M-DEPTH: Maternal Depression Treatment in HIV
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Depression Care 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
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.
|
| No Intervention: Usual care 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). |
Outcome Measures
Primary Outcome Measures
- Rate of maternal HIV viral suppression [One month post pregnancy]
Proportion of participants who achieve undetectable HIV viral load as measured by blood assay
- Mean maternal antiretroviral (ART) adherence [From study enrollment to one-month post pregnancy]
Group mean proportion 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]
Proportion of participants who continue to attend antenatal care (ANC) visits as measured by chart abstraction
- Rate of delivery in health facility [one month post pregnancy]
Proportion of participants who delivery their baby of in a health facility as measured by chart abstraction
- Rate of infant use of ART [First 6 weeks of life]
Proportion of delivered infants who receive ART as measured by chart abstraction
- Rate of universal infant feeding [First 6 months of life]
Proportion of delivered infants who receive uniform feeding method (breastfeeding or formula) as documented by self-report
- Rate of complete infant HIV testing [18 months after birth]
Proportion of delivered infants who are tested for HIV at all specified intervals, as measured by chart abstraction
Secondary Outcome Measures
- Child HIV status [18 months after birth]
HIV status of child
Eligibility Criteria
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Makerere University | Kampala | Uganda |
Sponsors and Collaborators
- RAND
- Makerere University
- Mildmay Uganda Limited
Investigators
- Principal Investigator: Glenn Wagner, PhD, RAND
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2017-1041