N/A
N=131
Tel-Me-Box: Testing a New, Real-time Strategies for Monitoring HIV Medication Adherence in India
HIV · Medication Adherence
Bottom Line
View on ClinicalTrials.gov: NCT03086655 ↗Enrolled (actual)
131
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: Tel-me-box Adherence — 10; 16.5; 1.5; 7 days (out of 30)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Tel-me-box with reminder features (Behavioral); Tel-me-box (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tel-me-box Adherence |
10; 16.5; 1.5; 7; 0; 1 | — |
| PRIMARY HIV Viral Load (VL) |
37; 34; 34; 45; 34; 44 | 0.08 |
| PRIMARY Hair Concentrations of Anti-retroviral Medications (ARV), in ng/mg |
0.12; 0.28 | <0.05 sig |
| SECONDARY Self-reported Adherence in the Past Month |
4; 5; 49; 37; 44; 35 | 0.08 |
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.
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT03086655). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.