Examining trends in the incidence of HIV infection among people with a history of drug use to inform an outbreak investigation and response: A retrospective cohort study.

BACKGROUND: In the context of an outbreak of HIV among people who inject drugs in Glasgow, Scotland, identified in 2015, our objectives were to: (1) develop epidemiological methods to estimate HIV incidence using data linkage, and (2) examine temporal changes in HIV incidence to inform public health responses. METHODS: This was a retrospective cohort study involving data linkage of laboratory HIV testing data to identify individuals with a history of drug use. Person-years (PY) and Poisson regression were used to estimate incidence by time period (pre-outbreak: 2000-2010 and 2011-2013; early outbreak: 2014-2016; ongoing outbreak: 2017-2019). RESULTS: Among 13 484 individuals tested for HIV, 144 incident HIV infections were observed from 2000 to 2019. Incidence rates increased from pre-outbreak periods (1.00/1000 PY (95% confidence interval, CI: 0.60-1.65) in 2000-2010 and 1.70/1000 PY (95% CI: 1.14-2.54) in 2011-2013) to 3.02/1000 PY (95% CI: 2.36-3.86) early outbreak (2014-2016) and 2.35 (95% CI 1.74-3.18) during the ongoing outbreak period (2017-2019). Compared with the pre-outbreak period (2000-2010), the incidence rates were significantly elevated during both the early outbreak (2014-16) (adjusted incidence rate ratio (aIRR) = 2.87, 95% CI: 1.62-5.09, p < 0.001) and the ongoing outbreak periods (2017-19) (aIRR = 2.12, 95% CI: 1.16-3.90, p = 0.015). CONCLUSIONS: Public health responses helped to curb the rising incidence of HIV infection among people with a history of drug use in Glasgow, but further efforts are needed to reduce it to levels observed prior to the outbreak. Data linkage of routine diagnostic test data to assess and monitor incidence of HIV infection provided enhanced surveillance, which is important to inform outbreak investigations and guide national strategies on elimination of HIV transmission.

Asymptomatic Rectal Bacterial Pathogens Show Large Prospective Relationships With HIV Incidence in a Cohort of Young Sexual and Gender Minorities: Implications for STI Screening and HIV Prevention.

Background: We estimated the predictive value of rectal (bacterial sexually transmitted infection [bSTI]) pathogen detection for future HIV seroconversion among young adult sexual and gender minorities (YSGMs) assigned male at birth (AMAB). Methods: Data were collected between March 2018 and August 2022 from RADAR, a longitudinal cohort study of YSGMs AMAB living in the Chicago metropolitan area (n = 1022). Rates of rectal bSTIs and the proportion of self-reported rectal bSTI symptoms are reported. We examined whether the presence of rectal bSTIs predicted HIV seroconversion using generalized estimating equations (GEEs). Results: Participants tested reactive for rectal Mycoplasma genitalium (MGen), Neisseria gonorrhoeae (NG), and Chlamydia trachomatis (CT) at a rate of 20.8 (95% CI, 18.4-23.5), 6.5 (95% CI, 5.0-8.2), and 8.4 (95% CI, 6.8-10.3) cases per 100 persons, respectively. There were no statistically significant pairwise differences in self-reported rectal bSTI symptoms between participants with self-collected swabs testing nonreactive vs reactive for rectal MGen (χ2 = 0.04; P = .84), NG (χ2 = 0.45; P = .37), or CT (χ2 = 0.39; P = .46). In multivariate GEE analysis, rectal NG (adjusted odds ratio, 5.11; 95% CI, 1.20-21.77) was a statistically significant predictor of HIV seroconversion after controlling for other bSTIs, demographics, and sexual risk behavior. Conclusions: Our findings provide a robust longitudinal estimation of the relationship between primarily asymptomatic rectal NG nucleic acid detection and HIV infection. These findings highlight the importance of asymptomatic screening for bSTIs and targeting biobehavioral intervention to prevent HIV infection among YSGMs with rectal bSTI agents detected.

Pre-exposure prophylaxis (PrEP) use trajectories and incidence of HIV and other sexually transmitted infections among PrEP users in Belgium: a cohort analysis of insurance claims data from 2017 to 2019.

BACKGROUND: Since June 2017, oral pre-exposure prophylaxis (PrEP) has been reimbursed in Belgium for people at substantial risk of HIV. To inform the national PrEP programme, we described sociodemographic characteristics of PrEP users, PrEP dispensing practices, testing for HIV and sexually transmitted infections (STIs; gonorrhoea, chlamydia and syphilis), and incidence of HIV and STIs. METHODS: Analysis of routinely collected social health insurance claims data from all individuals who were dispensed at least one PrEP prescription between June 2017 and December 2019. Using logistic regression adjusted for age, we examined associations between sociodemographic characteristics and having been dispensed PrEP only once in the first six months of PrEP use. RESULTS: Overall, 4559 individuals were dispensed PrEP. Almost all PrEP users were male (99.2%, 4522/4559), with a median age of 37 years (IQR 30-45). A minority were entitled to an increased healthcare allowance (11.4%, 514/4559). 18% (657/3636) were dispensed PrEP only once in the first six months of PrEP use. PrEP users younger than 25 years, unemployed, entitled to an increased healthcare allowance, and who initiated PrEP between January 2019 and June 2019 were more likely to have had no PrEP dispensing after initiation compared to their counterparts. The testing rates for bacterial STIs and HIV were 4.2 tests per person-year (95% CI 4.1-4.2) and 3.6 tests per person-year (95% CI 3.5-3.6), respectively. Twelve individuals were identified to have seroconverted during the study period, resulting in an HIV incidence rate of 0.21/100 person-years (95% CI 0.12-0.36). The incidence of bacterial STIs was 81.2/100 person-years (95% CI 78.7-83.8). CONCLUSIONS: The study highlights challenges in PrEP persistence and a high incidence of bacterial STIs among individuals receiving PrEP. Tailored prevention support is crucial for individuals with ongoing HIV risk to optimise PrEP effectiveness. Integrated STI testing and prevention interventions within PrEP care are necessary to mitigate STI acquisition and transmission among PrEP users.

Investigating the effects of cytokine biomarkers on HIV incidence: a case study for individuals randomized to pre-exposure prophylaxis vs. control.

Introduction: Understanding and identifying the immunological markers and clinical information linked with HIV acquisition is crucial for effectively implementing Pre-Exposure Prophylaxis (PrEP) to prevent HIV acquisition. Prior analysis on HIV incidence outcomes have predominantly employed proportional hazards (PH) models, adjusting solely for baseline covariates. Therefore, models that integrate cytokine biomarkers, particularly as time-varying covariates, are sorely needed. Methods: We built a simple model using the Cox PH to investigate the impact of specific cytokine profiles in predicting the overall HIV incidence. Further, Kaplan-Meier curves were used to compare HIV incidence rates between the treatment and placebo groups while assessing the overall treatment effectiveness. Utilizing stepwise regression, we developed a series of Cox PH models to analyze 48 longitudinally measured cytokine profiles. We considered three kinds of effects in the cytokine profile measurements: average, difference, and time-dependent covariate. These effects were combined with baseline covariates to explore their influence on predictors of HIV incidence. Results: Comparing the predictive performance of the Cox PH models developed using the AIC metric, model 4 (Cox PH model with time-dependent cytokine) outperformed the others. The results indicated that the cytokines, interleukin (IL-2, IL-3, IL-5, IL-10, IL-16, IL-12P70, and IL-17 alpha), stem cell factor (SCF), beta nerve growth factor (B-NGF), tumor necrosis factor alpha (TNF-A), interferon (IFN) alpha-2, serum stem cell growth factor (SCG)-beta, platelet-derived growth factor (PDGF)-BB, granulocyte macrophage colony-stimulating factor (GM-CSF), tumor necrosis factor-related apoptosis-inducing ligand (TRAIL), and cutaneous T-cell-attracting chemokine (CTACK) were significantly associated with HIV incidence. Baseline predictors significantly associated with HIV incidence when considering cytokine effects included: age of oldest sex partner, age at enrollment, salary, years with a stable partner, sex partner having any other sex partner, husband's income, other income source, age at debut, years lived in Durban, and sex in the last 30 days. Discussion: Overall, the inclusion of cytokine effects enhanced the predictive performance of the models, and the PrEP group exhibited reduced HIV incidences compared to the placebo group.

HIV acute infection and long-term undisclosed HIV status among blood donors from the highly endemic Amazonas state, located in the Brazilian Amazon.

BACKGROUND: The Amazonas state/AM and Manaus rank among the highest AIDS detection rates in Brazil. High proportion of HIV infected blood donors and transmission clusters of multidrug antiretroviral/ARV resistant viruses were described in HEMOAM blood donors, a main Amazonas public blood bank. Recent and long-term infections among previously genotyped donors are reported. METHODS/MATERIALS: The recency immunoassay Lag Avidity EIA (Maxim, USA) was employed. Clinical/CD4/viral load medical file data of the main local HIV management center (FMT-HVD) and ARV treatment/ART data were reviewed. RESULTS: Among 142 HIV-blood donors, chronic infection predominated (n = 87; 61.3 %), 79 based on LAg EIA and 8 undisclosed HIV identified in FMT-HVD records, mostly young adult, single males, 4 repeat donors, all ART-naive. Recent infections represented 30.3 % (n = 43), 39 identified by LAg EIA and 4 immunologic windows (antibody negative/NAT/RNA positive). The overall profile of recent and long-term infections was similar, including moderate rate of transmitted drug resistance/TDR, however with multiple resistance mutations to more than one ARV-class, suggesting ART/failure. DISCUSSION: Recent/acute and undisclosed/long-term HIV infections represent blood safety alerts suggesting test-seeking behavior of at-risk populations. Early ART use in Brazil, can turn HIV diagnosis more challenging representing a blood transfusion risk in the highly endemic Brazilian Amazon.

An enhanced cross-sectional HIV incidence estimator that incorporates prior HIV test results.

Incidence estimation of HIV infection can be performed using recent infection testing algorithm (RITA) results from a cross-sectional sample. This allows practitioners to understand population trends in the HIV epidemic without having to perform longitudinal follow-up on a cohort of individuals. The utility of the approach is limited by its precision, driven by the (low) sensitivity of the RITA at identifying recent infection. By utilizing results of previous HIV tests that individuals may have taken, we consider an enhanced RITA with increased sensitivity (and specificity). We use it to propose an enhanced estimator for incidence estimation. We prove the theoretical properties of the enhanced estimator and illustrate its numerical performance in simulation studies. We apply the estimator to data from a cluster-randomized trial to study the effect of community-level HIV interventions on HIV incidence. We demonstrate that the enhanced estimator provides a more precise estimate of HIV incidence compared to the standard estimator.

The impact of non-disclosure of HIV status and antiretroviral therapy on HIV recency testing and incidence algorithms.

BACKGROUND AND OBJECTIVES: Accurate HIV incidence estimates among blood donors are necessary to assess the effectiveness of programs aimed at limiting transfusion-transmitted HIV. We assessed the impact of undisclosed HIV status and antiretroviral (ARV) use on HIV recency and incidence estimates using increasingly comprehensive recent infection testing algorithms. MATERIALS AND METHODS: Using 2017 donation data from first-time and lapsed donors, we populated four HIV recency algorithms: (1) serology and limiting-antigen avidity testing, (2) with individual donation nucleic amplification testing (ID-NAT) added to Algorithm 1, (3) with viral load added to Algorithm 2 and (4) with ARV testing added to Algorithm 3. Algorithm-specific mean durations of recent infection (MDRI) and false recency rates (FRR) were calculated and used to derive and compare incidence estimates. RESULTS: Compared with Algorithm 4, progressive algorithms misclassified fewer donors as recent: Algorithm 1: 61 (12.1%); Algorithm 2: 14 (2.8%) and Algorithm 3: 3 (0.6%). Algorithm-specific MDRI and FRR values resulted in marginally lower incidence estimates: Algorithm 1: 0.19% per annum (p.a.) (95% confidence interval [CI]: 0.13%-0.26%); Algorithm 2: 0.18% p.a. (95% CI: 0.13%-0.22%); Algorithm 3: 0.17% p.a. (95% CI: 0.13%-0.22%) and Algorithm 4: 0.17% p.a. (95% CI: 0.13%-0.21%). CONCLUSION: We confirmed significant misclassification of recent HIV cases when not including viral load and ARV testing. Context-specific MDRI and FRR resulted in progressively lower incidence estimates but did not fully account for the context-specific variability in incidence modelling. The inclusion of ARV testing, in addition to viral load and ID-NAT testing, did not have a significant impact on incidence estimates.

Uptake and challenges with daily oral pre-exposure prophylaxis among men who have sex with men and transgender women, suburban Yangon, Myanmar.

BACKGROUND: Pre-exposure prophylaxis (PrEP) is effective for human immunodeficiency virus (HIV) prevention in risk groups. We assessed PrEP uptake and 12-month retention among men who have sex with men (MSM) and transgender women (TGW) in Myanmar during the coronavirus disease 2019 pandemic and a political crisis. METHODS: Using prospectively collected data, we assessed the proportion of persons eligible, initiated and retained 12 months on PrEP. We calculated HIV and syphilis incidence among those initiated on PrEP. Predictors of compliance to scheduled visits were assessed with fractional logistic regression. RESULTS: Among 652 persons screened between July and December 2020, 85.3% were eligible and 38.8% initiated PrEP. The daily pill burden was the main reason (86.5%) for refusing PrEP. A history of HIV post-exposure prophylaxis (PEP) and having an HIV-positive partner not on anti-retroviral therapy (ART) was associated with PrEP uptake (p<0.05). The 12-month retention among those initiating PrEP was 43.0%. Age ≥25 y, a history of PEP and having an HIV-positive partner not on ART predicted better compliance with scheduled visits (p<0.05). HIV incidence among PrEP initiators was 3.1 per 100 person-years (95% confidence interval [CI] 1.3 to 7.4) and syphilis incidence was 17.6 per 100 person-years (95% CI 12.3 to 25.1). CONCLUSIONS: A PrEP program for MSM and TGW in Myanmar was implemented successfully under difficult circumstances. Alternative strategies are needed addressing PrEP uptake and retention.

The path towards an HIV-free generation: engaging adolescent boys and young men (ABYM) in sub-Saharan Africa from lessons learned and future directions.

This paper highlights the pressing need to address the HIV epidemic among adolescent boys and young men (ABYM) in sub-Saharan Africa. Despite progress in HIV prevention, ABYM still experience low diagnosis rates, treatment adherence, and linkage to care. The paper emphasizes ABYM's vulnerability due to societal norms, limited healthcare access, and economic pressures. It calls for gender-responsive interventions, including comprehensive sexual education, youth-friendly health services, community engagement, and targeted outreach. Comprehensive sexual education is pivotal in HIV prevention for ABYM, providing them with age-appropriate sexual health knowledge and safer sexual practices to reduce HIV incidence. Harmful masculine norms must be countered to promote respectful relationships, benefiting boys, men, and their partners. Inadequate access to youth-friendly health services hampers HIV prevention. Establishing spaces with confidential, non-judgmental care offering testing, counselling, circumcision, and provision of pre-exposure prophylaxis (PrEP) is essential, especially considering ABYM's unique clinic experiences. Engaging communities, leaders, educators, and peers combats stigma and discrimination. ABYM's input in intervention design, targeted outreach, and innovative technology enhances effectiveness of HIV prevention programmes. Economic factors should also be addressed. Comprehensive multi-sectoral interventions, including conditional cash transfers, effective for AGYW, could benefit ABYM. Addressing structural factors alongside behaviour change and social support is key.

Demographics, Trends, and Clinical Characteristics of HIV Pre-Exposure Prophylaxis Recipients and People Newly Diagnosed with HIV from Large Electronic Health Records in Florida.

Florida is one of the HIV epicenters with high incidence and marked sociodemographic disparities. We analyzed a decade of statewide electronic health record/claims data-OneFlorida+-to identify and characterize pre-exposure prophylaxis (PrEP) recipients and newly diagnosed HIV cases in Florida. Refined computable phenotype algorithms were applied and a total of 2186 PrEP recipients and 7305 new HIV diagnoses were identified between January 2013 and April 2021. We examined patients' sociodemographic characteristics, stratified by self-reported sex, along with both frequency-driven and expert-selected descriptions of clinical conditions documented within 12 months before the first PrEP use or HIV diagnosis. PrEP utilization rate increased in both sexes; higher rates were observed among males with sex differences widening in recent years. HIV incidence peaked in 2016 and then decreased with minimal sex differences observed. Clinical characteristics were similar between the PrEP and new HIV diagnosis cohorts, characterized by a low prevalence of sexually transmitted infections (STIs) and a high prevalence of mental health and substance use conditions. Study limitations include the overrepresentation of Medicaid recipients, with over 96% of female PrEP users on Medicaid, and the inclusion of those engaged in regular health care. Although PrEP uptake increased in Florida, and HIV incidence decreased, sex disparity among PrEP recipients remained. Screening efforts beyond individuals with documented prior STI and high-risk behavior, especially for females, including integration of mental health care with HIV counseling and testing, are crucial to further equalize PrEP access and improve HIV prevention programs.

HIV acute infection and long-term undisclosed HIV status among blood donors from the highly endemic Amazonas state, located in the Brazilian Amazon

ABSTRACT Background: The Amazonas state/AM and Manaus rank among the highest AIDS detection rates in Brazil. High proportion of HIV infected blood donors and transmission clusters of multidrug antiretroviral/ARV resistant viruses were described in HEMOAM blood donors, a main Amazonas public blood bank. Recent and long-term infections among previously genotyped donors are reported. Methods/materials: The recency immunoassay Lag Avidity EIA (Maxim, USA) was employed. Clinical/CD4/viral load medical file data of the main local HIV management center (FMTHVD) and ARV treatment/ART data were reviewed. Results: Among 142 HIV-blood donors, chronic infection predominated (n = 87; 61.3 %), 79 based on LAg EIA and 8 undisclosed HIV identified in FMT-HVD records, mostly young adult, single males, 4 repeat donors, all ART-naive. Recent infections represented 30.3 % (n = 43),39 identified by LAg EIA and 4 immunologic windows (antibody negative/NAT/RNA positive). The overall profile of recent and long-term infections was similar, including moderate rate of transmitted drug resistance/TDR, however with multiple resistance mutations to more than one ARV-class, suggesting ART/failure. Discussion: Recent/acute and undisclosed/long-term HIV infections represent blood safety alerts suggesting test-seeking behavior of at-risk populations. Early ART use in Brazil, can turn HIV diagnosis more challenging representing a blood transfusion risk in the highly endemic Brazilian Amazon.

Recent HIV infection and annualized HIV incidence rates among sexual and gender minorities in Brazil and Peru (ImPrEP seroincidence study): a cross-sectional, multicenter study.

Background: HIV incidence estimation is critical for monitoring the HIV epidemic dynamics and the effectiveness of public health prevention interventions. We aimed to identify sexual and gender minorities (SGM) with recent HIV infections, factors associated with recent HIV infection, and to estimate annualised HIV incidence rates. Methods: Cross-sectional multicentre study in HIV testing services in Brazil and Peru (15 cities). Inclusion criteria: 18+ years, SGM assigned male at birth, not using pre-/post-exposure prophylaxis. We identified recent HIV infection using the Maxim HIV-1 LAg-Avidity EIA assay as part of a recent infection testing algorithm (RITA). Annualized HIV incidence was calculated using the UNAIDS/WHO incidence estimator tool. Multivariable logistic regression models were used to estimate factors associated with recent HIV infection. Trial registration: NCT05674682. Findings: From 31-Jan-2021 to 29-May-2022, 6899 individuals participated [Brazil: 4586 (66.5%); Peru: 2313 (33.5%)]; 5946 (86.2%) cisgender men, 751 (10.9%) transgender women and 202 (2.9%) non-binary/gender diverse. Median age was 27 (IQR: 23-34) years. HIV prevalence was 11.4% (N = 784/6899); 137 (2.0%) SGM were identified with recent HIV infection. The overall annualized HIV incidence rate was 3.88% (95% CI: 2.86-4.87); Brazil: 2.62% (95% CI: 1.78-3.43); Peru: 6.69% (95% CI: 4.62-8.69). Participants aged 18-24 years had higher odds of recent HIV infection compared to those aged 30+ years in both countries. Interpretation: Our results highlight the significant burden of HIV epidemic among SGM in large urban centres of Brazil and Peru. Public health policies and interventions to increase access to effective HIV prevention methods such as PrEP are urgently needed in Latin America. Funding: Unitaid, WHO (Switzerland), Ministry of Health from Brazil and Peru.

Probabilistic HIV recency classification-a logistic regression without labeled individual level training data.

Accurate HIV incidence estimation based on individual recent infection status (recent vs long-term infection) is important for monitoring the epidemic, targeting interventions to those at greatest risk of new infection, and evaluating existing programs of prevention and treatment. Starting from 2015, the Population-based HIV Impact Assessment (PHIA) individual-level surveys are implemented in the most-affected countries in sub-Saharan Africa. PHIA is a nationally-representative HIV-focused survey that combines household visits with key questions and cutting-edge technologies such as biomarker tests for HIV antibody and HIV viral load which offer the unique opportunity of distinguishing between recent infection and long-term infection, and providing relevant HIV information by age, gender, and location. In this article, we propose a semi-supervised logistic regression model for estimating individual level HIV recency status. It incorporates information from multiple data sources - the PHIA survey where the true HIV recency status is unknown, and the cohort studies provided in the literature where the relationship between HIV recency status and the covariates are presented in the form of a contingency table. It also utilizes the national level HIV incidence estimates from the epidemiology model. Applying the proposed model to Malawi PHIA data, we demonstrate that our approach is more accurate for the individual level estimation and more appropriate for estimating HIV recency rates at aggregated levels than the current practice - the binary classification tree (BCT).

