Project SMART Automated Pillbox Study

HIV/AIDS Clinical Trial

— SMART  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04418076
• Other study ID #: 1508016342
• Secondary ID: 1R21DA039842-01A
• Status: Completed
• Phase: N/A
• Start date: June 8, 2017
• Est. completion date: August 18, 2020

Study information

• Verified date: April 2023
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: August 18, 2020
• Est. primary completion date: August 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Cocaine Use
• HIV Infections
• HIV/AIDS

Intervention

Device:
• Group A_No feedback
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.
• Group B_Automated feedback
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.
• Group C_Automated feedback + Clinician feedback
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.
• Group D_Automated feedback + Social Network feedback
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.

Locations

Country	Name	City	State
United States	Yale Clinical Research	New Haven	Connecticut

Sponsors (5)

Lead Sponsor	Collaborator
Yale University	National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH), University at Albany, University of Connecticut

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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)
Secondary	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)
Secondary	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)