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

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 team^a

 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