Medical Mistrust and Adherence to Care Among a Heterogeneous Cohort of Women Living with HIV, Followed in a Large, U.S. Safety Net Clinic.
Lunthita M Duthely, Alex P Sanchez-Covarrubias, Varsha Prabhakar...
https://pubmed.ncbi.nlm.nih.gov/34909537Actively Recruiting
Phase Not Applicable
Age: 18Years +
FEMALE
ID03738410
A Multi-Lingual, Culturally-Competent Mobile Health Intervention to Reduce Medical Mistrust, Stigma, and Improve Treatment Adherence Among Women Living With HIV/AIDS
Led by University of Miami · Updated on 2026-01-21
80
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
Sponsors
U
University of Miami
Lead Sponsor
N
National Institute on Drug Abuse (NIDA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying a mobile health (mHealth) system designed to help women living with HIV/AIDS improve their treatment adherence and address barriers like stigma, medical mistrust, and resilience. This study focuses on both pregnant and non-pregnant women and aims to see if the mHealth system is feasible, well accepted, and positively impacts patient health. It is a randomized interventional study conducted by the University of Miami. Participants are assigned to one of several groups: a control group receiving standard care, a group receiving standard care plus patient navigation and mobile health messaging with psycho-educational content, and a focus group to help design the intervention. The mobile health messaging is delivered over a 12-month period to remind women about appointments, medication, and overcoming barriers to HIV care. During the study, participants' clinic attendance, stigma, medical mistrust, and resilience are evaluated at the start and after 12 months. Researchers track enrollment rates and how well participants accept the mHealth application. The study includes regular assessments and uses patient navigation and motivational interviewing to support adherence. Participation lasts at least 12 months to monitor ongoing effects and outcomes.
CONDITIONS
Brief Title
An mHealth Intervention to Improve Outcomes for Women With HIV/AIDS
Who Can Participate
Age: 18Years +
FEMALE
Eligibility Criteria
You may qualify if you...
- Confirmed HIV diagnosis as per the clinic standard
- Female 18 years old or older at enrollment
- Currently active or recently returned into care or newly enrolled
- Two or more previously scheduled visits in the 12 months prior to study enrollment
- In the 12 months prior to enrollment, missed one or more visits or had detectable viral load (>20 mL) or not taking prescribed HIV anti-retroviral medications
You will not qualify if you...
- Men
- Women who are cognitively impaired or unable to consent for themselves
- No working cell phone
- Adolescents under 18 years old at enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Outpatient Treatment
Duration - 12 months
Participants receive the mobile health messaging intervention along with standard care, or standard care alone, to improve treatment adherence and reduce stigma.
Regular contact through mobile messaging over 12 months
Trial Site Locations
Total: 1 location
1
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
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Research Team
L
Lunthita M Duthely, Ed.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
3
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Published Research Related To This Trial
Targeted client communication via mobile devices for improving sexual and reproductive health.
Melissa J Palmer, Nicholas Henschke, Gemma Villanueva...
https://pubmed.ncbi.nlm.nih.gov/32779730A Multilingual, Culturally Competent Mobile Health Intervention to Improve Treatment Adherence Among Women Living With HIV: Protocol for a Randomized Controlled Trial.
Lunthita M Duthely, Alex P Sanchez-Covarrubias, Adhar B Mohamed...
https://pubmed.ncbi.nlm.nih.gov/32438338