Computer Assisted Rx Education for HIV-Positives: CARE+

NCT ID: NCT00443378

Last Updated: 2008-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2007-07-31

Brief Summary

This study evaluates an interactive computer counseling tool to help HIV-positive individuals develop an integrated health promotion plan incorporating antiretroviral (ART) adherence and HIV transmission risk reduction. We hypothesize that evidence-based counseling for ART adherence support and for HIV transmission risk reduction can be delivered effectively in a self-administered computer tool.

Detailed Description

Strict adherence to ART regimens is necessary for viral suppression and to avoid development of viral resistance, yet average ART adherence among HIV-positive individuals in North America is only 55%. Focused prevention efforts are key to reduce secondary HIV transmission to sexual and needle-sharing partners, yet many HIV patients do not receive counseling about these behaviors from their providers. Despite the global pandemic and a rising HIV incidence among some US populations, few health promotion interventions have integrated ART adherence with transmission risk reduction for people living with HIV. Most of the efficacious adherence or prevention interventions to date are not practical to scale up, as they require intense staff training and quality assurance and can be delivered to relatively few individuals at any one time.

An interactive health communication tool promises the possibility of a cost-effective adjunct to existing human-delivered counseling, or a stand-alone intervention when no other counseling would otherwise be offered.

This RCT of one such tool -- CARE+ --will provide empiric evidence of the benefits and limits of a computerized health promotion intervention to integrate ART adherence with transmission prevention for individuals with HIV. CARE+ is a .NET based application on tablet computers that comprises risk assessment, medication monitoring, tailored feedback, stage-based skills-building videos, motivational interviewing counseling, an integrated health promotion plan, and printout with referrals. Evidence-based approaches (pharmacist education, self-efficacy/importance scaling exercises, and consequence-framing) are incorporated.

Comparison: The CARE+ longitudinal RCT compares clinical and behavioral outcomes of CARE+ users to a control arm which assesses audio computer-assisted self-interview risk behaviors only. Participants were recruited and enrolled at two study sites, 1) an urban outpatient HIV clinic and 2) a community based AIDS Service Organization.

Aim 1: Identify common elements of adherence and transmission behaviors, health communication needs, and technology attitudes (n=30 interviews); incorporate into CARE+ and test software usability (n=30). Aim 2: Randomized clinical trial of HIV-positive adults on ART. Arm 1: CARE+ (n=120); Arm 2: computer risk assessment only (n=120). Arms 1 and 2 perform baseline, 3-, 6-, and 9-month session. Compare outcomes: a) ART adherence by plasma HIV viral load, CD4, self-report and b) HIV transmission sexual risk behaviors at follow-up. Aim 3: Provide data for HIV transmission dynamics impact modeling.

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

1

Arm 1, "CARE+ arm" is the study arm that receives the CARE+ computer intervention.

Group Type: EXPERIMENTAL

CARE+

Intervention Type: BEHAVIORAL

CARE+ is a .NET based application on tablet computers that comprises risk assessment, medication monitoring, tailored feedback, stage-based skills-building videos, motivational interviewing counseling, an integrated health promotion plan, and printout with referrals. Evidence-based approaches (pharmacist education, self-efficacy/importance scaling exercises, and consequence-framing) are incorporated.

2

Arm 2, the control arm, is the study arm that receives computerized risk assessment only.

Group Type: NO_INTERVENTION

CARE+

Intervention Type: BEHAVIORAL

CARE+ is a .NET based application on tablet computers that comprises risk assessment, medication monitoring, tailored feedback, stage-based skills-building videos, motivational interviewing counseling, an integrated health promotion plan, and printout with referrals. Evidence-based approaches (pharmacist education, self-efficacy/importance scaling exercises, and consequence-framing) are incorporated.

Interventions

CARE+

CARE+ is a .NET based application on tablet computers that comprises risk assessment, medication monitoring, tailored feedback, stage-based skills-building videos, motivational interviewing counseling, an integrated health promotion plan, and printout with referrals. Evidence-based approaches (pharmacist education, self-efficacy/importance scaling exercises, and consequence-framing) are incorporated.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• HIV positive
• currently taking highly active antiretroviral medication

Exclusion Criteria

• unable to understand spoken English
• unable to give informed consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centers for Disease Control and Prevention

FED

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

University of Washington

Principal Investigators

Ann Kurth, CNM, PhD

Role: PRINCIPAL_INVESTIGATOR

University Washington, School of Nursing

Locations

Lifelong AIDS Alliance

Seattle, Washington, United States

Madison Clinic, Harborview Medical Center

Seattle, Washington, United States

Countries

United States

Other Identifiers

04-3810-C 01

Identifier Type: -

Identifier Source: org_study_id