Trial Outcomes & Findings for HIV Adherence Bottle Intervention Trial (NCT NCT03772327)
NCT ID: NCT03772327
Last Updated: 2019-10-02
Results Overview
Using dried blood spots from red blood cells, TFV-DP levels will be assessed.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
63 participants
Primary outcome timeframe
Baseline and Week 12
Results posted on
2019-10-02
Participant Flow
Recruitment occurred primarily from the clinic population receiving care for HIV at New York Presbyterian Hospital Center for Special Studies located in New York City. A total of 24 and 42 participants were recruited from the Upper East Side and Chelsea locations respectively from May 2015 to August 2018.
67 were screened for the study and 4 did not enroll because: 1 elected not to participate given excellent adherence to medications, 1 was ineligible after a switch off a tenofovir containing regimen, 1 did not come to the enrollment appointment, and 1 did not provide consent.
Participant milestones
| Measure |
Routine Counseling + AdhereTech Bottle
Participants will receive routine medication adherence counseling and be given the AdhereTech "smart bottle" with reminders.
Adheretech "smart bottle": A "smart pill bottle" that measures the exact number of pills in the bottle in real-time, sends this HIPAA-compliant data to a central server, and based on the results, can remind participants to take their medication through a phone call or text message.
Routine adherence counseling: Participants will be provided with routine adherence counseling
|
Routine Counseling
Participants will receive routine medication adherence counseling.
Routine adherence counseling: Participants will be provided with routine adherence counseling
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
33
|
|
Overall Study
Week 0 Visit
|
28
|
33
|
|
Overall Study
COMPLETED
|
25
|
26
|
|
Overall Study
NOT COMPLETED
|
5
|
7
|
Reasons for withdrawal
| Measure |
Routine Counseling + AdhereTech Bottle
Participants will receive routine medication adherence counseling and be given the AdhereTech "smart bottle" with reminders.
Adheretech "smart bottle": A "smart pill bottle" that measures the exact number of pills in the bottle in real-time, sends this HIPAA-compliant data to a central server, and based on the results, can remind participants to take their medication through a phone call or text message.
Routine adherence counseling: Participants will be provided with routine adherence counseling
|
Routine Counseling
Participants will receive routine medication adherence counseling.
Routine adherence counseling: Participants will be provided with routine adherence counseling
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
4
|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
Baseline Characteristics
2 participants in the Routine counseling + AdhereTech bottle group were lost to follow up before the medication data could be collected at the baseline visit.
Baseline characteristics by cohort
| Measure |
Routine Counseling + AdhereTech Bottle
n=30 Participants
Participants will receive routine medication adherence counseling and be given the AdhereTech "smart bottle" with reminders.
Adheretech "smart bottle": A "smart pill bottle" that measures the exact number of pills in the bottle in real-time, sends this HIPAA-compliant data to a central server, and based on the results, can remind participants to take their medication through a phone call or text message.
Routine adherence counseling: Participants will be provided with routine adherence counseling
|
Routine Counseling
n=33 Participants
Participants will receive routine medication adherence counseling.
Routine adherence counseling: Participants will be provided with routine adherence counseling
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52 years
n=30 Participants
|
49 years
n=33 Participants
|
51 years
n=63 Participants
|
|
Sex/Gender, Customized
Male
|
23 Participants
n=30 Participants
|
23 Participants
n=33 Participants
|
46 Participants
n=63 Participants
|
|
Sex/Gender, Customized
Female
|
6 Participants
n=30 Participants
|
8 Participants
n=33 Participants
|
14 Participants
n=63 Participants
|
|
Sex/Gender, Customized
Transgender
|
1 Participants
n=30 Participants
|
2 Participants
n=33 Participants
|
3 Participants
n=63 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=30 Participants
|
10 Participants
n=33 Participants
|
16 Participants
n=63 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=30 Participants
|
20 Participants
n=33 Participants
|
41 Participants
n=63 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=30 Participants
|
3 Participants
n=33 Participants
|
6 Participants
n=63 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=30 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=63 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=30 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=63 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=30 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=63 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=30 Participants
|
14 Participants
n=33 Participants
|
30 Participants
n=63 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=30 Participants
|
12 Participants
n=33 Participants
|
20 Participants
n=63 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=30 Participants
|
0 Participants
n=33 Participants
|
2 Participants
n=63 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=30 Participants
|
7 Participants
n=33 Participants
|
11 Participants
n=63 Participants
|
|
HIV RNA <= 20 copies/mL
|
16 Participants
n=30 Participants
|
15 Participants
n=33 Participants
|
31 Participants
n=63 Participants
|
|
CD4
|
380 cells/μL
n=30 Participants
|
428 cells/μL
n=33 Participants
|
409 cells/μL
n=63 Participants
|
|
Number of daily antiretroviral pills
|
2 pills per day
n=28 Participants • 2 participants in the Routine counseling + AdhereTech bottle group were lost to follow up before the medication data could be collected at the baseline visit.
|
3 pills per day
n=33 Participants • 2 participants in the Routine counseling + AdhereTech bottle group were lost to follow up before the medication data could be collected at the baseline visit.
|
3 pills per day
n=61 Participants • 2 participants in the Routine counseling + AdhereTech bottle group were lost to follow up before the medication data could be collected at the baseline visit.
|
|
Number of participants reporting days of no missed doses in prior 4 days
4 days
|
18 Participants
n=28 Participants • 2 participants in the Routine counseling + AdhereTech bottle group were lost to follow up before the adherence could be collected at the baseline visit.
|
19 Participants
n=33 Participants • 2 participants in the Routine counseling + AdhereTech bottle group were lost to follow up before the adherence could be collected at the baseline visit.
|
37 Participants
n=61 Participants • 2 participants in the Routine counseling + AdhereTech bottle group were lost to follow up before the adherence could be collected at the baseline visit.
|
|
Number of participants reporting days of no missed doses in prior 4 days
3 days
|
6 Participants
n=28 Participants • 2 participants in the Routine counseling + AdhereTech bottle group were lost to follow up before the adherence could be collected at the baseline visit.
|
2 Participants
n=33 Participants • 2 participants in the Routine counseling + AdhereTech bottle group were lost to follow up before the adherence could be collected at the baseline visit.
|
8 Participants
n=61 Participants • 2 participants in the Routine counseling + AdhereTech bottle group were lost to follow up before the adherence could be collected at the baseline visit.
|
|
Number of participants reporting days of no missed doses in prior 4 days
2 days
|
4 Participants
n=28 Participants • 2 participants in the Routine counseling + AdhereTech bottle group were lost to follow up before the adherence could be collected at the baseline visit.
|
6 Participants
n=33 Participants • 2 participants in the Routine counseling + AdhereTech bottle group were lost to follow up before the adherence could be collected at the baseline visit.
|
10 Participants
n=61 Participants • 2 participants in the Routine counseling + AdhereTech bottle group were lost to follow up before the adherence could be collected at the baseline visit.
|
|
Number of participants reporting days of no missed doses in prior 4 days
1 day
|
0 Participants
n=28 Participants • 2 participants in the Routine counseling + AdhereTech bottle group were lost to follow up before the adherence could be collected at the baseline visit.
|
3 Participants
n=33 Participants • 2 participants in the Routine counseling + AdhereTech bottle group were lost to follow up before the adherence could be collected at the baseline visit.
|
3 Participants
n=61 Participants • 2 participants in the Routine counseling + AdhereTech bottle group were lost to follow up before the adherence could be collected at the baseline visit.
|
|
Number of participants reporting days of no missed doses in prior 4 days
No days
|
0 Participants
n=28 Participants • 2 participants in the Routine counseling + AdhereTech bottle group were lost to follow up before the adherence could be collected at the baseline visit.
|
3 Participants
n=33 Participants • 2 participants in the Routine counseling + AdhereTech bottle group were lost to follow up before the adherence could be collected at the baseline visit.
|
3 Participants
n=61 Participants • 2 participants in the Routine counseling + AdhereTech bottle group were lost to follow up before the adherence could be collected at the baseline visit.
|
|
Number of participants prescribed a tenofovir containing regimen
|
28 Participants
n=28 Participants • 2 participants in the Routine counseling + AdhereTech bottle group were lost to follow up before the medication data could be collected at the baseline visit.
|
33 Participants
n=33 Participants • 2 participants in the Routine counseling + AdhereTech bottle group were lost to follow up before the medication data could be collected at the baseline visit.
|
61 Participants
n=61 Participants • 2 participants in the Routine counseling + AdhereTech bottle group were lost to follow up before the medication data could be collected at the baseline visit.
|
|
Number of participants prescribed a NRTI containing regimen
|
28 Participants
n=28 Participants • 2 participants in the Routine counseling + AdhereTech bottle group were lost to follow up before the medication data could be collected at the baseline visit.
|
33 Participants
n=33 Participants • 2 participants in the Routine counseling + AdhereTech bottle group were lost to follow up before the medication data could be collected at the baseline visit.
|
61 Participants
n=61 Participants • 2 participants in the Routine counseling + AdhereTech bottle group were lost to follow up before the medication data could be collected at the baseline visit.
|
|
Number of participants prescribed a NNRTI containing regimen
|
6 Participants
n=28 Participants • 2 participants in the Routine counseling + AdhereTech bottle group were lost to follow up before the medication data could be collected at the baseline visit.
|
7 Participants
n=33 Participants • 2 participants in the Routine counseling + AdhereTech bottle group were lost to follow up before the medication data could be collected at the baseline visit.
|
13 Participants
n=61 Participants • 2 participants in the Routine counseling + AdhereTech bottle group were lost to follow up before the medication data could be collected at the baseline visit.
|
|
Number of participants prescribed a Protease inhibitor containing regimen
|
10 Participants
n=28 Participants • 2 participants in the Routine counseling + AdhereTech bottle group were lost to follow up before the medication data could be collected at the baseline visit.
|
15 Participants
n=33 Participants • 2 participants in the Routine counseling + AdhereTech bottle group were lost to follow up before the medication data could be collected at the baseline visit.
|
25 Participants
n=61 Participants • 2 participants in the Routine counseling + AdhereTech bottle group were lost to follow up before the medication data could be collected at the baseline visit.
|
|
Number of participants prescribed an Integrase inhibitor containing regimen
|
14 Participants
n=28 Participants • 2 participants in the Routine counseling + AdhereTech bottle group were lost to follow up before the medication data could be collected at the baseline visit.
|
17 Participants
n=33 Participants • 2 participants in the Routine counseling + AdhereTech bottle group were lost to follow up before the medication data could be collected at the baseline visit.
|
31 Participants
n=61 Participants • 2 participants in the Routine counseling + AdhereTech bottle group were lost to follow up before the medication data could be collected at the baseline visit.
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Of the 5 in AdhereTech bottle group missing baseline TFV-DP levels 2 were lost to follow up prior to the visit and 3 are missing levels. 3 participants in AdhereTech group left the study before Week 12. 4 participants in the routine counseling group are missing TFV-DP levels from baseline visit and then 7 left the study prior to Week 12.
Using dried blood spots from red blood cells, TFV-DP levels will be assessed.
Outcome measures
| Measure |
Routine Counseling + AdhereTech Bottle
n=30 Participants
Participants will receive routine medication adherence counseling and be given the AdhereTech "smart bottle" with reminders.
Adheretech "smart bottle": A "smart pill bottle" that measures the exact number of pills in the bottle in real-time, sends this HIPAA-compliant data to a central server, and based on the results, can remind participants to take their medication through a phone call or text message.
Routine adherence counseling: Participants will be provided with routine adherence counseling
|
Routine Counseling
n=33 Participants
Participants will receive routine medication adherence counseling.
Routine adherence counseling: Participants will be provided with routine adherence counseling
|
|---|---|---|
|
Change in Tenofovir Diphosphate (TFV-DP) Drug Levels
Baseline
|
1230 fmol/punch
Interval 923.0 to 2066.0
|
1108 fmol/punch
Interval 418.0 to 1886.0
|
|
Change in Tenofovir Diphosphate (TFV-DP) Drug Levels
Week 12
|
1887 fmol/punch
Interval 797.0 to 2794.0
|
1084 fmol/punch
Interval 504.0 to 1175.0
|
SECONDARY outcome
Timeframe: Week 12Feasibility of using the AdhereTech "Smart Pill Bottles" in individuals living with HIV as measured by the proportion of participants that complete the study compared between arms. A statistically lower proportion in the AdhereTech bottle arm compared to the routine counseling arm would suggest use of the bottle is not feasible.
Outcome measures
| Measure |
Routine Counseling + AdhereTech Bottle
n=30 Participants
Participants will receive routine medication adherence counseling and be given the AdhereTech "smart bottle" with reminders.
Adheretech "smart bottle": A "smart pill bottle" that measures the exact number of pills in the bottle in real-time, sends this HIPAA-compliant data to a central server, and based on the results, can remind participants to take their medication through a phone call or text message.
Routine adherence counseling: Participants will be provided with routine adherence counseling
|
Routine Counseling
n=33 Participants
Participants will receive routine medication adherence counseling.
