Browsing by Author "Manasyan A"
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Item A color-coded tape for uterine height measurement: a tool to identify preterm pregnancies in low resource settings.(2015) Althabe F; Berrueta M; Hemingway-Foday J; Mazzoni A; Bonorino CA; Gowdak A; Gibbons L; Bellad MB; Metgud MC; Goudar S; Kodkany BS; Derman RJ; Saleem S; Iqbal S; Ala SH; Goldenberg RL; Chomba E; Manasyan A; Chiwila M; Imenda E; Mbewe F; Tshefu A; Lokomba V; Bose CL; Moore J; Meleth S; McClure EM; Koso-Thomas M; Buekens P; Belizán JM; Department of Community Health Sciences, Aga Khan University, Karachi Pakistan.; Kinshasa School of Public Health, Kinshasa, Democratic Republic of Congo.; Eunice Kennedy Shriver NICHD, Bethesda, Maryland, United States of America.; Department of Obstetrics and Gynecology, Columbia University, New York, New York, United States of America.; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia; University of North Carolina, Chapel Hill, North Carolina, United States of America.; University of North Carolina, Chapel Hill, North Carolina, United States of America.; RTI International; Durham, North Carolina, United States of America.; Institute for Clinical Effectiveness and Health Policy, Buenos Aires, Argentina.; School of Public Health and Tropical Medicine, Tulane University, Louisiana, United States of America.; KLE University's Jawaharlal Nehru Medical College, Belgaum, Karnataka, India.; Department of Obstetrics, Sindh Government Qatar Hospital, Karachi Pakistan.; Christiana Care, Newark, Delaware, United States of America.; University Teaching Hospital, Lusaka, Zambia.; Department of Obstetrics, Sobhraj Maternity Hospital, Karachi, Pakistan.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)INTRODUCTION: Neonatal mortality associated with preterm birth can be reduced with antenatal corticosteroids (ACS), yet <10% of eligible pregnant women in low-middle income countries. The inability to accurately determine gestational age (GA) leads to under-identification of high-risk women who could receive ACS or other interventions. To facilitate better identification in low-resource settings, we developed a color-coded tape for uterine height (UH) measurement and estimated its accuracy identifying preterm pregnancies. METHODS: We designed a series of colored-coded tapes with segments corresponding to UH measurements for 20-23.6 weeks, 24.0-35.6 weeks, and >36.0 weeks GA. In phase 1, UH measurements were collected prospectively in the Democratic Republic of Congo, India and Pakistan, using distinct tapes to address variation across regions and ethnicities. In phase 2, we tested accuracy in 250 pregnant women with known GA from early ultrasound enrolled at prenatal clinics in Argentina, India, Pakistan and Zambia. Providers masked to the ultrasound GA measured UH. Receiver operating characteristics (ROC) analysis was conducted. RESULTS: 1,029 pregnant women were enrolled. In all countries the tapes were most effective identifying pregnancies between 20.0-35.6 weeks, compared to the other GAs. The ROC areas under the curves and 95% confidence intervals were: Argentina 0.69 (0.63, 0.74); Zambia 0.72 (0.66, 0.78), India 0.84 (0.80, 0.89), and Pakistan 0.83 (0.78, 0.87). The sensitivity and specificity (and 95% confidence intervals) for identifying pregnancies between 20.0-35.6 weeks, respectively, were: Argentina 87% (82%-92%) and 51% (42%-61%); Zambia 91% (86%-95%) and 50% (40%-60%); India 78% (71%-85%) and 89% (83%-94%); Pakistan 63% (55%-70%) and 94% (89%-99%). CONCLUSIONS: We observed moderate-good accuracy identifying pregnancies ≤ 35.6 weeks gestation, with potential usefulness at the community level in low-middle income countries to facilitate the preterm identification and interventions to reduce preterm neonatal mortality. Further research is needed to validate these findings on a population basis.Item 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 K; Moono M; Mwanahamuntu M; Roumet M; Limacher A; Kapesa H; Madliwa T; Rutjes A; Basu P; Low N; Manasyan A; Bohlius J; Center for Infectious Disease Research in Zambia, Lusaka, Zambia.; Department of histopathology, Lancet Laboratories, Richmond, South Africa.; International Agency for Research on Cancer, Lyon, France.; Levy Mwanawasa Medical University Hospital, Lusaka, Zambia.; University of Basel, Basel, Switzerland.; Clinical Trials Unit, University of Bern, Bern, Switzerland.; Institute of Social and Preventative Medicine, University of Bern, Bern, Switzerland.; University of Alabama at Birmingham (UAB), Birmingham, Alabama, USA.; University of Zambia University Teaching Hospital, Lusaka, Zambia.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)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.Item Association between birth attendant type and delivery site and perinatal outcomes.(2019-May) Manasyan A; Chomba E; Moore J; Wallace D; McClure EM; Koso-Thomas M; Carlo WA; RTI International, Durham, NC, USA.; University of Alabama at Birmingham, Birmingham, AL, USA.; University of Zambia, Lusaka, Zambia.; Centre for Infectious Disease Research in Zambia (CIDRZ), Lusaka, Zambia.; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Bethesda, MD, USA.OBJECTIVE: To test the hypothesis that modified perinatal mortality, early neonatal mortality, and other measures of perinatal mortality are lower with facility births than with home births among deliveries conducted by traditional birth attendants (TBAs) or nurse-midwives. METHOD: This population-based observational study used data collected prospectively for home and facility deliveries conducted by TBAs and nurse-midwives in 13 rural communities in Zambia between September 1, 2009, and December 31, 2015. RESULTS: We enrolled 48 956 pregnant women. In adjusted analysis, modified perinatal mortality (adjusted odds ratio [aOR] 0.63, 95% confidence interval [CI] 0.45-0.88), early neonatal mortality (0.48, 0.33-0.69), and fresh stillbirth/day-1 neonatal mortality (0.55, 0.38-0.80) were lower among home deliveries than among facility deliveries conducted by TBAs, but did not differ among deliveries conducted by nurse-midwives. Rates of fresh stillbirth did not differ between home and facility delivery by either TBAs (aOR 1.03, 95% CI 0.64-1.66) or nurse-midwives (1.19, 0.67-2.10). CONCLUSION: Our findings show significant reductions in modified perinatal mortality, early neonatal mortality, and fresh stillbirth/day-1 neonatal mortality among home deliveries done by TBAs. This may be explained by robust community structures built by our program and referral bias of complicated cases.Item Benzathine penicillin G stockouts and other barriers to documented syphilis treatment in pregnancy in Zambia.(2024) Jones AV; Manasyan A; Xue Y; Kapesa H; Mwendafilumba K; Nalwamba L; Mzumara M; Mubiana-Mbewe M; Dionne JA; Department of Medicine, Division of Infectious Diseases, University of Alabama at Birmingham, University of Alabama at Birmingham Hospital, Birmingham, Alabama, United States of America.; Heersink School of Medicine, University of Alabama at Birmingham, Birmingham, Alabama, United States of America.; Center for Women's Reproductive Health, University of Alabama at Birmingham, University of Alabama at Birmingham Hospital, Birmingham, Alabama, United States of America.; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.; Department of Pediatrics, University of Alabama at Birmingham, Children's of Alabama Hospital, Birmingham, Alabama, United States of America.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)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.Item Cervical cancer prevention and care in HIV clinics across sub-Saharan Africa: results of a facility-based survey.(2024-Jul) Asangbeh-Kerman SL; Davidović M; Taghavi K; Dhokotera T; Manasyan A; Sharma A; Jaquet A; Musick B; Twizere C; Chimbetete C; Murenzi G; Tweya H; Muhairwe J; Wools-Kaloustian K; Technau KG; Anastos K; Yotebieng M; Jousse M; Ezechi O; Orang'o O; Bosomprah S; Pierre Boni S; Basu P; Bohlius J; Department of Biostatistics, School of Public Health, University of Ghana, Accra, Ghana.; SolidarMed, Partnerships for Health, Maseru, Lesotho.; Programme National de Lutte contre le Cancer (PNLCa), Abidjan, Côte d'Ivoire.; Department of Medicine and Epidemiology, Albert Einstein College of Medicine, Bronx, New York, USA.; Moi University, Eldoret, Kenya.; Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana, USA.; Programme PAC-CI, Site ANRS Treichville, Abidjan, Côte d'Ivoire.; Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland.; Newlands Clinic, Harare, Zimbabwe.; Department of Clinical Sciences, Nigerian Institute of Medical Research, Lagos, Nigeria.; Department of Medicine, Albert Einstein College of Medicine, Bronx, New York, USA.; Department of Paediatrics and Child Health, Rahima Moosa Mother and Child Hospital, Johannesburg-Braamfontein, South Africa.; University of Basel, Basel, Switzerland.; Empilweni Services and Research Unit, Rahima Moosa Mother and Child Hospital, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.; Graduate School for Health Sciences, University of Bern, Bern, Switzerland.; Early Detection, Prevention and Infections Branch, International Agency for Research on Cancer, Lyon, France.; SolidarMed, Partnership for Health, Chiure, Mozambique.; Institute of Global Health, University of Geneva, Geneva, Switzerland.; Centre National de Reference en Matière de VIH/SIDA, Bujumbura, Burundi.; Division of Neonatology, Department of Pediatrics, University of Alabama at Birmingham, Birmingham, Alabama, USA.; Einstein-Rwanda Research and Capacity Building Programme, Research for Development and Rwanda Military Hospital, Kigali, Rwanda.; Graduate School of Cellular and Biomedical Sciences, University of Bern, Bern, Switzerland.; University of Bordeaux, National Institute for Health and Medical Research (INSERM) UMR 1219, Research Institute for Sustainable Development (IRD) EMR 271, Bordeaux Population Health Centre, Bordeaux, France.; International Training and Education Centre for Health (I-TECH), Lilongwe, Malawi.; Swiss Tropical and Public Health Institute, Allschwil, Switzerland.; Department of Biostatistics and Health Data Science, School of Medicine, Indiana University, Indianapolis, Indiana, USA.; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)INTRODUCTION: To eliminate cervical cancer (CC), access to and quality of prevention and care services must be monitored, particularly for women living with HIV (WLHIV). We assessed implementation practices in HIV clinics across sub-Saharan Africa (SSA) to identify gaps in the care cascade and used aggregated patient data to populate cascades for WLHIV attending HIV clinics. METHODS: Our facility-based survey was administered between November 2020 and July 2021 in 30 HIV clinics across SSA that participate in the International epidemiology Databases to Evaluate AIDS (IeDEA) consortium. We performed a qualitative site-level assessment of CC prevention and care services and analysed data from routine care of WLHIV in SSA. RESULTS: Human papillomavirus (HPV) vaccination was offered in 33% of sites. Referral for CC diagnosis (42%) and treatment (70%) was common, but not free at about 50% of sites. Most sites had electronic health information systems (90%), but data to inform indicators to monitor global targets for CC elimination in WLHIV were not routinely collected in these sites. Data were collected routinely in only 36% of sites that offered HPV vaccination, 33% of sites that offered cervical screening and 20% of sites that offered pre-cancer and CC treatment. CONCLUSIONS: Though CC prevention and care services have long been available in some HIV clinics across SSA, patient and programme monitoring need to be improved. Countries should consider leveraging their existing health information systems and use monitoring tools provided by the World Health Organization to improve CC prevention programmes and access, and to track their progress towards the goal of eliminating CC.Item Cervical cancer screening outcomes in Zambia, 2010-19: a cohort study.(2021-Jun) Pry JM; Manasyan A; Kapambwe S; Taghavi K; Duran-Frigola M; Mwanahamuntu M; Sikazwe I; Matambo J; Mubita J; Lishimpi K; Malama K; Bolton Moore C; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia; Department of Pediatrics, School of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia; Department of Internal Medicine, School of Medicine, Washington University, St Louis, MO, USA. Electronic address: jakepry@cidrz.org.; Ministry of Health, Lusaka, Zambia; University Teaching Hospital, Women and Newborn Hospital, Lusaka, Zambia.; Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland; The Graduate School for Cellular and Biomedical Sciences, University of Bern, Bern, Switzerland.; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia; Department of Medicine, School of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.; Ministry of Health, Lusaka, Zambia.; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia; Joint IRB-BSC-CRG Program in Computational Biology, Institute for Research in Biomedicine, The Barcelona Institute of Science and Technology, Barcelona, Spain; Ersilia Open Source, Cambridge, UK.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)BACKGROUND: Globally, cervical cancer is the fourth leading cause of cancer-related death among women. Poor uptake of screening services contributes to the high mortality. We aimed to examine screening frequency, predictors of screening results, and patterns of sensitisation strategies by age group in a large, programmatic cohort. METHODS: We did a cohort study including 11 government health facilities in Lusaka, Zambia, in which we reviewed routine programmatic data collected through the Cervical Cancer Prevention Program in Zambia (CCPPZ). Participants who underwent cervical cancer screening in one of the participating study sites were considered for study inclusion if they had a screening result. Follow-up was accomplished per national guidelines. We did descriptive analyses and mixed-effects logistic regression for cervical cancer screening results allowing random effects at the individual and clinic level. FINDINGS: Between Jan 1, 2010, and July 31, 2019, we included 183 165 women with 204 225 results for visual inspection with acetic acid and digital cervicography (VIAC) in the analysis. Of all those screened, 21 326 (10·4%) were VIAC-positive, of whom 16 244 (76·2%) received treatment. Of 204 225 screenings, 92 838 (45·5%) were in women who were HIV-negative, 76 607 (37·5%) were in women who were HIV-positive, and 34 780 (17·0%) had an unknown HIV status. Screening frequency increased 65·7% between 2010 and 2019 with most appointments being first-time screenings (n=158 940 [77·8%]). Women with HIV were more likely to test VIAC-positive than women who were HIV-negative (adjusted odds ratio 3·60, 95% CI 2·14-6·08). Younger women (≤29 years) with HIV had the highest predictive probability (18·6%, 95% CI 14·2-22·9) of screening positive. INTERPRETATION: CCPPZ has effectively increased women's engagement in screening since its inception in 2006. Customised sensitisation strategies relevant to different age groups could increase uptake and adherence to screening. The high proportion of screen positivity in women younger than 20 years with HIV requires further consideration. Our data are not able to discern if women with HIV have earlier disease onset or whether this difference reflects misclassification of disease in an age group with a higher sexually transmitted infection prevalence. These data inform scale-up efforts required to achieve WHO elimination targets. FUNDING: US President's Emergency Plan for AIDS Relief.Item Diagnostic accuracy of ASQ for screening of neurodevelopmental delays in low resource countries.(2023-May-23) Manasyan A; Salas AA; Nolen T; Chomba E; Mazariegos M; Tshefu Kitoto A; Saleem S; Naqvi F; Hambidge KM; Goco N; McClure EM; Wallander JL; Biasini FJ; Goldenberg RL; Bose CL; Koso-Thomas M; Krebs NF; Carlo WA; University of Colorado Denver - Anschutz Medical Campus, Aurora, Colorado, USA.; Aga Khan University, Karachi, Pakistan.; Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland, USA.; Research Triangle Institute, Durham, North Carolina, USA.; The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.; Department of Pediatrics, The University of Alabama at Birmingham School of Medicine, Birmingham, Alabama, USA.; Department of Pediatrics, The University of Alabama at Birmingham School of Medicine, Birmingham, Alabama, USA AlbertManasyan@uabmc.edu.; Department of Obstetrics and Gynecology, Columbia University, New York, New York, UK.; University of Kinshasa, Kinshasa, Congo (the Democratic Republic of the).; Psychological Sciences and Health Sciences Research Institute, University of California Merced, Merced, California, USA.; University of Colorado Denver, Denver, Colorado, USA.; University of Zambia, Lusaka, Zambia.; Department of Reproductive, Maternal, Newborn, and Child Health, Center for Infectious Disease Research in Zambia, Lusaka, Zambia.; Institute of Nutrition for Central America and Panamá (INCAP), Guatemala City, Panama.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)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.Item 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 A; Tembo T; Dale H; Pry JM; Itoh M; Williamson D; Kapesa H; Derado J; Beard RS; Iyer S; Gass S; Mwila A; Herce ME; Institute for Global Health and Infectious Diseases, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.; U.S. Centers for Disease Control and Prevention, Atlanta, Georgia, USA.; University of Alabama at Birmingham, Birmingham, Alabama, USA albertmanasyan@uabmc.edu.; University of California, Davis, California, USA.; Centre for Infectious Disease Research in Zambia (CIDRZ), Lusaka, Zambia.; U.S. Centers for Disease Control and Prevention, Lusaka, Zambia.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.Item Home deliveries in the capital: a qualitative exploration of barriers to institutional deliveries in peri-urban areas of Lusaka, Zambia.(2018-Jun-01) Mulenga T; Moono M; Mwendafilumba M; Manasyan A; Sharma A; Centre For Infectious Diseases Research In Zambia (CIDRZ), P.O. Box 34681 Plot 34620 Off Alick Nkhata Road, Mass Media, 10101, Lusaka, Zambia.; University of Washington, Seattle, USA. Anjali.Sharma@cidrz.org.; Centre For Infectious Diseases Research In Zambia (CIDRZ), P.O. Box 34681 Plot 34620 Off Alick Nkhata Road, Mass Media, 10101, Lusaka, Zambia. Anjali.Sharma@cidrz.org.; University of Alabama at Birmingham, Birmingham, USA.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.Item Impact of enacted stigma on mental health, substance use, and HIV-related behaviors among sexual minority men in Zambia.(2024-Feb) Zhang R; Qiao S; Aggarwal A; Yuan G; Muttau N; Sharma A; Lwatula C; Ngosa L; Kabwe M; Manasyan A; Menon A; Ostermann J; Weissman S; Li X; Harper GW; University of South Carolina, Columbia, South Carolina, USA.; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia; University of Alabama at Birmingham, Birmingham, Alabama, USA.; Dignitate Zambia Limited, Lusaka, Zambia.; University of South Carolina, Columbia, South Carolina, USA. Electronic address: shanqiao@mailbox.sc.edu.; The Lotus Identity, Lusaka, Zambia.; University of Zambia, Lusaka, Zambia.; University of Michigan, Ann Arbor, Michigan, USA.; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)Sexual minority men (SMM) in Zambia face significant challenges including stigma, discrimination, and mental health issues, which further impact their HIV-related risk behaviors. This study aimed to investigate the associations between enacted stigma, substance abuse, HIV-related behaviors, and mental health (i.e., depression, anxiety, and post-traumatic stress disorder [PTSD] symptoms) among SMM in Zambia. SMM aged 18-35 years who reported having multiple and/or concurrent sexual partners or low and/or inconsistent condom use in the past three months were recruited from four districts in Zambia between February and November 2021. Participants completed an anonymous interviewer-administered survey. Key variables of interest were compared between participants with higher vs. lower levels of enacted stigma. Independent samples t-tests were used for continuous variables, and chi-squared tests were used for categorical variables. A total of 197 eligible SMM participated in the study (mean age = 24.41 years). Participants with a higher level of enacted stigma showed a higher level of anxiety symptoms (χItem Junk food use and neurodevelopmental and growth outcomes in infants in low-resource settings.(2024) Chiwila MK; Krebs NF; Manasyan A; Chomba E; Mwenechanya M; Mazariegos M; Sami N; Pasha O; Tshefu A; Lokangaka A; Goldenberg RL; Bose CL; Koso-Thomas M; Goco N; Do BT; McClure EM; Hambidge KM; Westcott JE; Carlo WA; School of Public Health, University of Kinshasa, Kinshasa, Democratic Republic of Congo.; University of Colorado School of Medicine, Aurora, CO, United States.; Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL, United States.; Department of Obstetrics and Gynecology, Columbia University, New York, NY, United States.; Department of Pediatrics, University of North Carolina, Chapel Hill, NC, United States.; Eunice Kennedy Shiver National Institute of Child Health and Human Development, Bethesda, MD, United States.; Global Network, University Teaching Hospital, Lusaka, Zambia.; Department of Community Health Sciences, Aga Khan University, Karachi, Pakistan.; Instituto de Nutrición de Centro América y Panamá, Guatemala City, Guatemala.; Research Triangle Institute International, Durham, NC, United States.; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)INTRODUCTION: Feeding infants a sub-optimal diet deprives them of critical nutrients for their physical and cognitive development. The objective of this study is to describe the intake of foods of low nutritional value (junk foods) and identify the association with growth and developmental outcomes in infants up to 18 months in low-resource settings. METHODS: This is a secondary analysis of data from an iron-rich complementary foods (meat versus fortified cereal) randomized clinical trial on nutrition conducted in low-resource settings in four low- and middle-income countries (Democratic Republic of the Congo, Guatemala, Pakistan, and Zambia). Mothers in both study arms received nutritional messages on the importance of exclusive breastfeeding up to 6 months with continued breastfeeding up to at least 12 months. This study was designed to identify the socio-demographic predictors of feeding infants' complementary foods of low nutritional value (junk foods) and to assess the associations between prevalence of junk food use with neurodevelopment (assessed with the Bayley Scales of Infant Development II) and growth at 18 months. RESULTS: 1,231 infants were enrolled, and 1,062 (86%) completed the study. Junk food feeding was more common in Guatemala, Pakistan, and Zambia than in the Democratic Republic of Congo. 7% of the infants were fed junk foods at 6 months which increased to 70% at 12 months. Non-exclusive breastfeeding at 6 months, higher maternal body mass index, more years of maternal and paternal education, and higher socioeconomic status were associated with feeding junk food. Prevalence of junk foods use was not associated with adverse neurodevelopmental or growth outcomes. CONCLUSION: The frequency of consumption of junk food was high in these low-resource settings but was not associated with adverse neurodevelopment or growth over the study period.Item Neonatal mortality risk of vulnerable newborns by fine stratum of gestational age and birthweight for 230 679 live births in nine low- and middle-income countries, 2000-2017.(2024-Jan-16) Hazel EA; Erchick DJ; Katz J; Lee ACC; Diaz M; Wu LSF; West KP; Shamim AA; Christian P; Ali H; Baqui AH; Saha SK; Ahmed S; Roy AD; Silveira MF; Buffarini R; Shapiro R; Zash R; Kolsteren P; Lachat C; Huybregts L; Roberfroid D; Zhu Z; Zeng L; Gebreyesus SH; Tesfamariam K; Adu-Afarwuah S; Dewey KG; Gyaase S; Poku-Asante K; Boamah Kaali E; Jack D; Ravilla T; Tielsch J; Taneja S; Chowdhury R; Ashorn P; Maleta K; Ashorn U; Mangani C; Mullany LC; Khatry SK; Ramokolo V; Zembe-Mkabile W; Fawzi WW; Wang D; Schmiegelow C; Minja D; Msemo OA; Lusingu JPA; Smith ER; Masanja H; Mongkolchati A; Keentupthai P; Kakuru A; Kajubi R; Semrau K; Hamer DH; Manasyan A; Pry JM; Chasekwa B; Humphrey J; Black RE; Pediatric Newborn Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA.; Child Health Research Foundation, Dhaka, Bangladesh.; Department of Global and Community Health, College of Public Health, George Mason University, Fairfax, Virginia, USA.; Infectious Diseases Research Collaboration, Kampala, Uganda.; Columbia University's Mailman School of Public Health, New York, New York, USA.; Post-Graduate Program in Epidemiology-Federal University of Pelotas, Pelotas, Brazil.; BRAC JP Grant School of Public Health, Dhaka, Bangladesh.; Health Systems Research Unit, South African Medical Research Council, Cape Town, South Africa.; Department of Immunology and Microbiology, Centre for Medical Parasitology, University of Copenhagen, Copenhagen, Denmark.; Section of Infectious Diseases, Department of Medicine, Boston University Chobanian & Avedisian School of Medicine, Boston, Massachusetts, USA.; Division of Global Health Equity, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA.; JiVitA Maternal and Child Health Research Project, Rangpur, Bangladesh.; Department of Food Technology, Safety, and Health, Faculty of Bioscience Engineering, Ghent University, Ghent, Belgium.; International Health Department, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.; Poverty, Health and Nutrition Division, International Food Policy Research Institute, Washington, District of Columbia, USA.; Research and Development Division, Ghana Health Service, Accra, Ghana.; Department of International Health, Center for Human Nutrition, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.; Ariadne Labs, Brigham and Women's Hospital and Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.; Faculty of Medicine and Health Technology, Tampere University and Tampere University Hospital, Tampere, Finland.; College of Medicine and Public Health, Ubon Ratchathani University, Ubon Ratchathani, Thailand.; Department of Nutrition, Institute for Global Nutrition, University of California, Davis, California, USA.; Gertrude H Sergievsky Center, Vagelos College of Physicians and Surgeons, Columbia University Irving Medical Center, New York, New York, USA.; Department of Medicine, Harvard Medical School, Boston, Massachusetts, USA.; Namur University, Namur, Belgium.; Ifakara Health Institute, Dar es Salaam, Tanzania.; Kintampo Health Research Centre, Kintampo, Ghana.; National Institute of Medical Research, Tanga, Tanzania.; Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.; Department of Nutrition and Food Science, University of Ghana, Accra, Ghana.; Centre for Health Research and Development, Society for Applied Studies, New Delhi, India.; Aravind Eye Hospital, Madurai, India.; Department of Epidemiology and Biostatistics, School of Public Health, Xi'an Jiaotong University Health Science Centre, Xi'an, China.; University of Alabama at Birmingham, Birmingham, Alabama, USA.; Department of Food Technology, Safety and Health, Ghent University, Ghent, Belgium.; School of Global and Public Health, Kamuzu University of Health Sciences, Blantyre, Malawi.; George Washington University Milken Institute School of Public Health, Washington, District of Columbia, USA.; HIV and Other Infectious Diseases Research Unit, South African Medical Research Council, Cape Town, South Africa.; ASEAN Institute for Health Development, Mahidol University, Salaya, Thailand.; Belgian Health Care Knowledge Centre, Brussels, Belgium.; Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.; Department of Global Health, Boston University School of Public Health, Boston, Massachusetts, USA.; Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.; College Graduate of Studies, University of South Africa, Pretoria, South Africa.; Department of Infectious Diseases, Copenhagen University Hospital, Copenhagen, Denmark.; Projahnmo Research Foundation, Dhaka, Bangladesh.; Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.; Department of Nutrition and Dietetics, School of Public Health, Addis Ababa University, Addis Ababa, Ethiopia.; Department of Global Health, Milken Institute School of Public Health, Washington, District of Columbia, USA.; NNIPS, Kathmandu, Nepal.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)OBJECTIVE: To describe the mortality risks by fine strata of gestational age and birthweight among 230 679 live births in nine low- and middle-income countries (LMICs) from 2000 to 2017. DESIGN: Descriptive multi-country secondary data analysis. SETTING: Nine LMICs in sub-Saharan Africa, Southern and Eastern Asia, and Latin America. POPULATION: Liveborn infants from 15 population-based cohorts. METHODS: Subnational, population-based studies with high-quality birth outcome data were invited to join the Vulnerable Newborn Measurement Collaboration. All studies included birthweight, gestational age measured by ultrasound or last menstrual period, infant sex and neonatal survival. We defined adequate birthweight as 2500-3999 g (reference category), macrosomia as ≥4000 g, moderate low as 1500-2499 g and very low birthweight as <1500 g. We analysed fine strata classifications of preterm, term and post-term: ≥42 MAIN OUTCOME MEASURES: Median and interquartile ranges by study for neonatal mortality rates (NMR) and relative risks (RR). We also performed meta-analysis for the relative mortality risks with 95% confidence intervals (CIs) by the fine categories, stratified by regional study setting (sub-Saharan Africa and Southern Asia) and study-level NMR (≤25 versus >25 neonatal deaths per 1000 live births). RESULTS: We found a dose-response relationship between lower gestational ages and birthweights with increasing neonatal mortality risks. The highest NMR and RR were among preterm babies born at <28 weeks (median NMR 359.2 per 1000 live births; RR 18.0, 95% CI 8.6-37.6) and very low birthweight (462.8 per 1000 live births; RR 43.4, 95% CI 29.5-63.9). We found no statistically significant neonatal mortality risk for macrosomia (RR 1.1, 95% CI 0.6-3.0) but a statistically significant risk for all preterm babies, post-term babies (RR 1.3, 95% CI 1.1-1.5) and babies born at 37 CONCLUSIONS: In addition to tracking vulnerable newborn types, monitoring finer categories of birthweight and gestational age will allow for better understanding of the predictors, interventions and health outcomes for vulnerable newborns. It is imperative that all newborns from live births and stillbirths have an accurate recorded weight and gestational age to track maternal and neonatal health and optimise prevention and care of vulnerable newborns.Item Neonatal mortality risk of vulnerable newborns: A descriptive analysis of subnational, population-based birth cohorts for 238 203 live births in low- and middle-income settings from 2000 to 2017.(2023-May-08) Hazel EA; Erchick DJ; Katz J; Lee ACC; Diaz M; Wu LSF; West KP; Shamim AA; Christian P; Ali H; Baqui AH; Saha SK; Ahmed S; Roy AD; Silveira MF; Buffarini R; Shapiro R; Zash R; Kolsteren P; Lachat C; Huybregts L; Roberfroid D; Zhu Z; Zeng L; Gebreyesus SH; Tesfamariam K; Adu-Afarwuah S; Dewey KG; Gyaase S; Poku-Asante K; Boamah Kaali E; Jack D; Ravilla T; Tielsch J; Taneja S; Chowdhury R; Ashorn P; Maleta K; Ashorn U; Mangani C; Mullany LC; Khatry SK; Ramokolo V; Zembe-Mkabile W; Fawzi WW; Wang D; Schmiegelow C; Minja D; Msemo OA; Lusingu JPA; Smith ER; Masanja H; Mongkolchati A; Keentupthai P; Kakuru A; Kajubi R; Semrau K; Hamer DH; Manasyan A; Pry JM; Chasekwa B; Humphrey J; Black RE; Child Health Research Foundation, Dhaka, Bangladesh.; Department of Global and Community Health, College of Public Health, George Mason University, Fairfax, Virginia, USA.; South African Research Chair in Social Policy at College Graduate of Studies, University of South Africa, Pretoria, South Africa.; Infectious Diseases Research Collaboration, Kampala, Uganda.; Columbia University's Mailman School of Public Health, New York, New York, USA.; BRAC JP Grant School of Public Health, Dhaka, Bangladesh.; Health Systems Research Unit, South African Medical Research Council, Cape Town, South Africa.; Section of Infectious Diseases, Department of Medicine, Boston University Chobanian & Avedisian School of Medicine, Boston, Massachusetts, USA.; Division of Global Health Equity, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA.; JiVitA Maternal and Child Health Research Project, Rangpur, Bangladesh.; Department of Food Technology, Safety, and Health, Faculty of Bioscience Engineering, Ghent University, Ghent, Belgium.; Post-Graduate Program in Epidemiology - Federal University of Pelotas, Pelotas, Brazil.; International Health Department, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.; Poverty, Health and Nutrition Division, International Food Policy Research Institute, Washington, District of Columbia, USA.; Research and Development Division, Ghana Health Service, Accra, Ghana.; Department of International Health, Center for Human Nutrition, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.; Ariadne Labs, Brigham and Women's Hospital and Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.; Faculty of Medicine and Health Technology, Tampere University and Tampere University Hospital, Tampere, Finland.; College of Medicine and Public Health, Ubon Ratchathani University, Ubon Ratchathani, Thailand.; Department of Nutrition, Institute for Global Nutrition, University of California, Davis, California, USA.; Gertrude H Sergievsky Center, Vagelos College of Physicians and Surgeons, Columbia University Irving Medical Center, New York, New York, USA.; Department of Medicine, Harvard Medical School, Boston, Massachusetts, USA.; Namur University, Namur, Belgium.; Ifakara Health Institute, Dar es Salaam, Tanzania.; Kintampo Health Research Centre, Kintampo, Ghana.; Centre for Medical Parasitology, Department of Immunology and Microbiology, University of Copenhagen, and Department of Infectious Diseases, Copenhagen University Hospital, Copenhagen, Denmark.; National Institute of Medical Research, Tanga, Tanzania.; Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.; Pediatric Newborn Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.; Department of Nutrition and Food Science, University of Ghana, Accra, Ghana.; Centre for Health Research and Development, Society for Applied Studies, New Delhi, India.; Aravind Eye Hospital, Madurai, India.; Department of Epidemiology and Biostatistics, School of Public Health, Xi'an Jiaotong University Health Science Centre, Xi'an, China.; University of Alabama at Birmingham, Birmingham, Alabama, USA.; Department of Food Technology, Safety and Health, Ghent University, Ghent, Belgium.; School of Global and Public Health, Kamuzu University of Health Sciences, Blantyre, Malawi.; George Washington University Milken Institute School of Public Health, Washington, District of Columbia, USA.; HIV and Other Infectious Diseases Research Unit, South African Medical Research Council, Cape Town, South Africa.; ASEAN Institute for Health Development, Mahidol University, Salaya, Thailand.; Belgian Health Care Knowledge Centre, Brussels, Belgium.; Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.; Department of Global Health, Boston University School of Public Health, Boston, Massachusetts, USA.; Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.; Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.; Projahnmo Research Foundation, Dhaka, Bangladesh.; Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.; Department of Nutrition and Dietetics, School of Public Health, Addis Ababa University, Addis Ababa, Ethiopia.; Department of Global Health, Milken Institute School of Public Health, Washington, District of Columbia, USA.; NNIPS, Kathmandu, Nepal.