Wagner 2019.

Study name	Maternal depression treatment in HIV (M‐DEPTH): study protocol for a cluster‐randomised controlled trial
Methods	Cluster‐randomised controlled trial
Participants	8 antenatal clinics in Uganda will be randomised Inclusion criteria 1. Pregnant up to 24 weeks' gestation, attending antenatal clinic 2. HIV positive, on ART for ≥ 4 weeks 3. Age ≥ 15 years 4. Patient Health Questionnaire (PHQ‐9) > 4 Exclusion criteria 1. Unstable health (about to start ART or on ART < 4 weeks; active, untreated opportunistic infection)
Interventions	Intervention Maternal depression treatment in HIV (M‐DEPTH) Stepped care approach. Usual care, problem‐solving therapy through manualised individual counselling sessions by trained peer mothers and antidepressant treatment (fluoxetine, imipramine, or amitriptyline) for severe or refractory depression after the first trimester prescribed by midwife nurses and supervised by the doctor‐in‐charge. Participants with clinical depression (defined as PHQ‐9 > 9) will be offered problem‐solving therapy (PST) or antidepressant therapy (ADT), but those with moderate to moderately severe depression will be recommended PST, and those with severe depression will be recommended ADT. Participants with sub‐threshold depressive symptoms (PHQ‐9 5 to 9) will receive depression psychoeducation and continued depressive monitoring. Treatment is discontinued if symptoms are in remission (PHQ‐0 < 5) for 6 months and patient is at least 6 months past completion of pregnancy. Supervision of peer mothers and midwife nurses will be conducted 1‐on‐1 and in groups, and will be weekly for the first 2 months, bi‐weekly for the next 4 months, and monthly thereafter. Supervisors are available 24/7 for suicide and emergency consultations  Control Usual care Referral to mental health specialist at district or regional hospital for care of depression. Access to the Family Support Group programme for care of HIV in pregnancy, including psychosocial support, instruction and education to support pregnancy, and postpartum care including PMTCT adherence through 24 two‐hour monthly group sessions. Pill counts and adherence counselling as needed
Outcomes	Primary outcomes 1. Rate of maternal HIV viral suppression 1 month post pregnancy 2. Mean maternal antiretroviral adherence from study enrolment to 1 month post pregnancy 3. Rate of prevention of mother‐to‐child transmission care retention through study completion 4. Rate of delivery in health facility 1 month post pregnancy 5. Rate of infant use of ART in first 6 weeks of life 6. Rate of universal infant feeding in first 6 months of life 7. Rate of complete infant HIV testing 18 months after birth Secondary outcomes 1. Pregnancy outcome 2. Inventory of functional status after childbirth self‐report 3. New baby sub‐scale of the Postpartum Adjustment Questionnaire 4. Child’s weight, height 5. Ages and Stages Questionnaire 6. Child HIV status at month 18 7. PHQ‐9 8. Rate of depression alleviation or response to depression treatment (PHQ‐9 < 5) 9. Depression treatment uptake and attendance 10. Other mental health services received Others 1. Process evaluation 2. Provider experience 3. Patient experience
Starting date	8 July 2019
Contact information	gwagner@rand.org
Notes	Estimated completion date: December 2022 Registered at clinicaltrials.gov as NCT03892915

CBA: controlled before‐and‐after; HIV: human immunodeficiency virus; HSCL: Hopkins Symptom Checklist; MINI: Mini International Neuropsychiatry Interview; NSHW: non‐specialist health worker; RCT: randomised controlled trial; STI: sexually transmitted infection.