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

University of Miami

Status: Enrolling

Conditions: HIV/AIDS

Treatments: Behavioral: Mobile Health Messaging application; Other: Standard of Care Treatment

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03738410

20170287

5R34DA057150 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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80 participants in 3 patient groups

Control Arm

Active Comparator group

Description:

The control arm will receive standard of care.

Treatment:

Other: Standard of Care Treatment

Mobile Health Messaging Arm

Experimental group

Description:

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.

Treatment:

Other: Standard of Care Treatment

Behavioral: Mobile Health Messaging application

Focus Group Arm

No Intervention group

Description:

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