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

Study Overview
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Brief Summary
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The purpose of this study is: 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). Investigators also want to see if the mHealth system is feasible, easily accepted and if it will impact patient health in a positive way.

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

Conditions
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HIV/AIDS

Intervention / Treatment
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* Behavioral: Mobile Health Messaging application
* Other: Standard of Care Treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: This is a qualitative/quantitative trial that utilizes a Sequential to Parallel intervention study design model. The initial 15 participants (first 5 each that speak English, Spanish, or Haitain Creole) will participate in the Qualitative arm. These participants may also be eligible to roll over into the quantitative portion of the study and randomized to either the control group or the mHealth Intervention group.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Arm<br>The control arm will receive standard of care. | Other: Standard of Care Treatment<br>* 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.<br>|
| Experimental: Mobile Health Messaging Arm<br>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. | Behavioral: Mobile Health Messaging application<br>* Mobile messaging sent to participants over a 12-month period.<br>Other: Standard of Care Treatment<br>* 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.<br>|
| No Intervention: Focus Group Arm<br>The results of the focus groups will contribute to the wording and design of the intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Acceptability of the mHealth application | The proportion of messages opened, which were received | Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Clinic Attendance | Change in attendance to HIV primary care visits within 12 months of randomization | Baseline, Month 12 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mHealth, mobile applications, culturally-competent, HIV stigma, Resilience