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Effectiveness of Nurse-delivered Care for Adherence/Mood in HIV in South Africa

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ClinicalTrials.gov Identifier: NCT02696824
Recruitment Status : Recruiting
First Posted : March 2, 2016
Last Update Posted : March 6, 2019
Sponsor:
Collaborators:
Massachusetts General Hospital
University of Cape Town
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Steven Safren, University of Miami

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Immunodeficiency Virus, Human Depressive Symptoms Behavioral: Cognitive Behavioral Therapy for Adherence and Depression Not Applicable

Detailed Description:
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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Nurse-delivered Care for Adherence/Mood in HIV in South Africa
Study Start Date : March 2016
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: CBT-AD
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.
Behavioral: Cognitive Behavioral Therapy for Adherence and Depression
This treatment involves integrating CBT for depression with CBT for adherence following our "Life-Steps" approach.

No Intervention: ETAU

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.




Primary Outcome Measures :
  1. Changes in HIV medication adherence throughout intervention phase [ Time Frame: Assessed between baseline and the 4 month assessment ]
    Percentage of prescribed antiviral therapy agent (medications ) taken as measured by real time wireless motoring device

  2. Depression scores as assessed by an independent (blind assessor) after intervention [ Time Frame: 4 month assessment ]
    Hamilton Depression Rating Scale


Secondary Outcome Measures :
  1. HIV viral load [ Time Frame: 12-month assessment ]
    Percentage of patients with a detectable viral load at the 12 month assessment

  2. CD4 [ Time Frame: 12-month assessment ]
    Mean CD4 cell counts at the 12 month assessment

  3. HIV medication adherence over follow-up [ Time Frame: Aggregate across 4,8, and 12-month assessment ]
    Percentage of prescribed antiviral therapy agent (medications ) taken as measured by real time wireless motoring device

  4. Depression scores as assessed by an independent (blind assessor) over follow-up [ Time Frame: Aggregate across 4,8, and 12-month assessment ]
    Hamilton Depression Rating Scale


Other Outcome Measures:
  1. Depression scores via self-report after intervention [ Time Frame: 4-month assessment ]
    Center for Epidemiological Studies-Depression (CES-D) scale

  2. Depression scores via self-report over follow up [ Time Frame: Aggregate across 4,8, and 12-month assessment ]
    CES-D scale



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV-seropositive
  • Current diagnosis of depression
  • Did not attain viral suppression from first-line ARV per local clinic standard

Exclusion Criteria:

  • Unable or unwilling to provide informed consent.
  • Active untreated, major mental illness (untreated psychosis or mania) that would interfere with CBT-AD.
  • Has not received CBT for depression.
  • Less than 18 years of age.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02696824


Contacts
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Contact: Steven A Safren, PhD 305-243-3471 ssafren@miami.edu

Locations
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United States, Florida
University of Miami Not yet recruiting
Miami, Florida, United States, 33146
Contact: Steven A Safren, PhD    305-243-3471    ssafren@miami.edu   
Principal Investigator: Steven A Safren, PhD         
United States, Massachusetts
The General Hospital Corp dba Massachusetts General Hospital Not yet recruiting
Boston, Massachusetts, United States, 02114
Contact: Conall M O'Cleirigh, PhD    617-643-0385    COCLEIRIGH@mgh.harvard.edu   
South Africa
University of Cape Town Recruiting
Cape Town, South Africa
Contact: John Joska, MD    901127214042154    john.joska@uct.ac.za   
Sponsors and Collaborators
University of Miami
Massachusetts General Hospital
University of Cape Town
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Steven A Safren, PhD University of Miami

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Responsible Party: Steven Safren, Professor, University of Miami
ClinicalTrials.gov Identifier: NCT02696824     History of Changes
Other Study ID Numbers: 20150399
1R01MH103770-01A1 ( U.S. NIH Grant/Contract )
First Posted: March 2, 2016    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: After all primary analyses are complete, de-identified data will be available per request of outside individual.

Additional relevant MeSH terms:
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Immunologic Deficiency Syndromes
Depression
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Behavioral Symptoms
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases