Prevalence of HIV in people with potential HIV-indicator conditions in Germany: an analysis of data from statutory health insurances.

Background: In care of people living with human immunodeficiency virus (HIV), early diagnosis of infection is one of the greatest challenges remaining. A promising approach to increase early diagnosis could be optimized HIV testing in persons with indicator conditions (ICs). ICs are conditions which are AIDS-defining in people living with HIV, conditions that may have significant adverse consequences for the individual's clinical management if the presence of HIV infection is not detected, and conditions with an (undiagnosed) HIV prevalence of ≥0.1%. Methods: In this cohort study, anonymous routine healthcare data of German statutory health insurances from 07/01/2016 to 06/30/2021 based on insured persons with an ICD-10-based diagnosis of selected ICs were analyzed. In a primary analysis, two stratifications (gender and age), and four sensitivity analyses HIV prevalence/incidence were calculated for persons with at least one of 26 IC described in international literature. This study is registered in the German Clinical Trials Register (identifier: DRKS0002874). Findings: Routine healthcare data from 513,509 insured persons were selected for analysis. In the primary analysis, only in malignant neoplasm of bronchus and lung a HIV prevalence was observed with a 95%-CI < 0.1%. ICs with particularly high HIV prevalence were pneumocystosis (40.33%), oral hairy leukoplakia (36.71%), and Kaposi's sarcoma (29.86%). When stratified by gender, it was observed that in female patients, the 95%-CI of HIV prevalence fell below 0.1% for seven ICs. No such effect was observed in male patients. Stratified by age, among patients aged 30 to <60 years, the 95%-CI of HIV prevalence were always ≥0.1%, while in the other groups the 95%-CI fell below 0.1% for several ICs. Interpretation: In samples of patients with ICs in Germany, HIV prevalences/incidences were found to be ≥0.1% for all ICs except malignant neoplasm of bronchus and lung. This confirms the classification of these conditions as ICs for the German context and emphasizes the importance of HIV testing in these populations. Funding: This analysis is part of the HIV testing recommendations in guidelines and practice study (German title of the study: "HIV-Testempfehlungen in Leitlinien und Praxis"; acronym: HeLP), which is funded by the German Federal Joint Committee as part of the Innovationsfonds program to further develop the German healthcare system (funding number 01VSF21050).

Routine Data Analysis of HIV Pre-Exposure Prophylaxis Use and Rates of Sexually Transmitted Infections Since Coverage of HIV Pre-Exposure Prophylaxis by the Statutory Health Insurance in Germany.

Human immunodeficiency virus pre-exposure prophylaxis (PrEP) is considered as an effective protection against a human immunodeficiency virus (HIV) infection. However, it is still unclear, how PrEP use is associated with the incidence of sexually transmitted infections (STI) other than HIV. PrEP became reimbursable in Germany from September 1, 2019 for persons with statutory health insurance (SHI). With the EvE-PrEP study, the Federal Ministry of Health commissioned the evaluation of the effects of the new reimbursement situation in Germany. In the presented module of the EvE-PrEP study, routine data from three large German SHI funds were analyzed in anonymized form for the period January 1, 2019 to March 31, 2020. Data were analyzed regarding: Characteristics and adherence of PrEP users, treatment success of PrEP, and changes in STI incidence rates before and since PrEP use. The cooperating SHI funds collectively covered about 52% of the overall population in Germany in 2019. A total of 7102 persons with PrEP use were included into the analysis. These were predominantly male (99%), on average 37.4 years old and a high proportion of persons lived in large cities. The average quotient of PrEP daily defined doses and assumed days on PrEP was 87%. The average STI rates normalized per 100 person-years at individual level pre PrEP did not statistically significant differ compared to since PrEP (chlamydia: 17.5 vs. 17.6, gonococcal infection: 29.1 vs. 30.7, and syphilis: 14.6 vs.13.6). A large data set was used to evaluate the introduction of PrEP as a SHI benefit in Germany. A potentially suspected increase in bacterial STI incidence rates was not found. A rather high average adherence rate was observed. The very high proportion of men and people from the largest German cities among PrEP users is striking. These results could indicate barriers to PrEP access for people at risk of HIV, especially if they are women or people living in less urban areas.

Optimization of HIV testing services in Germany using HIV indicator diseases: study protocol of the HeLP study.

BACKGROUND: Despite the potentially accompanying negative clinical, epidemiologic, and health economic effects, a large proportion of persons living with the human immunodeficiency virus (HIV) are diagnosed late. Internationally, numerous diseases are known to be HIV indicator diseases. Adequate HIV testing in the presence of HIV indicator diseases could help to diagnose unknown HIV infections earlier. The objective of the HeLP study is to validate published HIV indicator diseases for the German setting and to identify guidelines in terms of these indicator diseases in order to reduce knowledge gaps and increase HIV testing when HIV indicator diseases are diagnosed. METHODS: A mixed methods approach is used. In a first step, published HIV indicator diseases will be identified in a systematic literature review and subsequently discussed with clinical experts regarding their relevance for the German setting. For the validation of selected indicator diseases different data sets (two cohort studies, namely HIV-1 seroconverter study & ClinSurv-HIV, and statutory health insurance routine data) will be analyzed. Sensitivity analyses using different time periods will be performed. Guidelines of HIV indicator diseases validated in the HeLP study will be reviewed for mentioning HIV and for HIV testing recommendations. In addition, semi-standardized interviews (followed by a free discussion) with guideline creators will identify reasons why HIV testing recommendations were (not) included. Subsequently, a random sample of physicians in medical practices will be surveyed to identify how familiar physicians are with HIV testing recommendations in guidelines and, if so, which barriers are seen to perform the recommended tests in everyday care. DISCUSSION: The HeLP-study adopts the challenge to validate published HIV indicator diseases for the German setting and has the potential to close a knowledge gap regarding this objective. This has the potential to improve targeted HIV testing for patients with HIV indicator diseases and consequently lead to earlier HIV diagnosis. TRIAL REGISTRATION: DRKS00028743.

Quality of life and healthcare costs of patients with allergic respiratory diseases: a cross-sectional study.

BACKGROUND: Allergic rhinitis (AR) and allergic asthma (AA) are chronic respiratory diseases that represent a global health problem. One aim of this study was to analyze the Health-related Quality of Life (HRQoL) of the patients in order to identify statistically significant influencing factors that determine HRQoL. Another aim was to assess and analyze data on cost-of-illness from a statutory health insurance perspective. METHODS:  The EQ-5D-5L was used to evaluate the patients' HRQoL. To identify the factors influencing the HRQoL, a multinomial logistic regression analysis was conducted using groups based on the EQ-5D-5L index value as dependent variable. Routine data were analyzed to determine total healthcare costs. RESULTS:  The average EQ-5D-5L index was 0.85 (SD 0.20). A high age, the amount of disease costs, low internal health-related control beliefs and high ozone exposure in the residential area were found to be statistically significant influencing factors for a low HRQoL, whereas low age, male sex and a good possibility to avoid the allergens were found to be statistically significant factors influencing a high HRQoL. On average, the study participants incurred annual costs of €3072 (SD: 3485), of which €699 (SD: 743) could be assigned to allergic respiratory diseases. CONCLUSIONS:  Overall, the patients in the VerSITA study showed a high level of HRQoL. The identified influencing factors can be used as starting points for improving the HRQoL of patients with allergic respiratory diseases. From the perspective of a statutory health insurance, per person expenditures for allergic respiratory diseases are rather low.

[Evaluating the introduction of HIV pre-exposure prophylaxis as a benefit of statutory health insurance (EvE-PrEP) : Highly effective protection against HIV without an increase in sexually transmitted infections]. / Evaluation der Einführung der HIV-Präexpositionsprophylaxe als Leistung der gesetzlichen Krankenversicherung (EvE­PrEP) : Hocheffektiver Schutz vor HIV und keine Zunahme von sexuell übertragbaren Infektionen.

BACKGROUND: We investigated the impact of HIV pre-exposure prophylaxis (PrEP) as a new service of the statutory health insurance (SHI) on the incidence of HIV and other sexually transmitted infections (STIs) in Germany. In addition, PrEP needs and access barriers were analyzed. METHODS: The following data were evaluated as part of the evaluation project: HIV and syphilis notification data and extended surveillance by the Robert Koch Institute (RKI), pharmacy prescription data, SHI routine data, PrEP use in HIV-specialty care centers, Checkpoint, the BRAHMS and PrApp studies, as well as a community board. RESULTS: The majority of PrEP users were male (98-99%), primarily aged between 25-45 years, and predominantly of German nationality or origin (67-82%). The majority were men who have sex with men (99%). With regard to HIV infections, PrEP proved to be highly effective. There were only isolated cases of HIV infections (HIV incidence rate 0.08/100 person years); in most cases the suspected reason was low adherence. The incidences of chlamydia, gonorrhea, and syphilis did not increase but remained almost the same or even decreased. A need for information on PrEP for people in trans*/non-binary communities, sex workers, migrants, and drug users emerged. Needs-based services for target groups at increased risk of HIV are necessary. DISCUSSION: PrEP proved to be a very effective HIV prevention method. The partly feared indirect negative influences on STI rates were not confirmed in this study. Due to the temporal overlap with the containment measures during the COVID-19 pandemic, a longer observation period would be desirable for a conclusive assessment.

On the current psychotherapeutic situation for persons with pornography use disorder in Germany.

Background and aims: For the first time, the ICD-11 provides the diagnosis compulsive sexual behavior disorder (CSBD) that can be assigned for pornography use disorder (PUD). This study aimed to estimate the prevalence of PUD and associated consequences in Germany, to identify the psychotherapy demand among likely PUD (lPUD) cases and the treatment supply in different psychotherapeutic settings, to survey psychotherapists' level of expertise regarding PUD, and to identify predictors for psychotherapy demand. Methods: Four studies were conducted: 1. Online study in the general population (n = 2070; m = 48.9%, f = 50.8%, d = 0.2%), 2. Survey among practicing psychotherapists (n = 983), 3. Survey of psychotherapists in psychotherapeutic outpatient clinics (n = 185), 4. Interviews with psychotherapeutic inpatient clinics (n = 28). Results: The estimated prevalence of lPUD in the online study was 4.7% and men were 6.3 times more often affected than women. Compared to individuals without PUD, individuals with lPUD more often indicated negative consequences in performance-related areas. Among lPUD cases, 51.2% of men and 64.3% of women were interested in a specialized PUD treatment. Psychotherapists reported 1.2%-2.9% of lPUD cases among their patients. 43.2%-61.5% of psychotherapists stated to be poorly informed about PUD. Only 7% of psychotherapeutic inpatient clinics provided specific treatments to patients with PUD. While, among other factors, negative consequences attributed to lPUD were predictive for psychotherapy demand, weekly pornography consumption, subjective well-being, and religious attachment were not. Discussion and conclusions: Although PUD occurs quite often in Germany, availability of mental health care services for PUD is poor. Specific PUD treatments are urgently needed.

Socio-demographic and psycho-social determinants of HIV late presentation in Germany - results from the FindHIV study.

Delayed HIV diagnosis at advanced stages of disease remains common (33%-64%). This analysis of the multi-center FindHIV study including newly diagnosed HIV-infected adults in Germany, focused on the potential role of socio-demographic and psychological factors on late diagnosis (formerly "late presentation", AIDS diagnosis or CD4 cells <350/µL). These data were collected from patient profiles, physician-patient interviews and questionnaires. Participating centers (n = 40) represented the diverse health care settings in HIV care and geographic regions. Of 706 newly diagnosed adults (92% male, median age 39 years) between 2019 and 2020, 55% (388/706) were diagnosed late with a median CD4 cell count of 147/µL; 20% (142/706) presented with AIDS. From the physicians' perspective, earlier diagnosis would have been possible in 45% of participants (late versus non-late presentation 58% versus 29%). The most common physician-perceived reason was an underestimated risk for HIV infection by the patient (37%). In multivariable logistic regression analysis, older age, sexual contacts with both sexes as possible route of HIV transmission, being married, and a poor level of knowledge about HIV treatment were found to be associated with a significantly elevated risk for late presentation. Education, employment status, sexual relations, migration background and personality traits were not.Trial registration: German Clinical Trials Register (DRKS00016351).

Care with allergen immunotherapy for allergic respiratory diseases in Germany-Predictors and deficits.

BACKGROUND: Allergen immunotherapy (AIT) represents the only possibility of causal therapy for allergic respiratory diseases. Although the prevailing high prevalence of allergic diseases and restrictions in the daily lives of patients, AIT is offered to a suboptimal number of patients in Germany. METHODS: Insured patients with documented allergic respiratory disease of one of the largest statutory health insurances in Germany, 'DAK-Gesundheit', were contacted by postal mail and asked to participate in the study. In case of written consent, primary and secondary data of patients were collected and analysed. Patient characteristics, predictors of being offered AIT, predictors of performing AIT and guideline-compliant care were analysed. RESULTS: 2505 subjects were included in the VerSITA study. Allergy to tree pollen and native speaking were identified as predictors, which increase the probability of being offered AIT. The probability was significantly decreased by the characteristics allergic rhinitis only, allergic asthma only, age in years, non-German citizenship, no graduation and lower secondary qualification. Significant positive predictors for an AIT to be actually performed were: Allergy to tree pollen and male sex. Predictors that decrease the likelihood that AIT is performed were: only allergic asthma, current smoker, former smoker, age and non-German citizenship. Furthermore, it was possible to identify characteristics in which guideline-compliant patients differed significantly from the rest of the study population. CONCLUSIONS: Based on statutory health insurance data and patient survey data, the VerSITA study provides a broad and in-depth overview of the care situation with regard to AIT in Germany and identifies deficits.

