Psychometrics of the Children's Report of Parental Behavior Inventory among caregivers and youth with HIV.

Parenting has been implicated in a range of youth health outcomes. Positive parenting during adolescence, a critical period of developmental change, may equip youth with the necessary tools for their transition into adulthood and, for youth living with HIV, their transition from pediatric HIV care into adult HIV care. Yet, because few studies have carefully assessed the psychometric properties of parenting instruments applied cross-culturally, the validity of parenting research derived in these contexts remains unclear. This study tested the factor structure of the Children's Report of Parenting Behavior Inventory (CRPBI) in a novel setting (e.g., Rwanda), context (e.g., youth with HIV), and considering multiple informants (caregivers and youth). Youth (N = 330) were on average 16.78 years of age; 51% self-identified as female. Caregivers (N = 330) were on average 44.40 years of age; 80% self-identified as female. The factor structures for youth and caregiver CRPBIs appeared to be indicative of two dimensions: (a) acceptance and positive involvement, and (b) hostile detachment and rejection. The CRPBI worked well for youth reports and showed predictive validity. The CRPBI worked less well for caregivers, necessitating the removal of 10 items, seven of which were related to hostile detachment and rejection. The reliability of both CRPBIs was supported. The CRPBI appears to function well for youth, but not as well for caregivers, in this novel context with this unique population of youth with HIV. The findings support careful assessment of instruments developed in high-resource settings and then used in resource-constrained contexts. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Third COVID-19 vaccine dose boosts antibody function in Rwandans with high HIV viral load.

SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) causing COVID-19 (coronavirus disease 2019) poses a greater health risk to immunocompromized individuals including people living with HIV (PLWH). However, most studies on PLWH have been conducted in higher-income countries. We investigated the post-vaccination antibody responses of PLWH in Rwanda by collecting peripheral blood from participants after receiving a second or third COVID-19 vaccine. Virus-binding antibodies as well as antibody neutralization ability against all major SARS-CoV-2 variants of concern were analyzed. We found that people with high HIV viral loads and two COVID-19 vaccine doses had lower levels of binding antibodies that were less virus neutralizing and less cross-reactive compared to control groups. A third vaccination increased neutralizing antibody titers. Our data suggest that people with high HIV viral loads require a third dose of vaccine to neutralize SARS-CoV-2 virus and new variants as they emerge.

HIV, syphilis, and hepatitis B virus infection and male circumcision in five Sub-Saharan African countries: Findings from the Population-based HIV Impact Assessment surveys, 2015-2019.

Voluntary medical male circumcision (VMMC) has primarily been promoted for HIV prevention. Evidence also supports that male circumcision offers protection against other sexually transmitted infections. This analysis assessed the effect of circumcision on syphilis, hepatitis B virus (HBV) infection and HIV. Data from the 2015 to 2019 Population-based HIV Impact Assessments (PHIAs) surveys from Rwanda, Tanzania, Uganda, Zambia, and Zimbabwe were used for the analysis. The PHIA surveys are cross-sectional, nationally representative household surveys that include biomarking testing for HIV, syphilis and HBV infection. This is a secondary data analysis using publicly available PHIA data. Univariate and multivariable logistic regression models were created using pooled PHIA data across the five countries to assess the effect of male circumcision on HIV, active and ever syphilis, and HBV infection among sexually active males aged 15-59 years. Circumcised men had lower odds of syphilis infection, ever or active infection, and HIV, compared to uncircumcised men, after adjusting for covariates (active syphilis infection = 0.67 adjusted odds ratio (aOR), 95% confidence interval (CI), 0.52-0.87, ever having had a syphilis infection = 0.85 aOR, 95% CI, 0.73-0.98, and HIV = 0.53 aOR, 95% CI, 0.47-0.61). No difference between circumcised and uncircumcised men was identified for HBV infection (P = 0.75). Circumcised men have a reduced likelihood for syphilis and HIV compared to uncircumcised men. However, we found no statistically significant difference between circumcised and uncircumcised men for HBV infection.

Spatio-temporal dynamic of the COVID-19 epidemic and the impact of imported cases in Rwanda.

INTRODUCTION: Africa was threatened by the coronavirus disease 2019 (COVID-19) due to the limited health care infrastructure. Rwanda has consistently used non-pharmaceutical strategies, such as lockdown, curfew, and enforcement of prevention measures to control the spread of COVID-19. Despite the mitigation measures taken, the country has faced a series of outbreaks in 2020 and 2021. In this paper, we investigate the nature of epidemic phenomena in Rwanda and the impact of imported cases on the spread of COVID-19 using endemic-epidemic spatio-temporal models. Our study provides a framework for understanding the dynamics of the epidemic in Rwanda and monitoring its phenomena to inform public health decision-makers for timely and targeted interventions. RESULTS: The findings provide insights into the effects of lockdown and imported infections in Rwanda's COVID-19 outbreaks. The findings showed that imported infections are dominated by locally transmitted cases. The high incidence was predominant in urban areas and at the borders of Rwanda with its neighboring countries. The inter-district spread of COVID-19 was very limited due to mitigation measures taken in Rwanda. CONCLUSION: The study recommends using evidence-based decisions in the management of epidemics and integrating statistical models in the analytics component of the health information system.

Engagement in HIV continuum of care: Another step needed to close the gap toward UNAIDS 90-90-90 targets among younger men in Rwanda.

In this study, we measured Rwandan men's engagement in HIV services based on the UNAIDS 90-90-90 targets and assessed factors associated with linkage to HIV services. We analyzed the Rwanda Population-based HIV Impact Assessment (RPHIA) data for 15- to 64-year-old males. We conducted bivariate analysis to assess the distribution and association of sociodemographic characteristics with UNAIDS 90-90-90 targets. We adjusted multivariable models to understand the effect measurement of associated factors and determine the factors that best predict the achievement of UNAIDS 90-90-90. Of 13 780 males aged 15-64 years who participated in the RPHIA and consented to the blood draw and HIV testing, 302 had a positive HIV result, while 301 had valid responses to all variables analyzed in this paper and were included in the analysis. We found that age group was an explanatory and predictive factor for achievement of UNAIDS 90-90-90. Younger men living with HIV (MLHIV) are less likely to have achieved UNAIDS 90-90-90 compared to MLHIV 50-64 years old: adjusted odds ratio (aOR) for MLHIV aged 15-34 years was 0.21 (0.08-0.53) and aOR for MLHIV aged 35-49 years was 0.77 (0.36-1.66). To close the UNAIDS 90-90-90 gap in Rwanda, innovative service delivery strategies are needed to support young MLHIV to reach 90-90-90.

Association Between Time to Antiretroviral Therapy and Loss to Care Among Newly Diagnosed Rwandan People Living with Human Immunodeficiency Virus.

Despite improved clinical outcomes of initiating antiretroviral therapy (ART) soon after diagnosis, conflicting evidence exists regarding the impact of same-day ART initiation on subsequent clinical outcomes. We aimed to characterize the associations of time to ART initiation with loss to care and viral suppression in a cohort of newly diagnosed people living with HIV (PLHIV) entering care after Rwanda implemented a national "Treat All" policy. We conducted a secondary analysis of routinely collected data of adult PLHIV enrolling in HIV care at 10 health facilities in Kigali, Rwanda. Time from enrollment to ART initiation was categorized as same day, 1-7 days, or >7 days. We examined associations between time to ART and loss to care (>120 days since last health facility visit) using Cox proportional hazards models, and between time to ART and viral suppression using logistic regression. Of 2,524 patients included in this analysis, 1,452 (57.5%) were women and the median age was 32 (interquartile range: 26-39). Loss to care was more frequent among patients who initiated ART on the same day (15.9%), compared with those initiating ART 1-7 days (12.3%) or >7 days (10.1%), p < .001. In multivariable analyses, same-day ART initiation was associated with a greater hazard of loss to care compared with initiating >7 days after enrollment (adjusted hazard ratio 1.39, 95% confidence interval: 1.04-1.85). A total of 1,698 (67.3%) had available data on viral load measured within 455 days after enrollment. Of these, 1,476 (87%) were virally suppressed. A higher proportion of patients initiating ART on the same day were virally suppressed (89%) compared with those initiating 1-7 days (84%) or >7 days (88%) after enrollment. This association was not statistically significant. Our findings suggest that ensuring adequate, early support for PLHIV initiating ART rapidly may be important to improve retention in care for newly diagnosed PLHIV in the era of Treat All.

Benefits and challenges of consolidating public health functions into a National Public Health Institute: a policy analysis.

National Public Health Institutes (NPHIs) around the world vary in composition. Consolidated organizational models can bring together critical functions such as disease surveillance, emergency preparedness and response, public health research, workforce development and laboratory diagnosis within a single focal point. This can lead to enhanced coordination and management of resources and enable more efficient and effective public health operations. We explored stakeholders' perceptions about the benefits and challenges of consolidating public health functions in an NPHI in seven countries where the US Centers for Disease Control and Prevention has supported NPHI establishment and strengthening. From August 2019 through January 2020, we interviewed a total of 96 stakeholders, including NPHI staff (N = 43), non-NPHI government staff (N = 29) and non-governmental and international organization staff (N = 24) in Cambodia, Colombia, Liberia, Mozambique, Nigeria, Rwanda and Zambia. We conducted a policy analysis using Tea Collins's health policy analysis framework to assess various possible options for coordinating public health functions and their likely effectiveness. The findings can be used by policymakers as they consider public health infrastructure. We found that consolidating functions in an NPHI, to the extent politically and organizationally feasible, promotes efficiency, flexibility and coordination, as well as supports data-driven health recommendations to government decision makers. Countries pursuing NPHI establishment can weigh the potential challenges and benefits of consolidating functions when determining which public health functions will comprise the NPHI, including clarity of role, access to resources, influence over decisions and political viability.

Advancing detection and response capacities for emerging and re-emerging pathogens in Africa.

Recurrent disease outbreaks caused by a range of emerging and resurging pathogens over the past decade reveal major gaps in public health preparedness, detection, and response systems in Africa. Underlying causes of recurrent disease outbreaks include inadequacies in the detection of new infectious disease outbreaks in the community, in rapid pathogen identification, and in proactive surveillance systems. In sub-Saharan Africa, where 70% of zoonotic outbreaks occur, there remains the perennial risk of outbreaks of new or re-emerging pathogens for which no vaccines or treatments are available. As the Ebola virus disease, COVID-19, and mpox (formerly known as monkeypox) outbreaks highlight, a major paradigm shift is required to establish an effective infrastructure and common frameworks for preparedness and to prompt national and regional public health responses to mitigate the effects of future pandemics in Africa.

Monitoring of Adverse Events in Recipients of the 2-Dose Ebola Vaccine Regimen of Ad26.ZEBOV Followed by MVA-BN-Filo in the UMURINZI Ebola Vaccination Campaign.

BACKGROUND: From 2019 to 2021, Rwandan residents of the border with the Democratic Republic of the Congo were offered the Ad26.ZEBOV (adenovirus type 26 vector vaccine encoding Ebola virus glycoprotein) and MVA-BN-Filo (modified vaccinia virus Ankara vector vaccine, encoding glycoproteins from Ebola, Sudan, Marburg, and nucleoprotein from Tai Forest viruses) Ebola vaccine regimen. METHODS: Nonpregnant persons aged ≥2 years were eligible. Unsolicited adverse events (UAEs) were reported through phone calls or visits, and serious adverse events (SAEs) were recorded per International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use guidelines. RESULTS: Following Ad26.ZEBOV, UAEs were reported by 0.68% of 216 113 vaccinees and were more common in younger children (aged 2-8 years, 1.2%) compared with older children (aged 9-17 years, 0.4%) and adults (aged ≥18 years, 0.7%). Fever and headache were the most reported symptoms. All 17 SAEs related to vaccine were in children aged 2-8 years (10 postvaccination febrile convulsions ± gastroenteritis and 7 fever and/or gastroenteritis). The incidence of febrile seizures was 8 of 26 062 (0.031%) prior to initiation of routine acetaminophen in December 2020 and 2 of 15 897 (0.013%) thereafter. Nonobstetric SAEs were similar in males and females. All 20 deaths were unrelated to vaccination. Young girls and adult women with UAEs were less likely to receive the second dose than those without UAEs. Seven unrelated SAEs occurred in 203 267 MVA-BN-Filo recipients. CONCLUSIONS: Postvaccination febrile convulsions in young children were rare but not previously described after Ad26.ZEBOV and were reduced with routine acetaminophen. The regimen was otherwise safe and well-tolerated.

Cancer in patients with and without HIV infection in the national cancer registry of Rwanda.

OBJECTIVE: As antiretroviral therapy (ART) has been widely scaled up in Rwanda, life expectancies among people with HIV (PWH) have increased. With increasing viral suppression, AIDS-defining cancers (ADCs) typically decrease; however, as the PWH population ages, non-AIDS-defining cancers (NADCs) will be expected to increase. The aim of this study was to compare cancer diagnoses between PWH and patients without HIV in Rwanda and to describe the changes in the number and types of cancer over time. DESIGN: Retrospective cohort study. METHODS: Rwanda National Cancer Registry (RNCR) recorded the HIV status, primary site, and morphological description for cancer diagnoses from 2007 to 2018. Descriptive analyses were carried out by cancer group (HIV+ and HIV-). A portion of patients whose HIV status was unknown (63%) were excluded from the present analysis. RESULTS: Among the 20 258 cases registered in the Registry, there were 1048 PWH and 6359 HIV- individuals. The proportion of ADCs were significantly higher in the PWH group compared to those without HIV ( P  < 0.001). Among PWH, there was a longitudinal increase in NADCs and a decrease in ADCs ( P  < 0.001) over time. Among the ADCs in the PWH group, there was a significant decline in Kaposi sarcoma cases over time. CONCLUSIONS: The study demonstrates a decreasing frequency of ADCs driven by declines in Kaposi sarcoma diagnoses and an increased frequency of NADCs among PWH in Rwanda over time. These findings support a need for focusing early detection and management efforts on NADCs, as they begin to play a larger role in the disease processes that affect the aging PWH population.

Use of trained scent dogs for detection of COVID-19 and evidence of cost-saving.

Background: One of the lessons learned from the coronavirus disease 2019 (COVID-19) pandemic is the importance of early, flexible, and rapidly deployable disease detection methods. Currently, diagnosis of COVID-19 requires the collection of oro/nasopharyngal swabs, nasal turbinate, anterior nares and saliva but as the pandemic continues, disease detection methods that can identify infected individuals earlier and more quickly will be crucial for slowing the spread of the virus. Previous studies have indicated that dogs can be trained to identify volatile organic compounds (VOCs) produced during respiratory infections. We sought to determine whether this approach could be applied for detection of COVID-19 in Rwanda and measured its cost-saving. Methods: Over a period of 5 months, four dogs were trained to detect VOCs in sweat samples collected from human subjects confirmed positive or negative for COVID-19 by reverse transcription polymerase chain reaction (RT-PCR) testing. Dogs were trained using a detection dog training system (DDTS) and in vivo diagnosis. Samples were collected from 5,253 participants using a cotton pad swiped in the underarm to collect sweat samples. Statistical analysis was conducted using R statistical software. Findings: From August to September 2021 during the Delta wave, the sensitivity of the dogs' COVID-19 detection ranged from 75.0 to 89.9% for the lowest- and highest-performing dogs, respectively. Specificity ranged from 96.1 to 98.4%, respectively. In the second phase coinciding with the Omicron wave (January-March 2022), the sensitivity decreased substantially from 36.6 to 41.5%, while specificity remained above 95% for all four dogs. The sensitivity and specificity by any positive sample detected by at least one dog was 83.9, 95% CI: 75.8-90.2 and 94.9%; 95% CI: 93.9-95.8, respectively. The use of scent detection dogs was also found to be cost-saving compared to antigen rapid diagnostic tests, based on a marginal cost of approximately $14,000 USD for testing of the 5,253 samples which makes 2.67 USD per sample. Testing turnaround time was also faster with the scent detection dogs, at 3 h compared to 11 h with routine diagnostic testing. Conclusion: The findings from this study indicate that trained dogs can accurately identify respiratory secretion samples from asymptomatic and symptomatic COVID-19 patients timely and cost-effectively. Our findings recommend further uptake of this approach for COVID-19 detection.

Toward a New Paradigm of North-South and South-South Partnerships for Pandemic Preparedness: Lessons Learned from COVID-19 and Other Outbreaks.

COVID-19 underscores the need to reimagine North-South partnerships and redefine best practices for building public health and research capacity to address emergent health threats and pandemic preparedness in low- and-middle income countries (LMICs). Historically, outbreak and emergency responses have failed to ensure that the Global South has the autonomy and capacity to respond to public health threats in a timely and equitable manner. The COVID-19 response, however, has demonstrated that innovations and solutions in the Global South can not only fill resource and capacity gaps in LMICs but can also provide solutions to challenges globally. These innovations offer valuable lessons about strengthening local manufacturing capacity to produce essential diagnostic, treatment, and prevention tools; implementing high-quality research studies; expanding laboratory and research capacity; and promoting effective cooperation and governance. We discuss specific examples of capacity-building from Rwanda, South Africa, and Senegal. To fulfill promises made to the Global South during the COVID-19 pandemic, restore and resume health service delivery, and effectively prevent and respond to the next health threat, we need to prioritize equitable access to local manufacturing of basic health tools while building health systems capacities in the Global South.

A multinational Delphi consensus to end the COVID-19 public health threat.

Despite notable scientific and medical advances, broader political, socioeconomic and behavioural factors continue to undercut the response to the COVID-19 pandemic1,2. Here we convened, as part of this Delphi study, a diverse, multidisciplinary panel of 386 academic, health, non-governmental organization, government and other experts in COVID-19 response from 112 countries and territories to recommend specific actions to end this persistent global threat to public health. The panel developed a set of 41 consensus statements and 57 recommendations to governments, health systems, industry and other key stakeholders across six domains: communication; health systems; vaccination; prevention; treatment and care; and inequities. In the wake of nearly three years of fragmented global and national responses, it is instructive to note that three of the highest-ranked recommendations call for the adoption of whole-of-society and whole-of-government approaches1, while maintaining proven prevention measures using a vaccines-plus approach2 that employs a range of public health and financial support measures to complement vaccination. Other recommendations with at least 99% combined agreement advise governments and other stakeholders to improve communication, rebuild public trust and engage communities3 in the management of pandemic responses. The findings of the study, which have been further endorsed by 184 organizations globally, include points of unanimous agreement, as well as six recommendations with >5% disagreement, that provide health and social policy actions to address inadequacies in the pandemic response and help to bring this public health threat to an end.

Leveraging artificial intelligence and data science techniques in harmonizing, sharing, accessing and analyzing SARS-COV-2/COVID-19 data in Rwanda (LAISDAR Project): study design and rationale.

