HIV Adherence Bottle Intervention Trial (HABIT)
Status
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
63 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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