NCT03711786

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 946 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2019-05-09
• Primary completion: 2022-03-31
• Completion: 2022-06-30
• First posted: 2018-10-18
• Last updated: 2023-03-01
• Results posted: 2023-03-01

Locations

12 sites across 1 country: Malawi