NCT03086655 is a NA clinical trial of Tel-me-box with reminder features in HIV, sponsored by University of California, San Francisco.

Who is sponsoring NCT03086655?

NCT03086655 is sponsored by University of California, San Francisco.

What drugs are being tested in NCT03086655?

Interventions in NCT03086655: Tel-me-box with reminder features, Tel-me-box.

What condition does NCT03086655 study?

NCT03086655 studies HIV, Medication Adherence.

Is NCT03086655 still recruiting?

NCT03086655 is currently completed. Last updated 22 August 2025.

Are results published for NCT03086655?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-08-22 · How we verify

NCT03086655

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed NA Results posted Last updated 22 August 2025

What this trial tests

NA trial testing Tel-me-box with reminder features in HIV in 131 participants. Completed in 11 January 2023.

Timeline

13 August 2021

Primary endpoint
11 January 2023

11 January 2023

Quick facts

Lead sponsor	University of California, San Francisco
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	other
Enrollment	131
Start date	13 August 2021
Primary completion	11 January 2023
Estimated completion	11 January 2023
Sites	1 location across India

Drugs / interventions tested

Tel-me-box with reminder features
Tel-me-box

Conditions studied

HIV — all drugs for HIV →
Medication Adherence — all drugs for Medication Adherence →

Sponsor

University of California, San Francisco

Who can join

18 and older, any sex, with HIV or Medication Adherence. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Tel-me-box Adherence Primary · 30 days prior to each follow-up assessment (3, 6, 9 and 12 months post baseline).

Number of days over past 30 days with at least one device-recorded pill box opening.

No. days box opened (0-30) at 3 mo. follow-up

Group	Value	95% CI
Pillbox ('Tel-me-box') With Reminder Features	10	1 – 24
Pillbox ('Tel-me-box') Without Reminder Features	16.5	2 – 25

No. days box opened (0-30) at 6 mo. follow-up

Group	Value	95% CI
Pillbox ('Tel-me-box') With Reminder Features	1.5	0 – 12
Pillbox ('Tel-me-box') Without Reminder Features	7	0 – 17

No. days box opened (0-30) at 9 mo. follow-up

Group	Value	95% CI
Pillbox ('Tel-me-box') With Reminder Features	0	0 – 2.5
Pillbox ('Tel-me-box') Without Reminder Features	1	0 – 13

No. days box opened (0-30) at 12 mo. follow-up

Group	Value	95% CI
Pillbox ('Tel-me-box') With Reminder Features	0	0 – 1
Pillbox ('Tel-me-box') Without Reminder Features	0	0 – 8

HIV Viral Load (VL) Primary · Baseline, and 6 and 12 month follow-up

HIV viral load (number of copies/ml of blood), dichotomized as undetectable VL (= suppressed, meaning \<50 copies/ml detected) vs. detectable (or unsuppressed, meaning \>= 50 copies/ml detected)

Undetectable VL at Baseline

Group	Value	95% CI
Pillbox ('Tel-me-box') With Reminder Features	37
Pillbox ('Tel-me-box') Without Reminder Features	34

Undetectable VL at 6mo FU

Group	Value	95% CI
Pillbox ('Tel-me-box') With Reminder Features	34
Pillbox ('Tel-me-box') Without Reminder Features	45

Undetectable VL at 12 mo FU

Group	Value	95% CI
Pillbox ('Tel-me-box') With Reminder Features	34
Pillbox ('Tel-me-box') Without Reminder Features	44

Hair Concentrations of Anti-retroviral Medications (ARV), in ng/mg Primary · 12 month follow-up

Hair concentrations of Efavirenz (EFV) or Dolutegravir (DTG) in ng/mg, and log transformed to improve normality of the distribution if necessary. The vast majority of participants were on an ARV regimen that included either EFV or DTG at the time of the study.

Group	Value	95% CI
Pillbox ('Tel-me-box') With Reminder Features	0.12	± 0.71
Pillbox ('Tel-me-box') Without Reminder Features	0.28	± 0.64

Self-reported Adherence in the Past Month Secondary · 30 days prior to baseline and 3, 6, 9, and 12 month follow-up

Participant self-report measured using the visual analogue scale to assess percent of pills taken in the past month, further dichotomized into optimal (100%) vs. suboptimal adherence (\<100%)

Optimally adherent at baseline

Group	Value	95% CI
Pillbox ('Tel-me-box') With Reminder Features	4
Pillbox ('Tel-me-box') Without Reminder Features	5

Optimally adherent at 3 month follow up

Group	Value	95% CI
Pillbox ('Tel-me-box') With Reminder Features	49
Pillbox ('Tel-me-box') Without Reminder Features	37

Optimally adherent at 6 month follow up

Group	Value	95% CI
Pillbox ('Tel-me-box') With Reminder Features	44
Pillbox ('Tel-me-box') Without Reminder Features	35

Optimally adherent at 9 month follow up

Group	Value	95% CI
Pillbox ('Tel-me-box') With Reminder Features	45
Pillbox ('Tel-me-box') Without Reminder Features	40

Optimally adherent at 12 month follow up

Group	Value	95% CI
Pillbox ('Tel-me-box') With Reminder Features	45
Pillbox ('Tel-me-box') Without Reminder Features	50

Presence of Tel-me-box Adherence Data (>0) in Past 30 Days Secondary · 30 days prior to assessment at 3, 6, 9, and 12 mo follow-up

The number of participants for whom at least 1 pill box opening was registered in the 30 days before an assessment

any box use data at 3 mo FU

Group	Value	95% CI
Pillbox ('Tel-me-box') With Reminder Features	47
Pillbox ('Tel-me-box') Without Reminder Features	48

any box use data at 6 mo FU

Group	Value	95% CI
Pillbox ('Tel-me-box') With Reminder Features	38
Pillbox ('Tel-me-box') Without Reminder Features	41

any box use data at 9 mo FU

Group	Value	95% CI
Pillbox ('Tel-me-box') With Reminder Features	26
Pillbox ('Tel-me-box') Without Reminder Features	31

any box use data at 12 mo FU

Group	Value	95% CI
Pillbox ('Tel-me-box') With Reminder Features	16
Pillbox ('Tel-me-box') Without Reminder Features	22

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Adherence Measurements in HIV: New Advancements in Pharmacologic Methods and Real-Time Monitoring.
Castillo-Mancilla JR, Haberer JE. · · 2018 · cited 116× · PMID 29380227 · DOI 10.1007/s11904-018-0377-0
Accuracy of measures for antiretroviral adherence in people living with HIV.
Smith R, Villanueva G, Probyn K, Sguassero Y, et al · · 2022 · cited 34× · PMID 35871531 · DOI 10.1002/14651858.cd013080.pub2
Actionable Adherence Monitoring: Technological Methods to Monitor and Support Adherence to Antiretroviral Therapy.
Bell KM, Haberer JE. · · 2018 · cited 18× · PMID 30232578 · DOI 10.1007/s11904-018-0413-0
Scaling up delivery of HIV services in Africa through harnessing trends across global emerging innovations.
Chibi M, Wasswa W, Ngongoni CN, Lule F. · · 2023 · cited 1× · PMID 38028944 · DOI 10.3389/frhs.2023.1198008

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03086655 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of California, San Francisco
Last refreshed: 22 August 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03086655.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing