Effectiveness of a combination strategy for linkage and retention in adult HIV care in Swaziland: The Link4Health cluster randomized trial

Abstract

Background

Gaps 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 findings

Link4Health, 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.

Conclusions

A 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 registration

ClinicalTrials.gov NCT01904994.

Abstract

In a cluster-randomized trial done in Swaziland, Margaret McNairy and colleagues test a combined intervention for linking and retaining adults with HIV infection in care.

Author summary

Why was this study done?

• Linkage to care, retention in care, and achievement of viral load suppression on antiretroviral therapy (ART) among HIV-positive adults are necessary in order to achieve optimal health outcomes in terms of reduced morbidity and mortality and to decrease the risk of HIV transmission to others.

• Barriers to linkage to and retention in care are multifactorial and include both individual- and health system-level factors.

• We hypothesized that a multicomponent strategy using a combination of evidence-based interventions was needed to address the multiple gaps in linkage to and retention in care across the HIV care continuum.

What did the researchers do and find?

• Ten clusters of affiliated HIV clinics in Swaziland were randomized to receive the standard of care (SOC; 1,101 participants) or a combination intervention strategy (CIS; 1,096 participants). The CIS included provision of participants with point-of-care CD4+ count testing at time of HIV testing, accelerated ART initiation among eligible patients, mobile phone appointment reminders, health educational packages, and noncash financial incentives.

• Participants were followed for 12 months from the time of testing HIV positive, and the primary study outcome was prompt linkage to care within 1 month of testing HIV-positive plus retention in care at 12 months after testing HIV positive. Secondary outcomes included additional steps in the HIV care continuum.

• We found that participants receiving care at HIV clinics randomized to the CIS study arm, as compared to the SOC study arm, were significantly more likely to achieve the primary outcome of prompt linkage to care plus 12-month retention (64% in the CIS arm versus 43% in the SOC arm, relative risk [RR] 1.52, 95% CI 1.19–1.96, p = 0.002).

• We also found that participants at CIS sites versus SOC sites had faster linkage to care, were more likely to be assessed for ART initiation, and had faster time to ART start. However, we did not find significant differences in viral suppression or mortality at 12-months after testing HIV positive.

What do these findings mean?

• The Link4Health study showed that a CIS was 50% more effective than the SOC on prompt linkage to HIV care plus 12-month retention after HIV-testing and that the effect appeared to be primarily driven by enhanced retention in care.

• Limitations of this study include a small number of clusters and the inability to evaluate the contribution of each of the components of the strategy to the effect noted.

• The combination strategy used in this study could be easily adapted to other resource-limited settings and may be relevant to the challenges faced in engaging HIV-positive vulnerable and key populations.