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

ConditionHIV/AIDS
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Miami

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Design model

Sequential

Treatments tested in this trial

  • Mobile Health Messaging application

    Behavioral

    Mobile messaging sent to participants over a 12-month period.

  • Standard of Care Treatment

    Other intervention

    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.

Treatment groups

80 Participants
are divided into 3 treatment groups
Group A: Control ArmActive comparator 1 intervention
Group B: Mobile Health Messaging ArmExperimental treatment 2 interventions
Group C: Focus Group ArmNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Rate of Enrollment

The proportion of participants enrolled and proportion of participants declined enrollment or screen failed out of total number of participants approached.

Time frame
Month 12
2

Acceptability of the mHealth application

The proportion of messages opened, which were received

Time frame
Month 12

Secondary outcomes

1

Change in Clinic Attendance

Change in attendance to HIV primary care visits within 12 months of randomization

Time frame
Baseline, Month 12
2

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).

Time frame
Baseline, Month 12
3

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).

Time frame
Baseline, Month 12
4

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).

Time frame
Baseline, Month 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Miami

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

Source ClinicalTrials.gov
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