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

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

Integrated vs. referred management of CVD risk factors for HIV positive patients on antiretroviral therapy in Swaziland

Cardiovascular disease risk factors (CVDRF) are prevalent in people living with HIV (PLHIV), but the optimal clinical management strategy for patients with both HIV and CVDRF in low resource settings is unknown. In some contexts, care for both HIV and CVDRF is provided in the HIV clinic (“integrated care”), which may be more convenient for patients. In others, PLHIV are referred to specialist clinics for management of their CVDRF (“referred care”) which may lead to higher quality CVDRF management. We compared integrated vs. referred strategies for patients with HIV and CVDRF at an urban health facility in Swaziland, exploring linkage to and retention in CVDRF care, intervention fidelity, and HIV and CVDRF-related health outcomes

The Link4Health study to evaluate the effectiveness of a combination intervention strategy for linkage to and retention in HIV care in Swaziland: protocol for a cluster randomized trial

Background: Gaps in the HIV care continuum contribute to suboptimal individual health outcomes and increased risk of HIV transmission at the population level. Implementation science studies are needed to evaluate clinic-based interventions aimed at improving retention of patients across the continuum. Methods/design: Link4Health uses an unblended cluster site-randomized design to evaluate the effectiveness of a combination intervention strategy (CIS) as compared to standard of care on linkage to and retention in care among HIV-diagnosed adults in Swaziland. The CIS intervention targets a multiplicity of structural, behavioral, and biomedical barriers through five interventions: (1) point-of-care CD4 testing at time of HIV testing, (2) accelerated antiretroviral therapy (ART) initiation for eligible patients, (3) mobile phone appointment reminders, (4) care and prevention packages, and (5) non-cash financial incentives for linkage and retention. The unit of randomization is a network of HIV clinics inclusive of a secondary facility coupled with an affiliated primary facility. Ten study units were randomized based on implementing partner, geographic location, and historic volume of HIV patients. Target enrollment was 2200 individuals, each to be followed for 12 months. Eligibility criteria includes HIV-positive test, age >18 years, willing to receive HIV care at a clinic in the study unit and consent to study procedures. Exclusion criteria included previous HIV care in the past 6 months, planning to leave the community, and current pregnancy. The primary study outcome is linkage within 1 month and retention at 12 months after testing HIV positive. Secondary outcomes include viral load suppression at 12 months, time to ART eligibility and initiation, participant acceptability, and cost-effectiveness. The trial status is that study enrollment is complete and follow-up procedures are ongoing. Discussion: Link4Health evaluates a novel and pragmatic combination intervention strategy to improve linkage to and retention in care among adults with HIV in Swaziland. If the strategy is found to be effective, this study has the potential to inform HIV service delivery in resource-limited settings. Keywords: HIV Linkage Retentio

Engagement in care among women and their infants lost to follow-up under Option B+ in eSwatini.

BackgroundUniversal antiretroviral treatment (ART) for pregnant women with HIV, Option B+, has been adopted widely for prevention of mother-to-child HIV transmission (PMTCT). Some evidence shows high loss to follow-up (LTF) under this model. However, gaps in data systems limit this evidence. We collected additional information for women and infants LTF from Option B+ in Eswatini to assess more accurate outcomes.MethodsLTF at 6-months postpartum was assessed using facility data. Additional data was gathered from: 1) the national ART database and paper records; 2) patient tracing; and 3) interviews and abstraction from patient-held records. Engagement in care was defined as any clinic visit within 91 days before or after 6-months postpartum or completion of a documented transfer; or, for those traced but not completing study interviews, visits at 6-months postpartum or later (for infants), or visits within 3-months of tracing (for women). Multivariable loglinear models were used to identify correlates of engagement.ResultsOne-hundred-ninety-four (44.7%) of 434 LTF women had outcomes ascertained, including 122 (62.9%) women engaged in care. Among 510 LTF infants, 265 (52.0%) had ascertained outcomes, including 143 (54.0%) engaged in care, 47 (17.7%) pregnancy losses, and 18 (6.8%) deaths. Seventy-two of 189 live infants (38.1%) with ascertained outcomes had a 6-week early infant diagnostic (EID) test. Among women with ascertained outcomes, gestational age of 20+ weeks (vs. fewer than 20 weeks, aRR 0.80; 95% CI 0.68-0.94) and age 25-29 years (vs. 15-24 years, aRR 0.81; 95% CI 0.67-0.97), were associated with lower engagement; initiating ART after first ANC visit was associated with higher engagement (vs. at first ANC visit, aRR 1.12; 95% CI 1.04-1.21). Among infants with ascertained outcomes, mother not initiating ART was associated with lower engagement (vs. ART at first ANC visit, aRR 0.71; 95% CI 0.54-0.91).ConclusionSubstantial numbers of women and infants classified as LTF under Option B+ were engaged in care, though a suboptimal level of 6-week EID testing was observed. These findings highlight a need to improve coverage of routine EID testing, and improve data systems to better capture PMTCT patient outcomes

A time-motion study of cardiovascular disease risk factor screening integrated into HIV clinic visits in Swaziland.

IntroductionScreening of modifiable cardiovascular disease (CVD) risk factors is recommended but not routinely provided for HIV-infected patients, especially in low-resource settings. Potential concerns include limited staff time and low patient acceptability, but little empirical data exists. As part of a pilot study of screening in a large urban HIV clinic in Swaziland, we conducted a time-motion study to assess the impact of screening on patient flow and HIV service delivery and exit interviews to assess patient acceptability.MethodsA convenience sample of patients ≥40&nbsp;years of age attending routine HIV clinic visits was screened for hypertension, diabetes, hyperlipidemia and tobacco smoking. We observed HIV visits with and without screening and measured time spent on HIV and CVD risk factor screening activities. We compared screened and unscreened patients on total visit time and time spent receiving HIV services using Wilcoxon rank-sum tests. A separate convenience sample of screened patients participated in exit interviews to assess their satisfaction with screening.ResultsWe observed 172 patient visits (122 with CVD risk factor screening and 50 without). Screening increased total visit time from a median (range) of 4&nbsp;minutes (2 to 11) to 15&nbsp;minutes (9 to 30) (p&nbsp;&lt;&nbsp;0.01). Time spent on HIV care was not affected: 4 (2 to 10) versus 4 (2 to 11) (p&nbsp;=&nbsp;0.57). We recruited 126 patients for exit interviews, all of whom indicated that they would recommend screening to others.ConclusionProvision of CVD risk factor screening more than tripled the length of routine HIV clinic visits but did not reduce the time spent on HIV services. Programme managers need to take longer visit duration into account in order to effectively integrate CVD risk factor screening and counselling into HIV programmes

Low rates of prior HIV testing among HIV-positive adults accessing outpatient services in Eswatini

Prior HIV testing and awareness of HIV-positive status were assessed among HIV-positive adults at 20 clinics in Eswatini. Of 2196 HIV-positive adults, 1183 (53.8%) reported no prior HIV testing, and 1948 (88.7%) were unaware of their HIV-positive status. Males [adjusted odds ratio, AOR, (95% confidence interval): 0.7 (0.5–0.9)], youth 18–25 years [AOR 0.6 (0.4–0.95)], adults ≥ 50 years [AOR 0.5 (0.3–0.9)], those needing family support [AOR 0.6 (0.5–0.8)], and those living ≥ 45 min from clinic [AOR 0.5 (0.4–0.8)] were less likely to know their HIV-positive status. More HIV testing is needed to achieve 95-95-95 targets, with targeted strategies for those less likely to test for HIV

Cost-effectiveness of a combination strategy to enhance the HIV care continuum in Swaziland: Link4Health.

