Onu 2016.

Study name	Interpersonal psychotherapy for depression and post‐traumatic stress disorder among HIV‐positive women in Kisumu, Kenya: study protocol for a randomised controlled trial
Methods	Randomised controlled trial
Participants	Inclusion criteria 1. HIV+ women enrolled at Family AIDS Care Education and Services, Kisumu, Nyanza, Kenya (FACES‐Kisumu) 2. Diagnosis with depression (MDD, dysthymia, minor depression) and PTSD secondary to gender‐based violence (GBV) on the CIDI 3. Ability to attend weekly therapy sessions and repeated measures 4. Age ≥ 18 years 5. Ability to give informed consent. Exclusion criteria 1. Cognitive dysfunction requiring a higher level of care or compromising ability to participate in interpersonal therapy (IPT) 2. Severe thought or mood disorder symptoms requiring a higher level of care or interfering with ability to participate in IPT 3. Current drug and alcohol dependence requiring substance use treatment
Interventions	Intervention Interpersonal psychotherapy Interpersonal psychotherapy is an evidence‐based structured, brief psychotherapy that focuses on improving relationships to improve mood and reduce anxiety Control Treatment as usual Usual clinic psychosocial treatment
Outcomes	Primary outcome measures 1. Depression, PTSD [Time Frame: Change from 0 to 12 weeks, 12 to 24 weeks, and 24 to 36 weeks] 2. Structured clinical interview: Composite International Diagnostic Interview (CIDI) Secondary outcome measure   1. ARV adherence [Time Frame: Change from 0 to 12 weeks, 12 to 24 weeks, and 24 to 36 weeks] Visual analogue scale self‐report 1. HIV viral load [Time Frame: 12 weeks, 24 weeks, 36 weeks] Other outcome measures 1. Cost analyses [Time Frame: Cost: 12 weeks; benefits (DALYS and productivity): Change from 0 to 12 weeks, 12 to 24 weeks, and 24 to 36 weeks] 2. Neurocognitive outcomes [Time Frame: Change from 0 to 12 weeks, 12 to 24 weeks, and 24 to 36 weeks]
Starting date	September 2015
Contact information	Susan M Meffert, MD, MPH University of California, San Francisco
Notes	Completed 31 January 2019