Trial Outcomes & Findings for Tel-Me-Box: Testing a New, Real-time Strategies for Monitoring HIV Medication Adherence in India (NCT NCT03086655)
NCT ID: NCT03086655
Last Updated: 2025-08-22
Results Overview
Number of days over past 30 days with at least one device-recorded pill box opening.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
131 participants
Primary outcome timeframe
30 days prior to each follow-up assessment (3, 6, 9 and 12 months post baseline).
Results posted on
2025-08-22
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Baseline Assessment
STARTED
|
69
|
62
|
|
Baseline Assessment
COMPLETED
|
69
|
62
|
|
Baseline Assessment
NOT COMPLETED
|
0
|
0
|
|
3 Month Follow-up Assessment
STARTED
|
69
|
62
|
|
3 Month Follow-up Assessment
COMPLETED
|
62
|
58
|
|
3 Month Follow-up Assessment
NOT COMPLETED
|
7
|
4
|
|
6 Month Follow-up Assessment
STARTED
|
67
|
62
|
|
6 Month Follow-up Assessment
COMPLETED
|
58
|
55
|
|
6 Month Follow-up Assessment
NOT COMPLETED
|
9
|
7
|
|
9 Month Follow-up Assessment
STARTED
|
65
|
61
|
|
9 Month Follow-up Assessment
COMPLETED
|
56
|
57
|
|
9 Month Follow-up Assessment
NOT COMPLETED
|
9
|
4
|
|
12 Month Follow-up = Final Assessment
STARTED
|
65
|
61
|
|
12 Month Follow-up = Final Assessment
COMPLETED
|
58
|
57
|
|
12 Month Follow-up = Final Assessment
NOT COMPLETED
|
7
|
4
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
3 Month Follow-up Assessment
Lost to Follow-up
|
5
|
4
|
|
3 Month Follow-up Assessment
Withdrawal by Subject
|
2
|
0
|
|
6 Month Follow-up Assessment
Lost to Follow-up
|
7
|
6
|
|
6 Month Follow-up Assessment
Withdrawal by Subject
|
2
|
1
|
|
9 Month Follow-up Assessment
Lost to Follow-up
|
9
|
4
|
|
12 Month Follow-up = Final Assessment
Lost to Follow-up
|
7
|
3
|
|
12 Month Follow-up = Final Assessment
Death
|
0
|
1
|
Baseline Characteristics
Tel-Me-Box: Testing a New, Real-time Strategies for Monitoring HIV Medication Adherence in India
Baseline characteristics by cohort
| Measure |
Pillbox ('Tel-me-box') With Reminder Features
n=69 Participants
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.
|
Pillbox ('Tel-me-box') Without Reminder Features
n=62 Participants
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.
|
Total
n=131 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Region of Enrollment
India
|
69 participants
n=5 Participants
|
62 participants
n=7 Participants
|
131 participants
n=5 Participants
|
|
Type of reminder feature (in intervention group only)
Buzzer
|
34 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Type of reminder feature (in intervention group only)
Light + vibration
|
35 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Type of reminder feature (in intervention group only)
None (only applicable to arm without reminder features)
|
0 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Age, Continuous
|
37.3 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
41.8 years
STANDARD_DEVIATION 9.6 • n=7 Participants
|
39.4 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
69 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
131 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 days prior to each follow-up assessment (3, 6, 9 and 12 months post baseline).Population: Overall number analyzed = number of participants enrolled at baseline. Numbers analyzed reported below reflect missing data due to loss to follow-up.
Number of days over past 30 days with at least one device-recorded pill box opening.
Outcome measures
| Measure |
Pillbox ('Tel-me-box') With Reminder Features
n=69 Participants
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.
|
Pillbox ('Tel-me-box') Without Reminder Features
n=62 Participants
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.
