Clinical trial NCT01760759: Antiretroviral Therapy Adherence and Secondary Prevention of Human Immunodeficiency Virus
Official title: Antiretroviral Therapy Adherence and Secondary Prevention of Human Immunodeficiency Virus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: HIV
Antiretroviral therapy adherence
Lead sponsor: UConn Health
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2013-01-04
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: change in copies of human immunodeficiency virus per milliliter
timeFrame: Week 48
measure: self-report of medication adherence
timeFrame: baseline
measure: self-report of medication adherence
timeFrame: Week 8
measure: self-report of medication adherence
timeFrame: Week 16
measure: self-report of medication adherence
timeFrame: Week 24
measure: self-report of medication adherence
timeFrame: Week 36
measure: self-report of medication adherence
timeFrame: Week 48
Secondary outcomes:
Other outcomes:
Locations:
city: Farmington
country: United States
facility: University of Connecticut Health Center
state: Connecticut
city: New Haven
country: United States
facility: Nathan Smith Clinic, Yale-New Haven Hospital
state: Connecticut
Study officials:
affiliation: UConn Health
name: Carla Rash, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: