Antiretroviral Therapy Adherence and Secondary Prevention of Human Immunodeficiency Virus
Primary Purpose
HIV
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
cell phone reminders
contingency management for adherence
Sponsored by
About this trial
This is an interventional treatment trial for HIV focused on measuring HIV, Antiretroviral therapy adherence
Eligibility 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
Sites / Locations
- University of Connecticut Health Center
- Nathan Smith Clinic, Yale-New Haven Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
Usual care
Usual care plus cell phone reminders
Usual care, reminders & contingency management for adherence
Arm Description
Patients receive usual care from their medical providers.
Patients receive reminders, scheduled to occur daily at time(s) of scheduled antiretroviral therapy dosing.
Patients receive reminders and reinforcement in the form of vouchers for each video that they send in indicating adherence at the appropriate time.
Outcomes
Primary Outcome Measures
change in copies of human immunodeficiency virus per milliliter
self-report of medication adherence
self-report of medication adherence
self-report of medication adherence
self-report of medication adherence
self-report of medication adherence
self-report of medication adherence
Secondary Outcome Measures
Full Information
NCT ID
NCT01760759
First Posted
August 21, 2012
Last Updated
September 11, 2019
Sponsor
UConn Health
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT01760759
Brief Title
Antiretroviral Therapy Adherence and Secondary Prevention of Human Immunodeficiency Virus
Official Title
Antiretroviral Therapy Adherence and Secondary Prevention of Human Immunodeficiency Virus
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
November 2012 (Actual)
Primary Completion Date
April 2019 (Actual)
Study Completion Date
April 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UConn Health
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV
Keywords
HIV, Antiretroviral therapy adherence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
104 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Patients receive usual care from their medical providers.
Arm Title
Usual care plus cell phone reminders
Arm Type
Experimental
Arm Description
Patients receive reminders, scheduled to occur daily at time(s) of scheduled antiretroviral therapy dosing.
Arm Title
Usual care, reminders & contingency management for adherence
Arm Type
Experimental
Arm Description
Patients receive reminders and reinforcement in the form of vouchers for each video that they send in indicating adherence at the appropriate time.
Intervention Type
Behavioral
Intervention Name(s)
cell phone reminders
Intervention Description
Patients receive reminders, scheduled to occur daily at time(s) of scheduled antiretroviral therapy dosing.
Intervention Type
Behavioral
Intervention Name(s)
contingency management for adherence
Intervention Description
Patients will receive reinforcement in the form of vouchers for each video that they send in indicating adherence at the appropriate time.
Primary Outcome Measure Information:
Title
change in copies of human immunodeficiency virus per milliliter
Time Frame
Week 48
Title
self-report of medication adherence
Time Frame
baseline
Title
self-report of medication adherence
Time Frame
Week 8
Title
self-report of medication adherence
Time Frame
Week 16
Title
self-report of medication adherence
Time Frame
Week 24
Title
self-report of medication adherence
Time Frame
Week 36
Title
self-report of medication adherence
Time Frame
Week 48
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carla Rash, Ph.D.
Organizational Affiliation
UConn Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Connecticut Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030-3944
Country
United States
Facility Name
Nathan Smith Clinic, Yale-New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Antiretroviral Therapy Adherence and Secondary Prevention of Human Immunodeficiency Virus
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