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| Name | Class |
|---|---|
| Makerere University | OTHER |
| Mildmay Uganda Limited | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Depression Status | 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). | 2 months postpartum |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Glenn Wagner, PhD | RAND | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Makerere University | Kampala | Uganda |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40188047 | Derived | 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. | |
| 40018208 |
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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.
Following publication of the main paper(s) for this study and the grant end-date.
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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Once enrolled, participants were automatically assigned to their group, given the cluster randomization (e.g., they received what their site was assigned to)
Recruitment took place between July 2019 and January 2021 at the antenatal clinic sites
| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| FG001 | 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). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Rate of Maternal HIV Viral Suppression | Percentage of participants who achieve undetectable HIV viral load as measured by blood assay | Posted | Count of Participants | Participants | Two months post pregnancy |
|
24 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| death to fetus/newborn | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | miscarriage, abortion, stillbirth, neonatal death |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Glenn Wagner | RAND Corporation | 310-393-0411 | 7695 | gwagner@rand.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 16, 2019 | Sep 16, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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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
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|
| 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. |
| 39301593 | 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. |
| 36907945 | 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. |
| 36127627 | 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. |
| 31277180 | 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. |
| Withdrawal by Subject |
|
| unsuccessful delivery |
|
| BG001 | 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). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Any secondary education | Count of Participants | Participants |
|
| In a committed relationship | Count of Participants | Participants |
|
| Gestation week | Mean | Standard Deviation | weeks |
|
| Newly diagnosed with HIV | Count of Participants | Participants |
|
| undetectable HIV viral load | Count of Participants | Participants |
|
| depressive symptoms | PHQ-9 (Patient Health Questionnaire, 9-item) total score (range is 0-27, with higher scores representing greater depression), measures depression | Mean | Standard Deviation | units on a scale |
|
| OG001 | 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 | Mean Maternal Antiretroviral (ART) Adherence | Group mean percentage of prescribed ART doses taken as measured by pharmacy refill data | Posted | Mean | Standard Deviation | percentage of prescribed doses taken | Past 6 months, assessed at 2 months after the completion of pregnancy |
|
|
|
|
| Primary | 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 | Number of participants randomly assigned to this group | Posted | Count of Participants | Participants | through study completion, an average of 48 weeks |
|
|
|
| Primary | Rate of Delivery in Health Facility | Percentage of participants who delivery their baby of in a health facility as measured by chart abstraction | Posted | Count of Participants | Participants | two months post pregnancy |
|
|
|
|
| Primary | Rate of Infant Use of ART | Percentage of delivered infants who receive ART as measured by chart abstraction | Posted | Count of Participants | Participants | First 6 weeks of life |
|
|
|
|
| Secondary | Depression Status | 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). | Posted | Count of Participants | Participants | 2 months postpartum |
|
|
|
|
| 0 |
| 191 |
| 13 |
| 191 |
| 0 |
| 191 |
| EG001 | 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). | 2 | 200 | 18 | 200 | 0 | 200 |
|
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