CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 131 enrolled
Drug / intervention
Tel-me-box with reminder features +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03086655
NCT03086655N/ACompleted

Tel-Me-Box: Validating and Testing a Novel, Low-cost, Real-time Monitoring Device With Hair Level Analysis Among Adherence-challenged Patients

University of California, San Francisco·interventional·Posted Mar 22, 2017·Updated Aug 22, 2025

In Brief

A clinical study evaluating Tel-me-box with reminder features and Tel-me-box for HIV and Medication Adherence. Completed, enrolled 131 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesIndia

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedMar 22, 2017
Enrollment StartAug 13, 2021
Primary CompletionJan 11, 2023
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 9.3 years ago

Interventions

Tel-me-box with reminder featuresbehavioral

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-boxbehavioral

Participants receive tel-me-box device with no reminder features added.