Project SMART Automated Pillbox Study

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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

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

Trial documents
2

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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