HIV
Conditions
Keywords
HIV, Antiretroviral therapy adherence
Brief summary
In this study, investigators propose to randomize 165 human immunodeficiency virus positive patients to one of three 16-week treatment conditions: (1) standard care; (2) standard care + cell phone-based adherence reminders; or (3) standard care + cell phone-based adherence reminders and contingency management. In this latter condition, patients will earn reinforcement for sending in time- and date-stamped self videos of antiretroviral therapy medication ingestion. Primary outcomes will include viral loads and self-report measures of adherence, and effects will be evaluated both during the treatment period and throughout a one-year follow-up. Investigators hypothesize that the cell phone reminder condition will improve adherence relative to standard care, and the cell phone reminder plus contingency management condition will have the best outcomes. Results from this study may have widespread implications for the use of cell phones as a novel technology to improve initial adherence to antiretroviral therapy, thereby reducing the spread of drug resistant human immunodeficiency virus strains to the community.
Interventions
BEHAVIORALcell phone reminders
Patients receive reminders, scheduled to occur daily at time(s) of scheduled antiretroviral therapy dosing.
BEHAVIORALcontingency management for adherence
Patients will receive reinforcement in the form of vouchers for each video that they send in indicating adherence at the appropriate time.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
UConn Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age \> 18 years * initiating or on an antiretroviral therapy regimen and have a viral load \>200 copies/mL in the past 6 months * one or more risk factors for poor adherence * English speaking * willing to use a cell phone to receive reminders and record medication ingestion for up to 16 weeks * able to read at 5th grade level and pass a brief quiz related to understanding the informed consent form
Exclusion criteria
* living in an environment or has a visiting nurse that dispenses antiretroviral therapy medication * participating in another antiretroviral therapy adherence study * uncontrolled psychiatric disorders * significant cognitive impairment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change in copies of human immunodeficiency virus per milliliter | Week 48 |
| self-report of medication adherence | baseline |
Countries
United States
Outcome results
None listed