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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01MH103770-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Massachusetts General Hospital | OTHER |
| University of Cape Town | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
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The purpose of this study is to conduct a two-arm effectiveness trial in Cape Town, South Africa of a Xhosa-adapted, nurse-delivered, cognitive behavioral therapy (CBT) treatment for depression and adherence, integrated into the HIV care setting in patients with HIV who did not achieve viral suppression from first-line treatment. The CBT treatment will be compared to enhanced usual care (Enhanced Treatment As Usual - ETAU) on study endpoints (as described in study endpoints section below).
Clinical Clinical depression is one of the highest comorbidities to HIV/AIDS, with estimated rates up to 34.9 percent. Depression, in the context of HIV, leads to poor self-care behavior such as non-adherence to ART and worse retention in care, which are critical for treatment success. Based on our prior work, and given that CBT is an evidenced-based treatment for depression, this is a two-arm effectiveness randomized controlled trial of nurse-delivered cognitive behavioral therapy for depression and adherence integrated into the HIV primary care setting in S. Africa. To ensure that those who need this intervention the most will receive it, participants will be patients with HIV who did not achieve viral suppression from their first line ART, and have a unipolar depressive mood disorder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBT-AD | Experimental | Those assigned to the CBT-AD [cognitive behavioral therapy for adherence and depression) condition, will have up to 8 additional sessions delivered by the study clinic nurse. Additionally, those assigned to CBT-AD will have the procedures available to those assigned to ETAU.](streamdown:incomplete-link) |
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| ETAU | No Intervention | Participants in both conditions receive usual care plus the following procedures below. All participant will have the benefit of the psychosocial assessment, and the clinic nurse will provide feedback to the participant and to their clinic doctor about their depression. Additionally, all participants will undergo standard of care "second line treatment" adherence counseling in the clinic . The clinic doctor will not be restricted in terms of referral or treatment of depression for their patient with respect to antidepressant medications or other interventions available. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Therapy for Adherence and Depression | Behavioral | This treatment involves integrating CBT for depression with CBT for adherence following our "Life-Steps" approach. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in HIV medication adherence throughout intervention phase | Percentage of prescribed antiviral therapy agent (medications ) taken as measured by real time wireless motoring device | Assessed between baseline and the 4 month assessment |
| Depression scores as assessed by an independent (blind assessor) after intervention. | Hamilton Depression Rating Scale The Hamilton Depression Rating Scale has a total score ranging from 0-54, with higher scores indicated greater depressive symptoms. | 4 month assessment |
| Measure | Description | Time Frame |
|---|---|---|
| HIV viral load | Percentage of patients with a detectable viral load at the 12 month assessment | 12-month assessment |
| CD4 | Mean CD4 cell counts at the 12 month assessment |
| Measure | Description | Time Frame |
|---|---|---|
| Depression scores via self-report after intervention | Center for Epidemiological Studies-Depression (CES-D) scale The CES-D has a total score ranging from 0-60, with higher scores indicated greater depressive symptoms. | 4-month assessment |
| Depression scores via self-report over follow up |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven A Safren, PhD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33146 | United States | ||
| The General Hospital Corp dba Massachusetts General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34708929 | Derived | Safren SA, O'Cleirigh C, Andersen LS, Magidson JF, Lee JS, Bainter SA, Musinguzi N, Simoni J, Kagee A, Joska JA. Treating depression and improving adherence in HIV care with task-shared cognitive behavioural therapy in Khayelitsha, South Africa: a randomized controlled trial. J Int AIDS Soc. 2021 Oct;24(10):e25823. doi: 10.1002/jia2.25823. | |
| 32012114 | Derived | Joska JA, Andersen LS, Smith-Alvarez R, Magidson J, Lee JS, O'Cleirigh C, Safren SA. Nurse-Delivered Cognitive Behavioral Therapy for Adherence and Depression Among People Living With HIV (the Ziphamandla Study): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Feb 3;9(2):e14200. doi: 10.2196/14200. |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D003863 | Depression |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| 12-month assessment |
| HIV medication adherence over follow-up | Percentage of prescribed antiviral therapy agent (medications ) taken as measured by real time wireless motoring device | Aggregate across 4,8, and 12-month assessment |
| Depression scores as assessed by an independent (blind assessor) over follow-up | Hamilton Depression Rating Scale The Hamilton Depression Rating Scale has a total score ranging from 0-54, with higher scores indicated greater depressive symptoms. | Aggregate across 4,8, and 12-month assessment |
CES-D scale The CES-D has a total score ranging from 0-60, with higher scores indicated greater depressive symptoms. |
| Aggregate across 4,8, and 12-month assessment |
| Boston |
| Massachusetts |
| 02114 |
| United States |
| University of Cape Town | Cape Town | South Africa |
| 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 |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |