Community-facility linkage models and maternal and infant health outcomes in Malawi's PMTCT/ART program: A cohort study.

BACKGROUND: In sub-Saharan Africa, 3 community-facility linkage (CFL) models-Expert Clients, Community Health Workers (CHWs), and Mentor Mothers-have been widely implemented to support pregnant and breastfeeding women (PBFW) living with HIV and their infants to access and sustain care for prevention of mother-to-child transmission of HIV (PMTCT), yet their comparative impact under real-world conditions is poorly understood. METHODS AND FINDINGS: We sought to estimate the effects of CFL models on a primary outcome of maternal loss to follow-up (LTFU), and secondary outcomes of maternal longitudinal viral suppression and infant "poor outcome" (encompassing documented HIV-positive test result, LTFU, or death), in Malawi's PMTCT/ART program. We sampled 30 of 42 high-volume health facilities ("sites") in 5 Malawi districts for study inclusion. At each site, we reviewed medical records for all newly HIV-diagnosed PBFW entering the PMTCT program between July 1, 2016 and June 30, 2017, and, for pregnancies resulting in live births, their HIV-exposed infants, yielding 2,589 potentially eligible mother-infant pairs. Of these, 2,049 (79.1%) had an available HIV treatment record and formed the study cohort. A randomly selected subset of 817 (40.0%) cohort members underwent a field survey, consisting of a questionnaire and HIV biomarker assessment. Survey responses and biomarker results were used to impute CFL model exposure, maternal viral load, and early infant diagnosis (EID) outcomes for those missing these measures to enrich data in the larger cohort. We applied sampling weights in all statistical analyses to account for the differing proportions of facilities sampled by district. Of the 2,049 mother-infant pairs analyzed, 62.2% enrolled in PMTCT at a primary health center, at which time 43.7% of PBFW were ≤24 years old, and 778 (38.0%) received the Expert Client model, 640 (31.2%) the CHW model, 345 (16.8%) the Mentor Mother model, 192 (9.4%) ≥2 models, and 94 (4.6%) no model. Maternal LTFU varied by model, with LTFU being more likely among Mentor Mother model recipients (adjusted hazard ratio [aHR]: 1.45; 95% confidence interval [CI]: 1.14, 1.84; p = 0.003) than Expert Client recipients. Over 2 years from HIV diagnosis, PBFW supported by CHWs spent 14.3% (95% CI: 2.6%, 26.1%; p = 0.02) more days in an optimal state of antiretroviral therapy (ART) retention with viral suppression than women supported by Expert Clients. Infants receiving the Mentor Mother model (aHR: 1.24, 95% CI: 1.01, 1.52; p = 0.04) and ≥2 models (aHR: 1.44, 95% CI: 1.20, 1.74; p < 0.001) were more likely to undergo EID testing by age 6 months than infants supported by Expert Clients. Infants receiving the CHW and Mentor Mother models were 1.15 (95% CI: 0.80, 1.67; p = 0.44) and 0.84 (95% CI: 0.50, 1.42; p = 0.51) times as likely, respectively, to experience a poor outcome by 1 year than those supported by Expert Clients, but not significantly so. Study limitations include possible residual confounding, which may lead to inaccurate conclusions about the impacts of CFL models, uncertain generalizability of findings to other settings, and missing infant medical record data that limited the precision of infant outcome measurement. CONCLUSIONS: In this descriptive study, we observed widespread reach of CFL models in Malawi, with favorable maternal outcomes in the CHW model and greater infant EID testing uptake in the Mentor Mother model. Our findings point to important differences in maternal and infant HIV outcomes by CFL model along the PMTCT continuum and suggest future opportunities to identify key features of CFL models driving these outcome differences.

Development and application of tools to cost the delivery of environmental health services in healthcare facilities: a financial analysis in urban Malawi.

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.

Timing of HIV testing among pregnant and breastfeeding women and risk of mother-to-child HIV transmission in Malawi: a sampling-based cohort study.

INTRODUCTION: Pregnant women living with HIV can achieve viral suppression and prevent HIV mother-to-child transmission (MTCT) with timely HIV testing and early ART initiation and maintenance. Although it is recommended that pregnant women undergo HIV testing early in antenatal care in Malawi, many women test positive during breastfeeding because they did not have their HIV status ascertained during pregnancy, or they tested negative during pregnancy but seroconverted postpartum. We sought to estimate the association between the timing of last positive HIV test (during pregnancy vs. breastfeeding) and outcomes of maternal viral suppression and MTCT in Malawi's PMTCT programme. METHODS: We conducted a two-stage cohort study among mother-infant pairs in 30 randomly selected high-volume health facilities across five nationally representative districts of Malawi between 1 July 2016 and 30 June 2017. Log-binomial regression was used to estimate prevalence ratios (PR) and risk ratios (RR) for associations between timing of last positive HIV test (i.e. breastfeeding vs. pregnancy) and maternal viral suppression and MTCT, controlling for confounding using inverse probability weighting. RESULTS: Of 822 mother-infant pairs who had available information on the timing of the last positive HIV test, 102 mothers (12.4%) had their last positive test during breastfeeding. Women who lived one to two hours (PR = 2.15; 95% CI: 1.29 to 3.58) or >2 hours (PR = 2.36; 95% CI: 1.37 to 4.10) travel time to the nearest health facility were more likely to have had their last positive HIV test during breastfeeding compared to women living <1 hour travel time to the nearest health facility. The risk of unsuppressed VL did not differ between women who had their last positive HIV test during breastfeeding versus pregnancy (adjusted RR [aRR] = 0.87; 95% CI: 0.48 to 1.57). MTCT risk was higher among women who had their last positive HIV test during breastfeeding compared to women who had it during pregnancy (aRR = 6.57; 95% CI: 3.37 to 12.81). CONCLUSIONS: MTCT in Malawi occurred disproportionately among women with a last positive HIV test during breastfeeding. Testing delayed until the postpartum period may lead to higher MTCT. To optimize maternal and child health outcomes, PMTCT programmes should focus on early ART initiation and providing targeted testing, prevention, treatment and support to breastfeeding women.

Environmental modifiers of RTS,S/AS01 malaria vaccine efficacy in Lilongwe, Malawi.

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.

Case reduction and cost-effectiveness of the RTS,S/AS01 malaria vaccine alongside bed nets in Lilongwe, Malawi.

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).

Application of tools to monitor environmental conditions, identify exposures, and inform decision-making to improve infection prevention and control practices in Malawian maternity wards.

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.

Energy access in Malawian healthcare facilities: consequences for health service delivery and environmental health conditions.

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.

Bubble continuous positive airway pressure for children with high-risk conditions and severe pneumonia in Malawi: an open label, randomised, controlled trial.

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.

"I would love if there was a young woman to encourage us, to ease our anxiety which we would have if we were alone": Adapting the Mothers2Mothers Mentor Mother Model for adolescent mothers living with HIV in Malawi.

BACKGROUND: Pregnant and post-partum adolescent girls and young women (AGYW) living with HIV in sub-Saharan Africa experience inferior outcomes along the prevention of mother-to-child transmission of HIV (PMTCT) cascade compared to their adult counterparts. Yet, despite this inequality in outcomes, scarce data from the region describe AGYW perspectives to inform adolescent-sensitive PMTCT programming. In this paper, we report findings from formative implementation research examining barriers to, and facilitators of, PMTCT care for HIV-infected AGYW in Malawi, and explore strategies for adapting the mothers2mothers (m2m) Mentor Mother Model to better meet AGYW service delivery-related needs and preferences. METHODS: Qualitative researchers conducted 16 focus group discussions (FGDs) in 4 Malawi districts with HIV-infected adolescent mothers ages 15-19 years categorized into two groups: 1) those who had experience with m2m programming (8 FGDs, n = 38); and 2) those who did not (8 FGDs, n = 34). FGD data were analyzed using thematic analysis to assess major and minor themes and to compare findings between groups. RESULTS: Median participant age was 17 years (interquartile range: 2 years). Poverty, stigma, food insecurity, lack of transport, and absence of psychosocial support were crosscutting barriers to PMTCT engagement. While most participants highlighted resilience and self-efficacy as motivating factors to remain in care to protect their own health and that of their children, they also indicated a desire for tailored, age-appropriate services. FGD participants indicated preference for support services delivered by adolescent HIV-infected mentor mothers who have successfully navigated the PMTCT cascade themselves. CONCLUSIONS: HIV-infected adolescent mothers expressed a preference for peer-led, non-judgmental PMTCT support services that bridge communities and facilities to pragmatically address barriers of stigma, poverty, health system complexity, and food insecurity. Future research should evaluate implementation and health outcomes for adolescent mentor mother services featuring these and other client-centered attributes, such as provision of livelihood assistance and peer-led psychosocial support.

Exploring the spatial relationship between primary road distance to antenatal clinics and HIV prevalence in pregnant females of Lilongwe, Malawi.

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.

Infant and young child feeding learning sessions during savings groups are feasible and acceptable for HIV-positive and HIV-negative women in Malawi.

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.

Achieving the first 90 for key populations in sub-Saharan Africa through venue-based outreach: challenges and opportunities for HIV prevention based on PLACE study findings from Malawi and Angola.

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.

HIV-positive Malawian women with young children prefer overweight body sizes and link underweight body size with inability to exclusively breastfeed.

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.

Infant and Young Child Feeding Decision Making and Practices: Malawian Mothers' and Fathers' Roles in the Context of HIV.

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.

CPAP IMPACT: a protocol for a randomised trial of bubble continuous positive airway pressure versus standard care for high-risk children with severe pneumonia using adaptive design methods.

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.

Factors influencing postnatal Option B+ participation and breastfeeding duration among HIV-positive women in Lilongwe District, Malawi: A qualitative study.

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.

Infant and Young Child Feeding Counseling, Decision-Making, and Practices Among HIV-Infected Women in Malawi's Option B+ Prevention of Mother-to-Child Transmission Program: A Mixed Methods Study.

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+.

Recruiting male partners for couple HIV testing and counselling in Malawi's option B+ programme: an unblinded randomised controlled trial.

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.

Supporting Option B+ scale up and strengthening the prevention of mother-to-child transmission cascade in central Malawi: results from a serial cross-sectional study.

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.

Frequent nevirapine resistance in infants infected by HIV-1 via breastfeeding while on nevirapine prophylaxis.

OBJECTIVE: The objective of this study is to assess nevirapine (NVP) resistance in infants who became infected in the three arms of the Breastfeeding, Antiretrovirals and Nutrition (BAN) study: daily infant NVP prophylaxis, triple maternal antiretrovirals or no extra intervention for 28 weeks of breastfeeding. DESIGN: A prospective cohort study. METHODS: The latest available plasma or dried blood spot specimen was tested from infants who became HIV-positive between 3 and 48 weeks of age. Population sequencing was used to detect mutations associated with reverse transcriptase inhibitor resistance. Sequences were obtained from 22 out of 25 transmissions in the infant-NVP arm, 23 out of 30 transmissions in the maternal-antiretroviral arm and 33 out of 38 transmissions in the control arm. RESULTS: HIV-infected infants in the infant-NVP arm were significantly more likely to have NVP resistance than infected infants in the other two arms of the trial, especially during breastfeeding through 28 weeks of age (56% in infant-NVP arm vs. 6% in maternal-antiretroviral arm and 11% in control arm, P»0.004). There was a nonsignificant trend, suggesting that infants with NVP resistance tended to be infected earlier and exposed to NVP while infected for a greater duration than infants without resistance. CONCLUSION: Infants on NVP prophylaxis during breastfeeding are at a reduced risk of acquiring HIV, but are at an increased risk of NVP resistance if they do become infected. These findings point to the need for frequent HIV testing of infants while on NVP prophylaxis, and for the availability of antiretroviral regimens excluding NVP for treating infants who become infected while on such a prophylactic regimen.