Computer Assisted Rx Education for HIV-Positives: CARE+

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT00443378
First received: March 5, 2007
Last updated: January 22, 2008
Last verified: January 2008

March 5, 2007
January 22, 2008
March 2006
June 2007   (final data collection date for primary outcome measure)
  • HIV-1 viral load [ Time Frame: 0,3,6 and 9 months ] [ Designated as safety issue: No ]
  • Self-reported 30-day visual analogue scale and 7-day missed dose report (adherence) [ Time Frame: 0,3,6 and 9 months ] [ Designated as safety issue: No ]
  • Self-reported unprotected sex w/ nonconcordant partner (HIV transmission risk) [ Time Frame: 0,3,6 and 9 months ] [ Designated as safety issue: No ]
  • CD4 cell count [ Time Frame: 0,3,6 and 9 months ] [ Designated as safety issue: No ]
  • HIV-1 viral load
  • Self-reported 30-day visual analogue scale and 7-day missed dose report (adherence)
  • Self-reported unprotected sex w/ nonconcordant partner (HIV transmission risk)
  • CD4 cell count
  • all above taken at 0,3,6,9 months
Complete list of historical versions of study NCT00443378 on ClinicalTrials.gov Archive Site
Compare self-report to pharmacy refill and other chart data at 0,3,6,9 months [ Time Frame: 0,3,6 and 9 months ] [ Designated as safety issue: No ]
Compare self-report to pharmacy refill and other chart data at 0,3,6,9 months
Not Provided
Not Provided
 
Computer Assisted Rx Education for HIV-Positives: CARE+
Computer Assisted Rx Education for HIV-Positives: CARE+

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
Behavioral: 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.
  • Experimental: 1
    Arm 1, "CARE+ arm" is the study arm that receives the CARE+ computer intervention.
    Intervention: Behavioral: CARE+
  • No Intervention: 2
    Arm 2, the control arm, is the study arm that receives computerized risk assessment only.
    Intervention: Behavioral: CARE+
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
240
July 2007
June 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • HIV positive
  • currently taking highly active antiretroviral medication

Exclusion Criteria:

  • unable to understand spoken English
  • unable to give informed consent
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00443378
04-3810-C 01
Yes
Ann Kurth, CNM, PhD, University of Washington
University of Washington
Centers for Disease Control and Prevention
Principal Investigator: Ann Kurth, CNM, PhD University Washington, School of Nursing
University of Washington
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP