Maternal Depression Treatment in HIV

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Depression Care to Improve Adherence to Prevention of Mother-to-Child-Transmission (PMTCT) Care Continuum & Pregnancy Outcomes

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Combination Product: evidence-based depression treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: detection of pregnancy through 24 weeks gestation (to ensure at least 12 weeks remaining antenatal period for assessing adherence to all stages of PMTCT care cascade) HIV-positive positive screen for potential depression on 2-item Patient Health Questionnaire (PHQ-2>0) on ART for at least 4 weeks Exclusion Criteria: unstable health (about to start ART or on ART < 4 weeks; active, untreated opportunistic infection)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Cluster randomized controlled trial with 4 sites randomly assigned to implement evidence-based depression care in addition to usual care and 4 sites randomly assigned to implement usual care only
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Depression Care<br>Task-shifted depression care, consisting of (1) depression screening and psychoeducation, (2) depression diagnosis, and (3) 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 in addition to usual care. | Combination Product: evidence-based depression treatment<br>* 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.<br>|
| No Intervention: Usual care<br>Usual care processes for treating depression consist of referrals to mental health specialists and access to the Family Support Group program (a nation wide Ministry of Health program for HIV+ women at public ANC clinics, consisting of monthly sessions designed to provide psychosocial support and education to promote pregnancy management and PMTCT adherence). | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of maternal HIV viral suppression | Proportion of participants who achieve undetectable HIV viral load as measured by blood assay | One month post pregnancy | 
| Mean maternal antiretroviral (ART) adherence | Group mean proportion of prescribed ART doses taken as measured by pharmacy refill data | From study enrollment to one-month post pregnancy | 
| Rate of prevention of mother-to-child-transmission (PMTCT) care retention | Proportion of participants who continue to attend antenatal care (ANC) visits as measured by chart abstraction | through study completion, an average of 48 weeks | 
| Rate of delivery in health facility | Proportion of participants who delivery their baby of in a health facility as measured by chart abstraction | one month post pregnancy | 
| Rate of infant use of ART | Proportion of delivered infants who receive ART as measured by chart abstraction | First 6 weeks of life | 
| Rate of universal infant feeding | Proportion of delivered infants who receive uniform feeding method (breastfeeding or formula) as documented by self-report | First 6 months of life | 
| Rate of complete infant HIV testing | Proportion of delivered infants who are tested for HIV at all specified intervals, as measured by chart abstraction | 18 months after birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child HIV status | HIV status of child | 18 months after birth |