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

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ClinicalTrials.gov Identifier: NCT03711786
Recruitment Status : Recruiting
First Posted : October 18, 2018
Last Update Posted : May 24, 2021
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Ministry of Health, Malawi
University of Malawi College of Medicine
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:
The investigators will conduct an implementation science research study that will compare two different implementation strategies to facilitate ongoing Ministry of Health efforts to scale up depression treatment within non-communicable diseases clinics, as well as assessing clinic-related factors that will influence uptake.

Condition or disease Intervention/treatment Phase
Depression Other: Basic implementation package Other: Enhanced implementation package Not Applicable

Detailed Description:
This implementation science research study will integrate depression treatment into 10 non-communicable diseases (NCD) clinics in Malawi. Clinics will be randomized 1:1 to one of two 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. From each clinic, 116 patients with elevated depressive symptoms (defined as a Patient Health Questionnaire score >= 5) will be enrolled into an observational cohort, for a total sample of 1,160 patients over a two-year period; follow-up will extend an additional 12 months. The investigators will assess key implementation and effectiveness outcomes comparing the two implementation strategies. The investigators will also assess clinic characteristics that may influence uptake and fidelity.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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.

Primary Purpose: Health Services Research
Official Title: The Sub-Saharan Africa Regional Partnership (SHARP) for Mental Health Capacity Building
Actual Study Start Date : May 9, 2019
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : July 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health

Arm Intervention/treatment
Active Comparator: Basic implementation package
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
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.

Experimental: Enhanced implementation package
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
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 Measures :
  1. Probability that each patient eligible for depression screening completes depression screening. [ Time Frame: At time of enrollment ]
    Fidelity in depression screening. Completion of depression screening is defined as completing the Patient Health Questionnaire-2 (PHQ-2), and, if the PHQ-2 score is >0, also completing the PHQ-9.

  2. Probability that each patient eligible for depression treatment actually starts treatment within 30 days of identification. [ Time Frame: Within 30 days of enrollment ]
    Fidelity in depression treatment initiation. Confirmed depression is defined as having a PHQ-9 total score of 5 or above and having a final determination from the treating clinician that the patient is appropriate for depression treatment.

  3. Probability at each follow-up appointment in the first three months of depression treatment that the clinical treatment decision follows the depression treatment guidelines. [ Time Frame: Within the first three months of follow-up ]
    Fidelity in following the depression treatment algorithm.


Secondary Outcome Measures :
  1. Probability that each patient achieves depression remission at 3 months. [ Time Frame: Three months post enrollment ]
    Depressive severity is determined using the Patient Health Questionnaire-9 (PHQ-9). 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 being minimum indicating no depressive symptoms, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression, 20-27 severe depression. Depression remission is defined as a score <5.

  2. Probability that each NCD patient's NCD is well controlled at 3 months. [ Time Frame: Three months post enrollment ]
    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 NCD will be defined for hypertension patients as systolic blood pressure <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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03711786


Contacts
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Contact: Brian W Pence, PhD (919) 966-7446 bpence@unc.edu
Contact: Mina Hosseinipour, MD, MPH 265-1-755-056 mina_hosseinipour@med.unc.edu

Locations
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Malawi
Chilumba Rural Hospital Recruiting
Chilumba, Karonga, Malawi
Contact: Jullita Malava         
Karonga District Hospital Recruiting
Karonga, Malawi
Contact: Jullita Malava         
MEIRU Recruiting
Karonga, Malawi
Contact: Jullita Malava, MS    +265 999312514    jullita.malava@kpsmw.org   
Kasungu District Hospital Recruiting
Kasungu, Malawi
Contact: Chifundo Zimba         
Bwaila Hospital Recruiting
Lilongwe, Malawi
Contact: Chifundo Zimba, PhD         
UNC Project Malawi Recruiting
Lilongwe, Malawi
Contact: Chifundo Zimba, PhD    +265 991720092    czimba@unclilongwe.org   
Machinga District Hospital Recruiting
Machinga, Malawi
Contact: Harriet Akello    +265 995622855    h.akello@dignitasinternational.org   
Mchinji District Hospital Recruiting
Mchinji, Malawi
Contact: Chifundo Zimba         
Mulanje District Hospital Recruiting
Mulanje, Malawi
Contact: Harriet Akello         
Phalombe Rural Health Center Recruiting
Phalombe, Malawi
Contact: Harriet Akello         
Salima District Hospital Not yet recruiting
Salima, Malawi
Contact: Chifundo Zimba         
Zomba Central Hospital Recruiting
Zomba, Malawi
Contact: Harriet Akello         
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institute of Mental Health (NIMH)
Ministry of Health, Malawi
University of Malawi College of Medicine
Investigators
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Principal Investigator: Brian W Pence, PhD UNC-Chapel Hill
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03711786    
Other Study ID Numbers: 18-2211
1U19MH113202-01 ( U.S. NIH Grant/Contract )
First Posted: October 18, 2018    Key Record Dates
Last Update Posted: May 24, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Time Frame: Data will be uploaded every 6 months. The first expected upload is on July 15, 2019.
Access Criteria: Access to the National Institute of Mental Health Data Archive is governed by the National Institute of Mental Health.
URL: https://ndar.nih.gov/contribute_data_sharing_regimen.html

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms