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BackgroundHIV testing among the sexual partners of HIV-positive clients is critical for case identification and reduced transmission in southern and eastern Africa. HIV self-testing (HIVST) may improve uptake of HIV services among sexual partners of antiretroviral therapy (ART) clients, but the impact of HIVST on partner testing and subsequent ART initiation remains unclear.Methods and findingsWe conducted an individually randomized, unblinded trial to assess if an index HIVST intervention targeting the partners of ART clients improves uptake of testing and treatment services in Malawi. The trial was conducted at 3 high-burden facilities in central and southern Malawi. ART clients attending HIV treatment clinics were randomized using simple randomization 1:2·5 to: (1) standard partner referral slip (PRS) whereby ART clients were given facility referral slips to distribute to their primary sexual partners; or (2) index HIVST whereby ART clients were given HIVST kits + HIVST instructions and facility referral slips to distribute to their primary sexual partners. Inclusion criteria for ART clients were: ≥15 years of age, primary partner with unknown HIV status, no history of interpersonal violence (IPV) with partner, and partner lives in facility catchment area. The primary outcome was partner testing 4-weeks after enrollment, reported by ART clients using endline surveys. Medical chart reviews and tracing activities with partners with a reactive HIV test measured ART initiation at 12 months. Analyses were conducted based on modified intention-to-treat principles, whereby we excluded individuals who did not have complete endline data (i.e., were loss to follow up from the study). Adjusted models controlled for the effects of age and marital status. A total of 4,237 ART clients were screened and 484 were eligible and enrolled (77% female) between March 28, 2018 and January 5, 2020. A total of 365 participants completed an endline survey (257/34 index HIVST arm; 107/13 P

We thank Augello and Wu [...].

BACKGROUND AND OBJECTIVE: HIV treatment options remain limited in children. Dolutegravir is a potent and well-tolerated, once-daily HIV-1 integrase inhibitor recommended for HIV-1 infection in both adults and children down to 4 weeks of age. To support pediatric dosing of dolutegravir in children, we used a population pharmacokinetic model with dolutegravir data from the P1093 and ODYSSEY clinical trials. The relationship between dolutegravir exposure and selected safety endpoints was also evaluated. METHODS: A population pharmacokinetic model was developed with data from P1093 and ODYSSEY to characterize the pharmacokinetics and associated variability and to evaluate the impact of pharmacokinetic covariates. The final population pharmacokinetic model simulated exposures across weight bands, doses, and formulations that were compared with established adult reference data. Exploratory exposure-safety analyses evaluated the relationship between dolutegravir pharmacokinetic parameters and selected clinical laboratory parameters and adverse events. RESULTS: A total of N = 239 participants were included, baseline age ranged from 0.1 to 17.5 years, weight ranged from 3.9 to 91 kg, 50% were male, and 80% were black. The final population pharmacokinetic model was a one-compartment model with first-order absorption and elimination, enabling predictions of dolutegravir concentrations in the pediatric population across weight bands and doses/formulations. The predicted geometric mean trough concentration was comparable to the adult value following a 50-mg daily dose of dolutegravir for all weight bands at recommended doses. Body weight, age, and formulation were significant predictors of dolutegravir pharmacokinetics in pediatrics. Additionally, during an exploratory exposure-safety analysis, no correlation was found between dolutegravir exposure and selected safety endpoints or adverse events. CONCLUSIONS: The dolutegravir dosing in children ≥ 4 weeks of age on an age/weight

Analytical treatment interruptions (ATIs) have become a key methodological approach to evaluate the effects of experimental HIV cure-related research interventions. During ATIs, sex partners of trial participants might be at risk of acquiring HIV. This risk raises both ethical and feasibility concerns about ATI trials. We propose a partner protection package (P3) approach to address these concerns. A P3 approach would provide guidance to investigators, sponsors, and those who are designing and implementing context-specific partner protections in HIV cure-related trials involving ATIs. The approach would also help assure institutional review boards, trial participants, and communities that ATI trials with a P3 would provide appropriate partner protections. We offer a prototype P3 framework that delineates three basic considerations for protecting participants sex partners during ATI trials: (1) ensuring the scientific and social value of the ATI and the trial, (2) reducing the likelihood of unintended HIV transmission, and (3) ensuring prompt management of any acquired HIV infection. We outline possible ways of implementing these basic considerations.

BACKGROUND: Interventions to reduce sexually transmitted infections (STIs) among men who have sex with men (MSM) are needed. METHODS: We conducted an open-label, randomized study involving MSM and transgender women who were taking preexposure prophylaxis (PrEP) against human immunodeficiency virus (HIV) infection (PrEP cohort) or living with HIV infection (persons living with HIV infection [PLWH] cohort) and who had had Neisseria gonorrhoeae (gonorrhea), Chlamydia trachomatis (chlamydia), or syphilis in the past year. Participants were randomly assigned in a 2:1 ratio to take 200 mg of doxycycline within 72 hours after condomless sex (doxycycline postexposure prophylaxis) or receive standard care without doxycycline. STI testing was performed quarterly. The primary end point was the incidence of at least one STI per follow-up quarter. RESULTS: Of 501 participants (327 in the PrEP cohort and 174 in the PLWH cohort), 67% were White, 7% Black, 11% Asian or Pacific Islander, and 30% Hispanic or Latino. In the PrEP cohort, an STI was diagnosed in 61 of 570 quarterly visits (10.7%) in the doxycycline group and 82 of 257 quarterly visits (31.9%) in the standard-care group, for an absolute difference of -21.2 percentage points and a relative risk of 0.34 (95% confidence interval [CI], 0.24 to 0.46; P<0.001). In the PLWH cohort, an STI was diagnosed in 36 of 305 quarterly visits (11.8%) in the doxycycline group and 39 of 128 quarterly visits (30.5%) in the standard-care group, for an absolute difference of -18.7 percentage points and a relative risk of 0.38 (95% CI, 0.24 to 0.60; P<0.001). The incidences of the three evaluated STIs were lower with doxycycline than with standard care; in the PrEP cohort, the relative risks were 0.45 (95% CI, 0.32 to 0.65) for gonorrhea, 0.12 (95% CI, 0.05 to 0.25) for chlamydia, and 0.13 (95% CI, 0.03 to 0.59) for syphilis, and in the PLWH cohort, the relative risks were 0.43 (95% CI, 0.26 to 0.71), 0.26 (95% CI, 0.12 to 0.57), and 0.23

Personalized intervention strategies, in particular those that modify treatment based on a participants own response, are a core component of precision medicine approaches. Sequential multiple assignment randomized trials (SMARTs) are growing in popularity and are specifically designed to facilitate the evaluation of sequential adaptive strategies, in particular those embedded within the SMART. Advances in efficient estimation approaches that are able to incorporate machine learning while retaining valid inference can allow for more precise estimates of the effectiveness of these embedded regimes. However, to the best of our knowledge, such approaches have not yet been applied as the primary analysis in SMART trials. In this paper, we present a robust and efficient approach using targeted maximum likelihood estimation (TMLE) for estimating and contrasting expected outcomes under the dynamic regimes embedded in a SMART, together with generating simultaneous confidence intervals for the resulting estimates. We contrast this method with two alternatives (G-computation and inverse probability weighting estimators). The precision gains and robust inference achievable through the use of TMLE to evaluate the effects of embedded regimes are illustrated using both outcome-blind simulations and a real-data analysis from the Adaptive Strategies for Preventing and Treating Lapses of Retention in Human Immunodeficiency Virus (HIV) Care (ADAPT-R) trial (NCT02338739), a SMART with a primary aim of identifying strategies to improve retention in HIV care among people living with HIV in sub-Saharan Africa.

UNLABELLED: Recommendations for universal screening of patients with cancer for hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV) are inconsistent. A recent multisite screening study (S1204) from the SWOG Cancer Research Network found that a substantial number of patients with newly diagnosed cancer had previously unknown viral infections. The objective of this study was to determine the cost-efficiency of universal screening of patients with newly diagnosed cancer. We estimated the cost-efficiency of universal screening of new cancer cases for HBV, HCV, or HIV, expressed as cost per virus detected, from the health care payer perspective. The prevalence of each virus among this cohort was derived from S1204. Direct medical expenditures included costs associated with laboratory screening tests. Costs per case detected were estimated for each screening strategy. Secondary analysis examined the cost-efficiency of screening patients whose viral status at cancer diagnosis was unknown. Among the possible options for universal screening, screening for HBV alone ($581), HCV alone ($782), HBV and HCV ($631) and HBV, HCV, and HIV ($841) were most efficient in terms of cost per case detected. When screening was restricted to patients with unknown viral status, screening for HBV alone ($684), HBV and HCV ($872), HBV and HIV ($1,157), and all three viruses ($1,291) were most efficient in terms of cost per newly detected case. Efficient viral testing strategies represent a relatively modest addition to the overall cost of managing a patient with cancer. Screening for HBV, HCV, and HIV infections may be reasonable from both a budget and clinical standpoint. SIGNIFICANCE: Screening patients with cancer for HBV, HCV, and HIV is inconsistent in clinical practice despite national recommendations and known risks of complications from viral infection. Our study shows that while costs of viral screening strategies vary by choice of tests, they prese

People living with HIV who are seeking jobs experience unique barriers to obtaining employment at the individual, group, and community levels. Traditional employment assistance programs can provide support but may not be tailored to some people living with HIV who often experience barriers to work related to their social needs (such as housing instability) or their lack of consistent engagement in the workforce. To understand how people living with HIV return to work, in-depth interviews were conducted with 43 participants enrolled in interventions coordinating HIV care with housing and employment services at eight sites across the US. Four themes emerged on strategies to increase employment: (1) assessing and responding to employment needs that align with their socio-economic environment; (2) using social networks among family and friends for referrals and support; (3) engaging with navigators who are able to connect clients to skills building opportunities and job resources; and (4) addressing the system barriers such as helping with unmet basic needs (e.g. transportation), finding employers who can accommodate workers with income limits associated with public benefits, and helping immigrants, transgender individuals, and people experiencing homelessness secure legal documentsthat facilitate entry into employment by reducing stigmatized identities.

BACKGROUND: The prevalence of substance use in people with HIV (PWH) in the United States is higher than in the general population and is an important driver of HIV-related outcomes. We sought to assess if previously identified genetic associations that contribute to substance use are also observed in a population of PWH. METHODS: We performed genome-wide association studies (GWAS) of alcohol, smoking, and cannabis use phenotypes in a multi-ancestry population of 7,542 PWH from the Center for AIDS Research Network of Integrated Clinical Systems (CNICS). We conducted multi-ancestry GWAS for individuals of African (n = 3,748), Admixed American (n = 1,334), and European (n = 2,460) ancestry. Phenotype data were self-reported and collected using patient reported outcomes (PROs) and three questions from AUDIT-C, an alcohol screening tool. We analyzed nine phenotypes: 1) frequency of alcohol consumption, 2) typical number of drinks on a day when drinking alcohol, 3) frequency of five or more alcoholic drinks in a 30-day period, 4) smoking initiation, 5) smoking cessation, 6) cigarettes per day, 7) cannabis use initiation, 8) cannabis use cessation, 9) frequency of cannabis use during the previous 30 days. For each phenotype we considered a) variants previously identified as associated with a substance use trait and b) novel associations. RESULTS: We observed evidence for effects of previously reported single nucleotide polymorphisms (SNPs) related to alcohol (rs1229984, p = 0.001), tobacco (rs11783093, p = 2.22E-4), and cannabis use (rs2875907, p = 0.005). We also report two novel loci (19p13.2, p = 1.3E-8; and 20p11.21, p = 2.1E-8) associated with cannabis use cessation. CONCLUSIONS: Our analyses contribute to understanding the genetic bases of substance use in a population with relatively higher rates of use compared to the general population.

We found that urine tenofovir (TFV) levels >1500 ng/mL strongly predict virologic suppression among people with human immunodeficiency virus taking tenofovir alafenamide (odds ratio, 5.66; 95% confidence interval, 1.59-20.14; P = .007). This suggests an existing point-of-care assay developed for tenofovir disoproxil fumarate will support adherence monitoring for patients on all TFV-based antiretrovirals.

Early initiation of antiretroviral therapy (ART) alters viral rebound kinetics after analytic treatment interruption (ATI) and may play a role in promoting HIV-1 remission. Autologous neutralizing antibodies (aNAbs) represent a key adaptive immune response in people living with HIV-1. We aimed to investigate the role of aNAbs in shaping post-ATI HIV-1 rebound variants. We performed single-genome amplification of HIV-1 env from pre-ART and post-ATI plasma samples of 12 individuals who initiated ART early after infection. aNAb activity was quantified using pseudoviruses derived from the most common plasma variant, and the serum dilution that inhibited 50% of viral infections was determined. aNAb responses matured while participants were on suppressive ART, because on-ART plasma and purified immunoglobulin G (IgG) demonstrated improved neutralizing activity against pre-ART HIV-1 strains when compared with pre-ART plasma or purified IgG. Post-ATI aNAb responses exerted selective pressure on the rebounding viruses, because the post-ATI HIV-1 strains were more resistant to post-ATI plasma neutralization compared with the pre-ART virus. Several pre-ATI features distinguished post-treatment controllers from noncontrollers, including an infecting HIV-1 sequence that was more similar to consensus HIV-1 subtype B, more restricted proviral diversity, and a stronger aNAb response. Post-treatment control was also associated with the evolution of distinct N-glycosylation profiles in the HIV-1 envelope. In summary, aNAb responses appeared to mature after early initiation of ART and applied selective pressure on rebounding viruses. The combination of aNAb activity with select HIV-1 sequence and reservoir features identified individuals with a greater chance of post-treatment control.

BACKGROUND: Most people who inject drugs (PWID) in Iran have not undergone recent HIV testing. While PWID face barriers when seeking HIV testing at health facilities, HIV self-testing (HIVST) could be a promising approach to improve HIV testing uptake. We examined the awareness and willingness to use HIVST among PWID in Iran. We also identified participants characteristics associated with a higher willingness to use HIVST. METHODS: PWID were recruited in 11 cities using a respondent-driven sampling method. Willingness to use HIVST was defined as a binary variable (very low/low willingness vs. high/very high willingness). We performed multivariable modified Poisson regression to examine associated factors and report adjusted prevalence ratios (aPR) and 95% confidence intervals (CI). RESULTS: Of 2,252 PWID, 362 (16.2%; 95% CI 14.7, 17.8) had ever heard of HIVST; however, 1,658 (73.6%; 95% CI 71.7, 75.4) reported high/very high willingness to use HIVST. Willingness to use HIVST was higher among PWID who reported having a high/moderate HIV risk perception (aPR 1.22; 95% CI 1.09, 1.37), ever experiencing homelessness (aPR 1.15; 95% CI 1.03, 1.28), > 10 years of injecting history (aPR 1.16; 95% CI 1.00, 1.34), and high injection frequency in the last three months (aPR 1.18; 95% CI 1.05, 1.32). CONCLUSION: Most PWID in Iran, particularly those experiencing homelessness, have a longer injecting history, engage in more frequent injection practices, and possess a heightened perception of HIV risk would be willing to adopt HIVST. Enhancing HIVST awareness through increased access to HIVST and health education programs are needed. Additionally, conducting implementation science studies to effectively design and run HIVST programs in Iran can also increase PWIDs access to HIV testing.

OBJECTIVE: Identify system-level features in HIV migration within a host across body tissues. Evaluate heterogeneity in the presence and magnitude of these features across hosts. METHOD: Using HIV DNA deep sequencing data generated across multiple tissues from 8 people with HIV, we represent the complex dependencies of HIV migration among tissues as a network and model these networks using the family of exponential random graph models (ERGMs). ERGMs allow for the statistical assessment of whether network features occur more (or less) frequently in viral migration than might be expected by chance. The analysis investigates five potential features of the viral migration network: (1) bi-directional flow between tissues; (2) preferential migration among tissues in the same biological system; (3) heterogeneity in the level of viral migration related to HIV reservoir size; (4) hierarchical structure of migration; and (5) cyclical migration among several tissues. We calculate the Cohrans Q statistic to assess heterogeneity in the magnitude of the presence of these features across hosts. The analysis adjusts for missing data on body tissues. RESULTS: We observe strong evidence for bi-directional flow between tissues; migration among tissues in the same biological system; and hierarchical structure of the viral migration network. This analysis shows no evidence for differential level of viral migration with respect to the HIV reservoir size of a tissue. There is evidence that cyclical migration among three tissues occurs less frequent than expected given the amount of viral migration. The analysis also provides evidence for heterogeneity in the magnitude that these features are present across hosts. Adjusting for missing tissue data identifies system-level features within a host as well as heterogeneity in the presence of these features across hosts that are not detected when the analysis only considers the observed data. DISCUSSION: Identification of common features in vira

HIV post-treatment controllers (PTCs) are rare individuals who maintain low levels of viremia after stopping antiretroviral therapy (ART). Understanding the mechanisms of HIV post-treatment control will inform development of strategies aiming at achieving HIV functional cure. In this study, we evaluated 22 PTCs from 8 AIDS Clinical Trials Group (ACTG) analytical treatment interruption (ATI) studies who maintained viral loads ≤400 copies/mL for ≥24 wk. There were no significant differences in demographics or frequency of protective and susceptible human leukocyte antigen (HLA) alleles between PTCs and post-treatment noncontrollers (NCs, n = 37). Unlike NCs, PTCs demonstrated a stable HIV reservoir measured by cell-associated RNA (CA-RNA) and intact proviral DNA assay (IPDA) during analytical treatment interruption (ATI). Immunologically, PTCs demonstrated significantly lower CD4+ and CD8+ T cell activation, lower CD4+ T cell exhaustion, and more robust Gag-specific CD4+ T cell responses and natural killer (NK) cell responses. Sparse partial least squares discriminant analysis (sPLS-DA) identified a set of features enriched in PTCs, including a higher CD4+ T cell% and CD4+/CD8+ ratio, more functional NK cells, and a lower CD4+ T cell exhaustion level. These results provide insights into the key viral reservoir features and immunological profiles for HIV PTCs and have implications for future studies evaluating interventions to achieve an HIV functional cure.

OBJECTIVE: Tenofovir disoproxil fumarate (TDF) is a common component of antiretroviral therapy in hepatitis B virus (HBV)-HIV co-infected adults but few studies have evaluated worsening renal function and bone turnover, known effects of TDF. METHODS: Adults from eight North American sites were enrolled in this cohort study. Research assessments were conducted at entry and every 24 weeks for ≤192 weeks. Bone markers were tested at baseline, week 96 and week 192 from stored serum. We evaluated changes in markers of renal function and bone turnover over time and potential contributing factors. RESULTS: A total of 115 patients were prospectively followed; median age 49 years, 91% male and 52% non-Hispanic Black. Duration of HIV was 20.5 years. TDF use ranged from 80% to 92% throughout follow-up. Estimated glomerular filtration rate (eGFR) (ml/min/1.73m2 ) decreased from 87.1 to 79.9 over 192 weeks (p < 0.001); however, the prevalence of eGFR <60 ml/min/1.73m2 did not appear to differ over time (always <16%; p = 0.43). From baseline to week 192, procollagen type I N-terminal propeptide (P1NP) (146.7 to 130.5 ng/ml; p = 0.001), osteocalcin (14.4 to 10.2 ng/ml; p < 0.001) and C-terminal telopeptides of type I collagen (CTX-1) (373 to 273 pg/ml; p < 0.001) decreased. Younger age, male sex and overweight/obesity versus normal weight predicted a decrease in eGRF. Black race, healthy weight versus underweight, advanced fibrosis, undetectable HBV DNA, and lower parathyroid hormone level predicted worsening bone turnover. CONCLUSION: In this HBV-HIV cohort with high prevalence of TDF use, several biomarkers of renal function and bone turnover indicated worsening status over approximately 4 years, highlighting the importance of clinical awareness in co-infected adults.

Persistence of HIV in people living with HIV (PWH) on suppressive antiretroviral therapy (ART) has been linked to physiological mechanisms of CD4+ T cells. Here, in the same 37 male PWH on ART we measure longitudinal kinetics of HIV DNA and cell turnover rates in five CD4 cell subsets: naïve (TN), stem-cell- (TSCM), central- (TCM), transitional- (TTM), and effector-memory (TEM). HIV decreases in TTM and TEM but not in less-differentiated subsets. Cell turnover is ~10 times faster than HIV clearance in memory subsets, implying that cellular proliferation consistently creates HIV DNA. The optimal mathematical model for these integrated data sets posits HIV DNA also passages between CD4 cell subsets via cellular differentiation. Estimates are heterogeneous, but in an average participants year ~10 (in TN and TSCM) and ~104 (in TCM, TTM, TEM) proviruses are generated by proliferation while ~103 proviruses passage via cell differentiation (per million CD4). In simulations, therapies blocking proliferation and/or enhancing differentiation could reduce HIV DNA by 1-2 logs over 3 years. In summary, HIV exploits cellular proliferation and differentiation to persist during ART but clears faster in more proliferative/differentiated CD4 cell subsets and the same physiological mechanisms sustaining HIV might be temporarily modified to reduce it.

BACKGROUND: Multiple HIV outbreaks among people who inject drugs (PWIDs) have occurred in the USA since 2015, highlighting the need for additional HIV prevention tools. Despite high levels of need, pre-exposure prophylaxis (PrEP) is drastically underutilized among PWIDs. Implicit bias toward PWID held by clinicians may impede PrEP scale-up among these underserved patients. This study examined how primary care providers (PCPs) clinical decisions related to PrEP can be impacted by biases when the patient has a history of substance use. METHODS: We conducted an online survey of PCPs (n = 208). The survey included the implicit association test (IAT) to assess unconscious attitudes toward PWIDs, direct questions regarding clinicians explicit PWID attitudes, and an embedded experiment in which we systematically varied the risk behavior of a hypothetical patient and asked PCPs to make clinical judgments. RESULTS: A minority (32%) of PCPs reported explicit PWID bias. The IAT indicated strong implicit PWID bias (meant IAT score = 0.59, p < .0001) among 88% of the sample. Only 9% of PCPs had no implicit or explicit PWID bias. PWID patients were judged as less likely to adhere to a PrEP regimen, less responsible, and less HIV safety conscious than heterosexual or gay male patients. Anticipated lack of adherence mediated PCPs intent to prescribe PrEP to PWID. CONCLUSIONS: PCPs bias may contribute to PrEP being under-prescribed to PWID. Implicit and explicit PWID biases were common in our sample. This study illustrates the need to develop and test tailored interventions to decrease biases against PWID in primary care settings.

Family rejection has negative health consequences for Latinx sexual minority men (LSMM). However, LSMM often reconcile with their families, a phenomenon cross-sectional studies miss. We analyzed longitudinal data from the Healthy Young Mens Study in Los Angeles. We used individual fixed-effects Poisson regression to model changes over time in the associations among family support, drug use, and depressive symptoms. We found that (1) the initiation of drug use was associated with a 7.2% (Ratio=1.072, 95% CI 1.006 - 1.142, p = 0.03) increase in family support among LSMM who reported high depressive symptoms (depression subscale T-score ≥ 63) in at least one data wave; (2) a 1-unit increase in family support was associated with a 4.7% (RR = ;0.953, 95% CI 0.931 - 0.976, p < 0.001) decrease in the probability of high depressive symptoms; and (3) no significant association between a change in drug use and a change in high depressive symptoms. Over time, LSMM appear to benefit from the health effects of family support associated with Latinx family structures.

BACKGROUND AND AIMS: Reduction of alcohol consumption is important for people undergoing treatment for HIV. We tested the efficacy of a brief intervention for reducing the average volume of alcohol consumed among patients on HIV antiretroviral therapy (ART). DESIGN, SETTING AND PARTICIPANTS: This study used a two-arm multi-centre randomized controlled trial with follow-up to 6 months. Recruitment occurred between May 2016 and October 2017 at six ART clinics at public hospitals in Tshwane, South Africa. Participants were people living with HIV, mean age 40.8 years [standard deviation (SD) = 9.07], 57.5% female, and on average 6.9 years (SD = 3.62) on ART. At baseline (BL), the mean number of drinks consumed over the past 30 days was 25.2 (SD = 38.3). Of 756 eligible patients, 623 were enrolled. INTERVENTION: Participants were randomly assigned to a motivational interviewing (MI)/problem-solving therapy (PST) intervention arm (four modules of MI and PST delivered over two sessions by interventionists) or a treatment as usual (TAU) comparison arm. People assessing outcomes were masked to group assignment. MEASUREMENTS: The primary outcome was the number of standard drinks (15 ml pure alcohol) consumed during the past 30 days assessed at 6-month follow-up (6MFU). FINDINGS: Of the 305 participants randomized to MI/PST, 225 (74%) completed the intervention (all modules). At 6MFU, retention was 88% for the control and 83% for the intervention arm. In support of the hypothesis, an intention-to-treat-analysis for the primary outcome at 6MFU was -0.410 (95% confidence interval = -0.670 to -0.149) units lower on log scale in the intervention group than in the control group (P = 0.002), a 34% relative reduction in the number of drinks. Sensitivity analyses were undertaken for patients who had alcohol use disorders identification test (AUDIT) scores ≥ 8 at BL (n = 299). Findings were similar to those of the whole sample. CONCLUSIONS: In South Africa, a motivational interviewing

BACKGROUND: Living with HIV requires lifelong care to support engagement with and adherence to antiretroviral therapy. The Middle East and North Africa region provides access to ART, but research is lacking on the lived-experiences of people living with HIV. Globally, complementary and alternative medicine (CAM) is increasingly used by patients who need support alongside receiving medical treatment for chronic conditions. This study aims to examine the frequency and reasons behind the use of CAM, as well as identify its associated factors among people living with HIV in Shiraz, Iran. METHODS: In this cross-sectional study, a total of 320 patients (aged 18-70 years) with a confirmed diagnosis of HIV residing in Fars province and diagnosed between 1999 and 2019 were recruited randomly through their clinical record numbers from five HIV treatment centers. They were surveyed on their quality of life and CAM use via the Short-Form Health Survey questionnaire (SF-36) and a semi-structured survey of CAM use. The data analysis for this study involved the use of Chi-squared test, independent t-test, and multiple logistic regression model. RESULTS: Of 287 patients, 89.22% reported using CAM in the previous year. CAM use was more prevalent among those with a family history of CAM use (94.3% vs. 81.8%, p = 0.023). Frequent reasons for using CAM were reported to be sexual dysfunction (32.4%), depression (28.3%), thirstiness (23.3%), and nausea (17.5%). Quality of life, as measured via the SF-36 questionnaire in all its 8 sub-domains, did not differ among those who used CAM versus those who did not (61.5 ± 27.6 vs. 58.1 ± 30.9, p = 0.626). CONCLUSION: CAM was used among a majority of people living with HIV in Shiraz, Iran. People who used CAM appeared to experience a similar quality of life relative to those who did not use CAM. Future studies on the modalities of engagement with CAM can improve patient-physician shared decision-making and increase lifelong care options for peopl

BACKGROUND: Neurofilament light (NFL) chain concentrations, reflecting axonal damage, are seen in several polyneuropathies but have not been studied in human immunodeficiency virus (HIV) distal sensory polyneuropathy (DSP). We evaluated NFL in cerebrospinal fluid (CSF) and plasma in relation to DSP in people with HIV (PWH) from 2 independent cohorts and in people without HIV (PWoH). METHODS: Cohort 1 consisted of PWH from the CHARTER Study. Cohort 2 consisted of PWH and PWoH from the HIV Neurobehavioral Research Center (HNRC). We evaluated DSP signs and symptoms in both cohorts. Immunoassays measured NFL in CSF for all and for plasma as well in Cohort 2. RESULTS: Cohort 1 consisted of 111 PWH, mean ± SD age 56.8 ± 8.32 years, 15.3% female, 38.7% Black, 49.6% White, current CD4+ T-cells (median, interquartile range [IQR]) 532/µL (295, 785), 83.5% with plasma HIV RNA ≤50 copies/mL. Cohort 2 consisted of 233 PWH of similar demographics to PWH in Cohort 1 but also 51 PWoH, together age 58.4 ± 6.68 years, 41.2% female, 18.0% Black, Hispanic, non-Hispanic White 52.0%, 6.00% White. In both cohorts of PWH, CSF and plasma NFL were significantly higher in both PWH with DSP signs. Findings were similar, albeit not significant, for PWoH. The observed relationships were not explained by confounds. CONCLUSIONS: Both plasma and CSF NFL were elevated in PWH and PWoH with DSP. The convergence of our findings with others demonstrates that NFL is a reliable biomarker reflecting peripheral nerve injury. Biomarkers such as NFL might provide, validate, and optimize clinical trials of neuroregenerative strategies in HIV DSP.

Depression is associated with key HIV-related prevention and treatment behaviors in sub-Saharan Africa. We aimed to identify the association of depressive symptoms with HIV testing, linkage to care, and ART adherence among a representative sample of 18-49 year-olds in a high prevalence, rural area of South Africa. Utilizing logistic regression models (N = 1044), depressive symptoms were inversely associated with reported ever HIV testing (AOR 0.92, 95% CI 0.85-0.99; p = 0.04) and ART adherence (AOR 0.82, 95% CI: 0.73-0.91; p < 0.01) among women. For men, depressive symptoms were positively associated with linkage to care (AOR: 1.21, 95% CI: 1.09-1.34; p < 0.01). Depression may adversely impact ART adherence for HIV-positive women and reduce the likelihood of HIV testing for women not aware of their HIV status which, in settings with high HIV prevalence, carries severe consequences. For HIV-positive men, findings suggest that depression may encourage help-seeking behavior, thereby impacting their health system interactions. These findings underscore the need for health-care settings to factor mental health, such as depression, into their programs to address health-related outcomes, particularly for women.

BACKGROUND: The phase 2b proof-of-concept Antibody Mediated Prevention (AMP) trials showed that VRC01, an anti-HIV-1 broadly neutralising antibody (bnAb), prevented acquisition of HIV-1 sensitive to VRC01. To inform future study design and dosing regimen selection of candidate bnAbs, we investigated the association of VRC01 serum concentration with HIV-1 acquisition using AMP trial data. METHODS: The case-control sample included 107 VRC01 recipients who acquired HIV-1 and 82 VRC01 recipients who remained without HIV-1 during the study. We measured VRC01 serum concentrations with a qualified pharmacokinetic (PK) Binding Antibody Multiplex Assay. We employed nonlinear mixed effects PK modelling to estimate daily-grid VRC01 concentrations. Cox regression models were used to assess the association of VRC01 concentration at exposure and baseline body weight, with the hazard of HIV-1 acquisition and prevention efficacy as a function of VRC01 concentration. We also compared fixed dosing vs. body weight-based dosing via simulations. FINDINGS: Estimated VRC01 concentrations in VRC01 recipients without HIV-1 were higher than those in VRC01 recipients who acquired HIV-1. Body weight was inversely associated with HIV-1 acquisition among both placebo and VRC01 recipients but did not modify the prevention efficacy of VRC01. VRC01 concentration was inversely correlated with HIV-1 acquisition, and positively correlated with prevention efficacy of VRC01. Simulation studies suggest that fixed dosing may be comparable to weight-based dosing in overall predicted prevention efficacy. INTERPRETATION: These findings suggest that bnAb serum concentration may be a useful marker for dosing regimen selection, and operationally efficient fixed dosing regimens could be considered for future trials of HIV-1 bnAbs. FUNDING: Was provided by the National Institutes of Health, National Institute of Allergy and Infectious Diseases (NIAID) (UM1 AI068614, to the HIV Vaccine Trials Network [HVTN]; UM1 A

BackgroundThe social processes around initiating injection may be well-suited to intervention, yet there is substantial heterogeneity in the reported experiences of people who inject drugs (PWID) who assist with another individual's first drug injection. We aimed to describe the lifetime prevalence and context of providing initiation assistance among a cohort of PWID.MethodsParticipants of the AIDS Linked to the IntraVenous Experience (ALIVE) cohort of PWID in Baltimore, Maryland (n=848) were surveyed during 2019-2020 about assisting with another person's first injection. Associations between factors related to injection risk and history of providing assistance were estimated using logistic regression models adjusted for sociodemographic and behavioral characteristics.ResultsAt baseline, participants were primarily male (66.1%), black (82.9%), aged a median of 42 years, and had been injecting a median of 18 years. Overall, 19% (n=157) of participants reported ever providing assistance for a median of 2 people (Interquartile Range: 1-4). Having hepatitis C infection (adjusted Odds Ratio [95% Confidence Interval]: 2.5 [1.4-4.6]), syringe sharing (2.2 [1.2-3.9]), and injecting ≥3 times per day (2.0 [1.2-3.4]) at study enrollment were associated with a history of assistance. Participants primarily assisted friends (58.0%), acquaintances (29.9%), and partners (21.7%). Common reasons for assisting were the other person's lack of injection knowledge (73.7%) or sharing drugs (44.9%). Additional reasons included to prevent injury.ConclusionPWID with a history of assisting with another person's first injection exhibited heightened vulnerability to infections and more frequent substance use. Expanding implementation of interventions with an emphasis on harm reduction is needed.

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.

Acquired immunodeficiency syndrome (AIDS)-associated Kaposi sarcoma (KS) is an angioproliferative neoplasia caused by infection with human herpesvirus 8 (HHV-8). It typically presents with mucocutaneous involvement, but it can be disseminated. Initial presentation with primarily pulmonary KS is rare. We present a case of a 32-year-old male with untreated human immunodeficiency virus (HIV) diagnosed 1 year before presentation who developed progressively worsening cough and shortness of breath for 6 months. He was hospitalized twice and treated for unresolved pneumonia in an outside hospital. The patient concomitantly developed purplish nodules on his face, then the upper trunk, back, chest, and thighs bilaterally that gradually increased in size and number. Histopathology findings from skin lesions were consistent for KS. Bronchoscopy found multiple erythematous plaques throughout the tracheobronchial tree with telangiectasias and inflammation suggestive of pulmonary KS. His imaging findings and positive serum HHV-8 polymerase chain reaction (PCR) were consistent with disseminated KS. He started antiretroviral therapy (ART) to treat his HIV infection, followed by liposomal doxorubicin chemotherapy. But both ART and chemotherapy were interrupted due to adherence and insurance issues. The patient was readmitted with acute respiratory failure requiring mechanical ventilation with multiple vasopressors that led to the patients demise. The late recognition of KS diagnosis and delayed treatment can lead to worse outcomes.

INTRODUCTION: Widowed women make up 18-40% of the 12 million women living with HIV in eastern and southern Africa. Widowhood has also been associated with greater HIV morbidity and mortality. We compared the effectiveness of a multisectoral climate adaptive agricultural livelihood intervention (called Shamba Maisha) on food insecurity, and HIV related health outcomes among widowed and married women living with HIV in western Kenya. METHODS: We implemented Shamba Maisha (NCT02815579) using a cluster-randomized control trial design. The intervention arm received an US$175 in-kind loan to purchase a micro-irrigation pump, seeds, and fertilizer, and received eight training sessions on sustainable agriculture and financial management. Study outcomes were measured every 6 months over a 24-month follow-up period and trends in outcomes assessed using multilevel mixed-effects models. RESULTS: The trial enrolled 232 (61.5%) married and 145 (38.5%) widowed women. Widowed women (mean age 42.8 ± 8.4 years) were older than married women (35.8 ± 9.0 years) (p < 0.01). Almost all widowed women (97.2%) self-identified as household heads compared to 10.8% of married women. Comparing widowed vs married women, reduction in food insecurity (-3.13, 95%CI -4.42, -1.84 vs. -3.08, 95%CI -4.15, -2.02), depressive symptoms (-0.21, 95%CI -0.36, -0.07 vs. -0.19, 95%CI -0.29, -0.08), internalized stigma (-0.33, 95%CI -0.55, -0.11 vs. -0.38, 95%CI -0.57, -0.19), and anticipated stigma (-0.46 95%CI -0.65, -0.28 vs. -0.35, 95%CI -0.50, -0.21) was similar for both groups. In contrast, improvements in social support (-2.22, 95%CI -3.85, -0.59 vs. -4.00, 95%CI -5.16, -2.84; p = 0.08) and reduction in enacted stigma (0.01, 95%CI -0.06, 0.08 vs. -0.14, 95%CI -0.20, -0.09; p < 0.01) were weaker for widowed than married women. CONCLUSIONS: Our study is among the first comparing the effect of a livelihood intervention on HIV health outcomes among wido

Oral pre-exposure prophylaxis (PrEP) is the usage of antiretroviral medications by HIV uninfected persons to prevent HIV. It has the potential to significantly reduce HIV acquisition among adolescent girls and young women (AGYW) aged 15–24 who have not yet been exposed to HIV. The purpose of this study was to explore health care workers’ experiences on prescribing Pre-exposure prophylaxis to adolescent girls and young woman at high risk of HIV in Windhoek. The objectives of the study were to explore health care workers’ experiences to prescribing PrEP to adolescent girls and young woman at high risk of HIV infections and to explore health care workers views on PrEP delivery services among AGYW at public health centers. A qualitative, phenomenology design was conducted at public health centers in Windhoek, Khomas region to explore health care workers’ experiences to prescribing PrEP to adolescent girls and young woman at high risk of HIV infections and explore their views on PrEP service delivery among AGYW. Population of the study were nurses that are PrEP prescribers and health centers contain of 58 nurses. Convenience sampling method was used to recruit nurses into the study. A semi-structured interview guide was used as a data collection instrument. Data were analyzed using thematic content analysis. Majority of HCWs indicated that they promoted PrEP uptake among AGYW and were willing and comfortable with prescribing Prep to AGYW. Few HCWs were not comfortable prescribing PrEP to AGYW citing that it promotes the reduction in condom use. The study highlighted a need to sensitize PrEP and sexual reproductive health for AGYW in all departments within the health centers. PrEP introduction among AGYW requires more than solely training HCWs on the clinical aspects of prescribing PrEP. It involves addressing HCWs’ biases and preference regarding sexual health services to AGYW and preparing the health facilities organization for the introduction of PrEP among AGYW. Furth

Oral pre-exposure prophylaxis (PrEP) is the usage of antiretroviral medications by HIV uninfected persons to prevent HIV. It has the potential to significantly reduce HIV acquisition among adolescent girls and young women (AGYW) aged 15–24 who have not yet been exposed to HIV. The purpose of this study was to explore health care workers’ experiences on prescribing Pre-exposure prophylaxis to adolescent girls and young woman at high risk of HIV in Windhoek. The objectives of the study were to explore health care workers’ experiences to prescribing PrEP to adolescent girls and young woman at high risk of HIV infections and to explore health care workers views on PrEP delivery services among AGYW at public health centers. A qualitative, phenomenology design was conducted at public health centers in Windhoek, Khomas region to explore health care workers’ experiences to prescribing PrEP to adolescent girls and young woman at high risk of HIV infections and explore their views on PrEP service delivery among AGYW. Population of the study were nurses that are PrEP prescribers and health centers contain of 58 nurses. Convenience sampling method was used to recruit nurses into the study. A semi-structured interview guide was used as a data collection instrument. Data were analyzed using thematic content analysis. Majority of HCWs indicated that they promoted PrEP uptake among AGYW and were willing and comfortable with prescribing Prep to AGYW. Few HCWs were not comfortable prescribing PrEP to AGYW citing that it promotes the reduction in condom use. The study highlighted a need to sensitize PrEP and sexual reproductive health for AGYW in all departments within the health centers. PrEP introduction among AGYW requires more than solely training HCWs on the clinical aspects of prescribing PrEP. It involves addressing HCWs’ biases and preference regarding sexual health services to AGYW and preparing the health facilities organization for the introduction of PrEP among AGYW. Furth

Oral pre-exposure prophylaxis (PrEP) is the usage of antiretroviral medications by HIV uninfected persons to prevent HIV. It has the potential to significantly reduce HIV acquisition among adolescent girls and young women (AGYW) aged 15–24 who have not yet been exposed to HIV. The purpose of this study was to explore health care workers’ experiences on prescribing Pre-exposure prophylaxis to adolescent girls and young woman at high risk of HIV in Windhoek. The objectives of the study were to explore health care workers’ experiences to prescribing PrEP to adolescent girls and young woman at high risk of HIV infections and to explore health care workers views on PrEP delivery services among AGYW at public health centers. A qualitative, phenomenology design was conducted at public health centers in Windhoek, Khomas region to explore health care workers’ experiences to prescribing PrEP to adolescent girls and young woman at high risk of HIV infections and explore their views on PrEP service delivery among AGYW. Population of the study were nurses that are PrEP prescribers and health centers contain of 58 nurses. Convenience sampling method was used to recruit nurses into the study. A semi-structured interview guide was used as a data collection instrument. Data were analyzed using thematic content analysis. Majority of HCWs indicated that they promoted PrEP uptake among AGYW and were willing and comfortable with prescribing Prep to AGYW. Few HCWs were not comfortable prescribing PrEP to AGYW citing that it promotes the reduction in condom use. The study highlighted a need to sensitize PrEP and sexual reproductive health for AGYW in all departments within the health centers. PrEP introduction among AGYW requires more than solely training HCWs on the clinical aspects of prescribing PrEP. It involves addressing HCWs’ biases and preference regarding sexual health services to AGYW and preparing the health facilities organization for the introduction of PrEP among AGYW. Furth

