HIV Infections Clinical Trial
Official title:
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
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