Problem solving therapy to improve CMD and HIV care outcomes for PWH on ART in Vietnam: a randomized controlled trial

About This Grant

Globally, people with HIV (PWH) with comorbid common mental disorders (CMDs) experience worse HIV-related outcomes than those without, including decreased antiretroviral therapy (ART) adherence, reduced viral suppression, and increased mortality. These same mechanisms drive poor HIV outcomes in the United States, underscoring the need for scalable mental health interventions to improve domestic HIV care. Despite their high prevalence and impact, CMDs remain under-diagnosed and undertreated among PWH, particularly in low- and middle-income countries (LMICs), due to weak mental health infrastructure and severe workforce shortages. Similar access barriers persist in resource-constrined United States settings, including rural and safety-net clinics, making task-shifting directly relevant to US populations. Testing task-shifted interventions in LMICs provides a rigorous scientific advantage. Conducting this study in Vietnam—rather than the US—is a deliberate strategy to evaluate the intervention under conditions where its core mechanisms are most observable. Vietnam’s limited mental health workforce and high burden of untreated CMDs create a high-contrast environment that amplifies intervention effects and clarifies causal pathways linking mental health improvements to HIV outcomes. This constraint-based setting enables identification of the minimally effective components, efficient delivery strategies, and essential supervision structures required for scalability. In contrast, more resource-rich and heterogeneous US systems can obscure these mechanisms, limiting the ability to optimize implementation. Establishing effectiveness and efficiency under constraint strengthens internal validity and enhances generalizability to resource-constrained U.S. settings facing similar barriers. Problem-solving therapy (PST) is an evidence-based, non-specialist-delivered intervention shown to improve mental health outcomes in sub-Saharan Africa. Yet, its impact on HIV outcomes among PWH has not been established, particularly among those initiating or re-initiating ART, who may derive the greatest benefit. We recently culturally adapted PST for PWH with CMDs in Vietnam and demonstrated feasibility, acceptability, and high-fidelity delivery in a pilot randomized trial, with promising signals of effectiveness. We propose a randomized, controlled, hybrid type I effectiveness-implementation trial to evaluate adapted PST versus enhanced usual care among PWH initiating or re-initiating ART with CMDs in Vietnam. We will assess CMD and HIV outcomes, cost-effectiveness, and implementation factors to support translation. We hypothesize that PST will improve CMD outcomes at 3 months and viral suppression at 6 months. By rigorously testing PST in a resource-constrained setting, we will generate actionable evidence and an implementation blueprint to support scalable, cost-effective integration of mental health care into HIV services, accelerating translation to improve outcomes in resource-constrained US populations.