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 c...

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Main Authors: Jacob Bor, Matthew P Fox, Sydney Rosen, Atheendar Venkataramani, Frank Tanser, Deenan Pillay, Till Bärnighausen
Format: Article
Language:English
Published: Public Library of Science (PLoS) 2017-11-01
Series:PLoS Medicine
Online Access:http://europepmc.org/articles/PMC5705070?pdf=render
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author Jacob Bor
Matthew P Fox
Sydney Rosen
Atheendar Venkataramani
Frank Tanser
Deenan Pillay
Till Bärnighausen
author_facet Jacob Bor
Matthew P Fox
Sydney Rosen
Atheendar Venkataramani
Frank Tanser
Deenan Pillay
Till Bärnighausen
author_sort Jacob Bor
collection DOAJ
description 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.
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spelling doaj.art-2568fd8fed8642ddb8b1c6e585efec392022-12-22T00:40:36ZengPublic Library of Science (PLoS)PLoS Medicine1549-12771549-16762017-11-011411e100246310.1371/journal.pmed.1002463Treatment eligibility and retention in clinical HIV care: A regression discontinuity study in South Africa.Jacob BorMatthew P FoxSydney RosenAtheendar VenkataramaniFrank TanserDeenan PillayTill BärnighausenBACKGROUND: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.http://europepmc.org/articles/PMC5705070?pdf=render
spellingShingle Jacob Bor
Matthew P Fox
Sydney Rosen
Atheendar Venkataramani
Frank Tanser
Deenan Pillay
Till Bärnighausen
Treatment eligibility and retention in clinical HIV care: A regression discontinuity study in South Africa.
PLoS Medicine
title Treatment eligibility and retention in clinical HIV care: A regression discontinuity study in South Africa.
title_full Treatment eligibility and retention in clinical HIV care: A regression discontinuity study in South Africa.
title_fullStr Treatment eligibility and retention in clinical HIV care: A regression discontinuity study in South Africa.
title_full_unstemmed Treatment eligibility and retention in clinical HIV care: A regression discontinuity study in South Africa.
title_short Treatment eligibility and retention in clinical HIV care: A regression discontinuity study in South Africa.
title_sort treatment eligibility and retention in clinical hiv care a regression discontinuity study in south africa
url http://europepmc.org/articles/PMC5705070?pdf=render
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