HIV Adherence Bottle Intervention Trial

HIV-1-infection Clinical Trial

— HABIT  

Official title:

HIV Adherence Bottle Intervention Trial (HABIT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03772327
• Other study ID #: 1308014206
• Status: Completed
• Phase: N/A
• Start date: May 2015
• Est. completion date: November 2018

Study information

• Verified date: September 2019
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: November 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adherence, Medication
• HIV-1-infection

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	AdhereTech

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	TFV-DP Plasma Levels	Assess TFV-DP plasma levels to compare to dried blood spot levels	Baseline and Week 12
Secondary	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