Trial Outcomes & Findings for ARemind: A Personalized System to Remind for Adherence (NCT NCT01229722)
NCT ID: NCT01229722
Last Updated: 2019-03-20
Results Overview
MEMS pill caps or boxes will be used to monitor adherence. Each participant will place the drug containing the protease inhibitor, or, if no such drug is being taken, the drug with the highest dosing frequency, inside of a MEMS device, which automatically records each time the pillbox was opened. Participants will bring this to the clinic during their regularly scheduled visits, and those daily measurements will be downloaded to a clinic machine.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
70 participants
Primary outcome timeframe
Assessed at Baseline and 8 timepoints (every 3 weeks) over 24 weeks. T1 (Baseline), T2 (12 weeks), and T3 (24 weeks) reported here.
Results posted on
2019-03-20
Participant Flow
Patients receiving HIV care at Boston Medical Center were eligible to participate if they were 18+ years of age and prescribed an ART regimen for at least 90 days. Participants were recruited between 2011-2012 during their doctor visit and/or via study flyers in the clinic. Eligibility was confirmed in person or via telephone pre-screening.
Participant milestones
| Measure |
Beeper
Patients randomized to the control arm (Beeper) will receive the standard of care at each clinic visit. Although the frequency of the study visit is higher than what is observed in standard of care, the subjects will simply asked to bring their HIV medications every 3 weeks (MEMS measure, pill count) and questioned on their adherence to antiretroviral therapy (ART) in the past 7 days. They will not receive any text messages addressing their adherence to ART between each study visit. Their providers will not be receiving any adherence reports but will be asked to assess their adherence at at the start of the trial (Time 1 or T1) and at subsequent clinic visit scheduled according to a frequency defined by standard of care. The decision to restrict the provision of adherence reports to providers and adherence reinforcement messages to intervention group subjects is appropriate, as it is not yet known whether or not the interventions are more effective than the standard of care.
|
Cell Phone
Participants will receive a text message reminder at scheduled intervals, with varying frequency. They will also be subject to a remote adherence assessment, over text messages, interactive voice response (IVR), or a remote pill count with assistance over the phone from a counselor. Those who demonstrate lower adherence rates may receive a call from a counselor.
ARemind: ARemind will personalize reminder messages based on adherence levels and facilitate patient phone calls with social workers/adherence counselors when appropriate. It will also consist of a text-messaging or interactive voice response (IVR) or phone-based pill count remote adherence assessment module.
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
34
|
|
Overall Study
COMPLETED
|
36
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ARemind: A Personalized System to Remind for Adherence
Baseline characteristics by cohort
| Measure |
Beeper (Control)
n=36 Participants
Patients randomized to the control arm (Beeper) will receive the standard of care at each clinic visit. Although the frequency of the study visit is higher than what is observed in standard of care, the subjects will simply asked to bring their HIV medications every 3 weeks (MEMS measure, pill count) and questioned on their adherence to antiretroviral therapy (ART) in the past 7 days. They will not receive any text messages addressing their adherence to ART between each study visit. Their providers will not be receiving any adherence reports but will be asked to assess their adherence at at the start of the trial (Time 1 or T1) and at subsequent clinic visit scheduled according to a frequency defined by standard of care. The decision to restrict the provision of adherence reports to providers and adherence reinforcement messages to intervention group subjects is appropriate, as it is not yet known whether or not the interventions are more effective than the standard of care.
|
Cell Phone (Intervention)
n=30 Participants
Participants will receive a text message reminder at scheduled intervals, with varying frequency. They will also be subject to a remote adherence assessment, over text messages, interactive voice response (IVR), or a remote pill count with assistance over the phone from a counselor. Those who demonstrate lower adherence rates may receive a call from a counselor.
ARemind: ARemind will personalize reminder messages based on adherence levels and facilitate patient phone calls with social workers/adherence counselors when appropriate. It will also consist of a text-messaging or interactive voice response (IVR) or phone-based pill count remote adherence assessment module.
