Improving Treatment Adherence in HIV-Infected Individuals
|ClinicalTrials.gov Identifier: NCT00247611|
Recruitment Status : Completed
First Posted : November 2, 2005
Results First Posted : December 20, 2013
Last Update Posted : December 20, 2013
|Condition or disease||Intervention/treatment||Phase|
|HIV Antiretroviral Therapy (ART) Adherence Health Behavior||Behavioral: LifeWindows Intervention Sessions Other: Control||Phase 2|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Participants will receive the control condition
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.
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.
- 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.
- 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
- Viral Load Count [ Time Frame: Measured over 18 months ]Viral load data extracted from medical records beginning 30 days prior to baseline.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00247611
|United States, Connecticut|
|University of Connecticut Health Center|
|Farmington, Connecticut, United States, 06030-3212|
|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, Connecticut, United States, 06708|
|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)|