Precision detection of recent HIV infections using high-throughput genomic incidence assay.

HIV incidence is a key measure for tracking disease spread and identifying populations and geographic regions where new infections are most concentrated. The HIV sequence population provides a robust signal for the stage of infection. Large-scale and high-precision HIV sequencing is crucial for effective genomic incidence surveillance. We produced 1,034 full-length envelope gene sequences from a seroconversion cohort by conducting HIV microdrop sequencing and measuring the genomic incidence assay's genome similarity index (GSI) dynamics. The measured dynamics of 9 of 12 individuals aligned with the GSI distribution estimated independently using 417 publicly available incident samples. We enhanced the capacity to identify individuals with recent infections, achieving predicted detection accuracies of 92% (89%-94%) for cases within 6 months and 81% (74%-87%) for cases within 9 months. These accuracy levels agreed with the observed detection accuracy intervals of an independent validation data set. Additionally, we produced 131 full-length envelope gene sequences from eight individuals with chronic HIV infection. This analysis confirmed a false recency rate (FRR) of 0%, which was consistent with 162 publicly available chronic samples. The mean duration of recent infection (MDRI) was 238 (209-267) days, indicating an 83% improvement in performance compared to current recent infection testing algorithms. The shifted Poisson mixture model was then used to estimate the time since infection, and the model estimates showed an 88% consistency with the days post infection derived from HIV RNA test dates and/or seroconversion dates. HIV microdrop sequencing provides unique prospects for large-scale incidence surveillance using high-throughput sequencing. IMPORTANCE Accurate identification of recently infected individuals is vital for prioritizing specific populations for interventions, reducing onward transmission risks, and optimizing public health services. However, current HIV-specific antibody-based methods have not been satisfactory in accurately identifying incident cases, hindering the use of HIV recency testing for prevention efforts and partner protection. Genomic incidence assays offer a promising alternative for identifying recent infections. In our study, we used microdroplet technologies to produce a large number of complete HIV envelope gene sequences, enabling the accurate detection of early infection signs. We assessed the dynamics of the incidence assay's metrics and compared them with statistical models. Our approach demonstrated high accuracy in identifying individuals with recent infections, achieving predicted detection rates exceeding 90% within 6 months and over 80% within 9 months of infection. This high-resolution method holds significant potential for enhancing the effectiveness of HIV incidence screening for case-based surveillance in public health initiatives.

The Association Between Heterosexual anal Intercourse and HIV Acquisition in Three Prospective Cohorts of Women.

The extent to which receptive anal intercourse (RAI) increases the HIV acquisition risk of women compared to receptive vaginal intercourse (RVI) is poorly understood. We evaluated RAI practice over time and its association with HIV incidence during three prospective HIV cohorts of women: RV217, MTN-003 (VOICE), and HVTN 907. At baseline, 16% (RV 217), 18% (VOICE) of women reported RAI in the past 3 months and 27% (HVTN 907) in the past 6 months, with RAI declining during follow-up by around 3-fold. HIV incidence in the three cohorts was positively associated with reporting RAI at baseline, albeit not always significantly. The adjusted hazard rate ratios for potential confounders (aHR) were 1.1 (95% Confidence interval: 0.8-1.5) for VOICE and 3.3 (1.6-6.8) for RV 217, whereas the ratio of cumulative HIV incidence by RAI practice was 1.9 (0.6-6.0) for HVTN 907. For VOICE, the estimated magnitude of association increased slightly when using a time-varying RAI exposure definition (aHR = 1.2; 0.9-1.6), and for women reporting RAI at every follow-up survey (aHR = 2.0 (1.3-3.1)), though not for women reporting higher RAI frequency (> 30% acts being RAI vs. no RAI in the past 3 months; aHR = 0.7 (0.4-1.1)). Findings indicated precise estimation of the RAI/HIV association, following multiple RVI/RAI exposures, is sensitive to RAI exposure definition, which remain imperfectly measured. Information on RAI practices, RAI/RVI frequency, and condom use should be more systematically and precisely recorded and reported in studies looking at sexual behaviors and HIV seroconversions; standardized measures would aid comparability across geographies and over time.

Developing HIV risk prediction tools in four African settings.

