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Table 3 A Type I effectiveness-implementation hybrid trial design for global mental health: implementation

From: Novel implementation research designs for scaling up global mental health care: overcoming translational challenges to address the world’s leading cause of disability

Implementation factor Goal Strategy
Treatment implementation
 Study location Deliver mental health care in patients’ preferred manner using a system that can be taken to scale Integrate mental health treatment within the HIV clinic, with clear delineation of the treatment pathway, including case identification, treatment, discharge and referral decision rules
 Study personnel Promote knowledge and integration of mental health care within the HIV clinic Employ clinic staff as study personnel when possible
 Clinic staff involvement Engage clinic staff in a dialogue on the need for and benefits of mental health care within the HIV clinic and develop a common understanding of potential facilitators and barriers to treatment Key clinic staff serve as study advisors and attend weekly meeting—e.g., IPT peer supervision is attended by leaders of the clinic’s ARV adherence teama
 Study treatment personnel Evaluate the success of implementing mental health treatment delivered by local non-specialists Train and employ local, non-specialists to provide low cost, mental health care
 Supervision Build sustainable, local IPT supervision IPT study therapists are supervised by IPT experts and by a weekly peer group of study therapists. During the study, supervision responsibility is transferred from experts to the local peer group
 Sampling frame Optimize applicability of study Broad eligibility
 Non mental health outcomes Identify key correlates of mental health treatment:  
 HIV health HIV health outcomes: viral load, ART adherence
 Cognitive function Neurocognitive testing
 Economic gains Cost-benefit analyses of mental health care for HIV+ women, including changes in formal and informal income
 Psychosocial Quality of life, functionality, re-victimization
 Identify participant, therapist and clinic experience with delivering mental health treatment, including burden to clinic staff and suggestions for improvement Qualitative interviews throughout and at the conclusion of the study, with integration of feedback to optimize treatment implementation parameters
 Policy maker involvement Collaborate with policy makers to create a scalable mental health treatment for HIV+ women in Kenya Meet with local policy makers and invite them to the study, identify their data needs for scaling up mental health care, work to meet these needs
 Refinements for scale up Refine treatment, delivery and stakeholder involvement to optimize the intervention for national scale up Formative evaluation of using qualitative exit interviews with study participants, therapists, clinic staff, policy makers and other stakeholders
  1. ART anti-retroviral therapy, IPT interpersonal psychotherapy
  2. aThe clinic’s ART adherence team leader and other members were identified during the needs assessment and training period as local experts in psychosocial needs and emotional communication with the clinic’s patients