NCT06721078

Evaluation of Long-Acting Injectable (LAI) and Teen Clubs in Adolescents (ATTUNE).

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 720 (estimated)
• Sponsor: Africa Health Research Institute · Academic / Other
• Sex: All
• Age: 12 Years – 19 Years
• Healthy volunteers: Accepted

Summary

This is a 2-stage study assessing the effect of peer navigation (support from peers) and long-acting injectable antiretroviral therapy (ART) on viral suppression and retention in care among adolescents living with HIV and receiving care in South Africa.

Detailed description

This study aims to deploy peer-navigated support (psychosocial support, HIV education, appointment reminders, adherence support, sexual and reproductive health, and healthcare navigation) to facilitate viral suppression and retention in care as adolescents living with HIV transition into adult care. The study population includes adolescents from South Africa aged 12 to less than 19 years, living with HIV, aware of their HIV status and receiving ART for at least six months. In Stage 1, the peer navigation intervention in a stepped-wedge, cluster-randomised trial implemented over 18-24 months in two 6-month steps across 12 clinics will be evaluated. In addition, during Stage 1, user and key stakeholder preferences will be evaluated for the uptake and use of long-acting injectable ART, perform a costing and economic analysis and a program evaluation of the public health impact of the intervention. In Stage 2, an individually-randomised trial will be nested in a subset of clinics to evaluate long-acting injectable ART in adolescents with HIV. The study procedures include a peer navigation intervention in Stage 1, alongside a user and key stakeholder preferences evaluation for the uptake and use of long-acting injectable ART and a cost and economic evaluation. The study duration is two years (about 5-7 visits). The stepped-wedge trial will be implemented in the first 18 months, after which participants will be followed for an additional 12 months to assess the sustainability of the intervention. The nested individually-randomised trial of long-acting ART will be conducted during the second 18-month period.

Conditions

• Hiv

Interventions

Type	Name	Description
BEHAVIORAL	Peer navigation effectiveness	To determine the effectiveness of peer navigation on viral suppression and retention in care among adolescents living with HIV in South Africa.

Timeline

• Start date: 2026-02-09
• Primary completion: 2028-03-01
• Completion: 2029-06-30
• First posted: 2024-12-06
• Last updated: 2026-04-03

Locations

12 sites across 1 country: South Africa