Computer Assisted Rx Education for HIV-Positives: CARE+

NCT00443378 | Completed DMC

• 1 other identifier: 04-3810-C 01
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 2

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.

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Keywords

computer counseling; HIV; antiretroviral adherence; sexual behavior; prevention with positives; HIV seronegativity

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

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

  0,3,6 and 9 months

Study Arms (2)

1

EXPERIMENTAL

Arm 1, "CARE+ arm" is the study arm that receives the CARE+ computer intervention.

Behavioral: CARE+

2

NO INTERVENTION

Arm 2, the control arm, is the study arm that receives computerized risk assessment only.

Behavioral: CARE+

Interventions

CARE+ BEHAVIORAL

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.

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV positive
• currently taking highly active antiretroviral medication

You may not qualify if:

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

Sponsors & Collaborators

• University of Washington: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (2)

Lifelong AIDS Alliance

Seattle, Washington, 98104, United States

Location

Madison Clinic, Harborview Medical Center

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome; Sexual Behavior

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; Behavior

Study Officials

• Ann Kurth, CNM, PhD

  University Washington, School of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 5, 2007
• First Posted: March 6, 2007
• Study Start: March 1, 2006
• Primary Completion: June 1, 2007
• Study Completion: July 1, 2007
• Last Updated: January 29, 2008

Record last verified: 2008-01

Locations

US (2)