Maternal Depression Treatment in HIV (M-DEPTH)

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

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 Overview

• Status: Active, not recruiting
• Conditions: Depression
• Intervention / Treatment: Combination product: evidence-based depression treatment

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.

• Study Type: Interventional
• Enrollment (Actual): 391
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Uganda
  • Kampala, Uganda
    • Makerere University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of maternal HIV viral suppression	Proportion of participants who achieve undetectable HIV viral load as measured by blood assay	One month post pregnancy
Mean maternal antiretroviral (ART) adherence	Group mean proportion of prescribed ART doses taken as measured by pharmacy refill data	From study enrollment to one-month post pregnancy
Rate of prevention of mother-to-child-transmission (PMTCT) care retention	Proportion of participants who continue to attend antenatal care (ANC) visits as measured by chart abstraction	through study completion, an average of 48 weeks
Rate of delivery in health facility	Proportion of participants who delivery their baby of in a health facility as measured by chart abstraction	one month post pregnancy
Rate of infant use of ART	Proportion of delivered infants who receive ART as measured by chart abstraction	First 6 weeks of life
Rate of universal infant feeding	Proportion of delivered infants who receive uniform feeding method (breastfeeding or formula) as documented by self-report	First 6 months of life
Rate of complete infant HIV testing	Proportion of delivered infants who are tested for HIV at all specified intervals, as measured by chart abstraction	18 months after birth

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child HIV status	HIV status of child	18 months after birth

Collaborators and Investigators

• Sponsor: RAND
• Collaborators: Makerere University; Mildmay Uganda Limited
• Investigators: Principal Investigator: Glenn Wagner, PhD, RAND

Publications and helpful links

General Publications

• Wagner GJ, McBain RK, Akena D, Ngo V, Nakigudde J, Nakku J, Chemusto H, Beyeza-Kashesya J, Gwokyalya V, Faherty LJ, Kyohangirwe L, Nabitaka LK, Lukwata H, Linnemayr S, Ghosh-Dastidar B, Businge J, Mukasa B, Wanyenze RK. Maternal depression treatment in HIV (M-DEPTH): Study protocol for a cluster randomized controlled trial. Medicine (Baltimore). 2019 Jul;98(27):e16329. doi: 10.1097/MD.0000000000016329.
• Wagner GJ, Gwokyalya V, Akena D, Nakigudde J, McBain R, Faherty L, Ngo V, Nakku J, Kyohangirwe L, Banegura A, Beyeza-Kashesya J, Wanyenze RK. Stressors and Maladaptive Coping Mechanisms Associated with Elevated Perinatal Depressive Symptoms and Suicidality Among Women Living with HIV in Uganda. Int J Behav Med. 2023 Oct;30(5):743-752. doi: 10.1007/s12529-022-10124-3. Epub 2022 Sep 20.

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2019
• Primary Completion (Actual): August 31, 2023
• Study Completion (Estimated): May 31, 2024

Study Registration Dates

• First Submitted: March 21, 2019
• First Submitted That Met QC Criteria: March 25, 2019
• First Posted (Actual): March 27, 2019

Study Record Updates

• Last Update Posted (Estimated): November 16, 2023
• Last Update Submitted That Met QC Criteria: November 14, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: 2017-1041

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Time Frame: Following publication of the main paper(s) for this study and the grant end-date.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No