INTEGRATION OF SARS-CoV-2 RAPID ANTIGEN TEST IN HEALTH SERVICES IN KENYA AND CAMEROON

Background: Early diagnosis of COVID-19 is key to prevent severe cases and poor outcomes in vulnerable populations, including pregnant women and people living with HIV or infected with tuberculosis (TB). The feasibility of integration of SARS-CoV-2 antigen rapid diagnostic testing (Ag-RDT) into maternal neonatal, and child Health (MNCH);HIV;and TB clinics is unknown. Method(s): We analyzed data from a SARS-CoV-2 screen and test program implemented in 50 health facilities (25 in Kenya and 25 in Cameroon), integrating SARS-CoV-2 Ag-RDT in MNCH, HIV, and TB clinics between May and October 2022. Clients aged two and older attending MNCH, HIV, and TB clinics were offered SARS-CoV-2 screening, and those eligible were tested using SARS-CoV-2 Ag-RDT. Routine SARS-CoV-2 program data were captured through dedicated paper forms in Cameroon or an electronic medical record (EMR) interface in Kenya and transferred to a database for analysis. We estimated the proportion of clients screened and tested and the SARS-CoV-2 positivity rates. Result(s): Overall, 527,184 attendee visits were reported in Cameroon (282,404) and Kenya (244,780), with screening for COVID-19 symptoms and exposure performed in 256,033 (48.5%) with substantive variations between countries (62.6% in Cameroon and 32.4% in Kenya). Among the 256,033 screened, 19,058 (7.4%) were eligible for testing (9.0% in Cameroon and 3.9% in Kenya), of whom 12,925 (67.8%) were tested for SARS-CoV-2 with substantial variation in testing rates between countries (61.9% in Cameroon and 97.9% in Kenya) and clinics (59.9% in MNCH, 68.7% in HIV, and 92.8% in TB clinics). A total of 390 (3.0%) positive tests were identified (329 (3.3%) in Cameroon and 61 (2.0%) in Kenya). The estimated case detection rate was 1.26 (95% CI=0.76-1.75) per 1,000 attendee visits in Cameroon and 0.49 (95% CI=0.12-0.86) per 1,000 attendee visits in Kenya. Country integration strategy, facility level, setting, and clinic were independently associated with screening (Table 1) and testing. Conclusion(s): Integration of SARS-CoV-2 Ag-RDT in HIV, TB, and MNCH clinics was feasible in both countries despite challenges with low screening rates in Kenya and low testing rates in Cameroon. Decentralization of SARS-CoV-2 testing at different facility clinics allowed detection of SARS-CoV-2 cases among vulnerable populations. Integration strategies should consider facility settings (rural compared to urban) and additional human resources in high volume facilities to improve screening and testing rates.

CLUSTER-RANDOMIZED TRIAL COMPARING TWO SARS-CoV-2 TESTING MODELS IN AFRICA

Background: Most programs use a screen and test strategy to identify SARS-CoV-2 infection, but this strategy does not identify individuals with asymptomatic infection. We determined the SARS-CoV-2 case detection rates in a test-all model compared to the standard screen-and-test model in Kenya and Cameroon. Method(s): A cluster-randomized trial was conducted in 20 health facilities between May-October 2022. In each country, 5 facilities were randomized to test all (testing offered regardless of screening outcome) or screen and test (testing offered if screened positive) arms. Additional staff were hired to support implementation of the two models in Kenya (K) and the test all model in Cameroon (C). Clients age>2 years attending HIV, TB and MNCH clinics were tested using SARS-CoV-2 rapid antigen tests. We estimated case detection rates (CDR) with facility level weighted averages and used a weighted t-test with robust standard errors for between arm comparison. Result(s): Overall, 80,828 attendee visits were reported in the test-all arm (63,492 C and 17,336 K) and 71,254 attendee visits were reported in the screenand- test arm (56,589 C and 14,665 K). In the test-all arm, 42,325 (52.4%) were screened for COVID-19 symptoms (46.7% C and 73.2% K) and 21,536 (26.6%) were tested (29.2% C and 17.4% in Kenya) with a positivity rate of 1.4% (2.0% C and 1.1% K). In the screen-and-test arm, 48,314 (67.8%) were screened (72.8% C and 48.6% K), and 3,629 (7.5%) were eligible for testing (8.2% C and 3.7% K) - of those, 2,139 (58.9%) were tested (57.1% C and 82.4% K) with a positivity rate of 4.1% (3.4% C and 10% K). The estimated CDR was 3.59 (95% CI:1.55-5.64) per 1,000 attendee visits in the test-all arm and 1.46 (95% CI:0.60-2.32) per 1,000 attendee visits in the screen-and-test arm. Compared to the screen-and-test arm, the test-all arm had significantly higher COVID-19 CDR in MNCH clinics (3.57 vs.1.29, p=0.034). There were no significant differences in COVID-19 CDR between the two arms in HIV (4.20 vs.1.98, p=0.174) and TB (10.33 vs. 5.03, p=0.283) clinics, though the number of SARS-CoV-2 infections was small. Conclusion(s): The test-all arm identified more SARS-CoV-2 cases than the routine screen-and-test model, despite overall low testing coverage. The test-all model should be considered in future epidemics to improve early detection of SARS-CoV-2 infection among vulnerable populations, but effective implementation requires additional human resources to manage the clinic volumes. COVID-19 Case Detection Rates Per 1,000 Attendees: Comparison of Screen-and- Test and Test-All Arms.

HIV matters when diagnosing TB in young children: an ancillary analysis in children enrolled in the INPUT stepped wedge cluster randomized study.

BACKGROUND: Children under age five years, particularly those living with HIV (CLHIV), are at risk for rapid progression of tuberculosis (TB). We aimed to describe TB clinical presentations, diagnostic pathways and treatment outcomes in CLHIV compared to children without HIV in Cameroon and Kenya. METHODS: This sub-analysis of a cluster-randomized trial evaluating the integration of pediatric TB services from May 2019 to March 2021 enrolled children age < 5 years with TB. We estimated the HIV infection rate with 95% confidence interval (CI). We compared TB clinical presentations, diagnostic pathways and treatment outcomes in CLHIV and children without HIV. Finally, we investigated whether HIV infection was associated with a shorter time to TB diagnosis (≤ 3 months from symptoms onset) after adjusting for covariates. Univariable and multivariable logistic regression analysis were performed with adjusted odds ratios (AORs) presented as measures of the association of covariates with HIV status and with shorter time to TB diagnosis. RESULTS: We enrolled 157 children with TB (mean age was 1.5 years) and 22/157 (14.0% [9.0-20.4%]) were co-infected with HIV. CLHIV were more likely to initially present with acute malnutrition (AOR 3.16 [1.14-8.71], p = 0.027). Most TB diagnoses (140/157, 89%) were made clinically with pulmonary TB being the most common presentation; however, there was weak evidence of more frequent bacteriologic confirmation of TB in CLHIV, 18% vs. 9% (p = 0.067), due to the contribution of lateral-flow urine lipoarabinomannan to the diagnosis. HIV positivity (AOR: 6.10 [1.32-28.17], p = 0.021) was independently associated with a shorter time to TB diagnosis as well as fatigue (AOR: 6.58 [2.28-18.96], p = 0.0005), and existence of a household contact diagnosed with TB (AOR: 5.60 [1.58-19.83], p = 0.0075), whereas older age (AOR: 0.35 [0.15-0.85], p = 0.020 for age 2-5 years), night sweats (AOR: 0.24 [0.10-0.60], p = 0.0022) and acute malnutrition (AOR: 0.36 [0.14-0.92], p = 0.034) were associated with a delayed diagnosis. The case fatality rate was 9% (2/22) in CLHIV and 4% (6/135) in children without HIV, p = 0.31. CONCLUSIONS: These results altogether advocate for better integration of TB services into all pediatric entry points with a special focus on nutrition services, and illustrate the importance of non-sputum-based TB diagnostics especially in CLHIV. TRIAL REGISTRATION: NCT03862261, first registration 05/03/2019.

SARS-CoV-2 INFECTION and PREGNANCY in AFRICA: A 6-COUNTRY RETROSPECTIVE COHORT STUDY

Background: Limited data are available on pregnancy and COVID-19 in sub-Saharan Africa (SSA). Methods: We conducted a retrospective cohort study of women ≥18 years old hospitalized at 23 health facilities in six SSA countries between March 1, 2020, and March 31, 2021. We assessed the impact of pregnancy on SARS-CoV-2 infection, and of SARS-CoV-2 on pregnant women, through comparisons of clinical outcomes among: 1) pregnant and non-pregnant women hospitalized with RT-PCR-confirmed SARS-CoV-2 infection, and 2) pregnant women confirmed to be positive or negative for SARS-CoV-2 infection by RT-PCR. The primary outcome for both analyses was intensive care unit (ICU) admission. Secondary outcomes included need for oxygen supplementation or mechanical ventilation, pregnancy outcomes, and maternal or neonatal mortality. We performed negative log-binomial regression models to estimate the impact of pregnancy on SARS-CoV-2 among all women in the cohort, and the impact of SARS-CoV-2 on pregnancy outcomes. Factors associated with mortality were evaluated using competing-risk regression based on Fine and Gray's proportional hazards model. Results: We analyzed data on 1,315 hospitalized women: 510 pregnant women with SARS-CoV-2 infection;403 non-pregnant women with SARS-CoV-2 infection, and 402 pregnant women without SARS-CoV-2 infection. Among those with SARS-CoV-2 infection, pregnancy was associated with increased risk of ICU admission (adjusted rate ratio [aRR]= 1.86, 95% CI: 1.07-3.22, p=0.003) and oxygen supplementation (aRR= 1.48, 95% CI: 1.06-2.08, p=0.001). Among pregnant women, those with SARS-CoV-2 infection had increased risk of ICU admission (aRR = 2.0, 95% CI: 1.20-3.35, p=0.008), oxygen supplementation (aRR = 1.57, 95% CI: 1.17-2.11, p=0.002) and maternal mortality (aRR=3.08, 95% CI: 1.21-7.85, p=0.018) (Figure). Comparing SARS-CoV-2-infected vs. uninfected pregnant women, infected women were more likely to deliver by Caesarean section (59.3% vs 37.9%, RR = 1.56, 95% CI: 1.29-1.89, p<0.001);however, proportions of pre-term infants (32.4% vs. 31.1%, respectively, p = 0.870), infants with low birth weight (33.8% vs. 30.9%, respectively, p=0.711) and neonatal deaths [8/209 (3.8%) vs. 8/306 (2.6%) (RR=1.46, 95% CI: 0.56-3.84, p=0.436, respectively)] were similar. Conclusion: Among hospitalized pregnant women, SARS-CoV-2 infection increased morbidity and mortality. These data support international recommendations to prioritize COVID-19 vaccination among pregnant women.

Syndromic surveillance for covid-19 and health care access among art patients, Malawi

Background: While little is known about the interaction of HIV and SARSCoV- 2, disruptions caused by the COVID-19 pandemic may impact the ability of people living with HIV (PLHIV) to access antiretroviral therapy (ART). We conducted syndromic surveillance to identify challenges in PLHIV's access to health care services in selected districts in Malawi. Methods: We conducted telephone-based syndromic surveillance among randomly selected PLHIV ≥18 years old who had a telephone number on file in 179 ART clinics across nine districts. Patients who answered the phone were asked to verify their identity and provide consent. Staff used a structured questionnaire to collect self-reported data on demographic characteristics, experience of COVID-19 symptoms (CS) within the past 14 days as defined by the World Health Organization, access to health services, and ART interruptions (≥1 dose missed in past week) during the pandemic. We summarized data using proportions and medians and used Chi-square tests to examine associations. Results: From August-October 2020, we dialed 17,944 numbers;26.1% (4,680) confirmed their identity, were on ART and were ≥18 years. Most (93.7%, n=4,385) eligible clients consented, and 98.6% (n=4323) completed interviews. Over half (53.8%) were female. The male median age was 42 years (interquartile range [IQR] 18 - 78) compared to 36 (IQR 18 -80) among females. Of 263 (6.1%) reporting at least one CS, persistent cough (35.7%), headache (40.3%) and fever (18.6%) were most common. Overall, 193 (4.5%) reported having been tested for SARS-CoV-2. Females were more likely to have missed school or work due to CS compared to males (37.3% vs. 21.8%, p=0.004), and were more likely to access medical care for CS (66.2% vs. 54.9%, p=0.048). Of all respondents, 17.6% reported not accessing health care services during the pandemic. Challenges included health facility closures (13.6%), no money for transport (13.9%) and fear of COVID-19 (45%). Few respondents (1.8%) reported missing ART doses. Conclusion: The telephone-based syndromic surveillance system proved to be feasible in monitoring the impact of COVID-19 among PLHIV in a resourcelimited setting. PLHIV reported missing school or work due to CS and not accessing health care services, though few missed their ART doses;these findings require further research. Similar systems can be used to rapidly identify and respond to COVID-19-related challenges with health care access for people on ART.