Optimizing Care Delivery to Support Reengagement in PLWH Returning to HIV Care After Treatment Lapses in Zambia

1.0 Introduction The scale-up of human immunodeficiency virus (HIV) treatment services has expanded rapidly in Zambia, facilitated by evolution of the HIV response from centralized services to decentralized care and now towards differentiated service delivery models. Nevertheless, optimal effectiveness remains elusive because timely engagement in care to allow uninterrupted access to antiretroviral therapy (ART) and sustained viral suppression remain incomplete. Ensuring retention in care is especially relevant since greater numbers of HIV-infected patients are also entering a phase of long-term follow-up. After receiving access to HIV care, a high fraction become lost to follow up with some estimates as high as 25-40%, which is defined as the outcome where the patient has missed their appointment by 30 days and has not died or seeking care at a different healthcare facility, or disengaged from care altogether. Research also suggests that LTFU outcomes are driven by a multitude of factors including structural and clinic-based barriers, individual and community-based barriers. A new generation of innovative interventions is needed to overcome these multifaceted barriers to optimization of the engagement of HIV infected patients with the public health systems that have emerged to serve them. Sustained retention is a critical determinant of viral suppression for PLWH, but treatment interruptions put them at high risk for viremia and mortality. Emerging evidence clearly demonstrates that people living with HIV (PLWH) frequently transition in and out of care over time in sub-Saharan Africa and the time of re-engagement in HIV care presents a critical opportunity to break these ongoing cycles of disengagement. Since the presence of specific barriers leads to disengagement from care for some patients, designing strategies targeting these barriers can offer up a natural prospect for ensuring long-term care engagement. It is evident that the strategies required to initiate a patient into care would be markedly different than those to ensure reengagement in care. Even when PLWH return to care after loss to follow-up (LTFU), rates of repeat LTFU in the future are very high. Our preliminary data from Zambia suggests that 30% become LTFU again within 6 months of return, and that 50% of those who are currently LTFU have previously cycled in and out of care. Few interventions have successfully improved return rates among those LTFU but an estimated 50-70% return to care on their own by one year. Strategies for intervening at the time of reengagement in care are urgently needed to break these cycles of disengagement in this high-risk population. To address these knowledge gaps, we seek to engage key stakeholders in developing a reengagement program to address critical barriers to reengagement and strengthen long-term reengagement in care. This reengagement study will provide important direction for future interventions and studies to formally test this health-system intervention for patients reengaging in HIV care after LTFU. 1.1 Rationale Evidence from our groups as well as throughout Africa highlight the critical needs to strengthen programs for reengagement into HIV care. It is well documented that PLWH frequently transition in and out of care over time in sub-Saharan Africa leading to treatment interruptions that can put them at high risk for viremia and mortality. Among those who return to care after loss to follow-up (LTFU), rates of repeat LTFU in the future are also very high with up to 30% becoming LTFU again within 6 months of return. Additionally, among those who are currently LTFU, 50% have previously cycled in and out of care indicating missed opportunities to intervene. As an estimated 50-70% of those LTFU return to care on their own by one year strategies for intervening at the time of reengagement in care are very promising to help break these cycles of disengagement in this high-risk population. 1.2 Research Question What are the most important needs and preferences of patients and providers for a multicomponent reengagement strategy? 2.0 Study Objectives 2.1 Study Specific Aim To develop a reengagement strategy that meets the needs and preferences of patients and providers in public health HIV settings. 2.2 Scientific Objectives The study has three main objectives. These include: 1. Assess patient and provider needs and preferences for reengagement strategies using best-worse scaling experiments. 2. Assess patient and provider needs and preferences for reengagement strategies using qualitative methods. 3. Develop an intervention to optimize the experience of reengagement in HIV care using human-centered design.

NCT Number	NCT06803316
Lead Sponsor	Centre for Infectious Disease Research in Zambia Collaborators: Washington University School of Medicine, National Institute of Mental Health (NIMH)
Conditions	HIV Antiretroviral Therapy (ART) Adherence
Enrollment	658 participants
Start Date	2022-08-10
Primary Completion	2025-07-31 (estimated)
Study Completion	2025-07-31 (estimated)
Updated on ClinicalTrials.gov	2026-08-12