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Clinical Trials/NCT01760759
NCT01760759
Completed
Not Applicable

Antiretroviral Therapy Adherence and Secondary Prevention of Human Immunodeficiency Virus

UConn Health2 sites in 1 country104 target enrollmentNovember 2012
ConditionsHIV

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV
Sponsor
UConn Health
Enrollment
104
Locations
2
Primary Endpoint
self-report of medication adherence
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2012
End Date
April 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
UConn Health
Responsible Party
Principal Investigator
Principal Investigator

Carla Rash

Assistant Professor

UConn Health

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

Outcomes

Primary Outcomes

self-report of medication adherence

Time Frame: Week 48

change in copies of human immunodeficiency virus per milliliter

Time Frame: Week 48

Study Sites (2)

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