Treatment eligibility and retention in clinical HIV care: a regression discontinuity study in South Africa

Background: Loss to follow-up is high among HIV patients not yet receiving antiretroviral therapy (ART). Clinical trials have demonstrated the clinical efficacy of early ART; however, these trials may miss an important real-world consequence of providing ART at diagnosis: its impact on retention in...

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Main Authors: Bor, Jacob (Author) , Bärnighausen, Till (Author)
Format: Article (Journal)
Language:English
Published: November 28, 2017
In: PLoS medicine
Year: 2017, Volume: 14, Issue: 11
ISSN:1549-1676
DOI:10.1371/journal.pmed.1002463
Online Access:Verlag, Volltext: http://dx.doi.org/10.1371/journal.pmed.1002463
Verlag, Volltext: http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1002463
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Author Notes:Jacob Bor, Matthew P. Fox, Sydney Rosen, Atheendar Venkataramani, Frank Tanser, Deenan Pillay, Till Bärnighausen

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520 |a Background: Loss to follow-up is high among HIV patients not yet receiving antiretroviral therapy (ART). Clinical trials have demonstrated the clinical efficacy of early ART; however, these trials may miss an important real-world consequence of providing ART at diagnosis: its impact on retention in care. Methods and findings We examined the effect of immediate (versus deferred) ART on retention in care using a regression discontinuity design. The analysis included all patients (N = 11,306) entering clinical HIV care with a first CD4 count between 12 August 2011 and 31 December 2012 in a public-sector HIV care and treatment program in rural South Africa. Patients were assigned to immediate versus deferred ART eligibility, as determined by a CD4 count < 350 cells/μl, per South African national guidelines. Patients referred to pre-ART care were instructed to return every 6 months for CD4 monitoring. Patients initiated on ART were instructed to return at 6 and 12 months post-initiation and annually thereafter for CD4 and viral load monitoring. We assessed retention in HIV care at 12 months, as measured by the presence of a clinic visit, lab test, or ART initiation 6 to 18 months after initial CD4 test. Differences in retention between patients presenting with CD4 counts just above versus just below the 350-cells/μl threshold were estimated using local linear regression models with a data-driven bandwidth and with the algorithm for selecting the bandwidth chosen ex ante. Among patients with CD4 counts close to the 350-cells/μl threshold, having an ART-eligible CD4 count (<350 cells/μl) was associated with higher 12-month retention than not having an ART-eligible CD4 count (50% versus 32%), an intention-to-treat risk difference of 18 percentage points (95% CI 11 to 23; p < 0.001). The decision to start ART was determined by CD4 count for one in four patients (25%) presenting close to the eligibility threshold (95% CI 20% to 31%; p < 0.001). In this subpopulation, having an ART-eligible CD4 count was associated with higher 12-month retention than not having an ART-eligible CD4 count (91% versus 21%), a complier causal risk difference of 70 percentage points (95% CI 42 to 98; p < 0.001). The major limitations of the study are the potential for limited generalizability, the potential for outcome misclassification, and the absence of data on longer-term health outcomes. Conclusions Patients who were eligible for immediate ART had dramatically higher retention in HIV care than patients who just missed the CD4-count eligibility cutoff. The clinical and population health benefits of offering immediate ART regardless of CD4 count may be larger than suggested by clinical trials. 
650 4 |a Antiretroviral therapy 
650 4 |a HIV 
650 4 |a HIV diagnosis and management 
650 4 |a South Africa 
650 4 |a Assisted reproductive technology 
650 4 |a Balance and falls 
650 4 |a Linear regression analysis 
650 4 |a Viral load 
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