BACKGROUND: Since the outbreak of COVID-19 pandemic in Rwanda, a vast amount of SARS-COV-2/COVID-19-related data have been collected including COVID-19 testing and hospital routine care data. Unfortunately, those data are fragmented in silos with different data structures or formats and cannot be used to improve understanding of the disease, monitor its progress, and generate evidence to guide prevention measures. The objective of this project is to leverage the artificial intelligence (AI) and data science techniques in harmonizing datasets to support Rwandan government needs in monitoring and predicting the COVID-19 burden, including the hospital admissions and overall infection rates. METHODS: The project will gather the existing data including hospital electronic health records (EHRs), the COVID-19 testing data and will link with longitudinal data from community surveys. The open-source tools from Observational Health Data Sciences and Informatics (OHDSI) will be used to harmonize hospital EHRs through the Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM). The project will also leverage other OHDSI tools for data analytics and network integration, as well as R Studio and Python. The network will include up to 15 health facilities in Rwanda, whose EHR data will be harmonized to OMOP CDM. EXPECTED RESULTS: This study will yield a technical infrastructure where the 15 participating hospitals and health centres will have EHR data in OMOP CDM format on a local Mac Mini ("data node"), together with a set of OHDSI open-source tools. A central server, or portal, will contain a data catalogue of participating sites, as well as the OHDSI tools that are used to define and manage distributed studies. The central server will also integrate the information from the national Covid-19 registry, as well as the results of the community surveys. The ultimate project outcome is the dynamic prediction modelling for COVID-19 pandemic in Rwanda. DISCUSSION: The project is the first on the African continent leveraging AI and implementation of an OMOP CDM based federated data network for data harmonization. Such infrastructure is scalable for other pandemics monitoring, outcomes predictions, and tailored response planning.

Cultural adaptation and psychometric evaluation of the Kinyarwanda version of the diabetes-39 (D-39) questionnaire.

BACKGROUND: In recent years, more importance is being given to the assessment of quality of life (QoL) among diabetic patients as a measure of their health and the goal of all health interventions. Other studies have reported a high prevalence of diabetes-related effects on; however, there is a knowledge gap in the region of Sub-Saharan Africa, as is the case for Rwanda, where the prevalence of diabetes is expected to rise over the next decade. The aim of this study is to report on the translation and cultural adaptation of the Diabetes-39 (D-39) questionnaire into the Kinyarwanda and its psychometric properties among diabetic patients in Rwanda. METHODS: The D-39 questionnaire-a five-scale, disease-specific QoL questionnaire-was translated from English to Kinyarwanda, then back-translated to English. A consensus meeting discussed discrepancies and agreed on changes. Interviews were conducted with 26 participants before producing a final version. For the psychometric evaluation, the adapted version was administered to 309 patients with diabetes mellitus. Participants either came from a separate cluster-randomised controlled trial or were recruited ad hoc for this study. The evaluation included testing internal consistency, known group validity, and construct validity. RESULTS: Participants' mean age was 51 ± 12.7 years with a predominance of women (64%) in the sample. All five scales of the questionnaire showed a good internal consistency, with composite reliability of above 0.7. The five-factor model of the questionnaire was fitted to the 39 items. Although the fit was not exact, there was a satisfactory approximate fit (CFI = 0.93, TLI = 0.92, RMSEA = 0.05). There was a good discriminant validity except for the "social burden" and "anxiety and worry" scales (inter-factor correlation = 0.80). CONCLUSIONS: Diabetes-39 is a questionnaire developed in English that was adapted and translated into Kinyarwanda. The Kinyarwanda version of D-39 is a reliable and valid instrument to measure QoL among diabetic patients in Rwanda. The questionnaire can be helpful in research and clinical practice improving health outcomes for patients with diabetes in Rwanda and other Kinyarwanda-competent areas in the sub-region. However, certain cross-cultural differences should be considered.

Safety, reactogenicity, and immunogenicity of a 2-dose Ebola vaccine regimen of Ad26.ZEBOV followed by MVA-BN-Filo in healthy adult pregnant women: study protocol for a phase 3 open-label randomized controlled trial.

BACKGROUND: Risks to mother and fetus following Ebola virus infection are very high. Evaluation of safety and immunogenicity of non-replicating Ebola vaccine candidates is a priority for use in pregnant women. This is the protocol for a randomized, open-label, single-center phase 3 clinical trial of the safety, reactogenicity, and immunogenicity of the 2-dose Ebola vaccine regimen in healthy adult pregnant women. This 2-dose regimen has been shown to be safe, judged effective, and approved in non-pregnant populations. METHODS: A total of 2000 adult (≥ 18 years of age) pregnant women will be enrolled from antenatal care facilities in Western Rwanda and randomized (1:1) to receive the 2-dose Ebola vaccine regimen (Ad26.ZEBOV, MVA-BN-Filo (group A)) or control (unvaccinated pregnant women (group B)). The primary objectives are to (1) assess adverse maternal/fetal outcomes in randomized pregnant women up to 1.5 months after delivery and (2) assess adverse neonatal/infant outcomes in neonates/infants born to randomized women up to 3.5 months after birth. The frequency and relatedness of all serious adverse events in women and newborns from randomization or birth, respectively, until study end will be reported. The reactogenicity and unsolicited adverse events of the 2-dose Ebola vaccine regimen in all vaccinated pregnant women (group A) will be reported. We will also assess the immunogenicity of the 2-dose Ebola vaccine regimen in 150 pregnant women who are anticipated to receive both vaccine doses within the course of their pregnancy (a subset of the 1000 pregnant vaccinated women from group A) compared to 150 non-pregnant women vaccinated after delivery (a subset of group B). The persistence of maternal antibodies in 75 infants born to women from the group A subset will be assessed. Exploratory analyses include assessment of acceptability of the 2-dose Ebola vaccine regimen among group A and assessment of maternal antibodies in breast milk in 50 women from group A and 10 controls (women from group B prior to vaccination). DISCUSSION: This study is intended to support a label variation to relax restrictions on use in pregnant women, a vulnerable population with high medical need. TRIAL REGISTRATION: Clinicaltrials.gov NCT04556526 . September 21, 2020.

Long-term effect of chronic hepatitis B on mortality in HIV-infected persons in a differential HBV transmission setting.

BACKGROUND: There remain gaps in quantifying mortality risk among individuals co-infected with chronic hepatitis B (HBV) and human immunodeficiency virus (HIV) in sub-Saharan African contexts. Among a cohort of HIV-positive individuals in Rwanda, we estimate the difference in time-to mortality between HBV-positive (HIV/HBV co-infected) and HBV-negative (HIV mono-infected) individuals. METHODS: Using a dataset of HIV-infected adults screened for hepatitis B surface antigen (HBsAg) from January to June 2016 in Rwanda, we performed time-to-event analysis from the date of HBsAg results until death or end of study (31 December 2019). We used the Kaplan-Meier method to estimate probability of survival over time and Cox proportional hazard models to adjust for other factors associated with mortality. RESULTS: Of 21,105 available entries, 18,459 (87.5%) met the inclusion criteria. Mean age was 42.3 years (SD = 11.4) and 394 (2.1%) died during follow-up (mortality rate = 45.7 per 100,000 person-months, 95% confidence interval (CI) 41.4-50.4) Mortality rate ratio for co-infection was 1.7, 95% CI 1.1-2.6, however, Cox regression analysis did not show any association with mortality between compared groups. The adjusted analysis of covariates stratified by co-infection status showed that males, residing outside of the capital Kigali, drinking alcohol, WHO-HIV-clinical stage 3 and 4 were associated with increased mortality in this HIV cohort. CONCLUSIONS: HBV infection does not significantly influence mortality among HIV-infected individuals in Rwanda. The current cohort is likely to have survived a period of high-risk exposure to HBV and HIV mortality and limited health care until their diagnosis.