behavioural | Single Arm: Virtual Promotoras Intervention |
Primary outcome
sexual health and healthcare access empowerment
Time frame: 3 months
The main goal of the proposed intervention is to develop and evaluate the feasibility of a culturally relevant, evidence based sexual health education (knowledge and skill building) and healthcare intervention to empower YLW to care for their SH and make informed reproductive health choices9. This is a development and feasibility study; therefore an evaluation of effectiveness of the intervention will not take place at this point. However, the key outcomes of the intervention are SH empowerment and SHCA empowerment. The Sexual and Reproductive Empowerment (SRE) for Adolescents and Young Adults Scale, developed by Upadhyay and colleagues (2021) will be utilized to measure this outcome. The scale includes 95 items in 3 subscales: Access to sexual and reproductive information; Access to sexual and reproductive health services; and use of Desired contraceptive method. Items are measured on a 5-point Likert scale from "not at all true" to "extremely true".
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Promotoras Program in people with Healthy, run by University of Alabama, Tuscaloosa at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sexual health and healthcare access empowerment (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.