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.
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.
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.
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.