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| ID | Type | Description | Link |
|---|---|---|---|
| R34MH077503 | U.S. NIH Grant/Contract | View source | |
| DAHBR 9A-ASNM |
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Inability to recruit enough eligible participants at study site.
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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This study will compare the effectiveness of a cognitive behavioral intervention versus usual clinic care in helping HIV infected adults with depression to take their HIV medications on schedule.
Antiretroviral therapy (ART) is a type of medication treatment for HIV that impairs the virus's ability to multiply. When used properly, it has been shown to be successful in reducing HIV-related deaths. A high adherence rate to ART is required to adequately suppress the virus, limit drug resistance, and reduce transmission. HIV infected people who are depressed often experience increased difficulty with adhering to their ART regimen. This study will compare the effectiveness of a cognitive behavioral intervention that targets both depression and adherence versus usual care practices which may or may not include mental health intervention with the goal of improving ART adherence among HIV infected adults with depression who are experiencing difficulty with adhering to their medication regimen.
This study will last 24 weeks. Participants will be randomly assigned to receive the cognitive behavioral intervention or usual care. Study visits for all participants will occur at baseline and Weeks 4, 8, 16, and 24. Those receiving the intervention will also have visits at Weeks 1 and 2. Participants receiving the intervention will attend five individual treatment sessions followed by one to three booster treatment sessions; these sessions will coincide with the study visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | No Intervention | Participants will receive usual clinical care, which may or may not include mental health treatment | |
| 2 | Experimental | Participants will receive cognitive behavioral intervention |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive behavioral therapy (CBT) | Behavioral | Participants in this group will receive individual sessions of cognitive-behavioral training for improvement of medication adherence and reduction of depression. |
| Measure | Description | Time Frame |
|---|---|---|
| Microelectronic medication adherence | Measured at Weeks 16 and 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported depression | Measured at Weeks 16 and 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Glenn J. Wagner, PhD | RAND | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LA Biomedical Institute at Harbor-UCLA | Torrance | California | United States |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
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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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| D007239 |
| Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |