HIV Adherence Bottle Intervention Trial (HABIT)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- HIV-1-infection
- Sponsor
- Weill Medical College of Cornell University
- Enrollment
- 63
- Primary Endpoint
- Change in Tenofovir Diphosphate (TFV-DP) Drug Levels
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- TFV-DP Plasma Levels(Baseline and Week 12)
- Number of Participants Completing the 12 Week AdhereTech Bottle Intervention Compared to the Routine Counseling Only Group.(Week 12)
- Change in Quantitative HIV Viral Load(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.(Baseline and Week 12)
- Number of Participants Reporting 100% Adherence to Antiretroviral Medications in During to the Prior 4 Days at Week 12.(Week 12)