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

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT03738410
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Mobile Health Messaging application — BEHAVIORAL
    Mobile messaging sent to participants over a 12-month period.
  • Standard of Care Treatment — OTHER
    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.

Study Details

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.

Key Dates

Start date
May 2, 2022
Status verified
Jan 2026
Primary completion
Jun 27, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Active Comparator: Control Arm
    The control arm will receive standard of care.
  • 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.
  • No Intervention: Focus Group Arm
    The results of the focus groups will contribute to the wording and design of the intervention.

Primary Outcome Measure

Rate of Enrollment [ Time Frame: Month 12 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136
mCARES Lab
[email protected]
305-243-5800
Lunthita M Duthely, Ed.D. (PRINCIPAL_INVESTIGATOR)

Find similar trials in Miami, FL

By condition
HIV
By specialty
Infectious disease
By research site
University of Miami· Miami, FL

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