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NCT Number: NCT02696824

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

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).

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Key information

Conditions

Immunodeficiency Virus, Human Acquired Immunodeficiency Syndrome Behavior Behavioral Symptoms Blood-Borne Infections Communicable Diseases Depression Depressive Symptoms Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Cape Town, Cape Town, South Africa

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cognitive Behavioral Therapy for Adherence and Depression

Behavioral

This treatment involves integrating CBT for depression with CBT for adherence following our "Life-Steps" approach.

Primary outcomes

  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

    The Hamilton Depression Rating Scale has a total score ranging from 0-54, with higher scores indicated greater depressive symptoms.

Secondary outcomes

  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

    The Hamilton Depression Rating Scale has a total score ranging from 0-54, with higher scores indicated greater depressive symptoms.

Other outcomes

  1. Depression scores via self-report after intervention

    Time frame: 4-month assessment

    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.

  2. Depression scores via self-report over follow up

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • Massachusetts General Hospital
  • National Institute of Mental Health (NIMH)
  • University of Cape Town

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Mar 2, 2016
Registry last updated
Jan 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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