Early Effects of Scaling Up Dolutegravir-Based ARV Regimens Among Children Living with HIV in Malawi.

Viral suppression (VS) in children has remained suboptimal compared to that in adults. We evaluated the impact of transitioning children weighing < 20 kg to a pediatric formulation of dolutegravir (pDTG) on VS in Malawi. We analyzed routine retrospective program data from electronic medical record systems pooled across 169 healthcare facilities in Malawi supported by the Elizabeth Glaser Pediatric AIDS Foundation (EGPAF). We included children who weighed < 20 kg and received antiretroviral therapy (ART) between July 2021-June 2022. Using descriptive statistics, we summarized demographic and clinical characteristics, ART regimens, ART adherence, and VS. We used logistic regression to identify factors associated with post-transition VS. A total of 2468 Children Living with HIV (CLHIV) were included, 55.3% of whom were < 60 months old. Most (83.8%) had initiated on non-DTG-based ART; 71.0% of these had a viral load (VL) test result before transitioning to pDTG, and 62.5% had VS. Nearly all (99.9%) CLHIV transitioned to pDTG-based regimens. Six months after the transition, 52.7% had good ART adherence, and 38.6% had routine VL testing results; 81.7% achieved VS. Post-transition VS was associated with good adherence and pre-transition VS: adjusted odds ratios of 2.79 (95% CI 1.65-4.71), p < 0.001 and 5.32 (95% CI 3.23-9.48), p < 0.001, respectively. After transitioning to pDTG, VS was achieved in most children tested within the first 6 months. However, adherence remained suboptimal post-transition and VL testing at 6 months was limited. Interventions to improve VL testing and enhance ART adherence are still needed in CLHIV on pDTG-based regimens.

Factors associated with COVID-19 vaccine receipt among mobile phone users in Malawi: Findings from a national mobile-based syndromic surveillance survey, July 2021-April 2022.

Malawi recommended COVID-19 vaccines for adults aged ≥18 years in March 2021. We assessed factors associated with receiving COVID-19 vaccines in Malawi as part of a telephone-based syndromic surveillance survey. We conducted telephone-based syndromic surveillance surveys with questions on COVID-19 vaccine receipt among adults (≥18 years old) upon verbal consent from July 2021 to April 2022. We used random digit dialing to select mobile phone numbers and employed electronic data collection forms on secure tablets. Survey questions included whether the respondent had received at least one dose of a COVID-19 vaccine. We used multivariable analysis to identify factors associated with COVID-19 vaccine receipt. Of the 51,577 participants enrolled; 65.7% were male. Males were less likely to receive the COVID-19 vaccine than females (AOR 0.83, 95% CI 0.80-0.86). Compared to those aged 18-24 years, older age had increased odds of vaccine receipt: 25-34 years (AOR 1.32, 95% CI 1.24-1.40), 35-44 years (AOR 2.00, 95% CI 1.88-2.13), 45-54 years (AOR 3.02, 95% CI 2.82-3.24), 55-64 years (AOR 3.24, 95% CI 2.93-3.57) and 65 years+ (AOR 3.98, 95% CI 3.52-4.49). Respondents without formal education were less likely to receive vaccination compared to those with primary (AOR 1.30, 95% CI 1.14-1.48), secondary (AOR 1.76, 95% CI 1.55-2.01), and tertiary (AOR 3.37, 95% CI 2.95-3.86) education. Respondents who thought COVID-19 vaccines were unsafe were less likely to receive vaccination than those who thought it was very safe (AOR 0.26, 95% CI 0.25-0.28). Residents of the Central and Southern regions had reduced odds of vaccine receipt compared to those in the North (AORs 0.79, (95% CI 0.74-0.84) and 0.55, (95% CI 0.52-0.58) respectively). Radio (72.6%), health facilities (52.1%), and social media (16.0%) were the more common self-reported sources of COVID-19 vaccine information. COVID-19 vaccine receipt is associated with gender, age, education, and residence. It is important to consider these factors when implementing COVID-19 vaccination programs.

Safety of Janssen Ad26.COV.S and Astra Zeneca AZD1222 COVID-19 Vaccines among Mobile Phone Users in Malawi: Findings from a National Mobile-Based Syndromic Surveillance Survey, July 2021 to December 2021.

The safety profiles of the Ad26.COV2.S and AZD1222 COVID-19 vaccines have not been described in the general population in Malawi. We present self-reported adverse events (AE) following the receipt of these vaccines in Malawi as part of a national syndromic surveillance survey. We conducted phone-based syndromic surveillance surveys among adults (≥18 years) with verbal consent. We used secure tablets through random digit dialing to select mobile phone numbers and collected data electronically. Survey questions included whether the respondent had received the COVID-19 vaccines, whether they had experienced any AE following vaccination, and the severity of the AE. We used multivariable analysis to identify factors associated with self-reported AE post-COVID-19 vaccination. A total of 11,924 (36.0%) out of 33,150 respondents reported receiving at least one dose of either Ad26.COV2.S or AZD1222 between July-December 2021; of those, 65.1% were female. About 49.2% of the vaccine recipients reported at least one AE, 90.6% of which were mild, and 2.6% were severe. Higher education level and concern about the safety of COVID-19 vaccines were associated with AE self-report (Adjusted Odds Ratio [AOR] 2.63 [95% CI 1.96-3.53] and 1.44, [95% CI 1.30-1.61], respectively), while male gender and older age were associated with reduced likelihood of AE self-report (AORs 0.81, [95% CI 0.75-0.88], 0.62 [95% CI 0.50-0.77], respectively). Ad26.COV2.S and AZD1222 vaccines are well-tolerated, with primarily mild and few severe AE among adults living in Malawi. Self-reporting of AE following COVID-19 vaccination is associated with gender, age, education, and concern about the safety of the vaccines. Recognizing these associations is key when designing and implementing COVID-19 vaccination communication messages to increase vaccination coverage.

Understanding gender differences of people with HIV newly diagnosed or returning to care with advanced HIV disease in Malawi: a qualitative study.

BACKGROUND: Despite tremendous progress in improving antiretroviral therapy (ART) access, advanced HIV disease (AHD) still remains a challenge globally. Reasons for delayed presentation to care and ART adherence may be affected by gender. We present qualitative study findings on gender differences in decisions for HIV testing and ART initiation/adherence in adults with AHD in Malawi. METHODS: We used a qualitative study design, interviewing 16 men and 16 women aged 18 years and above diagnosed with AHD in sites implementing an optimized package of AHD care, from December 2021-February 2022. We included study participants receiving AHD services for at least two months. We also interviewed 16 lay workers and 16 health care workers supporting people living with AHD. In-depths interviews (IDIs) were conducted in English or Chichewa by trained research assistants using semi-structured interview guides. A short-answer analysis was conducted, and findings were interpreted according to thematic areas. RESULTS: Both men and women reported stigma as a main barrier influencing their decision to test for HIV and to initiate and adhere to ART. Fear of side effects, insufficient food, and the need for more information were other barriers reported among men and women as well as perceived as barriers by HCWs. Men appear to have tested later for HIV and stated that they were waiting until experiencing significant symptoms before testing. According to clients and HCWs, men were also less inclined to initiate ART after a HIV diagnosis, whereas women were motivated to start treatment to remain healthy and care for the family. Both genders reported that treatment could be delayed if they were feeling healthy. Treatment fatigue was reported among all groups as the main reason to discontinue treatment. CONCLUSIONS: There were similarities and differences between genders in decision-making about HIV care. Concerns about stigma were important reasons for delay in HIV care in both genders. Motivations for accessing HIV treatment and care were different among men and women, pushing the need for gender-tailored counseling services and community messaging that educate both men and women on the benefits of initiating ART early, in turn reducing the number of people presenting with AHD. TRIAL REGISTRATION: NCT05510973, first registration 22/08/2022.

Fall injuries in Sub-Saharan Africa: analysis of prospective injury registry from 23 health facilities in Malawi and Tanzania.

BACKGROUND: Low-and middle-income countries account for over 80% of fall-related fatalities globally. However there is little emphasis on the issue and limited high quality data to understand the burden, and to inform preventive and management strategies. We characterise the burden of fall injuries in Malawi and Tanzania. METHODS: This multi-centre prospective descriptive study utilized trauma registry data from 10 hospitals in Malawi and 13 hospitals in Tanzania. The study included twelve months of data in Tanzania (October 2019 to September 2020), and eighteen months of data from Malawi (September 2018 to March 2020). We describe patient demographics, the causes, location, and nature of injuries, timing of arrival to hospital, and final disposition. Regression analyses were performed to determine risk factors for serious injuries. RESULTS: There were 93,178 trauma patients in the registries of both countries, of which 44,609 (47.9%) had fall related complaints. Fall injuries accounted for 55.3% and 17.4% of all trauma cases in Malawi and Tanzania respectively. Overall the median age was 16 years (Interquartile range (IQR) 8-31 years), and 62.8% were male. Most fall injuries (69.9%) occurred at home, were unintentional (98.1%), and were due to a ground level fall (74.9%). Nearly half of patients (47.9%) arrived at a facility using public transport, with median arrival time of 10 h (IQR 8-13 h) from initial injury. Extremities (87.0%) were the most commonly injured region, followed by head and neck (4.4%). Overall 3275 (7.4%) patients had potentially serious injuries. Age > 60 years was associated with two times odds of having serious injuries than those < 5 years, and those sustaining injury at work (adjusted Odds Ratio (aOR) 1.95 95% CI; 1.56-2.43) or recreational areas (aOR 3.47 95% CI; 2.93-4.10) had higher odds of serious injuries compared to those injured at home. CONCLUSIONS: In these facilities in Sub-Saharan Africa, fall injuries accounted for a substantial fraction of all injuries. While most common in younger males, those aged 5-13 and over 60 years were more likely to have serious injuries. Most falls occurred at home, but serious injuries were more likely to occur at recreational and work areas. Future efforts should focus on preventive strategies to mitigate these injuries.

Acceptability and usability of a paediatric HIV screening tool in high-volume outpatient settings in Malawi, perspectives from caregivers and healthcare workers.

BACKGROUND: Using an HIV pretest screening tool to identify children most at risk for HIV infection may be a more efficient and cost-effective approach to identify children living with HIV in resource-limited settings. These tools seek to reduce overtesting of children by increasing the positive predictive value while ensuring a high negative predictive value for those screened for HIV. METHODS: This qualitative study in Malawi evaluated acceptability and usability of a modified version of the Zimbabwe HIV screening tool to identify children aged 2-14 years most-at-risk. The tool included additional questions about previous hospitalisations due to malaria and prior documented diagnoses. Sixteen interviews were conducted with expert clients (ECs), trained peer-supporters, which administered the screening tool and 12 interviews with biological and non-biological caregivers of screened children. All interviews were audiorecorded, transcribed and translated. Transcripts were analysed manually using a short-answer analysis, compiling responses for each question by study participant group. Summary documents were generated, identifying common and outlier perspectives. RESULTS: The HIV paediatric screening tool was generally accepted by caregivers and ECs, with both groups seeing the benefit of the tool and promoting its use. The ECs who were primarily responsible for implementing the tool initially struggled with acceptance of the tool but started to accept it after additional training and mentorship was provided. Overall, caregivers accepted having their children tested for HIV, although non-biological caregivers expressed hesitancy in giving consent for HIV testing. ECs reported challenges with the ability for non-biological caregivers to answer some questions. CONCLUSION: This study found general acceptance of paediatric screening tools in children in Malawi and identified some minor challenges that raise important considerations for tool implementation. These include the need for a thorough orientation of the tools for the healthcare workers and caregivers, appropriate space at the facility, and adequate staffing and commodities.

Progesterone and prolactin levels in pregnant women living with HIV who delivered preterm and low birthweight infants: A nested case-control study.

BACKGROUND: Antiretroviral therapy (ART) is associated with high rates of adverse birth outcomes, including preterm birth and low birthweight. Studies suggest that progesterone and prolactin may play important intermediary roles. METHODS: We analyzed data from the Antenatal Component of the PROMISE trial, a multi-center study of pregnant women taking antiretroviral regimens (lopinavir/ritonavir-containing ART or zidovudine alone) to prevent mother-to-child HIV transmission. In a nested case-control study, we compared data from women who gave birth to preterm (<37 weeks gestation) and/or low birthweight (<2500 g) infants to matched individuals who did not. We measured serum progesterone and prolactin at 24-34 weeks gestation. We used conditional logistic regression to describe relationships between hormone levels, birth outcomes, and antiretroviral regimens. RESULTS: 299 women and their newborns were included (146 cases, 153 controls). When compared to women receiving zidovudine alone, those on ART had higher odds of progesterone levels under the 10th percentile (adjusted odds ratio [AOR]:2.34, 95%CI:1.41-3.89) and 25th percentile (AOR:2.07, 95%CI:1.46-2.94). However, higher levels of progesterone-rather than lower levels-were associated with our composite case outcome at the 10th percentile (AOR:1.88, 95%CI:0.77-4.59) and 25th percentile (AOR:1.96, 95%CI:1.06-3.61). Associations were not observed between prolactin, antiretroviral regimen, and birth outcomes. CONCLUSION: We observed lower progesterone levels among women allocated to ART regimens; however, higher progesterone levels were associated with preterm birth and/or low birthweight. While features of the study design may have contributed to these findings, they nevertheless highlight the potentially complex mechanisms underpinning adverse birth outcomes and HIV.

