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Antiretroviral Therapy Adherence and Secondary Prevention of Human Immunodeficiency Virus

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ClinicalTrials.gov Identifier: NCT01760759
Recruitment Status : Recruiting
First Posted : January 4, 2013
Last Update Posted : January 12, 2018
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Nancy Petry, UConn Health

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
HIV Drug: antiretroviral therapy Behavioral: cell phone reminders Behavioral: contingency management for adherence Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 165 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Antiretroviral Therapy Adherence and Secondary Prevention of Human Immunodeficiency Virus
Actual Study Start Date : November 2012
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. change in copies of human immunodeficiency virus per milliliter [ Time Frame: Week 48 ]
  2. self-report of medication adherence [ Time Frame: baseline ]
  3. self-report of medication adherence [ Time Frame: Week 8 ]
  4. self-report of medication adherence [ Time Frame: Week 16 ]
  5. self-report of medication adherence [ Time Frame: Week 24 ]
  6. self-report of medication adherence [ Time Frame: Week 36 ]
  7. self-report of medication adherence [ Time Frame: Week 48 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01760759


Contacts
Contact: Ruth Fetter 860.679.4556 fetter@uchc.edu

Locations
United States, Connecticut
University of Connecticut Health Center Recruiting
Farmington, Connecticut, United States, 06030-3944
Contact: Ruth Fetter    860-679-4556    fetter@uchc.edu   
Principal Investigator: Nancy M Petry, Ph.D.         
Nathan Smith Clinic, Yale-New Haven Hospital Recruiting
New Haven, Connecticut, United States, 06520
Contact: Ruth Fetter    860-679-4556    fetter@uchc.edu   
Principal Investigator: Merceditas Villanueva, M.D.         
Sub-Investigator: Frederick Altice, M.D.         
Sponsors and Collaborators
UConn Health
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Nancy M Petry, Ph.D. UConn Health
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Nancy Petry, Professor, UConn Health
ClinicalTrials.gov Identifier: NCT01760759     History of Changes
Other Study ID Numbers: 12-205O-2
R01HD075630 ( U.S. NIH Grant/Contract )
First Posted: January 4, 2013    Key Record Dates
Last Update Posted: January 12, 2018
Last Verified: January 2018

Keywords provided by Nancy Petry, UConn Health:
HIV
Antiretroviral therapy adherence

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