DepressionPhase 2/3M-DEPTHNCT03892915

Maternal Depression Treatment in HIV

A Phase 2/3 study testing evidence-based depression treatment in people with Depression, run by RAND at 1 site in Uganda.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Depression
What is being tested?: evidence-based depression treatment
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 391 participants
Where: 1 siteUganda
Study dates: 8 Jul 2019to 31 May 2024
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Uganda1 site

Makerere University
Kampala

Other trials in Uganda

About this study

Official title: Depression Care to Improve Adherence to Prevention of Mother-to-Child-Transmission (PMTCT) Care Continuum & Pregnancy Outcomes

Read the 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.

Conditions: Depression
Being tested: evidence-based depression treatment
Medical subject headings: Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

evidence-based depression treatmentCombination 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.

Study groups in NCT03892915
Study group	Role	What they receive
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. Receives: 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).

What is being measured

The primary outcome is the main question the study is designed to answer.

Rate of Maternal HIV Viral Suppression
Percentage of participants who achieve undetectable HIV viral load as measured by blood assay
Measured: Two months post pregnancy
Mean Maternal Antiretroviral (ART) Adherence
Group mean percentage of prescribed ART doses taken as measured by pharmacy refill data
Measured: 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
Measured: 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
Measured: two months post pregnancy
Rate of Infant Use of ART
Percentage of delivered infants who receive ART as measured by chart abstraction
Measured: First 6 weeks of life

Secondary outcomes (1)

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).
Measured: 2 months postpartum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Jul 201931 May 2024

First posted27 Mar 2019
Study start8 Jul 2019
Primary completion31 Aug 2023
Study completion31 May 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (6)Papers the sponsor has linked to this study.
Other trials for DepressionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
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
Masking: None (open label)
Enrolment: 391 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03892915
Sponsor's protocol ID: 2017-1041
Acronym: M-DEPTH
Status last verified: Sep 2024
First submitted: 21 Mar 2019
Last updated: 15 Nov 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: 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.

Publications

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.
PubMed 40188047
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.
PubMed 40018208
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.
PubMed 39301593
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.
PubMed 36907945
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.
PubMed 36127627
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.
PubMed 31277180

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Depression trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Depression Care to Improve Adherence to Prevention of Mother-to-Child-Transmission (PMTCT) Care Continuum & Pregnancy Outcomes
ClinicalTrials.gov ID: NCT03892915
Acronym / sponsor ID: M-DEPTH / 2017-1041
Conditions: Depression
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 391 participants (actual)
Lead sponsor: RANDUniversity, hospital or other
Collaborators: Makerere University, Mildmay Uganda Limited
Study start: 8 Jul 2019 (actual)
Primary completion: 31 Aug 2023 (actual)
Study completion: 31 May 2024 (actual)
First posted: 27 Mar 2019 (actual)
Results: Posted 15 Nov 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
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

Arm	Type	Receives
Depression Care	Experimental	Combination Product: evidence-based depression treatmentTask-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).

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
evidence-based depression treatmentWe 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.	Combination product	Depression Care

Primary outcome

Rate of Maternal HIV Viral Suppression
Time frame: Two months post pregnancy
Percentage of participants who achieve undetectable HIV viral load as measured by blood assay
Mean Maternal Antiretroviral (ART) Adherence
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: First 6 weeks of life
Percentage of delivered infants who receive ART as measured by chart abstraction

1 secondary outcome

Depression Status
Time frame: 2 months postpartum

Results and safety

Results posted to the registry on 15 Nov 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Depression Care	191	171
Usual Care	200	167

Primary outcome: Rate of Maternal HIV Viral Suppression

Time frame: Two months post pregnancy. Count of participants. Unit: Participants

Measure	Depression Care n = 191	Usual Care n = 200
Value	128	132

Depression Care vs Usual Care: Odds Ratio (OR): 1.19 (95% CI 0.73 to 1.93)

Primary outcome: Mean Maternal Antiretroviral (ART) Adherence

Time frame: Past 6 months, assessed at 2 months after the completion of pregnancy. Mean (Standard Deviation). Unit: percentage of prescribed doses taken

Measure	Depression Care n = 191	Usual Care n = 200
Value	95.2 (15.4)	90.8 (20.2)

Depression Care vs Usual Care: beta coefficient: 5.33

Primary outcome: Rate of Prevention of Mother-to-child-transmission (PMTCT) Care Retention

Time frame: through study completion, an average of 48 weeks. Count of participants. Unit: Participants

Measure	Depression Care n = 191	Usual Care n = 200
Value	184	185

Population analysed: Number of participants randomly assigned to this group

Primary outcome: Rate of Delivery in Health Facility

Time frame: two months post pregnancy. Count of participants. Unit: Participants

Measure	Depression Care n = 191	Usual Care n = 200
Value	171	165

Depression Care vs Usual Care: Odds Ratio (OR): 1.85 (95% CI 0.53 to 6.50)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 24 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Depression Care	13 of 191 (6.8%)	0 of 191 (0%)	0 of 191
Usual Care	18 of 200 (9%)	0 of 200 (0%)	2 of 200

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40188047Wagner 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.
Derived from this study: PubMed 40018208McBain 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.
Derived from this study: PubMed 39301593McBain 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.
Derived from this study: PubMed 36907945Wagner 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.
Derived from this study: PubMed 36127627Wagner 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.
Derived from this study: PubMed 31277180Wagner 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.
Individual participant dataSharing planned: 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Glenn Wagner, PhD principal investigator

RAND

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing evidence-based depression treatment in people with Depression, run by RAND at 1 site in Uganda.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Maternal HIV Viral Suppression (time frame: Two months post pregnancy). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03892915, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2024; AzTrials last refreshed its copy on 3 Nov 2026.