Clinical trial NCT00247611: Improving Treatment Adherence in HIV-Infected Individuals
Official title: Changing ART Adherence Behavior: The Lifewindows Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Antiretroviral Therapy (ART) Adherence
Health Behavior
Keywords: HIV
AIDS
Antiretroviral Medication Adherence
Lead sponsor: University of Connecticut
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2005-11-02
Enrollment: 594
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken
timeFrame: Measured at each clinical care visit over 18 months of participation
measure: Visual Analog Scale Measure of Adherence to ART
timeFrame: Measured at each clinical visit over 18 months of participation
Secondary outcomes:
measure: Viral Load Count
timeFrame: Measured over 18 months
Other outcomes:
Locations:
city: Farmington
country: United States
facility: University of Connecticut Health Center
state: Connecticut
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: New Haven
country: United States
facility: Yale-New Haven Hospital Nathan Smith Clinic
state: Connecticut
city: New Haven
country: United States
facility: Hospital of Saint Raphael
state: Connecticut
city: Waterbury
country: United States
facility: Waterbury Hospital
state: Connecticut
Study officials:
affiliation: University of Connecticut
name: Jeffrey D. Fisher, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Connecticut (*co-PI)
name: K. Rivet Amico*, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Connecticut (*co-PI)
name: Deborah H. Cornman*, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Western Ontario (*co-PI)
name: William A. Fisher*, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.