Routine adherence counseling: Participants will be provided with routine adherence counseling
|
|---|---|---|
|
Number of Participants Completing the 12 Week AdhereTech Bottle Intervention Compared to the Routine Counseling Only Group.
|
25 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: 5 and 7 participants left the AdhereTech bottle and routine counseling groups respectively. And additional participant in the AdhereTech bottle group is missing the Week 12 HIV viral load.
Comparative changes in quantitative HIV viral load between baseline and Week 12 in the AdhereTech bottle arm versus the routine counseling only arm.
Outcome measures
| Measure |
Routine Counseling + AdhereTech Bottle
n=30 Participants
Participants will receive routine medication adherence counseling and be given the AdhereTech "smart bottle" with reminders.
Adheretech "smart bottle": A "smart pill bottle" that measures the exact number of pills in the bottle in real-time, sends this HIPAA-compliant data to a central server, and based on the results, can remind participants to take their medication through a phone call or text message.
Routine adherence counseling: Participants will be provided with routine adherence counseling
|
Routine Counseling
n=33 Participants
Participants will receive routine medication adherence counseling.
Routine adherence counseling: Participants will be provided with routine adherence counseling
|
|---|---|---|
|
Change in Quantitative HIV Viral Load
Baseline
|
19 copies/mL
Interval 19.0 to 71.0
|
28 copies/mL
Interval 19.0 to 275.0
|
|
Change in Quantitative HIV Viral Load
Week 12
|
19 copies/mL
Interval 19.0 to 49.0
|
26 copies/mL
Interval 19.0 to 406.0
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: 5 and 7 participants left the AdhereTech bottle and routine counseling groups respectively. An additional participant in the AdhereTech bottle group is missing the Week 12 HIV viral load.
This is a measure of qualitative HIV RNA outcome. The number of participants "converting" from "detectable" (HIV RNA ≥ 20 copies/mL) at baseline to "undetectable" (HIV RNA \< 20 copies/mL) at week 12 in the AdhereTech bottle arm versus the routine counseling only arm.
Outcome measures
| Measure |
Routine Counseling + AdhereTech Bottle
n=24 Participants
Participants will receive routine medication adherence counseling and be given the AdhereTech "smart bottle" with reminders.
Adheretech "smart bottle": A "smart pill bottle" that measures the exact number of pills in the bottle in real-time, sends this HIPAA-compliant data to a central server, and based on the results, can remind participants to take their medication through a phone call or text message.
Routine adherence counseling: Participants will be provided with routine adherence counseling
|
Routine Counseling
n=26 Participants
Participants will receive routine medication adherence counseling.
Routine adherence counseling: Participants will be provided with routine adherence counseling
|
|---|---|---|
|
Number of Participants With HIV RNA ≥ 20 Copies/mL at Baseline That Had a Decrease in HIV RNA to < 20 Copies/mL at Week 12 in the AdhereTech Bottle Arm Versus the Routine Counseling Only Arm.
|
3 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Funding was not obtained to obtain TFV-DP plasma levels in the study
Assess TFV-DP plasma levels to compare to dried blood spot levels
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 12Population: 5 and 7 participants dropped out between baseline and week 12 in the AdhereTech bottle arm and routine counseling only arms respectively. One participant in the AdhereTech bottle arm did not fully complete the adherence questionnaire at week 12.
Analyze participant's self-reported adherence using National Institutes of Health AIDS Clinical Trials Group (ACTG) standardized and validated questionnaire of number of days with no missed doses of medication over prior 4 days (minimum 0, maximum 4). Number of days with missed doses was dichotomized to "no missed doses" (100% adherence) and "≥ 1 missed dose."
Outcome measures
| Measure |
Routine Counseling + AdhereTech Bottle
n=24 Participants
Participants will receive routine medication adherence counseling and be given the AdhereTech "smart bottle" with reminders.
Adheretech "smart bottle": A "smart pill bottle" that measures the exact number of pills in the bottle in real-time, sends this HIPAA-compliant data to a central server, and based on the results, can remind participants to take their medication through a phone call or text message.
Routine adherence counseling: Participants will be provided with routine adherence counseling
|
Routine Counseling
n=26 Participants
Participants will receive routine medication adherence counseling.
Routine adherence counseling: Participants will be provided with routine adherence counseling
|
|---|---|---|
|
Number of Participants Reporting 100% Adherence to Antiretroviral Medications in During to the Prior 4 Days at Week 12.
|
18 Participants
|
20 Participants
|
Adverse Events
Routine Counseling + AdhereTech Bottle
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Routine Counseling
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