Antiretroviral Therapy Adherence and Secondary Prevention of Human Immunodeficiency Virus

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.

Study Overview

• Status: Completed
• Conditions: HIV
• Intervention / Treatment: Behavioral: cell phone reminders; Behavioral: contingency management for adherence

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Farmington, Connecticut, United States, 06030-3944
      • University of Connecticut Health Center
    • New Haven, Connecticut, United States, 06520
      • Nathan Smith Clinic, Yale-New Haven Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
change in copies of human immunodeficiency virus per milliliter	Week 48
self-report of medication adherence	baseline
self-report of medication adherence	Week 8
self-report of medication adherence	Week 16
self-report of medication adherence	Week 24
self-report of medication adherence	Week 36
self-report of medication adherence	Week 48

Collaborators and Investigators

• Sponsor: UConn Health
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Carla Rash, Ph.D., UConn Health

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2012
• Primary Completion (Actual): April 1, 2019
• Study Completion (Actual): April 1, 2019

Study Registration Dates

• First Submitted: August 21, 2012
• First Submitted That Met QC Criteria: January 2, 2013
• First Posted (Estimate): January 4, 2013

Study Record Updates

• Last Update Posted (Actual): September 13, 2019
• Last Update Submitted That Met QC Criteria: September 11, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: HIV; Antiretroviral therapy adherence
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: 12-205O-2; R01HD075630 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No