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NCT02696824

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

Completed NA Last updated 19 January 2021
What this trial tests

NA trial testing Cognitive Behavioral Therapy for Adherence and Depression in Immunodeficiency Virus, Human in 161 participants. Completed in 9 June 2020.

Timeline
19 July 2016
Primary endpoint
17 October 2019
9 June 2020

Quick facts

Lead sponsorUniversity of Miami
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment161
Start date19 July 2016
Primary completion17 October 2019
Estimated completion9 June 2020
Sites3 locations across South Africa, United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Miami

Who can join

18 and older, any sex, with Immunodeficiency Virus, Human or Depressive Symptoms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Primary-level worker interventions for the care of people living with mental disorders and distress in low- and middle-income countries.
    van Ginneken N, Chin WY, Lim YC, Ussif A, et al · · 2021 · cited 89× · PMID 34352116 · DOI 10.1002/14651858.cd009149.pub3
  2. Treating depression and improving adherence in HIV care with task-shared cognitive behavioural therapy in Khayelitsha, South Africa: a randomized controlled trial.
    Safren SA, O'Cleirigh C, Andersen LS, Magidson JF, et al · · 2021 · cited 63× · PMID 34708929 · DOI 10.1002/jia2.25823
  3. Nurse-Delivered Cognitive Behavioral Therapy for Adherence and Depression Among People Living With HIV (the Ziphamandla Study): Protocol for a Randomized Controlled Trial.
    Joska JA, Andersen LS, Smith-Alvarez R, Magidson J, et al · · 2020 · cited 16× · PMID 32012114 · DOI 10.2196/14200

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Other University of Miami trials

Trials by the same sponsor.

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Data sources for this page

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