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

NCT03086655 | Completed Results

• 1 other identifier: R01MH109310
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV; Medication Adherence

Keywords

biological markers; monitoring device; wireless technology

Outcome Measures

Primary Outcomes (3)

• Tel-me-box Adherence

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

  30 days prior to each follow-up assessment (3, 6, 9 and 12 months post baseline).

• HIV Viral Load (VL)

  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)

  Baseline, and 6 and 12 month follow-up

• Hair Concentrations of Anti-retroviral Medications (ARV), in ng/mg

  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.

  12 month follow-up

Secondary Outcomes (1)

• Self-reported Adherence in the Past Month

  30 days prior to baseline and 3, 6, 9, and 12 month follow-up

Study Arms (2)

Pillbox ('Tel-me-box') with reminder features

EXPERIMENTAL

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

Pillbox ('Tel-me-box') without reminder features

OTHER

The control arm will include tel-me-box monitoring only. No reminder features will be included with the device.

Behavioral: Tel-me-box

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.

Pillbox ('Tel-me-box') with reminder features

Tel-me-box BEHAVIORAL

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

Pillbox ('Tel-me-box') without reminder features

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

St. John & Research Institute/St John & Medical College & Hospital

Bangalore, Karnataka, India

Location

Related Publications (23)

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• Cramer J, Rosenheck R, Kirk G, Krol W, Krystal J; VA Naltrexone Study Group 425. Medication compliance feedback and monitoring in a clinical trial: predictors and outcomes. Value Health. 2003 Sep-Oct;6(5):566-73. doi: 10.1046/j.1524-4733.2003.65269.x.

  PMID: 14627063 BACKGROUND

• de Bruin M, Hospers HJ, van Breukelen GJ, Kok G, Koevoets WM, Prins JM. Electronic monitoring-based counseling to enhance adherence among HIV-infected patients: a randomized controlled trial. Health Psychol. 2010 Jul;29(4):421-8. doi: 10.1037/a0020335.

  PMID: 20658830 BACKGROUND

• Vallabhaneni S, Chandy S, Heylen E, Ekstrand ML. Evaluation of WHO immunologic criteria for treatment failure: implications for detection of virologic failure, evolution of drug resistance and choice of second-line therapy in India. J Int AIDS Soc. 2013 Jun 3;16(1):18449. doi: 10.7448/IAS.16.1.18449.

  PMID: 23735817 BACKGROUND

• Bachman Desilva M, Gifford AL, Keyi X, Li Z, Feng C, Brooks M, Harrold M, Yueying H, Gill CJ, Wubin X, Vian T, Haberer J, Bangsberg D, Sabin L. Feasibility and Acceptability of a Real-Time Adherence Device among HIV-Positive IDU Patients in China. AIDS Res Treat. 2013;2013:957862. doi: 10.1155/2013/957862. Epub 2013 Jul 16.

  PMID: 23956851 BACKGROUND

• Vallabhaneni S, Chandy S, Heylen E, Ekstrand M. Reasons for and correlates of antiretroviral treatment interruptions in a cohort of patients from public and private clinics in southern India. AIDS Care. 2012;24(6):687-94. doi: 10.1080/09540121.2011.630370. Epub 2011 Nov 22.

  PMID: 22107044 BACKGROUND

• Steward WT, Herek GM, Ramakrishna J, Bharat S, Chandy S, Wrubel J, Ekstrand ML. HIV-related stigma: adapting a theoretical framework for use in India. Soc Sci Med. 2008 Oct;67(8):1225-35. doi: 10.1016/j.socscimed.2008.05.032. Epub 2008 Jul 1.

  PMID: 18599171 BACKGROUND

• Steward WT, Chandy S, Singh G, Panicker ST, Osmand TA, Heylen E, Ekstrand ML. Depression is not an inevitable outcome of disclosure avoidance: HIV stigma and mental health in a cohort of HIV-infected individuals from Southern India. Psychol Health Med. 2011 Jan;16(1):74-85. doi: 10.1080/13548506.2010.521568.

