Feasibility and impact of near-point-of-care integrated tuberculosis/HIV testing in Malawi and Zimbabwe.

OBJECTIVES: Near-point-of-care (POC) testing for early infant diagnosis (EID) and viral load expedites clinical action and improves outcomes but requires capital investment. We assessed whether excess capacity on existing near-POC devices used for TB diagnosis could be leveraged to increase near-POC HIV molecular testing, termed integrated testing, without compromising TB services. DESIGN: Preimplementation/postimplementation studies in 10 health facilities in Malawi and 8 in Zimbabwe. METHODS: Timeliness of EID and viral load test results and clinical action were compared between centralized and near-POC testing using Somers' D tests (continuous indicators) and risk ratios (RR, binary indicators); TB testing/treatment rates and timeliness were analyzed preintegration/postintegration. RESULTS: With integration, average device utilization increased but did not exceed 55%. Despite the addition of HIV testing, TB test volumes, timeliness, and treatment initiations were maintained. Although few HIV-positive infants were identified, near-POC EID testing improved treatment initiation within 1 month by 57% compared with centralized EID [Malawi RR: 1.57, 95% confidence interval (CI) 0.98-2.52], and near-POC viral load testing significantly increased the proportion of patients with elevated viral load receiving clinical action within 1 month (Zimbabwe RR: 5.26, 95% CI 3.38-8.20; Malawi RR: 3.90, 95% CI 2.58-5.91). CONCLUSION: Integrating TB/HIV testing using existing multidisease platforms is feasible and enables increased access to rapid diagnostics without disrupting existing TB services. Our results serve as an example of a novel, efficient implementation model that can increase access to critical testing services across disease silos and should be considered for additional clinical applications.

Evaluation of near point-of-care viral load implementation in public health facilities across seven countries in sub-Saharan Africa.

INTRODUCTION: In many low- and middle-income countries, HIV viral load (VL) testing occurs at centralized laboratories and time-to-result-delivery is lengthy, preventing timely monitoring of HIV treatment adherence. Near point-of-care (POC) devices, which are placed within health facility laboratories rather than clinics themselves (i.e. "true" POC), can offer VL in conjunction with centralized laboratories to expedite clinical decision making and improve outcomes, especially for patients at high risk of treatment failure. We assessed impacts of near-POC VL testing on result receipt and clinical action in public sector programmes in Cameroon, Democratic Republic of Congo, Kenya, Malawi, Senegal, Tanzania and Zimbabwe. METHODS: Routine health data were collected retrospectively after introducing near-POC VL testing at 57 public sector health facilities (2017 to 2019, country-dependent). Where possible, key indicators were compared to data from patients receiving centralized laboratory testing using hazard ratios and the Somers' D test. RESULTS: Data were collected from 6795 tests conducted on near-POC and 17614 tests on centralized laboratory-based platforms. Thirty-one percent (2062/6694) of near-POC tests were conducted for high-risk populations: pregnant and breastfeeding women, children and those with suspected failure. Compared to conventional testing, near-POC improved the median time from sample collection to return of results to patient [six vs. sixty-eight days, effect size: -32.2%; 95% CI: -41.0% to -23.4%] and to clinical action for individuals with an elevated HIV VL [three vs. fourty-nine days, effect size: -35.4%; 95% CI: -46.0% to -24.8%]. Near-POC VL results were two times more likely to be returned to the patient within 90 days compared to centralized tests [50% (1781/3594) vs. 27% (4172/15271); aHR: 2.22, 95% CI: 2.05 to 2.39]. Thirty-seven percent (340/925) of patients with an elevated near-POC HIV VL result had documented clinical follow-up actions within 30 days compared to 7% (167/2276) for centralized testing. CONCLUSIONS: Near-POC VL testing enabled rapid test result delivery for high-risk populations and led to significant improvements in the timeliness of patient result receipt compared to centralized testing. While there was some improvement in time-to-clinical action with near-POC VL testing, major gaps remained. Strengthening of systems supporting the utilization of results for patient management are needed to truly capitalize on the benefits of decentralized testing.

