Improving PMTCT outcomes for mother-infant pairs through community-facility linkage: Results from a mixed methods study in Malawi

To improve MIP care retention in Malawi, several prevention of mother-to-child transmission of HIV (PMTCT) care delivery models have emerged to strengthen community-facility linkage (CFL), a concept defined as any “formalized connection between a health facility and the communities it serves to support improved health outcomes.” Similar to other settings in sub-Saharan Africa, three models have been widely implemented to complement Malawi’s National PMTCT Programme: 1) mentor mothers; 2) expert clients; and 3) community health workers. While the rationale underpinning these models has been substantiated by evidence generated from general antiretroviral therapy and PMTCT programs across SSA, a clear and rigorous description of each model, including characterization of supervisory structures, training, and relationships with clinical services, is currently unavailable. Equally important, the comparative impact of these models and their components on MIP care retention and other health outcomes have not been well characterized, particularly in the era of test and start. In the USAID-funded Project SOAR “Maternal-Infant Retention Study” reported here, we have attempted to address these existing evidence gaps by rigorously characterizing these community-facility linkage models and comparing their impact against each other and the “traditional” standard of care according to routinely collected health outcomes for mother-infant pairs (MIPs), including maternal retention in care and viral suppression, and infant HIV-free survival. To this end, specific objectives of this study were to: (1) establish a clear typology for CFL models by describing the main components of, and patient and key stakeholder perspectives on, three such models in Malawi; (2) describe MIP health outcomes in each model, and compare outcomes across models; and (2a) examine associations between individual components of CFL models and MIP health outcomes, controlling for confounding

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

“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

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

How are countries in sub-Saharan African monitoring the impact of programmes to prevent vertical transmission of HIV?

Vertical transmission of HIV can occur during pregnancy, delivery, or through breast feeding. The main driver of vertical transmission is a high maternal viral load. Between 2002 and 2016, low and middle income countries (LMICs) in sub-Saharan Africa with high HIV prevalence improved their policies to prevent vertical transmission of HIV. In 2002, national policies recommended single dose nevirapine at the onset of labour, with limited or no breast feeding. By 2016, all Global Plan priority countries in sub-Saharan Africa (where 90% of the world’s HIV positive pregnant women live) had adopted Option B+ with promotion of breast feeding. Option B+ was a dramatic policy change recommending lifelong triple antiretroviral therapy (ART) for all pregnant and lactating women living with HIV. The aim is to protect the child from HIV infection, ensure the mother’s future health, and prevent horizontal transmission of HIV.The South African Medical Research Council (SAMRC)http://www.bmj.com/thebmjam2020Paediatrics and Child Healt

Baseline characteristics of study sites and women enrolled in a three-arm cluster randomized controlled trial: PMTCT uptake and retention (pure) Malawi

Abstract Background Malawi introduced an ambitious public health program known as “Option B+” which provides all HIV-infected pregnant and breastfeeding women with lifelong combination antiretroviral therapy, regardless of WHO clinical stage or CD4 cell count. The PMTCT Uptake and REtention (PURE) study aimed at evaluating the effect of peer-support on care-seeking and retention in care. Methods/design PURE Malawi was a three-arm cluster randomized controlled trial that compared facility-based and community-based models of peer support to standard of care under Option B+ strategy. Each arm was expected to enroll a minimum of 360 women with a total minimum sample size of 1080 participants. 21 sites (clusters) were selected for inclusion in the study. This paper describes the site selection, recruitment, enrollment process and baseline characteristics of study sites and women enrolled in the trial. Results Study implementation was managed by 3 partner organizations; each responsible for 7 study sites. The trial was conducted in the South East, South West, and Central West zones of Malawi, the zones where the implementing partners operate. Study sites included 2 district hospitals, 2 mission hospitals, 2 rural hospitals, 13 health centers and 1 private clinic. Enrollment occurred from November 2013 to November 2014, over a median period of 31 weeks (range 17–51) by site. A total of 1269 HIV-infected pregnant (1094) and breastfeeding (175) women, who were eligible to initiate ART under Option B+, were enrolled. Each site reached or surpassed the minimum sample size. Comparing the number of women enrolled versus antenatal cohort reports, sites recruited a median of 90% (IQR 75–100) of eligible reported women. In the majority of sites the ratio of pregnant and lactating women enrolled in the study was similar to the ratio of reported pregnant and lactating women starting ART in the same sites. The median age of all women was 27 (IQR 22–31) years. All women have ≥20 months of possible follow-up time; 96% ≥ 2 years (24–32 months). Conclusion The PURE Malawi study showed that 3 implementing partner organizations could successfully recruit a complex cohort of pregnant and lactating women across 3 geographical zones in Malawi within a reasonable timeline. Trial registration This study is registered at clinicaltrials.gov - ID Number NCT02005835 . Registered 4 December, 2013

Inadequate Coordination of Maternal and Infant HIV Services Detrimentally Affects Early Infant Diagnosis Outcomes in Lilongwe, Malawi

To assess the continuity of care and outcome of pediatric HIV prevention, testing, and treatment services, focusing on early infant diagnosis with DNA PCR

The value of informal care in the context of option B+ in Malawi: a contingent valuation approach

Abstract Background Informal care, the health care provided by the patient’s social network is important in low income settings although its monetary value is rarely estimated. The lack of estimates of the value of informal care has led to its omission in economic evaluations but this can result in incorrect decisions about cost effectiveness of an intervention. We explore the use of contingent valuation methods of willingness to pay (WTP) and willingness to accept (WTA) to estimate the value of informal care provided to HIV infected women that are accessing antiretroviral therapy (ART) under the Option B+ approach to prevention of mother-to-child transmission (PMTCT) of HIV in Malawi. Methods We collected cross sectional data from 93 caregivers of women that received ART care from six health facilities in Malawi. Caregivers of women that reported for ART care on the survey day and consented to participate in the survey were included until the targeted sample size for the facility was reached. We estimated the value of informal care by using the willingness to accept (WTA) and willingness to pay (WTP) approaches. Medians were used to summarize the values and these were compared by the Wilcoxon signed-rank test. Results The median WTA to provide informal care in a month was US$30 and the median WTP for informal care was US$13 and the two were statistically different (p < 0.000). Median WTP was higher in the urban areas than in the rural areas (US$21 vs. US$13, p < 0.001) and for caregivers from households from higher wealth quintile than in the lower quintile (US$15 vs. US$13, p < 0.0462). Conclusion Informal caregivers place substantial value on informal care giving. In low income settings where most caregivers are not formally employed, WTP and WTA approaches can be used to value informal care. Clinical trial number NCT02005835

Robust estimation of bacterial cell count from optical density

Optical density (OD) is widely used to estimate the density of cells in liquid culture, but cannot be compared between instruments without a standardized calibration protocol and is challenging to relate to actual cell count. We address this with an interlaboratory study comparing three simple, low-cost, and highly accessible OD calibration protocols across 244 laboratories, applied to eight strains of constitutive GFP-expressing E. coli. Based on our results, we recommend calibrating OD to estimated cell count using serial dilution of silica microspheres, which produces highly precise calibration (95.5% of residuals &lt;1.2-fold), is easily assessed for quality control, also assesses instrument effective linear range, and can be combined with fluorescence calibration to obtain units of Molecules of Equivalent Fluorescein (MEFL) per cell, allowing direct comparison and data fusion with flow cytometry measurements: in our study, fluorescence per cell measurements showed only a 1.07-fold mean difference between plate reader and flow cytometry data

Effect of cytomegalovirus infection on breastfeeding transmission of HIV and on the health of infants born to HIV-infected mothers

Cytomegalovirus (CMV) infection can be acquired in utero or postnatally through horizontal transmission and breastfeeding. The effect of postnatal CMV infection on postnatal HIV transmission is unknown