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Completed

NCT Number: NCT03772327

HIV Adherence Bottle Intervention Trial

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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Key information

Conditions

HIV-1-infection Adherence, Medication Behavior Health Behavior Medication Adherence Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Routine adherence counseling

Behavioral

Participants will be provided with routine adherence counseling

Primary outcomes

  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 outcomes

  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."

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • AdhereTech

Registry information

Official study title

HIV Adherence Bottle Intervention Trial (HABIT)

Acronym: HABIT

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Dec 11, 2018
Registry last updated
Oct 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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