- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03086655
Tel-Me-Box: Testing a New, Real-time Strategies for Monitoring HIV Medication Adherence in India
Tel-Me-Box: Validating and Testing a Novel, Low-cost, Real-time Monitoring Device With Hair Level Analysis Among Adherence-challenged Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Karnataka
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Bangalore, Karnataka, India
- St. John & Research Institute/St John & Medical College & Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tel-me-box with reminder features
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.
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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.
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Other: Tel-me-box with no reminder features
The control arm will include tel-me-box monitoring only.
No reminder features will be included with the device.
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Participants receive tel-me-box device with no reminder features added.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tel-me-box adherence
Time Frame: 1 year
|
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
Time Frame: 1 year
|
ARV (EFV and NVP) levels in hair samples
|
1 year
|
Self-reported adherence
Time Frame: 1 year
|
|
1 year
|
Collaborators and Investigators
Collaborators
Publications and helpful links
General Publications
- 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.
- Chesney MA. The elusive gold standard. Future perspectives for HIV adherence assessment and intervention. J Acquir Immune Defic Syndr. 2006 Dec 1;43 Suppl 1:S149-55. doi: 10.1097/01.qai.0000243112.91293.26.
- Nair BG, Newman SF, Peterson GN, Wu WY, Schwid HA. Feedback mechanisms including real-time electronic alerts to achieve near 100% timely prophylactic antibiotic administration in surgical cases. Anesth Analg. 2010 Nov;111(5):1293-300. doi: 10.1213/ANE.0b013e3181f46d89. Epub 2010 Sep 14.
- Berg KM, Arnsten JH. Practical and conceptual challenges in measuring antiretroviral adherence. J Acquir Immune Defic Syndr. 2006 Dec 1;43 Suppl 1(Suppl 1):S79-87. doi: 10.1097/01.qai.0000248337.97814.66.
- 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.
- 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.
- Farmer KC. Methods for measuring and monitoring medication regimen adherence in clinical trials and clinical practice. Clin Ther. 1999 Jun;21(6):1074-90; discussion 1073. doi: 10.1016/S0149-2918(99)80026-5.
- Kripalani S, Yao X, Haynes RB. Interventions to enhance medication adherence in chronic medical conditions: a systematic review. Arch Intern Med. 2007 Mar 26;167(6):540-50. doi: 10.1001/archinte.167.6.540.
- Patel UB, Ni Q, Clayton C, Lam P, Parks J. An attempt to improve antipsychotic medication adherence by feedback of medication possession ratio scores to prescribers. Popul Health Manag. 2010 Oct;13(5):269-74. doi: 10.1089/pop.2009.0053.
- Ruppar TM. Randomized pilot study of a behavioral feedback intervention to improve medication adherence in older adults with hypertension. J Cardiovasc Nurs. 2010 Nov-Dec;25(6):470-9. doi: 10.1097/JCN.0b013e3181d5f9c5.
- Burgess SW, Sly PD, Devadason SG. Providing feedback on adherence increases use of preventive medication by asthmatic children. J Asthma. 2010 Mar;47(2):198-201. doi: 10.3109/02770900903483840.
- Sabin LL, DeSilva MB, Hamer DH, Xu K, Zhang J, Li T, Wilson IB, Gill CJ. Using electronic drug monitor feedback to improve adherence to antiretroviral therapy among HIV-positive patients in China. AIDS Behav. 2010 Jun;14(3):580-9. doi: 10.1007/s10461-009-9615-1.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- R01MH109310 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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