HIV Adherence Bottle Intervention Trial

NCT03772327 | Completed Results

• 1 other identifier: 1308014206
• Study Type: interventional
• Target: 63
• Locations: 0 countries
• Sites: N/A

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.

Conditions

HIV-1-infection; Adherence, Medication

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Number of Participants Completing the 12 Week AdhereTech Bottle Intervention Compared to the Routine Counseling Only Group.

  Week 12

• Change in Quantitative HIV Viral Load

  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.

  Baseline and Week 12

• TFV-DP Plasma Levels

  Baseline and Week 12

• Number of Participants Reporting 100% Adherence to Antiretroviral Medications in During to the Prior 4 Days at Week 12.

  Week 12

Study Arms (2)

Routine counseling + AdhereTech bottle

EXPERIMENTAL

Participants will receive routine medication adherence counseling and be given the AdhereTech "smart bottle" with reminders.

Device: Adheretech "smart bottle"; Behavioral: Routine adherence counseling

Routine counseling

ACTIVE COMPARATOR

Participants will receive routine medication adherence counseling.

Behavioral: Routine adherence counseling

Interventions

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 counseling + AdhereTech bottle

Routine adherence counseling BEHAVIORAL

Participants will be provided with routine adherence counseling

Routine counseling; Routine counseling + AdhereTech bottle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Plans to change the current HIV drug regimen

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• AdhereTech: collaborator

Related Publications (1)

• 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.

  PMID: 33306564 DERIVED

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Grant Ellsworth
• Organization: Weill Cornell Medicine

gre9006@med.cornell.edu

212-746-7204

Study Officials

• Roy M Gulick, MD, MPH

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2018
• First Posted: December 11, 2018
• Study Start: May 1, 2015
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: October 2, 2019
• Results First Posted: October 2, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share