VITAL - Assessment of a viral load result-driven automated Differentiated Service Delivery Model for participants taking antiretroviral therapy in Lesotho

To sustainably provide good quality care to increasing numbers of people living with HIV (PLHIV) receiving antiretroviral therapy (ART) in resource-limited settings, care delivery has to shift from a “one-size-fits-all” approach to differentiated service delivery models. Such models should reallocate resources from PLHIV who are doing well to groups of PLHIV who may need more attention, such as those with treatment failure. The VITAL trial will assess a viral load-triggered, electronic health (eHealth)-supported, automated differentiated service delivery model (aDSDM). The implemented aDSDM will be guided by a clinical decision support tool, the VITALapp, and differentiate care according to clinical characteristics, sub-population and participants’ and health care providers’ preferences.

VITAL is a pragmatic, multicenter, cluster-randomized, non-blinded, non-inferiority trial with 1:1 allocation conducted at 18 nurse-led, rural health facilities in two districts of northern Lesotho enrolling adult PLHIV taking ART. The primary objective of VITAL is to assess if the aDSDM is at least non-inferior to standard of care in the proportion of participants engaged in care and virally suppressed at 24 months follow-up and if it is cost-saving. The secondary objective is to build through VITAL a well-documented cohort of PLHIV at participating health centers that allow further interventional studies responding to emerging health needs.

Establishing cost-saving monitoring strategies for people taking ART is crucial for the sustainability of ART programs in sub-Saharan Africa and viral load monitoring offers an ideal opportunity to differentiate care and reallocate resources. At the same time, the provided eHealth support for participants and the clinical decision support tool, the VITALapp, may help to increase the quality of care. These tool aim to improve the flow of information, empower of PLHIV and support clinical decision making through the provision of recommended clinical actions. The proposed aDSDM is designed for being scaled up at national and regional level as it mainly builds on the provision of differentiated clinical decision support and communication flow between PLHIV, health care workers and laboratory, thus not requiring additional human resources.

VITAL has multiple nested studies:

(i) An aDSDM for Tuberculosis prevention and care

(ii) Integrating mental health assessments for optimized patient outcomes

(iii) A resistance survey at the beginning and end of VITAL

(iv) The impact of an aDSDM on cervical cancer screening coverage

(v) Qualitative nested studies