Clinical trial Recruiting at 12 sites Interventional Ages 18 and up

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 typeInterventional
Ages18 Years and up
SexAll
Enrollment1080 (estimated)
SponsorUniversity of North Carolina, Chapel Hill
Academic / other
Locations12 sites (Chiradzulu and 11 other locations)
StatusRecruiting
StartedMay 1, 2025
Main results expectedMay 31, 2026
Study endsJune 30, 2027
Registry record updatedJuly 16, 2026
Trial IDNCT06399991 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

  • 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
  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.