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.11 years
STANDARD_DEVIATION 10.49 • n=5 Participants
|
46.73 years
STANDARD_DEVIATION 9.04 • n=7 Participants
|
47.48 years
STANDARD_DEVIATION 9.81 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
18 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
11 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Education
High School or Less
|
21 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Education
More than High School
|
15 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Employment
Employed
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Employment
Unemployed
|
30 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Living
Homeless
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Living
Not homeless
|
36 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Relationship
Married
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Relationship
Not married
|
34 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Country of Birth
United States
|
28 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Country of Birth
US Territory
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Country of Birth
Another Country
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Primary Language
English
|
35 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Primary Language
Non-English
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Baseline CD4 (per mm3)
|
523.5 cells/mm^3
n=5 Participants
|
600 cells/mm^3
n=7 Participants
|
554.5 cells/mm^3
n=5 Participants
|
|
Baseline Viral Load
|
20.0 copies/mL
n=5 Participants
|
23.5 copies/mL
n=7 Participants
|
20.0 copies/mL
n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed at Baseline and 8 timepoints (every 3 weeks) over 24 weeks. T1 (Baseline), T2 (12 weeks), and T3 (24 weeks) reported here.Population: A total of 66 Boston Medical Center HIV-positive patients participated in this study. All patients in the study had stable ART prior to enrollment.
MEMS pill caps or boxes will be used to monitor adherence. Each participant will place the drug containing the protease inhibitor, or, if no such drug is being taken, the drug with the highest dosing frequency, inside of a MEMS device, which automatically records each time the pillbox was opened. Participants will bring this to the clinic during their regularly scheduled visits, and those daily measurements will be downloaded to a clinic machine.
Outcome measures
| Measure |
Beeper (Control)
n=36 Participants
Patients randomized to the control arm (Beeper) received the standard of care at each clinic visit. Although the frequency of the study visit is higher than what is observed in standard of care, the subjects were simply asked to bring their HIV medications every 3 weeks (MEMS measure, pill count) and questioned on their adherence to antiretroviral therapy (ART) in the past 7 days. They did not receive any text messages addressing their adherence to ART between each study visit. Their providers did not receive any adherence reports but were asked to assess their adherence at at the start of the trial (Time 1 or T1) and at subsequent clinic visit scheduled according to a frequency defined by standard of care. The decision to restrict the provision of adherence reports to providers and adherence reinforcement messages to intervention group subjects is appropriate, as it is not yet known whether or not the interventions are more effective than the standard of care.
|
Cell Phone (Intervention)
n=30 Participants
Participants received a text message reminder at scheduled intervals, with varying frequency. They potentially received a remote adherence assessment, over text messages, interactive voice response (IVR), or a remote pill count with assistance over the phone from a counselor. Those who demonstrate lower adherence rates received a call from a counselor.
ARemind: ARemind will personalize reminder messages based on adherence levels and facilitate patient phone calls with social workers/adherence counselors when appropriate. It will also consist of a text-messaging or interactive voice response (IVR) or phone-based pill count remote adherence assessment module.
|
|---|---|---|
|
Adherence to Anti-retroviral Therapy
T1
|
0.69 proportion adherence
Standard Deviation 0.28
|
0.73 proportion adherence
Standard Deviation 0.25
|
|
Adherence to Anti-retroviral Therapy
T2
|
0.62 proportion adherence
Standard Deviation 0.27
|
.67 proportion adherence
Standard Deviation .24
|
|
Adherence to Anti-retroviral Therapy
T3
|
0.5 proportion adherence
Standard Deviation 0.3
|
.64 proportion adherence
Standard Deviation .26
|
PRIMARY outcome
Timeframe: Assessed at Baseline and 8 timepoints (every 3 weeks) over 24 weeks. T1 (Baseline), T2 (12 weeks), and T3 (24 weeks) reported here.Population: A total of 66 Boston Medical Center HIV-positive patients participated in this study. All patients in the study had stable ART prior to enrollment.
Participants were asked to recall what pills they took and what they missed. Adherence was measured by self report as well as Wise Pill and pill count.
