Cognitive Behavioral Therapy to Help HIV Infected Adults With Depression to Adhere to Antiretroviral Therapy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Cognitive Behavioral Adherence Intervention for Depressed HIV Patients

Conditions
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Depression, HIV Infection

Intervention / Treatment
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* Behavioral: Cognitive behavioral therapy (CBT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: reports significant depressive symptoms as indicated by score of 10 or greater on PHQ-9 Currently taking ART for HIV infection Less than 90% adherence rate to ART regimen Capable of walking and in stable health Speaks fluent English Exclusion Criteria: Depression therapy is needed immediately Meets criteria for current drug dependency Current diagnosis of psychotic disorder or bipolar depression

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br>Participants will receive usual clinical care, which may or may not include mental health treatment | |
| Experimental: 2<br>Participants will receive cognitive behavioral intervention | Behavioral: Cognitive behavioral therapy (CBT)<br>* Participants in this group will receive individual sessions of cognitive-behavioral training for improvement of medication adherence and reduction of depression.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microelectronic medication adherence |  | Measured at Weeks 16 and 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported depression |  | Measured at Weeks 16 and 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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antiretroviral, adherence, poor antiretroviral adherence