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

HIV/AIDS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03738410
• Other study ID #: 20170287
• Status: Recruiting
• Phase: N/A
• Start date: May 2, 2022
• Est. completion date: June 27, 2025

Study information

• Verified date: May 2024
• Source: University of Miami
• Contact: Lunthita M Duthely, Ed.D.
• Phone: 305-243-5800
• Email: lduthely[@]med.miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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. Investigators also want to see if the mHealth system is feasible, easily accepted and if it will impact patient health in a positive way.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: June 27, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV/AIDS

Intervention

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.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Acceptability of the mHealth application	The proportion of messages opened, which were received	Month 12
Secondary	Change in Clinic Attendance	Change in attendance to HIV primary care visits within 12 months of randomization	Baseline, Month 12
Secondary	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
Secondary	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
Secondary	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