Improving mental health services in Malawi through leadership alignment
Official title: Aligning Facility Leadership and Climate to Advance Mental Health Services Integration in Malawi (ALIGN)
Run by University of North Carolina, Chapel Hill · NCT06399991 · Data updated 2026-11-12
This study is testing if getting leaders on board with a new approach can help improve mental health services in Malawi more effectively than just having champions for the cause.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 1080 (estimated) |
| Sponsor | University of North Carolina, Chapel Hill Academic / other |
| Locations | 12 sites (Chiradzulu and 11 other locations) |
| Status | Recruiting |
| Started | May 1, 2025 |
| Main results expected | May 31, 2026 |
| Study ends | June 30, 2027 |
| Registry record updated | July 16, 2026 |
| Trial ID | NCT06399991 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older who are receiving medical care in the participating districts and have screened positive for common mental disorder symptoms.
✕Probably not a fit
Patients under 18 years old or those not currently receiving medical care in the participating districts will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness of a combined leadership alignment and champion implementation strategy versus a champion strategy alone for integrating evidence-based mental health treatments into various medical settings in Malawi. It addresses the significant mental health treatment gap in low- and middle-income countries by leveraging task-shared mental health interventions. The study aims to enhance the role of organizational leaders in supporting implementation efforts, thereby improving the overall climate for mental health services. By utilizing the Leadership and Organizational Change for Implementation (LOCI) strategy, the research seeks to foster a supportive environment for mental health care delivery.
Why it matters
Potential benefit: If successful, this approach could significantly improve access to and quality of mental health services for patients in Malawi.
How similar studies have gone: While similar approaches have been explored in high-income countries, this specific implementation strategy in low- and middle-income contexts is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years old or older * Patient receiving medical care in participating district who screened positive for elevated common mental disorder symptoms that day or in the preceding month. Exclusion Criteria: * \<18 years old * Not currently a patient receiving medical care in participating district who screened positive for elevated common mental disorder symptoms that day or in the preceding month.
Where it's running
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Chiradzulu District Hospital
Chiradzulu, Malawi Recruiting -
Dedza District Hospital
Dedza, Malawi Recruiting -
Kasungu District Hospital
Kasungu, Malawi Recruiting -
Machinga District Hospital
Machinga, Malawi Recruiting -
Mangochi District Hospital
Mangochi, Malawi Recruiting -
Mchinji District Hospital
Mchinji, Malawi Recruiting
Show 6 more locations
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Mulanje District Hospital
Mulanje, Malawi Recruiting -
Mzimba South District Hospital
Mzimba, Malawi Recruiting -
Nkhata Bay District Hospital
Nkhata Bay, Malawi Recruiting -
Ntcheu District Hospital
Ntcheu, Malawi Recruiting -
Phalombe District Hospital
Phalombe, Malawi Recruiting -
Salima District Hospital
Salima, Malawi Recruiting
Study contacts
- Principal investigator: Brian Pence — University of North Carolina, Chapel Hill
- Study coordinator: Brian Pence, PhD, MPH
- Email: bpence@unc.edu
- Phone: 1-919-966-7446
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.