Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00443378
Status:
COMPLETED
Last Update Posted:
2008-01-29
First Post:
2007-03-05
Brief Title:
Computer Assisted Rx Education for HIV-Positives CARE
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Computer Assisted Rx Education for HIV-Positives CARE
Status:
COMPLETED
Status Verified Date:
2008-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CARE
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-efficacyimportance 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 n30 interviews incorporate into CARE and test software usability n30 Aim 2 Randomized clinical trial of HIV-positive adults on ART Arm 1 CARE n120 Arm 2 computer risk assessment only n120 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
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-efficacyimportance 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 n30 interviews incorporate into CARE and test software usability n30 Aim 2 Randomized clinical trial of HIV-positive adults on ART Arm 1 CARE n120 Arm 2 computer risk assessment only n120 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None