N/A
N=63
HIV Adherence Bottle Intervention Trial
HIV-1-infection · Adherence, Medication
Bottom Line
View on ClinicalTrials.gov: NCT03772327 ↗Enrolled (actual)
63
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Change in Tenofovir Diphosphate (TFV-DP) Drug Levels — 1230; 1108; 1887; 1084 fmol/punch — p=0.070
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Adheretech "smart bottle" (Device); Routine adherence counseling (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Weill Medical College of Cornell University
- Primary completion
- Nov 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Tenofovir Diphosphate (TFV-DP) Drug Levels |
1230; 1108; 1887; 1084 | 0.070 |
| SECONDARY Number of Participants Completing the 12 Week AdhereTech Bottle Intervention Compared to the Routine Counseling Only Group. |
25; 26 | 0.89 |
| SECONDARY Change in Quantitative HIV Viral Load |
19; 28; 19; 26 | 0.328 |
| 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. |
3; 7 | 0.294 |
| SECONDARY TFV-DP Plasma Levels |
— | — |
| SECONDARY Number of Participants Reporting 100% Adherence to Antiretroviral Medications in During to the Prior 4 Days at Week 12. |
18; 20 | 1 |
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.
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
Data sourced from ClinicalTrials.gov (NCT03772327). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.