Evaluation of risk stratification and problem management plus (PM+) for pregnant women with HIV in Kenya (Tatua study): Protocol paper.

Background: While many pregnant and postpartum women with HIV (PPWH) in the African Region successfully engage in HIV care, a substantial number still face significant barriers, including poor mental health and HIV stigma. These psychosocial barriers contribute to poor medication and clinic visit adherence, poor health outcomes, including unsuppressed viral load, and increased risk of perinatal transmission of HIV. To efficiently improve health outcomes within a resource-constrained health system, responsive and effective interventions are urgently needed to support women who are at the highest risk of sub-optimal outcomes.

Objective: To determine whether risk stratification of PPWH in conjunction with an evidence-based, tailored, lay health worker-delivered psychological intervention can optimize health outcomes for PPWH and their infants.

Methods: Using human-centered design, we will adapt Problem Management Plus (PM+) with PPWH for in-person and mobile delivery formats to prevent sub-optimal treatment adherence and HIV care disengagement among PPWH in Kisumu, Kenya. We will test the adapted PM+ intervention among 120 PPWH randomized 1:1:1 to standard of care, in-person PM+, or mobile PM+ in a hybrid type 2 implementation effectiveness pilot trial. Implementation outcomes, including feasibility, acceptability, and intervention satisfaction, as well as preliminary effectiveness outcomes in mental health and HIV, will be evaluated.

Expected Study Outcomes: We anticipate that the adapted PM+ intervention will be highly acceptable and feasible to implement and have the potential to be effective at reducing care disengagement, viremia, and psychological distress in PPWH.