Browsing by Author "Manasyan, Albert"

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Accuracy of screening tests for cervical precancer in women living with HIV in low-resource settings: a paired prospective study in Lusaka, Zambia.
(2024) Taghavi, Katayoun; Moono, Misinzo; Mwanahamuntu, Mulindi; Roumet, Marie; Limacher, Andreas; Kapesa, Herbert; Madliwa, Thamsanqa; Rutjes, Anne; Basu, Partha; Low, Nicola; Manasyan, Albert; Bohlius, Julia
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 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.
Admission to the kangaroo mother care ward and maternal postpartum depression in Lusaka, Zambia: a randomised controlled trial study protocol
(2026-10-26) Manasyan, Albert; Lakhwani, Jyoti; Kapesa, Herbert; Menon, Anitha J.; Sharma, Anjali; Pry, Jake M.; Brown, Catherine; Tembo, Taniya; Carlo, Waldemar A.
Abstract Introduction: Postpartum depression (PPD) is a serious public health problem affecting 17% of women globally with higher rates (up to 40%) recorded in southern Africa. Admission to the neonatal intensive care unit (NICU) is a risk factor for PPD. The study aims to determine whether initiation of Kangaroo Mother Care (KMC) at the NICU followed by admission to the KMC Ward for continued support for more than 2 days before discharge home reduces maternal PPD and other maternal and infant adverse outcomes in low-resource settings. Methods and analysis: This study will enrol mother-infant dyads (n=612), fathers (up to n=612) and a purposive subset of mothers (n=24), fathers (n=24) and family members (n=24) who will complete in-depth interviews (IDIs). Mother-infant dyads will be recruited from the NICU at the Women and Newborn Hospital - University Teaching Hospitals in Lusaka, Zambia. Once deemed stable for admission to the KMC Ward as part of step-down care, mother-infant dyads will be randomised to either the control arm where they will remain at the KMC Ward ≤2 days per standard of care or the intervention arm where they will remain at the KMC Ward for >2 days. The primary outcome is maternal PPD at 6–8 weeks postnatal screened using the Edinburgh Postnatal Depression Scale (EPDS) screening tool. IDIs will explore the feasibility and barriers to practising KMC post-discharge from the perspective of the parents and other family members. Ethics and dissemination: The study was approved by the University of Zambia Biomedical Research Ethics Committee, the National Health Research Authority and the University of Alabama at Birmingham Institutional Review Board. A Data Safety Monitoring Board (DSMB) has been constituted. Dissemination will be via publications in peer-reviewed journals, conferences, social media and revision of national guidelines.
Cervical intraepithelial neoplasia progression and regression among women living with HIV in Zambia
(2025-10-16) Andoh, John; Taghavi, Katayoun; Moono, Misinzo; Basu, Partha; Madliwa, Thamsanqa; Mwanahamuntu, Mulindi H.; Low, Nicola; Manasyan, Albert; Rohner, Eliane
Abstract Objectives: Cervical screening and precancer treatment are less effective in women living with HIV (WLWH) than in women without HIV. We assessed high-risk human papillomavirus (HR-HPV) infection and cervical disease progression among screened WLWH in Zambia. Methods: Participants underwent visual inspection with acetic acid (VIA), HR-HPV testing and cervical biopsies at baseline and at follow-up 30-36 months later. Women with positive VIA results or high-grade histology were offered treatment. We assessed HR-HPV and cervical disease prevalence at both timepoints and used multivariable logistic regression to identify factors associated with cervical disease progression and regression. Results: Among 241 included women, HR-HPV prevalence declined from 44% (95% confidence interval [CI]: 39%-49%) at baseline to 24% (95% CI: 19%-31%) at follow-up. High-grade disease decreased from 25% (95% CI: 20%-31%) to 9% (95% CI: 5%-13%). In analyses adjusted for age, CD4 cell count, HIV RNA viral load, HR-HPV infection and histological results at baseline, precancer treatment was associated with increased odds of disease regression (adjusted odds ratio [aOR]: 2.74, 95% CI: 1.08-7.06) and reduced odds of progression (aOR: 0.45, 95% CI: 0.11-1.64). One-third of women with high-grade disease at follow-up (7/21) had previously undergone precancer treatment. Conclusions: Cervical screening and precancer treatment are key to reducing cervical disease progression among WLWH and ultimately achieving cervical cancer elimination, but efforts to improve treatment effectiveness among WLWH must be balanced with the risk of overtreatment.
Diagnostic accuracy of ASQ for screening of neurodevelopmental delays in low resource countries.
(2023-May-23) Manasyan, Albert; Salas, Ariel A.; Nolen, Tracy; Chomba, Elwyn ; Mazariegos, Manolo; Antoinette, Kitoto T.; Saleem, Sarah; Naqvi, Farnaz; Hambidge, Michael K.; Goco, Norman; McClure, Elizabeth M.; Wallander, Jan L.; Biasini, Fred J.; Goldenberg, Robert L.; Bose, Carl L.; Koso-Thomas, Marion; Krebs, Nancy F.; Carlo, Waldemar A.
OBJECTIVE: The Bayley Scales of Infant Development (BSID) is the most used diagnostic tool to identify neurodevelopmental disorders in children under age 3 but is challenging to use in low-resource countries. The Ages and Stages Questionnaire (ASQ) is an easy-to-use, low-cost clinical tool completed by parents/caregivers that screens children for developmental delay. The objective was to determine the performance of ASQ as a screening tool for neurodevelopmental impairment when compared with BSID second edition (BSID-II) for the diagnosis of moderate-to-severe neurodevelopmental impairment among infants at 12 and 18 months of age in low-resource countries. METHODS: Study participants were recruited as part of the First Bites Complementary Feeding trial from the Democratic Republic of Congo, Zambia, Guatemala and Pakistan between October 2008 and January 2011. Study participants underwent neurodevelopmental assessment by trained personnel using the ASQ and BSID-II at 12 and 18 months of age. RESULTS: Data on both ASQ and BSID-II assessments of 1034 infants were analysed. Four of five ASQ domains had specificities greater than 90% for severe neurodevelopmental delay at 18 months of age. Sensitivities ranged from 23% to 62%. The correlations between ASQ communications subscale and BSID-II Mental Development Index (MDI) (r=0.38) and between ASQ gross motor subscale and BSID-II Psychomotor Development Index (PDI) (r=0.33) were the strongest correlations found. CONCLUSION: At 18 months, ASQ had high specificity but moderate-to-low sensitivity for BSID-II MDI and/or PDI <70. ASQ, when administered by trained healthcare workers, may be a useful screening tool to detect severe disability in infants from rural low-income to middle-income settings. TRIAL REGISTRATION NUMBER: NCT01084109.
Differentiated community-based point-of-care early infant diagnosis to improve HIV diagnosis and ART initiation among infants and young children in Zambia: a quasi-experimental cohort study.
(2025-Feb-20) Manasyan, Albert; Tembo, Tannia; Dale, Helen; Pry, Jake M.; Itoh, Megumi; Williamson, Dhelia; Kapesa, Herbert; Derado, Josip; Beard, Rachel S.; Iyer, Shilpa; Gass, Salome; Mwila, Annie; Herce, Michael E.
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.
Feasibility of Vital Signs Assessment by Community Health Workers during Antenatal Care Community Outreach in Lusaka, Zambia: A Qualitative Study
(2022-09-13) Tembo, Taniya; Muttau, Nobutu; Manasyan, Albert; Mwamba, Chanda P.; Mwamba, Kabwe; Nyirenda, Herbert; Zulu, Tukiya K.; Hamweemba, Esther; Sharma, Anjali; Cauvel, Teresa; Shah, Sona; Nantume, Assumpta
Abstract Introduction The integration of digital tools in health initiatives marks a pivotal shift in traditional healthcare delivery methods. Technology-supported antenatal care (ANC) interventions have helped healthcare providers and community health workers (CHWs) to choose the course of action for individual patients. This study aimed to explore the suitability, feasibility, and acceptability of a wearable monitor, neoSpot, for measuring vital signs among pregnant women attending routine ANC visits during community outreach in Lusaka, Zambia. Methods This pilot feasibility trial was implemented between March and May 2023 at Kanyama 1st Level Hospital. We conducted 24 in-depth interviews (IDIs) among 12 purposively selected pregnant women and 12 trained CHWs. NeoSpot was placed on a pregnant woman’s arm to monitor vital signs and blood pressure. Thematic framework analysis used inductive and deductive reasoning for coding using NVivo and Excel for data organization. Qualitative data was analysed using NVivo. The suitability-feasibility-acceptability (SFA) framework was used to evaluate the potential of neoSpot as a tool for monitoring vital signs during routine ANC community outreach activities. Results The study revealed that neoSpot was accepted by pregnant women and CHWs for its ability to comprehensively assess vital signs, including those not typically assessed at clinics. Participants valued its speed, efficiency, and user-friendliness, believing it could reduce waiting times at antenatal clinics. Initially, pregnant women expressed concerns and apprehension about the new device, fuelled by misinformation and fears of its impact on their unborn babies and their skin. Conclusion Overall, all the study participants found the use of neoSpot to be suitable, feasible, and acceptable, and for use during ANC community outreach, largely due to its time efficiency, ability to simultaneously measure multiple vital signs, comfortable design, portability, and rechargeable battery. Incorporating recommendations could enhance the device’s efficiencies and its acceptability by community members and CHWs.
Genotype-specific agreement and accuracy of human papillomavirus DNA detection using AnyplexTM II HPV28 and XpertTM HPV among women with HIV in Lusaka, Zambia: a diagnostic accuracy analysis
(2026) Nathalie, Villalobos V. F; Moono, Misinzo; Andoh, John; Glass, Allison; Basu, Partha; Madliwa, Thamsanga; Mwanahamuntu, Mulindi; Rohner, Eliane; Low, Nicola; Manasyan, Albert; Taghavi, Katayoun
Abstract Objectives: The prevalence of cervicovaginal high-risk human papillomavirus (hrHPV) is high among women with human immunodeficiency virus (WHIV). Many hrHPV tests exist, but genotype-specific comparisons among WHIV are limited. We compared hrHPV detection and diagnostic accuracy using AnyplexTM II HPV 28 and XpertTM HPV among WHIV in Lusaka, Zambia. Methods: WHIV enrolled in a cervical screening test accuracy study (05/2019-03/2021) were invited for rescreening after 36 months. Trained nurses collected the cervical cytology and biopsy samples. Cytology samples were tested using Anyplex and Xpert. Women with paired and valid hrHPV results were included. We compared hrHPV and genotype-specific prevalence, overall agreement, Cohen kappa (κ), and relative sensitivity and specificity for the detection of high-grade squamous intraepithelial lesions (HSIL). Results: Among 230 women seen between 05/2022 and 06/2023, hrHPV prevalence was 24% (55/230) using Xpert and 36% (82/230) using Anyplex. Detection of HPV16 was higher with Anyplex (9%, 20/230) than with Xpert (6%, 13/230). Overall agreement was 85% (κ = 0.64; 95% confidence interval [CI] = 0.53-0.74). Genotype-specific agreement ranged from 88% (other hrHPV, κ = 0.66) to 96% (HPV16, κ = 0.70). For the detection of HSIL, the relative sensitivity of Anyplex compared with Xpert was 1.07 (95% CI = 0.94-1.21), and the relative specificity was 0.85 (95% CI = 0.79-0.91). Conclusion: Agreement between Anyplex and Xpert for hrHPV detection was high, but genotype-specific detection differed, with Anyplex detecting HPV16 more frequently than Xpert. While both assays had similar sensitivity, Xpert was more specific for HSIL. The choice of assay should balance the goals of maximizing HSIL detection with minimizing overtreatment.
Higher-volume breastmilk to improve growth among preterm infants in Zambia: A randomized clinical trial
(2026-05-05) Travers, Colm P; Salas, Ariel A; Jeffcoat, Seabrook; Lakhwani, Jyoti; Kapesa, Herbert; Nalwamba, Leukanji; Carlo, Waldemar A.; Manasyan, Albert
Abstract 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 1000-1999 g 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. Conclusions: 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.
Home deliveries in the capital: a qualitative exploration of barriers to institutional deliveries in peri-urban areas of Lusaka, Zambia.
(2018-Jun-01) Mulenga, Tamara; Moono, Misinzo; Mwendafilumba, Martha; Manasyan, Albert; Sharma, Anjali
BACKGROUND: A shortage of skilled birth attendants and low quality of care in health facilities along with unattended home deliveries contribute to the high maternal and neonatal mortality in sub Saharan Africa. Identifying and addressing context-specific reasons for not delivering at health care facilities could increase births assisted by skilled attendants who, if required, can provide life-saving interventions. METHODS: We conducted 22 in-depth interviews (IDIs) with midwives at three health facilities in peri-urban communities and 24 semi-structured surveys with mothers in two areas served by health facilities with the highest number of reported home deliveries in Lusaka, Zambia. Both IDIs and surveys were audio-recorded, transcribed and coded to identify themes around delivery and birthing experience. RESULTS: We found that most women preferred institutional deliveries to home deliveries, but were unable to utilize these services due to inability to recognize labour symptoms or lack of resources. Midwives speculated that women used herbal concoctions to reduce the duration of delivery with the result that women either did not present in time or endangered themselves and the baby with powerful contractions and precipitous labour. Respondents suggested that disrespectful and abusive maternity care dissuaded some women from delivering at health facilities. However, some midwives viewed such tactics as necessary to ensure women followed instructions and successfully delivered live babies. CONCLUSION: Difference in beliefs and birthing practices between midwives and mothers suggest the need for open dialogue to co-design appropriate interventions to increase facility usage. Further examination of the pharmaceutical properties and safety of herbal concoctions being used to shorten labour are required. Measures to reduce the economic burden of care seeking within this environment, increase respectful and patient-centred care, and improve the quality of midwifery could increase institutional deliveries.
Human papillomavirus detection in liquid-based cytology and cervical histology samples among women living with human immunodeficiency virus in Zambia
(2026-08-11) Taghavi, Katayoun; Moono, Misinzo; Villalobos, Nathalie V. F.; Andoh, John; Glass, Allison; Basu, Partha; Madliwa, Thamsanqa; Mwanahamuntu, Mulindi H.; Manasyan, Albert; Rohner, Eliane
Abstract Objectives: Cervicovaginal human papillomavirus (HPV) prevalence is high among women living with human immunodeficiency virus (WLHIV), but not all HPV genotypes detected in liquid-based cytology (LBC) may be present in cervical tissue. We explored HPV genotype concordance in paired LBC and histology samples among WLHIV in Zambia. Methods: WLHIV aged 18-65 years who were enrolled in a cervical screening test accuracy study were invited for follow-up after 30-36 months. LBC samples and two or more cervical biopsies were collected and tested for 28 HPV genotypes (Anyplex II/Allplex HPV28, Seegene, South Korea). HPV prevalence and genotype-specific agreement were assessed using Cohen's kappa. Results: From April 2022 to May 2023, 242 WLHIV (22 with high-grade squamous intraepithelial lesions) had valid paired HPV results. The prevalence of any HPV was similar on LBC (39%) and histology (34%). Multiple-type infections were more common on LBC (18%) than on histology (10%). HPV 16 was the most frequent genotype: 9% (n = 22) on LBC, and 15% (n = 36) on histology. Agreement for any high-risk HPV genotype was 66.1% (kappa = 0.27). Conclusions: Among Zambian WLHIV with mostly low-grade cervical lesions, LBC showed more multiple-type HPV infections and limited agreement with histology samples, possibly reflecting transient infections detected by LBC. The frequent detection of HPV 16 in histology samples but not in LBC warrants further investigation.