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)OBJECTIVE: We aimed to understand the mortality risks of vulnerable newborns (defined as preterm and/or born weighing smaller or larger compared to a standard population), in low- and middle-income countries (LMICs). DESIGN: Descriptive multi-country, secondary analysis of individual-level study data of babies born since 2000. SETTING: Sixteen subnational, population-based studies from nine LMICs in sub-Saharan Africa, Southern and Eastern Asia, and Latin America. POPULATION: Live birth neonates. METHODS: We categorically defined five vulnerable newborn types based on size (large- or appropriate- or small-for-gestational age [LGA, AGA, SGA]), and term (T) and preterm (PT): T + LGA, T + SGA, PT + LGA, PT + AGA, and PT + SGA, with T + AGA (reference). A 10-type definition included low birthweight (LBW) and non-LBW, and a four-type definition collapsed AGA/LGA into one category. We performed imputation for missing birthweights in 13 of the studies. MAIN OUTCOME MEASURES: Median and interquartile ranges by study for the prevalence, mortality rates and relative mortality risks for the four, six and ten type classification. RESULTS: There were 238 203 live births with known neonatal status. Four of the six types had higher mortality risk: T + SGA (median relative risk [RR] 2.6, interquartile range [IQR] 2.0-2.9), PT + LGA (median RR 7.3, IQR 2.3-10.4), PT + AGA (median RR 6.0, IQR 4.4-13.2) and PT + SGA (median RR 10.4, IQR 8.6-13.9). T + SGA, PT + LGA and PT + AGA babies who were LBW, had higher risk compared with non-LBW babies. CONCLUSIONS: Small and/or preterm babies in LIMCs have a considerably increased mortality risk compared with babies born at term and larger. This classification system may advance the understanding of the social determinants and biomedical risk factors along with improved treatment that is critical for newborn health.Item Screening test accuracy to improve detection of precancerous lesions of the cervix in women living with HIV: a study protocol.(2020-Dec-18) Taghavi K; Moono M; Mwanahamuntu M; Basu P; Limacher A; Tembo T; Kapesa H; Hamusonde K; Asangbeh S; Sznitman R; Low N; Manasyan A; Bohlius J; Obstetrics and Gynaecology, University Teaching Hospital, Lusaka, Zambia.; CTU Bern, University of Bern, Bern, Switzerland.; University of Alabama at Birmingham (UAB), Birmingham, Alabama, USA.; International Agency for Research on Cancer (IARC), World Health Organization, Lyon, France.; Women and Newborn health, Levy Mwanawasa Medical University Hospital, Lusaka, Zambia.; ARTORG Center for Biomedical Engineering Research, University of Bern, Bern, Switzerland.; Institute of Social and Preventive Medicine (ISPM), University of Bern, Bern, Switzerland.; Centre for Infectious Disease Research in Zambia (CIDRZ), Lusaka, Zambia.; Graduate School for Cellular and Biomedical Sciences, University of Bern, Bern, Switzerland.; Institute of Social and Preventive Medicine (ISPM), University of Bern, Bern, Switzerland katayoun.taghavi@ispm.unibe.ch.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.Item Strengthening global commitment to eliminating cervical cancer: What lessons from the past can we apply to the future?(2020-Dec) Taghavi K; Moono M; Asangbeh S; Gillett G; Pascoe M; Manasyan A; Newlands Clinic, Harare, Zimbabwe.; The Graduate School for Cellular and Biomedical Sciences of the University of Bern, Bern Switzerland.; University of Alabama at Birmingham, Alabama, USA.; Institute of Social and Preventive Medicine, University of Bern, Switzerland.; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.; Department of Bioethics, University of Otago, Dunedin, New Zealand.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)Item Strengthening Kangaroo Mother Care at a tertiary level hospital in Zambia: A prospective descriptive study.(2022) Muttau N; Mwendafilumba M; Lewis B; Kasprzyk K; Travers C; Menon JA; Mutesu-Kapembwa K; Mangangu A; Kapesa H; Manasyan A; The Brown School, Washington University in St. Louis, St. Louis, Missouri, United States of America.; Department of Reproductive, Maternal, Newborn, and Child Health, Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.; Department of Psychology, University of Zambia, Lusaka, Zambia.; Department of Neonatology, Women and Newborn Hospital, University Teaching Hospital, Lusaka, Zambia.; Department of Pediatrics, Division of Neonatology, University of Alabama at Birmingham, Birmingham, Alabama, United States of America.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)BACKGROUND: Globally, 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. METHODS: We 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. RESULTS: We 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. CONCLUSIONS: Based 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 REGISTRATION: The trial is registered under ClinicalTrials.gov under the following ID number: NCT03923023.Item "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 T; Dale H; Muttau N; Itoh M; Williamson D; Mwamba C; Manasyan A; Beard RS; Cox MH; Herce ME; Centre for Infectious Disease Research in Zambia (CIDRZ), Lusaka, Zambia. Taniya.Tembo@cidrz.org.; University of Alabama at Birmingham, Birmingham, AL, USA.; University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.; Centre for Infectious Disease Research in Zambia (CIDRZ), Lusaka, Zambia.; U.S. Centers for Disease Control and Prevention, Atlanta, GA, USA.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.Item The association of maternal age with adverse neonatal outcomes in Lusaka, Zambia: a prospective cohort study.(2020-Nov-11) Tembo T; Koyuncu A; Zhuo H; Mwendafilumba M; Manasyan A; Department of Reproductive, Maternal, Newborn and Child Health, Centre for Infectious Disease Research in Zambia, P.O Box 34681, Lusaka, Zambia.; Department of Reproductive, Maternal, Newborn and Child Health, Centre for Infectious Disease Research in Zambia, P.O Box 34681, Lusaka, Zambia. Taniya.Tembo@cidrz.org.; Division of Neonatology School of Medicine , University of Alabama at Birmingham , Birmingham, USA.; Analysis Unit , Centre for Infectious Disease Research in Zambia , P.O Box 34681, Lusaka, Zambia.; Surgical Outcomes and Epidemiology-Surgical Department , Yale University , Connecticut, CT 06520, New Haven, USA.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)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.Item The Impacts of Stigma Against Sexual Minority Men Within and Between Various Socioecological Levels: Breaking the Vicious Cycle in Zambia.(2023) Qiao S; Garrett CM; Addo PNO; Adeagbo O; Moore DM; Muttau N; Sharma A; Lwatula C; Ngosa L; Kabwe M; Manasyan A; Menon JA; Weissman S; Li X; Harper GW; School of Public Health, University of Michigan, Ann Arbor, MI, USA.; Department of Epidemiology, Arnold School of Public Health, University of South Carolina, Columbia, SC, USA.; The Lotus Identity (TLI), Lusaka, Zambia.; University of Zambia, Lusaka, Zambia.; Department of Community and Behavioral Health, College of Public Health, The University of Iowa, Iowa City, IA, USA.; Department of Internal Medicine, School of Medicine Columbia, University of South Carolina, Columbia, SC, USA.; Department of Health Promotion, Education, and Behavior, Arnold School of Public Health, University of South Carolina, Columbia, SC, USA.; Dignitate Zambia Limited (DZL), Lusaka, Zambia.; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.; School of Medicine, The University of Alabama at Birmingham, Birmingham, AL, USA.; Department of Global Health, University of Washington, Seattle, WA, USA.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)Sexual minority men (SMM) face persistent stigma in Zambia. From a holistic perspective, we aim to explore its impacts within and between multiple socioecological levels, demonstrating how their interactions create a vicious cycle of barriers to the well-being of SMM. In-depth interviews were conducted with 20 purposively recruited SMM from Lusaka, Zambia. All interviews were audio-recorded, after written consent, transcribed verbatim, and iteratively coded employing inductive (i.e., data-driven) approaches for thematic analysis using NVivo. Results suggest three key themes: (1) interpersonal socially perpetuated sexual minority stigma (SMS); (2) multidirectional interactions between psychosocial well-being and risk-taking behaviors; and (3) institutionally perpetuated SMS as a barrier to seeking and receiving health care. SMS permeates across all levels of the socioecological model to negatively impact the psychosocial well-being of SMM while acting also as a barrier to accessing HIV prevention and care. Our study necessitates structural public health intervention to decrease stigma and discrimination against SMM in Zambia, in efforts to increase their psychosocial well-being as well as their access to and utilization of HIV care by breaking the vicious cycle of SMS that pervades through the intrapersonal, interpersonal, and institutional levels of the socioecological model.Item Theory-driven process evaluation of a complementary feeding trial in four countries.(2014-Apr) Newman JE; Garces A; Mazariegos M; Michael Hambidge K; Manasyan A; Tshefu A; Lokangaka A; Sami N; Carlo WA; Bose CL; Pasha O; Goco N; Chomba E; Goldenberg RL; Wright LL; Koso-Thomas M; Krebs NF; Statistics and Epidemiology, RTI International, Research Triangle Park, NC 27709, USA, Multidisciplinary Health Institute, Francisco Marroquin University, Guatemala City 01011, Guatemala, Institute for Nutrition of Central America and Panama, Guatemala City 01011, Guatemala, Department of Pediatrics, Section of Nutrition, University of Colorado Denver, Aurora, CO 80045, USA, Centre for Infectious Disease Research in Zambia, Lusaka 34681, Zambia, Kinshasa School of Public Health, Kinshasa, Democratic Republic of Congo, Department of Community Health Science and Family Medicine, Aga Khan University Medical College, Karachi 74800, Pakistan, Department of Pediatrics/Division of Neonatology, University of Alabama at Birmingham, Birmingham, AL 35233, USA, Department of Pediatrics, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, USA, University Teaching Hospital, Lusaka 34681, Zambia, Obstetrics and Gynecology, Columbia University, New York, NY 10027, USA and Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Rockville, MD 20852, USA.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)We conducted a theory-driven process evaluation of a cluster randomized controlled trial comparing two types of complementary feeding (meat versus fortified cereal) on infant growth in Guatemala, Pakistan, Zambia and the Democratic Republic of Congo. We examined process evaluation indicators for the entire study cohort (N = 1236) using chi-square tests to examine differences between treatment groups. We administered exit interviews to 219 caregivers and 45 intervention staff to explore why caregivers may or may not have performed suggested infant feeding behaviors. Multivariate regression analysis was used to determine the relationship between caregiver scores and infant linear growth velocity. As message recall increased, irrespective of treatment group, linear growth velocity increased when controlling for other factors (P < 0.05), emphasizing the importance of study messages. Our detailed process evaluation revealed few differences between treatment groups, giving us confidence that the main trial's lack of effect to reverse the progression of stunting cannot be explained by differences between groups or inconsistencies in protocol implementation. These findings add to an emerging body of literature suggesting limited impact on stunting of interventions initiated during the period of complementary feeding in impoverished environments. The early onset and steady progression support the provision of earlier and comprehensive interventions.