Trial Outcomes & Findings for Maternal Depression Treatment in HIV (NCT NCT03892915)
NCT ID: NCT03892915
Last Updated: 2024-11-15
Results Overview
Percentage of participants who achieve undetectable HIV viral load as measured by blood assay
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
391 participants
Primary outcome timeframe
Two months post pregnancy
Results posted on
2024-11-15
Participant Flow
Recruitment took place between July 2019 and January 2021 at the antenatal clinic sites
Once enrolled, participants were automatically assigned to their group, given the cluster randomization (e.g., they received what their site was assigned to)
Unit of analysis: clinic site
Participant milestones
| Measure |
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.
|
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).
|
|---|---|---|
|
Overall Study
STARTED
|
191 4
|
200 4
|
|
Overall Study
COMPLETED
|
171 4
|
167 4
|
|
Overall Study
NOT COMPLETED
|
20 0
|
33 0
|
Reasons for withdrawal
| Measure |
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.
|
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).
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
12
|
|
Overall Study
Death
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
unsuccessful delivery
|
13
|
18
|
Baseline Characteristics
Maternal Depression Treatment in HIV
Baseline characteristics by cohort
| Measure |
Depression Care
n=191 Participants
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.
|
Usual Care
n=200 Participants
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).
|
Total
n=391 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27.3 years
STANDARD_DEVIATION 5.7 • n=5 Participants
|
27.7 years
STANDARD_DEVIATION 6.2 • n=7 Participants
|
27.5 years
STANDARD_DEVIATION 5.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
191 Participants
n=5 Participants
|
200 Participants
n=7 Participants
|
391 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
191 Participants
n=5 Participants
|
200 Participants
n=7 Participants
|
391 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Uganda
|
191 participants
n=5 Participants
|
200 participants
n=7 Participants
|
391 participants
n=5 Participants
|
|
Any secondary education
|
79 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
140 Participants
n=5 Participants
|
|
In a committed relationship
|
154 Participants
n=5 Participants
|
168 Participants
n=7 Participants
|
322 Participants
n=5 Participants
|
|
Gestation week
|
21.3 weeks
STANDARD_DEVIATION 6.4 • n=5 Participants
|
21.4 weeks
STANDARD_DEVIATION 5.6 • n=7 Participants
|
21.3 weeks
STANDARD_DEVIATION 6.0 • n=5 Participants
|
|
Newly diagnosed with HIV
|
41 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
undetectable HIV viral load
|
108 Participants
n=5 Participants
|
120 Participants
n=7 Participants
|
228 Participants
n=5 Participants
|
|
depressive symptoms
|
11.9 units on a scale
STANDARD_DEVIATION 4.5 • n=5 Participants
|
13.6 units on a scale
STANDARD_DEVIATION 5.6 • n=7 Participants
|
12.7 units on a scale
STANDARD_DEVIATION 5.2 • n=5 Participants
|
PRIMARY outcome
Timeframe: Two months post pregnancyPercentage of participants who achieve undetectable HIV viral load as measured by blood assay
Outcome measures
| Measure |
Depression Care
n=191 Participants
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.
|
Usual Care
n=200 Participants
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).
|
|---|---|---|
|
Rate of Maternal HIV Viral Suppression
|
128 Participants
|
132 Participants
|
PRIMARY outcome
Timeframe: Past 6 months, assessed at 2 months after the completion of pregnancyGroup mean percentage of prescribed ART doses taken as measured by pharmacy refill data
Outcome measures
| Measure |
Depression Care
n=191 Participants
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.
|
Usual Care
n=200 Participants
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).
|
|---|---|---|
|
Mean Maternal Antiretroviral (ART) Adherence
|
95.2 percentage of prescribed doses taken
Standard Deviation 15.4
|
90.8 percentage of prescribed doses taken
Standard Deviation 20.2
|
PRIMARY outcome
Timeframe: through study completion, an average of 48 weeksPopulation: Number of participants randomly assigned to this group
Percentage of participants who continue to attend antenatal care (ANC) visits as measured by chart abstraction
Outcome measures
| Measure |
Depression Care
n=191 Participants
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.
|
Usual Care
n=200 Participants
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).
|
|---|---|---|
|
Rate of Prevention of Mother-to-child-transmission (PMTCT) Care Retention
|
184 Participants
|
185 Participants
|
PRIMARY outcome
Timeframe: two months post pregnancyPercentage of participants who delivery their baby of in a health facility as measured by chart abstraction
Outcome measures
| Measure |
Depression Care
n=191 Participants
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.
|
Usual Care
n=200 Participants
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).
|
|---|---|---|
|
Rate of Delivery in Health Facility
|
171 Participants
|
165 Participants
|
PRIMARY outcome
Timeframe: First 6 weeks of lifePercentage of delivered infants who receive ART as measured by chart abstraction
Outcome measures
| Measure |
Depression Care
n=191 Participants
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.
|
Usual Care
n=200 Participants
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).
|
|---|---|---|
|
Rate of Infant Use of ART
|
174 Participants
|
164 Participants
|
SECONDARY outcome
Timeframe: 2 months postpartumDepression 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).
Outcome measures
| Measure |
Depression Care
n=191 Participants
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.
|
Usual Care
n=200 Participants
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).
|
|---|---|---|
|
Depression Status
|
37 Participants
|
102 Participants
|
Adverse Events
Depression Care
Serious events: 13 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care
Serious events: 18 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Depression Care
n=191 participants at risk
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.
|
Usual Care
n=200 participants at risk
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).
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
death to fetus/newborn
|
6.8%
13/191 • 24 months
|
9.0%
18/200 • 24 months
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place