Low syphilis treatment rates and associated birth outcomes in pregnant women with and without HIV in Zambia: A cohort study
(2025-09-03) Manasyan, Albert; Jones, Anna V.; Xue, Yumo; Kapesa, Herbert; Mzumara, Maureen; Dionne, Jodie A.; Mubiana-Mbewe, Mwangelwa
Abstract 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.
Postpartum depression among newly delivered mothers based on postnatal newborn care
(2025-11-28) Manasyan, Albert; Lakhwani, Jyoti; Kapesa, Herbert; Owuor, Kevin; Menon, Anitha J.; Bosomprah, Samuel; Nalwamba, Leukanji; Machona, Sylvia; Carlo, Waldemar A.
Abstract Background Postpartum depression (PPD) is a serious public health problem affecting ~ 17% of women globally, with higher rates recorded in southern Africa – ~40%. Admission to the neonatal intensive care unit (NICU) is a risk factor for PPD. Our primary hypothesis was that infant care in the Kangaroo Mother Care Ward (KMC) after NICU stay would be associated with a lower prevalence of maternal PPD. Methods We conducted a cross-sectional study among newly delivered mothers at the University Teaching Hospitals in Lusaka, Zambia, between June 2022 – May 2023. Mothers of infants discharged home from the Newborn Nursery (if NICU admission was not required), NICU (unwell newborns requiring NICU care), or NICU/KMC Ward (unwell newborns requiring NICU care followed by further monitoring at the KMC ward) were screened for PPD using the Edinburgh Postnatal Depression Scale (EPDS) screening tool at 6–8 weeks postnatally. Mothers who scored 11 + were categorized as having PPD. Poisson models were used to estimate prevalence ratios (PR) for screening positive for PPD. The primary outcome was PPD following KMC versus NICU discharge. Results We screened 1056 newly delivered women for PPD pooled from mother-infant pairs discharged from the newborn nursery (n = 352), NICU/KMC (n = 352), or NICU (n = 352). Overall, mothers’ average age was 27.5 years, 61.1% had secondary education, 59.2% were unemployed, and 11.2% were HIV-positive. The proportion of women who screened positive for maternal PPD among all three arms was 20.5% with anxiety reaching 50.5%. Mothers whose newborns were admitted to the NICU/KMC arm had a lower proportion of women who screened positive for PPD (21.3%) compared to those directly discharged home from the NICU (29.0%) (p < 0.001). The adjusted prevalence of PPD positivity rate was significantly higher in the NICU and KMC arms compared to the Newborn Nursery arm, RR = 2.44 (95% CI 1.61, 3.73) and RR = 1.94 (95% CI 1.04, 3.61), respectively. However, in the adjusted analysis, there was no significant difference in the PPD positivity rate between the KMC and the NICU arms. Conclusion Admission to the KMC ward following the NICU was not associated with a lower PPD prevalence among newly delivered mothers compared to direct NICU discharge.
Prevalence of Large-for-Gestational Age and Macrosomia Among Livebirths in 23 Low- and Middle-Income Countries Between 2000 and 2021: An Individual Participant Data Analysis
(2025-09-09) Kirakoya-Samadoulougou, Fati; Ukwishaka, Joyeuse; Ngwasiri, Calypse; Subedi, Seema; Hazel, Elizabeth A.; Erchick, Daniel J.; Wu, Lee S. F.; Grandi, Carlos; Lachat, Carl; Céline, Laéticia C.; Roberfroid, Dominique; Huybregts, Lieven; Labrique, Alain B.; Rashid, Mabhubur; Shaikh, Saijuddin; Haque, Rezwanul; Baqui, Abdullah H.; Saha, Samir K.; Khanam, Rasheda; Rahman, Sayedur; Silveira, Mariângela F.; Buffarini, Romina; Shapiro, Roger L.; Zash, Rebecca; Zhu, Zhonghai; Zeng, Lingxia; Qiu, Xiu; He, Jianrong; Gebreyesus, Seifu H.; Tesfamariam, Kokeb; Chan, Grace; Bekele, Delayehu; Adu-Afarwuah, Seth; Dewey, Kathryn G.; Gyaase, Stephaney; Wylie, Blair J.; Taneja, Sunita; Chowdhury, Ranadip; Babu, Giridhara R.; Deepa R.; Rishard, Mohamed; Lazzerini, Marzia; Rodriguez-Sibaja, Maria J.; Acevedo-Gallegos, Sandra; Ashorn, Per; Maleta, Kenneth; Mullany, Luke C.; Jehan, Fyezah; Ilyas, Muhammad; Rogerson, Stephen J.; Unger, Holger W.; Ghosh, Rakesh; Musange, Sabine; Mongkolchati, Aroonsri; Keentupthai, Paniya; Fawzi, Wafaie; Wang, Dongqing; Schmiegelow, Christentze; Minja, Daniel; Hjort, Line; Lusingu, John P. A.; Smith, Emily R.; Masanja, Honorati; Kabole, Fathma M.; Slim, Salim N.; Kakuru, Abel; Kajubi, Richard; Walker, Dilys; Waiswa, Peter; Ramokolo, Vundli; Zembe-Mkabile, Wanga; Semrau, Katherine; Hamer, Davidson H.; Chico, Matthew R.; Banda, Enesia C.; Manasyan, Albert
Abstract Objective: To examine the prevalence of large-for-gestational age (LGA) and macrosomia in 23 countries between 2000 and 2021. Design: Descriptive multi-country secondary data analysis. Setting: Subnational, population-based cohort studies (k = 45 for LGA, k = 25 for macrosomia) in 23 low- and middle-income countries (LMICs). Population: Liveborn infants. Methods: We conducted a secondary analysis of individual-level data from the Vulnerable Newborn Measurement Collaboration, using INTERGROWTH-21st standards to define LGA (> 90th centile for gestational age and sex) and macrosomia (≥ 4000 g, regardless of gestational age). We included LMIC population-based datasets with reliable gestational age and birthweight data, excluding studies with small sample sizes, high missing data, or implausible measurements. Prevalence estimates were stratified by region, study period and gestational age, and results were summarised as medians and interquartile ranges (IQR). Main outcome measures: Prevalence of LGA and macrosomia. Results: Among 476 939 live births, the median prevalence of LGA was 5.1% (IQR: 2.9%-9.6%) and was highest in Latin America and the Caribbean at 9.6% (4 studies, IQR: 2.7%-16.1%) and lowest in South Asia at 2.7% (13 studies, IQR: 2.3%-3.7%). Over time, the median LGA prevalence increased from 4.9% (12 studies; IQR: 4.1%-7.9%) during the period from 2000 to 2010 to 5.9% (33 studies, IQR: 2.7%-11.2%) from 2011 to 2021. Term LGA was more common at 3.2% (0.9-5.1) than preterm or post-term LGA. Among 313 064 live births, the median prevalence of macrosomia was 1.3% (n = 313 064, IQR: 0.2%-2.4%), which was highest in Latin America and the Caribbean (4 studies, 3.1%, IQR: 0.7%-6.8%) and lowest in South Asia (8 studies, 0.1%, IQR: 0.0%-0.7%). The median prevalence remained stable over time: 1.1% (8 studies, IQR: 0.2%-3.1%) in older studies (2000-2010) and 1.3% (17 studies, IQR: 0.5%-2.4%) in more recent studies (2011-2021). Term macrosomia was more common at 1.2% (0.2-2.0) than preterm and post-term macrosomia. Conclusions: The overall prevalence of LGA and macrosomia was lower in these LMIC studies than is reported in high-income countries. The prevalence of large babies was highest in Latin America and the Caribbean. DOI: 10.1111/1471-0528.70044
Screening test accuracy to improve detection of precancerous lesions of the cervix in women living with HIV: a study protocol.
(2020-Dec-18) Taghavi, Katayoun; Moono, Misinzo; Mwanahamuntu, Mulindi; Basu, Partha; Limacher, Andreas; Tembo, Taniya; Kapesa, Herbert; Hamusonde, Kalongo; Asangbeh, Serra; Sznitman, Raphael; Low, Nicola; Manasyan, Albert; Bohlius, Julia
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.
"Testing Can Be Done Anywhere": A Qualitative Assessment of Targeted Community-Based Point-of-Care Early Infant Diagnosis of HIV in Lusaka, Zambia.
(2022-Jun-29) Tembo, Tannia; Dale, Helen; Muttau, Nobutu ; Itoh, Megumi; Williamson, Dhelia; Mwamba, Chanda; Manasyan, Albert; Beard, Suzanne R.; Cox, Mackenzie H.; Herce, Michael E.
INTRODUCTION: Delayed HIV diagnosis in HIV-exposed infants (HEIs) results in missed opportunities for early antiretroviral therapy (ART), causing significant morbidity and mortality. Early infant diagnosis (EID) depends on the availability of accessible and reliable testing services. We explored the acceptability, appropriateness, and feasibility of deploying a targeted community-based point-of-care (POC) EID testing model (i.e., "community POC model") to reach high-risk mother-infant pairs (MIPs) in Lusaka, Zambia. METHODS: We conducted in-depth interviews with a purposive sample of health care workers, study staff, and caregivers in high-risk MIPs at 6 health facilities included in a larger implementation research study evaluating the community POC model. We defined "high-risk MIPs" as mothers who did not receive antenatal testing or an attended delivery or infants who missed EID testing milestones. Interviews were audio-recorded, translated, and transcribed verbatim in English. Content and thematic analysis were done using NVivo 10 software. RESULTS: Health care workers (n=20) and study staff (n=12) who implemented the community POC model noted that the portability and on-screen prompts of the POC platform made it mobile and easy to use, but maintenance and supply chain management were key to field operations. Respondents also felt that the community POC model reached more infants who had never had EID testing, allowing them to find infants with HIV infection and immediately initiate them on ART. Caregivers (n=22) found the community POC model acceptable, provided that privacy could be ensured because the service was convenient and delivered close to home. CONCLUSION: We demonstrate the acceptability, appropriateness, and feasibility of implementing the community POC model in Zambia, while identifying potential challenges related to client privacy and platform field operations. The community POC model may represent a promising strategy to further facilitate active HIV case finding and linkage to ART for children with undiagnosed HIV infection in the community.
The association of maternal age with adverse neonatal outcomes in Lusaka, Zambia: a prospective cohort study.
(2020-Nov-11) Tembo, Tannia; Koyuncu, Aybüke ; Zhuo, Haoran; Mwendafilumba, Martha; Manasyan, Albert
BACKGROUND: Pregnancy among adolescents, whether intended or not, is a public health concern as it is generally considered high risk for both mothers and their newborns. In Zambia, where many women engage in early sexual behaviour or marry at a young age, 28.5% of girls aged 15-19 years were pregnant with their first child in the year 2013-2014. This study sought to explore associations between maternal age and neonatal outcomes among pregnant women in Lusaka, Zambia. METHODS: This was a secondary analysis of data nested within a larger population-based prospective cohort study which was implemented in three government health facilities-two first level hospitals and one clinic in Lusaka, Zambia. Women presenting to the study sites for antenatal care were enrolled into the study and followed up for collection of maternal and neonatal outcomes at 7, 28 and 42 days postpartum. The study's primary outcomes were the incidence of maternal and newborn complications and factors associated with adverse neonatal outcomes. Statistical significance was evaluated at a significance level of P < 0.05. RESULTS: The study included 11,501 women, 15.6% of whom were adolescents aged 10-19 years. Generally, adolescence did not have statistically significant associations with poor maternal health outcomes. However, the risk of experiencing obstructed labour, premature rupture of membranes and postpartum hemorrhage was higher among adolescents than women aged 20-24 years while the risk of severe infection was lower and non-significant. Adolescents also had 1.36 times the odds of having a low birthweight baby (95% CI 1.12, 1.66) and were at risk of preterm birth (aOR = 1.40, 95% CI 1.06, 1.84). Their newborns were in need of bag and mask resuscitation at birth (aOR = 0.62, 95% CI 0.41, 0.93). Advanced maternal age was significantly associated with increased odds of hypertension/ pre-eclampsia (95% CI 1.54, 5.89) and preterm labour (aOR = 2.78, 95% CI 1.24, 6.21). CONCLUSIONS: Adolescence is a risk factor for selected pregnancy outcomes in urban health facilities in Lusaka, Zambia. Health care workers should intensify the provision of targeted services to improve neonatal health outcomes. TRIAL REGISTRATION: Clinical trial number and URL: NCT03923023 (Retrospectively registered). Clinical trial registration date: April 22, 2019.
The cervical cancer screening and precancer treatment journey: a qualitative study of experiences among Zambian women living with and without HIV
(2025-12-13) Moono, Misinzo; Sharma, Anjali; Bohlius, Julia; Mwanahamuntu, Mulindi; Taghavi, Katayoun; Mwamba, Chanda; Katota, Ntenje; Mwamba, Kabwe; Chipungu, Mwati; Hamweemba, Esther; Manasyan, Albert
Abstract Background: Zambia has the third highest cervical cancer incidence rate globally, and it remains the leading cause of cancer-related death among women. We explored the experiences of Zambian women who accessed cervical cancer screening and precancer treatment services to understand factors influencing care-seeking and access across urban, peri-urban, and rural settings. Methods: In 2020, we conducted eight focus group discussions with women living with and without Human Immunodeficiency Virus (HIV) who underwent cervical cancer screening between 2016 and 2020. To explore their care journey, participants were grouped by screening outcome—those with cervical precancerous lesions and those without. We also conducted 18 in-depth interviews with healthcare workers providing antiretroviral treatment, cervical cancer screening, or precancer treatment at government health facilities. Transcripts were coded and analyzed using thematic analysis. Results: Care-seeking unfolded across five stages: recognition of need to screen, hesitation and consultation, screening, result interpretation, and treatment. Women were generally knowledgeable about cervical cancer and sought screening promptly, though some delayed due to fear. Social networks and interactions with healthcare workers facilitated screening, while logistical and financial barriers, along with delays in histopathology services particularly in rural areas, hindered access to timely diagnosis and treatment. Conclusion: Improving cervical cancer screening and precancer treatment in Zambia requires addressing systemic inefficiencies by strengthening laboratory capacity, decentralizing diagnostics, and training healthcare workers to provide respectful, consistent counselling. Expanding community engagement to counter misinformation, leveraging social networks, and providing financial protection are also critical to ensuring timely, equitable, and reassuring care. DOI: 10.1093/oncolo/oyaf412
The impact of HIV and antiretroviral therapy on cervical cancer burden in Zambia: a modelling study
(2026-08-25) Andoh, John; Kapesa, Herbert; Msadabwe, Susan C.; Manasyan, Albert; Kamfwa, Paul; Zulu, Watson; Kerr, Cliff; Egger, Matthias; Rohner, Eliane; Stuart, Robyn; van Schalkwyk, Cari
Abstract 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.