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Abstract Background The introduction of dolutegravir (DTG) in treating HIV has shown enhanced efficacy and tolerability. This study examined changes in weight gain and body mass index (BMI) at 6- and 12-months after post-initiating antiretroviral therapy (ART), comparing people living with HIV (PLHIV) on DTG-based regimens with those on non-DTG-based regimens in Malawi. Methods Retrospective cohort data from 40 public health facilities in Malawi were used, including adult ART patients (aged ≥ 15 years) from January 2017 to March 2020. The primary outcomes were BMI changes/transitions, with secondary outcomes focused on estimating the proportion of mean weight gain > 10% post-ART initiation and BMI category transitions. Descriptive statistics and binomial regression were used to estimate the unadjusted and adjusted relative risks (RR) of weight gain of more than ( >) 10%. Results The study included 3,520 adult ART patients with baseline weight after ART initiation, predominantly female (62.7%) and aged 25–49 (61.1%), with a median age of 33 years (interquartile range (IQR), 23–42 years). These findings highlight the influence of age, ART history, and current regimen on weight gain. After 12months follow up, compared to those aged 15–24 years, individuals aged 25–49 had an Adjusted RR (ARR) of 0.5 (95% Confidence Interval (CI): 0.35–0.70), suggesting a 50% reduced likelihood of > 10% weight gain after post-ART initiation. Similarly, those aged 50 + had an ARR of 0.33 (95% CI: 0.20–0.58), indicating a 67% decreased likelihood compared to the youngest age group 15–24 years. This study highlights the positive impact of DTG-based regimens, revealing significant transitions from underweight to normal BMI categories at 6- and 12-months post-initiation. Conclusion This study provides insights into weight gain patterns in patients on DTG-based regimens compared with those on non-DTG regimens. Younger individuals (15–24 years) exhibited higher odds of weight gain, suggesting a need for increased surveillance in this age group. These findings contribute to the understanding DTG's potential effects on weight gain, aiding clinical decision making. Further research is required to comprehensively understand the underlying mechanisms and long-term implications of weight gain in patients receiving DTG-based regimens.

Summary: Background: Contact tracing was described as a key strategy to contribute to controlling the spread of severe acute respiratory syndrome of Coronavirus 2 (SARS-CoV-2) but implementing it can be a challenge. Digitalisation of contact tracing is among the proposed solutions being explored in sub-Saharan African settings. We assessed the effectiveness of a digital tool to expand SARS-CoV-2 testing in exposed individuals in Cameroon. Methods: We conducted a cluster-randomised (1:1) trial in eight health districts, including 22 facilities and SARS-CoV-2 testing units, randomly assigned to a digital (intervention) or standard (control) contact tracing approach. The intervention consisted of a contact tracing module added to the digital platform “Mamal PRO” used for monitoring and coordination of Coronavirus Disease 2019 pandemic response in Cameroon. The primary outcome was the proportion of contacts declared by SAR-CoV-2 index patients who were successfully traced and tested for SARS-CoV-2 evaluated with a Poisson regression model with cluster adjustment. This study is registered with ClinicalTrials.gov (NCT05684887). Findings: Between October 18, 2022, and March 31, 2023, we enrolled 164 index patients in the intervention arm and 149 in the control arm, who identified 854 and 849 contacts, respectively. In the intervention arm, 93.8% (801/854) of identified contacts were successfully reached by the tracing unit versus 54.5% (463/849) in the control arm. The intervention significantly increased the likelihood of successfully tracing contacts (adjusted relative risks (RR) 1.72 [95% CI: 1.00–2.95], p = 0.049). The median (interquartile range, IQR) time to successfully tracing contacts was 0 days [IQR: 0, 1] in the intervention and 1 day [IQR: 0, 2] in the control arm. In the intervention arm, 21.3% (182/854) of identified contacts received SARS-CoV-2 testing compared to 14.5% (123/849) in the control arm (adjusted RR 1.47 [95% CI: 0.44–4.90], p = 0.530). Interpretation: Digitalising the contact tracing process improved exposure notification and facilitated the tracing of a greater number of contacts of individuals infected with SARS-CoV-2 in resource-limited settings. Funding: The study was funded by FIND, United Kingdom (FCDO 40105983), Switzerland (81066910), Netherlands (SDD 4000004160), Canada (DFATD 7429348), The Kingdom of Saudi Arabia (FIND—ACT-A DX PARTNERSHIP 20.08.2020), The Rockefeller Foundation (2020 HTH 059), Germany (BMZ Covid-19 Diagnostic and Surveillance Response 27.07.2021), Australia (DFAT 76442), Kuwait (M239/2020), The Government of Portugal and Partners (ANF, BCP, CGF, APIFARMA) and The BlackRock Foundation (Grant Agreement as of April 20, 2022).

Background: The COVID-19 pandemic disrupted routine health services worldwide, including systems to detect antimicrobial resistance (AR). AR is a mounting global health threat with some studies showing the highest mortality rate from AR infection is in Sub-Saharan Africa (SSA). Antibiotic use is a major contributor to AR. We sought to characterize COVID-19-related changes to antibiotic use and AR detection capacity in two countries in SSA from 2019 to 2020. Methods: Health facilities (HF) in South Africa and Uganda were surveyed as part of a larger study assessing disruptions to essential health services in SSA in the context of COVID-19. Modified stratified random sampling of HF by facility level was conducted in regions with high COVID-19 cumulative prevalence. Hospital pharmacists were surveyed to identify perceived changes in antibiotic use. Among facilities with the capacity to detect AR, surveys were conducted with AR laboratory managers to identify perceived changes in staff, equipment, training, and supplies. Descriptive data analysis was conducted using frequencies and proportions. Results: A total of 39 HFs in South Africa and 45 HFs in Uganda responded to the antibiotic use survey. Increases in total antibiotic use from 2019 to 2020 were reported by 82% (23/28) of HF in South Africa and 68% (27/40) in Uganda. Increased use of antibiotics for multi-drug resistant bacteria (per World Health Organization Reserve classification) was reported by 36% (9/25) and 38% (8/21) of HFs in South Africa and Uganda, respectively. 19 HFs in South Africa and 12 HFs in Uganda responded to the AR detection capacity survey. HFs in both countries reported decreases in laboratory staff responsible for AR (33% [13/40] in South Africa and 31% [11/35] in Uganda). Decreased availability of reagents and consumables for bacteriology and antimicrobial susceptibility testing was reported by 50% (8/16) and 33% (4/12) of HFs, and decreased availability of specimen collection supplies for bacterial cultures was reported by 41% (7/17) and 42% (5/12) of HFs in South Africa and Uganda, respectively. Diversion of laboratory supplies was reported in both countries (32% [6/19] in South Africa and 25% [3/12] of HF in Uganda). Conclusions: HFs in South Africa and Uganda reported increases in antibiotic prescribing, a risk factor for increased AR, concurrently with disruptions in AR detection capacity during the early phases of the COVID-19 pandemic. These findings emphasize the importance of investing in bacteriology and AR testing in SSA and maintaining support during infectious disease pandemics.

Introduction Monitoring the SARS-CoV-2 pandemic in low-resource countries such as Malawi requires cost-effective surveillance strategies. This study explored the potential utility of phone-based syndromic surveillance in terms of its reach, monitoring trends in reported SARS-CoV-2-like/influenza-like symptoms (CLS/ILS), SARS-CoV-2 testing and mortality.Methods Mobile phone-based interviews were conducted between 1 July 2020 and 30 April 2022, using a structured questionnaire. Randomly digital dialled numbers were used to reach individuals aged ≥18 years who spoke Chichewa or English. Verbal consent was obtained, and trained research assistants with clinical and nursing backgrounds collected information on age, sex, region of residence, reported CLS/ILS in the preceding 2 weeks, SARS-CoV-2 testing and history of household illness and death. Data were captured on tablets using the Open Data Kit database. We performed a descriptive analysis and presented the frequencies and proportions with graphical representations over time.Findings Among 356 525 active phone numbers, 138 751 (38.9%) answered calls, of which 104 360 (75.2%) were eligible, 101 617 (97.4%) consented to participate, and 100 160 (98.6%) completed the interview. Most survey respondents were aged 25–54 years (72.7%) and male (65.1%). The regional distribution of the respondents mirrored the regional population distribution, with 45% (44%) in the southern region, 41% (43%) in the central region and 14% (13%) in the northern region. The reported SARS-CoV2 positivity rate was 11.5% (107/934). Of the 7298 patients who reported CLS/ILS, 934 (12.8%) reported having undergone COVID-19 testing. Of the reported household deaths, 47.2% (982 individuals) experienced CLS/ILS 2 weeks before their death.Conclusion Telephonic surveillance indicated that the number of SARS-CoV-2 cases was at least twice as high as the number of confirmed cases in Malawi. Our findings also suggest a substantial under-reporting of SARS-CoV-2-related deaths. Telephonic surveillance has proven feasible in Malawi, achieving the ability to characterise SARS-CoV-2 morbidity and mortality trends in low-resource settings.

Background: The available few laboratory-based CD4 assay for People Living with HIV (PLHIV) experience supply stock-outs and instrument breakdowns in developing countries, affecting the ability to diagnose Advance HIV disease (AHD). We evaluated the performance of the VISITECT CD4 point of care test among healthcare workers in HIV program in Tanzania. Methods: A retrospective diagnostic accuracy study was conducted among PLHIV who received both the VISITECT CD4 and a standard-of-care. Acceptability of the VISITECT CD4 by healthcare workers was assessed using a structured questionnaire. Both FACS Count and Pima CD4 assay were considered as reference standards. Findings were summarized as proportions with 95 % confidence intervals (CI). Data were analyzed using STATA 17 (StataCorp, College Station, TX). Results: A total of 1370 PLHIV were tested using VISITECT CD4 across 20 facilities between 3 April and 14 September 2022. The median age was 37 (Interquartile range (IQR):29–46). Overall, 897 (65.5 %) were females and 449 had both VISITECT CD4 test and standard of care. The sensitivity and specificity were; 95.9 % (95 % CI: 91.8 %–98.3 %) and 78.3 % (95 % CI: 73.0 %–83.0 %) respectively. 47 healthcare workers used the VISITECT CD4, of whom 57.5 % were non-laboratory healthcare workers. Majority of the healthcare workers were of the opinion that the training was adequate and VISITECT CD4 was easy and useful in clinical decisions. Conclusion: The VISITECT CD4 test was accurate, useable and acceptable among healthcare workers in Tanzania. The scale up of VISITECT CD4 should consider development of training curriculum and the use of job aids particularly for non-laboratory healthcare workers.

The global disruption caused by the SARS-CoV-2 pandemic profoundly affected healthcare systems, particularly impacting People Living with Human Immunodeficiency Virus (PLHIV). This study investigated the repercussions of SARS-CoV-2 infection on access to human immunodeficiency virus (HIV) care and antiretroviral therapy (ARV) in Malawi, emphasizing the critical need to sustain uninterrupted HIV services during health crises. Employing mobile phone-based syndromic surveillance, this study assessed the influence of SARS-CoV-2 on healthcare access for PLHIV across nine districts supported by the Elizabeth Glaser Pediatric AIDS Foundation (EGPAF). Telephone-based interviews were conducted to analyze demographic factors, challenges encountered in accessing HIV services, and adherence to ARV medication, illuminating the pandemic's effects on ARV uptake. The findings revealed that approximately 3.9% (n = 852) of 21981 participants faced obstacles in accessing crucial HIV services during the pandemic, resulting in approximately 1.2% (n = 270) reporting multiple missed doses of ARV medication in a particular month. After adjusting for various variables, males exhibited a higher likelihood of service inaccessibility than females (Adjusted Odds Ratio [AOR] = 1.39, 95% CI: 1.20-1.60, p < 0.001). Age also played a significant role, with individuals aged 35-49 years and those aged 50 years or older demonstrating reduced odds of service failure compared with the reference group aged 18-34 years. Only a small proportion of PLHIV reported disruption in HIV care access, which may be because Malawi did not initiate stringent travel restrictions during the SARS-CoV-2 pandemic. Nonetheless, enduring challenges have been observed in retaining younger PLHIV and men in HIV-care settings. Thus, targeted strategies are imperative for effectively engaging and sustaining these populations in HIV care during and after health crises.

In 2022, an estimated 1.25 million children 50% remained undiagnosed or unreported. WHO recently recommended integrated and decentralized models of care as an approach to improve access to TB services for children, but evidence remains limited. The Catalyzing Paediatric TB Innovation project (CaP-TB) implemented a multi-pronged intervention to improve TB case finding in children in nine sub-Saharan African countries. The intervention introduced systematic TB screening in different facility-based child-health entry-points, decentralisation of TB diagnosis and management, improved sample collection with access to Xpert® MTB/RIF or MTB/RIF Ultra testing, and implementation of contact investigation. Pre-intervention records were compared with those during intervention to assess effect on paediatric TB cascade of care. The intervention screened 1 991 401 children

IntroductionIn Eswatini, HIV incidence among women of childbearing age is 1.45%. Eswatini introduced oral pre-exposure prophylaxis (PrEP) for HIV prevention in 2016 and requires that all HIV-negative pregnant and post-natal women (PPW) visiting health care facilities be offered PrEP.MethodsBetween September-November 2021, we conducted a survey among HIV-negative PPW from 16 purposively selected healthcare facilities in the Hhohho and Shiselweni regions in Eswatini. We interviewed consenting HIV-negative PPW using a structured questionnaire to collect data on PrEP knowledge, attitudes, intentions, and practices, as well as information on partner HIV status and stigma. Multivariate logistic regression was used to determine predictors of PrEP use and intention, adjusted for significant covariates.ResultsOf 1,484 PPW women approached, 1,149 consented and were interviewed, of whom 704 (61.3%) were post-partum and 445 (38.7%) pregnant. The median age was 25 years [Interquartile Range (IQR) = 21–30 years], with 533 (46.4%) 18–24 years old. Among the 1,149 women, 930 (80.7%) had ever heard about PrEP; 635 (55.3%) had knowledge about PrEP; 183 (15.9%) were currently using PrEP; and 285 (24.8%) had ever used PrEP. Increased odds of PrEP use were associated having HIV-positive male partner (aOR:7.76, 95%CI 3.53- 17.04); positive attitudes to PrEP (aOR:1.56, 95%CI: 1.02–2.40); and high self-efficacy (aOR:1.49, 95%CI:1.13–1.98). Among 864 women who never used PrEP, 569 (65.3%) intended to use PrEP in the future. Odds of intention to use PrEP were higher among women with low levels of education (aOR:2.23, 95% CI: 1.32–3.77); who ever heard about PrEP (aOR:1.69, 95%CI: 1.12–2.56); and had high self-efficacy (aOR:1.57, 95%CI: 1.31–1.87). Regarding stigma, among all women, 759 (66%) either agreed or strongly agreed that people would think they have HIV if they were to use PrEP; 658 (57.3%) reported they would be labelled as having multiple sex partners; 468 (40.7%) reported that their partner would think they are having risky sex with other people. Of 102 women who had discontinued PrEP, a majority stopped due to side effects 32 (35.2%).ConclusionOnly about 50% of women had knowledge of PrEP, and PrEP uptake among PPW was low, though intention to use appeared high. More efforts to reduce stigma and promote PrEP use, including adequate information on side effects, are needed.

Abstract Background Reducing maternal mortality is a priority of Sustainable Development Goal 3.1 which requires frequent epidemiological analysis of trends and patterns of the causes of maternal deaths. We conducted two reproductive age mortality surveys to analyse the epidemiology of maternal mortality in Zimbabwe and analysed the changes in the causes of deaths between 2007-08 and 2018-19. Methods We performed a before and after analysis of the causes of death among women of reproductive ages (WRAs) (12-49 years), and pregnant women from the two surveys implemented in 11 districts, selected using multi-stage cluster sampling from each province of Zimbabwe (n=10); an additional district selected from Harare. We calculated mortality incidence rates and incidence rate ratios per 10000 WRAs and pregnant women (with 95% confidence intervals), in international classification of disease groups, using negative binomial models, and compared them between the two surveys. We also calculated maternal mortality ratios, per 100 000 live births, for selected causes of pregnancy-related deaths. Results We identified 6188 deaths among WRAs and 325 PRDs in 2007-08, and 1856 and 137 respectively in 2018-19. Mortality in the WRAs decreased by 82% in diseases of the respiratory system and 81% in certain infectious or parasitic diseases' groups, which include HIV/AIDS and malaria. Pregnancy-related deaths decreased by 84% in the indirect causes group and by 61% in the direct causes group, and HIV/AIDS-related deaths decreased by 91% in pregnant women. Direct causes of death still had a three-fold MMR than indirect causes (151 vs. 51 deaths per 100 000) in 2018-19. Conclusion Zimbabwe experienced a decline in both direct and indirect causes of pregnancy-related deaths. Deaths from indirect causes declined mainly due to a reduction in HIV/AIDS-related and malaria mortality, while deaths from direct causes declined because of a reduction in obstetric haemorrhage and pregnancy-related infections. Ongoing interventions ought to improve the coverage and quality of maternal care in Zimbabwe, to further reduce deaths from direct causes.

For adults and adolescents, the World Health Organization defines advanced HIV disease (AHD) as a CD4 (cluster of differentiation 4) count of

BackgroundIn Zimbabwe, children, adolescents and young adults living with HIV (CALWH) who are on public health antiretroviral therapy (ART) have inadequate viral load (VL) suppression. We assessed whether a clinic-based VL monitoring could decrease 12-month virologic failure rates among these CALWH.MethodsThe study was registered on ClinicalTrials.gov: NCT03986099. CALWH in care at Chidamoyo Christian Hospital (CCH) and 8 rural outreach sites (ROS) on long-term community-based ART were randomized (1:1) to 6 monthly VL monitoring by COBAS®Ampliprep®/Taqman48® HIV-1 at the provincial referral laboratory (PRL) as per standard of care (SOC) or by the clinic-based SAMBA II assay, Diagnostics for the Real World, at CCH. VL suppression, turn-around-time (TAT) for VL results, drug switching and drug resistance in second-line failure were assessed at 12 months.ResultsOf 390 CALWH enrolled 347 (89%) completed 12 months follow-up. Median (IQR) age and ART duration were 14.1 (9.7-18.2) and 6.4 (3.7-7.9) years, respectively. Over half (57%) of the participants were female. At enrolment, 78 (20%) had VL ≥1,000 copies/ml and VL suppression of 80% was unchanged after 12 months, with no significant difference between the SOC (81%) and the clinic-based (80%) arms (p = 0.528). Median (IQR) months to confirmatory VL result at CCH vs PRL was 4.0 (2.1-4.4) vs 4.5 (3.5-6.3) respectively; p = 0.027 at 12 months. Drug switching was documented among 26/347 (7%) participants with no difference between the median (IQR) time to switch in SOC vs clinic-based arms (5.1 (3.9-10.0) months vs 4.4 (2.5-8.4) respectively; p = 0.569). Out of 24 confirmed second-line failures, only 4/19 (21%) had protease inhibitor resistance.ConclusionIn rural Zimbabwe, the clinic-based SAMBA II assay was able to provide confirmatory VL results faster than the SOC VL assay at the PRL. However, this rapid TAT did not allow for a more efficient drug switch among these CALWH.

Introduction: Malawi experienced two waves of COVID-19 between April 2020 and February 2021. A High negative impact of COVID-19 was experienced in the second wave, with increased hospital admissions that overwhelmed the healthcare system. This paper describes a protocol to implement a telephone-based syndromic surveillance system to assist public health leaders in the guidance, implementation, and evaluation of programs and policies for COVID-19 prevention and control in Malawi. Study design: This is a serial cross-sectional telephonic-based national survey focusing on the general population and People living with HIV and AIDS. Methods: We will conduct a serial cross-sectional telephone survey to assess self-reported recent and current experience of influenza-like illness (ILI)/COVID-19-like-illness (CLI), household deaths, access to routine health services, and knowledge related to COVID-19. Structured questionnaires will be administered to two populations: 1) the general population and 2) people living with HIV (PLHIV) on antiretroviral therapy (ART) at EGPAF-supported health facilities. Electronic data collection forms using secure tablets will be used based on randomly selected mobile numbers from electronic medical records (EMR) for PLHIV. We will use random digit dialing (RDD) for the general population to generate phone numbers to dial respondents. The technique uses computer-generated random numbers, using the 10-digit basic structure of mobile phone numbers for the two existing mobile phone companies in Malawi. Interviews will be conducted only with respondents that will verbally consent. A near real-time online dashboard will be developed to help visualize the data and share results with key policymakers. Conclusion: The designed syndromic surveillance system is low-cost and feasible to implement under COVID-19 restrictions, with no physical contact with respondents and limited movement of the study teams and communities. The system will allow estimation proportions of those reporting ILI/CLI among the general population and PLHIV on ART and monitor trends over time to detect locations with possible COVID-19 transmission. Reported household deaths in Malawi, access to health services, and COVID-19 knowledge will be monitored to assess the burden and impact on communities in Malawi.

Abstract Background Sub-Saharan Africa continues to carry a high burden of communicable diseases such as TB and HIV and non-communicable diseases such as hypertension and other cardiovascular conditions. Although investment in research has led to advances in improvements in outcomes, a lot still remains to be done to build research capacity in health. Like many other regions in the world, Sub-Saharan Africa suffers from a critical shortage of biostatisticians and clinical trial methodologists. Methods Funded through a Fogarty Global Health Training Program grant, the Faculty of Medicine and Health Sciences at Stellenbosch University in South Africa established a new Masters Program in Biostatistics which was launched in January 2017. In this paper, we describe the development of a biostatistical and clinical trials collaboration Module, adapted from a similar course offered in the Health Research Methodology program at McMaster University. Discussion Guided by three core principles (experiential learning; multi-/inter-disciplinary approach; and formal mentorship), the Module aims to advance biostatistical collaboration skills of the trainees by facilitating learning in how to systematically apply fundamental statistical and trial methodological knowledge in practice while strengthening some soft skills which are necessary for effective collaborations with other healthcare researchers to solve health problems. We also share some preliminary findings from the first four cohorts that took the Module in January–November 2018 to 2021. We expect that this Module can provide an example of how to improve biostatistical and clinical trial collaborations and accelerate research capacity building in low-resource settings. Funding source Fogarty International Center of the National Institutes of Health.

Background Sustainable Development Goal (SDG) 3.1 target is to reduce the global maternal mortality ratio (MMR) to less than 70 maternal deaths per 100 000 live births by 2030. In the Ending Preventable Maternal Mortality strategy, a supplementary target was added, that no country has an MMR above 140 by 2030. We conducted two cross-sectional reproductive age mortality surveys to analyse changes in Zimbabwe’s MMR between 2007–2008 and 2018–2019 towards the SDG target.Methods We collected data from civil registration, vital statistics and medical records on deaths of women of reproductive ages (WRAs), including maternal deaths from 11 districts, randomly selected from each province (n=10) using cluster sampling. We calculated weighted mortality rates and MMRs using negative binomial models, with 95% CIs, performed a one-way analysis of variance of the MMRs and calculated the annual average reduction rate (ARR) for the MMR.Results In 2007–2008 we identified 6188 deaths of WRAs, 325 pregnancy-related deaths and 296 maternal deaths, and in 2018–2019, 1856, 137 and 130, respectively. The reproductive age mortality rate, weighted by district, declined from 11 to 3 deaths per 1000 women. The MMR (95% CI) declined from 657 (485 to 829) to 217 (164 to 269) deaths per 100 000 live births at an annual ARR of 10.1%.Conclusions Zimbabwe’s MMR declined by an annual ARR of 10.1%, against a target of 10.2%, alongside declining reproductive age mortality. Zimbabwe should continue scaling up interventions against direct maternal mortality causes to achieve the SDG 3.1 target by 2030.

Background: The COVID-19 pandemic disrupted essential health services (EHS) delivery worldwide; however, there are limited data for healthcare facility (HCF)–level EHS disruptions in low- and middle-income countries. We surveyed HCFs in 3 counties in Kenya to understand the extent of and reasons for EHS disruptions occurring during February 2020–May 2021. Methods: We included 3 counties in Kenya with high burden of COVID-19 at the time of study initiation. Stratified sampling of HCFs occurred by HCF level. HCF administrators were interviewed to collect information on types of EHS disruptions that occurred and reasons for disruptions, including those related to infection prevention and control (IPC). Analyses included descriptive statistics with proportions for categorical variables and median with interquartile range (IQR) for continuous variables. Results: In total, 59 HCFs in Kenya provided complete data. All 59 HCFs (100%) reported EHS disruptions due to COVID-19. Among all HCFs, limiting patient volumes was the most common disruption reported (97%), while 56% of HCFs reduced staffing of EHS and 52% suspended EHS. Median duration of disruptions ranged from 7 weeks (IQR, 0–15) for inpatient ward closures to 25 weeks (IQR, 14–37) for limiting patient volumes accessing EHS. Among HCFs that reported disruptions, the most cited reason (ie, 95% of HCFs) was fewer patients receiving services. The most common IPC-related reason for disruption was diversion of resources to accommodate physical distancing measures (76%) followed by COVID-19 outbreaks among patients or staff (34%); staff shortages due to COVID-19 illness (25%) or perceived infection risk (19%); and lack of adequate personal protective equipment (20%). Conclusions: Most HCFs reported disruptions to EHS during the pandemic, including many that were related to IPC. Some disruptions may be mitigated by strengthening IPC infrastructure and practices, including protecting healthcare personnel to prevent staffing shortages.

Abstract Background Tuberculosis is among the top-10 causes of mortality in children with more than 1 million children suffering from TB disease annually worldwide. The main challenge in young children is the difficulty in establishing an accurate diagnosis of active TB. The INPUT study is a stepped-wedge cluster-randomized intervention study aiming to assess the effectiveness of integrating TB services into child healthcare services on TB diagnosis capacities in children under 5 years of age. Methods Two strategies will be compared: i) The standard of care, offering pediatric TB services based on national standard of care; ii) The intervention, with pediatric TB services integrated into child healthcare services: it consists of a package of training, supportive supervision, job aids, and logistical support to the integration of TB screening and diagnosis activities into pediatric services. The design is a cluster-randomized stepped-wedge of 12 study clusters in Cameroon and Kenya. The sites start enrolling participants under standard-of-care and will transition to the intervention at randomly assigned time points. We enroll children aged less than 5 years with a presumptive diagnosis of TB after obtaining caregiver written informed consent. The participants are followed through TB diagnosis and treatment, with clinical information prospectively abstracted from their medical records. The primary outcome is the proportion of TB cases diagnosed among children

Abstract Background Sero- prevalence studies often have a problem of missing data. Few studies report the proportion of missing data and even fewer describe the methods used to adjust the results for missing data. The objective of this review was to determine the analytical methods used for analysis in HIV surveys with missing data. Methods We searched for population, demographic and cross-sectional surveys of HIV published from January 2000 to April 2018 in Pub Med/Medline, Web of Science core collection, Latin American and Caribbean Sciences Literature, Africa-Wide Information and Scopus, and by reviewing references of included articles. All potential abstracts were imported into Covidence and abstracts screened by two independent reviewers using pre-specified criteria. Disagreements were resolved through discussion. A piloted data extraction tool was used to extract data and assess the risk of bias of the eligible studies. Data were analysed through a quantitative approach; variables were presented and summarised using figures and tables. Results A total of 3426 citations where identified, 194 duplicates removed, 3232 screened and 69 full articles were obtained. Twenty-four studies were included. The response rate for an HIV test of the included studies ranged from 32 to 96% with the major reason for the missing data being refusal to consent for an HIV test. Complete case analysis was the primary method of analysis used, multiple imputations 11(46%) was the most advanced method used, followed by the Heckman’s selection model 9(38%). Single Imputation and Instrumental variables method were used in only two studies each, with 13(54%) other different methods used in several studies. Forty-two percent of the studies applied more than two methods in the analysis, with a maximum of 4 methods per study. Only 6(25%) studies conducted a sensitivity analysis, while 11(46%) studies had a significant change of estimates after adjusting for missing data. Conclusion Missing data in survey studies is still a problem in disease estimation. Our review outlined a number of methods that can be used to adjust for missing data on HIV studies; however, more information and awareness are needed to allow informed choices on which method to be applied for the estimates to be more reliable and representative.

