HIV-1-infectionHABITNCT03772327

HIV Adherence Bottle Intervention Trial

A study testing Adheretech "smart bottle" and Routine adherence counseling in people with HIV-1-infection and Adherence, Medication, run by Weill Medical College of Cornell University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV-1-infection, Adherence, Medication
What is being tested?: Adheretech "smart bottle" and Routine adherence counseling
Type of treatment: Pill or oral medicine, Medical device, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 63 participants
Where: No sites listed yet
Study dates: May 2015to Nov 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

Plans to change the current HIV drug regimen

About this study

Official title: HIV Adherence Bottle Intervention Trial (HABIT)

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
Being tested: Adheretech "smart bottle", Routine adherence counseling
Medical subject headings: Medication Adherence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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 adherence counselingBehavioural
Participants will be provided with routine adherence counseling

Study groups in NCT03772327
Study group	Role	What they receive
Routine counseling + AdhereTech bottle	Experimental	Participants will receive routine medication adherence counseling and be given the AdhereTech "smart bottle" with reminders. Receives: Device: Adheretech "smart bottle"; Behavioral: Routine adherence counseling
Routine counseling	Active comparator	Participants will receive routine medication adherence counseling. Receives: Behavioral: Routine adherence counseling

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (5)

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.
Measured: Week 12
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.
Measured: 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.
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.
Measured: Baseline and Week 12
TFV-DP Plasma Levels
Assess TFV-DP plasma levels to compare to dried blood spot levels
Measured: Baseline and Week 12
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."
Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2015Nov 2018

First posted11 Dec 2018
Study startMay 2015
Primary completionNov 2018
Study completionNov 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HIV-1-infectionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 63 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03772327
Sponsor's protocol ID: 1308014206
Acronym: HABIT
Status last verified: Sep 2019
First submitted: 26 Nov 2018
Last updated: 2 Oct 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 33306564

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: HIV Adherence Bottle Intervention Trial (HABIT)
ClinicalTrials.gov ID: NCT03772327
Acronym / sponsor ID: HABIT / 1308014206
Conditions: HIV-1-infection, Adherence, Medication
Study type: Interventional
Recruitment status: Completed
Enrolment: 63 participants (actual)
Lead sponsor: Weill Medical College of Cornell UniversityUniversity, hospital or other
Collaborators: AdhereTech
Study start: May 2015 (actual)
Primary completion: Nov 2018 (actual)
Study completion: Nov 2018 (actual)
First posted: 11 Dec 2018 (actual)
Results: Posted 2 Oct 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Routine counseling + AdhereTech bottle	Experimental	Device: Adheretech "smart bottle", Behavioral: Routine adherence counselingParticipants will receive routine medication adherence counseling and be given the AdhereTech "smart bottle" with reminders.
Routine counseling	Active comparator	Behavioral: Routine adherence counselingParticipants will receive routine medication adherence counseling.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (1 listed)

Plans to change the current HIV drug regimen

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Device	Routine counseling + AdhereTech bottle
Routine adherence counselingParticipants will be provided with routine adherence counseling	Behavioural	Routine counseling, Routine counseling + AdhereTech bottle

Primary outcome

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

5 secondary outcomes

Number of Participants Completing the 12 Week AdhereTech Bottle Intervention Compared to the Routine Counseling Only Group.
Time frame: Week 12
Change in Quantitative HIV Viral Load
Time frame: 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.
Time frame: Baseline and Week 12
TFV-DP Plasma Levels
Time frame: Baseline and Week 12
Number of Participants Reporting 100% Adherence to Antiretroviral Medications in During to the Prior 4 Days at Week 12.
Time frame: Week 12

Results and safety

Results posted to the registry on 2 Oct 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Routine Counseling + AdhereTech Bottle	30	25
Routine Counseling	33	26

Primary outcome: Change in Tenofovir Diphosphate (TFV-DP) Drug Levels

Time frame: Baseline and Week 12. Median (Inter-Quartile Range). Unit: fmol/punch

Measure	Routine Counseling + AdhereTech Bottle n = 30	Routine Counseling n = 33
Baseline	1230 (923 to 2066)	1108 (418 to 1886)
Week 12	1887 (797 to 2794)	1084 (504 to 1175)

Routine Counseling + AdhereTech Bottle vs Routine Counseling: Mean Difference (Net): 0.333 (95% CI -0.028 to 0.694), p = 0.070, t-test, 2 sided

Population analysed: Of the 5 in AdhereTech bottle group missing baseline TFV-DP levels 2 were lost to follow up prior to the visit and 3 are missing levels. 3 participants in AdhereTech group left the study before Week 12. 4 participants in the routine counseling group are missing TFV-DP levels from baseline visit and then 7 left the study prior to Week 12.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Routine Counseling + AdhereTech Bottle	0 of 30 (0%)	0 of 30 (0%)	0 of 30
Routine Counseling	0 of 33 (0%)	0 of 33 (0%)	0 of 33

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33306564Ellsworth 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.
Individual participant dataSharing planned: No

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Not yet recruitingObservational study
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Not yet recruitingPhase 1
A Study to Evaluate the Safety and Antiviral Activity of Two Human Monoclonal Antibodies (VRC07-523LS and PGT121.414.LS) During Analytic Treatment Interruption in Participants Living With HIV Who Initiated ART During Acute/Early HIV-1 Infection
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Roy M Gulick, MD, MPH principal investigator

Weill Medical College of Cornell University

Questions about this trial

What is this clinical trial studying?

A study testing Adheretech "smart bottle" and Routine adherence counseling in people with HIV-1-infection and Adherence, Medication, run by Weill Medical College of Cornell University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Tenofovir Diphosphate (TFV-DP) Drug Levels (time frame: Baseline and Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03772327, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2019.