Improving Treatment Adherence in HIV-Infected Individuals

Phase 2

Completed

Conditions: HIV Antiretroviral Therapy (ART) Adherence
Health Behavior

Interventions: Other: Control
Behavioral: LifeWindows Intervention Sessions

Registration Number: NCT00247611

Lead Sponsor: University of Connecticut

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 594

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

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	Participants will receive the control condition
Intervention	LifeWindows Intervention Sessions	Participants will receive the LifeWindows Intervention sessions

Primary Outcome Measures

Name	Time	Method
AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken	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	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

Secondary Outcome Measures

Name	Time	Method
Viral Load Count	Measured over 18 months	Viral load data extracted from medical records beginning 30 days prior to baseline.

Trial Locations

Locations (5): Hartford Hospital
🇺🇸
Hartford, Connecticut, United States
University of Connecticut Health Center
🇺🇸
Farmington, Connecticut, United States
Yale-New Haven Hospital Nathan Smith Clinic
🇺🇸
New Haven, Connecticut, United States
Hospital of Saint Raphael
🇺🇸
New Haven, Connecticut, United States
Waterbury Hospital
🇺🇸
Waterbury, Connecticut, United States