Antiretroviral Therapy Adherence and Secondary Prevention of Human Immunodeficiency Virus

• ClinicalTrials.gov Identifier: NCT01760759
• Recruitment Status: Completed
• First Posted: January 4, 2013
• Last Update Posted: September 13, 2019
• 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

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.

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

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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

• 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

Contacts and Locations

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

• Responsible Party: Carla Rash, Assistant Professor, UConn Health
• ClinicalTrials.gov Identifier: NCT01760759
• Other Study ID Numbers: 12-205O-2; R01HD075630 ( U.S. NIH Grant/Contract )
• First Posted: January 4, 2013
• Last Update Posted: September 13, 2019
• Last Verified: September 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; 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