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

October 31, 2005
November 26, 2013
October 2005
March 2008   (final data collection date for primary outcome measure)
  • 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

  • Adherence to ART; measured at each study visit
  • CD4 and viral load count; measured at each study visit
Complete list of historical versions of study NCT00247611 on ClinicalTrials.gov Archive Site
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.
Not Provided
Not Provided
Not Provided
 
Improving Treatment Adherence in HIV-Infected Individuals
Changing ART Adherence Behavior: The Lifewindows Project

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV Antiretroviral Therapy (ART) Adherence
  • Health Behavior
  • 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.
  • 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.
  • Control
    Participants will receive the control condition
    Intervention: Other: Control
  • Experimental: Intervention
    Participants will receive the LifeWindows Intervention sessions
    Intervention: Behavioral: LifeWindows Intervention Sessions
Fisher JD, Amico KR, Fisher WA, Cornman DH, Shuper PA, Trayling C, Redding C, Barta W, Lemieux AF, Altice FL, Dieckhaus K, Friedland G; LifeWindows Team. Computer-based intervention in HIV clinical care setting improves antiretroviral adherence: the LifeWindows Project. AIDS Behav. 2011 Nov;15(8):1635-46. doi: 10.1007/s10461-011-9926-x.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
594
March 2008
March 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Marked cognitive impairment
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00247611
R01 MH66684, R01MH066684, DAHBR 9A-ASPG
Yes
Jeffrey Fisher, University of Connecticut
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)
University of Connecticut
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP