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Maternal Depression Treatment in HIV

NCT03892915 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 391

Last updated 2024-11-15

Study results available
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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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Makerere University

    collaborator OTHER

  • Mildmay Uganda Limited

    collaborator OTHER

  • RAND

    lead OTHER

Principal Investigators

  • Glenn Wagner, PhD · RAND

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-08
Primary Completion
2023-08-31
Completion
2024-05-31

Countries

  • Uganda

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03892915 on ClinicalTrials.gov