- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00443378
Computer Assisted Rx Education for HIV-Positives: CARE+ (CARE+)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98104
- Lifelong AIDS Alliance
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Seattle, Washington, United States, 98104
- Madison Clinic, Harborview Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- HIV positive
- currently taking highly active antiretroviral medication
Exclusion Criteria:
- unable to understand spoken English
- unable to give informed consent
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Arm 1, "CARE+ arm" is the study arm that receives the CARE+ computer intervention.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
HIV-1 viral load
Time Frame: 0,3,6 and 9 months
|
0,3,6 and 9 months
|
Self-reported 30-day visual analogue scale and 7-day missed dose report (adherence)
Time Frame: 0,3,6 and 9 months
|
0,3,6 and 9 months
|
Self-reported unprotected sex w/ nonconcordant partner (HIV transmission risk)
Time Frame: 0,3,6 and 9 months
|
0,3,6 and 9 months
|
CD4 cell count
Time Frame: 0,3,6 and 9 months
|
0,3,6 and 9 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Compare self-report to pharmacy refill and other chart data at 0,3,6,9 months
Time Frame: 0,3,6 and 9 months
|
0,3,6 and 9 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ann Kurth, CNM, PhD, University Washington, School of Nursing
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
- Immunologic Deficiency Syndromes
Other Study ID Numbers
- 04-3810-C 01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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