NCT05632575

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".

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Nov 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 4, 2022

Completed
26 days until next milestone

First Posted

Study publicly available on registry

November 30, 2022

Completed
2 years until next milestone

Study Start

First participant enrolled

November 11, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2025

Completed
Last Updated

January 6, 2026

Status Verified

January 1, 2026

Enrollment Period

7 months

First QC Date

November 4, 2022

Last Update Submit

January 2, 2026

Conditions

Keywords

LatinasU.S. Southsexual healthhealthcare accessmHealth

Outcome Measures

Primary Outcomes (1)

  • 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".

    3 months

Study Arms (1)

Single Arm: Virtual Promotoras Intervention

OTHER

Single-arm study. Pre and post intervention. Observational. Behavioral

Behavioral: Virtual Promotoras Program

Interventions

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: 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.

Single Arm: Virtual Promotoras Intervention

Eligibility Criteria

Age16 Years - 21 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Alabama

Tuscaloosa, Alabama, 35209, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Observational, single group, pre-post test design.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2022

First Posted

November 30, 2022

Study Start

November 11, 2024

Primary Completion

May 30, 2025

Study Completion

August 30, 2025

Last Updated

January 6, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations