Improving Treatment Adherence in HIV-Infected Individuals

University of Connecticut

Status and phase: Completed; Phase 2

Conditions: HIV Antiretroviral Therapy (ART) Adherence; Health Behavior

Treatments: Behavioral: LifeWindows Intervention Sessions; Other: Control

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00247611

R01MH066684 (U.S. NIH Grant/Contract)

DAHBR 9A-ASPG

Details and patient eligibility

About

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.

Full 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.

Enrollment: 594 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Marked cognitive impairment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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594 participants in 2 patient groups

Control

Other group

Description:

Participants will receive the control condition

Treatment:

Other: Control

Intervention

Experimental group

Description:

Participants will receive the LifeWindows Intervention sessions

Treatment:

Behavioral: LifeWindows Intervention Sessions