Clinical trial NCT00443378: Computer Assisted Rx Education for HIV-Positives: CARE+
Official title: Computer Assisted Rx Education for HIV-Positives: CARE+
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Acquired Immunodeficiency Syndrome
Keywords: computer counseling
HIV
antiretroviral adherence
sexual behavior
prevention with positives
HIV seronegativity
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2007-03-06
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility criteria: Inclusion Criteria:

* HIV positive
* currently taking highly active antiretroviral medication

Exclusion Criteria:

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

Primary outcomes:
measure: HIV-1 viral load
timeFrame: 0,3,6 and 9 months
measure: Self-reported 30-day visual analogue scale and 7-day missed dose report (adherence)
timeFrame: 0,3,6 and 9 months
measure: Self-reported unprotected sex w/ nonconcordant partner (HIV transmission risk)
timeFrame: 0,3,6 and 9 months
measure: CD4 cell count
timeFrame: 0,3,6 and 9 months
Secondary outcomes:
measure: Compare self-report to pharmacy refill and other chart data at 0,3,6,9 months
timeFrame: 0,3,6 and 9 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Lifelong AIDS Alliance
state: Washington
city: Seattle
country: United States
facility: Madison Clinic, Harborview Medical Center
state: Washington
Study officials:
affiliation: University Washington, School of Nursing
name: Ann Kurth, CNM, PhD
role: PRINCIPAL_INVESTIGATOR
References: