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Table 2 A type I effectiveness-implementation hybrid trial design for global mental health: effectiveness

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

Study component Description
Treatment effectiveness: randomized controlled trial (RCT) within a routine clinical setting with minimal restrictions
 Target population HIV+ women affected by GBV with MDD and PTSD, enrolled in HIV care at the UCSF-KEMRI FACES clinic supported by PEPFAR, which treats >140,000 HIV+ individuals in the Nyanza region of Kenya
 Recruitment Study information provided in waiting area for self-referral, HIV clinic providers alerted to the study and eligibility criteria
 Eligibility HIV-infected women over age 18, enrolled in HIV care at FACES, PTSD secondary to GBV and MDD, absence of cognitive dysfunction, severe mood/thought disorders and substance abuse requiring a higher level/alternate care (qualitative needs assessment suggested that these criteria would identify a high proportion of HIV+GBV+ women in need of mental health care at FACES)
 Intervention Participants will be randomized to receive: [1] 12 sessions of weekly IPT delivered at the FACES clinic plus FACES psychosocial treatment as usual (TAU) or [2] FACES TAU; TAU group is offered IPT at week 12
 Concurrent treatment Any mental health counseling/psychotherapy, psychotropic medication, ARV adherence counseling, couples therapy, other study participation and/or other psychosocial intervention at the FACES clinic or outside is allowed and noted
 Retention For missed sessions or evaluations, participants are called up to four times and emergency contact is alerted
 RCT outcomes Primary: diagnosis of MDD/PTSD; Secondary: continuous measures of depression and PTSD symptoms, interpersonal functioning, anger, self-efficacy, substance use, quality of life, disability, HIV viral load, self-reported ARV adherence and neurocognitive functioning. Primary and secondary outcomes assessed at baseline and repeated at weeks 12, 24, 36
 IPT adaptation and therapist training Adaptations to IPT content and process to optimize fit while maintaining fidelity to IPT protocol, drawing on prior experience with IPT adaptation. Additional IPT adaptations were made based on feedback from therapist non-specialist trainees during 2 week formal IPT training and 12 week pilot cases
 Adherence to protocol Evaluated after each session by an IPT study supervisor, using a session-specific IPT adherence monitoring, consisting of 9–10 items scored on a 10 point likert scale, including a reverse coded item. All sessions are audio-recorded and a random 20 % of sessions are evaluated by an independent rater
 Sample size 220
 Data analysis Main analysis is comparison of change from baseline to post-treatment (12 weeks) between IPT+TAU and TAU. Maintenance of gains assessed by testing for significant change from 12 week to 24 and 36 week follow up assessments. Sub-group (sensitivity) analyses will be used to identify sub-groups for whom IPT+TAU is more or less effective
  1. ART anti-retroviral therapy; FACES family AIDS, care, GBV education and services; gender based violence; HIV+ HIV-positive; IPT interpersonal psychotherapy; KEMRI Kenya medical research institute; MDD major depressive disorder; PEPFAR president’s emergency plan for AIDS relief; PTSD posttraumatic stress disorder; TAU treatment as usual; UCSF University of California, San Francisco