NCT03772327

HIV Adherence Bottle Intervention Trial

HIV Adherence Bottle Intervention Trial (HABIT)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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.
BEHAVIORAL	Routine adherence counseling	Participants will be provided with routine adherence counseling

Timeline

• Start date: 2015-05-01
• Primary completion: 2018-11-01
• Completion: 2018-11-01
• First posted: 2018-12-11
• Last updated: 2019-10-02
• Results posted: 2019-10-02