The Sub-Saharan Africa Regional Partnership for Mental Health Capacity Building (SHARP)

University of North Carolina (UNC)

Status: Completed

Conditions: Depression

Treatments: Other: Enhanced implementation package; Other: Basic implementation package

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03711786

1U19MH113202-01 (U.S. NIH Grant/Contract)

18-2211

Details and patient eligibility

About

This is a 10-site cluster-randomized implementation science trial that compares two clinic-level implementation strategies to facilitate ongoing Ministry of Health efforts to scale up depression treatment within non-communicable diseases clinics in Malawi. Primary outcomes are clinical care indicators measured at the level of the visit (patient screened yes/no; depression treatment initiated if indicated yes/no; depression treatment algorithm followed at follow-up yes/no). Secondary outcomes are patient health outcomes measured at the level of the participant.

Full description

This 10-site cluster-randomized implementation science trial compares the success of two clinic-level strategies in achieving high-quality integration of depression treatment into 10 non-communicable diseases (NCD) clinics in Malawi. Clinics are randomized 1:1 to one of two clinic-level implementation strategies: a basic strategy involving an internal coordinator, and an enhanced strategy combining the internal coordinator with an external quality assurance monitoring and supervision team. During a pre-randomization run-in period (months 1-5), all clinics receive the basic strategy. During a post-randomization intervention period (months 6-38), half of the clinics continue to receive the basic strategy and half receive the enhanced strategy. Visit-level data (for primary outcomes) and participant enrollment and follow-up (for secondary outcomes) are collected from all 10 clinics during the run-in and intervention periods.

Enrollment: 946 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients who meet the following eligibility criteria will be invited to participate:

• Ages 18-65 years (antidepressant treatment considerations differ for those <18 or >65 years, and these age groups are expected to be very rare in the target clinics),
• Current or new patient receiving care for either hypertension or diabetes from a participating NCD clinic
• Elevated depressive symptoms (PHQ-9 score ≥5)

Exclusion criteria

Patients will be excluded if they have

• a history of bipolar or psychotic disorder, or show emergent threat of self-harm.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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946 participants in 2 patient groups

Basic implementation package

Active Comparator group

Description:

Ten Malawi non-communicable diseases clinics will be randomized 1:1 to one of two implementation strategies to be used for two years followed by a 12-month follow-up period.

Treatment:

Other: Basic implementation package

Enhanced implementation package

Experimental group

Description:

Ten Malawi non-communicable diseases clinics will be randomized 1:1 to one of two implementation strategies to be used for two years followed by a 12-month follow-up period.

Treatment:

Other: Enhanced implementation package