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| Name | Class |
|---|---|
| AdhereTech | UNKNOWN |
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This is a randomized study for participants treated with tenofovir-based antiretroviral drug regimens with a history of suboptimal adherence (detectable HIV RNA twice over the last year). Eligible participants are enrolled, receive routine adherence counseling and are randomized to receive an AdhereTech "smart pill bottle" or not (open label). The "smart pill bottle" quantitates the number of tenofovir-containing pills taken and sends this to a centralized server; if a dose is missed, the participant is contacted by either phone or text. Participants are assessed at baseline and weeks 4, 8, and 12 for tenofovir diphosphate (TFV-DP) levels (by plasma and dried red blood cell spots), HIV RNA level, and adherence using a standardized questionnaire. Primary outcome is change in TFV-DP levels from baseline in the 2 groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Routine counseling + AdhereTech bottle | Experimental | Participants will receive routine medication adherence counseling and be given the AdhereTech "smart bottle" with reminders. |
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| Routine counseling | Active Comparator | Participants will receive routine medication adherence counseling. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adheretech "smart bottle" | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Tenofovir Diphosphate (TFV-DP) Drug Levels | Using dried blood spots from red blood cells, TFV-DP levels will be assessed. | Baseline and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Completing the 12 Week AdhereTech Bottle Intervention Compared to the Routine Counseling Only Group. | Feasibility 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roy M Gulick, MD, MPH | Weill Medical College of Cornell University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33306564 | Derived | Ellsworth GB, Burke LA, Wells MT, Mishra S, Caffrey M, Liddle D, Madhava M, O'Neal C, Anderson PL, Bushman L, Ellison L, Stein J, Gulick RM. Randomized Pilot Study of an Advanced Smart-Pill Bottle as an Adherence Intervention in Patients With HIV on Antiretroviral Treatment. J Acquir Immune Defic Syndr. 2021 Jan 1;86(1):73-80. doi: 10.1097/QAI.0000000000002519. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Routine Counseling | Participants will receive routine medication adherence counseling. Routine adherence counseling: Participants will be provided with routine adherence counseling |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Change in Tenofovir Diphosphate (TFV-DP) Drug Levels | Using dried blood spots from red blood cells, TFV-DP levels will be assessed. | 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. | Posted | Median | Inter-Quartile Range | fmol/punch | Baseline and Week 12 |
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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Unmet recruitment goals. Unexpectedly high TFV-DP dried blood spot levels in 3 participants due to unexpected drug-drug interactions. 2 participants were switched from tenofovir disproxil fumarate to tenofovir alefenamide during study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Grant Ellsworth | Weill Cornell Medicine | 212-746-7204 | gre9006@med.cornell.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 30, 2016 | Jun 26, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
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| Routine adherence counseling | Behavioral | Participants will be provided with routine adherence counseling |
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| Week 12 |
| Change in Quantitative 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. | Baseline and Week 12 |
| 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. | 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. | Baseline and Week 12 |
| TFV-DP Plasma Levels | Assess TFV-DP plasma levels to compare to dried blood spot levels | Baseline and Week 12 |
| Number of Participants Reporting 100% Adherence to Antiretroviral Medications in During to the Prior 4 Days 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." | Week 12 |
| BG001 | Routine Counseling | Participants will receive routine medication adherence counseling. Routine adherence counseling: Participants will be provided with routine adherence counseling |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| HIV RNA <= 20 copies/mL | Count of Participants | Participants |
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| CD4 | Median | Inter-Quartile Range | cells/μL |
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| Number of daily antiretroviral pills | 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. | Median | Inter-Quartile Range | pills per day |
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| Number of participants reporting days of no missed doses in prior 4 days | In the four days prior to baseline visit the number of days on which participants reported missing no doses of antiretroviral medication | 2 participants in the Routine counseling + AdhereTech bottle group were lost to follow up before the adherence could be collected at the baseline visit. | Count of Participants | Participants |
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| Number of participants prescribed a tenofovir containing regimen | 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. | Count of Participants | Participants |
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| Number of participants prescribed a NRTI containing regimen | 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. | Count of Participants | Participants |
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| Number of participants prescribed a NNRTI containing regimen | 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. | Count of Participants | Participants |
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| Number of participants prescribed a Protease inhibitor containing regimen | 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. | Count of Participants | Participants |
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| Number of participants prescribed an Integrase inhibitor containing regimen | 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. | Count of Participants | Participants |
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| OG001 | Routine Counseling | Participants will receive routine medication adherence counseling. Routine adherence counseling: Participants will be provided with routine adherence counseling |
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| Secondary | Number of Participants Completing the 12 Week AdhereTech Bottle Intervention Compared to the Routine Counseling Only Group. | Feasibility 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. | Posted | Count of Participants | Participants | Week 12 |
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| Secondary | Change in Quantitative 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. | 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. | Posted | Median | Inter-Quartile Range | copies/mL | Baseline and Week 12 |
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| Secondary | 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. | 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. | 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. | Posted | Count of Participants | Participants | Baseline and Week 12 |
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| Secondary | TFV-DP Plasma Levels | Assess TFV-DP plasma levels to compare to dried blood spot levels | Funding was not obtained to obtain TFV-DP plasma levels in the study | Posted | Baseline and Week 12 |
|
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| Secondary | Number of Participants Reporting 100% Adherence to Antiretroviral Medications in During to the Prior 4 Days 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." | 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. | Posted | Count of Participants | Participants | Week 12 |
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| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Routine Counseling | Participants will receive routine medication adherence counseling. Routine adherence counseling: Participants will be provided with routine adherence counseling | 0 | 33 | 0 | 33 | 0 | 33 |
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| D001519 | Behavior |
| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| 2 days |
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| 1 day |
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| No days |
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| Week 12 |
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