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

Not Applicable

Recruiting

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

• Registration Number: NCT03738410
• Lead Sponsor: University of Miami

Brief 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. 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-11-08
• Study First Submitted QC: 2018-11-09
• Study First Posted: 2018-11-13
• Study Start: 2022-05-02
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-29
• Last Update Posted: 2024-11-01
• Primary Completion: 2025-04-30
• Study Completion: 2025-06-27

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 80

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Control Arm	Standard of Care Treatment	The control arm will receive standard of care.
Mobile Health Messaging Arm	Mobile Health Messaging application	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.
Mobile Health Messaging Arm	Standard of Care Treatment	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.

Primary Outcome Measures

Name	Time	Method
Rate of Enrollment	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	Month 12	The proportion of messages opened, which were received

Secondary Outcome Measures

Name	Time	Method
Change in HIV Stigma	Baseline, Month 12	Change in measured stigma (AIDS-related Stigma Scale) within 12 months of randomization (range 40=strongly disagree to 160=strongly agree).
Change in Medical Mistrust	Baseline, Month 12	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).
Change in Resilience	Baseline, Month 12	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).
Change in Clinic Attendance	Baseline, Month 12	Change in attendance to HIV primary care visits within 12 months of randomization

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States