Phase 3
Completed N=391
Maternal Depression Treatment in HIV
Source: ClinicalTrials.gov NCT03892915 ↗Enrolled (actual)
391
Serious AEs
7.9%
Results posted
Nov 2024
Primary outcomePrimary: Rate of Maternal HIV Viral Suppression — 128; 132 Participants
◆ Published Evidence
Emerging
10citations · ~3 / year
Effects of M-DEPTH Model of Depression Care on Maternal HIV Viral Suppression and Adherence to the PMTCT Care Continuum Among HIV-Infected Pregnant Women in Uganda: Results from a Cluster Randomized Controlled Trial at Pregnancy Completion.
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.
Linked Publications (5)
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Effects of M-DEPTH Model of Depression Care on Maternal HIV Viral Suppression and Adherence to the PMTCT Care Continuum Among HIV-Infected Pregnant Women in Uganda: Results from a Cluster Randomized Controlled Trial at Pregnancy Completion.
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Stressors and Maladaptive Coping Mechanisms Associated with Elevated Perinatal Depressive Symptoms and Suicidality Among Women Living with HIV in Uganda.
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Economic evaluation of Maternal Depression Treatment in HIV (M-DEPTH) for perinatal depression among women living with HIV in Uganda: a cost-effectiveness analysis.
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Effects of M-DEPTH model of depression care on maternal depression, functioning, and HIV care adherence, and infant developmental over eighteen months post-partum: results from a cluster randomized controlled trial.
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Trajectories of perinatal depression among women living with HIV in Uganda.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Maternal HIV Viral Suppression |
128; 132 | — |
| PRIMARY Mean Maternal Antiretroviral (ART) Adherence |
95.2; 90.8 | — |
| PRIMARY Rate of Prevention of Mother-to-child-transmission (PMTCT) Care Retention |
184; 185 | — |
| PRIMARY Rate of Delivery in Health Facility |
171; 165 | — |
| PRIMARY Rate of Infant Use of ART |
174; 164 | — |
| SECONDARY Depression Status |
37; 102 | — |
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)
Data sourced from ClinicalTrials.gov (NCT03892915) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.