HIV Adherence Bottle Intervention Trial

Study Overview
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Brief Summary
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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.

Official Title
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HIV Adherence Bottle Intervention Trial (HABIT)

Conditions
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HIV-1-infection, Adherence, Medication

Intervention / Treatment
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* Device: Adheretech smart bottle
* Behavioral: Routine adherence counseling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Routine counseling + AdhereTech bottle<br>Participants will receive routine medication adherence counseling and be given the AdhereTech smart bottle with reminders. | Device: Adheretech smart bottle<br>* 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.<br>Behavioral: Routine adherence counseling<br>* Participants will be provided with routine adherence counseling<br>|
| Active Comparator: Routine counseling<br>Participants will receive routine medication adherence counseling. | Behavioral: Routine adherence counseling<br>* Participants will be provided with routine adherence counseling<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |