Enhanced Problem-solving Therapy and HIV Engagement Support to Improve Perinatal Mental Health & HIV Outcomes in Malawi
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Enhanced Friendship Bench, Enhanced usual care.
- Who it may be relevant to
- Registry conditions: HIV, Depression, Depression, Postpartum. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Malawi
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Enhanced Problem-solving Therapy and HIV Engagement Support to Improve Perinatal Mental Health and HIV Outcomes in Malawi: A Randomized Controlled Trial
Overview
The main objective of the proposed study is to evaluate the effectiveness of the Enhanced Friendship Bench intervention to improve perinatal depression, HIV care engagement, and infant health outcomes among pregnant women with HIV and depression in Malawi.
Detailed description
In our R34 pilot trial, the Enhanced Friendship Bench intervention showed strong feasibility, acceptability, fidelity, and preliminary effectiveness to improve perinatal depression and engagement in HIV care. The goal of this proposal is to evaluate the effectiveness of the Enhanced Friendship Bench in a fully powered randomized control trial to improve perinatal depression, HIV care engagement, and infant health outcomes, examine mediators and moderators that help elucidate mechanisms of action, and collect key implementation measures to accelerate the translation of findings into practice.
Interventions
- Behavioral Enhanced Friendship Bench
Friendship Bench problem-solving therapy involving 4 prenatal and 2 postnatal counseling sessions, enhanced for HIV care engagement with 2 social support building sessions and monthly home visits for ART delivery and counseling during the 3rd trimester and the first 3 months postpartum. - Behavioral Enhanced usual care
Usual care for mental health in public facilities in Malawi includes options for basic supportive counseling by a primary provider or nurse, medication management by the primary provider (amitriptyline is the one antidepressant typically available at primary health centers and is rarely prescribed for depression), referral to the clinic psychiatric nurse or mental health clinic, or in more severe cases referral to the psychiatric units at tertiary care hospitals. For the proposed study, usual ca
Primary outcome measures
- Change in Depressive Symptoms [Time frame: 6 months post partum]
- HIV Care Retention [Time frame: 6 months post partum]
Secondary outcome measures (6)
- Change in Depressive Symptoms [Time frame: 6 months post partum]
- Proportion of patients achieving depression remission [Time frame: 6 months post partum]
- Proportion of patients achieving HIV viral suppression [Time frame: 12 months post partum]
- Infant Growth: height-for-age [Time frame: 6 months post partum]
- Infant Growth: weight-for-age [Time frame: 6 months post partum]
- Infant Growth: weight-for-height [Time frame: 6 months post partum]
Eligibility criteria
Inclusion criteria
- Presenting for antenatal care at one of our 5 recruitment sites
- ≥ 18 years of age
- ≤ 34 weeks gestation
- HIV-positive, based on medical records
- Initiating, re-initiating, or on established ART during index pregnancy
- Elevated depressive symptoms as indicated by a EPDS score ≥10. The EPDS is widely used to assess perinatal mood disorders that has been validated in perinatal populations in Malawi with this cut point to identify probable perinatal depression
Exclusion criteria
- Suicidal ideation evaluated as acute risk.
- Other health concerns requiring emergent response.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Malawi · 5 centers
- Area 18 Health Center — Lilongwe
- Area 25 Health Center — Lilongwe
- Bwaila Hospital — Lilongwe
- Kawale Health Center — Lilongwe
- Likuni Mission Hosptial — Lilongwe
Identifiers
NCT: NCT06702722 · 24-0690 · R01MH134660