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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 12

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I am a woman aged 18 or older.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Acceptability of the mHealth application

Rate of Enrollment

Secondary outcome measures

Change in Clinic Attendance

Change in HIV Stigma

Change in Medical Mistrust

+1 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Mobile Health Messaging ArmExperimental Treatment2 Interventions

The Mobile Health Messaging Arm will receive standard of care, as well as 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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor

900 Previous Clinical Trials

409,857 Total Patients Enrolled

National Institute on Drug Abuse (NIDA)NIH

2,468 Previous Clinical Trials

2,619,273 Total Patients Enrolled

Lunthita M Duthely, Ed.D.Principal InvestigatorUniversity of Miami

1 Previous Clinical Trials

30 Total Patients Enrolled

Media Library

Mobile Health Messaging application Clinical Trial Eligibility Overview. Trial Name: NCT03738410 — N/A

HIV/AIDS Research Study Groups: Control Arm, Mobile Health Messaging Arm, Focus Group Arm

HIV/AIDS Clinical Trial 2023: Mobile Health Messaging application Highlights & Side Effects. Trial Name: NCT03738410 — N/A

Mobile Health Messaging application 2023 Treatment Timeline for Medical Study. Trial Name: NCT03738410 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can you outline the key aims of this research?

"This medical research trial is scheduled to be evaluated after 12 months and its primary endpoint will be the Rate of Enrollment. Secondary objectives include a Change in Resilience, HIV Stigma, and Medical Mistrust - all measured with respective scales ranging from 0 to 100 or 40-160 depending on the metric."

Answered by AI

What is the current enrollment size of this clinical trial?

"Affirmative. According to clinicaltrials.gov, this research initiative is still open for recruitment since its inception on May 30th 2019 and most recent update on October 24th 2022. 75 patients from a single site are being sought after by the study's investigators."

Answered by AI

Are new participants being taken into the study at this time?

"Yes, according to the information provided by clinicaltrials.gov this trial is currently attempting to recruit participants; it was first posted on May 30th 2019 and its latest update occured on October 24th 2022. The study requires 75 individuals from a single site."

Answered by AI

Recent research and studies

JMIR Research ProtocolsJournal

A Multilingual, Culturally Competent Mobile Health Intervention to Improve Treatment Adherence Among Women Living with HIV: Protocol for a Randomized Controlled Trial

Duthely, Lunthita M, Alex P Sanchez-Covarrubias, Adhar B Mohamed, and JoNell E Potter. 2020. “A Multilingual, Culturally Competent Mobile Health Intervention to Improve Treatment Adherence Among Women Living with HIV: Protocol for a Randomized Controlled Trial”. JMIR Research Protocols. JMIR Publications Inc.. doi:10.2196/17656.

Health EquityJournal

Medical Mistrust and Adherence to Care Among a Heterogeneous Cohort of Women Living with HIV, Followed in a Large, U.S. Safety Net Clinic

Duthely, Lunthita M., Alex P. Sanchez-Covarrubias, Varsha Prabhakar, Megan R. Brown, Tanya E.S. Thomas, Emily K. Montgomerie, and JoNell E. Potter. 2021. “Medical Mistrust and Adherence to Care Among a Heterogeneous Cohort of Women Living with HIV, Followed in a Large, U.S. Safety Net Clinic”. Health Equity. Mary Ann Liebert Inc. doi:10.1089/heq.2020.0105.

clinicaltrials.govStudy

An mHealth Intervention to Improve Outcomes for Women With HIV/AIDS

Lunthita M. Duthely 2022. "An mHealth Intervention to Improve Outcomes for Women With HIV/AIDS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03738410.

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