Fawzi 2020.

Study name	Healthy Options: study protocol and baseline characteristics for a cluster‐randomised controlled trial of group psychotherapy for perinatal women living with HIV and depression in Tanzania
Methods	Cluster‐randomised controlled trial
Participants	Clusters were primary healthcare facilities with a reproductive and child health (RCH) clinic that provided PMTCT services and satellite facilities Inclusion criteria 1. Women age 18 years and older 2. Up to 30 weeks' gestation 3. HIV‐positive receiving ART 4. Symptoms consistent with major depressive disorder on the PHQ‐9, scoring ≥ 9 5. Planning to continue postpartum care at study facility Exclusion criteria 1. Plan to harm self, including suicide
Interventions	Intervention Healthy Options intervention Includes components from problem‐solving therapy and cognitive‐behavioural therapy approaches. Six psychosocial group therapy sessions and 1 orientation session prior to delivery provided problem‐solving therapy. Following delivery, women who scored ≥ 9 on the PHQ‐9 are invited to participate in 8 cognitive‐behavioural group sessions. Psychosocial support group sessions are facilitated by lay community‐based healthcare workers experienced in providing HIV‐related peer counselling and support, who have been trained for 2 weeks. Group sessions are 2 to 3 hours long and are held in health facilities, schools, or religious sites   Control Improved standard of care A 1‐day training session offered to clinical staff of the RCH clinics based on WHO mhGAP guidelines. Patients cared for in control group facilities are given access to counselling and antidepressant treatment when necessary, including immediate care if presenting with acute suicidal ideation
Outcomes	Primary outcomes 1. PHQ‐9 score Secondary outcomes 1. Intimate partner violence ‐ DHS 2. Social support – Duke University‐UNC Functional Social Support Questionnaire 3. Self‐efficacy – General Self‐Efficacy Scale 4. Hope – local scale 5. HIV‐related stigma – HIV Stigma Scale 6. ART adherence 7. Food insecurity – custom composite measure
Starting date	May 2015
Contact information	mksfawzi@msn.com
Notes	Registered under clinicaltrials.gov as NCT02039973