Donor coordination to support universal health coverage in Malawi.

Development assistance is a major source of financing for health in least developed countries. However, persistent aid fragmentation has led to inefficiencies and health inequities and constrained progress towards Universal Health Coverage (UHC). Malawi is a case study for this global challenge, with 55% of total health expenditure funded by donors and fragmentation across 166 financing sources and 265 implementing partners. This often leads to poor coordination and misalignment between government priorities and donor projects. To address these challenges, the Malawi Ministry of Health (MoH) has developed and implemented an architecture of aid coordination tools and processes. Using a case study approach, we documented the iterative development, implementation and institutionalization of these tools, which was led by the MoH with technical assistance from the Clinton Health Access Initiative. We reviewed the grey literature, including relevant policy documents, planning tools and databases of government/partner funding commitments, and drew upon the authors' experiences in designing, implementing and scaling up these tools. Overall, the iterative use and revision of these tools by the Government of Malawi across the national and subnational levels, including integration with the government's public financial management system, was critical to successful uptake. The tools are used to inform government and partner resource allocation decisions, assess financing and gaps for national and district plans and inform donor grant applications. As Malawi has launched the Health Sector Strategic Plan 2023-2030, these tools are being adapted for the 'One Plan, One Budget and One Report' approach. However, while the tools are an incremental mechanism to strengthen aid alignment, success has been constrained by the larger context of power imbalances and misaligned incentives between the donor community and the Government of Malawi. Reform of the aid architecture is therefore critical to ensure that these tools achieve maximum impact in Malawi's journey towards UHC.

Health care provider and client experiences of counselling on depot medroxyprogesterone acetate subcutaneous (DMPA-SC) for self-injection in Malawi.

Since the introduction of subcutaneous depot medroxyprogesterone acetate (DMPA-SC) in 2018, Malawi has achieved national coverage of trained providers in the public sector and steady increases in uptake of DMPA-SC. However, the rate of clients opting to self-inject DMPA-SC has remained lower than early acceptability studies suggested. Providers play an instrumental role in building client confidence to self-inject through counselling/training. This cross-sectional qualitative study explored the perspectives of providers and injectable clients on the integration of self-injection into contraceptive counselling, to identify best practices and potential gaps. The study was conducted at public sector sites in three districts (Nkhotakota, Mzimba South, Zomba) in Malawi. In-depth interviews were conducted with provider-administered injectable clients, self-injecting clients, and DMPA-SC trained providers. All providers interviewed reported successfully integrating self-injection into their approach. During group health education sessions, some providers reported focusing on benefits of self-injection to spark interest in the method, and then follow that up with more in-depth information during individual counselling. Due to time pressures, a minority of providers reported replacing individual counselling with small-group counselling and limited use of elements such as visualizations and demonstrations. Most providers skipped client practice on inanimate objects, feeling this was either not necessary or inappropriate given stock constraints. Self-injection clients tended to credit their decision to take up SI to receiving lengthy, comprehensive counselling/training, often inclusive of reassuring messages, visualizations, demonstrations and sometimes repeated trainings over time. Provider-administered clients tended to credit their lack of uptake of self-injection to fear and lack of confidence, often blaming themselves instead of the quality of their counselling/training-even while many felt their counselling/training had been rushed or incomplete. Providers should be supported to overcome time- and resource-pressures to invest in counselling/training best practices, to ensure sufficient support is provided to clients interested in self-injection.

Uptake of same-day initiation of HIV treatment in Malawi, South Africa, and Zambia as reported in routinely collected data: the SPRINT retrospective cohort study.

Background: Since 2017 global guidelines have recommended "same-day initiation" (SDI) of antiretroviral treatment (ART) for patients considered ready for treatment on the day of HIV diagnosis. Many countries have incorporated a SDI option into national guidelines, but SDI uptake is not well documented. We estimated average time to ART initiation at 12 public healthcare facilities in Malawi, five in South Africa, and 12 in Zambia. Methods: We sequentially enrolled patients eligible to start ART between January 2018 and June 2019 and reviewed their medical records from the point of HIV diagnosis or first HIV-related interaction with the clinic to the earlier date of treatment initiation or 6 months. We estimated the proportion of patients initiating ART on the same day or within 7, 14, 30, or 180 days of baseline. Results: We enrolled 826 patients in Malawi, 534 in South Africa, and 1,984 in Zambia. Overall, 88% of patients in Malawi, 57% in South Africa, and 91% in Zambia were offered and accepted SDI. In Malawi, most who did not receive SDI had not initiated ART ≤6 months. In South Africa, an additional 13% initiated ≤1 week, but 21% had no record of initiation ≤6 months. Among those who did initiate within 6 months in Zambia, most started ≤1 week. There were no major differences by sex. WHO Stage III/IV and tuberculosis symptoms were associated with delays in ART initiation. Conclusions: As of 2020, SDI of ART was widespread, if not nearly universal, in Malawi and Zambia but considerably less common in South Africa. Limitations of the study include pre-COVID-19 data that do not reflect pandemic adaptations and potentially missing data for Zambia. South Africa may be able to increase overall ART coverage by reducing numbers of patients who do not initiate ≤6 months. Registration: Clinicaltrials.gov ( NCT04468399; NCT04170374; NCT04470011).

Perspectives on DMPA-SC for self-injection among adolescents with unmet need for contraception in Malawi.

Introduction: Malawi has made progress in expanding access to modern contraceptive methods over the last decade, including the introduction of depot-medroxyprogesterone acetate subcutaneous (DMPA-SC) in 2018. DMPA-SC offers women the option to self-inject at home and may benefit adolescents with unmet need for contraception due to its discretion. This qualitative study was conducted to assess perspectives and preferences of adolescents with unmet need for contraception regarding the self-injection option of DMPA-SC in Malawi. Methods: Six focus group discussions were conducted involving 36 adolescents with unmet need for contraception (aged between 15 and 19 years, married and never-married) in October 2021 in three districts in Malawi. Data were coded inductively and analyzed thematically, using Dedoose software. Two validation workshops were conducted with other adolescents with unmet need in February 2022 to elucidate the preliminary findings. Results: DMPA-SC attributes such as discretion and reduced facility visits were ranked most appealing by both married and never-married adolescents, particularly for adolescents needing covert contraception use. Concerns about self-injection included fear of pain, injury, and doubt in ability to self-inject. Never-married adolescents had additional concerns around privacy at home if using covertly, and fears of affecting long-term fertility. Overall, health surveillance assistants (community-based healthcare workers) were voted to be the most private, convenient, and affordable sources for potential DMPA-SC self-injection training. Conclusion: Self-injection of DMPA-SC may offer an appealing option for adolescents in Malawi, aligning most closely to the needs of married adolescents who may wish to delay or space pregnancies conveniently and discreetly, and who also may face fewer access barriers to receiving self-injection training from health care providers. Access barriers including stigma and concerns about privacy at home for adolescents needing to use contraception covertly would need to be adequately addressed if never-married adolescents were to consider taking up this option.

Using modeling and scenario analysis to support evidence-based health workforce strategic planning in Malawi.

BACKGROUND: A well-trained and equitably distributed workforce is critical to a functioning health system. As workforce interventions are costly and time-intensive, investing appropriately in strengthening the health workforce requires an evidence-based approach to target efforts to increase the number of health workers, deploy health workers where they are most needed, and optimize the use of existing health workers. This paper describes the Malawi Ministry of Health (MoH) and collaborators' data-driven approach to designing strategies in the Human Resources for Health Strategic Plan (HRH SP) 2018-2022. METHODS: Three modelling exercises were completed using available data in Malawi. Staff data from districts, central hospitals, and headquarters, and enrollment data from all health training institutions were collected between October 2017 and February 2018. A vacancy analysis was conducted to compare current staffing levels against established posts (the targeted number of positions to be filled, by cadre and work location). A training pipeline model was developed to project the future available workforce, and a demand-based Workforce Optimization Model was used to estimate optimal staffing to meet current levels of service utilization. RESULTS: As of 2017, 55% of established posts were filled, with an average of 1.49 health professional staff per 1000 population, and with substantial variation in the number of staff per population by district. With current levels of health worker training, Malawi is projected to meet its establishment targets in 2030 but will not meet the WHO standard of 4.45 health workers per 1000 population by 2040. A combined intervention reducing attrition, increasing absorption, and doubling training enrollments would allow the establishment to be met by 2023 and the WHO target to be met by 2036. The Workforce Optimization Model shows a gap of 7374 health workers to optimally deliver services at current utilization rates, with the largest gaps among nursing and midwifery officers and pharmacists. CONCLUSIONS: Given the time and significant financial investment required to train and deploy health workers, evidence needs to be carefully considered in designing a national HRH SP. The results of these analyses directly informed Malawi's HRH SP 2018-2022 and have subsequently been used in numerous planning processes and investment cases in Malawi. This paper provides a practical methodology for evidence-based HRH strategic planning and highlights the importance of strengthening HRH data systems for improved workforce decision-making.

Health Sector Resource Mapping in Malawi: Sharing the Collection and Use of Budget Data for Evidence-Based Decision Making.

BACKGROUND: In 2011, the Ministry of Health in Malawi developed and institutionalized a resource-tracking process, known as resource mapping (RM), to collect information on planned funding flows across the health sector to support resource allocation and mobilization decisions. We analyze the RM process and tools and describe key uses of the data for health financing decision making to achieve universal health coverage (UHC). METHODS: We applied a case study approach, written as a collaboration between policy makers who have led the RM process in Malawi and the implementation team who have developed tools, collected data, and reported results over the period. It draws on our experiences in conducting RM in Malawi to document the RM process and data, key uses of data, implementation challenges, and lessons learned. We conducted a gray literature review to understand rounds of RM in which we did not participate. Finally, we conducted a search of published literature to situate our work in the international health resource-tracking literature. RESULTS: The RM exercise in Malawi is iteratively designed around the needs of the end users and policy priorities of the government, which in turn drives institutionalization of the exercise. We describe 4 ways in which RM data has been used, including national and district planning and budgeting; prioritization and coordination of existing funds by estimating resource availability; mobilization of new resources by conducting financial gap analysis against costed national strategic plans; and generation of evidence to support the national response to the coronavirus disease 2019 pandemic. DISCUSSION: To achieve UHC goals in Malawi, RM has equipped the government and development partners with critical data used for resource mobilization and coordination decisions. Lessons learned from RM in Malawi may be applicable to other countries starting or refining their own health resource-tracking exercise.

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.

Analysis of policy interventions to attract and retain nurse midwives in rural areas of Malawi: A discrete choice experiment.

BACKGROUND: Inadequate and unequal distribution of health workers are significant barriers to provision of health services in Malawi, and challenges retaining health workers in rural areas have limited scale-up initiatives. This study therefore aims to estimate cost-effectiveness of monetary and non-monetary strategies in attracting and retaining nurse midwife technicians (NMTs) to rural areas of Malawi. METHODS: The study uses a discrete choice experiment (DCE) methodology to investigate importance of job characteristics, probability of uptake, and intervention costs. Interviews and focus groups were conducted with NMTs and students to identify recruitment and retention motivating factors. Through policymaker consultations, qualitative findings were used to identify job attributes for the DCE questionnaire, administered to 472 respondents. A conditional logit regression model was developed to produce probability of choosing a job with different attributes and an uptake rate was calculated to estimate the percentage of health workers that would prefer jobs with specific intervention packages. Attributes were costed per health worker year. RESULTS: Qualitative results highlighted housing, facility quality, management, and workload as important factors in job selection. Respondents were 2.04 times as likely to choose a rural job if superior housing was provided compared to no housing (CI 1.71-2.44, p<0.01), and 1.70 times as likely to choose a rural job with advanced facility quality (CI 1.47-1.96, p<0.01). At base level 43.9% of respondents would choose a rural job. This increased to 61.5% if superior housing was provided, and 72.5% if all facility-level improvements were provided, compared to an urban job without these improvements. Facility-level interventions had the lowest cost per health worker year. CONCLUSIONS: Our results indicate housing and facility-level improvements have the greatest impact on rural job choice, while also creating longer-term improvements to health workers' living and working environments. These results provide practical evidence for policymakers to support development of workforce recruitment and retention strategies.

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.

Receipt of infant HIV DNA PCR test results is associated with a reduction in retention of HIV-exposed infants in integrated HIV care and healthcare services: a quantitative sub-study nested within a cluster randomised trial in rural Malawi.

BACKGROUND: Retention of HIV-infected mothers in integrated HIV and healthcare facilities is effective at reducing mother-to-child-transmission (MTCT) of HIV. In the context of Option B+, we examined maternal and HIV-exposed infant retention across three study arms to 18 months postpartum: mother-and-infant clinics (MIP), MIP with short-messaging service (MIP + SMS) and standard of care (SOC). In particular, we focused on the impact of mothers receiving an infant's HIV PCR test result on maternal and infant study retention. METHODS: A quantitative sub-study nested within a cluster randomised trial undertaken between May 2013 and August 2016 across 30 healthcare facilities in rural Malawi enrolling HIV-infected pregnant mothers and HIV-exposed infants on delivery, was performed. Survival probabilities of maternal and HIV-exposed infant study retention was estimated using Kaplan-Meier curves. Associations between mother's receiving an infant's HIV test result and in particular, an infant's HIV-positive result on maternal and infant study retention were modelled using time-varying multivariate Cox regression. RESULTS: Four hundred sixty-one, 493, and 396 HIV-infected women and 386, 399, and 300 HIV-exposed infants were enrolled across study arms; MIP, MIP + SMS and SOC, respectively. A total of 47.5% of mothers received their infant's HIV test results < 5 months postpartum. Receiving an infant's HIV result by mothers was associated with a 70% increase in infant non-retention in the study compared with not receiving an infant's result (HR = 1.70; P-value< 0.001). Receiving a HIV-positive result was associated with 3.12 times reduced infant retention compared with a HIV-negative result (P-value< 0.001). Of the infants with a HIV-negative test result, 87% were breastfed at their final study follow-up. CONCLUSIONS: Receiving an infant's HIV test result was a driving factor for reduced infant study retention, especially an infant's HIV-positive test result. As most HIV-negative infants were still breastfed at their last follow-up, this indicates a large proportion of HIV-exposed infants were potentially at future risk of MTCT of HIV via breastfeeding but were unlikely to undergo follow-up HIV testing after breastfeeding cessation. Future studies to identify and address underlying factors associated with infant HIV testing and reduced infant retention could potentially improve infant retention in HIV/healthcare facilities. TRIAL REGISTRATION: Pan African Clinical Trial Registry: PACTR201312000678196 .

Impact of program transfer from a non-governmental organization to a district health office: Evaluation of a program integrating water treatment and hygiene kits into reproductive health and HIV services, Machinga District, Malawi, 2010-2012.

BACKGROUND: In September 2009, the Machinga Integrated Antenatal Water Hygiene Kit Program began addressing problems of unsafe water, high infant mortality, and low antenatal care (ANC) attendance in Machinga District, Malawi. In March 2011, the supporting international non-governmental organization transitioned management of the program to the Machinga District Health Office (DHO). We evaluated maternal and HIV service use before and after program transition to the DHO. METHODS: We compared pre- and post-transition periods by examining data recorded in ANC and maternal registries in 15 healthcare facilities (HCFs) by proportion z-tests. We classified HCFs by size, using the median monthly patient volumes as the split for large or small facilities. We used logistic regression to evaluate changes in the use of ANC, maternal, and HIV services and their interactions with HCF size. RESULTS: The percentage of women attending their first ANC visit during the first trimester was similar in the pre-and post-transition periods (9.3% vs 10.2%). Although the percentage of women with ≥4 ANC visits was similar from pre- to post-transition (26.0% vs 24.8%), the odds increased among women in small facilities (OR: 1.37, 95% CI: 1.24-1.51), and decreased among women in large facilities (OR: 0.80, 95% CI: 0.75-0.85). Although a similar percentages of pregnant women were diagnosed with HIV in all HCFs in the pre- and post-transitions periods (6.4% vs 4.8%), a substantially larger proportion of women were not tested for HIV in large HCFs (OR: 6.34, 95% CI: 5.88-6.84). A larger proportion of women gave birth at both small (OR: 1.30, 95% CI: 1.16-1.45) and large HCFs (OR: 1.55, 95% CI: 1.43-1.67) in the post-transition vs. the pre-transition period. CONCLUSIONS: The evaluation results suggest that many positive aspects of this donor-supported program continued following transition of program management from a non-governmental organization to a DHO.

Diffusion of Handwashing Knowledge and Water Treatment Practices From Mothers in an Antenatal Hygiene Promotion Program to Nonpregnant Friends and Relatives, Machinga District, Malawi.

Access to safe drinking water and improved hygiene are essential for preventing diarrheal diseases in low- and middle-income countries. Integrating water treatment and hygiene products into antenatal clinic care can motivate water treatment and handwashing among pregnant women. Free water hygiene kits (water storage containers, sodium hypochlorite water treatment solution, and soap) and refills of water treatment solution and soap were integrated into antenatal care and delivery services in Machinga District, Malawi, resulting in improved water treatment and hygiene practices in the home and increased maternal health service use. To determine whether water treatment and hygiene practices diffused from maternal health program participants to friends and relatives households in the same communities, we assessed the practices of 106 nonpregnant friends and relatives of these new mothers at baseline and 1-year follow-up. At follow-up, friends and relatives were more likely than at baseline to have water treatment products observable in the home (33.3% vs. 1.2%, p < 0.00001) and detectable free chlorine residual in their water, confirming water treatment (35.7% vs. 1.4%; p < 0.00001). Qualitative data from in-depth interviews also suggested that program participants helped motivate adoption of water treatment and hygiene behaviors among their friends and relatives.

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.

Safe Water and Hygiene Integration with Human Immunodeficiency Virus and Antenatal Services: Leveraging Opportunities for Public Health Interventions and Improved Service Uptake.

Integrating public health interventions with antenatal clinic (ANC) visits may motivate women to attend ANC, thereby improving maternal and neonatal health, particularly for human immunodeficiency virus (HIV)-infected persons. In 2009, in an integrated ANC/Preventing Mother-to-Child Transmission program, we provided free hygiene kits (safe storage containers, WaterGuard water treatment solution, soap, and oral rehydration salts) to women at their first ANC visit and refills at subsequent visits. To increase fathers' participation, we required partners' presence for women to receive hygiene kits. We surveyed pregnant women at baseline and at 12-month follow-up to assess ANC service utilization, HIV counseling and testing (HCT), test drinking water for residual chlorine, and observe handwashing. We conducted in-depth interviews with pregnant women, partners, and health workers. We enrolled 106 participants; 97 (92%) were found at follow-up. During the program, 99% of pregnant women and their partners received HCT, and 99% mutually disclosed. Fifty-six percent of respondents had ≥ 4 ANC visits and 90% delivered at health facilities. From baseline to follow-up, the percentage of women who knew how to use WaterGuard (23% versus 80%, P < 0.0001), had residual chlorine in stored water (0% versus 73%, P < 0.0001), had confirmed WaterGuard use (0% versus 70%, P < 0.0003), and demonstrated proper handwashing technique (21% versus 64% P < 0.0001) increased. Program participants showed significant improvements in water treatment and hygiene, and high use of ANC services and HCT. This evaluation suggests that integration of hygiene kits, refills, and HIV testing during ANC is feasible and may help improve household hygiene and increase use of health services.

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.

Impact of Mother-Infant Pair Clinics and Short-Text Messaging Service (SMS) Reminders on Retention of HIV-Infected Women and HIV-Exposed Infants in eMTCT Care in Malawi: A Cluster Randomized Trial.

BACKGROUND: Poor retention of mothers and HIV-exposed infants (HEIs) in HIV care threatens efforts to eliminate pediatric HIV. Novel strategies are required to address this challenge. We compared 12-month maternal and HEI postpartum retention in health facilities implementing the following HIV care delivery models: integrated HIV and maternal, neonatal, and child health services [mother-infant pair (MIP) clinics], MIP clinics plus short-text messaging service (SMS) reminders to prevent default (MIP + SMS), and standard of care (SOC). METHODS: From May 2013 to August 2016, a cluster randomized trial was conducted in rural Malawi, which randomized 30 health facilities to the 3 service delivery models. HIV+ pregnant women and HEIs were enrolled and followed up to monitor compliance with prescheduled visits and retention. Log binomial regression, using generalized estimated equation, was used to assess the impact of the models on retention. RESULTS: The trial enrolled 461, 493, and 396 HIV+ pregnant women and 386, 399, and 300 HEIs into the MIP, MIP + SMS, and SOC arms, respectively. Compared with the 12-month maternal retention rate in the SOC arm (22.2%), the rates were similar in the MIP arm [19.3%, risk ratio (RR): 0.85, 95% confidence interval (CI): 0.56 to 1.30] and in the MIP + SMS arm (24.9%, RR: 1.08, 95% CI: 0.87 to 1.35). Compared with the 12-month infant retention rate in the SOC arm (9.8%), the rates were similar in the MIP arm (8.0%, RR: 0.89, 95% CI: 0.31 to 2.58) and in the MIP + SMS arm (19.5%, RR: 1.40, 95% CI: 0.85 to 2.31). CONCLUSIONS: MIP and MIP + SMS service delivery models were ineffective in improving maternal and infant retention in rural Malawi.

Integrating HIV and Maternal, Neonatal and Child Health Services in Rural Malawi: An Evaluation of the Implementation Processes and Challenges.

INTRODUCTION: Introducing Option B+ in Malawi increased antiretroviral therapy coverage among pregnant and breastfeeding women 3 fold. The Promoting Retention among Infants and Mothers Effectively (PRIME) study integrated care of Maternal, Neonatal and Child Health services through a mother-infant pair (MIP) clinic. This article evaluates the implementation processes and challenges health care workers' experienced in implementing these MIP clinics. METHODS: Between May 2013 and August 2016, 20 health facilities implemented MIP clinics. Health care workers' performance implementing MIP clinics was assessed through a mentorship score from 0 to 5 and supplemented with qualitative data from mentorship reports. Visit alignment of participants' appointment and attendance dates with MIP clinic dates were calculated and summarized by overall proportions among all patient visits. RESULTS: The average mentorship score was 3.8, improving from 3.0 to 4.2 from quarter one 2015 to quarter one 2016. Proportions of maternal and infant appointment dates that aligned with MIP clinic dates were 47.0% and 55.9%, with greatest improvement between 2013 and 2015. Proportions of maternal and infant attendance dates that aligned with MIP clinic dates were 41.7% and 51.2% and improved over time. DISCUSSION: Despite improvement in staff mentorship scores, many MIPs were not exposed to integrated HIV and Maternal, Neonatal and Child Health services offered through MIP clinics primarily because of clinic scheduling challenges. To improve utilization of integrated MIP clinics, careful design of a delivery approach is needed that is acceptable to clinic staff, addresses local realities, and includes appropriate investment and oversight.

Mother-infant pair clinic and SMS messaging as innovative strategies for improving access to and retention in eMTCT care and Option B+ in Malawi: a cluster randomized control trial (the PRIME study).

UNAIDS has set a goal of achieving the elimination of mother-to-child transmission (eMTCT) of HIV by 2015 and keeping HIV-positive (HIV+) mothers alive. In pursuit of this goal, in 2011, the Malawi Ministry of Health (MoH) adopted the Option B+ strategy, which entails lifelong antiretroviral treatment for all HIV+ mothers, irrespective of severity of HIV infection. Poor mother-child pair retention is one of the major challenges against achieving this goal. To improve retention of mother-infant pairs in the eMTCT continuum of care, the Promoting Retention among Infants and Mothers Effectively (PRIME) study is evaluating the effectiveness of 3 models of health care delivery namely, mother-infant pair clinics, which deliver integrated HIV and non-HIV services, mother-infant pair clinics plus electronic text message (SMS) reminders for mother-infant pairs who miss scheduled eMTCT follow-up clinics, and current standard of care. The primary outcome is "the proportion of HIV+ mothers and/or HIV-exposed infants (HEI) retained in eMTCT care at 12 months postpartum and received recommended HIV and non-HIV services during preceding scheduled visits." This 3-arm cluster randomized intervention study is being implemented in 30 primary health facilities (10 facilities per arm) in Mangochi and Salima districts, Malawi. At each clinic, a total of 41 HIV+ mothers attending maternal and child health services are being recruited and followed up for 18 months postpartum. This article describes the study methodology and interventions, successes and challenges experienced during the first 12 months of study implementation and relevance of study results to Malawi and other countries adopting the Option B+ strategy.