title: Interpersonal psychotherapy for depression and posttraumatic stress disorder among HIV-positive women in Kisumu, Kenya: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Mental disorders are the leading global cause of years lived with disability; the majority of this burden exists in low and middle income countries (LMICs). Over half of mental illness is attributable to depression and anxiety disorders, both of which have known treatments. While the scarcity of mental health care providers is recognized as a major contributor to the magnitude of untreated disorders in LMICs, studies in LMICs find that evidence-based treatments for depression and anxiety disorders, such as brief, structured psychotherapies, are feasible, acceptable and have strong efficacy when delivered by local non-specialist personnel. However, most mental health treatment studies using non-specialist providers in LMICs deploy traditional efficacy designs (T1) without the benefit of integrated mental health treatment models shown to succeed over vertical interventions or methods derived from new implementation science to speed policy change. Here, we describe an effectiveness-implementation hybrid study that evaluates non-specialist delivery of mental health treatment within an HIV clinic for HIV-positive (HIV+) women affected by gender- based violence (GBV) (HIV+ GBV+) in the Nyanza region of Kenya.
  
  
  METHODS
  In this effectiveness-implementation hybrid type I design, 200 HIV+ women with major depressive disorder (MDD) and posttraumatic stress disorder (PTSD) who are receiving care at a Family AIDS Care Education and Services (FACES)-supported clinic in Kisumu, Kenya will be randomized to: (1) interpersonal psychotherapy (IPT) + treatment as usual (TAU) or (2) TAU, both delivered within the HIV clinic. IPT will consist of 12 weekly 60-minute individual IPT sessions, delivered by non-specialists trained to provide IPT. Primary effectiveness outcomes will include MDD and PTSD diagnosis on the Mini International Diagnostic Interview (MINI). Primary implementation outcomes will include treatment cost-benefit, acceptability, appropriateness, feasibility and fidelity of the IPT delivery within an HIV clinic.
  
  
  CONCLUSIONS
  This trial leverages newly defined effectiveness-implementation hybrid designs to gather data on mental health treatment implementation within an HIV care clinic, while testing the effectiveness of an evidence-based treatment for use with a large underserved population (HIV+ GBV+ women) in Kenya.
  
  
  BACKGROUND
  
  
  
  BACKGROUND
  NCT02320799, registered on 9 September 2014.
authors: School of Medicine, University of California, San Francisco, 500 Parnassus Avenue, San Francisco, CA, 94121, USA. chinwe.onu@ucsf.edu.
authors: Chinwe
authors: C
authors: Onu
authors: Kenya Medical Research Institute, PO Box 54840, 00200, Nairobi, Kenya. longeri@kemri.org.
authors: Linnet
authors: L
authors: Ongeri
authors: Department of Psychiatry, University of Nairobi, Kenya, PO Box 19676, Nairobi, Kenya. ebukusi@kemri.org.|Department of Obstetrics and Gynecology, University of Nairobi, Kenya, PO Box 19676, Nairobi, Kenya. ebukusi@kemri.org.
authors: Elizabeth
authors: E
authors: Bukusi
authors: Department of Obstetrics and Gynecology, University of California, San Francisco, 550 16th Street, San Francisco, CA, 94158, USA. ccohen@globalhealth.ucsf.edu.
authors: Craig R
authors: CR
authors: Cohen
authors: Department of Psychiatry, University of California, San Francisco, 4150 Clement Street, San Francisco, CA, 94121, USA. Thomas.Neylan@ucsf.edu.
authors: Thomas C
authors: TC
authors: Neylan
authors: Family AIDS Care Education and Services, Kenya, PO Box 614-40100, Kisumu, Kenya. Poyaro@kemri-ucsf.org.
authors: Patrick
authors: P
authors: Oyaro
authors: Family AIDS Care Education and Services, Kenya, PO Box 614-40100, Kisumu, Kenya. grcrota@gmail.com.
authors: Grace
authors: G
authors: Rota
authors: Family AIDS Care Education and Services, Kenya, PO Box 614-40100, Kisumu, Kenya. fotewa@kemri-ucsf.org.
authors: Faith
authors: F
authors: Otewa
authors: Department of Psychiatry, University of California, San Francisco, 401 Parnassus avenue, San Francisco, CA, 94143, USA. Kevin.delucchi@ucsf.edu.
authors: Kevin L
authors: KL
authors: Delucchi
authors: Department of Psychiatry, University of California, San Francisco, 401 Parnassus avenue, San Francisco, CA, 94143, USA. Susan.meffert@ucsf.edu.
authors: Susan M
authors: SM
authors: Meffert
mesh_terms: D002985:Clinical Protocols; D003627:Data Interpretation, Statistical; D003865:Major Depressive Disorder / Q000628:therapy*; D005260:Female; D006679:HIV Seropositivity / Q000523:psychology*; D006801:Humans; D008605:Mental Health Services; D011613:Psychotherapy / Q000379:methods*; D018401:Sample Size; D013313:Stress Disorders, Post-Traumatic / Q000628:therapy*