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

NCT ID: NCT03711786

Last Updated: 2023-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 946 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-09
• Study Completion Date: 2022-06-30

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.

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Basic implementation package

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Enhanced implementation package

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Ministry of Health, Malawi

OTHER_GOV

Sponsor Role: collaborator

Kamuzu University of Health Sciences

OTHER

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brian W Pence, PhD

Role: PRINCIPAL_INVESTIGATOR

UNC-Chapel Hill

Locations

Chilumba Rural Hospital

Chilumba, Karonga, Malawi

Karonga District Hospital

Karonga, , Malawi

MEIRU

Karonga, , Malawi

Kasungu District Hospital

Kasungu, , Malawi

Bwaila Hospital

Lilongwe, , Malawi

UNC Project Malawi

Lilongwe, , Malawi

Machinga District Hospital

Machinga, , Malawi

Mchinji District Hospital

Mchinji, , Malawi

Mulanje District Hospital

Mulanje, , Malawi

Phalombe Rural Health Center

Phalombe, , Malawi

Salima District Hospital

Salima, , Malawi

Zomba Central Hospital

Zomba, , Malawi

Countries

Malawi

References

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.

Reference Type: DERIVED

PMID: 40050899 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 38408462 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 38098079 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34116699 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33291973 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32429877 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1U19MH113202-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

18-2211

Identifier Type: -

Identifier Source: org_study_id