The Sub-Saharan Africa Regional Partnership for Mental Health Capacity Building (SHARP)
Primary Purpose
Depression
Status
Completed
Phase
Not Applicable
Locations
Malawi
Study Type
Interventional
Intervention
Basic implementation package
Enhanced implementation package
Sponsored by
About this trial
This is an interventional health services research trial for Depression
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.
Sites / Locations
- Chilumba Rural Hospital
- Karonga District Hospital
- MEIRU
- Kasungu District Hospital
- Bwaila Hospital
- UNC Project Malawi
- Machinga District Hospital
- Mchinji District Hospital
- Mulanje District Hospital
- Phalombe Rural Health Center
- Salima District Hospital
- Zomba Central Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Basic implementation package
Enhanced implementation package
Arm 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.
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT03711786
First Posted
January 12, 2018
Last Updated
January 30, 2023
Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute of Mental Health (NIMH), Ministry of Health, Malawi, Kamuzu University of Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT03711786
Brief Title
The Sub-Saharan Africa Regional Partnership for Mental Health Capacity Building
Acronym
SHARP
Official Title
The Sub-Saharan Africa Regional Partnership (SHARP) for Mental Health Capacity Building
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
May 9, 2019 (Actual)
Primary Completion Date
March 31, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute of Mental Health (NIMH), Ministry of Health, Malawi, Kamuzu University of Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Masking Description
As randomization is at the clinic level and cannot be masked, participants, care providers, and investigators will not be masked to allocation.
Outcome assessors do not need to know study arm, but it will be operationally difficult to blind them to whether a clinic is receiving the basic or enhanced implementation package.
Allocation
Randomized
Enrollment
946 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Basic implementation package
Arm Type
Active Comparator
Arm 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.
Arm Title
Enhanced implementation package
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Basic implementation package
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Enhanced implementation package
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fidelity in Depression Screening: Number of Screening-eligible Visits at Which Depression Screening is Completed
Description
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.
Time Frame
Measured based on data from clinic visits on each clinic day throughout study period
Title
Fidelity in Depression Treatment Initiation: Number of Treatment-eligible Visits for Which Depression Treatment Actually Starts Within 30 Days of Identification
Description
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.
Time Frame
Measured based on data from clinic visits on each clinic day throughout study period
Title
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
Description
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.
Time Frame
Within the first three months of follow-up after initiating depression treatment
Secondary Outcome Measure Information:
Title
Number of Participants Achieving Depression Remission at 3 Months
Description
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.
Time Frame
Three months post enrollment
Title
Number of Participants With Well Controlled NCD at 3 Months
Description
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.
Time Frame
Three months post enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian W Pence, PhD
Organizational Affiliation
UNC-Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chilumba Rural Hospital
City
Chilumba
State/Province
Karonga
Country
Malawi
Facility Name
Karonga District Hospital
City
Karonga
Country
Malawi
Facility Name
MEIRU
City
Karonga
Country
Malawi
Facility Name
Kasungu District Hospital
City
Kasungu
Country
Malawi
Facility Name
Bwaila Hospital
City
Lilongwe
Country
Malawi
Facility Name
UNC Project Malawi
City
Lilongwe
Country
Malawi
Facility Name
Machinga District Hospital
City
Machinga
Country
Malawi
Facility Name
Mchinji District Hospital
City
Mchinji
Country
Malawi
Facility Name
Mulanje District Hospital
City
Mulanje
Country
Malawi
Facility Name
Phalombe Rural Health Center
City
Phalombe
Country
Malawi
Facility Name
Salima District Hospital
City
Salima
Country
Malawi
Facility Name
Zomba Central Hospital
City
Zomba
Country
Malawi
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be shared via the National Institute of Mental Health Data Archive. This will include de-identified individual-level data. Other researchers can apply to the National Institute of Mental Health Data Archive to access these data.
IPD Sharing Time Frame
Data will be uploaded every 6 months. The first expected upload is on July 15, 2019.
IPD Sharing Access Criteria
Access to the National Institute of Mental Health Data Archive is governed by the National Institute of Mental Health.
IPD Sharing URL
https://nda.nih.gov/
Citations:
PubMed Identifier
34116699
Citation
Zimba CC, Akiba CF, Matewere M, Thom A, Udedi M, Masiye JK, Kulisewa K, Go VF, Hosseinipour MC, Gaynes BN, Pence BW. Facilitators, barriers and potential solutions to the integration of depression and non-communicable diseases (NCDs) care in Malawi: a qualitative study with service providers. Int J Ment Health Syst. 2021 Jun 11;15(1):59. doi: 10.1186/s13033-021-00480-0.
Results Reference
derived
PubMed Identifier
33291973
Citation
Gaynes BN, Akiba CF, Hosseinipour MC, Kulisewa K, Amberbir A, Udedi M, Zimba CC, Masiye JK, Crampin M, Amarreh I, Pence BW. The Sub-Saharan Africa Regional Partnership (SHARP) for Mental Health Capacity-Building Scale-Up Trial: Study Design and Protocol. Psychiatr Serv. 2021 Jul 1;72(7):812-821. doi: 10.1176/appi.ps.202000003. Epub 2020 Dec 9.
Results Reference
derived
PubMed Identifier
32429877
Citation
Akiba CF, Zimba CC, Thom A, Matewere M, Go V, Pence B, Gaynes BN, Masiye J. The role of patient-provider communication: a qualitative study of patient attitudes regarding co-occurring depression and chronic diseases in Malawi. BMC Psychiatry. 2020 May 19;20(1):243. doi: 10.1186/s12888-020-02657-2.
Results Reference
derived
Learn more about this trial
The Sub-Saharan Africa Regional Partnership for Mental Health Capacity Building
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