Clinical trial NCT02696824: Effectiveness of Nurse-delivered Care for Adherence/Mood in HIV in South Africa
Official title: Effectiveness of Nurse-delivered Care for Adherence/Mood in HIV in South Africa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immunodeficiency Virus, Human
Depressive Symptoms
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Massachusetts General Hospital
name: University of Cape Town
name: National Institute of Mental Health (NIMH)
First posted: 2016-03-02
Enrollment: 161
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility 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.

Primary outcomes:
measure: Changes in HIV medication adherence throughout intervention phase
timeFrame: Assessed between baseline and the 4 month assessment
measure: Depression scores as assessed by an independent (blind assessor) after intervention.
timeFrame: 4 month assessment
Secondary outcomes:
measure: HIV viral load
timeFrame: 12-month assessment
measure: CD4
timeFrame: 12-month assessment
measure: HIV medication adherence over follow-up
timeFrame: Aggregate across 4,8, and 12-month assessment
measure: Depression scores as assessed by an independent (blind assessor) over follow-up
timeFrame: Aggregate across 4,8, and 12-month assessment
Other outcomes:
measure: Depression scores via self-report after intervention
timeFrame: 4-month assessment
measure: Depression scores via self-report over follow up
timeFrame: Aggregate across 4,8, and 12-month assessment
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Boston
country: United States
facility: The General Hospital Corp dba Massachusetts General Hospital
state: Massachusetts
city: Cape Town
country: South Africa
facility: University of Cape Town
Study officials:
affiliation: University of Miami
name: Steven A Safren, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Safren SA, O'Cleirigh C, Andersen LS, Magidson JF, Lee JS, Bainter SA, Musinguzi N, Simoni J, Kagee A, Joska JA. Treating depression and improving adherence in HIV care with task-shared cognitive behavioural therapy in Khayelitsha, South Africa: a randomized controlled trial. J Int AIDS Soc. 2021 Oct;24(10):e25823. doi: 10.1002/jia2.25823.
citation: Joska JA, Andersen LS, Smith-Alvarez R, Magidson J, Lee JS, O'Cleirigh C, Safren SA. Nurse-Delivered Cognitive Behavioral Therapy for Adherence and Depression Among People Living With HIV (the Ziphamandla Study): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Feb 3;9(2):e14200. doi: 10.2196/14200.