Maternal Depression Treatment in HIV

NCT03892915 | Completed Phase 2 Results DMC

• 1 other identifier: 2017-1041
• Study Type: interventional
• Target: 391
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (5)

• Rate of Maternal HIV Viral Suppression

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

  Two months post pregnancy

• Mean Maternal Antiretroviral (ART) Adherence

  Group mean percentage of prescribed ART doses taken as measured by pharmacy refill data

  Past 6 months, assessed at 2 months after the completion of pregnancy

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

  Percentage 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

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

  two months post pregnancy

• Rate of Infant Use of ART

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

  First 6 weeks of life

Secondary Outcomes (1)

• Depression Status

  2 months postpartum

Study Arms (2)

Depression Care

EXPERIMENTAL

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

Usual care

NO INTERVENTION

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).

Interventions

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.

Depression Care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• unstable health (about to start ART or on ART \< 4 weeks; active, untreated opportunistic infection)

Sponsors & Collaborators

• RAND: lead
• Makerere University: collaborator
• Mildmay Uganda Limited: collaborator

Study Sites (1)

Makerere University

Kampala, Uganda

Location

Related Publications (6)

• Wagner GJ, Ghosh-Dastidar B, Gwokyalya V, Faherty LJ, Beyeza-Kashesya J, Nakku J, Nabitaka LK, Akena D, Nakigudde J, Ngo V, McBain R, Lukwata H, Kyohangirwe L, Mukasa B, Wanyenze RK. Effects of M-DEPTH model of depression care on maternal depression, functioning, and HIV care adherence, and infant developmental over eighteen months post-partum: results from a cluster randomized controlled trial. BMC Pregnancy Childbirth. 2025 Apr 5;25(1):400. doi: 10.1186/s12884-025-07443-0.

  PMID: 40188047 DERIVED

• McBain R, Okunogbe A, Gwokyalya V, Wanyenze RK, Wagner G. Economic evaluation of Maternal Depression Treatment in HIV (M-DEPTH) for perinatal depression among women living with HIV in Uganda: a cost-effectiveness analysis. BMJ Public Health. 2024 Jul 16;2(1):e000754. doi: 10.1136/bmjph-2023-000754. eCollection 2024 Jun.

  PMID: 40018208 DERIVED

• McBain RK, Schuler MS, Rukundo T, Wanyenze RK, Wagner GJ. Trajectories of perinatal depression among women living with HIV in Uganda. J Glob Health. 2024 Sep 20;14:04147. doi: 10.7189/jogh.14.04147.

  PMID: 39301593 DERIVED

• Wagner GJ, Gwokyalya V, Faherty L, Akena D, Nakigudde J, Ngo V, McBain R, Ghosh-Dastidar B, Beyeza-Kashesya J, Nakku J, Kyohangirwe L, Nabitaka LK, Lukwata H, Mukasa B, Wanyenze RK. Effects of M-DEPTH Model of Depression Care on Maternal HIV Viral Suppression and Adherence to the PMTCT Care Continuum Among HIV-Infected Pregnant Women in Uganda: Results from a Cluster Randomized Controlled Trial at Pregnancy Completion. AIDS Behav. 2023 Sep;27(9):2902-2914. doi: 10.1007/s10461-023-04014-2. Epub 2023 Mar 13.

  PMID: 36907945 DERIVED

• 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.

  PMID: 36127627 DERIVED

• 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.

  PMID: 31277180 DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Limitations and Caveats

With all participants being stable on ART and exhibiting a consistent HIV/ANC care retention throughout the study, as well as most having an undetectable HIV viral load at baseline, this may have contributed to a ceiling effect and limited the generalizability of our findings. The benefits of depression care may be more evident among women with a greater range of engagement in care, which in turn may be related to increased vulnerability to post-partum depression.

Results Point of Contact

• Title: Glenn Wagner
• Organization: RAND Corporation

gwagner@rand.org

310-393-0411

Study Officials

• Glenn Wagner, PhD

  RAND

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: March 21, 2019
• First Posted: March 27, 2019
• Study Start: July 8, 2019
• Primary Completion: August 31, 2023
• Study Completion: May 31, 2024
• Last Updated: November 15, 2024
• Results First Posted: November 15, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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.

Locations

UG (1)