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• Steward WT, Bharat S, Ramakrishna J, Heylen E, Ekstrand ML. Stigma is associated with delays in seeking care among HIV-infected people in India. J Int Assoc Provid AIDS Care. 2013 Mar-Apr;12(2):103-9. doi: 10.1177/1545109711432315. Epub 2012 Jan 26.

  PMID: 22282878 BACKGROUND

• Shet A, DeCosta A, Heylen E, Shastri S, Chandy S, Ekstrand M. High rates of adherence and treatment success in a public and public-private HIV clinic in India: potential benefits of standardized national care delivery systems. BMC Health Serv Res. 2011 Oct 17;11:277. doi: 10.1186/1472-6963-11-277.

  PMID: 22004573 BACKGROUND

• Setia MS, Lindan C, Jerajani HR, Kumta S, Ekstrand M, Mathur M, Gogate A, Kavi AR, Anand V, Klausner JD. Men who have sex with men and transgenders in Mumbai, India: an emerging risk group for STIs and HIV. Indian J Dermatol Venereol Leprol. 2006 Nov-Dec;72(6):425-31. doi: 10.4103/0378-6323.29338.

  PMID: 17179617 BACKGROUND

• Rodriguez DC, Krishnan AK, Kumarasamy N, Krishnan G, Solomon D, Johnson S, Vasudevan CK, Solomon R, Ekstrand ML. Two sides of the same story: alcohol use and HIV risk taking in South India. AIDS Behav. 2010 Aug;14 Suppl 1(Suppl 1):S136-46. doi: 10.1007/s10461-010-9722-z.

  PMID: 20544382 BACKGROUND

• Nyamathi AM, William RR, Ganguly KK, Sinha S, Heravian A, Albarran CR, Thomas A, Greengold B, Ekstrand M, Ramakrishna P, Rao PR. Perceptions of Women Living with AIDS in Rural India Related to the Engagement of HIV-Trained Accredited Social Health Activists for Care and Support. J HIV AIDS Soc Serv. 2010 Oct;9(4):385-404. doi: 10.1080/15381501.2010.525474.

  PMID: 21331322 BACKGROUND

• Nyamathi AM, Sinha S, Ganguly KK, William RR, Heravian A, Ramakrishnan P, Greengold B, Ekstrand M, Rao PV. Challenges experienced by rural women in India living with AIDS and implications for the delivery of HIV/AIDS care. Health Care Women Int. 2011 Apr;32(4):300-13. doi: 10.1080/07399332.2010.536282.

  PMID: 21409663 BACKGROUND

• Navani-Vazirani S, Solomon D, Gopalakrishnan, Heylen E, Srikrishnan AK, Vasudevan CK, Ekstrand ML. Mobile phones and sex work in South India: the emerging role of mobile phones in condom use by female sex workers in two Indian states. Cult Health Sex. 2015;17(2):252-65. doi: 10.1080/13691058.2014.960002. Epub 2014 Oct 10.

  PMID: 25301669 BACKGROUND

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Limitations and Caveats

This was a pilot RCT to determine the feasibility and acceptability of the intervention, and a preliminary estimate of its potential efficacy of adding reminder features to the study pillbox. It was NOT fully powered to test differences in adherence between those participants who did and those who did not have a reminder feature of their choice included in their Tel-me-box pill dispenser.

Results Point of Contact

• Title: Dr. Maria Ekstrand
• Organization: University of California San Francisco

Maria.Ekstrand@ucsf.edu

+1 (415) 502-1000

Study Officials

• Maria Ekstrand, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2017
• First Posted: March 22, 2017
• Study Start: August 13, 2021
• Primary Completion: January 11, 2023
• Study Completion: January 11, 2023
• Last Updated: August 22, 2025
• Results First Posted: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)