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

Study Overview
=================
Brief Summary
-----------------
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.

Detailed 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.

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

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Other: Basic implementation package
* Other: Enhanced implementation package


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 10 clinics will be randomized 1:1 to either a basic or enhanced implementation package to support integration of evidence-based depression treatment.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Basic implementation package<br>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. | Other: Basic implementation package<br>* The basic implementation package will involve identifying an internal coordinator who is one of the full-time on-site providers at the clinic. The internal coordinator provides mentoring to peers and support to leadership in implementing the treatment program and aligning it with clinic priorities.<br>|
| Experimental: Enhanced implementation package<br>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. | Other: Enhanced implementation package<br>* The enhanced implementation package will combine the internal coordinator with an external quality assurance committee. This committee will complete quarterly audits at the facility to evaluate compliance with the depression treatment protocol as well as providing high-level support in implementing the treatment program through clinical expertise and limited on-site presence.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fidelity in Depression Screening: Number of Screening-eligible Visits at Which Depression Screening is Completed | This primary outcome is measured at the level of the clinician-patient visit out of all clinic visits during the intervention period, including visits with both consented and non-consented patients. The outcome is based on aggregate clinic process data including number of visits for which the patient is not already engaged in depression treatment (denominator) and number of visits for which the patient is screened for depression (numerator) on each clinic day at each facility. Completion of depression screening (successful outcome) is defined as the clinician completing the Patient Health Questionnaire-2 (PHQ-2), and, if the PHQ-2 score is >0, also completing the PHQ-9 with the patient. | Measured based on data from clinic visits on each clinic day throughout study period | 
| Fidelity in Depression Treatment Initiation: Number of Treatment-eligible Visits for Which Depression Treatment Actually Starts Within 30 Days of Identification | This primary outcome is measured at the level of the clinician-patient visit out of all treatment-eligible visits during the intervention period, including visits with both consented and non-consented patients. The outcome is based on aggregate clinic process data including number of visits for which the patient is eligible for depression treatment (denominator) and number of visits for which the patient initiates depression treatment (numerator) on each clinic day at each facility. Eligible for depression treatment is defined as PHQ-9 total score of 5 or above. Initiating depression treatment is defined as prescription of antidepressant medication or referral to Friendship Bench psychosocial counselors within 30 days of positive screen. | Measured based on data from clinic visits on each clinic day throughout study period | 
| Fidelity in Following the Depression Treatment Algorithm: Number of Treatment Follow-up Appointments in the First Three Months of Depression Treatment for Which the Clinical Treatment Decision Follows the Depression Treatment Guidelines | This primary outcome is measured at the level of the clinician-patient visit out of all eligible visits during the intervention period. Eligible visits are clinical visits by consented participants within the first 90 days after initiating depression treatment. The outcome is based on clinic process data including number of clinic visits for which the participant is already engaged in depression treatment (denominator) and number of visits where the treatment decision follows the treatment algorithm (numerator) on each clinic day at each facility. Following the algorithm (positive outcome) is defined as: (1) if the participant has completed 6 counseling sessions, any action is acceptable; (2) otherwise, if the participant started counseling, either continuing counseling or starting medication; (3) if the participant started medication and PHQ-9 score <10, continuing medication; (4) if the participant started medication and PHQ-9 score >=10, continuing medication and increasing dose. | Within the first three months of follow-up after initiating depression treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Achieving Depression Remission at 3 Months | This secondary outcome is measured at the level of the consented participant. Depressive severity is determined using the Patient Health Questionnaire-9 (PHQ-9; range 0-27). The PHQ-9 is a self-reported questionnaire measuring depressive symptoms.This is a nine item measure with a response score for each item on a 4-point scale ranging from 0 (not at all) to 3 (nearly every day). Thus, the total score ranges from 0 to 27, with 0-4 indicating no depressive symptoms, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression, and 20-27 severe depression. Depression remission is defined as a score <5. | Three months post enrollment | 
| Number of Participants With Well Controlled NCD at 3 Months | This secondary outcome is measured at the level of the consented participant. Hypertension is measured by research assistants at each study visit while fasting blood glucose is measured as part of routine clinical care and will be abstracted. Well-controlled non-communicable disease (NCD) will be defined for hypertension patients as systolic blood pressure (BP) <140 mmHg AND diastolic blood pressure <90 mmHg, and for diabetes patients as fasting blood glucose <130 mg/dl, following the Malawi Clinical Guidelines for the Management of NCDs. | Three months post enrollment |