HIV Adherence Bottle Intervention Trial

Not Applicable

Completed

• Conditions: Adherence, Medication; HIV-1-infection
• Interventions: Behavioral: Routine adherence counseling; Device: Adheretech "smart bottle"

• Registration Number: NCT03772327
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05
• Primary Completion: 2018-11
• Study Completion: 2018-11
• Study First Submitted: 2018-11-26
• Study First Submitted QC: 2018-12-10
• Study First Posted: 2018-12-11
• Results First Submitted: 2019-07-29
• Status Verified: 2019-09
• Results First Submitted QC: 2019-09-09
• Last Update Submitted: 2019-09-09
• Results First Posted: 2019-10-02
• Last Update Posted: 2019-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Routine counseling	Routine adherence counseling	Participants will receive routine medication adherence counseling.
Routine counseling + AdhereTech bottle	Routine adherence counseling	Participants will receive routine medication adherence counseling and be given the AdhereTech "smart bottle" with reminders.
Routine counseling + AdhereTech bottle	Adheretech "smart bottle"	Participants will receive routine medication adherence counseling and be given the AdhereTech "smart bottle" with reminders.

Primary Outcome Measures

Name	Time	Method
Change in Tenofovir Diphosphate (TFV-DP) Drug Levels	Baseline and Week 12	Using dried blood spots from red blood cells, TFV-DP levels will be assessed.

Secondary Outcome Measures

Name	Time	Method
TFV-DP Plasma Levels	Baseline and Week 12	Assess TFV-DP plasma levels to compare to dried blood spot levels
Number of Participants Completing the 12 Week AdhereTech Bottle Intervention Compared to the Routine Counseling Only Group.	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.
Change in Quantitative HIV Viral Load	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.
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.	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.
Number of Participants Reporting 100% Adherence to Antiretroviral Medications in During to the Prior 4 Days at Week 12.	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."