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Maternal Depression Treatment in HIV (M-DEPTH)

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ClinicalTrials.gov Identifier: NCT03892915
Recruitment Status : Recruiting
First Posted : March 27, 2019
Last Update Posted : September 11, 2019
Sponsor:
Collaborators:
Makerere University
Mildmay Uganda
Information provided by (Responsible Party):
RAND

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
Depression Combination Product: evidence-based depression treatment 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Cluster randomized controlled trial with 4 sites randomly assigned to implement evidence-based depression care in addition to usual care and 4 sites randomly assigned to implement usual care only
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Depression Care to Improve Adherence to Prevention of Mother-to-Child-Transmission (PMTCT) Care Continuum & Pregnancy Outcomes
Actual Study Start Date : July 8, 2019
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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).



Primary Outcome Measures :
  1. Rate of maternal HIV viral suppression [ Time Frame: One month post pregnancy ]
    Proportion of participants who achieve undetectable HIV viral load as measured by blood assay

  2. Mean maternal antiretroviral (ART) adherence [ Time Frame: From study enrollment to one-month post pregnancy ]
    Group mean proportion 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 ]
    Proportion of participants who continue to attend antenatal care (ANC) visits as measured by chart abstraction

  4. Rate of delivery in health facility [ Time Frame: one month post pregnancy ]
    Proportion 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 ]
    Proportion of delivered infants who receive ART as measured by chart abstraction

  6. Rate of universal infant feeding [ Time Frame: First 6 months of life ]
    Proportion of delivered infants who receive uniform feeding method (breastfeeding or formula) as documented by self-report

  7. Rate of complete infant HIV testing [ Time Frame: 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 :
  1. Child HIV status [ Time Frame: 18 months after birth ]
    HIV status of child



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03892915


Contacts
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Contact: Glenn Wagner, PhD 310-393-0411 ext 7698 gwagner@rand.org

Locations
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Uganda
Makerere University Recruiting
Kampala, Uganda
Contact: Violet Gwokyalya       vgwokyalya@musph.ac.ug   
Sponsors and Collaborators
RAND
Makerere University
Mildmay Uganda
Investigators
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Principal Investigator: Glenn Wagner, PhD RAND

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: RAND
ClinicalTrials.gov Identifier: NCT03892915     History of Changes
Other Study ID Numbers: 2017-1041
First Posted: March 27, 2019    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We will make the data publicly available in the form of an electronic database for researchers who successfully complete a registration process. Data will be de-identified. We will provide documentation in the form of a codebook in which each variable name and response options are defined. Users must agree to the conditions of use governing access to the public release data. Users must submit brief proposals regarding intended use of the data; the study team will determine the scientific soundness of the proposal, as well as whether adequate data protections in place, as part of the decision for the researcher to be able to access the public use dataset.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Following publication of the main paper(s) for this study and the grant end-date.
Access Criteria: Users must submit brief proposals regarding intended use of the data; the study team will determine the scientific soundness of the proposal, as well as whether adequate data protections in place, as part of the decision for the researcher to be able to access the public use dataset.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders