HIV-negative Participants Research Articles

Urine lipoarabinomannan concentrations among HIV-negative adults with pulmonary or extrapulmonary tuberculosis disease in Vietnam.

Lipoarabinomannan (LAM) is a promising target biomarker for diagnosing subclinical and clinical tuberculosis (TB). Urine LAM (uLAM) testing using rapid diagnostic tests (RDTs) has been approved for people living with HIV (PLWH), however there is limited data regarding uLAM levels in HIV-negative (HIV-ve) adults with clinical TB. We conducted a clinical study of adults presenting with clinical TB-related symptoms at the National Lung Hospital in Hanoi, Vietnam. The uLAM concentrations were measured using electrochemiluminescent (ECL) immunoassays and compared to a microbiological reference standard (MRS) using GeneXpert Ultra and TB culture testing. Estimated uLAM concentrations above plate specific calculated limit of detection (LOD) were considered uLAM positive. Additional microbiological testing was conducted for possible extrapulmonary TB (EPTB). Among 745 participants enrolled, 335 (44.9%) participants with presumptive pulmonary TB (PTB) and 6 (11.3%) participants with presumptive EPTB had confirmed TB disease. Overall, the S/A antibody pair had a sensitivity of 39% (95% Confidence Interval [CI] 0.33, 0.44) and a specificity of 97% (95% CI 0.96, 0.99) compared to the MRS. The F/A antibody pair had a sensitivity of 41% (95% CI 0.35, 0.47) and a specificity of 79% (95% CI 0.75, 0.84). S/A provided greater discriminatory ability compared to F/A for both individuals with presumptive PTB (AUROC: 0.74 vs 0.63, p<0.0001) and presumptive EPTB (0.76 vs 0.54, p = 0.045) when using the MRS. Among HIV-ve participants in an adult cohort in Vietnam, the concentrations of uLAM remained relatively low for people with clinical TB, which may present challenges for improving RDT sensitivity.

High Clinical Burden of Cryptosporidium spp. in Adult Patients with Acquired Immunodeficiency in Ghana

There is a paucity of information on the prevalence, risk factors, and clinical correlates of people living with HIV (PLWH) who are co-infected with Cryptosporidium spp. in the post-combined antiretroviral therapy era in Ghana. To provide such data, in this observational study, stool samples of 640 HIV-positive and 83 HIV-negative individuals in Ghana were screened for Cryptosporidium spp. Additionally, sociodemographic parameters, clinical symptoms, medication intake, and immunological parameters were assessed. The prevalence of Cryptosporidium spp. was 11.8% (n = 73) in HIV-positive and 1.2% (n = 1) in HIV-negative participants (p &lt; 0.001). Within the group of HIV-positive participants, the prevalence reached 26.0% in patients with CD4+ T cell counts below 200 cells/µL and 46.2% in the subgroup with CD4+ T cell counts below 50 cells/µL. The frequencies of the clinical manifestation of weight loss and gastrointestinal symptoms were significantly higher in patients with Cryptosporidium spp. compared to those without co-infection (45.8% vs. 21.4%, p &lt; 0.001 and 22.2% vs. 12.2%, p = 0.031, respectively). In the modern post-cART era, the acquisition of Cryptosporidium spp. among PLWH in Ghana is driven largely by the degree of immunosuppression. Access to cART and screening for Cryptosporidium spp. as part of routine care might help control and reduce the burden of the infection.

Population pharmacokinetics of cabotegravir following intramuscular thigh injections in adults with and without HIV.

Cabotegravir intramuscular gluteal injection is approved for HIV treatment (with rilpivirine) and prevention. Thigh muscle is a potential alternative injection site. We aim to characterize cabotegravir pharmacokinetics and its association with demographics following intramuscular thigh injection in comparison with gluteal injection using population pharmacokinetic (PPK) analysis. Fourteen HIV-negative participants received 600 mg single thigh injection in phase 1 study 208832 and 118 participants with HIV received thigh injections 400 mg monthly 4× or 600 mg once-every-2-months 2× after ≥3 years of gluteal injections in phase 3b study ATLAS-2M provided 1,249 cabotegravir concentrations from 366 thigh injections and 1,998 concentrations from 1,618 gluteal injections. The established gluteal PPK model was modified by adding thigh injection compartment and fit to pharmacokinetic data following both gluteal and thigh injections, enabling within-person comparison in ATLAS-2M. Gluteal parameters were fixed. Similar to the gluteal absorption rate constant (KAgluteal), the thigh absorption rate constant (KAthigh) was slower in females than males and in participants with higher BMI. KAthigh was strongly correlated with KAgluteal (correlation coefficient 0.766), best described by the additive linear relationship KAthigh = KAgluteal + 0.0002527 h-1. Terminal half-life of thigh injection was 26% (male) and 39% (female) shorter than gluteal injection. Relative bioavailability of thigh to gluteal was estimated to be 89.9%. The impact of covariates on cabotegravir exposure following thigh injections was ≤35%. In conclusion, cabotegravir absorption following thigh injection was correlated with, faster than, and 10% less bioavailable than gluteal injection, and correlated with sex and BMI. The cabotegravir thigh PPK model can inform dosing strategies and future study design.

Seroprevalence and risk factors of Toxoplasmosis in HIV positive and negative patients attending the Bamenda Regional Hospital, North West Region, Cameroon

Background: Toxoplasmosis, caused by Toxoplasma gondii, can infect almost all warm-blooded animals including humans. T. gondii is regarded as an important opportunistic pathogen that can cause infection in HIV/AIDS patients associated with high mortality. The objective of this study is to determine the prevalence and risk factors of T. gondii infection in HIV-positive and negative patients and establish the relationship between HIV viral load and active toxoplasmosis in the Bamenda Regional Hospital Cameroon. Methodology: Three hundred and three (201 HIV-positive and 102 HIV-negative) participants attending the Bamenda Regional Hospital, Cameroon, were randomly recruited into the study. Well-structured questionnaires were used to obtain information on demographic characteristics and potential risk factors from each participant. Venous blood samples were collected for serological detection of toxoplasmosis using One-Step Toxo IgG/IgM rapid diagnostic test (RDT) kits, followed by confirmation of all positive samples by Toxoplasma IgM ELISA test. Data were analysed on SPSS version 23.0. Association of potential risk factors with seroprevalence of toxoplasmosis was done using Chi square test, and comparison of means HIV loads between participant categories was done using Mann-Whitney U-test and Kruskal-Wallis as applicable, with p&lt;0.05 considered as significant level. Results: Of the 303 participants, 93 were positive for Toxoplasma IgG, giving latent toxoplasmosis seroprevalence rate of 30.7%, while 2 of the 303 participants were seropositive for Toxoplasma IgM, indicating active toxoplasmosis in 0.7%. The seroprevalence of latent toxoplasmosis was 28.9% (n=58/201) in HIV-positive compared to 34.3% (n=35/102) in HIV-negative participants (χ2=0.948, OR=0.775, p=0.330), while the seroprevalence of active toxoplasmosis was 1.0% (n=2/201) in HIV-positive compared to 0% (n=0/102) in HIV-negative participants (χ2=0.068, OR=2.568, p=0.552). Viral load was detectable (≥ 42 viral copies/ml) in 54 of the 201 HIV-positive participants, giving an overall detectable viral load rate of 26.9%. The sero-prevalence of latent toxoplasmosis was higher in HIV-positive participants with detectable viral load than those with non-detectable viral load, and the two HIV-positive patients with active toxoplasmosis had detectable viral loads. The risk factors significantly associated (p&lt;0.05) with the latent toxoplasmosis were owning a cat, presence of stray cats, playing with cats, and eating soya. Conclusion: Latent toxoplasmosis is prevalent among HIV-positive and negative patients attending the Bamenda Regional Hospital in Cameroon, with active infection only among HIV-infected patients.

Electrocardiographic abnormalities and associated factors among HIV-infected adults on antiretroviral therapy.

Individuals living with HIV are at increased risk of developing cardiovascular diseases. This heightened vulnerability is influenced by various factors, including the direct impact of HIV infection, the side effects of HIV medications, and a higher presence of traditional cardiovascular risk factors. Detecting and managing cardiovascular diseases early in HIV-infected individuals is crucial for their overall health and well-being. Electrocardiography, a simple and non-invasive test, can provide valuable information in this regard. However, there is currently no published data on the prevalence of electrocardiographic abnormalities and the associated factors among HIV-infected adults in Ethiopia. This study was aimed at assessing the prevalence of ECG abnormalities and associated factors among HIV-infected adults on antiretroviral therapy. A hospital-based comparative cross-sectional study was conducted at Mettu Karl Specialized Hospital (MKSH), southwest Ethiopia, among 96 HIV-infected patients and 96 HIV-negative control groups. A systematic random sampling technique was used to select HIV-infected respondents, and HIV-negative respondents were purposively recruited from caregivers. A face-to-face interview with a semi-structured and pretested questionnaire was conducted to collect the socio-demographic and behavioral characteristics of the study participants. Electrocardiography was done for all study participants using a 12-lead electrocardiograph, interpreted by a cardiologist, and classified according to the Minnesota Code classification system. The data were entered into Epi-Data version 4.6 and exported to SPSS version 25 for analysis. Finally, descriptive statistics, chi-square, independent t-test, bivariable, and multivariable logistic regression analyses were done at a 5% significance level. The study found that 49% of HIV-infected and 19.8% of HIV-negative participants had at least one ECG abnormality. The proportion of coded ST-segment abnormalities, T-wave abnormalities, longer QT interval, and sinus tachycardia was significantly higher in HIV-infected respondents than in HIV-negatives. Being a smoker [AOR = 3.7, 95%CI: 1.03-13.6], being on Protease inhibitors [AOR = 3.6, 95%CI: 1.02-13.1] and having CD4 less than 350 cells/mm3 [AOR = 3.2, 95%CI: 1.22-8.49] were significantly associated with ECG abnormalities among HIV-infected respondents. Compared to HIV-negative participants, HIV-infected patients had a significantly higher prevalence of ECG abnormalities. Screening for ECG abnormalities is needed for the early detection of cardiac abnormalities and the reduction of future complications.

Mpox and Vaccine Knowledge, Beliefs, and Sources of Trusted Information Among Gay, Bisexual, and Other Men Who Have Sex With Men in the U.S.

ObjectivesThis research aims to characterize disparities in mpox- and vaccine-related knowledge in gay, bisexual, and other men who have sex with men (GBMSM) in the U.S. MethodsWe conducted a study using the American Men's Internet Survey (AMIS), which includes 823 cisgender (defined as their gender identity matching their sex assigned at birth) males aged 15 and older from August 5 – 15, 2022. We evaluated sociodemographic and behavioral factors associated with mpox knowledge, including race/ethnicity, region, age group, and HIV pre-exposure prophylaxis (PrEP) use using chi-squared tests. ResultsWe identified knowledge gaps with many participants unsure about whether individuals need two doses of the vaccine (34.4%), and if the vaccine confers immediate protection (27.2%). We observed racial and regional disparities (p<0.01), with 24.4% of Non-Hispanic Black men and 18.1% of men living in the South reporting little to no mpox awareness. Among the 707 self-reported HIV-negative participants, people who used PrEP within the past year were more likely to exhibit high awareness about mpox compared to people who did not use PrEP. ConclusionsFindings suggest the potential to leverage existing networks (i.e., STI or general healthcare services with PrEP use) for future targeted health service programming or education campaigns for mpox vaccination amongst GBMSM.

Incidence of Acute Kidney Injury and Associated Mortality among Individuals with Drug-Susceptible Tuberculosis in Uganda.

Although tuberculosis (TB) is associated with significant mortality and morbidity, its impact on kidney function is not well understood and is often attributed to anti-TB drugs. We aimed to assess the incidence of acute kidney injury (AKI) in the immediate post-TB diagnosis period in Uganda, a TB/HIV-endemic country in sub-Saharan Africa. We included patients enrolled in an observational cohort study of adults diagnosed with drug-susceptible TB followed longitudinally. Adults (≥ 18years) without known kidney disease were enrolled between 8/2022-7/2023 at three regional hospitals serving 12.5% of the Ugandan population. Our primary outcome was incidence of KDIGO-defined AKI within two weeks of TB diagnosis. Other outcomes included predictors of AKI and its association with 30-day survival. A total of 156 adults were included. The median (IQR) age was 39 (28-53) years, most were male (68.6%) and 49.4% had HIV. People with HIV had shorter time to TB diagnosis from symptom onset (21[7-30] days) compared to HIV-negative participants (60[23-90] days), p<0.001. The incidence of AKI was 33.3% (52/156), and was similar between people with and without HIV. Proteinuria or hematuria at enrollment was associated with higher odds of AKI (OR-2.68, 95%CI 1.09-6.70, p∼0.033). AKI was associated with significant risk of mortality (aHR-8.22, 95% CI, 1.94-34.72, p ∼0.004) independent of HIV status. The overall incidence of AKI in the immediate post-TB diagnosis period is high and associated with increased mortality risk. Our findings suggest monitoring kidney function should be routine for patients with TB, including prior to treatment initiation.

HIV Treatment Optimism Moderates the Relationship between Sexual Risk Behavior and HIV Risk Perception among Urban HIV-negative Gay, Bisexual, and Other Men who have Sex With Men.

Using baseline data of the Engage Cohort Study, a Canadian study of sexually active gay, bisexual and other men who have sex with men (GBM), we evaluated the association between sexual behavior and risk perception among HIV-negative participants and whether HIV treatment optimism moderated this relationship. Participants were recruited by respondent-driven-sampling (RDS). We defined high-risk sexual behavior in the past six months as any condomless anal sex with a casual partner (i.e. not the participant's main partner) with either unknown HIV-status where neither used pre-exposure prophylaxis or with a partner living with HIV having detectable/unknown viral load. We assessed HIV treatment optimism-skepticism using a 12-item scale. RDS-II-weighted adjusted logistic regression models examined associations with risk perception measured by the question "How would you assess your current risk of getting HIV?" (response options were on a 6-point Likert-scale ranging from "very unlikely" to "very likely", dichotomized into "No Perceived Risk" (very unlikely/unlikely) and "Perceived Risk" (somewhat likely/likely/very likely/I think I already have HIV). Of 1961 participants, engagement in high-risk sexual behavior was reported by 155 (17.0%), 62 (12.4%), 128 (17.2%) of participants in Montréal, Toronto, and Vancouver, respectively. High-risk sexual behavior increased the odds of perceived HIV risk (pooled adjusted odds ratio = 2.9, 95%CI = 2.2-3.8). HIV treatment optimism-skepticism scores moderated the relationship: for GBM engaging in high-risk sexual behavior, higher HIV treatment optimism-skepticism scores increased perceived HIV risk. Promoting awareness around advances related to HIV prevention and treatment is important for appropriate risk assessment and for increased engagement in prevention interventions.

Factors associated with PrEP use in a community sample of African American men who have sex with men (MSM) and transgender women (TGW) in the United States Midwest

ABSTRACT Black sexual minority men who have sex with men (MSM) in the United States are at disparate risk for contracting HIV infection, but pre-exposure prophylaxis (PrEP) use is suboptimal. Social network methods were used to recruit a community sample of racial minority MSM and transgender women (TGW) in two Midwestern US cities. 250 PrEP-eligible (HIV-negative) participants completed measures assessing current and intended PrEP use; demographic characteristics; PrEP knowledge, attitudes, norms, stigma, and self-efficacy; and structural barriers to PrEP. Multivariate analyses established predictors of current and intended PrEP use. Only 12% of participants reported currently using PrEP, which was associated with greater PrEP knowledge and not having a main partner, with trends for greater PrEP use by younger participants and those with partners living with HIV. Among participants not currently on PrEP, strength of PrEP use intentions was associated with higher PrEP knowledge, PrEP descriptive social norms, and PrEP use self-efficacy. This study is among few to directly compare Black who have adopted PrEP with those who have not. Its findings underscore the potential benefits of employing social network approaches for strengthening PrEP use peer norms, increasing PrEP knowledge and self-efficacy, and optimizing PrEP uptake among racial minority MSM and TGW.

Phase 1 randomized trials to assess safety, pharmacokinetics, and vaginal bleeding associated with use of extended duration dapivirine and levonorgestrel vaginal rings.

Vaginal rings formulated to deliver two drugs simultaneously have potential as user-controlled, long-acting methods for dual prevention of HIV and pregnancy. Two phase 1 randomized trials (MTN-030/IPM 041 and MTN-044/IPM 053/CCN019) respectively enrolled 24 and 25 healthy, HIV-negative participants to evaluate safety, pharmacokinetics, and vaginal bleeding associated with use of a vaginal ring containing 200mg dapivirine (DPV) and 320mg levonorgestrel (LNG) designed for 90-day use. MTN-030/IPM 041 compared the DPV/LNG ring to a DPV-only ring (200mg) over 14 days of use. MTN-044/IPM 053/CCN019 compared continuous or cyclic use of the DPV/LNG ring over 90 days of use. Safety was assessed by recording adverse events (AEs). DPV and LNG concentrations were quantified in plasma, cervicovaginal fluid, and cervical tissue. Vaginal bleeding was self-reported. There were no differences in the proportion of participants with grade ≥2 genitourinary AEs or grade ≥3 AEs with DPV/LNG ring vs. DPV ring use (p = .22), or with DPV/LNG ring continuous vs. cyclic use (p = .67). Higher plasma DPV concentrations were observed in users of DPV/LNG compared to DPV-only rings (Cmax p = 0.049; AUC p = 0.091). Plasma DPV and LNG concentrations were comparable with continuous and cyclic use (Cmax p = 0.74; AUC p = 0.25). With cyclic use, median nadir plasma DPV concentration was approximately 300 pg/mL two days after removal and median t1/2 for cervicovaginal fluid DPV concentration was 5.76 hours (n = 3). Overall bleeding experiences did not differ between continuous and cyclic users (p = 0.12). The extended duration DPV/ LNG rings were well tolerated and the observed DPV concentrations in plasma and cervicovaginal fluid when used continuously exceeded concentrations observed in previous DPV ring efficacy studies. LNG concentrations in plasma were comparable with other efficacious LNG-based contraceptives. Genital DPV concentrations had a short half-life and were thus not well sustained following ring removal.

Humoral response after mRNA COVID-19 primary vaccination and single booster dose in people living with HIV compared to controls: A French nationwide multicenter cohort study—ANRS0001s COV-POPART

BackgroundThis study aimed to compare the humoral responses to mRNA COVID-19 vaccination in people living with HIV (PWH) and HIV-negative individuals. MethodsWe included PWH with an undetectable viral load under ART and HIV-negative participants from the French nationwide ANRS COV-POPART cohort who had received two doses of vaccine as a primary vaccination. We compared humoral response between controls and PWH, stratified by CD4 cell count (<200/mm3 and ≥200/mm3 CD4 cell counts) at 1, 6, and 12 months after primary vaccination. ResultsA total of 1776 participants were included in this analysis, 684 PWH (99% were on ART, median CD4 counts 673 cells/mm3) and 1092 controls. At 1 month, after adjustment on age, sex, and BMI, PWH had lower seroneutralization titers than controls, and PWH with <200 CD4 cell/mm3 had lower anti-Spike SARS-CoV-2 IgG antibodies. Same results were found at 6 months. However, in participants who received a booster dose between 6 and 12 months postprimary vaccination, we did not observe differences between PWH and controls at 12 months. ConclusionPWH had high responses to primary mRNA COVID-19 vaccination. In those who received a booster dose after 6 months, the humoral response at 12 months increased to similar levels to controls, even in those with low CD4 counts at baseline.

What Is the Influence of HIV Serostatus on HbA1c? A Prospective Analysis Using Continuous Glucose Monitoring.

Type 2 diabetes (T2D) is reported to be more common in people living with HIV (PLWH). Clinical guidelines recommend screening for diabetes in PLWH, but there is no agreed method due to studies reporting HbA1c is falsely low in PLWH. These studies were performed in the early HIV era when participants were taking older preparations of antiretroviral therapy that are rarely used today. We aimed to investigate whether HIV serostatus influences HbA1c. We conducted a prospective cohort study of PLWH and age- and sex-matched HIV-negative participants who were purposely recruited from clinics in Brighton, U.K. Each participant wore a Dexcom G6 continuous glucose monitor (CGM) for up to 10 days, had glucose measured during an oral glucose tolerance test, and fructosamine and paired HbA1c were measured. We performed regression analysis to assess the influence of HIV on HbA1c and used a separate model for CGM glucose, venous glucose, and fructosamine. In addition, we included predictor variables used in previous studies that explored HbA1c discrepancy. We recruited 60 PLWH (90% men, 50% with T2D, mean ± SD age 57 ± 10.7 years, 100% undetectable viral load) and 48 people without HIV (92% men, 30% with T2D, mean age 57.7 ± 8.9 years). We found that HIV serostatus did not have a significant influence on HbA1c within the regression models. We performed a comprehensive assessment of glycemia to assess whether HIV serostatus influences HbA1c. We did not find any strong evidence that HIV serostatus influenced HbA1c. The results of our study support incorporating HbA1c into routine clinical blood work in PLWH.

Interest in I-PrEP and Willingness to Participate in Clinical Trials Among Men and Transfeminine Persons Who have Sex with Men in Sub-Saharan Africa: Quantitative and Qualitative Findings from HPTN 075.

This study explored interest in injectable PrEP (I-PrEP) and willingness to participate in clinical trials testing new biomedical HIV prevention strategies among men and transfeminine persons who have sex with men (MSM & TGP), using data collected in the HIV Prevention Trials Network (HPTN) 075 study, which took place at sites in Kenya, Malawi, and South Africa. Data result from a survey among 267 18-44years old HIV negative participants, complemented with semi-structured interviews with 80 purposively recruited persons. Correlations coefficients were calculated to identify demographic and psychosocial factors associated with interest in I-PrEP. Qualitative interviews were analyzed using concept-driven and subsequent data-driven coding. Most surveyed participants expressed an interest in I-PrEP. Quantitatively, only being interested in other HIV prevention measures was associated with interest in I-PrEP. Qualitatively, most participants preferred I-PrEP to O-PrEP and remained interested in I-PrEP despite barriers such as the somewhat invasive nature of the procedure and potential side effects of I-PrEP. Interest in I-PrEP was driven by the possibility of avoiding sexual or HIV stigma. Access to healthcare and altruism-such as assisting in the development of new HIV prevention methods-positively impacted willingness to participate in clinical trials. With I-PrEP favored by most participants, it is potentially a critical tool to prevent HIV infection among MSM & TGP in sub-Saharan Africa, with the mitigation of stigma as a major advance. Recruitment of MSM & TGP in biobehavioral clinical trials seems feasible, with altruistic reasons and receiving I-PrEP and free medical care as major motivators.

Chronic and Latent Viral Infections and Leukocyte Telomere Length across the Lifespan of Female and Male Individuals Living with or without HIV

Background: Chronic/latent viral infections may accelerate immunological aging, particularly among people living with HIV (PLWH). We characterized chronic/latent virus infections across their lifespan and investigated their associations with leukocyte telomere length (LTL). Methods: Participants enrolled in the CARMA cohort study were randomly selected to include n = 15 for each decade of age between 0 and &gt;60 y, for each sex, and each HIV status. Cytomegalovirus (CMV), Epstein–Barr virus (EBV), human herpesvirus 8 (HHV-8), herpes simplex virus 1 (HSV-1), and HSV-2 infection were determined serologically; HIV, hepatitis C (HCV), and hepatitis B (HBV) were self-reported. LTLs were measured using monochrome multiplex qPCR. Associations between the number of viruses, LTL, and sociodemographic factors were assessed using ordinal logistic and linear regression modeling. Results: The study included 187 PLWH (105 female/82 male) and 190 HIV-negative participants (105 female/84 male), ranging in age from 0.7 to 76.1 years. Living with HIV, being older, and being female were associated with harbouring a greater number of chronic/latent non-HIV viruses. Having more infections was in turn bivariately associated with a shorter LTL. In multivariable analyses, older age, living with HIV, and the female sex remained independently associated with having more infections, while having 3–4 viruses (vs. 0–2) was associated with a shorter LTL. Conclusions: Our results suggest that persistent viral infections are more prevalent in PLWH and females, and that these may contribute to immunological aging. Whether this is associated with comorbidities later in life remains an important question.

Long-acting cabotegravir pharmacokinetics with and without oral lead-in for HIV PrEP.

Long-acting cabotegravir is approved for pre-exposure prophylaxis and combination HIV treatment, both initiated with optional short-term oral lead-in (OLI). We evaluated the impact of OLI on long-acting cabotegravir pharmacokinetics. Cabotegravir plasma concentrations were compared between HIV-positive participants initiating injections with (n = 278) or without (n = 110) OLI in phase III treatment study FLAIR and in HIV-negative participants using OLI (n = 263) in pivotal pre-exposure prophylaxis studies HPTN 083 and HPTN 084. Cabotegravir pharmacokinetic profiles were simulated in three populations (assigned-male-at-birth, 50%-assigned-female-at-birth, and assigned-female-at-birth) under three scenarios: first injection given (A) 1 or (B) 3 days after final OLI dose (OLI-injection gap) or (C) without OLI. The PK objective was 80% of participants achieving 4× in vitro protein-adjusted 90% maximal inhibitory concentration (PA-IC90) and 50% achieving 8× PA-IC90. Observed trough concentrations (Cτ) were similar with and without OLI (P > 0.3). With a 3-day OLI-injection gap, simulated pre-injection Cτ remained above PK objective. Approximately 1-2 weeks after the first injection, simulated PK profiles became nearly identical among all scenarios. Without OLI, it was predicted that 80% of participants achieve 4× PA-IC90 in 1.2, 1.8, and 2.8 days after the first injection in each population, respectively, and 50% achieve 8× PA-IC90 in 1.4, 2.1, and 3.8 days, respectively. Observed long-acting cabotegravir exposure was similar with or without OLI, supporting optional OLI use. Cabotegravir exposure was predicted to remain above PK objective for OLI-injection gaps of ≤3 days and rapidly achieve PK objective after first injection without OLI. Findings are consistent between assigned-male-at-birth and assigned-female-at-birth populations.This study is registered with ClinicalTrials.gov as NCT02720094.

The influence of home versus clinic anal human papillomavirus sampling on high-resolution anoscopy uptake in the Prevent Anal Cancer Self-Swab Study.

Background Anal cancer disproportionately affects sexual and gender minority individuals living with HIV. High-resolution anoscopy (HRA) is an in-clinic procedure to detect precancerous anal lesions and cancer, yet prospective data on factors associated with HRA attendance are lacking. We examined whether anal HPV sampling at home versus in a clinic impacts HRA uptake and assessed HRA acceptability. Methods Sexual and gender minority individuals were randomised to home-based self-sampling or clinical sampling. All were asked to attend in-clinic HRA 1year later. We regressed HRA attendance on study arm using multivariable Poisson regression and assessed HRA acceptability using χ 2 tests. Results A total of 62.8% of 196 participants who engaged in screening attended HRA. Although not significant (P =0.13), a higher proportion of participants who engaged in clinic-based screening attended HRA (68.5%) compared to home-based participants (57.9%). Overall, HRA uptake was higher among participants with anal cytology history (aRR 1.40, 95% CI 1.07-1.82), and lower among participants preferring a versatile anal sex position versus insertive (aRR 0.70, 95% CI 0.53-0.91), but did not differ by race or HIV serostatus. In the clinic arm, persons living with HIV had lower HRA attendance (42.9%) versus HIV-negative participants (73.3%) (P =0.02) and Black non-Hispanic participants had lower HRA attendance (41.7%) than White non-Hispanic participants (73.1%), (P =0.04). No differences in attendance by race or HIV status were observed in the home arm. Conclusions HRA uptake differed significantly by race and HIV status in the clinic arm but not the home arm.

Trends in body mass index in the pre-dolutegravir period in South Africa.

Antiretroviral therapy (ART) is associated with weight gain, but this has been shown to be more marked with dolutegravir and other integrase strand transfer inhibitors. We studied weight gain in people living with HIV (PLWH) on ART compared to the general population in the period before dolutegravir was introduced in a rural South African cohort. Longitudinal analysis of the Ndlovu Cohort Study including 36-48 months' follow-up data. From 2014 to 2019, data were collected annually in Limpopo, rural South Africa. Linear mixed models using HIV status, demographics, ART use and cardiovascular risk factors were used to estimate trends in body mass index (BMI) over time. In total, 1518 adult, non-pregnant participants were included, of whom 518 were PLWH on ART (79.8%), 135 PLWH not yet on ART (20.2%) and 865 HIV-negative. HIV-negative participants had significantly higher BMIs than PLWH on ART at all study visits. There was a significant increase in BMI in all subgroups after 36 months (PLWH on ART, BMI +1.2 kg/m2, P < 0.001; PLWH not on ART, BMI +1.8 kg/m2, P < 0.001 and HIV-negative, BMI +1.3 kg/m2, P < 0.001). The increase in BMI in PLWH and HIV-negative participants is a serious warning signal as obesity results in morbidity and mortality.

Predictors of placental malaria in HIV-positive and HIV- negative pregnant women in Enugu, South-Eastern Nigeria

Background: Placental malaria has long been recognized as a complication of malaria in pregnancy with serious adverse outcome. Recognition of possible predictors is an effort in the right direction. Aim of the study: The study determined and compared the Predictors of placental malaria in HIV-positive and HIV- negative pregnant women attending antenatal clinics in Poly General Hospital, South-Eastern Nigeria. Material and method: A cross-sectional descriptive study, carried out on 200 HIV positive and 200 HIV negative pregnant women attending antenatal clinics in Poly General Hospital, Enugu, selected using simple random sampling technique between May to December 2023. Placenta blood samples were collected and thick blood films were examined for malaria parasite using Giemsa expert microscopy. A structured self-administered questionnaire was used for data collection and the data analysed using SPSS version 23. Results: The prevalence of malaria in HIV positive and negative pregnant women were 83.5% (167/200) and 75.5%(151/200) respectively (P &lt; 0.001). The HIV positive and HIV negative participants were between 16-45 years of age with majority in the age range of 31-35 years. Mean gestational age of HIV positive and HIV negative participants were 24.3±1.1 and 24.4±1.3 weeks respectively. Placental malaria was significantly associated with rural residence, hemoglobin genotype AA, not receiving intermittent preventive treatment in pregnancy (IPTp), and not sleeping under insecticide-treated bed nets (ITN) ((P&lt;0.001)). Conclusion: The study showed that Placental malaria was significantly associated with rural residence, hemoglobin genotype AA, not receiving intermittent preventive treatment in pregnancy (IPTp), and not sleeping under insecticide-treated bed nets (ITN). Recognition of these significant predictors will enhance review and implementation of strategies for the prevention of malaria in pregnancy.

A 12-week multicomponent exercise program enhances frailty by increasing robustness, improves physical performance, and preserves muscle mass in older adults with HIV: MOVIhNG study.

Our aim was to analyze the effects of a multicomponent exercise program (MEP) on frailty and physical performance in older adults with HIV (OAWH) since exercise can reverse frailty in the older population overall, but there is no data for OAWH. A prospective longitudinal study with intervention and control group was designed. Sedentary adults 50 or over with and without HIV were included. The intervention was a 12-week home-based MEP. Dependent variables were frailty (frailty phenotype), physical performance (Senior Fitness Test), muscle mass (ASMI) by bioimpedance. Pre- and postintervention measurements were analyzed using McNemar's test for categorical variables and the Wilcoxon signed-rank test for quantitative variables. 40 OAWH and 20 OA without HIV. The median age was 56.5 years. 23.3% were women. The prevalence of frailty was 6.6% with no frail HIV-negative participants. Three of the four frail HIV-participants transitioned two (50%) from frail to prefrail and one (25%) to robust after the MEP. In participants with an adherence ≥50%, physical performance was significantly improved [basal vs. 12 week]: upper extremity strength [13 (13-15) vs. 16 (15-19), p = 0.0001], lower extremity strength [13 (11-16) vs. 15 (13-16), p = 0.004], aerobic endurance [62 (55-71) vs. 66 (58-80), p = 0.005]. Participants with low adherence experienced a significant worsening in ASMI [8.35 (7.44-9.26) vs. 7.09 (6.08-8.62), p = 0.03]. A 12-week MEP enhances frailty by increasing robustness in OAWH, and improves physical performance, and preserves muscle mass in older adults with good adherence to the MEP independently of HIV status.

CD4+ T cell count and HIV-1 viral load dynamics positively impacted by H. pylori infection in HIV-positive patients regardless of ART status in a high-burden setting

BackgroundThere is a widespread co-infection of HIV and Helicobacter pylori (H. pylori) globally, particularly in developing countries, and it has been suggested that this co-infection may affect the course of HIV disease. However, the interplay between H. pylori infection and HIV disease progression is not fully elucidated. In this study, we investigated the effect of H. pylori co-infection on CD4+ T cell count and HIV viral load dynamics in HIV-positive individuals in a high co-endemic setting.MethodsA comparative cross-sectional study was conducted among 288 HIV-positive and 175 HIV-negative individuals, both with and without H. pylori infection. Among HIV-positive participants, 195 were on antiretroviral therapy (ART) and 93 were ART-naïve. CD4+ T cell count and HIV-1 viral load were measured and compared between H. pylori-infected and -uninfected individuals, taking into account different HIV and ART status.ResultOur study demonstrated that individuals infected with H. pylori had a significantly higher CD4+ T cell count compared to uninfected controls among both HIV-negative and HIV-positive participants, regardless of ART therapy. Conversely, HIV/H. pylori co-infected participants had lower HIV-1 viral load than those without H. pylori infection. Linear regression analysis further confirmed a positive association between H. pylori infection, along with other clinical factors such as BMI, ART, and duration of therapy, with CD4+ T cell count while indicating an inverse relationship with HIV-1 viral load in HIV-positive patients. Additionally, factors such as khat chewing, age and WHO clinical stage of HIV were associated with reduced CD4+ T cell count and increased HIV-1 viral load.ConclusionOur study demonstrates that H. pylori co-infection was associated with higher CD4+ T cell count and lower HIV-1 viral load in HIV-positive patients, regardless of ART status. These findings show a positive effect of H. pylori co-infection on the dynamics of HIV-related immunological and virological parameters. Further studies are needed to elucidate the underlying mechanisms of the observed effects.