Clinical trial NCT02165735: Get Ready And Empowered About Treatment
Official title: Addressing HIV Tx Disparities Through Patient Empowerment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2014-06-17
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to rigorously assess a program designed to empower patient living with HIV, to improve their health care and health, and to reduce disparities.

Detailed description: Our project has four major aims:

1. Assess improvement in patient empowerment
2. Assess improvement in patients' receipt of evidence-based care
3. Assess improvement in patients' health
4. Assess reduction in disparities in empowerment

Eligibility criteria: Inclusion Criteria:

* age18 years or older,
* confirmed HIV diagnosis
* receipt of care within a participating site.

Exclusion Criteria:

* inability to provide informed consent
* limited English proficiency (Trainings and Personal Health Record are currently only available in English)

Primary outcomes:
measure: Change in Patient Activation Measure (PAM)
timeFrame: Baseline and 1 year
Secondary outcomes:
measure: Change in eHealth Literacy Scale (eHEALS)
timeFrame: Baseline and 1 year
measure: Change in Decisional Self-Efficacy Scale (DSES)
timeFrame: Baseline and 1 year
measure: Change in Perceived Involvement in Care Scale (PICS)
timeFrame: Baseline and 1 year
measure: Change in Instrument on Doctor Patient Communication Skills (IDPCS)
timeFrame: Baseline and 1 year
measure: Change in HIV Adherence Self-Efficacy Scale (ASES)
timeFrame: Baseline and 1 year
measure: Change in Self-Reported Adherence
timeFrame: Baseline and 1 year
measure: Change in Undetectable Viral Load
timeFrame: Baseline and 1 year
measure: Change in Evidence-based Preventative Care
timeFrame: Baseline and 1 year
measure: Change in Short Form Health Survey: [Mental Health] (SF12)
timeFrame: Baseline and 1 year
measure: Change in Short Form Health Survey: [Physical Health] (SF12)
timeFrame: Baseline and 1 year
Other outcomes:
Locations:
city: New York
country: United States
facility: Clinical Directors Network
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Kevin A Fiscella, MD MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Directors Network CDN
name: Jonathan Tobin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carroll JK, Tobin JN, Luque A, Farah S, Sanders M, Cassells A, Fine SM, Cross W, Boyd M, Holder T, Thomas M, Overa CC, Fiscella K. "Get Ready and Empowered About Treatment" (GREAT) Study: a Pragmatic Randomized Controlled Trial of Activation in Persons Living with HIV. J Gen Intern Med. 2019 Sep;34(9):1782-1789. doi: 10.1007/s11606-019-05102-7. Epub 2019 Jun 25.
citation: Fiscella K, Boyd M, Brown J, Carroll J, Cassells A, Corales R, Cross W, El'Daher N, Farah S, Fine S, Fowler R, Hann A, Luque A, Rodriquez J, Sanders M, Tobin J. Activation of persons living with HIV for treatment, the great study. BMC Public Health. 2015 Oct 16;15:1056. doi: 10.1186/s12889-015-2382-1.