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/34909537/Actively Recruiting
Led by University of Miami · Updated on 2026-01-21
80
Participants Needed
1
Research Sites
4 weeks
Total Duration
Researchers are studying a mobile health mHealth system designed to help women living with HIVAIDS 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
An mHealth Intervention to Improve Outcomes for Women With HIV/AIDS
L
Lunthita M Duthely, Ed.D.
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University of Miami
Lead Sponsor
National Institute on Drug Abuse (NIDA)
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | mHealth Messaging (Trial) | Standard of Care (Trial) | Mobile Messaging in Usual Care (External Evidence) |
|---|---|---|---|
| What it is | Use of a mobile health messaging application delivering messages over 12 months | Usual standard of care as provided by licensed health care provider | Mobile messaging interventions have been shown in meta‑analyses to improve antiretroviral adherence |
| Role in the trial | This is the investigational behavioral arm delivering mobile messages | This arm receives usual care without additional messaging | Not part of this trial; reflects typical mHealth use in broader practice |
| Primary use | To support engagement in care and adherence via mobile messaging | Deliver routine HIV/AIDS care without added messaging support | Support ART adherence using mobile message reminders and interactive messages |
| How it is given or performed | Messages sent via mobile app over 12‑month period | Care provided in person by provider without messaging intervention | Mobile message reminders or interactive SMS delivered alongside usual care |
| Evidence status | Efficacy under investigation; trial ongoing, no published results yet | Effectiveness established in general practice, but specifics vary | Meta‑analyses show mHealth messaging improves ART adherence (OR ≈2.0) and viral suppression |
| Important risks | Unknown; behavioral intervention, no safety concerns described yet | Usual medical care risks apply, not specified here | No significant adverse effects reported for SMS‑based mHealth messaging |
| Important limitations | Effectiveness not yet known; results pending | Delivery may vary across settings; no standardized messaging support | Effect sizes vary by setting; most data from low‑ and middle‑income contexts |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
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
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
3
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Lunthita M Duthely, Alex P Sanchez-Covarrubias, Varsha Prabhakar...
https://pubmed.ncbi.nlm.nih.gov/34909537/Lunthita M Duthely, Alex P Sanchez-Covarrubias, Adhar B Mohamed...
https://pubmed.ncbi.nlm.nih.gov/32438338/Melissa J Palmer, Nicholas Henschke, Gemma Villanueva...
https://pubmed.ncbi.nlm.nih.gov/32779730/University of Miami
Lead Sponsor
National Institute on Drug Abuse (NIDA)
Collaborating Sponsor