Protocol to implement a syndromic surveillance survey of COVID-19 in Malawi.

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.

Comparison of adverse birth outcomes among HIV-infected and HIV-uninfected women delivering in high and low risk settings in the era of universal ART in Malawi: a registry study.

Background: Recent studies show that ART is associated with an adverse birth outcome in HIV-infected women.Aim: To compare rates of low birthweight (LBW) and preterm birth (PTB) between HIV-infected women receiving lifelong ART and HIV-uninfected women giving birth in low- and high-risk settings in Malawi.Methods: This observational, registry study was conducted from January 2016 to August 2017 in one large, tertiary referral hospital and four primary healthcare (PHC) facilities in Blantyre, Malawi. Women who delivered singleton live births or stillbirths of ≥20 weeks gestation were included in the analysis. Descriptive and stratified analyses were conducted using χ2 tests and multivariable logistic models to control for maternal age, gravidity and health facility.Results: A total of 14,233 births were included in the analysis (7715 from the tertiary hospital and 6518 from PHC facilities). In the univariable analysis, there were no differences in rates of LBW (6.7% vs 6.4%) and PTB (42.5% vs 42.0%) between HIV-infected and -uninfected women delivering in PHC facilities. However, differences in LBW were significantly higher in HIV-infected women in multivariable analysis (LBW aOR 1.40, 95% CI 1.01-1.95). Rates of LBW and PTB were significantly higher in HIV-infected women than in uninfected women delivering at the tertiary hospital (LBW 17.6% vs 13.2%, aOR 1.53, 95% CI 1.27-1.85; PTB 28.2% vs 24.9%, aOR 1.37, 95% CI 1.17-1.60)Conclusion: Rates of adverse birth outcomes are significantly higher in HIV-infected women than in HIV-uninfected women, and this is more apparent in high-risk hospital settings than in low-risk PHC settings.

Pregnancy Outcomes in the Era of Universal Antiretroviral Treatment in Sub-Saharan Africa (POISE Study).

BACKGROUND: Adverse pregnancy outcomes such as preterm birth (PTB), low birth weight (LBW), and small for gestational age (SGA) remain major global problems. We compared pregnancy outcomes among HIV-infected women receiving antiretroviral treatment (ART) and with CD4 ≥350 cells, and HIV-uninfected women to assess whether disparities associated with HIV infection have been eliminated through use of ART. SETTING: Observational study conducted at 5 health facilities in Blantyre, Malawi, during 2016-2017. METHODS: HIV-infected women receiving the national ART regimen (efavirenz + lamivudine + tenofovir) and HIV-uninfected women were consented and enrolled at delivery. Data collected included sociodemographic and clinical; gestational age; BW; infant/maternal anthropometry; and laboratory results. We defined PTB as GA <37 weeks; LBW as BW <2·5 kg; and SGA as BW <10th percentile of GA. SGA infants were classified into proportionate and disproportionate based on ponderal index. Descriptive, stratified, and multivariate logistic and linear regression analyses were used. RESULTS: Of 5423 women approached, 614 HIV-infected and 685 HIV-uninfected women were enrolled. Rates of PTB, LBW, and SGA were 10.6%, 7.2%, and 17.1% among HIV-infected women on ART and 9.5%, 5.0%, and 18.4% among HIV-uninfected women, respectively. None of these differences were statistically significant in univariate- or multivariate-adjusted analyses (P > 0.05). Of 231 SGA infants, 78.8% were proportionate and 21% were disproportionate. Of the 614 HIV-infected women on ART, 75% had undetectable virus at delivery. CONCLUSIONS: ART use has reduced the high rates of adverse pregnancy outcomes among HIV-infected women. However, the rates remain high irrespective of HIV infection and require appropriate interventions.