National medical specialty guidelines of HIV indicator conditions in Europe lack adequate HIV testing recommendations: a systematic guideline review.

BackgroundAdequate identification and testing of people at risk for HIV is fundamental for the HIV care continuum. A key strategy to improve timely testing is HIV indicator condition (IC) guided testing.AimTo evaluate the uptake of HIV testing recommendations in HIV IC-specific guidelines in European countries.MethodsBetween 2019 and 2021, European HIV experts reviewed guideline databases to identify all national guidelines of 62 HIV ICs. The proportion of HIV IC guidelines recommending HIV testing was reported, stratified by subgroup (HIV IC, country, eastern/western Europe, achievement of 90-90-90 goals and medical specialty).ResultsOf 30 invited European countries, 15 participated. A total of 791 HIV IC guidelines were identified: median 47 (IQR: 38-68) per country. Association with HIV was reported in 69% (545/791) of the guidelines, and 46% (366/791) recommended HIV testing, while 42% (101/242) of the AIDS-defining conditions recommended HIV testing. HIV testing recommendations were observed more frequently in guidelines in eastern (53%) than western (42%) European countries and in countries yet to achieve the 90-90-90 goals (52%) compared to those that had (38%). The medical specialties internal medicine, neurology/neurosurgery, ophthalmology, pulmonology and gynaecology/obstetrics had an HIV testing recommendation uptake below the 46% average. None of the 62 HIV ICs, countries or medical specialties had 100% accurate testing recommendation coverage in all their available HIV IC guidelines.ConclusionFewer than half the HIV IC guidelines recommended HIV testing. This signals an insufficient adoption of this recommendation in non-HIV specialty guidelines across Europe.

Understanding and avoiding late presentation for HIV diagnosis - study protocol of a trial using mixed methods (FindHIV).

Many patients infected with HIV are diagnosed at an advanced stage of illness. These late presenters are individuals with a CD4 cell count of less than 350 cells/µL and/or an AIDS defining disease at initial HIV diagnosis. Purpose of FindHIV is to develop and distribute a questionnaire/scoring system aimed at a reduction in late presentation. FindHIV uses a mixed methods approach. In a first step, primary data of patients were collected. Inclusion criteria were: age ≥ 18 years, cognitive ability and language skills to participate in the study, initial HIV diagnosis within the past 6 months, and patient informed consent. Descriptive methods and regression models are used to identify: (1) patient characteristics associated with late presentation and (2) contacts to the healthcare system with indicator diseases that did not lead to HIV testing. Secondly, a questionnaire/scoring system is created by an expert panel. Afterwards the questionnaire/scoring system is to be disseminated. The greatest challenge was in reaching an adequate sample size. Another risk may be a recall bias. Nevertheless, FindHIV is devised as an in-depth study of the phenomenon of late presentation with potential to significantly improve HIV detection.

Cost of Human Immunodeficiency Virus (HIV) and Determinants of Healthcare Costs in HIV-Infected Treatment-Naive Patients Initiated on Antiretroviral Therapy in Germany: Experiences of the PROPHET Study.

OBJECTIVES: The purpose of the prospective clinical and pharmacoeconomic outcomes study of different first-line antiretroviral treatment strategies (PROPHET) was to examine the healthcare costs of human immunodeficiency virus (HIV)-infected persons in Germany treated with different antiretroviral therapy (ART) strategies and to identify variables associated with high costs. METHODS: The setting was a 24-month prospective multicenter observational cohort study in a German HIV-specialized care setting from 2014 to 2017. A microcosting approach was used for the estimation of healthcare costs. Data were obtained via electronic case report forms. The costs were calculated from both the societal and the statutory health insurance perspective. Regression models were performed that took into consideration the impact of several independent variables. RESULTS: Four hundred thirty-four patients from 24 centers throughout Germany were included. Average annual healthcare costs were €20 118 (standard deviation [SD] €6451) per patient from the societal perspective (n = 336) and €17 306 (SD €4106) from the statutory health insurance perspective (n = 292). Expenditures for the ART medication had the highest impact. Total costs declined in the second year of therapy. There was a significant association between the amount of total cost and clinical or therapeutic variables from both perspectives; a diagnosis of acquired immune deficiency syndrome (AIDS) led to higher costs as well as the chosen ART strategy. Age also increased cost from the statutory health insurance perspective. CONCLUSIONS: The main cost driver of the healthcare costs for HIV-positive patients was antiretroviral drug expenses. Further variables that influenced the costs were identified. The results provide a detailed overview of the resource use of patients in the PROPHET cohort.