Clinical trial NCT03892915: Maternal Depression Treatment in HIV
Official title: Depression Care to Improve Adherence to Prevention of Mother-to-Child-Transmission (PMTCT) Care Continuum & Pregnancy Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Depression
Lead sponsor: RAND
Sponsor class: OTHER
Collaborators: name: Makerere University
name: Mildmay Uganda Limited
First posted: 2019-03-27
Enrollment: 391
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Rate of Maternal HIV Viral Suppression
timeFrame: Two months post pregnancy
measure: Mean Maternal Antiretroviral (ART) Adherence
timeFrame: Past 6 months, assessed at 2 months after the completion of pregnancy
measure: Rate of Prevention of Mother-to-child-transmission (PMTCT) Care Retention
timeFrame: through study completion, an average of 48 weeks
measure: Rate of Delivery in Health Facility
timeFrame: two months post pregnancy
measure: Rate of Infant Use of ART
timeFrame: First 6 weeks of life
Secondary outcomes:
measure: Depression Status
timeFrame: 2 months postpartum
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Makerere University
Study officials:
affiliation: RAND
name: Glenn Wagner, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.