A Multi-Lingual, Culturally-Competent Mobile Health Intervention to Reduce Medical Mistrust, Stigma, and Improve Treatment Adherence Among Women Living With HIV/AIDS (WLWH)

University of Miami1 site in 1 country80 target enrollmentMay 2, 2022

ConditionsHIV/AIDS

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: HIV/AIDS
Sponsor: University of Miami
Enrollment: 80
Locations: 1
Primary Endpoint: Rate of Enrollment
Status: Recruiting
Last Updated: 3 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is:

To develop a new mobile health (mHealth) system that will send text messages to remind both pregnant and non-pregnant women with HIV to adhere to their treatment plan (like keeping appointments, fillings prescriptions, and taking their medication) and address individual barriers to HIV care (like stigma, medical mistrust and resilience).
The intervention will also include patient navigation and motivational interviewing

2) Investigators also want to see if the mHealth system is feasible, easily accepted and if it will impact patient health in a positive way.

Registry

clinicaltrials.gov

Start Date

May 2, 2022

End Date

July 31, 2026

Last Updated

3 months ago

Study Type

Interventional

Study Design

Sequential

Sex

Female

Investigators

Sponsor

University of Miami

Responsible Party

Principal Investigator

Lunthita M. Duthely

Research Associate Professor

University of Miami

Eligibility Criteria

Inclusion Criteria

•Confirmed HIV diagnosis as per the clinic standard
•Female \>= 18 years old at enrollment
•Currently active or recently returned into care or newly enrolled
•With two or more previously scheduled visits (12 months prior to study enrollment
•in the 12 months prior to enrollment:
•missed one or more visits or
•viral load detectable (\>20 mL) or
•not taking prescribed HIV anti-retroviral medications

Exclusion Criteria

•women who are cognitively impaired or are not able to consent for themselves
•non-working cell phone
•adolescents \< 18 years old at enrollment

Outcomes

Primary Outcomes

Rate of Enrollment

Time Frame: Month 12

The proportion of participants enrolled and proportion of participants declined enrollment or screen failed out of total number of participants approached.

Acceptability of the mHealth application

Time Frame: Month 12

The proportion of messages opened, which were received