Trial Outcomes & Findings for SteadyRx: Smartphone ART Adherence Intervention for Drug Users (NCT NCT02317614)
NCT ID: NCT02317614
Last Updated: 2018-11-20
Results Overview
The MEMS cap is a device that records the date and time whenever a patient opens a vial to monitor medication adherence. Percentage of participant to achieve 95% adherence will then be recorded.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
51 participants
Primary outcome timeframe
Six months
Results posted on
2018-11-20
Participant Flow
The originally planned recruitment strategy did not work. We thus expanded our recruitment to the entire city of Baltimore instead of just one clinic.
Participant milestones
| Measure |
SteadyRx
This group will be assessed at monthly intervals. They will receive their usual care at their regular providers. In addition, they will be given Smartphones loaded with the SteadyRx intervention.
SteadyRx: The proposed intervention consists of four core elements. The intervention will include a Smartphone application that allows direct interaction with the SteadyRx system, as well as automatic events controlled via a central server. The CONSULT element will facilitate patient-provider communication with links to care providers and other care resources. The REMIND element will provide telephonic reminders for late doses. The OBSERVE element will feature electronically observed dosing through time-stamped video recordings made on the Smartphone and sent securely to a central server. The REWARD element will feature monetary incentives designed to reinforce short- and long-term medication adherence and promote reductions in viral load.
|
Usual Care
This group will be assessed at monthly intervals. They will receive their usual care at their regular providers. They will not receive a Smartphone or the SteadyRx adherence intervention.
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
25
|
|
Overall Study
COMPLETED
|
23
|
23
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
SteadyRx
This group will be assessed at monthly intervals. They will receive their usual care at their regular providers. In addition, they will be given Smartphones loaded with the SteadyRx intervention.
SteadyRx: The proposed intervention consists of four core elements. The intervention will include a Smartphone application that allows direct interaction with the SteadyRx system, as well as automatic events controlled via a central server. The CONSULT element will facilitate patient-provider communication with links to care providers and other care resources. The REMIND element will provide telephonic reminders for late doses. The OBSERVE element will feature electronically observed dosing through time-stamped video recordings made on the Smartphone and sent securely to a central server. The REWARD element will feature monetary incentives designed to reinforce short- and long-term medication adherence and promote reductions in viral load.
|
Usual Care
This group will be assessed at monthly intervals. They will receive their usual care at their regular providers. They will not receive a Smartphone or the SteadyRx adherence intervention.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Death
|
1
|
1
|
Baseline Characteristics
SteadyRx: Smartphone ART Adherence Intervention for Drug Users
Baseline characteristics by cohort
| Measure |
SteadyRx
n=25 Participants
This group will be assessed at monthly intervals. They will receive their usual care at their regular providers. In addition, they will be given Smartphones loaded with the SteadyRx intervention.
SteadyRx: The proposed intervention consists of four core elements. The intervention will include a Smartphone application that allows direct interaction with the SteadyRx system, as well as automatic events controlled via a central server. The CONSULT element will facilitate patient-provider communication with links to care providers and other care resources. The REMIND element will provide telephonic reminders for late doses. The OBSERVE element will feature electronically observed dosing through time-stamped video recordings made on the Smartphone and sent securely to a central server. The REWARD element will feature monetary incentives designed to reinforce short- and long-term medication adherence and promote reductions in viral load.
|
Usual Care
n=25 Participants
This group will be assessed at monthly intervals. They will receive their usual care at their regular providers. They will not receive a Smartphone or the SteadyRx adherence intervention.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.36 Years
STANDARD_DEVIATION 10.69 • n=99 Participants
|
54 Years
STANDARD_DEVIATION 7.81 • n=107 Participants
|
53.18 Years
STANDARD_DEVIATION 9.25 • n=206 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
23 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
25 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
|
Education (years)
|
11.96 years
STANDARD_DEVIATION 1.24 • n=99 Participants
|
11.88 years
STANDARD_DEVIATION 2.13 • n=107 Participants
|
11.92 years
STANDARD_DEVIATION 1.69 • n=206 Participants
|
|
Test of Functional Health Literacy in Adults (TOFHLA) score
|
85.16 units on a scale
STANDARD_DEVIATION 12.36 • n=99 Participants
|
80.28 units on a scale
STANDARD_DEVIATION 15.27 • n=107 Participants
|
82.72 units on a scale
STANDARD_DEVIATION 13.82 • n=206 Participants
|
|
number (and percentage) of participants with clinical depression
|
9 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
number (and percentage) of participants with cocaine or non-prescribed opioids in the last 30 days
|
9 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
number (and percentage) of participants with cocaine or non-prescribed opioid use in their lifetime
|
24 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
|
number (and percentage) of participants with an undetectable HIV viral load
|
22 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Six monthsPopulation: Participants' monthly data over six months were included. Missing data were treated as missing.
The MEMS cap is a device that records the date and time whenever a patient opens a vial to monitor medication adherence. Percentage of participant to achieve 95% adherence will then be recorded.
Outcome measures
| Measure |
SteadyRx
n=25 Participants
This group will be assessed at monthly intervals. They will receive their usual care at their regular providers. In addition, they will be given Smartphones loaded with the SteadyRx intervention.
SteadyRx: The proposed intervention consists of four core elements. The intervention will include a Smartphone application that allows direct interaction with the SteadyRx system, as well as automatic events controlled via a central server. The CONSULT element will facilitate patient-provider communication with links to care providers and other care resources. The REMIND element will provide telephonic reminders for late doses. The OBSERVE element will feature electronically observed dosing through time-stamped video recordings made on the Smartphone and sent securely to a central server. The REWARD element will feature monetary incentives designed to reinforce short- and long-term medication adherence and promote reductions in viral load.
|
Usual Care
n=25 Participants
This group will be assessed at monthly intervals. They will receive their usual care at their regular providers. They will not receive a Smartphone or the SteadyRx adherence intervention.
|
|---|---|---|
|
Medication Adherence as Assessed by the Medication Event Monitoring System (MEMS) Cap
|
52.2 percentage of participants
|
27.2 percentage of participants
|
PRIMARY outcome
Timeframe: Six monthsMeasured twice in six months to assess the percentage of participants to achieve a viral load \<400 HIV-RNA/mL (Y/N)
Outcome measures
| Measure |
SteadyRx
n=25 Participants
This group will be assessed at monthly intervals. They will receive their usual care at their regular providers. In addition, they will be given Smartphones loaded with the SteadyRx intervention.
SteadyRx: The proposed intervention consists of four core elements. The intervention will include a Smartphone application that allows direct interaction with the SteadyRx system, as well as automatic events controlled via a central server. The CONSULT element will facilitate patient-provider communication with links to care providers and other care resources. The REMIND element will provide telephonic reminders for late doses. The OBSERVE element will feature electronically observed dosing through time-stamped video recordings made on the Smartphone and sent securely to a central server. The REWARD element will feature monetary incentives designed to reinforce short- and long-term medication adherence and promote reductions in viral load.
|
Usual Care
n=25 Participants
This group will be assessed at monthly intervals. They will receive their usual care at their regular providers. They will not receive a Smartphone or the SteadyRx adherence intervention.
|
|---|---|---|
|
Percentage of Participants Achieving an Undetectable Viral Load in Six Months
|
88.1 percentage of participants
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: Six monthsThis measure is calculated for each participant in each study month. The number of days in the month in which the participant correctly consumed their antiretroviral medication is divided by the number of days in the month. The measure is collected by an electronic pill bottle cap (a.k.a. "MEMS cap").
Outcome measures
| Measure |
SteadyRx
n=25 Participants
This group will be assessed at monthly intervals. They will receive their usual care at their regular providers. In addition, they will be given Smartphones loaded with the SteadyRx intervention.