Outcome measures
| Measure |
Beeper (Control)
n=36 Participants
Patients randomized to the control arm (Beeper) received the standard of care at each clinic visit. Although the frequency of the study visit is higher than what is observed in standard of care, the subjects were simply asked to bring their HIV medications every 3 weeks (MEMS measure, pill count) and questioned on their adherence to antiretroviral therapy (ART) in the past 7 days. They did not receive any text messages addressing their adherence to ART between each study visit. Their providers did not receive any adherence reports but were asked to assess their adherence at at the start of the trial (Time 1 or T1) and at subsequent clinic visit scheduled according to a frequency defined by standard of care. The decision to restrict the provision of adherence reports to providers and adherence reinforcement messages to intervention group subjects is appropriate, as it is not yet known whether or not the interventions are more effective than the standard of care.
|
Cell Phone (Intervention)
n=30 Participants
Participants received a text message reminder at scheduled intervals, with varying frequency. They potentially received a remote adherence assessment, over text messages, interactive voice response (IVR), or a remote pill count with assistance over the phone from a counselor. Those who demonstrate lower adherence rates received a call from a counselor.
ARemind: ARemind will personalize reminder messages based on adherence levels and facilitate patient phone calls with social workers/adherence counselors when appropriate. It will also consist of a text-messaging or interactive voice response (IVR) or phone-based pill count remote adherence assessment module.
|
|---|---|---|
|
Self-Report
T1
|
.93 proportion of 7-day adherence
Standard Deviation .1
|
.95 proportion of 7-day adherence
Standard Deviation .07
|
|
Self-Report
T2
|
.95 proportion of 7-day adherence
Standard Deviation .07
|
.95 proportion of 7-day adherence
Standard Deviation .07
|
|
Self-Report
T3
|
.93 proportion of 7-day adherence
Standard Deviation .1
|
.95 proportion of 7-day adherence
Standard Deviation .06
|
PRIMARY outcome
Timeframe: Assessed at Baseline and 8 timepoints (every 3 weeks) over 24 weeks. T1 (Baseline), T2 (12 weeks), and T3 (24 weeks) reported here.Population: A total of 66 Boston Medical Center HIV-positive patients participated in this study. All patients in the study had stable ART prior to enrollment.
During the clinic visits ever 3 weeks over the course of the study, participants will be asked to bring all their pill bottles and count the contents of each bottle with assistance from the study coordinator. This count will be compared with the refill history for that patient from the pharmacy in order to get a sense of how many pills they have taken.
Outcome measures
| Measure |
Beeper (Control)
n=36 Participants
Patients randomized to the control arm (Beeper) received the standard of care at each clinic visit. Although the frequency of the study visit is higher than what is observed in standard of care, the subjects were simply asked to bring their HIV medications every 3 weeks (MEMS measure, pill count) and questioned on their adherence to antiretroviral therapy (ART) in the past 7 days. They did not receive any text messages addressing their adherence to ART between each study visit. Their providers did not receive any adherence reports but were asked to assess their adherence at at the start of the trial (Time 1 or T1) and at subsequent clinic visit scheduled according to a frequency defined by standard of care. The decision to restrict the provision of adherence reports to providers and adherence reinforcement messages to intervention group subjects is appropriate, as it is not yet known whether or not the interventions are more effective than the standard of care.
|
Cell Phone (Intervention)
n=30 Participants
Participants received a text message reminder at scheduled intervals, with varying frequency. They potentially received a remote adherence assessment, over text messages, interactive voice response (IVR), or a remote pill count with assistance over the phone from a counselor. Those who demonstrate lower adherence rates received a call from a counselor.
ARemind: ARemind will personalize reminder messages based on adherence levels and facilitate patient phone calls with social workers/adherence counselors when appropriate. It will also consist of a text-messaging or interactive voice response (IVR) or phone-based pill count remote adherence assessment module.
|
|---|---|---|
|
Pill Count
T1
|
.59 proportion of pills taken as scheduled
Standard Deviation .34
|
.66 proportion of pills taken as scheduled
Standard Deviation .41
|
|
Pill Count
T2
|
.62 proportion of pills taken as scheduled
Standard Deviation .22
|
.6 proportion of pills taken as scheduled
Standard Deviation .24
|
|
Pill Count
T3
|
.58 proportion of pills taken as scheduled
Standard Deviation .24
|
.62 proportion of pills taken as scheduled
Standard Deviation .25
|
Adverse Events
Beeper
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cell Phone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place