Introduction. One of the most frequent psychological consequences of COVID-19 is fear, which could lead to non-optimal therapeutic adherence and, therefore, to the disease progression. Objectives. To evaluate the possible association between the fear of contracting COVID-19 and adherence to antiretroviral therapy in persons with HIV during the period between the third and fourth epidemic wave of COVID-19 in Peru. Methods. Analytical cross-sectional study in adults with HIV from the specialized center “Vía Libre” enrolled by non-probabilistic sampling. The validated “Fear of COVID-19 Scale” was used to measure the fear of getting sick from COVID-19, and the “SMAQ” questionnaire to assess therapeutic adherence. Results were presented descriptively, using chi-square for bivariate analysis and generalized linear models, Poisson family to calculate crude and adjusted prevalence ratios (aPR). Results. Between February and July of 2022, 149 adults with a median age of 35 years were enrolled, 91.3% being male, and 75,2% had undetectable viral load levels. No association was found between fear of contracting COVID-19 and HAART adherence (aPR: 0,99; 95% CI 0,97 to 1,02). Persons with a comorbidity were 89% more adherent than persons without comorbidities (RPa: 1,89; 95% CI 1,52 to 2,35). Conclusion. The fear of contracting COVID-19 was not associated with adherence to HAART during the third wave of COVID-19 pandemic in Peru. However, presenting a comorbidity was associated with optimal HAART adherence. Emphasis should be placed on potential factors affecting medication adherence in people with HIV during the COVID-19 pandemic., Introducción. Una de las consecuencias psicológicas más frecuentes del COVID-19 es el miedo. Éste podría ocasionar una adherencia terapéutica no óptima y permitir la progresión de la enfermedad en personas con VIH. Objetivo. Evaluar la asociación entre el miedo a contraer COVID-19 y la adherencia al tratamiento antirretroviral en personas con VIH entre la tercera y cuarta ola epidémica de COVID-19 en el Perú. Métodos. Estudio transversal analítico en adultos con VIH del centro especializado Vía Libre enrolados por muestreo no probabilístico. Se empleó la escala Fear of COVID-19 Scale para medir el miedo a contraer COVID-19, y el cuestionario SMAQ para evaluar la adherencia terapéutica. Los resultados se presentaron de forma descriptiva, usando chi cuadrado para el análisis bivariado y modelos lineales generalizados familia Poisson para estimar razones de prevalencia crudas y ajustadas (RPa). Resultados. Entre febrero - julio del 2022, se enrolaron 149 personas con una mediana de edad de 35 años, el 91,3% fueron varones, y el 75,2% con carga viral indetectable. No se halló asociación entre el miedo a contraer COVID-19 y la adherencia terapéutica (RPa: 0,99; IC95%: 0,97 a 1,02). Adicionalmente, encontramos que las personas que presentaban alguna comorbilidad fueron 89% más adherentes que los que no las presentaban (RPa: 1,89; IC95%: 1,52 a 2,35).Conclusión. El miedo a contraer COVID-19 no se asoció a la adherencia al TARGA durante la tercera ola de pandemia en el Perú. Sin embargo, el presentar alguna comorbilidad se asoció a una adherencia terapéutica óptima. Se debe poner énfasis en los posibles factores que afecten la adherencia en personas con VIH durante la pandemia por COVID-19.

Producción Científica, Background: Immune recovery in people living with HIV (PLWHIV) is a residual aspect of antiretroviral treatment (ART) in most patients, but in a non-negligible proportion of them, the CD4+ lymphocytes count, or CD4/CD8 ratio remains suboptimal. Methods: We performed a model of the immune response after 24 weeks of switching to a 2DR with DTG plus 3TC in a retrospective multicenter cohort of undetectable and experienced patients using significant predictor variables associated with the parameters or situations defined as success and failure. Clinical variables studied were CD4+ and CD8+ lymphocyte count, percentage of CD4, and CD4/CD8 ratio. These parameters were assessed at baseline and 24 weeks after the switch. Based on the evolution of each variable, four categories of immune response and four categories of non-immune response were defined. Immune response was defined as CD4+ count > 500 cells/mm3, %CD4 > 30%, CD8+ count < 1000 cells/mm3 and CD4/CD8 ratio ≥ 0.9. Non-response is just the opposite. Results: In our different models of immunological response, the presence of stage of AIDS (p = 0.035, p = 0.065) and current age over 50 years (p = 0.045) are postulated as statistically significative limiting factors in achieving an improvement in CD4, %CD4, CD8, and CD4/CD8 ratio. Late HIV diagnosis (p = 0.156), without statistical significance, enhanced late the previous variables. In contrast, conditions where patients start with CD4 > 500 cells/mm3 (p = 0.054); CD4 > 30% (p = 0.054, p = 0.084); CD8 < 1000 cells/mm3 (p = 0.018), and CD4/CD8 ≥ 0.9 (p = 0.013, p = 0.09) are detected as stimulating or conducive to DTG plus 3TC treatment success. Conclusion: These models represent a proof of concept that could become a valuable tool for clinicians to predict the effects of DTG plus 3TC on immunological responses prior to the switch in undetectable pre-treated PLWHIV with immune dysfunction. The main predictors for immunological failure were late HIV diagnosis, stage of A

During the first years of the HIV pandemic, the virus diffusion was responsible for discriminatory behavior from medical and dental care workers towards HIV-infected patients, as described by our research group in 2009. The aim of the current study was to provide an update on the previous data, investigating the presence of discriminatory behaviors, evaluating the level of dentists’ knowledge about the virus and proposing strategies to be implemented to avoid professional exposure and cross-infections. This study was a cross-sectional, online, national survey on dentists, members of the main national dental associations (ANDI and AIO). The questionnaire was divided into four major sections, with the same structure as the questionnaire administered in 2009. The differences between groups were analyzed using the software program IBM SPSS Statistic, version 21.0. A total of 1054 dentists filled out the questionnaire completely. Among them 0.04% revealed a discriminatory attitude towards HIV-infected patients. The univariate analysis showed that discrimination towards HIV + patients was statistically associated with personal experiences and the level of fear associated with treating them (p = 0.001) and with the type of dental treatments performed (p = 0.01). This cross-sectional study revealed the persistence of dentists who still discriminate against HIV + patients, and the percentage of these dentists was only slightly lower than that in the previous survey (4.3% in the present survey vs. 4.5%). The survey also depicted other information worthy of consideration, such as a perceived ability to detect HIV + patients based on their appearance, complaints about not having received adequate training for treating HIV + individuals, and a lack of scientific knowledge about the virus. From the evidence reported by the present survey, it can be argued that universities, professional boards, and training institutions must increase their efforts in spreading correct knowledge a