SteadyRx: The proposed intervention consists of four core elements. The intervention will include a Smartphone application that allows direct interaction with the SteadyRx system, as well as automatic events controlled via a central server. The CONSULT element will facilitate patient-provider communication with links to care providers and other care resources. The REMIND element will provide telephonic reminders for late doses. The OBSERVE element will feature electronically observed dosing through time-stamped video recordings made on the Smartphone and sent securely to a central server. The REWARD element will feature monetary incentives designed to reinforce short- and long-term medication adherence and promote reductions in viral load.
|
Usual Care
n=25 Participants
This group will be assessed at monthly intervals. They will receive their usual care at their regular providers. They will not receive a Smartphone or the SteadyRx adherence intervention.
|
|---|---|---|
|
Monthly Percent Adherence to Antiretroviral Medications.
|
87.97 percentage of adherence to ART
Standard Error 1.64
|
73.88 percentage of adherence to ART
Standard Error 2.4
|
SECONDARY outcome
Timeframe: Six monthsActual HIV-RNA levels, measured at the same time as the undetectable viral load outcome measure
Outcome measures
| Measure |
SteadyRx
n=25 Participants
This group will be assessed at monthly intervals. They will receive their usual care at their regular providers. In addition, they will be given Smartphones loaded with the SteadyRx intervention.
SteadyRx: The proposed intervention consists of four core elements. The intervention will include a Smartphone application that allows direct interaction with the SteadyRx system, as well as automatic events controlled via a central server. The CONSULT element will facilitate patient-provider communication with links to care providers and other care resources. The REMIND element will provide telephonic reminders for late doses. The OBSERVE element will feature electronically observed dosing through time-stamped video recordings made on the Smartphone and sent securely to a central server. The REWARD element will feature monetary incentives designed to reinforce short- and long-term medication adherence and promote reductions in viral load.
|
Usual Care
n=25 Participants
This group will be assessed at monthly intervals. They will receive their usual care at their regular providers. They will not receive a Smartphone or the SteadyRx adherence intervention.
|
|---|---|---|
|
Viral Load
|
248.17 copies/mL blood
Standard Error 182.64
|
23.38 copies/mL blood
Standard Error 1.37
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Six monthsThe 35-item questionnaire includes ten dimensions (health perceptions, pain, physical, role, social and cognitive functioning, mental health, energy, health distress and quality of life (QoL). Subscales are scored on a 0-100 scale (a higher score indicates better health) and separate physical and mental health summary scores are calculated. Summary scores for these items are transforms with a mean of 50 and a standard deviation of 10. Thus, for both scores, being of average (physical or mental) health leads to a score of 50, with a range of 20 to 80.
Outcome measures
| Measure |
SteadyRx
n=25 Participants
This group will be assessed at monthly intervals. They will receive their usual care at their regular providers. In addition, they will be given Smartphones loaded with the SteadyRx intervention.
SteadyRx: The proposed intervention consists of four core elements. The intervention will include a Smartphone application that allows direct interaction with the SteadyRx system, as well as automatic events controlled via a central server. The CONSULT element will facilitate patient-provider communication with links to care providers and other care resources. The REMIND element will provide telephonic reminders for late doses. The OBSERVE element will feature electronically observed dosing through time-stamped video recordings made on the Smartphone and sent securely to a central server. The REWARD element will feature monetary incentives designed to reinforce short- and long-term medication adherence and promote reductions in viral load.
|
Usual Care
n=25 Participants
This group will be assessed at monthly intervals. They will receive their usual care at their regular providers. They will not receive a Smartphone or the SteadyRx adherence intervention.
|
|---|---|---|
|
Mental and Physicial Health as Assessed by the Medical Outcomes Study HIV Health Survey (MOS-HIV)
Mental health score
|
54.6 score on a scale
Standard Deviation 8.33
|
51.4 score on a scale
Standard Deviation 12.36
|
|
Mental and Physicial Health as Assessed by the Medical Outcomes Study HIV Health Survey (MOS-HIV)
Physical health score
|
45.63 score on a scale
Standard Deviation 11.41
|
42.75 score on a scale
Standard Deviation 12.95
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Six monthsPopulation: Includes data from six months (repeated measures), with missing data treated as missing. Percent of participants reporting use of either cocaine, opiates, or both is the reported value.
Measured using monthly self-report. Response will be binary (Yes/No). The percentage of the participants that reported yes will be recorded for each month and then an average for the 6 month period calculated.
Outcome measures
| Measure |
SteadyRx
n=25 Participants
This group will be assessed at monthly intervals. They will receive their usual care at their regular providers. In addition, they will be given Smartphones loaded with the SteadyRx intervention.
SteadyRx: The proposed intervention consists of four core elements. The intervention will include a Smartphone application that allows direct interaction with the SteadyRx system, as well as automatic events controlled via a central server. The CONSULT element will facilitate patient-provider communication with links to care providers and other care resources. The REMIND element will provide telephonic reminders for late doses. The OBSERVE element will feature electronically observed dosing through time-stamped video recordings made on the Smartphone and sent securely to a central server. The REWARD element will feature monetary incentives designed to reinforce short- and long-term medication adherence and promote reductions in viral load.
|
Usual Care
n=25 Participants
This group will be assessed at monthly intervals. They will receive their usual care at their regular providers. They will not receive a Smartphone or the SteadyRx adherence intervention.
|
|---|---|---|
|
Opiate and Cocaine Use
|
20.0 percentage of participants
Standard Deviation 9.0
|
22.8 percentage of participants
Standard Deviation 4.9
|
Adverse Events
SteadyRx
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Usual Care
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
SteadyRx
n=25 participants at risk
This group will be assessed at monthly intervals. They will receive their usual care at their regular providers. In addition, they will be given Smartphones loaded with the SteadyRx intervention.
SteadyRx: The proposed intervention consists of four core elements. The intervention will include a Smartphone application that allows direct interaction with the SteadyRx system, as well as automatic events controlled via a central server. The CONSULT element will facilitate patient-provider communication with links to care providers and other care resources. The REMIND element will provide telephonic reminders for late doses. The OBSERVE element will feature electronically observed dosing through time-stamped video recordings made on the Smartphone and sent securely to a central server. The REWARD element will feature monetary incentives designed to reinforce short- and long-term medication adherence and promote reductions in viral load.
|
Usual Care
n=25 participants at risk
This group will be assessed at monthly intervals. They will receive their usual care at their regular providers. They will not receive a Smartphone or the SteadyRx adherence intervention.
|
|---|---|---|
|
Immune system disorders
Death
|
4.0%
1/25 • Number of events 1 • 6 months
The FDA definition of adverse events was used to guide adverse event reporting to the funding agency and IRB during this study. According to the FDA definition, no adverse events occurred during the monitoring period. In addition, adverse events were recorded based on the clinicaltrials.gov definitions.
|
4.0%
1/25 • Number of events 1 • 6 months
The FDA definition of adverse events was used to guide adverse event reporting to the funding agency and IRB during this study. According to the FDA definition, no adverse events occurred during the monitoring period. In addition, adverse events were recorded based on the clinicaltrials.gov definitions.
|
|
Immune system disorders
Hospitalization
|
4.0%
1/25 • Number of events 1 • 6 months
The FDA definition of adverse events was used to guide adverse event reporting to the funding agency and IRB during this study. According to the FDA definition, no adverse events occurred during the monitoring period. In addition, adverse events were recorded based on the clinicaltrials.gov definitions.
|
0.00%
0/25 • 6 months
The FDA definition of adverse events was used to guide adverse event reporting to the funding agency and IRB during this study. According to the FDA definition, no adverse events occurred during the monitoring period. In addition, adverse events were recorded based on the clinicaltrials.gov definitions.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place