ABSTRACT
Background: There is an urgent need for more efficient models of differentiated anti-retroviral therapy (ART) delivery, with the World Health Organization and PEPFAR calling for evidence to guide whether 12-monthly ART prescriptions and clinic review (12M scripts) should be recommended in global guidelines. We assessed the association between 12M scripts (allowed temporarily during the COVID-19 pandemic) and clinical outcomes in South Africa. Method(s): We performed a retrospective cohort study using routine, deidentified data from 59 public clinics in KwaZulu-Natal. We included PLHIV aged >18 years with a recent suppressed viral load (VL), and who had been referred from their clinic into a community ART delivery programme with a standard 6-month prescription and clinic review (6M script) or a 12M script. In the community ART programme, PLHIV collected ART every two months at external pick-up points, before returning to the clinic after 6 or 12 months for a new script. We used multivariable modified Poisson regression, accounting for clinic clustering, to compare 12-month retention-in-care (not >90 days late for any visit) and viral suppression (< 50 copies/mL) between 6M and 12M script groups. Result(s): Among 27,148 PLHIV referred for community ART between Jun-Dec 2020, 42.6% received 6M scripts and 57.4% 12M scripts. The median age was 39 years (interquartile range [IQR] 33-46) and 69.4% were women. Age, gender, prior community ART use and time on ART were similar in the two groups (Table). However, a larger proportion of the 12M script group had a dolutegravirbased regimen (60.0% versus 46.3%). The median (IQR) number of clinic visits in the 12 months of follow-up was 1(1-1) in the 12M group and 2(2-3) in the 6M group. Retention at 12 months was 94.6% (95% confidence interval [CI] 94.2%- 94.9%) among those receiving 12M scripts and 91.8% (95% CI 91.3%-92.3%) among those with 6M scripts. 16.8% and 16.7% of clients in the 12M and 6M groups were missing follow-up VL data, respectively. Among those with VLs, 90.4% (95% CI 89.9%-91.0%) in the 12M group and 88.9% (95% CI 88.3%- 89.5%) in the 6M group were suppressed. After adjusting for age, gender, ART regimen, time on ART and prior community ART use, retention (adjusted risk ratio [aRR]: 1.03, 95% CI 1.01-1.04) and suppression (aRR: 1.02(1.01-1.03) were higher with 12M scripts. Conclusion(s): COVID-19 led to temporary introduction of 12M scripts in South Africa. Wider use could reduce clinic visits without negative impacts on shortterm clinical outcomes.