Evaluation of the clinical outcomes of the Test and Treat strategy to implement Treat All in Nigeria: Results from the Nigeria Multi-Center ART Study.

In December 2016, the Nigerian Federal Ministry of Health updated its HIV guidelines to a Treat All approach, expanding antiretroviral therapy (ART) eligibility to all individuals with HIV infection, regardless of CD4+ cell count, and recommending ART be initiated within two weeks of HIV diagnosis (i.e., the Test and Treat strategy). The Test and Treat policy was first piloted in 32 local government areas (LGAs). The primary objective of this study was to evaluate the clinical outcomes of adult patients initiated on ART within two weeks of HIV diagnosis during this pilot. We conducted a retrospective cohort analysis of patients who initiated ART within two weeks of new HIV diagnosis between October 2015 and September 2016 in eight randomly selected LGAs participating in the Test and Treat pilot study. 2,652 adults were newly diagnosed and initiated on ART within two weeks of HIV diagnosis. Of these patients, 8% had documentation of a 12-month viral load measurement, and 13% had documentation of a six-month viral load measurement. Among Test and Treat patients with a documented viral load, 79% were suppressed (≤400 copies/ml) at six months and 78% were suppressed at 12 months. By 12 months post-ART initiation, 34% of the patients who initiated ART under the Test and Treat strategy were lost to follow-up. The median CD4 cell count among patients initiating ART within two weeks of HIV diagnosis was 323 cells/mm3 (interquartile range, 161-518). While randomized controlled trials have demonstrated that Test and Treat strategies can improve patient retention and increase viral suppression compared to standard of care, these findings indicate that the effectiveness of Test and Treat in some settings may be far lower than the efficacy demonstrated in randomized controlled trials. Significant attention to the way Test and Treat strategies are implemented, monitored, and improved particularly related to early retention, can help expand access to ART for all patients.