Maternal Depression Treatment in HIV

Depression Clinical Trial

— M-DEPTH  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03892915
• Other study ID #: 2017-1041
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: July 8, 2019
• Est. completion date: May 31, 2024

Study information

• Verified date: November 2023
• Source: RAND
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 391
• Est. completion date: May 31, 2024
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Combination Product:
• 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.

Locations

Country	Name	City	State
Uganda	Makerere University	Kampala

Sponsors (3)

Lead Sponsor	Collaborator
RAND	Makerere University, Mildmay Uganda Limited

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of maternal HIV viral suppression	Proportion of participants who achieve undetectable HIV viral load as measured by blood assay	One month post pregnancy
Primary	Mean maternal antiretroviral (ART) adherence	Group mean proportion of prescribed ART doses taken as measured by pharmacy refill data	From study enrollment to one-month post pregnancy
Primary	Rate of prevention of mother-to-child-transmission (PMTCT) care retention	Proportion of participants who continue to attend antenatal care (ANC) visits as measured by chart abstraction	through study completion, an average of 48 weeks
Primary	Rate of delivery in health facility	Proportion of participants who delivery their baby of in a health facility as measured by chart abstraction	one month post pregnancy
Primary	Rate of infant use of ART	Proportion of delivered infants who receive ART as measured by chart abstraction	First 6 weeks of life
Primary	Rate of universal infant feeding	Proportion of delivered infants who receive uniform feeding method (breastfeeding or formula) as documented by self-report	First 6 months of life
Primary	Rate of complete infant HIV testing	Proportion of delivered infants who are tested for HIV at all specified intervals, as measured by chart abstraction	18 months after birth
Secondary	Child HIV status	HIV status of child	18 months after birth