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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH137280 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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Depression is a common psychiatric condition among Youth with HIV (YWH), with prevalence as high as 25% in the United States. The treatment of depression is essential for improving both psychiatric and medical outcomes for YWH (e.g., adherence to antiretroviral treatment). Practice guidelines for the treatment of depression and substantial research (including for those with and without HIV), indicate that measured-care treatment (care decisions guided by systematic symptom measurement) and using a combination of a medication management algorithm (MMA) and cognitive behavioral therapy (CBT) that is tailored to the population is efficacious. Unfortunately, these methods are seldom fully implemented in practice, leading to markedly reduced intervention effectiveness.
This proposed project will compare an enhanced version of combination treatment (COMBEX) to our previously tested combination treatment (COMB) in a Hybrid Type 2 Cluster Randomized Trial. COMBEX will be enhanced by five ERIC implementation strategies as suggested in our post-trial interviews from our efficacy trial and it will also continue to use the ERIC strategies used in COMB. It is hypothesized that these additional ERIC strategies will improve sustainability and depression outcomes at 48 and 72 weeks.
Depression is a common psychiatric condition among Youth with HIV (YWH), with prevalence as high as 25% in the United States. The treatment of depression is essential for improving both psychiatric and medical outcomes for YWH (e.g., adherence to antiretroviral treatment). Practice guidelines for the treatment of depression and substantial research (including for those with and without HIV), indicate that measured-care treatment (care decisions guided by systematic symptom measurement) and using a combination of a medication management algorithm (MMA) and cognitive behavioral therapy (CBT) that is tailored to the population is efficacious. Unfortunately, these methods are seldom fully implemented in practice, leading to markedly reduced intervention effectiveness.
This proposed project will compare an enhanced version of combination treatment (COMBEX) to our previously tested combination treatment (COMB) in a Hybrid Type 2 Cluster Randomized Trial. COMBEX will be enhanced by five ERIC implementation strategies as suggested in our post-trial interviews from our efficacy trial and it will also continue to use the ERIC strategies used in COMB. It is hypothesized that these additional ERIC strategies will improve sustainability and depression outcomes at 48 and 72 weeks.
The specific co-primary aims of this proposed study are to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COMBEX | Experimental | COMB + additional ERIC strategies |
|
| COMB | Active Comparator | Combined approach to routine psychotherapy (including CBT and medication management) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COMBEX | Behavioral | The intervention (COMBEX) is a combined approach to routine psychotherapy (including CBT and medication management) with additional ERIC strategies incorporated. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Health Questionnaire-9 (PHQ-9) | Self-reported depression symptoms score | Assessed at baseline and Weeks 12, 24, 36, 48, 60, and 72 |
| Measure | Description | Time Frame |
|---|---|---|
| HIV viral load | Quantitative VL levels (copies/mL) will be abstracted from the medical records | Measured at baseline and Weeks 12, 24, 36, 48, 60, and 72 |
| Measure | Description | Time Frame |
|---|---|---|
| General Quality of Life | Self-reported score on PROMIS Global Measure | Assessed at baseline and Weeks 12, 24, 36, 48, 60, and 72 |
| Antidepressant prescription | Prescription of any antidepressant in past 3 months from medical record abstraction |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Larry K Brown, MD | Contact | (401)-793-8808 | lkbrown@brownhealth.org | |
| Graham Emslie, MD | Contact | 214-456-5918 | Graham.Emslie@UTSouthwestern.edu |
| Name | Affiliation | Role |
|---|---|---|
| Larry K Brown, MD | Rhode Island Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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Hybrid Type 2 Cluster Randomized Trial
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| COMB | Behavioral | COMB is a combined approach to routine psychotherapy (including CBT and medication management). |
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| Assessed at Weeks 12, 24, 36, 48, 60, and 72 |
| ART Prescription | Prescription of ART in past 3 months from medical record abstraction | Assessed at Weeks 12, 24, 36, 48, 60, and 72 |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |