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.

BackgroundToday's uncertain HIV funding landscape threatens to slow progress towards treatment goals. Understanding the costs of antiretroviral therapy (ART) will be essential for governments to make informed policy decisions about the pace of scale-up under the 2013 WHO HIV Treatment Guidelines, which increase the number of people eligible for treatment from 17.6 million to 28.6 million. The study presented here is one of the largest of its kind and the first to describe the facility-level cost of ART in a random sample of facilities in Ethiopia, Malawi, Rwanda, South Africa and Zambia.Methods & FindingsIn 2010–2011, comprehensive data on one year of facility-level ART costs and patient outcomes were collected from 161 facilities, selected using stratified random sampling. Overall, facility-level ART costs were significantly lower than expected in four of the five countries, with a simple average of $208 per patient-year (ppy) across Ethiopia, Malawi, Rwanda and Zambia. Costs were higher in South Africa, at $682 ppy. This included medications, laboratory services, direct and indirect personnel, patient support, equipment and administrative services. Facilities demonstrated the ability to retain patients alive and on treatment at these costs, although outcomes for established patients (2–8% annual loss to follow-up or death) were better than outcomes for new patients in their first year of ART (77–95% alive and on treatment).ConclusionsThis study illustrated that the facility-level costs of ART are lower than previously understood in these five countries. While limitations must be considered, and costs will vary across countries, this suggests that expanded treatment coverage may be affordable. Further research is needed to understand investment costs of treatment scale-up, non-facility costs and opportunities for more efficient resource allocation.

IntroductionSeveral 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.MethodsA 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.ResultsParticipants 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.ConclusionsDocumenting 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.