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HIV Adherence Bottle Intervention Trial (HABIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03772327
Recruitment Status : Completed
First Posted : December 11, 2018
Results First Posted : October 2, 2019
Last Update Posted : October 2, 2019
Sponsor:
Collaborator:
AdhereTech
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
HIV-1-infection Adherence, Medication Device: Adheretech "smart bottle" Behavioral: Routine adherence counseling Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: HIV Adherence Bottle Intervention Trial (HABIT)
Actual Study Start Date : May 2015
Actual Primary Completion Date : November 2018
Actual Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Routine counseling + AdhereTech bottle
Participants will receive routine medication adherence counseling and be given the AdhereTech "smart bottle" with reminders.
Device: 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.

Behavioral: Routine adherence counseling
Participants will be provided with routine adherence counseling

Active Comparator: Routine counseling
Participants will receive routine medication adherence counseling.
Behavioral: Routine adherence counseling
Participants will be provided with routine adherence counseling




Primary Outcome Measures :
  1. Change in Tenofovir Diphosphate (TFV-DP) Drug Levels [ Time Frame: Baseline and Week 12 ]
    Using dried blood spots from red blood cells, TFV-DP levels will be assessed.


Secondary Outcome Measures :
  1. Number of Participants Completing the 12 Week AdhereTech Bottle Intervention Compared to the Routine Counseling Only Group. [ Time Frame: Week 12 ]
    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.

  2. Change in Quantitative HIV Viral Load [ Time Frame: Baseline and Week 12 ]
    Comparative changes in quantitative HIV viral load between baseline and Week 12 in the AdhereTech bottle arm versus the routine counseling only arm.

  3. 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. [ Time Frame: Baseline and Week 12 ]
    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.

  4. TFV-DP Plasma Levels [ Time Frame: Baseline and Week 12 ]
    Assess TFV-DP plasma levels to compare to dried blood spot levels

  5. Number of Participants Reporting 100% Adherence to Antiretroviral Medications in During to the Prior 4 Days at Week 12. [ Time Frame: 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."



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV-infected
  • Taking a tenofovir-containing antiretroviral regimen for HIV treatment
  • Documented suboptimal adherence (2 HIV RNA levels documented above the level of detection, i.e. not suppressed, on 2 occasions over the prior 52 weeks

Exclusion Criteria:

  • Plans to change the current HIV drug regimen

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03772327


Sponsors and Collaborators
Weill Medical College of Cornell University
AdhereTech
Investigators
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Principal Investigator: Roy M Gulick, MD, MPH Weill Cornell Medicine
  Study Documents (Full-Text)

Documents provided by Weill Medical College of Cornell University:
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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT03772327    
Other Study ID Numbers: 1308014206
First Posted: December 11, 2018    Key Record Dates
Results First Posted: October 2, 2019
Last Update Posted: October 2, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No