Interactive Transition Support for Adolescents Living with HIV Comparing Virtual and In-person delivery (InTSHA VIP): a stepped-wedge, cluster-randomised trial in South Africa

Background: Adolescents living with HIV(ALHIV) often experience lower retention in care and reduced viral suppression after transitioning to adult care. Differentiated care can enhance the uptake and utilisation of evidence-based transition interventions among populations with the greatest need. We aim to investigate the effectiveness, acceptability, feasibility, implementation, and costs of in-person and mHealth-based adolescent-friendly transition interventions. Methods: We are conducting a type 1 hybrid implementation-effectiveness design, with a cluster-randomised, stepped-wedge trial (SWT) to assess the effectiveness of in-person and mHealth-based adolescent-friendly transition interventions on retention in care and viral suppression among adolescents aged 15–19 years with perinatally-acquired HIV and low transition readiness. The SWT will be conducted in 16 clinics in urban (eThekwini) and rural (uMkhanyakude) KwaZulu-Natal over 24 months. Clinics will be randomly allocated to receive the intervention in period 1 (early) or period 2 (delayed). ALHIV, in the standard of care clinics, will be able to access the HIV prevention and treatment services delivered through the primary health clinics. We will use the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework to guide our implementation outcomes. The primary outcomes for effectiveness are: (1) retention in care and (2) viral suppression measured in three cross-sectional surveys. We will measure retention in care as 80% of ART pharmacy refills on time, and 80% of scheduled clinic appointments attended, and we define viral suppression as < 200 copies/ml. We will compare the effectiveness and implementation outcomes of the in-person intervention with the mHealth intervention and compare outcomes between urban and rural clinics. Discussion: The findings of this trial will inform the expansion of differentiated care models for ALHIV to improve the transition process from paediatric to adult HIV care, optimised to support retention in care and viral suppression. Trial registration: ClinicalTrials.gov Identifier NCT06035445.