Project SMART Automated Pillbox Study

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).

Conditions

• HIV/AIDS
• Cocaine Use

Interventions

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.

DEVICE

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.

DEVICE

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.

DEVICE

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.

Sponsors & Collaborators

• National Institutes of Health (NIH)

  collaborator NIH

• University at Albany

  collaborator OTHER

• University of Connecticut

  collaborator OTHER

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• Yale University

  lead OTHER

Principal Investigators

• Frederick Altice, M.D., M.A. · Yale University

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-06-08

Primary Completion

2020-08-18

Completion

2020-08-18

Countries

• United States

Study Locations