Antiretroviral Therapy Adherence and Secondary Prevention of Human Immunodeficiency Virus

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Connecticut Health Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Connecticut Health Center
ClinicalTrials.gov Identifier:
NCT01760759
First received: August 21, 2012
Last updated: April 22, 2014
Last verified: March 2014

August 21, 2012
April 22, 2014
November 2012
May 2017   (final data collection date for primary outcome measure)
  • change in copies of human immunodeficiency virus per milliliter [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  • self-report of medication adherence [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • self-report of medication adherence [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • self-report of medication adherence [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
  • self-report of medication adherence [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • self-report of medication adherence [ Time Frame: Week 36 ] [ Designated as safety issue: No ]
  • self-report of medication adherence [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01760759 on ClinicalTrials.gov Archive Site
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Antiretroviral Therapy Adherence and Secondary Prevention of Human Immunodeficiency Virus
Antiretroviral Therapy Adherence and Secondary Prevention of Human Immunodeficiency Virus

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.

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Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV
  • Drug: antiretroviral therapy
    Patients receive antiretroviral therapy.
  • Behavioral: cell phone reminders
    Patients receive reminders, scheduled to occur daily at time(s) of scheduled antiretroviral therapy dosing.
  • Behavioral: contingency 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.
  • Active Comparator: Usual care
    Patients receive antiretroviral therapy.
    Intervention: Drug: antiretroviral therapy
  • Experimental: Usual care plus cell phone reminders
    Patients receive reminders, scheduled to occur daily at time(s) of scheduled antiretroviral therapy dosing.
    Interventions:
    • Drug: antiretroviral therapy
    • Behavioral: cell phone reminders
  • Experimental: Usual care, reminders & contingency management for adherence
    Patients receive reminders and reinforcement in the form of vouchers for each video that they send in indicating adherence at the appropriate time.
    Interventions:
    • Drug: antiretroviral therapy
    • Behavioral: cell phone reminders
    • Behavioral: contingency management for adherence
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
165
May 2017
May 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • age > 18 years
  • initiating a new antiretroviral therapy regimen but not previously received > 2 antiretroviral therapy regimens and have a viral load >1000 copies/milliliter
  • 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
  • received 2 or more prior antiretroviral therapy regimens
  • participating in another antiretroviral therapy adherence study
  • uncontrolled psychiatric disorders
  • significant cognitive impairment
Both
18 Years and older
No
Contact: Ellen M Ciesielski 860.679.4556 eciesielski@uchc.edu
United States
 
NCT01760759
12-205-2, R01HD075630
Yes
University of Connecticut Health Center
University of Connecticut Health Center
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Nancy M Petry, Ph.D. University of Connecticut Health Center
University of Connecticut Health Center
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP