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

NCT03711786 | Completed Results DMC

• 2 other identifiers: 18-22111U19MH113202-01
• Study Type: interventional
• Target: 946
• Locations: 1 country
• Sites: 12

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Number of Participants Achieving Depression Remission at 3 Months

  Three months post enrollment

• Number of Participants With Well Controlled NCD at 3 Months

  Three months post enrollment

Study Arms (2)

Basic implementation package

ACTIVE COMPARATOR

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

Enhanced implementation package

EXPERIMENTAL

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

Interventions

Basic implementation package OTHER

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.

Basic implementation package

Enhanced implementation package OTHER

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.

Enhanced implementation package

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Patients will be excluded if they have
• a history of bipolar or psychotic disorder, or show emergent threat of self-harm.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute of Mental Health (NIMH): collaborator
• Ministry of Health, Malawi: collaborator
• Kamuzu University of Health Sciences: collaborator

Study Sites (12)

Chilumba Rural Hospital

Chilumba, Karonga, Malawi

Location

Karonga District Hospital

Karonga, Malawi

Location

MEIRU

Karonga, Malawi

Location

Kasungu District Hospital

Kasungu, Malawi

Location

Bwaila Hospital

Lilongwe, Malawi

Location

UNC Project Malawi

Lilongwe, Malawi

Location

Machinga District Hospital

Machinga, Malawi

Location

Mchinji District Hospital

Mchinji, Malawi

Location

Mulanje District Hospital

Mulanje, Malawi

Location

Phalombe Rural Health Center

Phalombe, Malawi

Location

Salima District Hospital

Salima, Malawi

Location

Zomba Central Hospital

Zomba, Malawi

Location

Related Publications (6)

• Zimba CC, Malava JK, Mbota M, Matewere M, Akello H, Akiba CF, Landrum KR, Morrison A, Go V, Hosseinipour MC, Gaynes BN, Udedi M, Masiye J, Pence BW. Barriers and potential solutions for effective integration of depression care into non-communicable diseases clinics in Malawi: a qualitative end-point evaluation of the SHARP randomized controlled trial. Int J Ment Health Syst. 2025 Mar 6;19(1):8. doi: 10.1186/s13033-025-00663-z.

  PMID: 40050899 DERIVED

• Pence BW, Gaynes BN, Udedi M, Kulisewa K, Zimba CC, Akiba CF, Dussault JM, Akello H, Malava JK, Crampin A, Zhang Y, Preisser JS, DeLong SM, Hosseinipour MC. Two implementation strategies to support the integration of depression screening and treatment into hypertension and diabetes care in Malawi (SHARP): parallel, cluster-randomised, controlled, implementation trial. Lancet Glob Health. 2024 Apr;12(4):e652-e661. doi: 10.1016/S2214-109X(23)00592-2. Epub 2024 Feb 23.

  PMID: 38408462 DERIVED

• Sansbury GM, Pence BW, Zimba C, Yanguela J, Landrum K, Matewere M, Mbota M, Malava JK, Tikhiwa H, Morrison AM, Akiba CF, Gaynes BN, Udedi M, Hosseinipour MC, Stockton MA. Improving integrated depression and non-communicable disease care in Malawi through engaged leadership and supportive implementation climate. BMC Health Serv Res. 2023 Dec 14;23(1):1413. doi: 10.1186/s12913-023-10344-7.

  PMID: 38098079 DERIVED

• 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.

  PMID: 34116699 DERIVED

• 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.

  PMID: 33291973 DERIVED

• 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.

  PMID: 32429877 DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Brian Pence, PhD
• Organization: University of North Carolina at Chapel Hill

bpence@unc.edu

919-966-7430

Study Officials

• Brian W Pence, PhD

  UNC-Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 10 clinics will be randomized 1:1 to either a basic or enhanced implementation package to support integration of evidence-based depression treatment.

Study Record Dates

• First Submitted: January 12, 2018
• First Posted: October 18, 2018
• Study Start: May 9, 2019
• Primary Completion: March 31, 2022
• Study Completion: June 30, 2022
• Last Updated: March 1, 2023
• Results First Posted: March 1, 2023

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• 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.

Locations

MA (12)