Maternal death surveillance and response system evaluation in Makonde District, Zimbabwe, 2021.

BACKGROUND: Maternal mortality is of global concern, almost 800 women die every day due to maternal complications. The maternal death surveillance and response (MDSR) system is one strategy designed to reduce maternal mortality. In 2021 Makonde District reported a maternal mortality ratio of 275 per 100 000 and only sixty-two percent of deaths recorded were audited. We evaluated the MDSR system in Makonde to assess its performance. METHODS: A descriptive cross-sectional study was conducted using the CDC guidelines for evaluating public health surveillance systems. An Interviewer-administered questionnaire was used to collect data from 79 health workers involved in MDSR and healthcare facilities. All maternal death notification forms, weekly disease surveillance forms, and facility monthly summary forms were reviewed. We assessed health workers' knowledge, usefulness and system attributes. RESULTS: We interviewed 79 health workers out of 211 workers involved in MDSR and 71 (89.9%) were nurses. The median years in service was 8 (IQR: 4-12). Overall health worker knowledge (77.2%) was good. Ninety-three percent of the deaths audited were of avoidable causes. Twelve out of the thirty-eight (31.6%) facilities were using electronic health records system. Feedback and documented shared information were evident at four facilities (21%) including the referral hospital. Nineteen (67.9%) out of 28 maternal death notification forms were completed within seven days and none were submitted to the PMD on time. CONCLUSION: The MDSR system was acceptable and simple but not timely, stable and complete. Underutilization of the electronic health system, work load, poor documentation and data management impeded performance of the system. We recommended appointment of an MDSR focal person, sharing audit minutes and improved data management.

Tuberculosis cohort analysis in Zimbabwe: The need to strengthen patient follow-up throughout the tuberculosis care cascade.

INTRODUCTION: Globally people with tuberculosis (TB) continue to be missed each year. They are either not diagnosed or not reported which indicates possible leakages in the TB care cascade. Zimbabwe is not spared with over 12000 missed cases in 2020. A preliminary review of TB treatment outcomes indicated patient leakages throughout the presumptive cascade and undesirable treatment outcomes in selected cities. Chegutu District had pre-diagnosis and pretreatment losses to follow-up while Mutare City among others had 22.0% of outcomes not evaluated in the second quarter of 2021, and death rates as high as 14% were recorded in Gweru District. The problem persists despite training on data analysis and use. The TB cohorts were analysed to determine the performance of the care cascade and the spatial distribution of treatment outcomes in Zimbabwe. METHODS: Using data from district health information software version 2.3 (DHIS2.3), a secondary data analysis of 2020 drug-sensitive (DS) TB treatment cohorts was conducted. We calculated the percentage of pre-diagnosis, and pre-treatment loss to follow-up (LTFU). For TB treatment outcomes, 'cured' and 'treatment completed' were categorized as treatment success, while 'death', 'loss to follow-up (LTFU), and 'not evaluated' were categorized as undesirable outcomes. Univariate analysis of the data was conducted where frequencies were calculated, and data was presented in graphs for the cascade, treatment success, and undesirable outcomes while tables were created for the description of study participants and data quality. QGIS was used to generate maps showing undesirable treatment outcomes. RESULTS: An analysis of national data found 107583 people were presumed to have TB based on symptomatic screening and or x-ray and 21.4% were LTFU before the specimen was investigated. Of the 84534 that got tested, 10.0% did not receive their results. The treatment initiation rate was 99.1%. Analysis of treatment outcomes done at the provincial level showed that Matabeleland South Province had the lowest treatment success rate of 77.3% and high death rates were recorded in Matabeleland South (30.0%), Masvingo (27.3%), and Matabeleland North (26.1%) provinces. Overall, there were high percentages of not-evaluated treatment outcomes. CONCLUSION: Pre-diagnosis LTFU was high, and high death and loss to follow-up rates were prevalent in provinces with artisanal and small-scale mining (ASM) activities. Unevaluated treatment outcomes were also prevalent and data quality remains a challenge within the national TB control program. We recommended strengthening patient follow-up at all levels within the TB care cascade, strengthening capacity-building for data analysis and use, further analysis to determine factors associated with undesirable outcomes and a study on why LTFU remains high.

Factors associated with COVID-19 fatality among patients admitted in Mashonaland West Province, Zimbabwe 2020-2022: a secondary data analysis.

