NCT03738410 · University of Miami
An mHealth Intervention to Improve Outcomes for Women With HIV/AIDS
What this study is about
The purpose of this study is: 1. 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). 2.
View original scientific description
The purpose of this study is: 1. 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). 2. 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.
Interventions
BEHAVIORAL
Mobile Health Messaging application
Mobile messaging sent to participants over a 12-month period.
OTHER
Standard of Care Treatment
Standard of care (SOC) is defined as the usual care a licensed health care provider would give patients to treat HIV/AIDS. SOC associated procedures and policies may vary across clinical settings.
Primary outcome measures
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Miami, Florida
Collaborators
National Institute on Drug Abuse (NIDA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 25, 2026 · Source of record for eligibility and locations