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Background: Environmental health services (EHS) in healthcare facilities (HCFs) are critical for providing a safe, functional healthcare environment, but little is known about their costs. Poor understanding of costs impedes progress towards universal access of EHS in HCFs. We developed frameworks of essential expenses required to provide EHS and conducted an ex-post financial analysis of EHS in a network of medical research and training facilities in Lilongwe, Malawi, serving an estimated 42,000 patients annually through seven outpatient buildings., Methods: We estimated the cost of providing the following EHS: water, sanitation, hygiene, personal protective equipment use at the point of care, waste management, cleaning, laundry, and vector control. We developed frameworks of essential outputs and inputs for each EHS through review of international guidelines and standards, which we used to identify expenses required for EHS delivery and evaluate the completeness of costs data in our case study. For costing, we use a mixed-methods approach, applying qualitative interviews to understand facility context and review of electronic records to determine costs. We calculated initial costs to establish EHS and annual operations and maintenance., Results: Available records contained little information on the upfront, capital costs associated with establishing EHS. Annual operations and maintenance totaled USD 220,427 for all EHS across all facilities (USD 5.21 per patient encounter), although costs of many essential inputs were missing from records. Annual operations and maintenance costs were highest for cleaning (USD 69,372) and waste management (USD 46,752)., Discussion: Missing expenses suggests that documented costs are substantial underestimates. Costs to establish services were missing predominantly because purchases pre-dated electronic records. Annual operations and maintenance costs were incomplete primarily because administrative records did not record sufficient detail to disaggregate and attribute expenses., Conclusions: Electronic health information systems have potential to support efficient data collection. However, we found that existing records systems were decentralized and poorly suited to identify EHS costs. Our research suggests a need to better code and disaggregate EHS expenses to properly leverage records for costing. Frameworks developed in this study are a potential tool to develop more accurate estimates of the cost of providing EHS in HCFs.

Background: RTS,S/AS01 is the first vaccine against malaria to undergo pilot implementation, beginning in 2019 and vaccinating 360,000 children per year in Malawi, Ghana, and Kenya. The four-dose vaccine is given as a primary three-dose series with a fourth dose given approximately 18 months later. The efficacy of RTS,S/AS01 was variable among the 11 sites participating in the 2009-2014 phase III trial (MALARIA-055, NCT00866619), possibly due to differences in transmission intensity. However, a within-site examination of environmental factors related to transmission intensity and their impact on vaccine efficacy has yet to be conducted., Methods: We implemented the phase III RTS,S/AS01 trial at the Malawi site, which enrolled 1578 infants (6-12 weeks) and children (5-17 months) living in the Lilongwe District in Central Malawi and followed them for 3 years between 2009 and 2014. A global positioning system survey and an ecological questionnaire were conducted to collect participant household locations and characteristics, while additional data on background malaria prevalence were obtained from a concurrent Malaria Transmission Intensity (MTI) survey. Negative binomial regression models were used to assess whether the efficacy of the vaccine varied by estimated background malaria prevalence, household roof type, or amount of nearby vegetation., Results: Vaccine efficacy did not significantly vary by estimated malaria prevalence or by roof type. However, increased vegetation cover was associated with an increase in the efficacy of the three-dose primary RTS,S/AS01 series in the 18 months before the fourth dose and a decrease in the efficacy of the primary vaccine series in the second 18 months following, if the fourth dose was not given. Vegetation cover did not alter the efficacy of the fourth dose in a statistically or practically significant manner., Conclusions: Vegetation coverage in this study site might be a proxy for nearness to rivers or branching, shallow wetlands called "dambos" which could serve as breeding sites for mosquitoes. We observed statistically significant modification of the efficacy of RTS,S/AS01 by forest cover, suggesting that initial vaccine efficacy and the importance of the fourth dose varies based on ecological context., Trial Registration: Efficacy of GSK Biologicals' Candidate Malaria Vaccine (257049) Against Malaria Disease Caused by P. falciparum Infection in Infants and Children in Africa. NCT00866619 prospectively registered 20 March 2009.

Background: RTS,S/AS01, the most advanced vaccine against malaria, is now undergoing pilot implementation in Malawi, Ghana, and Kenya where an estimated 360,000 children will be vaccinated each year. In this study we evaluate RTS,S/AS01 alongside bed net use and estimate cost-effectiveness., Methods: RTS,S/AS01 phase III trial and bed net prevalence data were used to determine the effect of vaccination in the urban/periurban and rural areas of Lilongwe, Malawi. Cost data were used to calculate the cost-effectiveness of various interventions over three years., Findings: Since bed nets reduce malaria incidence and homogeneous vaccine efficacy was assumed, participants without bed nets received greater relative benefit from vaccination with RTS,S/AS01 than participants with bed nets. Similarly, since malaria incidence in rural Lilongwe is higher than in urban Lilongwe, the impact and cost-effectiveness of vaccine interventions is increased in rural areas. In rural Lilongwe, we estimated that vaccinating one child without a bed net would prevent 2·59 (1·62 to 3·38) cases of malaria over three years, corresponding to a cost of $10·08 (7·71 to 16·13) per case averted. Alternatively, vaccinating one child with a bed net would prevent 1·59 (0·87 to 2·57) cases, corresponding to $16·43 (10·16 to 30·06) per case averted. Providing RTS,S/AS01 to 30,000 children in rural Lilongwe was estimated to cost $782,400 and to prevent 58,611 (35,778 to 82,932) cases of malaria over a three-year period. Joint interventions providing both vaccination and bed nets (to those without them) were estimated to prevent additional cases of malaria and to be similarly cost-effective, compared to vaccine-only interventions., Interpretation: To maximize malaria prevention, vaccination and bed net distribution programs could be integrated., Funding: Impacts of Environment, Host Genetics and Antigen Diversity on Malaria Vaccine Efficacy (1R01AI137410-01)., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2020 Elsevier Ltd. All rights reserved.)

Many healthcare facilities (HCFs) in low-income countries experience unreliable connectivity to energy sources, which adversely impacts the quality of health service delivery and provision of adequate environmental health services. This assessment explores the status and consequences of energy access through interviews and surveys with administrators and healthcare workers from 44 HCFs (central hospitals, district hospitals, health centres and health posts) in Malawi. Most HCFs are connected to the electrical grid but experience weekly power interruptions averaging 10 h; less than one-third of facilities have a functional back-up source. Inadequate energy availability is associated with irregular water supply and poor medical equipment sterilization; it adversely affects provider safety and contributes to poor lighting and working conditions. Some challenges, such as poor availability and maintenance of back-up energy sources, disproportionately affect smaller HCFs. Policymakers, health system actors and third-party organizations seeking to improve energy access and quality of care in Malawi and similar settings should address these challenges in a way that prioritizes the specific needs of different facility types., (© The Author(s) 2019. Published by Oxford University Press in association with The London School of Hygiene and Tropical Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Healthcare-acquired infections (HAIs) contribute to maternal and neonatal morbidity and mortality, especially in low- and middle-income countries (LMICs). Deficient environmental health (EH) conditions and infection prevention and control (IPC) practices in healthcare facilities (HCFs) contribute to the spread of HAIs, but microbial sampling of sources of contamination is rarely conducted nor reported in low-resource settings. The purpose of this study was to assess EH conditions and IPC practices in Malawian HCFs and evaluate how EH deficiencies contribute to pathogen exposures and HAIs, and to provide recommendations to inform improvements in EH conditions using a mixed-methods approach. Thirty-one maternity wards in government-run HCFs were surveyed in the three regions of Malawi. Questionnaires were administered in parallel with structured observations of EH conditions and IPC practices and microbial testing of water sources and facility surfaces. Results indicated significant associations between IPC practices and microbial contamination. Facilities where separate wards were not available for mothers and newborns with infections and where linens were not used for patients during healthcare services were more likely to have delivery tables with surface contamination (relative risk = 2.23; 1.49, 3.34). E. coli was detected in water samples from seven (23%) HCFs. Our results suggest that Malawian maternity wards could reduce microbial contamination, and potentially reduce the occurrence of HAIs, by improving EH conditions and IPC practices. HCF staff can use the simple, low-cost EH monitoring methods used in this study to incorporate microbial monitoring of EH conditions and IPC practices in HCFs in low-resource settings.

Background: Pneumonia is the leading cause of death among children globally. Most pneumonia deaths in low-income and middle-income countries (LMICs) occur among children with HIV infection or exposure, severe malnutrition, or hypoxaemia despite antibiotics and oxygen. Non-invasive bubble continuous positive airway pressure (bCPAP) is considered a safe ventilation modality that might improve child pneumonia survival. bCPAP outcomes for high-risk African children with severe pneumonia are unknown. Since most child pneumonia hospitalisations in Africa occur in non-tertiary district hospitals without daily physician oversight, we aimed to examine whether bCPAP improves severe pneumonia mortality in such settings., Methods: This open-label, randomised, controlled trial was done in the general paediatric ward of Salima District Hospital, Malawi. We enrolled children aged 1-59 months old with WHO-defined severe pneumonia and either HIV infection or exposure, severe malnutrition, or an oxygen saturation of less than 90%. Children were randomly assigned 1:1 to low-flow nasal cannula oxygen or nasal bCPAP. Non-physicians administered care; the primary outcome was hospital survival. Primary analyses were by intention-to-treat and interim and adverse events analyses per protocol. This trial is registered with ClinicalTrials.gov, number NCT02484183, and is closed., Findings: We screened 1712 children for eligibility between June 23, 2015, and March 21, 2018. The data safety and monitoring board stopped the trial for futility after 644 of the intended 900 participants were enrolled. 323 children were randomly assigned to oxygen and 321 to bCPAP. 35 (11%) of 323 children who received oxygen died in hospital, as did 53 (17%) of 321 who received bCPAP (relative risk 1·52; 95% CI 1·02-2·27; p=0·036). 13 oxygen and 17 bCPAP patients lacked hospital outcomes and were considered lost to follow-up. Suspected adverse events related to treatment occurred in 11 (3%) of 321 children receiving bCPAP and 1 (<1%) of 323 children receiving oxygen. Four bCPAP and one oxygen group deaths were classified as probable aspiration episodes, one bCPAP death as probable pneumothorax, and six non-death bCPAP events included skin breakdown around the nares., Interpretation: bCPAP treatment in a paediatric ward without daily physician supervision did not reduce hospital mortality among high-risk Malawian children with severe pneumonia, compared with oxygen. The use of bCPAP within certain patient populations and non-intensive care settings might carry risk that was not previously recognised. bCPAP in LMICs needs further evaluation before wider implementation for child pneumonia care., Funding: Bill & Melinda Gates Foundation, International AIDS Society, Health Empowering Humanity., (Copyright © 2019 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

Based on formative research, HIV-positive women in Lilongwe District, Malawi receive little infant and young child feeding (IYCF) counselling postpartum and want more support for IYCF from their husbands. To address these gaps, we implemented a behaviour change communication intervention promoting IYCF in village savings and loan associations (VSLAs) that included HIV-positive and HIV-negative women. The intervention consisted of 15 IYCF learning sessions facilitated by VSLA volunteers during regular VSLA meetings and included four sessions to which husbands were invited. We assessed the feasibility and acceptability of the intervention through learning session participation logs, structured observations of learning sessions, and in-depth interviews with HIV-positive and HIV-negative VSLA members, husbands of members, and VSLA volunteers. Nine VSLA volunteers conducted learning sessions with approximately 300-400 women, about one quarter of whom were lactating, and 25-35 men. VSLA volunteers consistently communicated technical information correctly, followed the learning session steps, and used visual aids. Sessions averaged 46 min, with <20% of observed sessions completed within the recommended time (20-25 min). Key themes from interviews were the following: (a) learning sessions were useful; (b) including HIV-positive and HIV-negative women in the sessions was acceptable; (c) information learned during sessions encouraged families to change IYCF practices; (d) IYCF messages were shared with others in the community; and (e) male participation was low because men considered VSLAs and IYCF to be women's activities. In conclusion, integrating IYCF learning sessions into VLSAs was feasible and acceptable for mixed groups of HIV-positive and HIV-negative women. Future research should test other strategies for involving men in IYCF., (© 2018 John Wiley & Sons Ltd.)

While urbanization in a sub-Saharan African (SSA) context can lead to greater independence in women, various sociological, biological, and geographical factors in urban areas may keep women at a higher risk for HIV than men. Access to major roads during Malawi's transition into rapid urbanization may leave women disproportionately vulnerable to HIV infection. It is not well established whether women who report to health clinics closer to major roads have higher or lower levels of HIV. In this study we explored the spatial heterogeneity of HIV prevalence among pregnant females in Lilongwe District, Malawi. Using Geographic Information Systems, we visually represented patterns of HIV prevalence in relation to primary roads. HIV prevalence data for 2015 were obtained from 44 antenatal clinics (ANC) in Lilongwe District. ANC prevalence data were aggregated to the administrative area and mapped. Euclidean distance between clinics and two primary roads that run through Lilongwe District were measured. A correlation was run to assess the relationship between area-level ANC HIV prevalence and clinic distance to the nearest primary road. ANC HIV prevalence ranged from 0% to 10.3%. Clinic to major road distance ranged from 0.1 to 35 km. Correlation results ( r= -0.622, p = 0.002) revealed a significant negative relationship between clinic distance to primary road and HIV prevalence, indicating that the farther the clinics stood from primary roads, the lower the reported antenatal HIV prevalence. Overall, the clinic catchments through which the major roads run reported higher ANC HIV prevalence. Antenatal HIV prevalence decreases as ANC distance from primary roads increases in Lilongwe, Malawi. As urbanization continues to grow in this region, road distance may serve as a good indicator of HIV burden and help to guide targeted prevention and treatment efforts.

Introduction: Providing outreach HIV prevention services at venues (i.e. "hotspots") where people meet new sex partners can decrease barriers to HIV testing services (HTS) for key populations (KP) in sub-Saharan Africa (SSA). We offered venue-based HTS as part of bio-behavioural surveys conducted in urban Malawi and Angola to generate regional insights into KP programming gaps and identify opportunities to achieve the "first 90" for KP in SSA., Methods: From October 2016 to March 2017, we identified and verified 1054 venues in Luanda and Benguela, Angola and Zomba, Malawi and conducted bio-behavioural surveys at 166 using the PLACE method. PLACE interviews community informants to systematically identify public venues where KP can be reached and conducts bio-behavioural surveys at a stratified random sample of venues. We present survey results using summary statistics and multivariable modified Poisson regression modelling to examine associations between receipt of outreach worker-delivered HIV/AIDS education and HTS uptake. We applied sampling weights to estimate numbers of HIV-positive KP unaware of their status at venues., Results: We surveyed 959 female sex workers (FSW), 836 men who have sex with men (MSM), and 129 transgender women (TGW). An estimated 71% of HIV-positive KP surveyed were not previously aware of their HIV status, receiving a new HIV diagnosis through PLACE venue-based HTS. If venue-based HTS were implemented at all venues, 2022 HIV-positive KP (95% CI: 1649 to 2477) who do not know their status could be reached, including 1666 FSW (95% CI: 1397 to 1987), 274 MSM (95% CI: 160 to 374), and 82 TG (95% CI: 20 to 197). In multivariable analyses, FSW, MSM, and TGW who received outreach worker-delivered HIV/AIDS education were 3.15 (95% CI: 1.99 to 5.01), 3.12 (95% CI: 2.17 to 4.48), and 1.80 (95% CI: 0.67 to 4.87) times as likely, respectively, as those who did not to have undergone HTS within the last six months. Among verified venues, <=68% offered any on-site HIV prevention services., Conclusions: Availability of HTS and other HIV prevention services was limited at venues. HIV prevention can be delivered at venues, which can increase HTS uptake and HIV diagnosis among individuals not previously aware of their status. Delivering venue-based HTS may represent an effective strategy to reach the "first 90" for KP in SSA., (© 2018 The Authors. Journal of the International AIDS Society published by John Wiley & sons Ltd on behalf of the International AIDS Society.)

Background: Few studies in low- and middle-income countries have examined the roles of couples in infant and young child feeding decision making and practices, and there is no corresponding data in the context of human immunodeficiency virus (HIV). Research aim: This study aimed to explore mothers' and fathers' perceptions of their roles in feeding decision making and practices., Methods: The authors conducted in-depth interviews with 15 mothers and their male partners, recruited from the catchment areas of two urban and two rural government clinics in Lilongwe District, Malawi. The mothers were ≥ 18 years of age, were HIV positive, and had a child < 24 months of age. Twelve of the 15 fathers were also HIV positive. The interviews were analyzed using content analysis., Results: Mothers were responsible for child care, including breastfeeding and complementary feeding. Fathers provided monetary support for purchasing food and offered verbal support to encourage mothers to implement recommended feeding practices. Many fathers found it difficult to support adequate complementary feeding because of household food insecurity. Mothers were advised on child feeding during prevention of mother-to-child transmission clinic visits. No fathers in this study accompanied women to clinic appointments, so they were less well-informed about feeding than mothers. Fathers usually deferred to mothers in feeding decision making. One-third of mothers wanted fathers to be more involved in child feeding., Conclusion: Malawian mothers' and fathers' roles in feeding decision making in the context of HIV align with local gender norms. Strategies are needed to improve fathers' knowledge of and involvement in child feeding, as desired by mothers.

Before the prevention of mother-to-child transmission (PMTCT) program was widely implemented in Malawi, HIV-positive women associated exclusive breastfeeding with accelerated disease progression and felt that an HIV-positive woman could more successfully breastfeed if she had a larger body size. The relationship between breastfeeding practices and body image perceptions has not been explored in the context of the Option B+ PMTCT program, which offers lifelong antiretroviral therapy. We conducted in-depth interviews with 64 HIV-positive women in Lilongwe District, Malawi to investigate body size perceptions, how perceptions of HIV and body size influence infant feeding practices, and differences in perceptions among women in PMTCT and those lost to follow-up. Women were asked about current, preferred, and healthy body size perceptions using nine body image silhouettes of varying sizes, and vignettes about underweight and overweight HIV-positive characters were used to elicit discussion of breastfeeding practices. More than 80% of women preferred an overweight, obese, or morbidly obese silhouette, and most women (83%) believed that an obese or morbidly obese silhouette was healthy. Although nearly all women believed that an HIV-positive overweight woman could exclusively breastfeed, only about half of women thought that an HIV-positive underweight woman could exclusively breastfeed. These results suggest that perceptions of body size may influence beliefs about a woman's ability to breastfeed. Given the preference for large body sizes and the association between obesity and risk of noncommunicable diseases, we recommend that counseling and health education for HIV-positive Malawian women focus on culturally sensitive healthy weight messaging and its relationship with breastfeeding practices., (© 2017 John Wiley & Sons Ltd.)

Introduction: Pneumonia is a leading cause of mortality among children in low-resource settings. Mortality is greatest among children with high-risk conditions including HIV infection or exposure, severe malnutrition and/or severe hypoxaemia. WHO treatment recommendations include low-flow oxygen for children with severe pneumonia. Bubble continuous positive airway pressure (bCPAP) is a non-invasive support modality that provides positive end-expiratory pressure and oxygen. bCPAP is effective in the treatment of neonates in low-resource settings; its efficacy is unknown for high-risk children with severe pneumonia in low-resource settings., Methods and Analysis: CPAP IMPACT is a randomised clinical trial comparing bCPAP to low-flow oxygen in the treatment of severe pneumonia among high-risk children 1-59 months of age. High-risk children are stratified into two subgroups: (1) HIV infection or exposure and/or severe malnutrition; (2) severe hypoxaemia. The trial is being conducted in a Malawi district hospital and will enrol 900 participants. The primary outcome is in-hospital mortality rate of children treated with standard care as compared with bCPAP., Ethics and Dissemination: CPAP IMPACT has approval from the Institutional Review Boards of all investigators. An urgent need exists to determine whether bCPAP decreases mortality among high-risk children with severe pneumonia to inform resource utilisation in low-resource settings., Trial Registration Number: NCT02484183; Pre-results., Competing Interests: Competing interests: None declared.

To ensure the health of mothers and children, prevention of mother-to-child HIV transmission (PMTCT) programs test women for HIV, engage HIV-positive women in care, and promote recommended breastfeeding practices. Under Malawi's Option B+ PMTCT program, ~20% of women are lost-to-follow-up (LTFU) and little is known about their breastfeeding practices. The purpose of this study is to describe facilitators and barriers to Option B+ participation and how participation influences breastfeeding duration. We conducted in-depth interviews with HIV-positive women in Option B+ (n = 32) or LTFU from Option B+ (n = 32). They were recruited from four government clinics in Lilongwe District and had a child aged 0-23 months. Women in Option B+ had better disclosure experiences and more social support than LTFU women. The most common reasons for LTFU were fear of HIV disclosure, anticipated or experienced stigma, and insufficient social support. Other reasons included: non-acceptance of HIV status, antiretroviral therapy (ART) side effects, lack of funds for transport, and negative experiences with clinic staff. Worries about possible transmission, even while on ART, influenced timing of weaning for some women in Option B+. Despite their knowledge of the risk of HIV transmission to the child, most LTFU women continued to breastfeed after stopping ART because they considered breastmilk to be an important source of nutrients for the child. Given that HIV-positive Malawian women LTFU from Option B+ breastfeed in the absence of ART, efforts are needed to use evidence-based strategies to address the barriers to Option B+ participation and avert preventable transmission through breastmilk.

This study examined infant and young child feeding (IYCF) counseling, decision-making, and practices among HIV-infected women with children 0-23 months participating in Malawi's Option B+ prevention of mother-to-child transmission (PMTCT) program. We conducted 160 survey interviews, 32 in-depth interviews, and 32 observations of PMTCT visits. Surveys indicated that exclusive breastfeeding was common (75 %) among children <6 months, while minimum dietary diversity (41 %) and minimum acceptable diet (40 %) for children 6-23 months occurred less often. In-depth interviews supported these findings. Most women felt comfortable with current breastfeeding recommendations, but chronic food insecurity made it difficult for them to follow complementary feeding guidelines. Women trusted IYCF advice from health workers, but mainly received it during pregnancy. During observations of postnatal PMTCT visits, health workers infrequently advised on breastfeeding (41 % of visits) or complementary feeding (29 % of visits). This represents a missed opportunity for health workers to support optimal IYCF practices within Option B+.

Background: Couples HIV testing and counselling (CHTC) is encouraged but is not widely done in sub-Saharan Africa. We aimed to compare two strategies for recruiting male partners for CHTC in Malawi's option B+ prevention of mother-to-child transmission programme: invitation only versus invitation plus tracing and postulated that invitation plus tracing would be more effective., Methods: We did an unblinded, randomised, controlled trial assessing uptake of CHTC in the antenatal unit at Bwaila District Hospital, a maternity hospital in Lilongwe, Malawi. Women were eligible if they were pregnant, had just tested HIV-positive and therefore could initiate antiretroviral therapy, had not yet had CHTC, were older than 18 years or 16-17 years and married, reported a male sex partner in Lilongwe, and intended to remain in Lilongwe for at least 1 month. Women were randomly assigned (1:1) to either the invitation only group or the invitation plus tracing group with block randomisation (block size=4). In the invitation only group, women were provided with an invitation for male partners to present to the antenatal clinic. In the invitation plus tracing group, women were provided with the same invitation, and partners were traced if they did not present. When couples presented they were offered pregnancy information and CHTC. Women were asked to attend a follow-up visit 1 month after enrolment to assess social harms and sexual behaviour. The primary outcome was the proportion of couples who presented to the clinic together and received CHTC during the study period and was assessed in all randomly assigned participants. This study is registered with ClinicalTrials.gov, number NCT02139176., Findings: Between March 4, 2014, and Oct 3, 2014, 200 HIV-positive pregnant women were enrolled and randomly assigned to either the invitation only group (n=100) or the invitation plus tracing group (n=100). 74 couples in the invitation plus tracing group and 52 in the invitation only group presented to the clinic and had CHTC (risk difference 22%, 95% CI 9-35; p=0.001) during the 10 month study period. Of 181 women with follow-up data, two reported union dissolution, one reported emotional distress, and none reported intimate partner violence. One male partner, when traced, was confused about which of his sex partners was enrolled in the study. No other adverse events were reported., Interpretation: An invitation plus tracing strategy was highly effective at increasing CHTC uptake. Invitation plus tracing with CHTC could have many substantial benefits if brought to scale., Funding: National Institutes of Health., (Copyright © 2015 Elsevier Ltd. All rights reserved.)

Background: We established Safeguard the Family (STF) to support Ministry of Health (MoH) scale-up of universal antiretroviral therapy (ART) for HIV-infected pregnant and breastfeeding women (Option B+) and to strengthen the prevention of mother-to-child transmission (PMTCT) cascade from HIV testing and counseling (HTC) through maternal ART provision and post-delivery early infant HIV diagnosis (EID). To these ends, we implemented the following interventions in 5 districts: 1) health worker training and mentorship; 2) couples' HTC and male partner involvement; 3) women's psychosocial support groups; and 4) health and laboratory system strengthening for EID., Methods: We conducted a serial cross-sectional study using facility-level quarterly (Q) program data and individual-level infant HIV-1 DNA PCR data to evaluate STF performance on PMTCT indicators for project years (Y) 1 (April-December 2011) through 3 (January-December 2013), and compared these results to national averages., Results: Facility-level uptake of HTC, ART, infant nevirapine prophylaxis, and infant DNA PCR testing increased significantly from quarterly baselines of 66 % (n/N = 32,433/48,804), 23 % (n/N = 442/1,958), 1 % (n/N = 10/1,958), and 52 % (n/N = 1,385/2,644) to 87 % (n/N = 39,458/45,324), 96 % (n/N = 2,046/2,121), 100 % (n/N = 2,121/2,121), and 62 % (n/N = 1,462/2,340), respectively, by project end (all p < 0.001). Quarterly HTC, ART, and infant nevirapine prophylaxis uptake outperformed national averages over years 2-3. While transitioning EID laboratory services to MoH, STF provided first-time HIV-1 DNA PCR testing for 2,226 of 11,261 HIV-exposed infants (20 %) tested in the MoH EID program in STF districts from program inception (Y2) through Y3. Of these, 78 (3.5 %) tested HIV-positive. Among infants with complete documentation (n = 608), median age at first testing decreased from 112 days (interquartile range, IQR: 57-198) in Y2 to 76 days (IQR: 46-152) in Y3 (p < 0.001). During Y3 (only year with national data for comparison), non-significantly fewer exposed infants tested HIV-positive (3.6 %) at first testing in STF districts than nationally (4.1 %) (p = 0.4)., Conclusions: STF interventions, integrated within the MoH Option B+ program, achieved favorable HTC, maternal ART, infant prophylaxis, and EID services uptake, and a low proportion of infants found HIV-infected at first DNA PCR testing. Continued investments are needed to strengthen the PMTCT cascade, particularly around EID.

Background/aims: Retaining patients in prevention of mother-to-child transmission of HIV studies can be challenging in resource-limited settings, where high lost to follow-up rates have been reported. In this article, we describe the effectiveness of methods used to encourage retention in the Breastfeeding, Antiretrovirals, and Nutrition study and analyze factors associated with lost to follow-up in the study., Methods: The Breastfeeding, Antiretrovirals, and Nutrition clinical trial was designed to evaluate the efficacy of three different mother-to-child HIV transmission prevention strategies. Lower than expected participant retention prompted enhanced efforts to reduce lost to follow-up during the conduct of the trial. Following study completion, we employed regression modeling to determine predictors of perfect attendance and variables associated with being lost to follow-up., Results: During the study, intensive tracing efforts were initiated after the first 1686 mother-infant pairs had been enrolled, and 327 pairs were missing. Of these pairs, 60 were located and had complete data obtained. Among the 683 participants enrolling after initiation of intensive tracing efforts, the lost to follow-up rate was 3.4%. At study's end, 290 (12.2%) of the 2369 mother-infant pairs were lost to follow-up. Among successfully traced missing pairs, relocation was common and three were deceased. Log-binomial regression modeling revealed higher maternal hemoglobin and older maternal age to be significant predictors of perfect attendance. These factors and the presence of food insecurity were also significantly associated with lower rates of lost to follow-up., Conclusion: In this large HIV prevention trial, intensive tracing efforts centered on reaching study participants at their homes succeeded in finding a substantial proportion of lost to follow-up participants and were very effective in preventing further lost to follow-up during the remainder of the trial. The association between food insecurity and lower rates of lost to follow-up is likely related to the study's provision of nutritional support, including a family maize supplement, which may have contributed to patient retention., (© The Author(s) 2014.)

In sub-Saharan Africa, although male involvement in antenatal care is associated with positive outcomes for HIV-infected women and their infants, men rarely accompany female partners. We implemented a project to increase the number of male partners attending an antenatal clinic at Bwaila Hospital in Lilongwe, Malawi. We evaluated changes in the proportion of women who came with a partner over three periods. During period 1 (January 2007 - June 2008) there was didactic peer education. During period 2 (July 2008 - September 2009) a peer-led male-involvement drama was introduced into patient waiting areas. During period 3 (October 2009 - December 2009) changes to clinical infrastructure were introduced to make the clinic more male-friendly. The proportion of women attending ANC with a male partner increased from 0.7% to 5.7%, to 10.7% over the three periods. Peer education through drama and male-friendly hospital infrastructure coincided with substantially greater male participation, although further gains are necessary.

The objective of our intervention was to examine the benefits of incorporating traditional birth attendants (TBA) in HIV Prevention of Mother to Child Transmission (PMTCT) service delivery. We developed a training curriculum for TBAs related to PMTCT and current TBA roles in Malawi. Fourteen TBAs and seven TBA assistants serving 4 urban health centre catchment areas were assessed, trained and supervised. Focus group discussions with the TBAs were conducted after implementation of the program. From March 2008 to August 2009, a total of 4017 pregnant women visited TBAs, out of which 2133 (53.1%) were directly referred to health facilities and 1,884 (46.9%) women delivered at TBAs and subsequently referred. 168 HIV positive women were identified by TBAs. Of these, 86/168 (51.2%) women received nevirapine and 46/168 (27.4%) HIV exposed infants received nevirapine. The challenges in providing PMTCT services included lack of transportation for referrals and absence of a reporting system to confirm the woman's arrival at the health center. Non-disclosure of HIV status by patients to the TBAs resulted in inability to assist nevirapine uptake. TBAs, when trained and well-supervised, can supplement efforts to provide PMTCT services in communities.

Provider-initiated partner notification for HIV effectively identifies new cases of HIV in sub-Saharan Africa, but is not widely implemented. Our objective was to determine whether provider-based HIV partner notification strategies are cost-effective for preventing HIV transmission compared with passive referral. We conducted a cost-effectiveness analysis using a decision-analytic model from the health system perspective during a 1-year period. Costs and outcomes of all strategies were estimated with a decision-tree model. The study setting was an urban sexually transmitted infection clinic in Lilongwe, Malawi, using a hypothetical cohort of 5000 sex partners of 3500 HIV-positive index cases. We evaluated three partner notification strategies: provider notification (provider attempts to notify indexes' locatable partners), contract notification (index given 1 week to notify partners then provider attempts notification) and passive referral (index is encouraged to notify partners, standard of care). Our main outcomes included cost (US dollars) per transmission averted, cost per new case identified and cost per partner tested. Based on estimated transmissions in a 5000-person cohort, provider and contract notification averted 27.9 and 27.5 new infections, respectively, compared with passive referral. The incremental cost-effectiveness ratio (ICER) was $3560 per HIV transmission averted for contract notification compared with passive referral. Provider notification was more expensive and slightly more effective than contract notification, yielding an ICER of $51 421 per transmission averted. ICERs were sensitive to the proportion of partners not contacted, but likely HIV positive and the probability of transmission if not on antiretroviral therapy. The costs per new case identified were $36 (provider), $18 (contract) and $8 (passive). The costs per partner tested were $19 (provider), $9 (contract) and $4 (passive). We conclude that, in this population, provider-based notification strategies are potentially cost-effective for identifying new cases of HIV. These strategies offer a simple, effective and easily implementable opportunity to control HIV transmission.

Objective: To investigate the willingness of Traditional Birth Attendants (TBAs) to provide single dose antiretroviral prophylaxis to infants born to mothers with HIV and the feasibility of providing the TBAs with antiretroviral medication., Design: 2 focus groups with a total of 17 registered TBAs., Setting: Lilongwe, Malawi., Methods: TBAs were recruited by local health workers and participated in focus groups assessing their attitudes towards participation in a PMTCT program., Results: TBAs were willing to participate in this prevention of mother-to-child HIV transmission (PMTCT) program and helped identify barriers to their participation., Conclusions: Given appropriate support and training, TBAs' participation in PMTCT programs could be an additional way to deliver medication to mothers and neonates who might otherwise miss crucial doses of medication.

Objectives: HIV-infected women identified through antenatal care (ANC) often fail to access antiretroviral treatment (ART), leaving them and their infants at risk for declining health or HIV transmission. We describe results of measures to improve uptake of ART among eligible pregnant women., Methods: Between October 2006 and December 2009, interventions implemented at ANC and ART facilities in urban Lilongwe aimed to better link services for women with CD4 counts <250/μl. A monitoring system followed women referred for ART to examine trends and improve practices in referral completion, on-time ART initiation and ART retention., Results: Six hundred and twelve women were ART eligible: 604 (99%) received their CD4 result, 344 (56%) reached the clinic, 286 (47%) started ART while pregnant and 261 (43%) were either alive on ART or transferred out after 6 months. Between 2006 and 2009, the median (IQR) time between CD4 blood draw and ART initiation fell from 41 days (17, 349) to 15 days (7,42) (P = 0.183); the proportion of eligible individuals starting ART while pregnant and retained for 6 months improved from 17% to 65% (P < 0.001). Delays generally shortened within the continuum of care from 2006 to 2009; however, time from CD4 blood draw to ART referral increased from 7 to 14 days., Conclusions: Referrals between facilities and delays through CD4 count measurements create bottlenecks in patient care. Retention improved over time, but delays within the linkage process remained. ART initiation at ANC plus use of point-of-care CD4 tests may further enhance ART uptake., (© 2012 Blackwell Publishing Ltd.)

Objective: To assess the continuity of care and outcome of pediatric HIV prevention, testing, and treatment services, focusing on early infant diagnosis with DNA polymerase chain reaction (PCR)., Design: A retrospective observational cohort., Methods: Maternal HIV antibody, infant HIV DNA PCR test results, and outcome data from HIV-infected infants from the prevention of mother-to-child transmission, early infant diagnosis, and pediatric HIV treatment programs operating in Lilongwe, Malawi, between 2004 and 2008 were collected, merged, and analyzed., Results: Of the 14,669 pregnant women who tested HIV antibody positive, 7875 infants (53.7%) received HIV DNA PCR testing. One thousand eighty-four infants (13.8%) were HIV infected. Three hundred twenty (29.5%) children enrolled into pediatric HIV care, with 202 (63.1%) at the Baylor Center of Excellence. Among these, antiretroviral therapy was initiated on 110 infants (54.5%) whose median age was 9.1 months (interquartile range, 5.4-13.8) and a median of 2.5 months (interquartile range, 1.4-5.2) after HIV clinic registration. Sixty-nine HIV-infected infants (34.2%) died or were lost by December 2008. Initiation of antiretroviral therapy increased the likelihood of survival 7-fold (odds ratio, 7.1; 95% confidence interval, 3.68 to 13.70)., Conclusions: Separate programs for maternal and infant HIV prevention and care services demonstrated high attrition rates of HIV-exposed and HIV-infected infants, elevated levels of mother-to-child transmission, late infant diagnosis, delayed pediatric antiretroviral therapy initiation, and high HIV-infected infant mortality. Antiretroviral therapy increased HIV-infected infant survival, emphasizing the urgent need for improved service coordination and strategies that increase access to infant HIV diagnosis, improve patient retention, and reduce antiretroviral therapy initiation delays.

Delayed antiretroviral initiation is associated with increased mortality, but individuals frequently delay seeking treatment. To increase early antiretroviral therapy (ART) enrollment of HIV-positive women, antenatal clinics are implementing regular, postpartum CD4 count testing. We examined factors influencing women's utilization of extended CD4 count testing. About 53 in-depth interviews were conducted with nurses, patients, social support persons, and government health officials at three antenatal clinics in Lilongwe, Malawi. Counseling and positive interactions with staff emerged as facilitating factors. Women wanted to know their CD4 count, but didn't understand the importance of early ART initiation. Support from husbands facilitated women's return to the clinic. Reminders were perceived as helpful but ineffectively employed. Staff identified lack of communication, difficulty in tracking, and referring women as barriers. Counseling messages should emphasize the importance of starting ART early. Clinics should focus on male partner involvement, case management, staff communication, and appointment reminders. Follow-up should be offered at multiple service points.

Summary Objective: To evaluate a pilot prevention of mother-to-child transmission post-natal programme in Lilongwe, Malawi, through observed retention and infant diarrhoeal rates., Methods: Free fortified porridge and water hygiene packages were offered to mothers to encourage frequent post-natal visits and to reduce diarrhoeal rates in infants on replacement feeding. Participant retention and infant health outcome were assessed., Results: Of 474 patients enrolled, 357 (75.3%) completed 3-month follow-up visits. Ninety-nine percent of women reported hygiene package use, and only 17.7% (95% CI 13.8-22.0%) of the infants had diarrhoea at least once over the 3-month period. Being 12 months or younger, confirmed HIV positive, access to tap water, and having a mother with diarrhoea were all associated with increased risk of infant diarrhoea., Conclusion: The majority of participants adhered to their scheduled visits and retention was favourable, possibly because of the introduction of hygiene and nutrition incentives. The infant diarrhoeal rate was low, suggesting benefits of regular medical care with hygiene package usage and reliable replacement feeding options. Continuation and expansion of the programme would allow further studies and improve the post-natal care of HIV-exposed infants in Malawi and in other resource-constrained countries., (© 2010 Blackwell Publishing Ltd.)

Plasmodium falciparum infection during pregnancy causes maternal anemia and low birth weight (LBW), but the effect of frequency and timing of infection on the severity of these adverse effects is unknown. We conducted a cohort study recruiting 2462 pregnant women in Malawi. Microscopy was used to diagnose malaria at enrollment, follow-up and delivery. Birth weight and maternal hemoglobin were measured at delivery. The association between timing and frequency of infection and LBW and maternal anemia was analyzed using a binomial regression model. Compared with uninfected women, (i) the risk of LBW increased with the number of malaria episodes [one episode: prevalence ratio (PR) 1.62 (95% CI 1.07-2.46); two episodes: PR 2.41 (95% CI 1.39-4.18)]; (ii) the risk for maternal anemia increased with the number of malaria episodes [one episode: PR 1.15 (95% CI 0.86-1.54); two episodes: PR 1.82 (95% CI 1.28-2.62)]; and (iii) the risk of LBW was higher with infection in the second (PR 1.71; 95% CI 1.06-2.74) than third trimester or at delivery (PR 1.55; 95% CI 0.88-2.75). The timing and frequency of P. falciparum infection during pregnancy affected the risk of LBW but only frequency of infection had an effect on the risk of maternal anemia. Identification of gestational periods when malaria causes most adverse outcomes will facilitate effective targeting of interventions., (2010 Royal Society of Tropical Medicine and Hygiene. All rights reserved.)

Objective(s): To evaluate uptake of HIV testing in a prevention of mother-to-child transmission program (PMTCT) in Lilongwe, Malawi from April 2002 until December 2006., Design: Retrospective analysis of monthly reports from the beginning of the program., Setting: Four antenatal clinics in Lilongwe, Malawi., Methods: Pregnant women attending urban antenatal clinics in Lilongwe were invited to participate in a PMTCT program. Women were given information and education on antenatal care and PMTCT in groups of 8 to 12. Written informed consent for HIV testing was obtained privately. Women returned for the test result 1-2 weeks later. Mothers and infants were given the HIVNET 012 regimen. Rapid HIV testing and 'opt-out' testing were instituted in July 2003 and April 2005, respectively. Infants were tested using HIV DNA PCR and, if HIV positive, a CD4 cell percentage was obtained and the infants were referred for further medical evaluation and treatment., Results: The program reached 20 000 pregnant women in the first 12 months. Acceptance of HIV testing increased from 45% to 73% (P < 0.001) when rapid, same day testing was instituted. When opt-out testing was instituted, 99% of the mothers agreed to testing. Of the infants tested, 15.5% were HIV positive., Conclusion: Rapid HIV testing using the opt-out method increased acceptance of HIV testing in the PMTCT program to 99% in urban Lilongwe, Malawi.

Objective: New anti-malarial regimens are urgently needed in sub-Saharan Africa because of the increase in drug resistance. We investigated the safety and efficacy of azithromycin or artesunate combined with sulfadoxine-pyrimethamine used for treatment of malaria in pregnant women in Blantyre, Malawi., Methods/findings: This was a randomized open-label clinical trial, conducted at two rural health centers in Blantyre district, Malawi. A total of 141 pregnant women with uncomplicated Plasmodium falciparum malaria were recruited and randomly allocated to 3 treatment groups: sulfadoxine-pyrimethamine (SP; 3 tablets, 500 mg sulfadoxine and 25 mg pyrimethamine per tablet); SP plus azithromycin (1 g/dayx2 days); or SP plus artesunate (200 mg/dayx3 days). Women received two doses administered at least 4 weeks apart. Heteroduplex tracking assays were performed to distinguish recrudescence from new infections. Main outcome measures were incidence of adverse outcomes, parasite and fever clearance times and recrudescence rates. All treatment regimens were well tolerated. Two women vomited soon after ingesting azithromycin. The parasite clearance time was significantly faster in the SP-artesunate group. Recrudescent episodes of malaria were less frequent with SP-azithromycin [Hazard Ratio 0.19 (95% confidence interval 0.06 to 0.63)] and SP-artesunate [Hazard Ratio 0.25 (95% confidence interval 0.10 to 0.65)] compared with SP monotherapy. With one exception (an abortion in the SP-azithromycin group), all adverse pregnancy outcomes could be attributed to known infectious or obstetrical causes. Because of the small sample size, the effect on birth outcomes, maternal malaria or maternal anemia could not be evaluated., Conclusions: Both SP-artesunate and SP-azithromycin appeared to be safe, well tolerated and efficacious for the treatment of malaria during pregnancy. A larger study is needed to determine their safety and efficacy in preventing poor birth outcomes., Trial Registration: ClinialTrials.gov NCT00287300.