|
|---|---|---|
|
Tel-me-box Adherence
No. days box opened (0-30) at 3 mo. follow-up
|
10 days (out of 30)
Interval 1.0 to 24.0
|
16.5 days (out of 30)
Interval 2.0 to 25.0
|
|
Tel-me-box Adherence
No. days box opened (0-30) at 6 mo. follow-up
|
1.5 days (out of 30)
Interval 0.0 to 12.0
|
7 days (out of 30)
Interval 0.0 to 17.0
|
|
Tel-me-box Adherence
No. days box opened (0-30) at 9 mo. follow-up
|
0 days (out of 30)
Interval 0.0 to 2.5
|
1 days (out of 30)
Interval 0.0 to 13.0
|
|
Tel-me-box Adherence
No. days box opened (0-30) at 12 mo. follow-up
|
0 days (out of 30)
Interval 0.0 to 1.0
|
0 days (out of 30)
Interval 0.0 to 8.0
|
PRIMARY outcome
Timeframe: Baseline, and 6 and 12 month follow-upPopulation: 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.
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)
Outcome measures
| Measure |
Pillbox ('Tel-me-box') With Reminder Features
n=69 Participants
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.
|
Pillbox ('Tel-me-box') Without Reminder Features
n=62 Participants
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.
|
|---|---|---|
|
HIV Viral Load (VL)
Undetectable VL at Baseline
|
37 participants
|
34 participants
|
|
HIV Viral Load (VL)
Undetectable VL at 6mo FU
|
34 participants
|
45 participants
|
|
HIV Viral Load (VL)
Undetectable VL at 12 mo FU
|
34 participants
|
44 participants
|
PRIMARY outcome
Timeframe: 12 month follow-upPopulation: 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.
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.
Outcome measures
| Measure |
Pillbox ('Tel-me-box') With Reminder Features
n=48 Participants
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.
|
Pillbox ('Tel-me-box') Without Reminder Features
n=53 Participants
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.
|
|---|---|---|
|
Hair Concentrations of Anti-retroviral Medications (ARV), in ng/mg
|
0.12 log10 transformed concentration (ng/mg)
Standard Deviation 0.71
|
0.28 log10 transformed concentration (ng/mg)
Standard Deviation 0.64
|
SECONDARY outcome
Timeframe: 30 days prior to baseline and 3, 6, 9, and 12 month follow-upPopulation: Overall number of participants = number enrolled at baseline. At follow-up waves the number analyzed is lower due to loss to 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%)
Outcome measures
| Measure |
Pillbox ('Tel-me-box') With Reminder Features
n=69 Participants
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.
|
Pillbox ('Tel-me-box') Without Reminder Features
n=62 Participants
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.
|
|---|---|---|
|
Self-reported Adherence in the Past Month
Optimally adherent at 6 month follow up
|
44 participants
|
35 participants
|
|
Self-reported Adherence in the Past Month
Optimally adherent at 9 month follow up
|
45 participants
|
40 participants
|
|
Self-reported Adherence in the Past Month
Optimally adherent at baseline
|
4 participants
|
5 participants
|
|
Self-reported Adherence in the Past Month
Optimally adherent at 3 month follow up
|
49 participants
|
37 participants
|
|
Self-reported Adherence in the Past Month
Optimally adherent at 12 month follow up
|
45 participants
|
50 participants
|
POST_HOC outcome
Timeframe: 30 days prior to assessment at 3, 6, 9, and 12 mo follow-upThe number of participants for whom at least 1 pill box opening was registered in the 30 days before an assessment
Outcome measures
| Measure |
Pillbox ('Tel-me-box') With Reminder Features
n=69 Participants
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.
|
Pillbox ('Tel-me-box') Without Reminder Features
n=62 Participants
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.
|
|---|---|---|
|
Presence of Tel-me-box Adherence Data (>0) in Past 30 Days
any box use data at 3 mo FU
|
47 participants
|
48 participants
|
|
Presence of Tel-me-box Adherence Data (>0) in Past 30 Days
any box use data at 6 mo FU
|
38 participants
|
41 participants
|
|
Presence of Tel-me-box Adherence Data (>0) in Past 30 Days
any box use data at 9 mo FU
|
26 participants
|
31 participants
|
|
Presence of Tel-me-box Adherence Data (>0) in Past 30 Days
any box use data at 12 mo FU
|
16 participants
|
22 participants
|
Adverse Events
Pillbox ('Tel-me-box') With Reminder Features
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pillbox ('Tel-me-box') Without Reminder Features
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Maria Ekstrand
University of California San Francisco
Phone: +1 (415) 502-1000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place