Computer Assisted Rx Education for HIV-Positives: CARE+

Not Applicable

Completed

• Conditions: HIV Infections; Acquired Immunodeficiency Syndrome
• Interventions: Behavioral: CARE+

• Registration Number: NCT00443378
• Lead Sponsor: University of Washington

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.

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2007-03-05
• Study First Submitted QC: 2007-03-05
• Study First Posted: 2007-03-06
• Primary Completion: 2007-06
• Study Completion: 2007-07
• Status Verified: 2008-01
• Last Update Submitted: 2008-01-22
• Last Update Posted: 2008-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

• HIV positive
• currently taking highly active antiretroviral medication

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	CARE+	Arm 1, "CARE+ arm" is the study arm that receives the CARE+ computer intervention.
2	CARE+	Arm 2, the control arm, is the study arm that receives computerized risk assessment only.

Primary Outcome Measures

Name	Time	Method
HIV-1 viral load	0,3,6 and 9 months
Self-reported 30-day visual analogue scale and 7-day missed dose report (adherence)	0,3,6 and 9 months
Self-reported unprotected sex w/ nonconcordant partner (HIV transmission risk)	0,3,6 and 9 months
CD4 cell count	0,3,6 and 9 months

Secondary Outcome Measures

Name	Time	Method
Compare self-report to pharmacy refill and other chart data at 0,3,6,9 months	0,3,6 and 9 months

Trial Locations

Locations (2)

Madison Clinic, Harborview Medical Center; 🇺🇸 Seattle, Washington, United States

Lifelong AIDS Alliance; 🇺🇸 Seattle, Washington, United States