Tel-Me-Box: Testing a New, Real-time Strategies for Monitoring HIV Medication Adherence in India

Sponsor
University of California, San Francisco
Study ID
NCT03086655
Status
Completed

Conditions

  • HIV
  • Medication Adherence

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tel-me-box with reminder features — BEHAVIORAL
    Participants will meet with a study staff member to go over their daily routines, including their pill taking schedule, and to work out a plan for tailored reminders. The participant will choose from the reminders available and convey their preferences regarding when reminders should be sent for the TMB. Preferences will be stored in an online secure database. If requested by the participant, the reminder schedule and type of reminder can be reprogrammed by study staff via an online portal. When the reminder is reprogrammed the TMB receives a new configuration SMS to update the device reminder settings.
  • Tel-me-box — BEHAVIORAL
    Participants receive tel-me-box device with no reminder features added.

Study Details

Currently available methods to monitor antiretroviral (ARV) adherence to HIV treatment and prevention, such as self-report, pill counts, medication electronic monitoring system (MEMS), and devices which wirelessly monitor adherence in real-time, have multiple limitations, including over-reporting, inability to assess pill ingestion, and size/expense. Our multidisciplinary research team at the University of California, San Francisco (UCSF) and in India has designed a new adherence-monitoring device called "Tel-Me-Box" which is small, low-cost, rechargeable, inconspicuous, and could be programmed to deliver tailored real-time adherence reminders following additional hardware modifications. The aim of this study is to modify and validate this discreet Tel-Me-Box (TMB) adherence monitoring and reminder device against hair ARV concentrations as a pharmacologic measure of drug ingestion/adherence, a measure pioneered and validated by our team, with the expectation that this device and intermittent hair monitoring could have widespread utility for HIV and non-HIV adherence science, both in India and globally.

Key Dates

Start date
Aug 13, 2021
Status verified
Aug 2025
Primary completion
Jan 11, 2023
Completion
Jan 11, 2023

Study Design

Enrollment
131 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Pillbox ('Tel-me-box') with reminder features
    Participants randomly assigned to the intervention reminder condition will choose from the reminders available and convey their preferences regarding when reminders should be sent for the tel-me-box device.
  • Other: Pillbox ('Tel-me-box') without reminder features
    The control arm will include tel-me-box monitoring only. No reminder features will be included with the device.

Primary Outcome Measure

Tel-me-box Adherence [ Time Frame: 30 days prior to each follow-up assessment (3, 6, 9 and 12 months post baseline). ]

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