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Antiretroviral Therapy Adherence and Secondary Prevention of Human Immunodeficiency Virus

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ClinicalTrials.gov Identifier: NCT01760759
Recruitment Status : Completed
First Posted : January 4, 2013
Last Update Posted : September 13, 2019
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Carla Rash, UConn Health

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 Behavioral: cell phone reminders Behavioral: contingency management for adherence Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 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
Actual Primary Completion Date : April 2019
Actual Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
No Intervention: Usual care
Patients receive usual care from their medical providers.
Experimental: Usual care plus cell phone reminders
Patients receive reminders, scheduled to occur daily at time(s) of scheduled antiretroviral therapy dosing.
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.
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.




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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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


Locations
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United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030-3944
Nathan Smith Clinic, Yale-New Haven Hospital
New Haven, Connecticut, United States, 06520
Sponsors and Collaborators
UConn Health
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Carla Rash, Ph.D. UConn Health

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Responsible Party: Carla Rash, Assistant 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: September 13, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Carla Rash, UConn Health:
HIV
Antiretroviral therapy adherence
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents