Trial record 1 of 31 for:    " February 14, 2007":" March 16, 2007"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]
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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
  Purpose

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.


Condition Intervention
HIV Infections
Acquired Immunodeficiency Syndrome
Behavioral: CARE+

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Computer Assisted Rx Education for HIV-Positives: CARE+

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 240
Study Start Date: March 2006
Study Completion Date: July 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Arm 1, "CARE+ arm" is the study arm that receives the CARE+ computer intervention.
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.
No Intervention: 2
Arm 2, the control arm, is the study arm that receives computerized risk assessment only.
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV positive
  • currently taking highly active antiretroviral medication

Exclusion Criteria:

  • unable to understand spoken English
  • unable to give informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00443378

Locations
United States, Washington
Madison Clinic, Harborview Medical Center
Seattle, Washington, United States, 98104
Lifelong AIDS Alliance
Seattle, Washington, United States, 98104
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Ann Kurth, CNM, PhD University Washington, School of Nursing
  More Information

No publications provided

Responsible Party: Ann Kurth, CNM, PhD, University of Washington
ClinicalTrials.gov Identifier: NCT00443378     History of Changes
Other Study ID Numbers: 04-3810-C 01
Study First Received: March 5, 2007
Last Updated: January 22, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
computer counseling
HIV
antiretroviral adherence
sexual behavior
prevention with positives
HIV seronegativity

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
HIV Seropositivity
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 28, 2014