Introduction: approximately 15% of COVID-19 patients develop symptoms necessitating admission. From 2020 to 2022, Mashonaland West Province had an institutional case fatality rate of 23% against a national rate of 7%. Therefore, we evaluated the COVID-19 admissions in the province to determine the factors associated with COVID-19 mortality. Methods: we conducted an analytical cross-sectional study based on secondary data from isolation centers across the province using all 672 death audit forms and patient records. We obtained data on patient demographics, signs and symptoms, clinical management and oxygen therapy administered, among other things. Data were entered into an electronic form and imported into Epi-info 7 for analysis bivariate and multivariate conducted. Results: we found that being an older man, aOR 1.04 (1.03-1.05), who had diabetes aOR 6.0 (95% CI: 3.8-9.2) and hypertension aOR 4.5 (95% CI: 2.8-6.5) were independent risk factors. Patients put on dexamethasone aOR 2.4 (95% CI: 1.6-3.4) and heparin/clexane aOR 1.6 (95% CI: 1.1-2.2) had a higher mortality risk. However, vitamin C aOR 0.48 (95% CI: 0.31-0.71) and oxygen therapy aOR 0.14 (95% CI: 0.10-0.19) and being pregnant aOR 0.06 (95% CI: 0.02-0.14) were protective. Conclusion: mortality risk increased in older male patients with comorbidities and with those on dexamethasone and heparin therapy. Oxygen therapy and vitamin C were protective. There is a need to conduct further study of the source of these variations in risk across patients to establish the true impact of differences in individuals' mortality.

Predictors of COVID-19 infection among health care workers in Harare City, Zimbabwe, 2021.

Introduction: preventing COVID-19 infection among health workers maintains the health system capacity and reduces secondary transmission. Of 506 health workers tested for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in Harare City between December 2020 and February 2021 (second wave), 128 (25%) tested positive, affecting service delivery. We investigated factors associated with COVID-19 infection and described breakthrough infections among health workers. Methods: we conducted a cross-sectional study in Harare City. Interviews were conducted with 467 health workers to determine behavioral, occupational, and non-occupational factors associated with COVID-19 infection. Fifteen key informants were interviewed to verify responses. Records and line-list were reviewed to verify cases, outcomes, and vaccination status. Observations were done to check adherence to prevention measures. Epi-info generated means, frequencies, proportions and conducted univariate, bivariate and multivariate analysis. Statistical significance was at p-value<0.05. Results: we interviewed 467 health workers, 166 (35.5%) had a history of COVID-19 infection. Females were the majority 357 (76.4%), mostly nurses 200 (42.8%). Those not trained on infection control measures in the past six months (aOR=2.13; 95%CI 1.06-4.27; p=0.03), not observing social distance at mealtimes (aOR=6.33; 95%CI 3.36-11.89; p<0.01), having a household COVID-19 case (aOR=9.03; 95%CI 3.93-20.76; p<0.01) and not properly wearing facemasks (aOR=16.68; 95%CI 9.39-29.61; p<0.01) were significantly associated COVID-19 infection. Of 378 health workers fully vaccinated, 39 (10.3%) had breakthrough infections. Most with breakthrough infections, 33 (84.6%) had asymptomatic or mild disease. One death was recorded, a female, not vaccinated, with uncontrolled diabetes. Conclusion: predictors of COVID-19 infection among health workers were, no training on infection and prevention and control (IPC) measures, lack of social distancing at mealtimes, improper use of facemasks, and having a COVID-19 case at household level. We conducted refresher training to strengthen infection control measures.

Factors associated with COVID-19 fatality among patients admitted in Mashonaland West Province, Zimbabwe 2020-2022: a secondary data analysis

Introduction: approximately 15% of COVID-19 patients develop symptoms necessitating admission. From 2020 to 2022, Mashonaland West Province had an institutional case fatality rate of 23% against a national rate of 7%. Therefore, we evaluated the COVID-19 admissions in the province to determine the factors associated with COVID-19 mortality. Methods: we conducted an analytical cross-sectional study based on secondary data from isolation centers across the province using all 672 death audit forms and patient records. We obtained data on patient demographics, signs and symptoms, clinical management and oxygen therapy administered, among other things. Data were entered into an electronic form and imported into Epi-info 7 for analysis bivariate and multivariate was conducted. Results: we found that being an older man, aOR 1.04 (1.03-1.05), who had diabetes aOR 6.0 (95% CI: 3.8-9.2) and hypertension aOR 4.5 (95% CI: 2.8-6.5) were independent risk factors. Patients put on dexamethasone aOR 2.4 (95% CI: 1.6-3.4) and heparin/clexane aOR 1.6 (95% CI: 1.1-2.2) had a higher mortality risk. However, vitamin C aOR 0.48 (95% CI: 0.31-0.71) and oxygen therapy aOR 0.14 (95% CI: 0.10-0.19) and being pregnant aOR 0.06 (95% CI: 0.02-0.14) were protective. Conclusion: mortality risk increased in older male patients with comorbidities and with those on dexamethasone and heparin therapy. Oxygen therapy and vitamin C were protective. There is a need to conduct further study of the source of these variations in risk across patients to establish the true impact of differences in individuals' mortality.

Anthrax outbreak investigation in Tengwe, Mashonaland West Province, Zimbabwe, 2022.

BACKGROUND: Anthrax continues to be a disease of public health concern in Zimbabwe. Between December 2021 and February 2022, Tengwe reported 36 cases of human anthrax. Gastrointestinal anthrax has the potential to cause serious outbreaks leading to loss of human life. We investigated the outbreak, identified the risk factors using one health approach to inform outbreak control. MATERIALS AND METHODS: We conducted descriptive analysis of the outbreak and a 1:2 unmatched case control study to identify risk factors for anthrax. A case was any Tengwe resident who developed an ulcer and/or abdominal symptoms and epidemiologically linked to a confirmed environmental exposure. Validated, structured interviewer-administered questionnaires were used to collect data from the cases and neighbourhood controls. Soil and dried meat samples were collected for laboratory investigations. District preparedness and response was assessed using a checklist. Data was analysed using Epi Info version 7.2.5. The odds of exposure were calculated for each risk factor examined. Multivariable logistic regression analysis was performed to identify the independent factors associated with contracting anthrax. RESULTS: Through active case finding we identified 36 cases, 31 were interviewed. Twenty-one (67.7%) were males. The median age was 33 years (Inter quartile range: 22-54). Nineteen (61.2%) cases presented with abdominal symptoms with zero deaths reported. The independent risk factor for contracting anthrax was eating under-cooked meat (aOR = 12.2, 95% CI: 1.41-105.74, p = 0.023). All samples collected tested positive for anthrax. No livestock vaccinations or zoonotic meetings were being conducted prior to the outbreak. Notification of the outbreak was done 11 days after index case presentation however one health response was instituted within 24 hours. CONCLUSION: The anthrax was confirmed in Tengwe. Consumption of under-cooked meat was associated with gastrointestinal anthrax. The timely one health response resulted in excellent outcomes. Using one health approach in managing zoonotic threats is encouraged.

'The baby will have the right beginning': a qualitative study on mother and health worker views on point-of-care HIV birth testing across 10 sites in Zimbabwe.

BACKGROUND: The survival of HIV-infected infants depends on early identification and initiation on effective treatment. HIV-exposed infants are tested at 6 weeks of age; however, testing for HIV sooner (e.g., shortly after birth) can identify in utero infection, which is associated with rapid progression. Infant early diagnostic virologic tests often have long turnaround times, reducing the utility of early testing. Point-of-care (POC) testing allows neonates born in health facilities to get results prior to discharge. This study aimed to understand the views of mothers and health workers regarding the use and acceptability of POC birth testing. METHODS: Beginning in 2018, Zimbabwe offered standard HIV testing at birth to high-risk HIV-exposed infants; as part of a pilot program, at 10 selected hospitals, POC birth testing (BT) was offered to every HIV-exposed infant. In order to understand experiences at the selected sites, 48 interviews were held: 23 with mothers and 25 with health workers, including 6 nurses-in-charge. Participants were purposively sampled across the participating sites. Interviews were held in English, Shona, or Ndebele, and transcribed in English. Line-by-line coding was carried out, and the constant comparison method of analysis was used to identify key themes for each respondent type. RESULTS: Findings were organized under four themes: challenges with BT, acceptability of BT, benefits of BT, and recommendations for BT programs. Overall, BT was well accepted by mothers and health workers because it encouraged mothers to better care for their uninfected newborns or initiate treatment more rapidly for infected infants. While the benefits were well understood, mothers felt there were some challenges, namely that they should be informed in advance about testing procedures and tested in a more private setting. Mothers and HCWs also recommended improving awareness of BT, both among health care workers and in the community in general, as well as ensuring that facilities are well-stocked with supplies and can deliver results in a timely way before scaling up programs. CONCLUSIONS: Mothers and health workers strongly support implementation and expansion of birth testing programs due to the benefits for newborns. The challenges noted should be taken as planning guidance, rather than reasons to delay or discontinue birth testing programs.

An evaluation of the isoniazid preventive therapy program performance for under-fives in Kwekwe City, January 2019 - December 2020: a descriptive cross-sectional study.

Childhood tuberculosis (TB) is underserved in resource-constrained endemic areas. Zimbabwe National Tuberculosis Program recommends tuberculosis prevention treatment for children aged <5 years who are close contacts of smear-positive TB cases. The Isoniazid Preventive Therapy (IPT) program performance had never been evaluated since its inception in 2010. We therefore, assessed the IPT program's inputs, processes, outputs, and outcomes. We conducted a process evaluation using the logic model in Kwekwe City. We recruited twenty-seven health care workers from all the five municipal health facilities. Smear-positive guardians of under 5 children, health care workers, and registers were the study population. Data were collected using a questionnaire and checklists and presented as frequencies and proportions. The IPT program met requirements in provision of guidelines (10/10), screening tools (15/15) and on-the-job trainings done in all five health facilities. Isoniazid tablets supply and quarterly budgeting did not meet meeting program requirements. Fifty-nine out of 231 (25.5%) children contacts of sputum-positive TB patients were screened. Fifty-one of the 59 (86.4%) children were initiated on IPT, 42/51 (82.4%) completed the course, one developed TB, 3/51 were still on treatment and 5/51 were lost to follow up. No dropouts and deaths were recorded. Unavailability of drugs was a barrier to the IPT and negatively impacts the TB elimination program. Contact screening was the bottleneck in the successful implementation of the program. Adequate staff and provision of drugs might improve the program. We recommended the recruitment of more healthcare workers and the budget for the program.

An evaluation of the notifiable disease surveillance system in Chegutu District, Zimbabwe, 2020: a cross-sectional study.

Introduction: in 2018-2019 Chegutu District had one notification form Tally 1 (T1) that was completed instead of seven for detected notifiable diseases. Different figures of cholera were reported through weekly rapid disease notification system with 106 patients and Notifiable Diseases Surveillance System (NDSS) with 111 patients, causing data discrepancy. We evaluated the NDSS to determine reasons for underperformance and data discrepancy. Methods: we conducted descriptive cross-sectional study using updated centres for disease control and prevention guidelines for surveillance system evaluation. We recruited forty-six health workers. Interviewer-administered questionnaires and checklists were used to collect data on reasons for underperformance, reasons for data discrepancy, knowledge of NDSS, surveillance system attributes and usefulness. Epi InfoTM7 generated frequencies, proportions, and means. Likert scale was used to assess health worker knowledge. Results: of the forty-six health workers, 34 (78%) had fair knowledge of NDSS. The reason for system underperformance was lack of training in NDSS 42 (91%). Data discrepancy was attributed to typographical mistakes made during data entry on WhatsApp platform 32 (70%). Eighty per cent (37) were willing to complete T1 forms. Six participants who were timed took ten minutes to complete T1 forms. Among 17 health facilities, only three had fifteen T1 forms that were adequate to notify first five cases in an outbreak. Notifiable diseases surveillance system data was used for planning health education 28 (68%). Conclusion: the NDSS was unstable due to health workers' inadequate knowledge and unavailability of T1 forms. Notifiable diseases surveillance system was found to be simple, acceptable, and useful. We recommended NDSS training of health workers.

An evaluation of childhood tuberculosis program in Chegutu District, Zimbabwe, 2020: a descriptive cross-sectional study.

BACKGROUND: Childhood tuberculosis (TB) is a major global public health concern contributing to significant child morbidity and mortality. A records review of the TB notification for Chegutu District Health Information System 2 (DHIS2) showed a low childhood TB case detection rate. For 2018 and 2019, childhood TB notifications were 4% and 7% respectively against the annual national childhood 12% case detection rate. We evaluated the performance of the childhood TB program in Chegutu. METHODS: We conducted a descriptive cross-sectional study. Sixty-six health workers (HW) participated in the study. Interviewer-administered questionnaires and checklists were used to collect data on reasons for low TB case detection, HW childhood TB knowledge, program inputs, processes, and outputs. Strengths, Weaknesses, Opportunities and Threats analysis was used to assess the childhood TB processes. We analyzed the data using Epi Info 7™ to generate frequencies, proportions and means. A Likert scale was used to assess health worker knowledge. RESULTS: The majority 51/66(77%) of HW were nurses and 51/66(67%) of respondents were females. Reasons for the low childhood TB case detection were lack of HW confidence in collecting gastric aspirates 55/66(83%) and HW's negative attitudes towards gastric aspirate collection 23/66(35%). HW 24/66 (37%) had a fair knowledge of childhood TB notification. The district had only one functional X-ray machine for 34 health facilities. Only 6/18 motorcycles were functional with inadequate fuel supply. No desk guide for the management of TB in children for HW (2018) was available in 34 health facilities. Ethambutol 400 mg was out of stock and adult 800 mg tablets were used. Funds allocated for motor vehicle and motorcycles service ($1612USD/year) were inadequate. The district failed to perform planned quarterly TB review meetings, contact tracing and childhood TB training due to funding and COVID-19 lockdown restrictions. CONCLUSION: The childhood TB program failed to meet its targets due to inadequate inputs, HW suboptimal knowledge and COVID-19 lockdown measures. Case detection and notification can be improved through on-job training, mentorship, support and supervision and adequate resources.

Factors associated with a malaria outbreak at Tongogara refugee camp in Chipinge District, Zimbabwe, 2021: a case-control study.

BACKGROUND: Malaria is a leading cause of morbidity and mortality among forcibly displaced populations, including refugees, approximately two-thirds of whom reside in malaria endemic regions. Data from the rapid disease notification system (RDNS) reports for Manicaland Province in Zimbabwe showed that despite implementation of malaria control initiatives, there was an increase in number of malaria cases above action thresholds at Tongogara refugee camp in Chipinge district during weeks 12-14 of 2021. An investigation that described the outbreak by person, place and time was conducted. Malaria emergency preparedness, response, and appropriateness of case management were assessed. The factors associated with contracting malaria were determined to enable the formulation of appropriate interventions, establish control, and prevent future malaria outbreaks among this vulnerable population. METHODS: A 1:1 unmatched case-control study involving 80 cases and 80 controls was conducted using interviewer-administered questionnaires at household level. Data was entered into Epi Data version 3.1 and quantitative analysis was done using Epi Info™ version 7.2.2.6 to generate medians, proportions, odds ratios and their 95% confidence intervals. RESULTS: Malaria cases were distributed throughout the 10 residential sections within Tongogara refugee camp, the majority being from section 7, 28 (35%). Despite constituting 11% of the total population, Mozambican nationals accounted for 36 (45%) cases. Males constituted 47 (59%) among cases which was comparable to controls 43 (54%), p = 0.524. The median age for cases was 15 years [Interquartile range (IQR), 9-26] comparable to controls, which was 17 years (IQR, 10-30) (p = 0.755). Several natural and man-made potential vector breeding sites were observed around the camp. Risk factors associated with contracting malaria were engaging in outdoor activities at night [AOR = 2.74 (95% CI 1.04-7.22), wearing clothes that do not cover the whole body during outdoor activities [AOR 4.26 (95% CI, 1.43-12.68)], while residing in a refugee housing unit reduced the risk of contracting malaria [AOR = 0.18 (CI, 0.06-0.55)]. CONCLUSIONS: The malaria outbreak at Tongogara refugee camp reemphasizes the role of behavioural factors in malaria transmission. Intensified health education to address human behaviours that expose residents to malaria, habitat modification, and larviciding to eliminate mosquito breeding sites were recommended.

Trends of stillbirths in Harare City, Zimbabwe, 2015-2019: a secondary data analysis.

Introduction: in Zimbabwe, perinatal mortality is a major public health problem. Harare City data showed increase in stillbirth rate trend from 4/1000 live births in 2014 to 6/1000 live births in 2018, failing to meet the country's target of reducing stillbirth rate by 40%. We analysed the characteristics of stillbirths from 2015 to 2019 in Harare City. Methods: we conducted a retrospective analytical cross-sectional study using secondary data from Harare City Health Department's 12 baby-delivery polyclinics. Fourteen key informants were interviewed to verify information obtained. Using Epi-info, descriptive summaries and graphs were generated and bivariate and multivariate logistic regression was conducted. Statistical significance was considered at a p-value <0.05. Results: a total of 700(74.9%) perinatal death notification records were reviewed. The majority were macerated stillbirths 418(59.7%) followed by fresh stillbirths 189(27.0%). The median age for women who had fresh stillbirths was 26 years (Q1=22; Q2=32). Preterm delivery (aOR= 2.15; 95%CI 1.81- 3.89; p<0.01), having delivered by breech presentation (aOR= 3.32; 95%CI 1.72-6.41; p=<0.01), and being HIV positive (aOR= 1.69; 95%CI 1.02-2.79; p=0.04) were associated with preterm delivery. Conclusion: stillbirths in Harare City were increasing and were due to preventable causes. The younger maternal age group was most affected hence preventive activities should focus on them. Improving the quality of antenatal care, delivery, and new-born care can help reduce stillbirths and early neonatal death.

Evaluation of the weekly disease surveillance system for epidemic-prone diseases in Makonde District, Zimbabwe 2020: a descriptive cross-sectional study.

Introduction: the weekly disease surveillance system (WDSS) is a tool used to provide an early warning of potential public health threats in Zimbabwe. In 2020, Makonde District failed to detect an anthrax outbreak at one of its facilities, this untimely and poor response of the district increased morbidity. We evaluated the weekly disease surveillance system to determine reasons for missing outbreaks and determine the usefulness of the system in the detection of outbreaks. Methods: we conducted descriptive cross-sectional study using updated Centres for Disease Control and Prevention guidelines for surveillance system evaluation. We recruited 46 health workers. A structured pretested interviewer-administered questionnaire was used to collect data on reasons for missing outbreaks, knowledge, usefulness and surveillance system attributes. Data were cleaned and bivariate analysis was conducted. Results: health workers found the system simple (85%), acceptable (75%) and flexible (60%). However, we found only 5 (11%) health workers could correctly describe the surveillance system, only 2 (3%) were trained in disease surveillance, only 31 (65%) sent data on time, 57% of clinics had stock outs of forms, 60% of forms had entries with 100% of the data filled out and 22 (46%) of health workers analysed the data gathered and used it in meetings. Conclusion: the surveillance system was simple, flexible, acceptable, but unstable, untimely and not useful. There was poor knowledge on the surveillance system, health workers were not trained on disease surveillance, and quality of data was poor. Health workers should be trained in surveillance and data validation and adequate reporting tools provided.

Prevention of mother-to-child transmission activities after one-off clinical mentorship training in selected health facilities, Zimbabwe: 2014-2018.

This was a cross-sectional study describing HIV testing uptake and ART initiation for pregnant women and HIV-exposed infants after one-off clinical mentorship training in 2013 for nurses in 56 peripheral health-facilities, Zimbabwe. Between 2014-2018, 92% of 106411 pregnant women were HIV tested and 98% of HIV-positive women initiated antiretroviral therapy (ART). There were 15846 HIV-exposed infants, of whom 96% had dried blood spots collected for virologic diagnosis and 51% of those diagnosed HIV-positive initiated ART. In conclusion, this one-off clinical mentorship training in 2013 was associated with consistently high HIV testing and ART initiation in pregnant women and their children.

Impact of Routine Point-of-Care Versus Laboratory Testing for Early Infant Diagnosis of HIV: Results From a Multicountry Stepped-Wedge Cluster-Randomized Controlled Trial.

BACKGROUND: Although the World Health Organization recommends HIV-exposed infants receive a 6-week diagnostic test, few receive results by 12 weeks. Point-of-care (POC) early infant diagnosis (EID) may improve timely diagnosis and treatment. This study assesses the impact of routine POC versus laboratory-based EID on return of results by 12 weeks of age. METHODS: This was a cluster-randomized stepped-wedge trial in Kenya and Zimbabwe. In each country, 18 health facilities were randomly selected for inclusion and randomized to timing of POC implementation. FINDINGS: Nine thousand five hundred thirty-nine infants received tests: 5115 laboratory-based and 4424 POC. In Kenya and Zimbabwe, respectively, caregivers were 1.29 times [95% confidence interval (CI): 1.27 to 1.30, P < 0.001] and 4.56 times (95% CI: 4.50 to 4.60, P < 0.001) more likely to receive EID results by 12 weeks of age with POC versus laboratory-based EID. POC significantly reduced the time between sample collection and return of results to caregiver by an average of 23.03 days (95% CI: 4.85 to 21.21, P < 0.001) in Kenya and 62.37 days (95% CI: 58.94 to 65.80, P < 0.001) in Zimbabwe. For HIV-infected infants, POC significantly increased the percentage initiated on treatment, from 43.2% to 79.6% in Zimbabwe, and resulted in a nonsignificant increase in Kenya from 91.7% to 100%. The introduction of POC EID also significantly reduced the time to antiretroviral therapy initiation by an average of 17.01 days (95% CI: 9.38 to 24.64, P < 0.001) in Kenya and 56.00 days (95% CI: 25.13 to 153.76, P < 0.001) in Zimbabwe. CONCLUSIONS: POC confers significant advantage on the proportion of caregivers receiving timely EID results, and improves time to results receipt and treatment initiation for infected infants. Where laboratory-based EID systems are unable to deliver results to caregivers rapidly, POC should be implemented as part of an integrated testing system.

Strengthening Existing Laboratory-Based Systems vs. Investing in Point-of-Care Assays for Early Infant Diagnosis of HIV: A Model-Based Cost-Effectiveness Analysis.

BACKGROUND: To improve early infant HIV diagnosis (EID) programs, options include replacing laboratory-based tests with point-of-care (POC) assays or investing in strengthened systems for sample transport and result return. SETTING: We used the CEPAC-Pediatric model to examine clinical benefits and costs of 3 EID strategies in Zimbabwe for infants 6 weeks of age. METHODS: We examined (1) laboratory-based EID (LAB), (2) strengthened laboratory-based EID (S-LAB), and (3) POC EID (POC). LAB/S-LAB and POC assays differed in sensitivity (LAB/S-LAB 100%, POC 96.9%) and specificity (LAB/S-LAB 99.6%, POC 99.9%). LAB/S-LAB/POC algorithms also differed in: probability of result return (79%/91%/98%), time until result return (61/53/1 days), probability of initiating antiretroviral therapy (ART) after positive result (52%/71%/86%), and total cost/test ($18.10/$30.47/$30.71). We projected life expectancy (LE) and average lifetime per-person cost for all HIV-exposed infants. We calculated incremental cost-effectiveness ratios (ICERs) from discounted (3%/year) LE and costs in $/year-of-life saved (YLS), defining cost effective as an ICER <$580/YLS (reflecting programs providing 2 vs. 1 ART regimens). In sensitivity analyses, we varied differences between S-LAB and POC in result return probability, result return time, ART initiation probability, and cost. RESULTS: For infants who acquired HIV, LAB/S-LAB/POC led to projected one-year survival of 67.3%/69.9%/75.6% and undiscounted LE of 21.74/22.71/24.49 years. For all HIV-exposed infants, undiscounted LE was 63.35/63.38/63.43 years, at discounted lifetime costs of $200/220/240 per infant. In cost-effectiveness analysis, S-LAB was an inefficient use of resources; the ICER of POC vs. LAB was $830/YLS. CONCLUSIONS: Current EID programs will attain greater benefit from investing in POC EID rather than strengthening laboratory-based systems.

Effectiveness of Maternal Transmission Risk Stratification in Identification of Infants for HIV Birth Testing: Lessons From Zimbabwe.

BACKGROUND: In 2017, Zimbabwe adopted a modified version of the World Health Organization 2016 recommendation on HIV birth testing by offering HIV testing at birth only to infants at "high risk" of HIV transmission. There is limited evidence on the effectiveness of this approach. Our study assessed the sensitivity and specificity of birth testing "high risk" infants only. METHODS: We conducted a cross-sectional study at 10 health facilities from November 2018 to July 2019. A nucleic acid test for HIV was performed on all HIV-exposed infants identified within 48 hours of life, irrespective of risk status. Univariate and bivariate analyses were used to estimate the performance of the risk screening tool. RESULTS: HIV nucleic acid test was successfully performed on 1970 infants (95%), of whom 266 (13.5%) were classified as high-risk infants. HIV prevalence for all infants tested was 1.5% (95% CI: 1% to 2%), whereas prevalence among high-risk infants and low-risk infants was 6.8% (95% CI: 3.7% to 9.8%) and 0.6% (95% CI: 0.3% to 1%) respectively. Sensitivity and specificity of the maternal risk screening tool was at 62.1% (95% CI: 44.4% to 79.7%) and 87.2% (95% CI: 85.7% to 88.7%), respectively; positive and negative predictive values were 6.8% (95% CI: 3.7% to 9.8%) and 99.4% (95% CI: 99.0% to 99.7%) respectively. CONCLUSIONS: Despite high negative predictive value, sensitivity was relatively low, with potential of missing 2 in every 5 HIV infected infants. Given the potential benefits of early ART initiation for all exposed infants, where feasible, universal testing for HIV-exposed infants at birth may be preferred to reduce missing infected infants.

"We Need it the Same Day": A Qualitative Study of Caregivers and Community Members' Perspectives Toward the Use of Point-of-Care Early Infant Diagnosis.

BACKGROUND: Only half of the infants tested for HIV ever receive results, leading to low uptake of treatment and increased mortality and morbidity rates. Point-of-care (POC) nucleic acid diagnostic machines allow for the possibility of same-day results. In Kenya and Zimbabwe, as part of an evaluation comparing standard of care with POC testing for early infant diagnosis, a qualitative substudy was undertaken to understand the acceptability of POC among caregivers of HIV-exposed infants and community members. SETTING: Kenya and Zimbabwe. METHODS: In Kenya, 74 interviews were conducted with caregivers, and 6 focus group discussions were conducted with male and female community members and elders. In Zimbabwe, we conducted 85 interviews and 8 focus group discussions. Data were collected in 2 rounds: 1 before the introduction of POC platforms and 1 after the platforms had been in use for at least 3 months. Interviews were conducted in local languages, and content analysis and constant comparison were used to identify key themes. RESULTS: Reduced time to receive test results lowered caregiver anxiety about the child's HIV status and allowed families to put children on treatment earlier. Printed POC results were seen by some as more trustworthy than conventional handwritten results, believing this reduced the chance of human error; a few distrusted HIV results were generated too quickly. Community awareness of POC was lower among caregivers of HIV-exposed infants. CONCLUSION: Caregivers are generally very accepting of receiving POC HIV test results; however, additional sensitization among influential community members about the benefits of POC testing is needed.

Estimating the Cost of Point-of-Care Early Infant Diagnosis in a Program Setting: A Case Study Using Abbott m-PIMA and Cepheid GeneXpert IV in Zimbabwe.

BACKGROUND: Point-of-care early infant diagnosis (POC EID) increases access to HIV test results and shortens time to result-return and antiretroviral therapy initiation, as compared to central laboratory-based EID. However, to scale-up POC EID, governments need more information about programmatic costs. METHODS: We evaluated POC EID costs from a health systems perspective. Our primary analysis assessed the Abbott m-PIMA and 2 versions of the Cepheid GeneXpert IV platforms-with a solar battery or gel battery-used in Zimbabwe, with instrument purchase. We also included the following 2 scenarios with zero upfront equipment purchase: (1) m-PIMA using a reagent rental model, with an all-inclusive price when the buyer commits to an average testing volume, and (2) GeneXpert IV, reflecting contexts where GeneXpert is already in place for tuberculosis diagnosis or HIV viral load monitoring. We collected data from project expenditures, observations of health workers, and from government salary scales. We calculated cost per EID test based on number of EID tests performed on each machine per day. RESULTS: The cost per successfully completed test was $44.55 for m-PIMA with platform purchase and $25.89 for m-PIMA reagent rental. Costs for GeneXpert IV with platform purchase were $25.70 using a solar battery, $25.29 using a gel battery, and $23.85 under a scenario assuming no equipment costs. In our primary analyses, materials costs comprised 73%-74% total costs, equipment 14%-20%, labor 5%-8%, training 1%, facility upgrades 1%, and monitoring 1%. CONCLUSIONS: As countries consider scaling up POC EID, these data are important for budgeting and planning.

Front-Line Human Resource Time-Use for Early Infant HIV Diagnosis: A Comparative Time-Motion Study at Centralized and Point-of-Care Health Facilities in Zimbabwe.

BACKGROUND: Point-of-care (POC) assays for early infant diagnosis of HIV (EID) increase access to testing, shorten time to results, and expedite initiation of antiretroviral therapy when compared with laboratory-based assays. However, there is a significant gap in our understanding of its human resource impact at the facility level. This study evaluates front-line health workers' (HWs') time associated with EID. SETTING: Using time-motion methodology, we collected time-use data on EID tasks performed by HWs at 3 EID facility types in Zimbabwe-5 POC hubs, 9 POC spokes, and 11 facilities that used centralized laboratories. METHODS: Data collectors observed 30 EID processes and 30 HWs' provided self-reported time. Comparisons of mean differences of HWs' time-use between centralized and POC EID were performed with a 2-sample t test with unequal variances. RESULTS: Observed average total labor time per EID test at POC facilities was 28 minutes, 22 seconds [95% confidence interval (CI): 22:51 to 35:48], which was equivalent to the average preresult time at facilities using centralized EID. HWs performed other tasks while the machine processed samples. Observed average preresult time (counseling to sample preparation) was 18 minutes, 6 Supported by seconds (95% CI: 13:00 to 23:42) for POC compared with 27 minutes, 48 seconds (95% CI: 23:48 to 32:50) for facilities using centralized laboratories. The mean difference of 9 minutes, 42 seconds (95% CI: 03:04 to 16:18) was statistically significant. The differences in self-reported average total labor time per EID test between HWs at facilities using centralized laboratories or POC were not statistically significant. CONCLUSION: Use of POC assays did not incur additional human resource time compared with sending dried blood spots to a centralized laboratory for EID.