A Randomized Clinical Trial to Evaluate Solutions for the Management of Virologic Failure for Individuals on Tenofovir, Lamivudine, and Dolutegravir (TLD) in Sub-Saharan Africa

What this Trial Is About

Researchers are evaluating the best way to manage virologic failure in people living with HIV who are taking a combination antiretroviral therapy called TLD, which includes tenofovir, lamivudine, and dolutegravir. This trial takes place in public HIV clinics in Uganda and South Africa and focuses on individuals aged 15 years and older who have experienced two high viral load results despite being on TLD for at least 12 months. The main goal is to see which treatment strategy leads to viral suppression below 50 copies/mL at 48 weeks. Participants will be randomly assigned to one of three groups: standard care according to local health guidelines involving genotypic resistance testing and adherence counseling; individualized care guided by resistance testing and urine tenofovir adherence tests to tailor treatment; or an immediate switch to a protease inhibitor-based second-line therapy. The study includes scheduled visits at enrollment, 24 weeks, and 48 weeks, with ongoing adherence counseling and viral load monitoring throughout. During the study, participants will have viral load tests at weeks 24 and 48, resistance testing, urine tests for medication adherence, and side effect assessments depending on their group. Treatment decisions are made based on test results and participant input. The trial follows each person for one year, monitoring how well the virus is controlled and how the treatments are tolerated, aiming to find the most effective management for virologic failure on TLD in these settings.

A Randomized Clinical Trial to Evaluate Solutions for the Management of Virologic Failure on TLD in Sub-Saharan Africa