IntroductionMaintaining virologic suppression of children and adolescents on ART in rural communities in sub-Saharan Africa is challenging. We explored switching drug regimens to protease inhibitor (PI) based treatment and reducing nevirapine and zidovudine use in a differentiated community service delivery model in rural Zimbabwe.MethodsFrom 2016 through 2018, we followed 306 children and adolescents on ART in Hurungwe, Zimbabwe at Chidamoyo Christian Hospital, which provides compact ART regimens at 8 dispersed rural community outreach sites. Viral load testing was performed (2016) by Roche and at follow-up (2018) by a point of care viral load assay. Virologic failure was defined as viral load ≥1,000 copies/ml. A logistic regression model which included demographics, treatment regimens and caregiver's characteristics was used to assess risks for virologic failure and loss to follow-up (LTFU).ResultsAt baseline in 2016, 296 of 306 children and adolescents (97%) were on first-line ART, and only 10 were receiving a PI-based regimen. The median age was 12 years (IQR 8-15) and 55% were female. Two hundred and nine (68%) had viral load suppression (ConclusionViral load testing, and switching to second-line, ritonavir-boosted PI with abacavir significantly increased virologic suppression among HIV-infected children and adolescents in rural Zimbabwe.

To optimize HIV testing resources, programs are moving away from universal testing strategies toward a risk-based screening approach to testing children/adolescents, but there is little consensus around what defines an optimal risk screening tool. This study aimed to validate a 12-item risk screening tool among children and adolescents and provide suggested fewer-item tool options for screening both facility out-patient and community populations by age strata (

BackgroundSub-Saharan Africa (SSA) carries the highest burden of maternal mortality, yet, the accurate maternal mortality ratios (MMR) are uncertain in most SSA countries. Measuring maternal mortality is challenging in this region, where civil registration and vital statistics (CRVS) systems are weak or non-existent. We describe a protocol designed to explore the use of CRVS to monitor maternal mortality in Zimbabwe-an SSA country.MethodsIn this study, we will collect deliveries and maternal death data from CRVS (government death registration records) and health facilities for 2007-2008 and 2018-2019 to compare MMRs and causes of death. We will code the causes of death using classifications in the maternal mortality version of the 10th revision to the international classification of diseases. We will compare the proportions of maternal deaths attributed to different causes between the two study periods. We will also analyse missingness and misclassification of maternal deaths in CRVS to assess the validity of their use to measure maternal mortality in Zimbabwe.DiscussionThis study will determine changes in MMR and causes of maternal mortality in Zimbabwe over a decade. It will show whether HIV, which was at its peak in 2007-2008, remains a significant cause of maternal deaths in Zimbabwe. The study will recommend measures to improve the quality of CRVS data for future use to monitor maternal mortality in Zimbabwe and other SSA countries of similar characteristics.

IntroductionA family-centered care model (FCCM) providing family-based HIV services, rather than separate adult/pediatric services, has been proposed to increase pediatric retention and treatment adherence.Materials and methodsEight health-care facilities in the Hhohho region of Eswatini were randomized to implement FCCM (n = 4) or continue standard-of-care (SOC) separate adult/pediatric clinics (n = 4). HIV-positive children and caregivers were enrolled; caregiver interview and child/caregiver chart abstraction were done at enrollment and every three months; pediatric viral load was evaluated at enrollment and every six months through 12 months. Because of study group differences in 12-month viral load data availability (89.4% FCCM and 72.0% SOC children had 12-month viral load), we used three separate analyses to evaluate the effects of FCCM on children's viral suppression (ResultsWe enrolled 379 HIV-positive children and 363 caregivers. Among all children at enrollment, viral suppression and undetectability was 78.4% and 73.9%, respectively, improving to 90.2% and 87.3% at 12 months. In mITT and weighted mITT analyses, there was no significant difference in children's 12-month viral suppression between FCCM and SOC groups (89.2% and 91.6%, respectively). Using imputed ITT, there was a modest increase in 12-month viral suppression in FCCM versus SOC children (79.7% and 69.8%, respectively, p = 0.051) and 12-month undetectability (78.7% and 65.7%, respectively, p = 0.015). Among the 255 children suppressed at enrollment, more FCCM versus SOC children (98.0% versus 95.3%) were suppressed at 12-months, but this was not statistically significant in mITT or weighted mITT analyses, with a marginally significant difference using imputed mITT analysis (p = 0.042). A higher proportion of children suppressed at enrollment had undetectable viral load at 12 months in FCCM versus SOC children (98.0% versus 92.5%), a statistically significant difference across analytical methods. Among the 61 children unsuppressed at enrollment, achieving suppression was higher among SOC versus FCCM children, but this difference was not statistically significant and included only 38 children; and there were no significant differences in detectable viral load at 12 months. There were no significant differences between study groups in retention or ART adherence at 12 months for children or caregivers. Factors associated with lack of viral suppression/detectability at 12 months included lack of viral suppression at enrollment and having a younger caregiver (age ConclusionsFCCM in Eswatini was associated with a modest increase in viral suppression/undetectability at 12-months; 12-month retention and adherence did not differ by study group for children or caregivers. High levels of suppression and retention in both groups may have limited our ability to detect a difference.Trial registrationNCT03397420; ClinicalTrials.gov.

The increase in health research in sub-Saharan Africa (SSA) has led to a high demand for biostatisticians to develop study designs, contribute and apply statistical methods in data analyses. Initiatives exist to address the dearth in statistical capacity and lack of local biostatisticians in SSA health projects. The Sub-Saharan African Consortium for Advanced Biostatistics (SSACAB) led by African institutions was initiated to improve biostatistical capacity according to the needs identified by African institutions, through collaborative masters and doctoral training in biostatistics. SACCAB has created a critical mass of biostatisticians and a network of institutions over the last five years and has strengthened biostatistics resources and capacity for health research studies in SSA. SSACAB comprises 11 universities and four research institutions which are supported by four European universities. In 2015, only four universities had established Masters programmes in biostatistics and SSACAB supported the remaining seven to develop Masters programmes. In 2019 the University of the Witwatersrand became the first African institution to gain Royal Statistical Society accreditation for a Biostatistics Masters programme. A total of 150 fellows have been awarded scholarships to date of which 123 are Masters fellowships (41 female) of whom 58 have already graduated. Graduates have been employed in African academic (19) and research (15) institutions and 10 have enrolled for PhD studies. A total of 27 (10 female) PhD fellowships have been awarded; 4 of them are due to graduate by 2020. To date, SSACAB Masters and PhD students have published 17 and 31 peer-reviewed articles, respectively. SSACAB has also facilitated well-attended conferences, face-to-face and online short courses. Pooling of limited biostatistics resources in SSA combined with co-funding from external partners has shown to be an effective strategy for the development and teaching of advanced biostatistics methods, supervision and mentoring of PhD candidates.

Introduction: Competing risks arise when subjects are exposed to multiple mutually exclusive failure events, and the occurrence of one failure hinders the occurrence of other failure events. In the presence of competing risks, it is important to use methods accounting for competing events because failure to account for these events might result in misleading inferences. Methods and Objective: Using data from a multisite retrospective observational longitudinal study done in Ethiopia, we performed sensitivity analyses using Fine-Gray model, Cause-specific Cox (Cox-CSH) model, Cause-specific Accelerated Failure Time (CS-AFT) model, accounting for death as a competing risk to determine baseline covariates that are associated with a composite of unfavourable retention in care outcomes in people living with Human Immune Virus who were on both Isoniazid preventive therapy (IPT) and antiretroviral therapy (ART). Non-cause specific (non-CSH) model that does not account for competing risk was also performed. The composite outcome comprises of loss to follow-up, stopped treatment and death. Age, World Health Organisation (WHO) stage, gender, and CD4 count were the considered baseline covariates. Results: We included 3578 patients in our analysis. WHO stage III-or-IV was significantly associated with the composite of unfavourable outcomes, Sub-hazard ratio (SHR) = 1.31, 95% confidence interval (CI):1.04–1.65 for the sub-distribution hazard model, hazard ratio [HR] = 1.31, 95% CI:1.05–1.65, for the Cox-CSH model, and HR = 0.81, 95% CI:0.69–0.96, for the CS-AFT model. Gender and WHO stage were found to be significantly associated with the composite of unfavourable outcomes, HR = 1.56, 95% CI:1.27–1.90, HR = 1.28, 95% CI: 1.06–1.55 for males and WHO stage III-or-IV, respectively for the non-CSH model. Conclusions: Results show that WHO stage III-or-IV is significantly associated with unfavourable outcomes. The results from competing risk models were consistent. However, results obtained from the non-CSH model were inconsistent with those obtained from competing risk analysis models.

IntroductionPopulation-based HIV-free survival at 18-24 months of age among HIV-exposed infants in high prevalence settings in the era of treatment for all is largely unknown. We conducted a community-based survey to determine outcomes of HIV-exposed infants at 18-24 months in Lesotho.MethodsBetween November 2015 and December 2016, we conducted a survey among households with a child born 18-24 months prior to data collection. Catchment areas from 25 health facilities in Butha-Buthe, Maseru, Mohale's Hoek and Thaba-Tseka districts were randomly selected using probability proportional to size sampling. Consecutive households were visited and eligible consenting caregivers and children were enrolled. Rapid HIV antibody testing was performed on mothers of unknown HIV status (never tested or tested HIV-negative >3 months prior) and their children, and to children born to known HIV-positive mothers. Information on demographics, health-seeking behavior, HIV, and mortality were captured for mothers and children, including those who died. The difference in survival between subgroups was determined using the log-rank test.ResultsOf the 1,852 mothers/caregivers enrolled, 570 mothers were HIV-positive. The mother-to-child HIV transmission rate was 5.7% [95% CI: 4.0-8.0]. The mortality rate was 2.6% [95% CI: 1.6-4.2] among HIV-exposed children compared to 1.4% (95% CI: 0.9-2.3) among HIV-unexposed children. HIV-free survival was 91.8% [95% CI: 89.2-93.8] among HIV-exposed infants. Disclosure of mother's HIV status (aOR = 4.9, 95% CI: 1.3-18.2) and initiation of cotrimoxazole prophylaxis in the child (aOR = 3.9, 95% CI: 1.2-12.6) were independently associated with increased HIV-free survival while child growth problems (aOR = 0.2, 95% CI: 0.09-0.5) were independently associated with reduced HIV-free survival.ConclusionEven in the context of lifelong antiretroviral therapy among pregnant and breastfeeding women, HIV has a significant effect on survival among HIV-exposed children compared to unexposed children. Lesotho has not reached elimination of HIV transmission from mother to child.

