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

Study Overview
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Brief Summary
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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.

Detailed Description
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Novel, validated methods to monitor adherence to HIV treatment in real time are urgently needed given the well-known limitations of self-reported adherence, pill counts, and MEMS caps. In order to be scalable and sustainable in both resource-rich and resource limited settings, such devices need to be low-cost and designed in a way that does not increase the risk of accidental HIV disclosure and subsequent stigma. Devices which both monitor adherence in real time and provide tailored reminders to patients for medication-taking have the potential to greatly improve adherence to HIV treatment as well as to treatment for other chronic diseases. Our Indo-US collaborative team has been conducting research on HIV stigma, ARV adherence patterns and barriers, treatment outcome, and drug resistance for over a decade. The study investigators have also pioneered the use of ARV concentrations in small hair samples to measure long-term ARV adherence in resource-rich and limited settings (RLS). In response to the need for novel adherence measures, our team has recently developed Tel-Me-Box, a small, low-cost adherence device that monitors adherence in real time, by transmitting a wireless signal to a server when opened. The investigators now propose to add hardware that will enable the server software to wirelessly program the device to activate tailored medication-taking reminders (via a beep, vibration, or LED light) after a period of inactivity. The device fits in a pocket, can hold 1-2 weeks' worth of medications, has a long battery life, simple charging capability, and has been found acceptable to Indian patients with adherence challenges in pilot studies. Since HIV stigma serves as a profound barrier to ARV adherence in many settings, including India, the small, inconspicuous nature of Tel-Me-Box, along with its ability to deliver tailored reminder features honors participants' privacy concerns. Since this electronic device monitoring cannot assess actual drug ingestion, validating it against a biological measure of adherence, such as ARV hair concentrations, is crucial. This study includes a pilot randomized control trial (RCT) to examine acceptability and feasibility and to estimate the effect size of automated tailored real-time adherence reminders on hair ARV concentrations, device- monitored adherence, and viral load suppression in adherence-challenged patients. The aim of this study is to validate TMB as an innovative tool to assess adherence and predict treatment outcomes, and demonstrate the feasibility of hair analyses in RLS. If successful, pilot data will be available on the efficacy of the Tel-Me-Box automated, tailored reminders for a future large scale RCT.

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

Conditions
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HIV, Medication Adherence

Intervention / Treatment
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* Behavioral: Tel-me-box with reminder features
* Behavioral: Tel-me-box


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HIV-positive Currently on antiretroviral therapy (ART) Speaks one of the local languages Able and willing to participate in the study, provide informed consent, contact information, and express a willingness to return for follow-up visits every three months for 12 months after baseline. Adherence-challenged per self-report, i.e. report of <90% ART adherence or >2 ART treatment interruptions of at least 2 days in the past 3 months Exclusion Criteria: Unwilling or unable to participate in the study and/or return for follow-up appointments younger than 18 years old Not HIV-infected Not currently on ART Does not speak one of the local languages

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tel-me-box with reminder features<br>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. | Behavioral: Tel-me-box with reminder features<br>* 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.<br>|
| Other: Tel-me-box with no reminder features<br>The control arm will include tel-me-box monitoring only. No reminder features will be included with the device. | Behavioral: Tel-me-box<br>* Participants receive tel-me-box device with no reminder features added.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tel-me-box adherence | Percent adherence score for the past month based on device-recorded missed doses, either using only data from the same period as covered by other adherence measures, or averaged over the 3 or 6-month measurement window, depending on analysis with other adherence outcomes. | 1 year | 
| ARV Hair concentrations | ARV (EFV and NVP) levels in hair samples | 1 year | 
| Self-reported adherence | Self-report: Participant self report measured using the visual analogue scale to assess percent of pills taken in the past month. Treatment interruptions: frequency of such interruptions, length of last interruption and typical length of interruptions during the past year. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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biological markers, monitoring device, wireless technology