Date Published: November 7, 2017
Publisher: Public Library of Science
Author(s): Margaret L. McNairy, Matthew R. Lamb, Averie B. Gachuhi, Harriet Nuwagaba-Biribonwoha, Sean Burke, Sikhathele Mazibuko, Velephi Okello, Peter Ehrenkranz, Ruben Sahabo, Wafaa M. El-Sadr, Steven G. Deeks
Abstract: BackgroundGaps in the HIV care continuum contribute to poor health outcomes and increase HIV transmission. A combination of interventions targeting multiple steps in the continuum is needed to achieve the full beneficial impact of HIV treatment.Methods and findingsLink4Health, a cluster-randomized controlled trial, evaluated the effectiveness of a combination intervention strategy (CIS) versus the standard of care (SOC) on the primary outcome of linkage to care within 1 month plus retention in care at 12 months after HIV-positive testing. Ten clusters of HIV clinics in Swaziland were randomized 1:1 to CIS versus SOC. The CIS included point-of-care CD4+ testing at the time of an HIV-positive test, accelerated antiretroviral therapy (ART) initiation for treatment-eligible participants, mobile phone appointment reminders, health educational packages, and noncash financial incentives. Secondary outcomes included each component of the primary outcome, mean time to linkage, assessment for ART eligibility, ART initiation and time to ART initiation, viral suppression defined as HIV-1 RNA < 1,000 copies/mL at 12 months after HIV testing among patients on ART ≥6 months, and loss to follow-up and death at 12 months after HIV testing. A total of 2,197 adults aged ≥18 years, newly tested HIV positive, were enrolled from 19 August 2013 to 21 November 2014 (1,096 CIS arm; 1,101 SOC arm) and followed for 12 months. The median participant age was 31 years (IQR 26–39), and 59% were women. In an intention-to-treat analysis, 64% (705/1,096) of participants at the CIS sites achieved the primary outcome versus 43% (477/1,101) at the SOC sites (adjusted relative risk [RR] 1.52, 95% CI 1.19–1.96, p = 0.002). Participants in the CIS arm versus the SOC arm had the following secondary outcomes: linkage to care regardless of retention at 12 months (RR 1.08, 95% CI 0.97–1.21, p = 0.13), mean time to linkage (2.5 days versus 7.5 days, p = 0.189), retention in care at 12 months regardless of time to linkage (RR 1.48, 95% CI 1.18–1.86, p = 0.002), assessment for ART eligibility (RR 1.20, 95% CI 1.07–1.34, p = 0.004), ART initiation (RR 1.16, 95% CI 0.96–1.40, p = 0.12), mean time to ART initiation from time of HIV testing (7 days versus 14 days, p < 0.001), viral suppression among those on ART for ≥6 months (RR 0.97, 95% CI 0.88–1.07, p = 0.55), loss to follow-up at 12 months after HIV testing (RR 0.56, 95% CI 0.40–0.79, p = 0.002), and death (N = 78) within 12 months of HIV testing (RR 0.80, 95% CI 0.46–1.35, p = 0.41). Limitations of this study include a small number of clusters and the inability to evaluate the incremental effectiveness of individual components of the combination strategy.ConclusionsA combination strategy inclusive of 5 evidence-based interventions aimed at multiple steps in the HIV care continuum was associated with significant increase in linkage to care plus 12-month retention. This strategy offers promise of enhanced outcomes for HIV-positive patients.Trial registrationClinicalTrials.gov NCT01904994.
Partial Text: Achieving the desired impact of HIV treatment, as measured by individual health outcomes and reduced transmission to others, is contingent upon completing all steps in the HIV care continuum, from identifying all individuals who are living with HIV and linking those found to be HIV positive to HIV care to retaining them in lifelong care and on antiretroviral therapy (ART) . Over the past decade, the scale-up of HIV programs has been substantial, with over 18 million persons having initiated ART by the end of 2015 in low- and middle-income countries and an associated substantial decrease in HIV-related morbidity and mortality, as well as evidence of a decrease in HIV incidence in many of the most severely affected countries . However, in order to achieve epidemic control, further optimization of the HIV care continuum is needed so as to achieve the Joint United Nations Programme on HIV/AIDS (UNAIDS) 90/90/90 targets, which require that 90% of individuals with HIV are aware of their diagnosis, that 90% of those aware of their HIV infection are initiated on ART, and that 90% of those on treatment achieve and maintain viral suppression .
In this cluster-randomized study, a novel combination strategy, inclusive of 5 evidence-based interventions, was 50% more effective than the SOC in enhancing linkage to care plus retention in care among HIV-positive individuals. The robustness of this outcome is supported by the consistent findings in the per-protocol analysis, in sensitivity analyses, and across subgroups of participants. In addition, the combination strategy was associated with improvements across multiple steps of the care continuum, with an increased proportion of participants who were assessed for ART eligibility, decreased time to ART eligibility assessment, decreased time to ART initiation, increased retention at 12 months after HIV testing regardless of time to linkage and ART status, and decreased mortality among participants prior to ART initiation. However, high rates of viral suppression were similar among ART patients by study arm.