Preferences for services in a patient’s first six months on antiretroviral therapy for HIV in South Africa and Zambia (PREFER): research protocol for a prospective observational cohort study

Background For patients on HIV treatment in sub-Saharan Africa (SSA), the highest risk for loss from care consistently remains the first six months after antiretroviral (ART) initiation, when patients are not yet eligible for most existing differentiated service delivery (DSD) models. To reduce disengagement from care during this period, we must gain a comprehensive understanding of patients’ needs, concerns, resources, and preferences for service delivery during this period. The PREFER study will use a sequential mixed-methods approach to survey a sample of patients in South Africa and Zambia 0-6 months after ART initiation to develop a detailed profile of patient characteristics and needs. Protocol PREFER is an observational, prospective cohort study of adult patients on ART for ≤6 months at 12 public sector healthcare facilities in Zambia and 18 in South Africa that aims to inform the design of DSD models for the early HIV treatment period. It has four components: 1) survey of clients 0-6 months after ART initiation; 2) follow up through routinely collected medical records for <12 or <24 months after enrollment; 3) focus group discussions to explore specific issues raised in the survey; and 4) in South Africa only, collection of blood samples self-reported naïve participants to assess the prevalence of ARV metabolites indicating prior ART use. Results will include demographic and clinical characteristics of patients, self-reported HIV care histories, preferences for treatment delivery, and predictors of disengagement. Conclusions PREFER aims to understand why the early treatment period is so challenging and how service delivery can be amended to address the obstacles that lead to early disengagement from care and to distinguish the barriers encountered by naïve patients to those facing re-initiators. The information collected by PREFER will help respond to patients’ needs and design better strategies for service delivery and improve resource allocation going forward.