Antiretroviral Therapy Adherence and Secondary Prevention of Human Immunodeficiency Virus

This study is currently recruiting participants.
Verified December 2013 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: February 24, 2014
Last verified: December 2013
  Purpose

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.


Condition Intervention
HIV
Drug: antiretroviral therapy
Behavioral: cell phone reminders
Behavioral: contingency management for adherence

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Antiretroviral Therapy Adherence and Secondary Prevention of Human Immunodeficiency Virus

Resource links provided by NLM:


Further study details as provided by University of Connecticut Health Center:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 165
Study Start Date: November 2012
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Usual care
Patients receive antiretroviral therapy.
Drug: antiretroviral therapy
Patients receive antiretroviral therapy.
Experimental: Usual care plus cell phone reminders
Patients receive reminders, scheduled to occur daily at time(s) of scheduled antiretroviral therapy dosing.
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.
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.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01760759

Contacts
Contact: Ellen M Ciesielski 860.679.4556 eciesielski@uchc.edu

Locations
United States, Connecticut
University of Connecticut Health Center Recruiting
Farmington, Connecticut, United States, 06030-3944
Contact: Ellen M Ciesielski    860-679-4556    eciesielski@gmail.com   
Principal Investigator: Nancy M Petry, Ph.D.         
Nathan Smith Clinic, Yale-New Haven Hospital Recruiting
New Haven, Connecticut, United States, 06520
Contact: Ellen Ciesielski    860-679-4556    eciesielski@uchc.edu   
Principal Investigator: Merceditas Villanueva, M.D.         
Sub-Investigator: Frederick Altice, M.D.         
Sponsors and Collaborators
University of Connecticut Health Center
Investigators
Principal Investigator: Nancy M Petry, Ph.D. University of Connecticut Health Center
  More Information

No publications provided

Responsible Party: University of Connecticut Health Center
ClinicalTrials.gov Identifier: NCT01760759     History of Changes
Other Study ID Numbers: 12-205-2, R01HD075630
Study First Received: August 21, 2012
Last Updated: February 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Connecticut Health Center:
HIV
Antiretroviral therapy adherence

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on April 21, 2014