CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 2,002 enrolled
Drug / intervention
Primary care 101 plus mental health +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02407691
NCT02407691N/ACompleted

Collaborative Care for the Detection and Management of Depression Among Adults Receiving Antiretroviral Therapy in South Africa: a Pragmatic Cluster Randomized Controlled Trial

University of Cape Town·interventional·Posted Apr 3, 2015·Updated Nov 29, 2023

In Brief

A clinical study evaluating Primary care 101 plus mental health and Standard Primary Care 101 for HIV/AIDS and 2 related conditions. Completed, enrolled 2,002 participants across 2 sites.

Detailed Summary

With increasing access to antiretroviral therapy (ART) in South Africa, HIV has transitioned from a terminal illness to a long-term condition. It is likely to be accompanied by higher levels of disability and other chronic non-communicable diseases, resulting from the HIV itself, as well as adverse effects of medication. This requires an expansion of the purview of HIV care beyond direct HIV clinical care to also include a more comprehensive and integrated package of treatment and care for physical and mental conditions and their consequences. COBALT is a pragmatic cluster randomized controlled trial (RCT) in public sector primary care clinics in the North West Province of SA. It will assess mental health and HIV outcomes for depressed adults receiving ART by measuring the real-world effectiveness of a facility-based stepped care intervention combining depression case detection by non-physician clinicians with group counselling intervention delivered by lay-health workers.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSouth Africa

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 3, 2015
Enrollment StartApr 1, 2015
Primary CompletionJan 1, 2018
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 11.2 years ago

Interventions

Primary care 101 plus mental healthother

A facility-based stepped care intervention combining depression case detection by non-physician clinicians with group counselling intervention delivered by lay-health workers.

Standard Primary Care 101other

Standard Primary Care 101 guideline with standard training