Piloting risk stratification and tailored interventions with pregnant and postpartum women with HIV in Kenya to prevent disengagement from care and viral failure

Despite the notable scale up of antiretroviral therapy (ART) coverage among pregnant and postpartum women
living with HIV (PWLWH) globally, reductions in new HIV infections in children have plateaued and significant
numbers of PWLWH are still not able to achieve optimal health outcomes. In sub-Saharan Africa, emerging
evidence indicates some vulnerable sub-groups of PWLWH are at higher risk of poor ART adherence,
disengagement from HIV care, and unsuppressed viral loads. In order to eliminate mother-to-child transmission
and protect maternal health, it is critical to identify these PWLWH at risk of suboptimal outcomes early and
provide effective interventions that address key challenges. There is significant evidence that psychosocial
stressors—HIV-related stigma, intimate partner violence, and lack of ability to disclose HIV status—are major
drivers of treatment lapses in this population. Problem Management Plus (PM+) is a lay health worker-delivered
intervention that has high potential to address psychosocial stressors and promote treatment engagement for
high risk PWLWH. PM+ combines problem-solving therapy and behavioral strategies to address mental distress
and has been adapted and implemented in other populations in Kenya. In the current study, we propose to
develop and validate a multivariable prediction tool (i.e., “risk calculator”) using socio-demographic, clinical, and
psychosocial data from our recent longitudinal studies with large samples of PWLWH in southwestern Kenya,
the same setting where our current study is proposed (Aim 1). We will establish risk prioritization scores (critical,
moderate, minor) that predict the combined outcome of a missed visit (> 30 days) or treatment failure (elevated
viral load >400 copies/ml). Next, we will utilize a human centered design (HCD) approach to work collaboratively
with PWLWH and key stakeholders to tailor modifiable components of the PM+ intervention to address
challenges to achieving optimal HIV treatment outcomes in this population (Aim 2). We will collaborate with
PWLWH and lay health workers to develop both mobile phone (mHealth) and in-person PM+ delivery formats to
be able to deliver the intervention safely and efficiently to a mobile population. Finally, we will pilot our tailored
intervention in a hybrid type 2 effectiveness-implementation trial in which pregnant women identified as critical
or moderate risk are randomized to one of three study arms 1:1:1 standard of care, in-person PM+, or mHealth
PM+ and followed through 6 months postpartum (N=120). Feasibility, acceptability, intervention satisfaction, and
preliminary effects on mental health and HIV outcomes will be assessed. Findings from this research will prepare
us for a large-scale trial in which we intend to use an adaptive design to test which interventions (including
adapted PM+), combination of interventions, and sequence of interventions are the most effective and efficient
to support the most vulnerable PWLWH in low-resource settings. This research will result in effective tools and
adaptive intervention modalities which will contribute to eliminating mother-to-child transmission and achieving
related global maternal and child health goals.

Grant Number: 5R34MH126857-03
NIH Institute/Center: NIH
Principal Investigator: Lisa Abuogi