HIV Adherence Bottle Intervention Trial

NCT ID: NCT03772327

Last Updated: 2019-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2018-11-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Routine counseling + AdhereTech bottle

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

Group Type: EXPERIMENTAL

Adheretech "smart bottle"

Intervention Type: 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

Intervention Type: BEHAVIORAL

Participants will be provided with routine adherence counseling

Routine counseling

Participants will receive routine medication adherence counseling.

Group Type: ACTIVE_COMPARATOR

Routine adherence counseling

Intervention Type: BEHAVIORAL

Participants will be provided with routine adherence counseling

Interventions

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.

Intervention Type: DEVICE

Routine adherence counseling

Participants will be provided with routine adherence counseling

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AdhereTech

UNKNOWN

Sponsor Role: collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roy M Gulick, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

References

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.

Reference Type: DERIVED

PMID: 33306564 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1308014206

Identifier Type: -

Identifier Source: org_study_id