BACKGROUND:Lifelong antiretroviral therapy (ART) reduces mother-to-child HIV transmission (MTCT) and improves maternal health. Data on the outcomes of HIV-exposed infants (HEI) compared to their unexposed counterparts in the era of universal ART is limited. We compared birth and 6-week outcomes among infants born to HIV-positive and HIV-negative women in Lesotho. METHODS:941 HIV-negative and 653 HIV-positive pregnant women were enrolled in an observational cohort to evaluate the effectiveness of prevention of mother-to-child HIV transmission (PMTCT) program after implementation of universal maternal ART in 14 health facilities. Pregnancy, delivery, birth, and 6-week data were collected through participant interviews and medical record review. DNA PCR testing for HEI was conducted within 2 weeks of birth and at around 6 weeks of age. Data were analysed to estimate the distribution of birth outcomes, mortality, HIV transmission and HIV-free survival at 6 weeks. RESULTS:HIV-positive women were older (mean age of 28.7 vs. 24.4 years) and presented for antenatal care earlier (mean gestational age of 23.0 weeks vs 25.3 weeks) than HIV-negative women. Prematurity was more frequent among HEI, 7.8% vs. 3.6%. There was no difference in rates of congenital anomalies between HEI (1.0%) and HIV-unexposed infants (HUI) (0.6%). Cumulative HIV transmission was 0.9% (N = 4/431) (95% CI:0.25-2.36) at birth and 1.0% (N = 6/583) (95% CI:0.38-2.23) at 6 weeks. Overall mortality, including stillbirths, was 5.2% and 6.0% by 6 weeks for HUI and HEI respectively. Among liveborn infants, 6-week HIV-free survival for HEI was 95.6% (95% CI:93.7-97.1) compared to 96.8% (95% CI:95.4-97.9) survival for HUI. CONCLUSIONS:Implementation of universal maternal ART lowers MTCT at 6 weeks of age with no differences in congenital anomalies or early mortality between HIV exposed Infants and HIV unexposed infants. However, HIV exposed infants continue to have high rates of prematurity despite improved maternal health on ART.

In sub-Saharan Africa, most women who test HIV negative at the first antenatal care encounter are rarely tested again during pregnancy and postpartum, yet data suggests that pregnancy is associated with increased risk of HIV acquisition compared to non-pregnant women. We describe HIV incidence during pregnancy and postpartum in Lesotho, a high prevalence setting, and factors associated with HIV seroconversion. We enrolled a cohort of HIV negative women presenting at health facilities for antenatal care and followed them through delivery up to 24 months postpartum. Women were repeatedly tested for HIV according to the Lesotho Ministry of Health routine rapid HIV testing guidelines and responded to risk behavior questionnaire every three months. We estimated HIV incidence and associated 95% confidence intervals. We used mixed effects Cox regression models to identify independent factors associated with seroconversion accounting for repeated assessment. The estimated overall HIV incidence rate was 1.58 (95% CI: 1.05-2.28) per 100 person- years. The estimated HIV incidence rate during pregnancy (2.61 per 100 person-years, 95% CI: 1.12-5.14) was almost double the estimated HIV incidence during postpartum (1.36 per 100 person-years, 95% CI: 0.83-2.10). Women's age (14-24 years compared to 25-45 years), multiple sexual partnerships, urethral discharge and no condoms nor pre-exposure prophylaxis were independently associated with HIV infection. There is an increased need for counseling and support of HIV-uninfected pregnant and breastfeeding women to stay HIV-negative, including provision of pre-exposure prophylaxis during this high-risk period, particularly among adolescent and young women.

Background. Antiretroviral medications are key for prevention of mother-to-child transmission (PMTCT) of HIV, and transmission mitigation is affected by service delivery, adherence, and retention. Methods. We conducted a cluster-randomized controlled study in 26 facilities in Nyanza, Kenya, to determine the efficacy of SMS text messages on PMTCT outcomes. The relative risk and confidence intervals were estimated at the facility level using STATA. Results. 550 women were enrolled, from June 2012 to July 2013. The median age was 25.6 years, and 85.3% received ARVs. Maternal ARV use was similar between the intervention and control arms: 254/261 (97.3%) versus 241/242 (99.6%) at 34–36 weeks of gestation and 234/247 (94.7%) versus 229/229 (100%) at delivery. Among infants, 199/246 (80.9%) and 209/232 (90.1%) received ARVs (RR: 0.91; 95% CI: 0.77–1.14); 88% versus 88.6% were tested for HIV at 6 weeks, with 1/243 (0.4%) and 3/217 (1.4%) positive results in the intervention and control arms, respectively. Communication increased in both the intervention and control arms, with the mean number of 7.5 (SD: 5.70) compared with 6 (SD: 9.96), p

To address the need for capacity development in biostatistics in the Sub-Saharan African region and to move recommendations from previous workshops into action, we brought together biostatisticians from the region to provide an opportunity to brainstorm biostatistics capacity development in Africa, how to enhance what is being done and establish collaborative links to work together. In order to move key recommendations forward working groups were established to focus on the structure and content of a MSc Biostatistics and on the development of a concept paper for an Africa Centre for Biostatistics Excellence.

Anemia, syphilis and HIV are high burden diseases among pregnant women in sub-Saharan Africa. A quasi-experimental study was conducted in four health facilities in Southern Mozambique to evaluate the effect of point-of-care technologies for hemoglobin quantification, syphilis testing and CD4+ T-cell enumeration performed within maternal and child health services on testing and treatment coverage, and assessing acceptability by health workers.Demographic and testing data on women attending first antenatal care services were extracted from existing records, before (2011; n = 865) and after (2012; n = 808) introduction of point-of-care testing. Study outcomes per health facility were compared using z-tests (categorical variables) and Wilcoxon rank-sum test (continuous variables), while inverse variance weights were used to adjust for possible cluster effects in the pooled analysis. A structured acceptability-assessment interview was conducted with health workers before (n = 22) and after (n = 19).After implementation of point-of-care testing, there was no significant change in uptake of overall hemoglobin screening (67.9% to 83.0%; p = 0.229), syphilis screening (80.8% to 87.0%; p = 0.282) and CD4+ T-cell testing (84.9% to 83.5%; p = 0.930). Initiation of antiretroviral therapy for treatment eligible women was similar in the weighted analysis before and after, with variability among the sites. Time from HIV diagnosis to treatment initiation decreased (median of 44 days to 17 days; p