Objective To test the hypothesis that among very preterm infants, higher-volume feeding versus usual-volume feeding with exclusive breastmilk improves growth at 40-weeks’ postmenstrual age (PMA). Design/Methods We conducted a randomized controlled trial among preterm infants 28 0/7 to 31 6/7 weeks’ gestation or weighing 1000-1999g at birth admitted to the Kangaroo Mother Care Ward at the Women and Newborn Hospital, Lusaka, Zambia between June 2022 and February 2023. Study participants were randomized with a 1:1 parallel allocation to usual-volume breastmilk (140-180 ml/kg/day) or higher-volume breastmilk (200-240 ml/kg/day) achieved with additional breastmilk expression. Daily measurements of feeding volume were recorded until discharge. Following hospital discharge, study participants were assessed at 40-weeks’ postmenstrual age for weight, length, mid-arm circumference, and head circumference. The primary outcome was growth velocity from enrolment to 40-weeks’ postmenstrual age. Results 190 preterm infants were enrolled. The mean±standard deviation (SD) number of days from enrollment to discharge was 9±4 days. Recorded breastmilk volumes during hospitalization differed between groups (239±47 mL/kg/day in higher-volume versus 189±84 mL/kg/day in usual-volume; p< 0.001). There was no difference in growth velocity to 40 weeks’ PMA between groups (mean±SD, higher-volume 14.1±4.8 g/kg/day versus usual-volume 14.6±5.4 g/kg/day; p=0.51). The mid-arm circumference increased in the higher-volume group (10.9±1.3 cm versus 10.5±1.1 cm; p=0.04) but other growth parameters did not differ at 40-weeks’ postmenstrual age. Adverse outcomes did not differ. Conclusion(s) Higher-volume exclusive breastmilk feeding with breastmilk expression is feasible but did not improve growth velocity at 40-weeks’ postmenstrual age in very preterm infants.

Cervical cancer is the leading cause of cancer death among women in Zambia, where widespread HIV infection elevates cervical cancer risk. However, HIV’s contribution to Zambia’s cervical cancer burden and the extent to which antiretroviral therapy (ART) has mitigated this burden, remain poorly quantified. We adapted HPVsim, an existing open-source mathematical model simulating human papillomavirus (HPV) and cervical cancer natural history, to capture the dual burden of cervical cancer and HIV in Zambian women. We extended HPVsim by incorporating country-specific HIV incidence data and modeled how HIV alters cervical disease progression through CD4 cell count-dependent modification of HPV susceptibility and disease severity. We calibrated the model to GLOBOCAN cervical cancer estimates and cervical cancer incidence rate ratios by HIV status estimated from the Zambian Cancer Registry. We estimated that by 2025, 49.9% of all cervical cancer cases in Zambia could be attributed to HIV co-infection. Although ART prevented at least an estimated 5.4% of cervical cancer cases nationally and 8.7% of cases among women with HIV, HIV remains a major driver of the cervical cancer burden. HIV-stratified prevention strategies will be essential for Zambia to achieve the World Health Organization’s cervical cancer elimination targets.

OBJECTIVE:Postpartum hemorrhage (PPH) is the leading cause of maternal mortality globally. Most PPH deaths are preventable through evidence-based interventions. This study assessed the availability, direct costs, and economic implications of World Health Organization-recommended PPH interventions in public hospitals in Zambia. METHODS:A cross-sectional survey was conducted in 31 purposively selected public hospitals across seven provinces. Data (June 2019 to May 2020) on PPH prevalence, resource availability, and direct costs of PPH interventions were collected via a structured questionnaire administered to hospital administrators. An ingredients-based costing model compared an ideal pathway (severe PPH managed at a fully equipped primary-level health facility) to a referral pathway (patients unresponsive to early-stage interventions transferred to a tertiary hospital). Data were analyzed using Python. RESULTS:Among 74 238 deliveries, 1957 (2.6%) were PPH cases, resulting in 94 (4.8%) fatalities. Most cases (86.9%) received medical management, primarily by nurse-midwives. Tranexamic acid (TXA) was available in only 58.1% of the hospitals (subsidized cost: US$1.91/dose). Managing a severe PPH case in the ideal pathway cost US$133.46-US$276.22, compared to US$153.34-US$332.53 via the referral pathway , representing an 18.6% increase. Scaled nationally (approximately 672 000 births), this inefficiency translates to an avoidable annual burden of US$133121. CONCLUSION:While oxytocin is universally available, access to critical treatments such as TXA and advanced interventions remains limited. The low cost of preventive interventions contrasts with the high cost of managing severe PPH, which is exacerbated by system fragmentation. Strengthening primary-level facilities with essential commodities, surgical capacity, and training is critical to containing costs and reducing maternal mortality due to PPH.

BACKGROUND:Zambia established a recent infection testing algorithm (RITA) incorporating a novel point-of-care (POC) rapid test-the Asanté™ HIV-1 Rapid Recency® Assay (RTRI)-plus a HIV-1 viral load (VL) test to distinguish recent (≤12 months) from long-term (>12 months) HIV acquisition. This study evaluated the field performance of RTRI when implemented by healthcare workers at the POC. METHODS:We enrolled individuals newly diagnosed with HIV between 20 May 2021 and 10 March 2022 at two Ministry of Health facilities in Lusaka, Zambia. Participants received on-site RTRI testing and provided an additional sample for repeat RTRI and VL testing at a central laboratory. Final recent infection testing algorithm (RITA) results were returned to the study sites and were made available to clients at their study follow-up visit. Agreement between POC- and laboratory-RTRI was assessed using Cohen's Kappa. We compared recent versus long-term HIV classification across testing locations using the national RITA as the reference standard. Four focus group discussions (FGDs) with health staff explored perceptions surrounding POC-RTRI implementation. RESULTS:Agreement between POC and laboratory RTRI was 96.5%, with a Kappa of 0.812 (95% CI: 0.704-0.920). The POC-RTRI results indicated numerically more recent infections than laboratory-RTRI (30 vs 27), with three POC-RTRI false positives resulting in reduced sensitivity 85.0% for the POC-RTRI compared to 100.0% sensitivity for the laboratory-RTRI against the RITA reference standard. FGD participants (n = 28) agreed that POC RTRI was feasible and acceptable with adequate training, human resources, client counselling, and quality assurance measures. CONCLUSION:There was strong concordance between POC- and laboratory-RTRI results. The findings support the feasibility of implementing RTRI at POC by non-laboratory health workers, provided adequate training and health system resources are in place.

OBJECTIVE:Syphilis and HIV in pregnancy contribute to adverse birth outcomes in Africa. Benzathine penicillin G remains an effective treatment for syphilis in pregnancy, yet gaps persist in timely treatment. The aim of this study was to compare factors associated with adverse birth outcomes among pregnant women diagnosed with syphilis in health facilities according to their HIV status. METHODS:This retrospective cohort analysis included pregnant women who screened positive for syphilis with routine rapid plasma reagin (RPR) testing in 10 antenatal care (ANC) clinics in Zambia between January 2018 and December 2019. Adverse birth outcomes (preterm delivery, low birth weight, fetal demise, congenital syphilis, and neonatal death) were collected through June 2020. Patient characteristics according to HIV status were compared using Pearson chi-square test or Fisher exact test for categorical variables and Wilcoxon rank sum test for continuous variables. Logistic regression models were used to estimate the association between maternal and facility-level factors and a composite measure of adverse birth outcomes. RESULTS:In this cohort of 1204 pregnant women diagnosed with syphilis in health facilities, 42.5% had HIV coinfection and only 48.1% had documented penicillin treatment. Although preterm delivery rates were higher among women with syphilis and HIV (39.9% vs. 30.0% with syphilis alone; P = 0.003) the odds of having any adverse birth outcome were similar in both groups. CONCLUSION:Adverse birth outcomes were highly prevalent in Zambia among pregnant women with syphilis and treatment rates were low. Universal access to syphilis treatment in ANC clinic is needed to improve outcomes.

Introduction An estimated 800 000 children (<15 years) globally living with HIV remain undiagnosed. To reach these children with timely HIV testing services during infancy, we implemented a community-based differentiated care model using mobile point-of-care (POC) technology for early infant diagnosis (EID) of HIV, and assessed its effects on EID positivity, antiretroviral therapy (ART) initiation and 3-month retention in care.Methods Between 1 June 2019 and 31 May 2020 at six health facilities in Lusaka, Zambia, we enrolled mother-infant pairs (MIPs) at high risk for vertical transmission of HIV based on missing or late infant EID testing or other maternal risk factors. We offered these MIPs community POC EID testing (post-intervention), and compared their outcomes to historical high-risk controls at the same sites (1 June 2017–31 May 2018; pre-intervention). We used propensity score matched weighting and mixed effects regression modelling to estimate outcome differences pre-intervention and post-intervention, and to identify MIP characteristics predictive of vertical transmission of HIV.Results 2577 MIPs were included in the analysis: 1763 and 814 high-risk MIPs from the pre-intervention and post-intervention periods, respectively. Infant HIV positivity was significantly higher in the post-intervention (2.2%) vs pre-intervention (1.1%) period (p=0.038), however this difference was attenuated (0.83%, 95% CI: −0.50%, 2.15%) after adjusting for differences in maternal age, maternal antenatal care visits, infant birth month and facility. During the post-intervention period, MIPs where the mother disengaged from care were 12.97 (95% CI: 2.41, 69.98) times as likely to have an infant diagnosed with HIV vs those in which the infant received late EID testing without maternal care disengagement. Among 18 infants diagnosed with HIV by the intervention, 16 (88.9%) initiated same-day ART and all continued ART at 3-month follow-up.Conclusion Community-based differentiated care employing POC EID technology increased testing positivity in unadjusted analyses, and resulted in high ART initiation and early care retention, suggesting it may be a promising approach for reaching infants and young children living with HIV being missed by current facility-based approaches.Trial registration number This trial is registered under the following Clinicaltrials.gov Identifier: NCT03133728

Postpartum depression (PPD) is a serious public health problem affecting 17

OBJECTIVE:The prevalence of syphilis in Zambia remains high and is a critical public health concern. The Zambian Ministry of Health recommends universal screening and same-day treatment for syphilis in pregnancy, yet the syphilis screening rate is low, and treatment is poorly documented. The goal of this study was to document syphilis treatment rates and associated factors among pregnant women in care in Zambia. METHODS:This retrospective cohort study included pregnant women diagnosed with syphilis according to rapid plasma reagin (RPR) screening during routine antenatal care (ANC) in Lusaka, Zambia in 2018-2019. The main outcome of interest was lack of documented BPG treatment during pregnancy. Additional information about pregnancy and neonatal outcomes, partner referral for therapy, and facility level stockout data were included. Patient characteristics were compared by treatment status using Pearson Chi-Square Test and logistic regression models were created to estimate the association between individual level-factors, facility type, and lack of BPG treatment. A Cochran-Mantel-Haenszel test was used to evaluate facility-level data with significance set at p<0.05. RESULTS:Among 1,231 pregnant women who screened positive for syphilis at clinic, 643 (52%) lacked documented antibiotic treatment at the facility. BPG was the only antibiotic used to treat syphilis in the cohort and 8% of sex partners had evidence of referral for therapy. Preterm delivery rates were higher in women without documented BPG (43% vs 32%; p = 0.003). In adjusted models, only calendar year and hospital facility type were associated with lack of treatment. At the facility level, annual syphilis screening rates ranged from 37-65% and most (7/10) clinics reported at least one stockout of BPG. CONCLUSION:Treatment rates for syphilis in pregnancy in Zambia were low and BPG medication stockouts at the facility level were common. A consistent supply of BPG at all ANC facilities is needed to facilitate timely treatment and improve birth outcomes.

Objective This study aimed to provide evidence to improve cervical screening for women living with HIV (WLHIV). We assessed the accuracy of screening tests that can be used in low-resource settings and give results at the same visit. Methods and analysis We conducted a paired, prospective study among consecutive eligible WLHIV, aged 18–65 years, receiving cervical cancer screening at one hospital in Lusaka, Zambia. The histopathological reference standard was multiple biopsies taken at two time points. The target condition was cervical intraepithelial neoplasia grade 2 and above (CIN2+). The index tests were high-risk human papillomavirus detection (hrHPV, Xpert HPV, Cepheid), portable colposcopy (Gynocular, Gynius) and visual inspection with acetic acid (VIA). Accuracy of stand-alone and test combinations were calculated as the point estimate with 95% CIs. A sensitivity analysis considered disease when only visible lesions were biopsied. Results Women included in the study had well-controlled HIV infection (median CD4 count=542 cells/mm 3 ) and all except one were on antiretroviral therapy. Among 371 participants with histopathological results, 27% (101/371) women had CIN2+ and 23% (23/101) were not detected by any index test. Sensitivity and specificity for stand-alone tests were: hrHPV, 67.3% (95% CI 57.7% to 75.7%) and 65.3% (95% CI 59.4% to 70.7%); Gynocular 51.5% (95% CI 41.9% to 61.0%) and 80.0% (95% CI 74.8% to 84.3%); and VIA 22.8% (95% CI 15.7% to 31.9%) and 92.6% (95% CI 88.8% to 95.2%), respectively. Combining tests did not improve test accuracy measures. All test accuracies improved in sensitivity analysis. Conclusion The low accuracy of screening tests assessed might be explained by our reference standard, which reduced verification and misclassification biases. Better screening strategies for WLHIV in low-resource settings are urgently needed. Trial registration number NCT03931083 .

Objectives To estimate potential silent transfer using baseline viral load measures among individuals presenting as new to HIV care in routine HIV clinical settings in Lusaka, Zambia. Design Cross-sectional study. Setting Two large, urban government-operated health facilities supported by the Centre for Infectious Disease Research in Zambia. Participants A total of 248 participants with an incident positive HIV rapid test. Outcome measures The primary outcome measure was HIV viral suppression at baseline (i.e., potential silent transfer), defined as having a viral load ≤1000 RNA copies(c)/mL at the time of initiating HIV care. We also examined viral suppression at ≤60 c/mL. Methods We surveyed and measured baseline HIV viral load as part of the national recent infection testing algorithm among people living with HIV (PLWH) presenting as new to care. Using mixed effects Poisson regression, we identified characteristics among PLWH associated with potential silent transfer. Results Among the 248 PLWH included, 63% were women with median age of 30, and 66 (27% (66/248)) had viral suppression at ≤1000 c/mL and 53 (21% (53/248)) at ≤60 c/mL thresholds, respectively. Participants aged 40+ years had a significantly higher adjusted prevalence of potential silent transfer (adjusted prevalence ratio (aPR): 2.10; 95% CI: 2.08, 2.13) compared with participants aged 18–24 years. Participants reporting no formal education had a significantly higher adjusted prevalence of potential silent transfer (aPR: 1.63; 95% CI: 1.52, 1.75) compared with those completing primary education. Among 57 potential silent transfers who completed a survey, 44 (77%) indicated having tested positive previously at ≥1 of 38 clinics in Zambia. Conclusions The high proportion of PLWH with potential silent transfer points to clinic shopping and/or co-enrolment at multiple care sites simultaneously, suggesting an opportunity to improve care continuity at the time of HIV care entry.

Abstract Background Syphilis in pregnancy is common in Africa with prevalence as high as 10%. In high prevalence areas ( > 5%), WHO recommends universal syphilis screening and benzathine penicillin G treatment at the first antenatal clinic (ANC) visit. Implementation barriers include global stock outs and supply chain issues. Our goal was to document treatment rates and factors associated with lack of treatment among pregnant women with syphilis in Zambia. Methods The retrospective cohort study analyzed medical record data from pregnant women who sought care in 10 public ANC clinics in Lusaka, Zambia during 2018-2019 and tested positive for syphilis. Syphilis was diagnosed based on positive RPR testing and treatment was defined as documented penicillin therapy at the same facility. Patient characteristics were compared across treatment status using Wilcoxon Rank Sum Test for continuous variables, and Pearson Chi-Square Test for categorical variables. Simple logistic models with treatment status as the binary outcome were conducted to evaluate potential factors associated with lack of syphilis treatment in pregnancy. A multivariable logistic model was performed and a 2-sided P < 0.05 was accepted as statistically significant. Results Among 28,480 pregnant women screened for syphilis, 5.6% (n=1363) tested positive. Among those with syphilis, median age was 27 years, 21% of women were nulliparous and 43% were living with HIV. Most women (72%) had their initial ANC visit during the 2nd trimester and 96% were screened for syphilis at the first visit. The documented treatment rate was 42% and the only factor associated with lack of treatment was ANC entry in 2019 compared to 2018 (aOR 2.2; 95% CI 1.7-2.8; p < 0.001). (refer to Tables 1-2). Conclusion Syphilis prevalence among pregnant women tested in ANC clinic in Zambia during 2018-2019 was 5.6%. Recommended penicillin treatment was only documented in 42% of cases. No maternal or clinic characteristic was associated with lack of therapy. Calendar year may have been associated with treatment for unclear reasons. Novel approaches to ensure access to universal diagnosis and early treatment of syphilis among pregnant women in Zambia are needed to improve maternal and neonatal outcomes. Disclosures All Authors: No reported disclosures.

BackgroundGlobally, complications due to preterm birth are the leading contributor to neonatal mortality, resulting in an estimated one million deaths annually. Kangaroo Mother Care (KMC) has been endorsed by the World Health Organisation as a low cost, safe, and effective intervention in reducing morbidity and mortality among preterm infants. The objective of this study was to describe the implementation of a KMC model among preterm infants and its impact on neonatal outcomes at a tertiary level hospital in Lusaka, Zambia.MethodsWe conducted a prospective descriptive study using data collected from the KMC room at the University Teaching Hospital between January 2016 and September 2017. Mothers and government nurses were trained in KMC. We monitored skin-to-skin and breastfeeding practices, weight at admission, discharge, and length of admission.ResultsWe enrolled 573 neonates into the study. Thirteen extremely low weight infants admitted to the KMC room had graduated to Group A (1,000g-1,499g) at discharge, with a median weight gain of 500g. Of the 419 very low weight neonates at admission, 290 remained in Group A while 129 improved to Group B (1,500g-2,499g), with a median weight gain of 280g. Among the 89 low weight neonates, 1 regressed to Group A, 77 remained in Group B, and 11 improved to Group C (≥2,500g), individually gaining a median of 100g. Of the seven normal weight neonates, 6 remained in Group C individually gaining a median of 100g, and 1 regressed to Group B. Among all infants enrolled, two (0.35%) died in the KMC room.ConclusionsBased on the RE-AIM metrics, our results show that KMC is a feasible intervention that can improve neonatal outcomes among preterm infants in Zambia. The study findings show a promising, practical approach to scaling up KMC in Zambia.Trial registrationThe trial is registered under ClinicalTrials.gov under the following ID number: NCT03923023.

Introduction The simplest and cheapest method for cervical cancer screening is visual inspection after application of acetic acid (VIA). However, this method has limitations for correctly identifying precancerous cervical lesions (sensitivity) and women free from these lesions (specificity). We will assess alternative screening methods that could improve sensitivity and specificity in women living with humanimmunodeficiency virus (WLHIV) in Southern Africa.Methods and analysis We will conduct a paired, prospective, screening test accuracy study among consecutive, eligible women aged 18–65 years receiving treatment for HIV/AIDS at Kanyama Hospital, Lusaka, Zambia. We will assess a portable magnification device (Gynocular, Gynius Plus AB, Sweden) based on the Swede score assessment of the cervix, test for high-risk subtypes of human papillomavirus (HR-HPV, GeneXpert, Cepheid, USA) and VIA. All study participants will receive all three tests and the reference standard at baseline and at six-month follow-up. The reference standard is histological assessment of two to four biopsies of the transformation zone. The primary histological endpoint is cervical intraepithelial neoplasia grade two and above (CIN2+). Women who are VIA-positive or have histologically confirmed CIN2+ lesions will be treated as per national guidelines. We plan to enrol 450 women. Primary outcome measures for test accuracy include sensitivity and specificity of each stand-alone test. In the secondary analyses, we will evaluate the combination of tests. Pre-planned additional studies include use of cervigrams to test an automated visual assessment tool using image pattern recognition, cost-analysis and associations with trichomoniasis.Ethics and dissemination Ethical approval was obtained from the University of Zambia Biomedical Research Ethics Committee, Zambian National Health Regulatory Authority, Zambia Medicines Regulatory Authority, Swissethics and the International Agency for Research on Cancer Ethics Committee. Results of the study will be submitted for publication in a peer-reviewed journal.Trial registration number NCT03931083; Pre-results.