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Mobile Health Messaging for HIV/AIDS

N/A

Recruiting

Led By Lunthita M Duthely, Ed.D.

Research Sponsored by University of Miami

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Female >= 18 years old at enrollment

Be older than 18 years old

Must not have

Women who are cognitively impaired or are not able to consent for themselves

Adolescents < 18 years old at enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 12

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a new mobile health system that sends text reminders to HIV+ women to help them stick to their treatment plan. The system will also address individual barriers to care, like stigma and mistrust.

Who is the study for?

This trial is for women over 18 with HIV who have missed appointments, had a detectable viral load, or haven't taken their meds as prescribed. They must be currently in care or recently back in care and own a working cell phone. It's not for men, those under 18, cognitively impaired individuals unable to consent, or without a cell phone.

What is being tested?

The study is testing an mHealth system that sends text messages to help women with HIV stick to their treatment plans. The goal is to see if this method helps patients keep up with appointments, refill prescriptions on time, take medication regularly and overcome barriers like stigma.

What are the potential side effects?

Since the intervention involves mobile health messaging rather than medication or medical procedures, there are no direct physical side effects expected from participating in this trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a woman aged 18 or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am unable to make medical decisions for myself due to cognitive impairment.

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I am under 18 years old.

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I am a man.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptability of the mHealth application

Rate of Enrollment

Secondary study objectives

Change in Clinic Attendance

Change in HIV Stigma

Change in Medical Mistrust

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Mobile Health Messaging ArmExperimental Treatment2 Interventions

The Patient Navigation and Mobile Health Messaging Arm will receive standard of care, as well as patient navigation assistance and the mobile health intervention. The mHealth intervention includes psycho-educational messaging as well.

Group II: Control ArmActive Control1 Intervention

The control arm will receive standard of care.

Group III: Focus Group ArmActive Control1 Intervention

The results of the focus groups will contribute to the wording and design of the intervention.

0 / 4Eligibility criteria met