Evidence map›Paper›PMID 34530894›Full record

ArticleTrials2021

Stepped care for depression at integrated chronic care centers (IC3) in Malawi: study protocol for a stepped-wedge cluster randomized controlled trial.

Ryan K McBain, Owen Mwale, Todd Ruderman, Waste Kayira, Emilia Connolly, Mark Chalamanda, Chiyembekezo Kachimanga, Brown David Khongo, Jesse Wilson, Emily Wroe and 10 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04777006 (Integrating a Stepped Care Model of Screening and Treatment for Depression Into Malawi's National HIV Care Delivery Platform), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.9field-weighted citation impact, top 24% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04777006 phase4completednot on this map

Integrating a Stepped Care Model of Screening and Treatment for Depression Into Malawi's National HIV Care Delivery Platform

TypeinterventionalSponsorRANDRan2021 to 2025Enrolled487ConditionsDepressive DisorderArmsProblem Management Plus, Antidepressant Therapy
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 6 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors at 7 institutions in 3 countries.

Ryan K McBainRAND Corporation, Boston, 20 Park Plz, Boston, MA, 02116, USA. rmcbain@rand.org.
Owen MwalePartners in Health, Neno District, Malawi.
Todd RudermanPartners in Health, Neno District, Malawi.
Waste KayiraPartners in Health, Neno District, Malawi.
Emilia ConnollyPartners in Health, Neno District, Malawi.
Mark ChalamandaPartners in Health, Neno District, Malawi.
Chiyembekezo KachimangaPartners in Health, Neno District, Malawi.
Brown David KhongoPartners in Health, Neno District, Malawi.
Jesse WilsonPartners In Health, Boston, MA, USA.
Emily WroePartners In Health, Boston, MA, USA.
Giuseppe RaviolaPartners In Health, Boston, MA, USA.
Stephanie SmithPartners In Health, Boston, MA, USA.
Sarah ColemanPartners In Health, Boston, MA, USA.
Ksakrad KellyPartners In Health, Boston, MA, USA.
Amruta HoudePartners In Health, Boston, MA, USA.
Mahlet G TebekaRAND Corporation, Santa Monica, CA, USA.
Samuel WatsonUniversity of Birmingham, Birmingham, UK.
Kazione KulisewaBlantyre College of Medicine, Blantyre, Malawi.
Michael UdediMinistry of Health, Lilongwe, Malawi.
Glenn WagnerRAND Corporation, Santa Monica, CA, USA.
Partners In Health · USRAND Corporation · USBlantyre Institute for Community Ophthalmology · MWHarvard University · USMinistry of Health · MWUniversity of Birmingham · GBUniversity of Cincinnati Medical Center · US

Funding

Integrating a Stepped Care Model of Screening and Treatment for Depression into Malawi's National HIV Care Delivery PlatformR01MH117760 · NIMH · RAND CORPORATION · PI MCBAIN, RYAN K, WAGNER, GLENN JOHN · 2020 to 2024
$3.0M
Fogarty International Center (US) R01MH117760NIMH NIH HHS R01 MH117760NIMH NIH HHS R01MH117760
6 · The paper itself

Abstract

backgroundMalawi is a low-income country in sub-Saharan Africa that has limited resources to address a significant burden of disease-including HIV/AIDS. Additionally, depression is a leading cause of disability in the country but largely remains undiagnosed and untreated. The lack of cost-effective, scalable solutions is a fundamental barrier to expanding depression treatment. Against this backdrop, one major success has been the scale-up of a network of more than 700 HIV clinics, with over half a million patients enrolled in antiretroviral therapy (ART). As a chronic care system with dedicated human resources and infrastructure, this presents a strategic platform for integrating depression care and responds to a robust evidence base outlining the bi-directionality of depression and HIV outcomes.

methodsWe will evaluate a stepped model of depression care that combines group-based Problem Management Plus (group PM+) with antidepressant therapy (ADT) for 420 adults with moderate/severe depression in Neno District, Malawi, as measured by the Patient Health Questionnaire-9 (PHQ-9) and Mini-International Neuropsychiatric Interview (MINI). Roll-out will follow a stepped-wedge cluster randomized design in which 14 health facilities are randomized to implement the model in five steps over a 15-month period. Primary outcomes (depression symptoms, functional impairment, and overall health) and secondary outcomes (e.g., HIV: viral load, ART adherence; diabetes: A1C levels, treatment adherence; hypertension: systolic blood pressure, treatment adherence) will be measured every 3 months through 12-month follow-up. We will also evaluate the model's cost-effectiveness, quantified as an incremental cost-effectiveness ratio (ICER) compared to baseline chronic care services in the absence of the intervention model. DISCUSSION: This study will conduct a stepped-wedge cluster randomized trial to compare the effects of an evidence-based depression care model versus usual care on depression symptom remediation as well as physical health outcomes for chronic care conditions. If determined to be cost-effective, this study will provide a model for integrating depression care into HIV clinics in additional districts of Malawi and other low-resource settings with high HIV prevalence.

trial registrationClinicalTrials.gov NCT04777006 . Registered on 1 March, 2021.

Indexed as

DepressionHIV InfectionsAdultCost-Benefit AnalysisHumansMalawiRandomized Controlled Trials as TopicViral LoadAntidepressant therapyCare integrationChronic careDepressionFluoxetineLow-resource settingMalawiProblem Management PlusRandomized controlled trialStepped care

Identifiers

PMID34530894
PMCPMC8444539
OpenAlexW3199700602

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.