Project SMART Automated Pillbox Study

Study Overview
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Brief Summary
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The aim of this study is to examine the effect of mHealth tools on antiretroviral (ART) adherence and persistence among HIV-infected individuals with co-occurring cocaine use disorders (CUDs).

Detailed Description
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To conduct qualitative assessments using focus groups of people living with HIV (PLH) who use cocaine and healthcare providers that will assess the acceptability, feasibility, facilitators and barriers of implementing mHealth interventions; and will aid in developing the final design and content of both automated and clinician feedback in preparation for designing a pilot feasibility study. To conduct a 12-week pilot feasibility RCT among PLH with co-occurring CUDs that will examine the impact of mHealth tools (cellular-enabled smart pill boxes and cell phones) and feedback (no feedback vs. automated feedback vs. automated + clinician feedback) on primary (ART adherence and persistence) and secondary outcomes (HIV viral suppression, cocaine use, retention in HIV care).

Official Title
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Improving Antiretroviral Adherence and Persistence Using mHealth Tools in HIV-infected Cocaine Users

Conditions
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HIV/AIDS, Cocaine Use

Intervention / Treatment
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* Device: Group A_No feedback
* Device: Group B_Automated feedback
* Device: Group C_Automated feedback + Clinician feedback
* Device: Group D_Automated feedback + Social Network feedback


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age equal to or greater than 18 years Clinic-confirmed HIV diagnosis Currently prescribed or eligible for ART Currently has insurance Self-reported cocaine use in the past 30 days Willing and able to use a cell phone and electronic pill box for the 12-week intervention Exclusion Criteria: Unable to provide informed consent Verbally or physically threatening to research staff Unable to communicate in either English or Spanish

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: No feedback<br>For participants in the control group (Group A), no feedback from the TowerView Health® smart pill box or clinical nurse will be given. | Device: Group A_No feedback<br>* In the control (Group A), the feedback option will be deactivated on the device on the TowerView Health® smart pill box, effectively serving to only monitor natural pill-taking patterns.<br>|
| Experimental: Automated feedback<br>For participants in Group B (automated feedback), automated feedback will be generated from the TowerView Health® smart pill box and sent to participants' smartphone as text messages. | Device: Group B_Automated feedback<br>* For participants in Group B (automated feedback), missed dosages will prompt an automated text message to be sent to the participants' smartphone. The TowerView Health® pill box consists of in-built alarm and flashing color lights, and the ability to send text messages to the participants' phone either as reminder in the event of missed dosage or a message of encouragement when all dosages are taken.<br>|
| Experimental: Automated feedback + Clinician feedback<br>For participants in Group C, automated feedback will be generated from the TowerView Health® smart pill box and sent to participants' smartphone as text messages. In addition, clinical nurse will also send personalized feedback and suggestions to the participants in this group. | Device: Group C_Automated feedback + Clinician feedback<br>* For participants in Group C, the survey app responses will be assessed each week by the RA who in turn will communicate the results to a clinical nurse. The clinical nurse will be funded through this study; he/she will be responsible for providing personalized feedback to all Group C participants. The clinic nurse will contact the subject with appropriate feedback about their health behavior and suggestions for sustained adherence.<br>|
| Experimental: Automated feedback + Social Network feedback<br>For participants in Group D, automated feedback will be generated from the TowerView Health® smart pill box and sent to participants' smartphone as text messages. In addition, a weekly text reminder will be sent to each participant from a social network designee chosen by the participant. | Device: Group D_Automated feedback + Social Network feedback<br>* For participants in Group D, a social network designee will be chosen based on the names provided by the participants during screening. One social network designee will be consented and chosen to send the participant a weekly text reminder the participant to take their medication. The text for the message will be chosen by the social network designee.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to Anti-Retroviral Therapy (ART) at the End of 12-Week Intervention Period | Adherence will be measured in percentage of times pills taken in time or within 90 mins of reminder based on the real time record of the behavior provided by the electronic pill box. | Week 12 | 
| Adherence to Anti-Retroviral Therapy (ART) at the End of 16 Weeks (4-week Post-intervention Period) | This is a follow up period where participants adherence will be measured in percentage of times pills taken in time or within 90 mins of reminder after being the study for 16 weeks. The information will be based on the real time record of the behavior provided by the electronic pill box. | Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in HIV 1 RNA, QN PCR (Copies/ML) | HIV RNA (viral load) and HIV disease progression to manage and monitor HIV infection. | End of intervention (Week 12) | 
| Percent Change in CD4 Count From Baseline to Week 12 | CD4 T lymphocyte (CD4) cell count are markers of antiretroviral treatment (ART) responses. Participants will be asked to perform testing including CD4 lymphocyte count at the end of intervention (Week 12). The value is calculated by the percentage of CD4 at Week 12 minus the percentage of CD4 at baseline. | Baseline and End of intervention (Week 12) | 
| Retention in Care | Participants medical chart review will be reviewed to look at the number of doctor's visit for for the duration of the study (4 months). | up to End of the study (week 16) |