A Phase 2/3 interventional study of evidence-based depression treatment in Depression, sponsored by RAND. Completed at 1 site in Uganda. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-15.
Sponsored by RAND · Phase 2/3, Interventional, and Treatment
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.
8,240 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 391 is above the median of 84 across 6,869 interventional studies indexed under Depression.
Browse Depression studies →RAND is the lead sponsor of 114 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
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 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).
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.
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
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
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
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
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
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
Recruitment took place between July 2019 and January 2021 at the antenatal clinic sites
| Milestone | Depression Care | Usual Care |
|---|---|---|
| Started | 191 | 200 |
| Completed | 171 | 167 |
| Not completed | 20 | 33 |
| Withdrew: Lost to follow-up | 6 | 12 |
| Withdrew: Death | 0 | 2 |
| Withdrew: Withdrawal by subject | 1 | 1 |
| Withdrew: Unsuccessful delivery | 13 | 18 |
Percentage of participants who achieve undetectable HIV viral load as measured by blood assay
| Participants | Depression Care | Usual Care |
|---|---|---|
| Rate of Maternal HIV Viral Suppression | 128 | 132 |
Group mean percentage of prescribed ART doses taken as measured by pharmacy refill data
| percentage of prescribed doses taken | Depression Care | Usual Care |
|---|---|---|
| Mean Maternal Antiretroviral (ART) Adherence | 95.2 ± 15.4 | 90.8 ± 20.2 |
Percentage of participants who continue to attend antenatal care (ANC) visits as measured by chart abstraction
| Participants | Depression Care | Usual Care |
|---|---|---|
| Rate of Prevention of Mother-to-child-transmission (PMTCT) Care Retention | 184 | 185 |
Percentage of participants who delivery their baby of in a health facility as measured by chart abstraction
| Participants | Depression Care | Usual Care |
|---|---|---|
| Rate of Delivery in Health Facility | 171 | 165 |
Percentage of delivered infants who receive ART as measured by chart abstraction
| Participants | Depression Care | Usual Care |
|---|---|---|
| Rate of Infant Use of ART | 174 | 164 |
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).
| Participants | Depression Care | Usual Care |
|---|---|---|
| Depression Status | 37 | 102 |
Collected over 24 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Depression Care | 0/191 (0%) | 13/191 (6.8%) | 0/191 (0%) |
| Usual Care | 2/200 (1%) | 18/200 (9%) | 0/200 (0%) |
| Event | Depression Care | Usual Care |
|---|---|---|
| death to fetus/newbornPregnancy, puerperium and perinatal conditions | 13/191 | 18/200 |
| Age, Continuous(years) | Depression Care | Usual Care | Total |
|---|---|---|---|
| Mean | 27.3 ± 5.7 | 27.7 ± 6.2 | 27.5 ± 5.9 |
| Sex: Female, Male(Participants) | Depression Care | Usual Care | Total |
|---|---|---|---|
| Female | 191 | 200 | 391 |
| Male | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Depression Care | Usual Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 191 | 200 | 391 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Depression Care | Usual Care | Total |
|---|---|---|---|
| Uganda | 191 | 200 | 391 |
| Any secondary education(Participants) | Depression Care | Usual Care | Total |
|---|---|---|---|
| Count of participants | 79 | 61 | 140 |
| In a committed relationship(Participants) | Depression Care | Usual Care | Total |
|---|---|---|---|
| Count of participants | 154 | 168 | 322 |
| Gestation week(weeks) | Depression Care | Usual Care | Total |
|---|---|---|---|
| Mean | 21.3 ± 6.4 | 21.4 ± 5.6 | 21.3 ± 6.0 |
| Newly diagnosed with HIV(Participants) | Depression Care | Usual Care | Total |
|---|---|---|---|
| Count of participants | 41 | 40 | 81 |
2 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
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.
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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