Clinical trial NCT03711786: The Sub-Saharan Africa Regional Partnership for Mental Health Capacity Building
Official title: The Sub-Saharan Africa Regional Partnership (SHARP) for Mental Health Capacity Building
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Ministry of Health, Malawi
name: Kamuzu University of Health Sciences
First posted: 2018-10-18
Enrollment: 946
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 10 clinics will be randomized 1:1 to either a basic or enhanced implementation package to support integration of evidence-based depression treatment.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Fidelity in Depression Screening: Number of Screening-eligible Visits at Which Depression Screening is Completed
timeFrame: Measured based on data from clinic visits on each clinic day throughout study period
measure: Fidelity in Depression Treatment Initiation: Number of Treatment-eligible Visits for Which Depression Treatment Actually Starts Within 30 Days of Identification
timeFrame: Measured based on data from clinic visits on each clinic day throughout study period
measure: 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
timeFrame: Within the first three months of follow-up after initiating depression treatment
Secondary outcomes:
measure: Number of Participants Achieving Depression Remission at 3 Months
timeFrame: Three months post enrollment
measure: Number of Participants With Well Controlled NCD at 3 Months
timeFrame: Three months post enrollment
Other outcomes:
Locations:
city: Chilumba
country: Malawi
facility: Chilumba Rural Hospital
state: Karonga
city: Karonga
country: Malawi
facility: Karonga District Hospital
city: Karonga
country: Malawi
facility: MEIRU
city: Kasungu
country: Malawi
facility: Kasungu District Hospital
city: Lilongwe
country: Malawi
facility: Bwaila Hospital
city: Lilongwe
country: Malawi
facility: UNC Project Malawi
city: Machinga
country: Malawi
facility: Machinga District Hospital
city: Mchinji
country: Malawi
facility: Mchinji District Hospital
city: Mulanje
country: Malawi
facility: Mulanje District Hospital
city: Phalombe
country: Malawi
facility: Phalombe Rural Health Center
city: Salima
country: Malawi
facility: Salima District Hospital
city: Zomba
country: Malawi
facility: Zomba Central Hospital
Study officials:
affiliation: UNC-Chapel Hill
name: Brian W Pence, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.