Maternal Depression Treatment in HIV

Phase 2

Completed

Conditions: Depression

Interventions: Combination Product: evidence-based depression treatment

Registration Number: NCT03892915

Lead Sponsor: RAND

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 391

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Depression Care	evidence-based depression treatment	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.

Primary Outcome Measures

Name	Time	Method
Rate of Infant Use of ART	First 6 weeks of life	Percentage of delivered infants who receive ART as measured by chart abstraction
Rate of Maternal HIV Viral Suppression	Two months post pregnancy	Percentage of participants who achieve undetectable HIV viral load as measured by blood assay
Mean Maternal Antiretroviral (ART) Adherence	Past 6 months, assessed at 2 months after the completion of pregnancy	Group mean percentage of prescribed ART doses taken as measured by pharmacy refill data
Rate of Prevention of Mother-to-child-transmission (PMTCT) Care Retention	through study completion, an average of 48 weeks	Percentage of participants who continue to attend antenatal care (ANC) visits as measured by chart abstraction
Rate of Delivery in Health Facility	two months post pregnancy	Percentage of participants who delivery their baby of in a health facility as measured by chart abstraction

Secondary Outcome Measures

Name	Time	Method
Depression Status	2 months postpartum	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).