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

NCT02696824 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 161

Last updated 2021-01-19

No results posted yet for this study

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).

Conditions

  • Immunodeficiency Virus, Human
  • Depressive Symptoms

Interventions

BEHAVIORAL

Cognitive Behavioral Therapy for Adherence and Depression

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

Sponsors & Collaborators

  • Massachusetts General Hospital

    collaborator OTHER

  • University of Cape Town

    collaborator OTHER

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • University of Miami

    lead OTHER

Principal Investigators

  • Steven A Safren, PhD · University of Miami

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-19
Primary Completion
2019-10-17
Completion
2020-06-09

Countries

  • United States
  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02696824 on ClinicalTrials.gov