Project SMART Automated Pillbox Study

Yale University

Status: Completed

Conditions: Cocaine Use; HIV/AIDS

Treatments: Device: Group A_No feedback; Device: Group B_Automated feedback; Device: Group D_Automated feedback + Social Network feedback; Device: Group C_Automated feedback + Clinician feedback

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04418076

1508016342

1R21DA039842-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full 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).

Enrollment: 78 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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78 participants in 4 patient groups

No feedback

Experimental group

Description:

For participants in the control group (Group A), no feedback from the TowerView Health® smart pill box or clinical nurse will be given.

Treatment:

Device: Group A_No feedback

Automated feedback

Experimental group

Description:

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.

Treatment:

Device: Group B_Automated feedback

Automated feedback + Clinician feedback

Experimental group

Description:

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.

Treatment:

Device: Group C_Automated feedback + Clinician feedback

Automated feedback + Social Network feedback

Experimental group

Description:

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.

Treatment:

Device: Group D_Automated feedback + Social Network feedback