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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH084759 | U.S. NIH Grant/Contract | View source | |
| U01AR057954 | U.S. NIH Grant/Contract | View source | |
| ADH HIV001 | Other Identifier | UW |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute of Mental Health (NIMH) | NIH |
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
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Among HIV-infected patients, adherence to antiretroviral medications is one of the most important determinants of clinical outcomes including viral suppression, viral resistance, disease progression, and death. Unfortunately poor adherence among patients with HIV is very common, mean levels of adherence in clinical cohorts are 60-75% or less. Alcohol, drug abuse, and mental illness particularly depression symptoms are key predictors of poor adherence, common among HIV-infected individuals, and important to identify and treat among nonadherent patients. This study will examine the ability of patient reported outcomes (PROs) and a targeted care management approach to improve clinical outcomes with a randomized controlled trial (RCT) in routine clinical care of patients with HIV. The investigators will determine whether healthcare delivery team notification of PROs including antiretroviral medication adherence and barriers of adherence such as depression and substance abuse along with tailored intervention recommendations and targeted care management leads to improvement in both process and clinical outcomes including patient-reported outcomes. The investigators will examine process outcomes such as use of clinic support services, and patient outcomes such as improvement in adherence, substance use, depression, and HIV-1 RNA levels.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | No Intervention | Patients not randomized to the intervention will receive usual care which includes a patient reported outcomes assessment every 6 months as part of routine clinical procedures and patient-initiated interactions with case managers. | |
| Care management | Experimental | The intervention will include frequent healthcare delivery team notification of PROs including medication adherence and adherence barriers such as depression symptoms along with tailored intervention recommendations and targeted care management using a stepped care approach. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Care management | Behavioral | The intervention will include healthcare delivery team notification of patient reported outcomes (PROs) including medication adherence and adherence barriers such as depression symptoms along with intervention recommendations and targeted care management using a stepped care approach. Patients will receive structured calls from their care manager 2 and 6 weeks after enrollment. An assessment including depression, adherence, and substance use will be completed at the beginning of each call. After the 2nd call, a stepped care approach will be used where patients with a greater need based on adherence and depression will receive more intensive interventions based on the PEARL intervention. The components include: a) problem solving treatment, b) social and physical activation, c) pleasant events scheduling, d) patient support and education regarding medication use, and e) medical and psychiatric consultation. Patients will also receive follow-up calls at ~9 and 12 months after enrollment. |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported adherence | up to 1 year after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| HIV-1 RNA level | up to 1 year after enrollment | |
| Self-reported substance use | Up to 1 year after enrollment | |
| Health related quality of life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heidi M Crane, MD, MPH | University of Washington | Principal Investigator |
| Paul K Crane, MD MPH | University of Washington | Principal Investigator |
| Donald Patrick, PhD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington | Seattle | Washington | 98125 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27707688 | Derived | Crane HM, Fredericksen RJ, Church A, Harrington A, Ciechanowski P, Magnani J, Nasby K, Brown T, Dhanireddy S, Harrington RD, Lober WB, Simoni J, Safren SA, Edwards TC, Patrick DL, Saag MS, Crane PK, Kitahata MM. A Randomized Controlled Trial Protocol to Evaluate the Effectiveness of an Integrated Care Management Approach to Improve Adherence Among HIV-Infected Patients in Routine Clinical Care: Rationale and Design. JMIR Res Protoc. 2016 Oct 5;5(4):e156. doi: 10.2196/resprot.5492. |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| Up to 1 year after enrollment |
| Physical activity levels | up to 1 year after enrollment |
| Self-reported depression | Up to 1 year |