Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01MH109310 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported Adherence in the Past Month | 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%) | 30 days prior to baseline and 3, 6, 9, and 12 month follow-up |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Maria Ekstrand, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. John & Research Institute/St John & Medical College & Hospital | Bangalore | Karnataka | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10440628 | Background | 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. | |
| 17133199 | Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Pillbox ('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. Tel-me-box with reminder features: 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. |
| FG001 | Pillbox ('Tel-me-box') Without Reminder Features | The control arm will include tel-me-box monitoring only. No reminder features will be included with the device. Tel-me-box: Participants receive tel-me-box device with no reminder features added. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline Assessment |
| |||||||||||||
| 3 Month Follow-up Assessment |
| |||||||||||||
| 6 Month Follow-up Assessment |
| |||||||||||||
| 9 Month Follow-up Assessment |
| |||||||||||||
| 12 Month Follow-up = Final Assessment |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pillbox ('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. Tel-me-box with reminder features: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Tel-me-box Adherence | Number of days over past 30 days with at least one device-recorded pill box opening. | Overall number analyzed = number of participants enrolled at baseline. Numbers analyzed reported below reflect missing data due to loss to follow-up. | Posted | Median | Inter-Quartile Range | days (out of 30) | 30 days prior to each follow-up assessment (3, 6, 9 and 12 months post baseline). |
|
1 year, i.e. between baseline and the final follow-up 12 months later
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pillbox ('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. Tel-me-box with reminder features: 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. |
Not provided
Not provided
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Maria Ekstrand | University of California San Francisco | +1 (415) 502-1000 | 17142 | Maria.Ekstrand@ucsf.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 2, 2021 | Jan 11, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 22, 2023 | Jan 11, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Tel-me-box | Behavioral | Participants receive tel-me-box device with no reminder features added. |
|
| 17133207 | Background | 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. |
| 17389285 | Background | 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. |
| 20841414 | Background | 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. |
| 20879908 | Background | 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. |
| 20856132 | Background | 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. |
| 20170329 | Background | 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. |
| 19771504 | Background | 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. |
| 14627063 | Background | 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. |
| 20658830 | 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. |
| 23735817 | 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. |
| 23956851 | 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. |
| 22107044 | 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. |
| 18599171 | 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. |
| 21218366 | 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. |
| 22282878 | Background | 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. |
| 22004573 | 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. |
| 17179617 | 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. |
| 20544382 | 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:S136-46. doi: 10.1007/s10461-010-9722-z. |
| 21331322 | 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. |
| 21409663 | 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. |
| 25301669 | 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. |
| NOT COMPLETED |
|
|
| NOT COMPLETED |
|
|
| NOT COMPLETED |
|
|
| NOT COMPLETED |
|
|
| BG001 | Pillbox ('Tel-me-box') Without Reminder Features | The control arm will include tel-me-box monitoring only. No reminder features will be included with the device. Tel-me-box: Participants receive tel-me-box device with no reminder features added. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Type of reminder feature (in intervention group only) | Count of Participants | Participants |
|
| OG001 | Pillbox ('Tel-me-box') Without Reminder Features | The control arm will include tel-me-box monitoring only. No reminder features will be included with the device. Tel-me-box: Participants receive tel-me-box device with no reminder features added. |
|
|
|
| Primary | 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) | Overall number analyzed = number of participants enrolled at baseline. Numbers analyzed reported below reflect missing data for VL due to failed lab tests or loss to follow-up. | Posted | Number | participants | Baseline, and 6 and 12 month follow-up |
|
|
|
|
| Primary | 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. | Of the 131 participants who started the pilot trial, 111 were interviewed at 12 mo. follow-up. Ten of these participants were on a regimen that did not include EFV or DTG, resulting in n=101 for analysis. | Posted | Mean | Standard Deviation | log10 transformed concentration (ng/mg) | 12 month follow-up |
|
|
|
|
| Secondary | Self-reported Adherence in the Past Month | 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%) | Overall number of participants = number enrolled at baseline. At follow-up waves the number analyzed is lower due to loss to follow-up. | Posted | Number | participants | 30 days prior to baseline and 3, 6, 9, and 12 month follow-up |
|
|
|
|
| Post-Hoc | Presence of Tel-me-box Adherence Data (>0) in Past 30 Days | The number of participants for whom at least 1 pill box opening was registered in the 30 days before an assessment | Posted | Number | participants | 30 days prior to assessment at 3, 6, 9, and 12 mo follow-up |
|
|
|
| 0 |
| 69 |
| 0 |
| 69 |
| 0 |
| 69 |
| EG001 | Pillbox ('Tel-me-box') Without Reminder Features | The control arm will include tel-me-box monitoring only. No reminder features will be included with the device. Tel-me-box: Participants receive tel-me-box device with no reminder features added. | 1 | 62 | 0 | 62 | 0 | 62 |
Not provided
Not provided
| D001519 | Behavior |
| Undetectable VL at 6mo FU |
|
|
| Undetectable VL at 12 mo FU |
|
|
| Optimally adherent at 3 month follow up |
|
|
| Optimally adherent at 6 month follow up |
|
|
| Optimally adherent at 9 month follow up |
|
|
| Optimally adherent at 12 month follow up |
|
|
| any box use data at 9 mo FU |
|
| any box use data at 12 mo FU |
|