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Completed

NCT Number: NCT03892915

Maternal Depression Treatment in HIV

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Makerere University

Kampala, Uganda

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

evidence-based depression treatment

Combination Product

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.

Primary outcomes

  1. Rate of Maternal HIV Viral Suppression

    Time frame: Two months post pregnancy

    Percentage of participants who achieve undetectable HIV viral load as measured by blood assay

  2. Mean Maternal Antiretroviral (ART) Adherence

    Time frame: 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

  3. Rate of Prevention of Mother-to-child-transmission (PMTCT) Care Retention

    Time frame: through study completion, an average of 48 weeks

    Percentage of participants who continue to attend antenatal care (ANC) visits as measured by chart abstraction

  4. Rate of Delivery in Health Facility

    Time frame: two months post pregnancy

    Percentage of participants who delivery their baby of in a health facility as measured by chart abstraction

  5. Rate of Infant Use of ART

    Time frame: First 6 weeks of life

    Percentage of delivered infants who receive ART as measured by chart abstraction

Secondary outcomes

  1. Depression Status

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

RAND

Other

Collaborators

  • Makerere University
  • Mildmay Uganda Limited

Registry information

Official study title

Depression Care to Improve Adherence to Prevention of Mother-to-Child-Transmission (PMTCT) Care Continuum & Pregnancy Outcomes

Acronym: M-DEPTH

Important dates

Study start
2019
Primary completion
2023
Study completion
2024
First posted
Mar 27, 2019
Registry last updated
Nov 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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