Protocol and Operational Procedures for the implementation of a Differentiated HIV Service Delivery Model in North-Western Tanzania

Introduction WHO recommendation to “treat all diagnosed with HIV” challenges the capacity of health systems, especially in low- and middle- resource countries. The current Tanzanian National Guidelines for the Management of HIV and AIDS views differentiated service delivery (DSD) models as promising approaches to improve HIV services. Nonetheless, social, economic and health system factors greatly influence their efficacy and sustainability and call for context-specific evidence. Objectives This implementation research protocol outline plans to assesses the feasibility and effectiveness of a DSD intervention for stable ART clients in Tanzania. Methodology Quantitative and qualitative methods will be employed to assess implementation which started in July 2018 and will run until July 2021 at four HIV clinics (CTC) located in Shinyanga (2) and Simiyu (2) regions. Stable clients [age >5 years, receiving ART first-line regimen ≥ six months, viral load (VL) ≤50 copies/ml, and no current illnesses] are offered the opportunity to join a club - community-based groups of 25-30 clients living in the same area who receive drug refills and health monitoring every three months (annual VL at the CTC) led by lay-workers. Findings Primary outcome will be the proportion of ART clients maintaining virologic suppression within the club model over the intervention period (measured at 12, 24, and 36 months). Secondary outcomes will include retention in care, patient and provider costs and client perspectives, stratified by geographical location. Conclusions/ Recommendations Research finding will be published in peer-reviewed journals and useful for informing policy and the HIV program in Tanzania.