Recipient organisationAfrica Health Research Institute
Funding£1.9M
PeriodMar 2024 — Feb 2029
In plain English
AI plain-English summary
In South Africa, researchers are embedding peer-led family support and financial incentives directly into HIV treatment programmes for children and adolescents in KwaZulu-Natal to improve viral suppression and keep young patients engaged in care. This matters because, despite global progress in preventing mother-to-child transmission, many children and adolescents on antiretroviral therapy still fail to achieve viral suppression. Standard care often misses the social and practical barriers young people face—such as stigma, transition to adult clinics, and lack of family support. The study tests whether biosocial interventions, co-designed with the community and delivered by peers, can close that gap. If the interventions prove effective and cost-effective, they could provide a scalable model for HIV programmes across South Africa and similar settings. The research also assesses whether new long-acting formulations—like injectables and microarray patches—are acceptable to children, caregivers, and health workers, potentially shifting HIV care from daily pills to less frequent, more discreet options. Beyond immediate clinical outcomes, the project builds local capacity for adaptive trials and sustained patient and public involvement, strengthening the infrastructure for future innovations in paediatric HIV care.
View original technical description
Research question: This study will use participatory research with patients and public involvement (PPI) in an HIV treatment programme that is embedded within a population-based longitudinal HIV incidence cohort in rural and urban KwaZulu-Natal to answer: Will biosocial interventions developed in consultation with the community and delivered by peer support improve viral suppression and engagement in clinical services for children and adolescents (aged 0-19) on ART? Are these interventions cost-effective, deliverable, and scalable? Are novel long-acting formulations acceptable and feasible in rural and urban KZN? Background: The global scale-up of antiretroviral treatment (ART) and prevention of mother-to-child strategies has dramatically reduced new paediatric infections. Despite this, there were 160 000 new paediatric infections globally in 2021. Early initiation of ART improves HIV-associated mortality and morbidity. These goals are undermined by poor viral suppression due to poor treatment options and social. Using the shifting to a child-friendly dolutegravir-based regimen in 2023, we will evaluate the effect on adherence, retention and viral suppression in addition to a peer-led family support intervention. Nested within this study, we will evaluate caregiver perceptions of the acceptability and feasibility of the new regimen and future formulations. Aims and Objectives: The study will consist of four work packages linked to the four main study aims. Aim 1: Using a stepped-wedge cluster randomised controlled trial, determine the effectiveness of in-person or mHealth-based adolescent-friendly transition interventions compared to standard care on retention in care and viral suppression among adolescents (aged 15-19) living with HIV who have low transition readiness. The study is funded by the NIH (InTSHA VIP Grant: R01MH131434) Aim 2: Using a stepped-wedge cluster randomised controlled trial to determine the effectiveness of the peer-led interventions with or without financial incentives with families and carers compared to standard care on retention in care and viral suppression among children (1month-14 years) living with HIV. The study will be conducted in the same sites as an NIH-funded adolescent study (InTSHA-VIP). It will leverage the clinic staff and study set-up but will adapt the intervention to be family-based with a younger cohort of participants. Aim 3: Using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework, determine the implementation factors involved in the provision of the interventions (aims 1 and 2). Aim 4: Conduct a nested acceptability and feasibility study to evaluate children, adolescents, caregivers, HCWs, and policymakers' perceptions of novel ART formulations in urban and rural settings in South Africa, including long-acting injectables and micro-array patches (MAP). Output: To develop a: Scalable, cost-effective interventions to improve viral suppression and retention in the care of children and adolescents within SA; Robust and sustainable infrastructure and framework for participatory engagement and active PPI for young people to lead on innovations in delivery and new product introductions in KZN; and Build local capacity to conduct innovative adaptive trials and implementation experiments through the AHRI Implementation and Complex Intervention Centre and the KZN clinical trials consortium
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