Antiretroviral Therapy Adherence and Secondary Prevention of Human Immunodeficiency Virus

This study is currently recruiting participants. (see Contacts and Locations)

Verified November 2014 by University of Connecticut Health Center

Sponsor:

Collaborator:

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

Information provided by (Responsible Party):

University of Connecticut Health Center

ClinicalTrials.gov Identifier:

NCT01760759

First received: August 21, 2012

Last updated: November 6, 2014

Last verified: November 2014

History of Changes

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	Drug: antiretroviral therapy Behavioral: cell phone reminders Behavioral: contingency management for adherence


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Antiretroviral Therapy Adherence and Secondary Prevention of Human Immunodeficiency Virus

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by University of Connecticut Health Center:

Primary Outcome Measures:

change in copies of human immunodeficiency virus per milliliter [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
self-report of medication adherence [ Time Frame: baseline ] [ Designated as safety issue: No ]
self-report of medication adherence [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
self-report of medication adherence [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
self-report of medication adherence [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
self-report of medication adherence [ Time Frame: Week 36 ] [ Designated as safety issue: No ]
self-report of medication adherence [ Time Frame: Week 48 ] [ Designated as safety issue: No ]


Estimated Enrollment:	165
Study Start Date:	November 2012
Estimated Study Completion Date:	May 2017
Estimated Primary Completion Date:	May 2017 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Usual care Patients receive antiretroviral therapy.	Drug: antiretroviral therapy Patients receive antiretroviral therapy.
Experimental: Usual care plus cell phone reminders Patients receive reminders, scheduled to occur daily at time(s) of scheduled antiretroviral therapy dosing.	Drug: antiretroviral therapy Patients receive antiretroviral therapy. 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.	Drug: antiretroviral therapy Patients receive antiretroviral therapy. 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


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

age > 18 years
initiating a new antiretroviral therapy regimen but not previously received > 2 antiretroviral therapy regimens and have a viral load >1000 copies/milliliter
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
received 2 or more prior antiretroviral therapy regimens
participating in another antiretroviral therapy adherence study
uncontrolled psychiatric disorders
significant cognitive impairment

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

Contacts


Contact: Ellen M Ciesielski	860.679.4556	eciesielski@uchc.edu

Locations


United States, Connecticut
University of Connecticut Health Center	Recruiting
Farmington, Connecticut, United States, 06030-3944
Contact: Ellen M Ciesielski 860-679-4556 eciesielski@uchc.com
Principal Investigator: Nancy M Petry, Ph.D.
Nathan Smith Clinic, Yale-New Haven Hospital	Recruiting
New Haven, Connecticut, United States, 06520
Contact: Ellen Ciesielski 860-679-4556 eciesielski@uchc.edu
Principal Investigator: Merceditas Villanueva, M.D.
Sub-Investigator: Frederick Altice, M.D.

Sponsors and Collaborators

University of Connecticut Health Center

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

Investigators


Principal Investigator:	Nancy M Petry, Ph.D.	University of Connecticut Health Center

More Information

No publications provided


Responsible Party:	University of Connecticut Health Center
ClinicalTrials.gov Identifier:	NCT01760759 History of Changes
Other Study ID Numbers:	12-205-2, R01HD075630
Study First Received:	August 21, 2012
Last Updated:	November 6, 2014
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Connecticut Health Center:


HIV Antiretroviral therapy adherence

Additional relevant MeSH terms:


Acquired Immunodeficiency Syndrome HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Lentivirus Infections RNA Virus Infections	Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Virus Diseases

ClinicalTrials.gov processed this record on March 03, 2015

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