Improving Treatment Adherence in HIV-Infected Individuals

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jeffrey Fisher, University of Connecticut
ClinicalTrials.gov Identifier:
NCT00247611
First received: October 31, 2005
Last updated: November 26, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
HIV Antiretroviral Therapy (ART) Adherence
Health Behavior
Behavioral: LifeWindows Intervention Sessions
Other: Control
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Changing ART Adherence Behavior: The Lifewindows Project

Resource links provided by NLM:


Further study details as provided by University of Connecticut:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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.


  • Visual Analog Scale Measure of Adherence to ART [ Time Frame: Measured at each clinical visit over 18 months of participation ] [ Designated as safety issue: No ]

    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:
  • Viral Load Count [ Time Frame: Measured over 18 months ] [ Designated as safety issue: No ]
    Viral load data extracted from medical records beginning 30 days prior to baseline.


Enrollment: 594
Study Start Date: October 2005
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Control
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.

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.

  Eligibility

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

Inclusion Criteria:

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

Exclusion Criteria:

  • Marked cognitive impairment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00247611

Locations
United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030-3212
Hartford Hospital
Hartford, Connecticut, United States, 06102
Hospital of Saint Raphael
New Haven, Connecticut, United States, 06511
Yale-New Haven Hospital Nathan Smith Clinic
New Haven, Connecticut, United States, 06510
Waterbury Hospital
Waterbury, Connecticut, United States, 06708
Sponsors and Collaborators
University of Connecticut
Investigators
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)
  More Information

Additional Information:
Publications:
Responsible Party: Jeffrey Fisher, Principal Investigator, University of Connecticut
ClinicalTrials.gov Identifier: NCT00247611     History of Changes
Other Study ID Numbers: R01 MH66684, R01MH066684, DAHBR 9A-ASPG
Study First Received: October 31, 2005
Results First Received: August 1, 2013
Last Updated: November 26, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Connecticut:
HIV
AIDS
Antiretroviral Medication Adherence

ClinicalTrials.gov processed this record on April 20, 2014