Same-day antiretroviral therapy is associated with increased loss to follow-up in South African public health facilities: a prospective cohort study of patients diagnosed with HIV.

INTRODUCTION: South Africa introduced Universal Test and Treat in 2016 including antiretroviral therapy (ART) initiation on the same-day as HIV diagnosis. Our study sought to evaluate the impact of same-day ART initiation on loss to follow-up (LTFU) and mortality comparing with patients who initiated ART after their HIV diagnosis. METHODS: We conducted a file review of patients with a HIV diagnosis and ART start date on file between September 2016 and May 2018 in six high HIV burden districts. Our primary outcome was LTFU (>90 days from the last clinical visit or drug pick-up until database closure 31 July 2018). The secondary outcome was mortality after ART initiation. Time to outcome was assessed comparing same-day vs. one to seven, eight to twenty-one and ≥ twenty-two days to ART initiation using Kaplan-Meier estimators stratified by sex. We investigated predictors using univariate and multivariable Cox proportional hazards models, adjusting for a priori characteristics. RESULTS: Overall, 92,609 ART patients contributed 43,922 person-years from ART initiation, with a median follow-up time of 246 days (IQR = 112 to 455). Of these patients, 33,399 (36%) initiated ART on the same-day as their HIV diagnosis date and had a median follow-up time of 174 days (IQR = 85 to 349). Same-day patients were predominantly non-pregnant females (56%) and aged 25 to 34 years (40%). Same-day ART initiation increased from 2.8% in September 2016 to 7.1% in April 2018. In same-day patients, 33% (n = 11,114) were classified as LTFU with a median time of 55 days (IQR = 1 to 185), compared to 371 mean days (IQR = 161 to 560) in patients who initiated ≥22 days after diagnosis. A similar proportion of LTFU was observed for patients who initiated later: 31% 1 to 21 day and 33% ≥22 day. Same-day ART patients had an increased risk of LTFU vs. ≥1 day (adjusted hazard ratio (aHR) = 1.28, 95% CI = 1.24 to 1.33) adjusting for covariates. Although all-cause mortality was slightly lower in same-day patients (0.9%) vs. >1 day (1.4%; aHR = 0.87, 95% CI = 0.72 to 1.05) adjusting for covariates. Men had highest risk of mortality and LTFU. CONCLUSIONS: Same-day ART increased the risk of LTFU, but same-day patients experienced slightly lower mortality. Same-day patients may require additional counselling and interventions to improve retention. Additional research is needed on targeted interventions, including differentiated care, to reduce LTFU in patients initiating ART same-day.

Long-term virologic responses to antiretroviral therapy among HIV-positive patients entering adherence clubs in Khayelitsha, Cape Town, South Africa: a longitudinal analysis.

INTRODUCTION: In South Africa, an estimated 4.6 million people were accessing antiretroviral therapy (ART) in 2018. As universal Test and Treat is implemented, these numbers will continue to increase. Given the need for lifelong care for millions of individuals, differentiated service delivery models for ART services such as adherence clubs (ACs) for stable patients are required. In this study, we describe long-term virologic outcomes of patients who have ever entered ACs in Khayelitsha, Cape Town. METHODS: We included adult patients enrolled in ACs in Khayelitsha between January 2011 and December 2016 with a recorded viral load (VL) before enrolment. Risk factors for an elevated VL (VL >1000 copies/mL) and confirmed virologic failure (two consecutive VLs >1000 copies/mL one year apart) were estimated using Cox proportional hazards models. VL completeness over time was assessed. RESULTS: Overall, 8058 patients were included in the analysis, contributing 16,047 person-years of follow-up from AC entry (median follow-up time 1.7 years, interquartile range [IQR]:0.9 to 2.9). At AC entry, 74% were female, 46% were aged between 35 and 44 years, and the median duration on ART was 4.8 years (IQR: 3.0 to 7.2). Among patients virologically suppressed at AC entry (n = 8058), 7136 (89%) had a subsequent VL test, of which 441 (6%) experienced an elevated VL (median time from AC entry 363 days, IQR: 170 to 728). Older age (adjusted hazard ratio [aHR] 0.64, 95% confidence interval [CI] 0.46 to 0.88), more recent year of AC entry (aHR 0.76, 95% CI 0.68 to 0.84) and higher CD4 count (aHR 0.67, 95% CI 0.54 to 0.84) were protective against experiencing an elevated VL. Among patients with an elevated VL, 52% (150/291) with a repeat VL test subsequently experienced confirmed virologic failure in a median time of 112 days (IQR: 56 to 168). Frequency of VL testing was constant over time (82 to 85%), with over 90% of patients remaining virologically suppressed. CONCLUSIONS: This study demonstrates low prevalence of elevated VLs and confirmed virologic failure among patients who entered ACs. Although ACs were expanded rapidly, most patients were well monitored and remained stable, supporting the continued rollout of this model.