Cluster randomized controlled trial to compare the effects of task-shifted, evidence-based depression care vs. usual care on adherence to each step of the prevention of mother-to-child-transmission (PMTCT) care cascade at 8 antenatal care (ANC) clinics in Uganda.
This study is a cluster randomized controlled trial (RCT) to compare the effects of task-shifted, evidence-based depression care vs. usual care on adherence to each step of the PMTCT care cascade at 8 ANC clinics in Uganda. At 4 experimental sites, task-shifted, depression care will include (1) depression screening and psychoeducation, (2) depression diagnosis, and (3) provision of evidence-based problem solving therapy (PST), or antidepressant therapy (ADT) for those with severe and refractory depression (or who decline PST), to be implemented by trained peer mothers and midwife nurses, respectively. The 4 control sites will use usual care services for managing depression, which consist of referrals to a mental health specialist and access to the Family Support Group program (comprehensive, monthly multi-session psychosocial program to enhance pregnancy management and PMTCT adherence). At each site, 50 HIV-positive newly pregnant women (total n=400) who screen positive for potential depression will be enrolled and followed until 18-months post-delivery to assess how depression and depression alleviation relate to primary (adherence to each component of the PMTCT care continuum, maternal virologic suppression) and secondary (infant HIV status; post-natal maternal and child health outcomes) outcomes, as well as processes of depression care (treatment uptake and depression alleviation among clinically depressed patients). A cost-effectiveness analysis will be used to compare the two study arms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
391
We will use a stepped care approach to depression treatment. Participants with clinical depression (defined as PHQ-9\>9) will be offered either Problem Solving Therapy (PST) or Antidepressant Therapy (ADT), but those with moderate to moderately severe depression will be recommended PST, while those with severe depression will be recommended ADT. Participants with subthreshold depressive symptoms (PHQ-9: 5-9) will receive depression psychoeducation and continued depressive monitoring.
Makerere University
Kampala, Uganda
Rate of Maternal HIV Viral Suppression
Percentage of participants who achieve undetectable HIV viral load as measured by blood assay
Time frame: Two months post pregnancy
Mean Maternal Antiretroviral (ART) Adherence
Group mean percentage of prescribed ART doses taken as measured by pharmacy refill data
Time frame: Past 6 months, assessed at 2 months after the completion of pregnancy
Rate of Prevention of Mother-to-child-transmission (PMTCT) Care Retention
Percentage of participants who continue to attend antenatal care (ANC) visits as measured by chart abstraction
Time frame: through study completion, an average of 48 weeks
Rate of Delivery in Health Facility
Percentage of participants who delivery their baby of in a health facility as measured by chart abstraction
Time frame: two months post pregnancy
Rate of Infant Use of ART
Percentage of delivered infants who receive ART as measured by chart abstraction
Time frame: First 6 weeks of life
Depression Status
Depression was assessed with the 9-item Patient Health Questionnaire (PHQ-9); total score range is 0-27, with higher scores representing greater depression. total score \> 9 represents clinical depression and the binary depression status variable = yes (depressed).
Time frame: 2 months postpartum
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