Improving Treatment Adherence in HIV-Infected Individuals

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00247611
Recruitment Status : Completed
First Posted : November 2, 2005
Results First Posted : December 20, 2013
Last Update Posted : December 20, 2013
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Jeffrey Fisher, University of Connecticut

Brief Summary:
This study will develop and evaluate the efficacy of an individualized, interactive, computer software program delivered in conjunction with clinical care in increasing and supporting antiretroviral therapy adherence in HIV-infected individuals.

Condition or disease Intervention/treatment Phase
HIV Antiretroviral Therapy (ART) Adherence Health Behavior Behavioral: LifeWindows Intervention Sessions Other: Control Phase 2

Detailed Description:

When antiretroviral therapy (ART) is taken correctly, it can dramatically improve the health and well-being of HIV-infected individuals. However, when the treatment regimen is not followed carefully, the therapy can be ineffective in managing one's HIV, and also can allow for the development of strains of HIV that may be resistant to treatment. Effective ART adherence interventions can help patients to avoid potentially serious individual and public health consequences of suboptimal adherence, but such interventions are often expensive and too intensive for clinics to support offering over time to their patients. This study will develop and evaluate the effectiveness of an individualized, interactive, computer-software intervention program delivered in clinical care in increasing ART adherence in HIV-infected individuals. Because the intervention is a software program, clinic resources required for implementation and sustaining availability over time are minimized.

Participants in this ~18-month study were recruited from one of 5 participating clinics that provide HIV care and randomly assigned to control (an assessment only version of the software) or intervention (assessment and tailored intervention software) arm. Participants completed their assigned task in concert with their regularly scheduled HIV medical care visits (but no more frequently than once a month). Primary outcomes were measured at each medical visit. The effect of the adherence intervention was evaluated through comparison of treatment and control arm adherence reports over time and VL.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 594 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Changing ART Adherence Behavior: The Lifewindows Project
Study Start Date : October 2005
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Participants will receive the control condition
Other: Control
At each clinical care visit, control arm participants use the portion of the LifeWindows software program that provides a welcome from the avatar and collection of assessment items/surveys.

Experimental: Intervention
Participants will receive the LifeWindows Intervention sessions
Behavioral: LifeWindows Intervention Sessions
At each clinical care visit, intervention arm participants use the full LifeWindows program, which includes welcome and assessment surveys and also includes the active intervention modules. ART adherence promotion intervention activities are tailored to the participant's assessment responses. Participants select which activities he or she wishes to use which culminates in an adherence specific goal.

Primary Outcome Measures :
  1. AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken [ Time Frame: Measured at each clinical care visit over 18 months of participation ]

    This measure asks participants to report the number of doses taken on each of the past 3-days, relative to number he or she was prescribed to take, and produces a % adherence score. For this study, adherence over the past 3-days was established for each medication separately then averaged over the full regimen. For main outcomes, perfect vs imperfect adherence was evaluated. Significant findings on perfect/imperfect adherence were followed with sensitivity tests to determine if lowest threshold (eg., 90%, 80%, 70% adherence) effect was maintained.

    See: Chesney MA, Ickovics JR, Chambers DB, et al. Self-reported adherence to antiretroviral medications among participants in HIV clinical trials: the AACTG adherence instruments. Patient care committee & adherence working group of the outcomes committee of the adult AIDS clinical trials group (AACTG). AIDS Care. 2000;12(3):255-266.

  2. Visual Analog Scale Measure of Adherence to ART [ Time Frame: Measured at each clinical visit over 18 months of participation ]

    This measure asks participants to rate their adherence over the past 3 to 4 weeks using a line that marks from 0 to 100% of doses taken. For this study, this item was asked for each antiretroviral in one's regimen and a total score was produced by averaging all reports. For main outcomes, perfect vs imperfect adherence was evaluated.

    See: Walsh JC, Mandalia S, Gazzard BG. Responses to a 1 month self-report on adherence to antiretroviral therapy are consistent with electronic data and virological treatment outcome. AIDS.2002;16:269-77

Secondary Outcome Measures :
  1. Viral Load Count [ Time Frame: Measured over 18 months ]
    Viral load data extracted from medical records beginning 30 days prior to baseline.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • HIV-infected
  • English-speaking
  • Currently receiving treatment at one of the participating sites
  • Currently receiving antiretroviral therapy

Exclusion Criteria:

  • Marked cognitive impairment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00247611

United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030-3212
Hartford Hospital
Hartford, Connecticut, United States, 06102
Yale-New Haven Hospital Nathan Smith Clinic
New Haven, Connecticut, United States, 06510
Hospital of Saint Raphael
New Haven, Connecticut, United States, 06511
Waterbury Hospital
Waterbury, Connecticut, United States, 06708
Sponsors and Collaborators
University of Connecticut
National Institute of Mental Health (NIMH)
Principal Investigator: Jeffrey D. Fisher, PhD University of Connecticut
Principal Investigator: K. Rivet Amico*, PhD University of Connecticut (*co-PI)
Principal Investigator: Deborah H. Cornman*, PhD University of Connecticut (*co-PI)
Principal Investigator: William A. Fisher*, PhD University of Western Ontario (*co-PI)

Additional Information:
Publications of Results:
Responsible Party: Jeffrey Fisher, Principal Investigator, University of Connecticut Identifier: NCT00247611     History of Changes
Other Study ID Numbers: R01MH066684 ( U.S. NIH Grant/Contract )
R01MH066684 ( U.S. NIH Grant/Contract )
First Posted: November 2, 2005    Key Record Dates
Results First Posted: December 20, 2013
Last Update Posted: December 20, 2013
Last Verified: November 2013

Keywords provided by Jeffrey Fisher, University of Connecticut:
Antiretroviral Medication Adherence