Depression
Conditions
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.
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.
Interventions
COMBINATION_PRODUCTevidence-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.
Sponsors
Makerere University
Mildmay Uganda Limited
RAND
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Maternal HIV Viral Suppression | Two months post pregnancy | Percentage of participants who achieve undetectable HIV viral load as measured by blood assay |
| Mean Maternal Antiretroviral (ART) Adherence | 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 |
| Rate of Prevention of Mother-to-child-transmission (PMTCT) Care Retention | through study completion, an average of 48 weeks | Percentage of participants who continue to attend antenatal care (ANC) visits as measured by chart abstraction |
| Rate of Delivery in Health Facility | two months post pregnancy | Percentage of participants who delivery their baby of in a health facility as measured by chart abstraction |
| Rate of Infant Use of ART | First 6 weeks of life | Percentage of delivered infants who receive ART as measured by chart abstraction |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depression Status | 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). |
Countries
Uganda
Participant flow
Recruitment details
Recruitment took place between July 2019 and January 2021 at the antenatal clinic sites
Pre-assignment details
Once enrolled, participants were automatically assigned to their group, given the cluster randomization (e.g., they received what their site was assigned to)
Participants by arm
| Arm | Count |
|---|---|
| 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. | 191 |
| 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). | 200 |
| Total | 391 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 2 |
| Overall Study | Lost to Follow-up | 6 | 12 |
| Overall Study | unsuccessful delivery | 13 | 18 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Usual Care | Total | Depression Care |
|---|---|---|---|
| Age, Continuous | 27.7 years STANDARD_DEVIATION 6.2 | 27.5 years STANDARD_DEVIATION 5.9 | 27.3 years STANDARD_DEVIATION 5.7 |
| Any secondary education | 61 Participants | 140 Participants | 79 Participants |
| depressive symptoms | 13.6 units on a scale STANDARD_DEVIATION 5.6 | 12.7 units on a scale STANDARD_DEVIATION 5.2 | 11.9 units on a scale STANDARD_DEVIATION 4.5 |
| Gestation week | 21.4 weeks STANDARD_DEVIATION 5.6 | 21.3 weeks STANDARD_DEVIATION 6 | 21.3 weeks STANDARD_DEVIATION 6.4 |
| In a committed relationship | 168 Participants | 322 Participants | 154 Participants |
| Newly diagnosed with HIV | 40 Participants | 81 Participants | 41 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 200 Participants | 391 Participants | 191 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Uganda | 200 participants | 391 participants | 191 participants |
| Sex: Female, Male Female | 200 Participants | 391 Participants | 191 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| undetectable HIV viral load | 120 Participants | 228 Participants | 108 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 191 | 2 / 200 |
| other Total, other adverse events | 0 / 191 | 0 / 200 |
| serious Total, serious adverse events | 13 / 191 | 18 / 200 |
Outcome results
Primary
Mean Maternal Antiretroviral (ART) Adherence
Group mean percentage of prescribed ART doses taken as measured by pharmacy refill data
Time frame: Past 6 months, assessed at 2 months after the completion of pregnancy
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Depression Care | Mean Maternal Antiretroviral (ART) Adherence | 95.2 percentage of prescribed doses taken | Standard Deviation 15.4 |
| Usual Care | Mean Maternal Antiretroviral (ART) Adherence | 90.8 percentage of prescribed doses taken | Standard Deviation 20.2 |
Primary
Rate of Delivery in Health Facility
Percentage of participants who delivery their baby of in a health facility as measured by chart abstraction
Time frame: two months post pregnancy
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Depression Care | Rate of Delivery in Health Facility | 171 Participants |
| Usual Care | Rate of Delivery in Health Facility | 165 Participants |
95% CI: [0.53, 6.5]
Primary
Rate of Infant Use of ART
Percentage of delivered infants who receive ART as measured by chart abstraction
Time frame: First 6 weeks of life
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Depression Care | Rate of Infant Use of ART | 174 Participants |
| Usual Care | Rate of Infant Use of ART | 164 Participants |
95% CI: [0.45, 16.64]
Primary
Rate of Maternal HIV Viral Suppression
Percentage of participants who achieve undetectable HIV viral load as measured by blood assay
Time frame: Two months post pregnancy
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Depression Care | Rate of Maternal HIV Viral Suppression | 128 Participants |
| Usual Care | Rate of Maternal HIV Viral Suppression | 132 Participants |
95% CI: [0.73, 1.93]
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
Time frame: through study completion, an average of 48 weeks
Population: Number of participants randomly assigned to this group
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Depression Care | Rate of Prevention of Mother-to-child-transmission (PMTCT) Care Retention | 184 Participants |
| Usual Care | Rate of Prevention of Mother-to-child-transmission (PMTCT) Care Retention | 185 Participants |
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).
Time frame: 2 months postpartum
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Depression Care | Depression Status | 37 Participants |
| Usual Care | Depression Status | 102 Participants |
95% CI: [0.05, 0.83]