OBJECTIVE: HIV risk prediction tools are a critical component of efforts to end the HIV pandemic. We aimed to create and validate tools for identifying individuals at highest risk of prevalent and incident HIV in an African setting. METHODS: We used Logistic regression and Poisson regression to determine risk factors for HIV prevalence and incidence in a multi-country HIV vaccine trial preparedness cohort study among individuals at high risk of HIV, and used the identified factors to create and validate tools that predict HIV risk. We also assessed the performance of the VOICE risk score in predicting HIV incidence among women in the cohort. RESULTS: The prevalent HIV prediction tool created had good predictive ability [area under the curve (AUC) = 0.70, 95% CI 0.66-0.74]. It included the following participant variables: age, sex, recreational drug use, unprotected male-to-male anal sex, a sexual partner who had other partners, transactional sex and having a partner who was a long-distance truck driver/miner. It was not possible to create a valid HIV incidence prediction tool. Participants with high VOICE risk scores (≥7) had slightly higher HIV incidence but this tool performed poorly within our study (AUC = 0.58, 95% CI 0.51-0.64: Harrell's concordance index = 0.59). CONCLUSION: We created a prevalent HIV prediction tool that could be used to increase efficiency in diagnosis of HIV and linkage to care in sub-Saharan Africa. Existing incident HIV prediction tools may need modification to include context-specific predictors such as calendar period, participant occupation, study site, before adoption in settings different from those in which they were developed.

Exploring the Relationship Between Community-Level Economic Deprivation and HIV Infection Among Hospital Admissions in Washington, DC.

Introduction Human immunodeficiency virus (HIV) infection is a significant health concern in the United States, affecting 38 million Americans. Despite a recent decline in prevalence, social determinants of health remain an important factor driving infections, particularly among minority populations. However, the relationship between community-level economic deprivation indices and HIV infection among hospital admissions has been understudied in the literature. Objectives This study investigated the association between community-level economic deprivation, measured by the Distressed Community Index (DCI), and HIV infection among hospital admissions in Washington, District of Columbia (DC). Methods We utilized data from the State Inpatient Database (SID) for Washington, DC, between 2016 and 2019, identifying all admissions with a history of HIV. The multivariate analysis determined the association between DCI quintiles and HIV infection among hospital admissions. Also included in the multivariate analysis were patients' age, sex, race/ethnicity, insurance type, smoking status, obesity, sexually transmitted infections (STIs), hepatitis B infections, and mental health conditions. Results Of the 213,682 admissions captured in the DCI quintiles, 67.4% were Black, 17.2% were White, and 10.7% were Hispanic. The prevalence of HIV infection in the study population was 4.4%. There was a statistically significant association between the DCI quintiles and HIV infection among hospital admissions. The residents of the richest neighborhoods defined as prosperous quintile (also the reference group) had the lowest odds of HIV infections compared to the other quintiles (comfortable, odds ratio {OR}=1.94 and 95% confidence interval {CI}=1.38-2.74; mid-tier, OR=1.49 and 95% CI=1.04-2.14; at risk, OR=1.75 and 95% CI=1.22-2.49; and distressed, OR=1.97 and 95% CI=1.38-2.82). Other significant predictors of HIV infection were Black race (OR=1.82; 95% CI=1.41-2.33), age between 45 and 65 years (OR=1.55; 95% CI=1.32-1.80), male sex (OR=1.58; 95% CI=1.40-1.77), and depression (OR=1.21; 95% CI=1.03-1.43). Conclusion This study reveals a significant association between increased levels of economic distress and the prevalence of HIV among hospital admissions in Washington, DC. Our findings emphasize the importance of taking social determinants of health into account when addressing HIV prevention and management. Implementing targeted interventions and resources in economically distressed communities may be crucial for reducing HIV prevalence and improving health outcomes for affected populations.

Estimating HIV Incident Diagnoses Among Men Who Have Sex With Men Eligible for Pre-exposure Prophylaxis but Not Taking It: Protocol and Feasibility Assessment of Data Sources and Methods.

BACKGROUND: HIV incidence estimates are published each year for all Ending the HIV Epidemic (EHE) counties, but they are not stratified by the demographic variables highly associated with risk of infection. Regularly updated estimates of HIV incident diagnoses available at local levels are required to monitor the epidemic in the United States over time and could contribute to background incidence rate estimates for alternative clinical trial designs for new HIV prevention products. OBJECTIVE: We describe methods using existing, robust data sources within areas in the United States to reliably estimate longitudinal HIV incident diagnoses stratified by race and age categories among men who have sex with other men (MSM) eligible for pre-exposure prophylaxis (PrEP) but not taking it. METHODS: This is a secondary analysis of existing data sources to develop new estimates of incident HIV diagnoses in MSM. We reviewed past methods used to estimate incident diagnoses and explored opportunities to improve these estimates. We will use existing surveillance data sources and population sizes of HIV PrEP-eligible MSM estimated from population-based data sources (eg, US Census data and pharmaceutical prescription databases) to develop metropolitan statistical area-level estimates of new HIV diagnoses among PrEP-eligible MSM. Required parameters are number of new diagnoses among MSM, estimates of MSM with an indication for PrEP, and prevalent PrEP use including median duration of use; these parameters will be stratified by jurisdiction and age group or race or ethnicity. Preliminary outputs will be available in 2023, and updated estimates will be produced annually thereafter. RESULTS: Data to parameterize new HIV diagnoses among PrEP-eligible MSM are available with varying levels of public availability and timeliness. In early 2023, the most recent available data on new HIV diagnoses were from the 2020 HIV surveillance report, which reports 30,689 new HIV infections in 2020, and 24,724 of them occurred in an MSA with a population of ≥500,000. Updated estimates for PrEP coverage based on commercial pharmacy claims data through February 2023 will be generated. The rate of new HIV diagnoses among MSM can be estimated from new diagnoses within each demographic group (numerator) and the total person-time at risk of diagnosis for each group (denominator) by metropolitan statistical area and year. To estimate time at risk, the person-time of individuals on PrEP or person-time after incident HIV infection but before diagnosis should be removed from stratified population size estimates of the total number of person-years with indications for PrEP. CONCLUSIONS: Reliable, serial, cross-sectional estimates for rates of new HIV diagnoses for MSM with PrEP indications can serve as benchmark community estimates of failures of HIV prevention and opportunities to improve services and will support public health epidemic monitoring and alternative clinical trial designs. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/42267.

Risk Factors Associated with HIV Acquisition in Males Participating in HIV Vaccine Efficacy Trials in South Africa.

In South Africa, HIV acquisition risk has been studied less in people assigned male at birth. We studied the associations between risk behaviors, clinical features and HIV incidence amongst males in two South African HIV preventive vaccine efficacy trials. We used Cox proportional hazards models to test for associations between demographics, sexual behaviors, clinical variables and HIV acquisition among males followed in the HVTN 503 (n = 219) and HVTN 702 (n = 1611) trials. Most males reported no male sexual partners (99.09% in HVTN 503) or identified as heterosexual (88.08% in HVTN 702). Annual HIV incidence was 1.39% in HVTN 503 (95% CI 0.76-2.32%) and 1.33% in HVTN 702 (95% CI 0.80-2.07%). Increased HIV acquisition was significantly associated with anal sex (HR 6.32, 95% CI 3.44-11.62), transactional sex (HR 3.42, 95% CI 1.80-6.50), and non-heterosexual identity (HR 16.23, 95%CI 8.13-32.41) in univariate analyses and non-heterosexual identity (HR 14.99, 95% CI 4.99-45.04; p < 0.01) in multivariate analysis. It is appropriate that prevention efforts in South Africa, although focused on the severe epidemic in young women, also encompass key male populations, including men who have sex with men, but also men who engage in anal or transactional sex.

Providing HIV pre-exposure prophylaxis to men who have sex with men and transgender women in hospitals and community-led clinics in Thailand: acceptance, patterns of use, trends in risk behaviors, and HIV incidence.

From May 2015 to June 2018, we conducted a PrEP demonstration project at two hospitals and four community-led clinics in Bangkok and Pattaya. HIV-negative, MSM and TGW aged ≥18 years old, reporting sex without a condom, were offered daily PrEP. Participants received HIV testing and completed a computer-based questionnaire at enrollment, 6 and 12 months. We collected self-reported PrEP adherence at months 1, 3, 6, 9, and 12. We used logistic regression to determine factors associated with the decision to take PrEP and calculated HIV incidence among baseline HIV-negative participants. Of 803 participants enrolled, 349 (43.5%) started PrEP. Participants were more likely to start PrEP if they were sex workers, had moderate or high self-perceived risk of HIV, or a high PrEP-knowledge score. Participants used PrEP for a median of 6.1 months. Reported condom use increased and the number of sex partners decreased during follow-up regardless of PrEP use. Six participants not-taking PrEP acquired HIV (HIV incidence 2.2 per 100 person-years), and five taking PrEP acquired HIV (HIV incidence 2.1 per 100 person-years). All five reported taking <4 pills the weeks before study visits.