Abstract
Background
Egypt has fastest-growing HIV rate in the Middle East and North Africa. This study aimed to determine the prevalence of late diagnosis (LD) and examine the associated epidemiological and clinical characteristics in a cohort of Egyptian individuals living with HIV.
Methods
A cross sectional study included newly diagnosed people living with HIV (PLHIV) who presented to the Cairo University HIV Clinic between September 2022 and May 2023. People with a CD4 + cell count <350 cells/µL or an AIDS-defining event were classified as Late disease (LD), while those who presented with a CD4 + cell count <200 cells/µL or an AIDS-defining event were classified as LD with advanced HIV disease (LDAD). Descriptive statistics were used to characterize the study population. Chi-square test and independent t-test were employed to compare categorical and continuous variables between groups. Logistic regression analysis was performed to identify factors associated with late diagnosis. Statistical significance was set at p < 0.05.
Results
Out of 402 newly diagnosed individuals, 65 (16.2%) had LDAD and 172 (42.8%) had LD. The mean age of LD patients was 36.8 ± 10.5 years, and 82.6% were male. The majority (57.4%) had a viral load more than 10,000–100,000 copies/ml. AIDS-related conditions were observed in 52 patients (30.2%), with wasting syndrome (27%), lymphoma (19%), recurrent bacterial infections (19%), and tuberculosis (15%), being the most common..
Conclusion
The high prevalence of LD among newly diagnosed PLHIV emphasizes the need for interventions for early HIV testing, and enhancing prevention programs to facilitate early diagnosis and timely initiation of treatment.
Background
According to the Joint United Nations data on HIV/AIDS (UNAIDS), approximately 39.9 million people worldwide were living with HIV in 2024.1. UNAIDS has ambitious 95–95–95 target to combat the HIV/AIDS epidemic, aiming for 95% of people living with HIV (PLHIV) to know their status, 95% of them receiving antiretroviral therapy (ART), and 95% of those receiving treatment to achieve viral suppression by 2025. 2 One major concern hindering these goals is the late HIV diagnosis (LD). Egypt has the fastest-growing HIV rate in the Middle East and North Africa, with a 25%–30% annual increase in the number of new cases over the last decade. 3 Despite a low HIV prevalence of <0.02% among the general population, the country faces a concentrated epidemic among key populations, including people who inject drugs (PWID) and men who have sex with men (MSM). According to UNAIDS data, only 74% of PLHIV in Egypt are aware of their status, 47% are receiving treatment, and just 39% have achieved viral suppression. 4
Late HIV diagnosis (LD) has been defined as a person first diagnosed with HIV with a CD4 count below 350 cells/mm3 or with an AIDS defining event (ADE), regardless of the CD4 count, excluding individuals with evidence of recent HIV infection.5,6
Late Diagnosis of PLHIV has negative consequences for both individual health and public health systems. Delayed HIV diagnosis significantly increases the risk of unintentional HIV transmission among individuals unaware of their status, with this risk estimated to be at least three times higher than for those diagnosed early. 7 Studies have also revealed that LD has worse immune recovery than do people with early diagnosis, and a lower CD4 count is associated with a greater incidence of non-AIDS-defining malignancies.8,9 Additionally, LD is related to increased morbidity and mortality due to increased risk of opportunistic infections such as invasive fungal and bacterial infections and tuberculosis.10,11
A recent large Italian study that included 6813 patients demonstrated that individuals with late diagnosis had a significantly greater risk of all-cause mortality compared to those diagnosed earlier. 10 Moreover, LD group were more likely to experience treatment failure than their asymptomatic counterparts. 10 LD has also been associated with a greater risk for drug-related toxicities, such as anemia 11 and immune reconstitution inflammatory syndrome (IRIS). 12
To the best of our knowledge there are no previous Egyptian studies describing the prevalence and characteristics of LD among people newly diagnosed with HIV. The aim of this study was to estimate the prevalence and epidemiological and clinical characteristics of late diagnosis among newly diagnosed HIV-positive individuals attending the HIV clinic in Cairo, Egypt.
Methods
Study design
A cross sectional study reviewed the medical records of newly diagnosed HIV-positive individuals who presented to the HIV clinic at Cairo University Hospital between September 2022 and May 2023.
Study settings-site
The study was conducted in HIV clinic at Cairo University Hospital is a tertiary care facility affiliated with Cairo University in Cairo, Egypt. The clinic was established in September 2022. The clinic provides initial evaluations for newly diagnosed patients and ongoing follow-up care for individuals on ART. This includes routine screening and management for viral hepatitis, syphilis, and opportunistic infections, as well as monitoring and managing metabolic comorbidities. We provide medical care for aound 80 patients per month with a total number of 1500 patients active in care.
Study population
The study included newly diagnosed HIV-positive individuals,diagnosed by positive HIV antigen antibody test and positive HIV RNA PCR.
Inclusion and exclusion criteria
Inclusion criteria were: (1) ART-naive at the time of the recorded CD4 + T-cell count; (2) aged 18 years or older; and (3) had a documented CD4 + T-cell count within 3 months of HIV diagnosis. Exclusion criteria were (1) PLHIV whose CD4 + T-cell count was not recorded, (2)whose first CD4 + T-cell count was obtained more than 3 months after diagnosis, or those who had initiated ART prior to their first CD4 + count measurement.
Sample size
This cross-sectional study included all newly diagnosed HIV-positive individuals who met inclusion criteria during the study period (September 2022 to May 2023). No formal a priori sample size calculation was performed, as this was a descriptive study including all eligible patients presenting during the specified timeframe (n = 402). Post-hoc analysis demonstrated that with 402 participants and observed prevalences of 42.8% for late diagnosis (LD) and 16.2% for late diagnosis with advanced disease (LDAD), the study achieved precisions of ±4.85% and ±3.60% at 95% confidence level, respectively. These precisions are adequate for reliable prevalence estimation, with the LDAD precision falling within the recommended range of 3%–5%.
Sampling techniques
A consecutive sampling technique was employed, whereby all newly diagnosed HIV-positive individuals who met the inclusion criteria and presented to the clinic during the study period were enrolled. This approach minimized selection bias and ensured representation of the target population.
Sampling variables
Dependent variables
Late Diagnosis (LD): defined as HIV diagnosis with CD4 count <350 cells/mm3 or presentation with an AIDS-defining event.
Late Diagnosis with Advanced Disease (LDAD): defined as HIV diagnosis with CD4 count <200 cells/mm3 or presentation with an AIDS-defining event.
Independent variables
Sociodemographic: age, gender, sexual orientation, residence, educational level, employment, marital status.
Clinical: symptoms at diagnosis, comorbidities (diabetes, hypertension, cardiovascular disease), BMI.
Laboratory: HIV viral load, hemoglobin, opportunistic infections, malignancies, AIDS-defining conditions.
Data collection
Data collection was performed through systematic review of medical records and clinic databases. A standardized data extraction form was developed by the research team to ensure consistency. Medical data were retrieved from electronic medical records, laboratory information systems, clinic visit records, and hospital admission records. Data collection was performed by trained medical personnel who underwent training on the study protocol and confidentiality requirements.
Ethical considerations
This study was conducted in accordance with the Declaration of Helsinki and approved by the Medical Ethics Board of the Faculty of Medicine, Cairo University (IRB: NO-0329(V2)).
Written informed consent
Written informed consent was obtained from all participants. The consent process included explanation of the study’s purpose, voluntary nature, right to withdraw, and confidentiality measures.
Confidentiality and data protection
All patient data were de-identified with unique study IDs. Electronic data on password-protected computers; hard copies in locked cabinets. Access limited to authorized personnel.
Definitions of terms
Late Diagnosis (LD): First HIV diagnosis with CD4 <350 cells/mm3 or AIDS-defining event.
Late Diagnosis with Advanced Disease (LDAD): First HIV diagnosis with CD4 <200 cells/mm3 or AIDS-defining event.
AIDS-defining events: CDC classification conditions including OIs, AIDS-related malignancies, wasting syndrome, HIV-associated dementia.
Opportunistic malignancies: Cancers with increased frequency in immunocompromised individuals.
HIV infection diagnosis: Confirmed by positive 4th generation ELISA and HIV RNA PCR.
Newly diagnosed HIV infection: Diagnosis within 3 months prior to or at clinic presentation.
Clinical management after HIV diagnosis
All patients diagnosed with HIV, including those with LD or LDAD, received comprehensive care according to:
World Health Organization (WHO) guidelines for HIV/AIDS management.
National Egyptian guidelines for HIV care (aligned with WHO).
Infectious Diseases Society of America (IDSA) guidelines for opportunistic infections.
Management included immediate ART initiation, OI screening/prophylaxis, treatment of active infections, comorbidity management, regular monitoring, and adherence counseling.
Data analysis
Data were entered into Microsoft Excel and analyzed using IBM SPSS Statistics. Descriptive statistics included mean ± SD or median and IQR for continuous variables, and frequencies and percentages for categorical variables. Independent t-test or Mann-Whitney U test compared continuous variables; chi-square or Fisher’s exact test compared categorical variables. Logistic regression identified independent predictors of late diagnosis. Statistical significance was set at p < 0.05 for all two-tailed tests.
Results
Demographic and clinical data of the included population.
HCV: hepatitis C virus; HBV: hepatitis B virus; TB: tuberculosis; CMV: cytomegalovirus; PML: progressive multifocal leukoencephalopathy; significant p value <0.05.
Immunological and virological results of the included population.
Among the 52 patients (30.2%) who had AIDS, the most common AIDS-related event was wasting syndrome attributed to HIV, which represented approximately 27% of the cases, as shown in Figure 1. Non-Hodgkin’s lymphoma and multiple or recurring bacterial infections were equally represented, each comprising 19% of the conditions. Pulmonary or extra-pulmonary tuberculosis (TB) affected 15% of the LD group, followed by patients with Kaposi sarcoma, who represented 12% of the cases. Pneumocystis pneumonia (PCP), progressive multi-focal leukoencephalopathy (PML), and cytomegalovirus (CMV) retinitis were the least common events, with percentages of 4%, 2% and 2%, respectively.
13
Distribution of AIDS defining conditions among late HIV presenters (n = 52).
As presented in figure 2, more than half of the patients with malignancies had non-Hodgkin’s lymphoma, making it the most common malignancy among our LD cohort (53%). Kaposi sarcoma ranked second, with approximately 32% of LD being affected by it. Non-AIDS-defining malignancies such as thyroid cancer and breast cancer were reported in 10% and 5% of LD group, respectively. AIDS-defining and non–AIDS-defining cancers among late presenters (n = 19).
Discussion
Despite significant efforts in the diagnosis and treatment of PLHIV, late HIV diagnosis remains a serious public health concern. Almost half of the patients (42.8%) newly diagnosed with HIV infection in our clinic were classified as LD, and 16.2% were LD with advanced HIV. This high prevalence is close to the prevalence of LD in European countries in 2017 (49%), highlighting the global significance of this challenge. 14
According to UNAIDS data, an estimated 27,000 adult males are living with HIV in Egypt, which is greater than the number of females living with HIV, which is nearly 14,000; this may explain why most LD people in our cohort were males. 15
Similarly, Jiang H. et al. Reported in their meta-analysis that males are at greater risk of LD than females. In another study, females were at significantly lower risk of late presentation (p < 0.001).16,17 This difference may be attributed to a nationwide campaign implemented in Egypt in recent years, aimed at the early screening of asymptomatic pregnant women for HIV, viral hepatitis, and syphilis to prevent mother-to-child transmission. 18 Additionally, an African study found that men were less likely to engage with public health campaigns, such as radio messages, about HIV. 19
The mean age of LD was slightly greater than that of non-LD patients. Although we did not identify a statistically significant difference in age between LD and non-LD participants, previous studies have identified older age as a determinant of LD. 20
Late HIV diagnosis was associated with significant complications in our study; for example, individuals with LD reported a notably higher prevalence of non-communicable comorbidities compared to those with non-LD. These findings align with those reported in an Italian study by Guaraldi G. et al. in 2017, where the prevalence of noninfectious comorbidities (NICM) and multi morbidity (defined as the concurrent presence of ≥2 NICM) was found to be fourfold greater in the LD than in the general population at any given age (p < 0.001). 21 The higher prevalence of comorbidities also significantly contributed to the higher cost of care for PLHIV compared to the general population, as reported in the same study. 21 This increased comorbidity burden in the LD group may be attributed to delayed health-seeking behavior, which results in a greater accumulation of comorbidities by the time individuals seek care. Additionally, the higher viral load in the LD group may have contributed to greater HIV-related immune activation and chronic inflammation. 22 The incidence of pulmonary infections is influenced by the immunological status of PLWHIV; this may explain why LD Group in our cohort who had lower CD4 + T-cell counts had significantly greater numbers of pulmonary infections.23,24
The most common AIDS-defining event in our cohort was wasting syndrome attributed to HIV, accounting for approximately 27% of AIDS-defining events; a finding consistent with in a large German cohort study conducted between 1999 and 2018. 25 Pulmonary or extrapulmonary TB was present in 15% of patients, while PCP was observed in only 4%. This aligns with literature reporting a decline in PCP cases, likely due to improved prophylaxis, while the increase in TB and bacterial infections suggests a need for enhanced preventive measures for these opportunistic infections.26,27
Another significant consequence of late HIV diagnosis was the notably higher prevalence of malignancies, which was also demonstrated in a Turkish study in which participants with CD4 counts <350/mm3 represented 79% of patients with malignancies than 53% of patients without malignancies (p < 0.001).
The distribution of malignancies in this study was similar to that in our study; thirty-five (72.9%) patients had AIDS-defining cancers, 23 had Kaposi sarcoma, and 12 had NHL. 28 In our cohort, this also may be attributed to the fact that our center being located within a tertiary care hospital, which likely contributed to the increased diagnosis of malignancies.
Our results highlight the urgent need for targeted interventions to address the issue of late HIV diagnosis to help the country meet the UNAIDS triple 95% targets. These interventions should include expanding HIV testing campaigns, particularly for high-risk populations, and enhancing public health efforts to reduce stigma, especially within healthcare settings, while promoting early engagement with healthcare services. Furthermore, improving prophylactic measures for opportunistic infections, such as tuberculosis, should be prioritized to prevent complications among individuals diagnosed late. Additionally, focusing on improving the management of noncommunicable comorbidities should be a priority in the care of PLHIV. Training healthcare providers to identify and address these comorbidities early will help mitigate their impact on patient health. Given the high prevalence of malignancies, particularly AIDS-defining cancers like Kaposi sarcoma and non-Hodgkin’s lymphoma, integrating comprehensive cancer screening into HIV care is essential for early detection and effective management of these conditions.
This is the first study to address the prevalence rates of late HIV diagnosis and AIDS among newly diagnosed individuals in Egypt, along with their epidemiological and clinical characteristics. However, our study has some limitations, including its cross sectional design, which depends on the accuracy and completeness of medical records, potentially leading to biases or missing data. Additionally, the study was conducted at a single tertiary care facility and on a limited number of subjects and timeline, which may limit the generalization of the findings to other settings or populations.
Conclusion
The high prevalence of late diagnosis among newly diagnosed individuals with HIV in our study emphasizes a critical gap in early HIV detection in Egypt. With 42.8% of newly diagnosed patients presenting with late diagnosis and 16.2% with advanced disease, our findings reveal substantial delays in HIV testing and diagnosis. The significant associations between late diagnosis and increased prevalence of comorbidities, opportunistic infections, and malignancies underscore the severe clinical consequences of delayed diagnosis. These results highlight the urgent need for interventions to promote earlier HIV testing and diagnosis in Egypt to improve individual patient outcomes and reduce community transmission.
Recommendations
Based on our findings, we recommend the following interventions to address the issue of late HIV diagnosis in Egypt: 1. Enhanced HIV testing programs: Expand PITC, routine screening, community-based testing 2. Targeted awareness campaigns: Culturally appropriate campaigns to reduce stigma, multi-platform education 3. Healthcare provider education: Train providers to recognize HIV indicators, increase testing awareness 4. Strengthening linkage to care: Rapid linkage systems, quick ART initiation, comprehensive support 5. Research priorities: Qualitative barrier studies, intervention evaluation, trend monitoring 6. Policy considerations: National testing guidelines, resource allocation, alignment with UNAIDS 95-95-95 targets
These recommendations aim to reduce the burden of late HIV diagnosis and improve outcomes for people living with HIV in Egypt.
Abbreviations Late Diagnosis (LD), Late diagnosis with advanced HIV disease (LDAD), UNAIDS, immune reconstitution inflammatory syndrome (IRIS), noninfectious comorbidities (NICM)
Footnotes
Ethics approval and consent to participate
The study was performed in accordance with the Declaration of Helsinki and approved by the Medical Ethics Board of Faculty of Medicine, (IRB no:NO-0329(V2)). All cases in this research were coded in numbers instead of names to keep confidentiality of the participants. Patients provided an informed written consent before participating in the study.
Author contributions
The concept for this study was developed by Rahma Mohamed and Ahmed Cordie. Material preparation and data collection were performed by Ahmed Cordie, Rahma Mohamed, Ammar Hatem, Lamiaa Al Sehemy, Naeema El Garhy, Reham AwadAwad, Mariam Ismail Abdelraouf, Aya M. Al-sharif, and Mirella Sherif, Gamal Esmat. Engy El Khateeb, Zainab Ali Elsaadany, and Hend Hamed Tamim carried out the laboratory work. The first draft of the manuscript was written by Lamiaa Al Sehemy. The final draft was prepared by Rahma Mohamed and Ahmed Cordie. All authors read and approved the final manuscript.
Funding
The authors received no financial support for the research, authorship, and/or publication of this article.
Declaration of conflicting interests
The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Data Availability Statement
The datasets used and analyzed during the current study are available from the corresponding author on reasonable request.