Patient and health worker experiences of differentiated models of care for stable HIV patients in Malawi: A qualitative study.

INTRODUCTION: Several models of differentiated care for stable HIV patients on antiretroviral therapy (ART) in Malawi have been introduced to ensure that care is efficient and patient-centered. Three models have been prioritized by the government for a deeper and broader understanding: adjusted appointment spacing through multi-month scripting (MMS); fast-track drug refills (FTRs) on alternating visits; and community ART groups (CAGs) where rotating group members collect medications at the facility for all members. This qualitative study aimed to understand the challenges and successes of implementing these models of care and of the process of patient differentiation. METHODS: A qualitative study was conducted as a part of a broader process evaluation in 30 purposefully selected ART facilities between February and May 2016. Semi-structured, in-depth interviews with 32 health workers that managed and coordinated ART clinics and 30 focus groups were held with 216 ART patients. Interviews and focus groups were audio recorded, transcribed, and coded thematically. RESULTS: Participants reported that the models of differentiated care have yielded key benefits, including: reduced patients' travel and visit time, decongestion of facilities, and enhanced social support. Participants suggested that these benefits could lead to improved HIV treatment outcomes for patients. At the same time, some challenges were reported, such as inconsistent stocks of drugs, which can inhibit implementation of MMS. For CAGs, the group-based nature of the model presented some unique problems, such as conflicts within groups or concerns about privacy. Health workers also described some of the reasons why eligible patients may not receive the models or conversely why ineligible patients sometimes get the models. CONCLUSIONS: Documenting patient and health worker perspectives on models of differentiated care is critical to understanding and improving these models. While these models can offer important benefits, the models may not be appropriate for all sites or patients, and patient status and needs may change over time. Key challenges should be recognized and addressed for optimal utilization of the models.

Multi-month prescriptions, fast-track refills, and community ART groups: results from a process evaluation in Malawi on using differentiated models of care to achieve national HIV treatment goals.

INTRODUCTION: In order to facilitate scale-up of antiretroviral therapy (ART) in Malawi, innovative and pragmatic models have been developed to optimize the efficiency of HIV service delivery. In particular, three models of differentiated care have emerged for stable patients: adjusted appointment spacing through multi-month scripting (MMS); fast-track drug refills (FTRs) on alternating visits; and community ART groups (CAGs) where group members rotate in collecting medications at the facility for all members. This study aimed to assess the extent to which ART patients in Malawi are differentiated based on clinical stability and describe the characteristics and costs associated with the models of differentiated care offered. METHODS: A mixed methods process evaluation was conducted from 30 purposefully selected ART facilities. Cross-sectional data for this evaluation was collected between February and May 2016. The following forms of data collection are reported here: structured surveys with 136 health care workers; reviews of 75,364 patient clinical records; 714 observations of visit time and flow; and 30 questionnaires on facility characteristics. RESULTS: Among ART patients, 77.5% (95% confidence interval [CI] 74.1-80.6) were eligible for differentiated models of care based on criteria for clinical stability from national guidelines. Across all facilities, 69% of patients were receiving MMS. In facilities offering FTRs and CAGs, 67% and 6% of patients were enrolled in the models, respectively. However, eligibility criteria were used inconsistently: 72.9% (95% CI 66.3-78.6) of eligible patients and 42.3% (95% CI 33.1-52.0) ineligible patients received MMS. Results indicated that patient travel and time costs were reduced by 67%, and the unit costs of ART service delivery through the MMS, FTR and CAG models were similar, representing a reduction of approximately 10% in the annual unit cost of providing care to stable patients that receive no model. CONCLUSIONS: MMS is being implemented nationally and has already generated cost savings and efficiencies in Malawi for patients and the health system, but could be improved by more accurate patient differentiation. While expanding FTRs and CAGs may not offer significant further cost savings in Malawi, future studies should investigate if such alternative models lead to improvements in patient satisfaction or clinical outcomes that might justify their implementation.