Training Providers to Conduct PRIDES-sSA (PRIDE-sSA)
PRIDE SSA - Partnerships in Research to Implement and Disseminate Sustainable and Scalable Evidence Based Practices in Sub-Saharan Africa
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Working in three geographically separate Mozambican provinces and in rural (N=24), peri-urban (i.e., rural urban transition zone; N=6), and urban (N=6) clinics, the scale-up study first will conduct a two-year (12 months implementation, 12 months sustainability), cluster-randomized, three-arm hybrid effectiveness-implementation type 1 trial, guided by Proctor's implementation framework. The delivery pathway showing the highest overall effectiveness after this two-year trial in 36 clinics will then be implemented in clinics from the other two arms for two additional "cross-over" years. Throughout the trial and the "cross-over" years, qualitative and other process data will complement structured assessments to examine implementation, sustainability, and scale-up.
Scale-up PRIDES Mozambique has the following Specific Aims:
Aim 1. To determine the most effective delivery pathway in terms of 1) implementation outcomes (reach, retention, pathway fidelity, cost-effectiveness); 2) service-level outcomes (efficiency); and 3) patient-level outcomes (function/disability, comprehensive MH screener, patient satisfaction). As an Exploratory Sub-Aim: To assess the impact of: pre-implementation stage factors (acceptability, adoption); mediators (work self-efficacy, MH literacy); and moderators (clinic characteristics: rural, peri-urban, urban, epilepsy program implementation) on implementation, services, and patient outcomes.
Aim 2. To evaluate implementation, sustainability, and scale-up requirements of the most effective pathway (determined in Aim 1) in order to inform regional policies. A rigorous process evaluation mixed-methods approach will identify barriers and facilitators to implementing, sustaining, and scaling-up the most effective pathway in all clinics during the "cross-over" two years using purposive sampling for mixed-methods evaluation in a subset of 18 clinics (6 per Province).
Aim 3. To develop an implementation tool-kit for low-cost, feasible, and sustainable system-wide implementation of the most effective WHO Mental Health Gap Action Programme (mhGAP) delivery pathway in Sub-Saharan Africa (sSA) with collaboration of Members of the PRIDES sSA Five-Country Council, External Advisory Board and the WHO.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Cidade de Maputo
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Maputo, Cidade de Maputo, Mozambique, 1101
- MIHER: Mozambique Institute for Health Education and Research
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Staff in one of the 36 clinics - Clinic directors, trainers, supervisors, providers of participating clinics: Community Health Workers; Nurses; and Medicine, Preventive Medicine andPsychiatric Technicians.
Exclusion Criteria:
- Other clinic staff besides clinic directors, trainers, supervisors, providers of participating clinics: Community Health Workers; Nurses; and Medicine, Preventive Medicine andPsychiatric Technicians.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Specialty Care
Psychiatric medications and evidence-based psychotherapies to be provided at a specialty mental clinic facilitated by psychiatric technicians, the mental health specialty workforce already in place in Mozambique.
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Patients who screen positive with any psychiatric condition are referred for evaluation and treatment according to the treatment arm.
This may combine psychiatric medications or evidence based psychotherapies according to treatment.
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Experimental: Integrated Care
Psychiatric medications and evidence-based psychotherapies to be provided by primary care providers.
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Patients who screen positive with any psychiatric condition are referred for evaluation and treatment according to the treatment arm.
This may combine psychiatric medications or evidence based psychotherapies according to treatment.
|
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Experimental: Community Clinic Stepped Care
Psychiatric medications and evidence-based psychotherapies to be provided by primary care providers and community health workers, respectively.
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Patients who screen positive with any psychiatric condition are referred for evaluation and treatment according to the treatment arm.
This may combine psychiatric medications or evidence based psychotherapies according to treatment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Reach (implementation)
Time Frame: Change from Baseline in Reach at 12 months
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Number of people who access mental health care from those who need care
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Change from Baseline in Reach at 12 months
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Cost
Time Frame: Cost of implementing each arm will be calculated through study completion, an average of 2 years
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Cost of Implementing each arm through the Stages of Implementation Completion (SIC) measure together with the Cost of Implementing New Strategies (COINS) method
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Cost of implementing each arm will be calculated through study completion, an average of 2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Retention (implementation)
Time Frame: Change from Baseline in Retention at 12 months
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Number of people who receive mental health care from those who need care
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Change from Baseline in Retention at 12 months
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Change in Clinical symptoms
Time Frame: Change from Baseline CmhTool at 12 months
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Symptom reduction using a newly validated tool - the Comprehensive Mental Health Tool (CmhTool) to monitor symptoms of common and severe mental disorders as well as substance use disorders
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Change from Baseline CmhTool at 12 months
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Collaborators and Investigators
Investigators
- Principal Investigator: Milton L Wainberg, MD, NYSPI
Publications and helpful links
General Publications
- Wainberg ML, Lovero KL, Duarte CS, Fiks Salem A, Mello M, Bezuidenhout C, Mootz J, Feliciano P, Suleman A, Fortunato Dos Santos P, Weissman MM, Cournos F, Marques AH, Fumo W, Mabunda D, Alves-Bradford JE, Mello M, Mari JJ, Ngwepe P, Cidav Z, Mocumbi AO, Medina-Marino A, Wall M, Gouveia L, Oquendo MA. Partnerships in Research to Implement and Disseminate Sustainable and Scalable Evidence-Based Practices (PRIDE) in Mozambique. Psychiatr Serv. 2021 Jul 1;72(7):802-811. doi: 10.1176/appi.ps.202000090. Epub 2020 Dec 18.
- Wainberg ML, Scorza P, Shultz JM, Helpman L, Mootz JJ, Johnson KA, Neria Y, Bradford JE, Oquendo MA, Arbuckle MR. Challenges and Opportunities in Global Mental Health: a Research-to-Practice Perspective. Curr Psychiatry Rep. 2017 May;19(5):28. doi: 10.1007/s11920-017-0780-z.
- Dos Santos PF, Wainberg ML, Caldas-de-Almeida JM, Saraceno B, Mari Jde J. Overview of the mental health system in Mozambique: addressing the treatment gap with a task-shifting strategy in primary care. Int J Ment Health Syst. 2016 Jan 4;10:1. doi: 10.1186/s13033-015-0032-8. eCollection 2016.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 7485
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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