INTRODUCTION:Link4Health, a cluster-RCT, demonstrated the effectiveness of a combination strategy targeting barriers at various HIV continuum steps on linkage to and retention in care; showing effectiveness in achieving linkage to HIV care within 1 month plus retention in care at 12 months after HIV testing for people living with HIV (RR 1.48, 95% CI 1.19-1.96, p = 0.002). In addition to standard of care, Link4Health included: 1) Point-of-care CD4+ count testing; 2) Accelerated ART initiation; 3) Mobile phone appointment reminders; 4) Care and prevention package including commodities and informational materials; and 5) Non-cash financial incentive. Our objective was to evaluate the cost-effectiveness of a scale-up of the Link4Health strategy in Swaziland. METHODS AND FINDINGS:We incorporated the effects and costs of the Link4Health strategy into a computer simulation of the HIV epidemic in Swaziland, comparing a scenario where the strategy was scaled up to a scenario with no implementation. The simulation combined a deterministic compartmental model of HIV transmission with a stochastic microsimulation of HIV progression calibrated to Swaziland epidemiological data. It incorporated downstream health costs potentially saved and infections potentially prevented by improved linkage and treatment adherence. We assessed the incremental cost-effectiveness ratio of Link4Health compared to standard care from a health sector perspective reported in US$2015, a time horizon of 20 years, and a discount rate of 3$13,310 and an incremental cost per QALY gained of $3,560/QALY from the health sector perspective. CONCLUSIONS:Using a threshold of <3 x per capita GDP, the Link4Health strategy is likely to be a cost-effective strategy for responding to the HIV epidemic in Swaziland

Healthcare worker experiences with Option B+ for prevention of mother-to-child HIV transmission in eSwatini: findings from a two-year follow-up study

Background Prevention of mother-to-child transmission (PMTCT) across sub-Saharan Africa has rapidly shifted towards Option B+, an approach in which all HIV+ pregnant and breastfeeding women initiate lifelong antiretroviral therapy (ART) independent of CD4+ count. Healthcare workers (HCW) are critical to the success of Option B+, yet little is known regarding HCW acceptability of Option B+, particularly over time. Methods Ten health facilities in the Manzini and Lubombo regions of eSwatini transitioned from Option A to Option B+ between 2013 and 2014 as part of the Safe Generations study examining PMTCT retention. Fifty HCWs (5 per facility) completed questionnaires assessing feasibility and acceptability: (1) prior to transitioning to Option B+, (2) two months post transition, and (3) approximately 2 years post Option B+ transition. This analysis describes HCW perceptions and experiences two years after transitioning to Option B+. Results Two years after transition, 80% of HCWs surveyed reported that Option B+ was easy for HCWs, noting that it was particularly easy to explain and coordinate. Immediate ART initiation also reduced delays by eliminating need for laboratory tests prior to ART initiation. Additionally, HCWs reported ease of patient follow-up (58%), documentation (56%), and counseling (58%) under Option B+. Findings also indicate that a majority of HCWs reported that their workloads increased under Option B+. Sixty-eight percent of HCWs at two years post-transition reported more work under Option B+, specifically noting increased involvement in adherence counseling, prescribing/monitoring medications, and appointment scheduling/tracking. Some HCWs attributed their higher workloads to increased client loads, now that all HIV-positive women were initiated on ART. New barriers to patient uptake, and issues related to retention, adherence, and follow-up were also noted as challenges face by HCW when implementing Option B+. Conclusions Overall, HCWs found Option B+ to be acceptable and feasible while providing critical insights into the practical issues of universal ART. Further strengthening of the healthcare system may be necessary to alleviate worker burden and to ensure effective monitoring of client retention and adherence. HCW perceptions and experiences with Option B+ should be considered more broadly as countries implement Option B+ and consider universal treatment for all HIV+ individuals. Trial registration http://clinicaltrials.gov NCT01891799 , registered on July 3, 2013

Participant characteristics at HIV testing (<i>N</i> = 2,197).

<p>Participant characteristics at HIV testing (<i>N</i> = 2,197).</p

Comparison of combination intervention strategy (CIS) to standard of care (SOC) procedures.

<p>Comparison of combination intervention strategy (CIS) to standard of care (SOC) procedures.</p