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

PHASE4Active, not recruitingINTERVENTIONAL
Enrollment

487

Participants

Timeline

Start Date

September 1, 2021

Primary Completion Date

November 30, 2023

Study Completion Date

June 30, 2025

Conditions
Depressive Disorder
Interventions
BEHAVIORAL

Problem Management Plus

"PM+ is a cognitive-behavioral intervention that trains recipients to improve their management of practical problems, and uses the term problem management rather than problem solving to emphasize that many problems encountered by individuals living in adverse circumstances may not be solvable. The plus in PM+ underscores additional evidence-based behavioral strategies incorporated into the model, including: stress management strategies, behavioral activation, and social support strengthening. In total, PM+ comprises five sessions held once per week for 1.5. to 2.5 hours per session. The model has shown success in reducing depression symptoms in low-resource settings such as Nepal and Pakistan.4"

DRUG

Antidepressant Therapy

"Fluoxetine, a serotonin selective reuptake inhibitor (SSRI), and amitriptyline, a tricyclic antidepressant (TCA), are part of Malawi's national formulary. Neno District supply chain is supported by PIH, which reduces stock-outs relative to those observed in other Malawian settings. Fluoxetine is typically the first drug of choice because it is safer and better tolerated.~Daily dose will commence at 20 mg of fluoxetine, or 25 mg of amitriptyline. At monthly follow-up visits, a dose increment or medication change may be considered based on measures of treatment response and side effects, using an Antidepressant Side Effect Checklist. This algorithm-based process will be repeated every other week until the patient is fully responding to treatment (PHQ-9 \< 5) for a period of three months. Dose escalations of more than one increment and medication changes will be reviewed with the doctor-in-charge. If on ADT at end of study, it will be sustained as part of usual care."

Trial Locations (1)

Unknown

Partners In Health, Neno

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

National Institute of Mental Health (NIMH)

NIH

collaborator

Partners in Health

OTHER

collaborator

Brigham and Women's Hospital

OTHER

collaborator

Malawi Ministry of Health

UNKNOWN

collaborator

Blantyre College of Medicine

UNKNOWN

collaborator

University of Birmingham

OTHER

lead

RAND

OTHER