Improving Treatment Adherence in HIV-Infected Individuals

Health Behavior Clinical Trial

Official title:

Changing ART Adherence Behavior: The Lifewindows Project

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00247611
• Other study ID #: R01MH066684
• Secondary ID: R01MH066684DAHBR
• Status: Completed
• Phase: Phase 2
• First received: October 31, 2005
• Last updated: November 26, 2013
• Start date: October 2005
• Est. completion date: March 2008

Study information

• Verified date: November 2013
• Source: University of Connecticut
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 594
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• HIV-infected

• English-speaking

• Currently receiving treatment at one of the participating sites

• Currently receiving antiretroviral therapy

Exclusion Criteria:

• Marked cognitive impairment

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Health Behavior
• HIV Antiretroviral Therapy (ART) Adherence

Intervention

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.

Locations

Country	Name	City	State
United States	University of Connecticut Health Center	Farmington	Connecticut
United States	Hartford Hospital	Hartford	Connecticut
United States	Hospital of Saint Raphael	New Haven	Connecticut
United States	Yale-New Haven Hospital Nathan Smith Clinic	New Haven	Connecticut
United States	Waterbury Hospital	Waterbury	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
University of Connecticut	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 LifeW — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken	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.	Measured at each clinical care visit over 18 months of participation	No
Primary	Visual Analog Scale Measure of Adherence to ART	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	Measured at each clinical visit over 18 months of participation	No
Secondary	Viral Load Count	Viral load data extracted from medical records beginning 30 days prior to baseline.	Measured over 18 months	No

External Links

•   PubMed record of results article