The SUSTAIN 2 Study - SUStained HIV Treatment for Adherence After Interruption in Care

Differentiated Service Delivery (DSD) models have been shown to provide equivalent orbetter retention in healthcare and viral (VL) suppression for people with HIV thanconventional care models. However, to date, DSD models have been offered only to peoplewith HIV (PWH) considered 'stable' (i.e., retained in care and virally suppressed). Thus,those at high risk of poor outcomes are ineligible for DSD models. In response, theinvestigators will work with the City of Cape Town to provide the data needed to impactpolicy guidelines. The investigators designed SUSTAIN2: SUStained HIV Treatment AdherenceAfter INterruption, which will test a scalable, evidence‐based DSD model (SUSTAIN‐DSD) toaddress individual, social, and structural barriers to long‐term engagement and toincrease VL suppression among PWH with an ART treatment interruption or unsuppressed VL(PWH‐Gaps).SUSTAIN‐DSD is a six‐month adherence club model of care that offers flexible serviceswith multi‐month dispensing of medication (de‐linked from clinic processes) and supportfrom lay counselors and peers, which has been proven to help PWH to sustain retention andviral suppression in the Western Cape. The study will implement a Hybrid Type 1randomized controlled trial (RCT) to evaluate the effectiveness of SUSTAIN‐DSD on viralsuppression among PWH‐Gaps at 24 months post‐enrollment, as compared to an enhancedstandard‐of‐care (an optimized guidelines‐based approach). The investigators will recruit300 participants from their parent study and clinics (SUSTAIN, R01MH125703, MPI:Orrell/Sabin; UCT Ethics Reference 568/2021), through which the investigators haveidentified persistent engagement gaps in 43% of the participants, despite adherencecounseling, to test this model of care. The investigators will then assess the mechanismsof intervention impact using mixed methods, guided by the Capability, Opportunity, andMotivation model of Behavior (COM‐B), and determine implementation outcomes usingProctor's model.Ultimately, the investigators' goal is to ensure that PWH are able to achieve andmaintain virologic suppression through provision of an effective and efficient model ofcare, which can be used in South Africa's efforts to reach the 2030 goals.The investigators' central hypothesis is that PWH‐Gaps receiving SUSTAIN‐DSD will havehigher rates of viral suppression than those who receive enhanced routine care. Theinvestigators will use a Hybrid Type 1 RCT design to answer the study questions.