CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 391 enrolled
Drug / intervention
evidence-based depression treatmentcombination
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03892915
NCT03892915Phase 3Completed
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Depression Care to Improve Adherence to Prevention of Mother-to-Child-Transmission (PMTCT) Care Continuum & Pregnancy Outcomes

RAND·interventional·Posted Mar 27, 2019·Updated Nov 15, 2024

In Brief

A Phase 3 clinical trial evaluating evidence-based depression treatment for Depression. Completed, enrolled 391 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepression
CountriesUganda
CollaboratorsMakerere University, Mildmay Uganda Limited

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedMar 27, 2019
Enrollment StartJul 8, 2019
Primary CompletionAug 31, 2023
Study CompletionMay 31, 2024
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 7.3 years ago

Interventions

evidence-based depression treatmentcombination

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.