ABSTRACT
In sub-Saharan Africa, universal access to antiretroviral therapy (ART) for pregnant and breastfeeding
persons, known as Option B+, has rapidly expanded ART access in low and middle-income countries, yielding
declines in vertical HIV transmission and improvements in viral suppression. However, disengagement from
perinatal HIV care in the perinatal period has emerged as a major challenge to sustaining the success of
Option B+. Interventions to support sustained engagement in perinatal HIV care are urgently needed.
Perinatal depression (PND) is common among WLHIV and is an important barrier to HIV care engagement.
PND is defined as onset of depression in pregnancy and/or within the first 3-6 months postpartum. Among
WLHIV in sub-Saharan Africa, 30-40% experience prenatal depression and 20%-30% experience postnatal
depression. PND in WLHIV has been linked to increased HIV viral load, postpartum disengagement from HIV
care, and reduced infant HIV testing, making PND an important barrier to reaching UNAIDS 2025 goals and
ending the HIV epidemic. To address these gaps, NIMH (NOT-MH-21-270) has prioritized testing interventions
to address PND among WLHIV in the perinatal period, including their impact on HIV-related outcomes among
the mothers and their infants. However, few evidence-based interventions exist that address both perinatal
mental health and HIV care outcomes for WLHIV, and even fewer are positioned for rapid translation into
practice through incorporation of a rigorous implementation science framework at the effectiveness trial stage.
Funded by NIMH (R34MH116806), our team enhanced The Friendship Bench, an evidence-based
counseling intervention, to address PND and HIV care engagement for WLHIV. In a pilot individually
randomized controlled trial, the Enhanced Friendship Bench demonstrated high levels of acceptability,
feasibility, and fidelity to the intervention protocol, as well as preliminary efficacy to improve both PND and
engagement in HIV care for WLHIV in Malawi.
Building on this work, the objective of this proposal is to evaluate the efficacy of the Enhanced Friendship
Bench, compared to usual care, in a fully powered randomized controlled trial to improve PND, HIV care
engagement, and secondary infant health outcomes through 12 months postpartum; test hypothesized
mediators and moderators that will help elucidate mechanisms of intervention action; and collect key
implementation science metrics in a Hybrid Type I design to accelerate translation of findings into practice.
Our team is exceptionally well qualified to address these aims given our development and enhancement of
the Friendship Bench for perinatal WLHIV; our expertise in HIV, perinatal mental health, and implementation
science; and our longstanding research infrastructure in Malawi. Completion of the proposed aims will shift
clinical practice by providing a culturally appropriate, scalable counseling intervention that improves PND and
engagement in HIV care outcomes for WLHIV that is poised for rapid translation into practice.
