Clinical Trials

MainTitle

Antiretroviral Therapy Adherence and Secondary Prevention of Human Immunodeficiency Virus

This study has been completed
Sponsor
UConn Health

Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Information provided by (Responsible Party)
Carla Rash, UConn Health

ClinicalTrials.gov Identifier
NCT01760759

First received: August 21, 2012
Last updated: September 11, 2019
Last Verified: September 2019
History of Changes
Purpose

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

Behavioral : cell phone reminders
Behavioral : contingency management for adherence

Study Type: Interventional
Study Design: 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

Further study details as provided by Carla Rash, UConn Health:

Primary Outcome Measures

  • change in copies of human immunodeficiency virus per milliliter [ Time Frame: Week 48 ]
  • self-report of medication adherence [ Time Frame: baseline ]
  • self-report of medication adherence [ Time Frame: Week 8 ]
  • self-report of medication adherence [ Time Frame: Week 16 ]
  • self-report of medication adherence [ Time Frame: Week 24 ]
  • self-report of medication adherence [ Time Frame: Week 36 ]
  • self-report of medication adherence [ Time Frame: Week 48 ]

Enrollment: 104
Study Start Date: November 2012
Study Completion Date: April 2019
Primary Completion Date: April 2019 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
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

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

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

Locations

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

Principal Investigator: Carla Rash, Ph.D. UConn Health
More Information

More Information


Responsible Party: Carla Rash, Assistant Professor, UConn Health  
ClinicalTrials.gov Identifier: NCT01760759   History of Changes  
Other Study ID Numbers: 12-205O-2  
  R01HD075630  
Study First Received: August 21, 2012  
Last Updated: September 11, 2019  

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:
Acquired Immunodeficiency Syndrome
HIV Infections

ClinicalTrials.gov processed this data on May 24, 2020
This information is provided by ClinicalTrials.gov.