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

A Multi-Lingual, Culturally-Competent Mobile Health Intervention to Reduce Medical Mistrust, Stigma, and Improve Treatment Adherence Among Women Living With HIV/AIDS (WLWH)

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.

Study Overview

• Status: Recruiting
• Conditions: HIV/AIDS
• Intervention / Treatment: Other: Standard of Care Treatment; Behavioral: Mobile Health Messaging application

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lunthita M Duthely, Ed.D.; Phone Number: 305-243-5800; Email: lduthely@med.miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • University of Miami
      • Principal Investigator: Lunthita M Duthely, Ed.D.
      • Contact: mCARES Lab; Phone Number: 305-243-5800; Email: mCARES@miami.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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:

• men
• women who are cognitively impaired or are not able to consent for themselves
• non-working cell phone
• adolescents < 18 years old at enrollment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Arm; The control arm will receive standard of care.	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.
No Intervention: Focus Group Arm; The results of the focus groups will contribute to the wording and design of the intervention.
Experimental: Mobile Health Messaging Arm; 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.	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.; Behavioral: Mobile Health Messaging application; Mobile messaging sent to participants over a 12-month period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Enrollment	The proportion of participants enrolled and proportion of participants declined enrollment or screen failed out of total number of participants approached.	Month 12
Acceptability of the mHealth application	The proportion of messages opened, which were received	Month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Clinic Attendance	Change in attendance to HIV primary care visits within 12 months of randomization	Baseline, Month 12
Change in HIV Stigma	Change in measured stigma (AIDS-related Stigma Scale) within 12 months of randomization (range 40=strongly disagree to 160=strongly agree).	Baseline, Month 12
Change in Medical Mistrust	Change in measured medical mistrust (Group-based Medical Mistrust) within 12 months of randomization (range 12=does not agree at all to 60=completely agrees).	Baseline, Month 12
Change in Resilience	Change in measured resiliency (Connor-Davidson Resiliency Scale) within 12 months of randomization (range 0=not true at all to 100=true nearly all of the time).	Baseline, Month 12

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Lunthita M Duthely, Ed.D., University of Miami

Publications and helpful links

General Publications

• Palmer MJ, Henschke N, Villanueva G, Maayan N, Bergman H, Glenton C, Lewin S, Fonhus MS, Tamrat T, Mehl GL, Free C. Targeted client communication via mobile devices for improving sexual and reproductive health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013680. doi: 10.1002/14651858.CD013680.
• Duthely LM, Sanchez-Covarrubias AP, Prabhakar V, Brown MR, Thomas TES, Montgomerie EK, Potter JE. 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. 2021 Sep 24;5(1):681-687. doi: 10.1089/heq.2020.0105. eCollection 2021.
• Duthely LM, Sanchez-Covarrubias AP, Mohamed AB, Potter JE. A Multilingual, Culturally Competent Mobile Health Intervention to Improve Treatment Adherence Among Women Living With HIV: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Jun 19;9(6):e17656. doi: 10.2196/17656.

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2022
• Primary Completion (Estimated): June 27, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: November 8, 2018
• First Submitted That Met QC Criteria: November 9, 2018
• First Posted (Actual): November 13, 2018

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 20, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: mHealth; mobile applications; Resilience; HIV stigma; culturally-competent
• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: 20170287; 5R34DA057150 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No