HIV reservoirs persist in anatomic compartments despite antiretroviral therapy (ART). Characterizing archival HIV DNA in the central nervous system (CNS) and other tissues is crucial to inform cure strategies. We evaluated paired autopsy brain-frontal cortex (FC), occipital cortex (OCC), and basal ganglia (BG)-and peripheral lymphoid tissues from 63 people with HIV. Participants passed away while virally suppressed on ART at the last visit and without evidence of CNS opportunistic disease. We quantified total HIV DNA in all participants and obtained full-length HIV-envelope (FL HIV-env) sequences from a subset of 14 participants. We detected HIV DNA (gag) in most brain (65.1%) and all lymphoid tissues. Lymphoid tissues had higher HIV DNA levels than the brain (P < 0.01). Levels of HIV gag between BG and FC were similar (P > 0.2), while OCC had the lowest levels (P = 0.01). Females had higher HIV DNA levels in tissues than males (gag, P = 0.03; 2-LTR, P = 0.05), suggesting possible sex-associated mechanisms for HIV reservoir persistence. Most FL HIV-env sequences (n = 143) were intact, while 42 were defective. Clonal sequences were found in 8 out of 14 participants, and 1 participant had clonal defective sequences in the brain and spleen, suggestive of cell migration. From 10 donors with paired brain and lymphoid sequences, we observed evidence of compartmentalized sequences in 2 donors. Our data further the idea that the brain is a site for archival HIV DNA during ART where compartmentalized provirus may occur in a subset of people. Future studies assessing FL HIV-provirus and replication competence are needed to further evaluate the HIV reservoirs in tissues. IMPORTANCE HIV infection of the brain is associated with adverse neuropsychiatric outcomes, despite efficient antiretroviral treatment. HIV may persist in reservoirs in the brain and other tissues, which can seed virus replication if treatment is interrupted, representing a major challenge to cure HIV. W

OBJECTIVE: Loneliness is prevalent in people with HIV (PWH) and associated with adverse health-related consequences, including depression. Chronic inflammation has been linked to depression in PWH, though its association with loneliness is less well established. Simultaneous examination of inflammation, loneliness and depression is needed to clarify these relationships. This study investigated the relationship between loneliness and inflammation, and the effects of loneliness and inflammation on depression in PWH. METHODS: 82 PWH who were on suppressive ART (mean age [SD] = 53.2 [9.0]) completed the UCLA Loneliness Scale-Version 3 and the Center for Epidemiologic Studies Depression Scale as part of a comprehensive evaluation. Biomarkers of systemic inflammation (CRP, IL-6, CCL2/MCP-1, sCD14) and coagulation (D-dimer) were measured in blood using commercial immunoassays. RESULTS: Multivariable linear regression analyses revealed that higher D-dimer, CCL2/MCP-1, and sCD14 were significant predictors of loneliness (ps < .05) while accounting for relevant covariates. Stepwise multiple linear regression models that included loneliness, biomarkers, and their interactions as predictors of depressive symptoms revealed significant main effects of loneliness and CCL2/MCP-1 levels (ps < .05), and a significant loneliness by D-dimer interaction (p < .05) whereby higher D-dimer was associated with increased depressive symptoms only at higher levels of loneliness. CONCLUSIONS: Increased coagulation activity is associated with loneliness, and in the context of loneliness, may increase risk for depression. Increased inflammation was associated with depression suggesting potentially dissociable underlying biological processes. To the extent that these processes are modifiable, such findings could have important implications in the treatment of loneliness and depression in PWH.

Disease investigation plan about human immunodeficiency virus (HIV). Includes information on the disease and epidemiology, public health control measures, and case investigation.

La discrepancia en los nuevos diagnósticos de VIH entre las personas hispanas y las personas de origen no hispano ha aumentado en los últimos años. Utah es el hogar de una considerable población hispana en vías de crecimiento. DHHS está comprometido a mejorar el estado de salud de todos los habitantes de Utah.

The disparity in new HIV diagnosis between people who are Hispanic and people of non-Hispanic origin has grown in recent years. Utah is home to a sizeable, and growing, Hispanic population. DHHS is committed to improving the health status of all Utahns.

This report describes new diagnoses of human immunodeficiency virus (HIV) in 2021 among persons whose primary residence was in Utah at the time of diagnosis. Data analysis assessed the demographics of new diagnoses (e.g., age, race/ethnicity, risk factors, etc.) as well as their geographic distribution. Trends for the past 10 years were included for comparison. Since there is often a delay in reporting deaths and address changes, analyses involving persons previously known to be HIV-positive only include data through the end of 2020. A few special topics related to HIV, such as stage 3 (AIDS) diagnoses and death rates, were also analyzed.

This research proposes a model of communication factors (content, style, context, and time) on consistent condom use in men. A total of one thousand five hundred twenty-four men answered a survey and participated through purposive sampling. Subsequently, three groups were formed: one with participants with an HIV diagnosis, another with those who have taken an HIV test but got a negative result, and the last with those who have never had an HIV detection test. We tested the model’s adjustment in all the samples and then per group through modeling structural equations. We adequately adjusted the first model that considered all the participants. The results were similar when doing this same analysis per group, although, in the case of men with HIV, we includedthe time they were diagnosed for a better model adjustment. The results are discussed in terms of the empirical evidence of the model and the design of intervention programs that promote condom use in men., O propósito da presente investigação é propor um modelo de fatores de comunicação (conteúdo,estilo,contexto e tempo) sobre a consistência no uso do preservativo em homens. Participaram 1524 homens por meio de uma amostragem intencional, os quais foram convidados a responder uma pesquisa, posteriormente foram formados três grupos, com diagnóstico de HIV; que realizaram um teste de HIV, mas que seu resultado foi negativo; e que nunca fizeram um teste de detecção. Por meio da modelagem de equações estruturais, foi testado o ajuste do modelo em toda a amostra e por grupo. O primeiro modelo que considerou todos os participantes foi adequadamente ajustado, ao fazer a mesma análise por grupo, os resultados foram semelhantes, embora no caso dos homens com HIV, o tempo de diagnóstico de HIV tenha sido incorporado para um melhor ajuste do modelo. Os resultados são discutidos em termos da evidência empírica do modelo e do desenho de programas de intervenção que promovam o uso do preservativo em homens., El propósito de la presente investigación es proponer un modelo de los factores de la comunicación (contenido, estilo, contexto y tiempo) sobre la consistencia en el uso del condón en hombres. Participaron 1524 hombres a través de un muestreo intencionado a quienes se les invitó a responder una encuesta, posteriormente se formaron tres grupos, con diagnóstico de VIH, que se han realizado una prueba de VIH pero que su resultado es negativo, y que nunca se han hecho una prueba de detección. A través del modelamiento de ecuaciones estructurales se probó el ajuste del modelo en toda la muestra y por grupo. El primer modelo que consideró a todos los participantes se ajustó adecuadamente, al hacer este mismo análisis por grupo, los resultados fueron similares, aunque en el caso de los hombres con VIH se incorporó el tiempo de diagnóstico de VIH para un mejor ajuste del modelo. Los resultados se discuten en términos de la evidencia empírica del modelo y del diseño de programas de intervención que promuevan el uso del condón en hombres.

IntroductionPerson-centred HIV prevention delivery models that offer structured choices in product, testing and visit location may increase coverage. However, data are lacking on the actual uptake of choices among persons at risk of HIV in southern Africa. In an ongoing randomized study (SEARCH; NCT04810650) in rural East Africa, we evaluated the uptake of choices made when offered in a person-centred, dynamic choice model for HIV prevention.MethodsUsing the PRECEDE framework, we developed a persont-centred, Dynamic Choice HIV Prevention (DCP) intervention for persons at risk of HIV in three settings in rural Kenya and Uganda: antenatal clinic (ANC), outpatient department (OPD) and in the community. Components include: provider training on product choice (predisposing); flexibility and responsiveness to client desires and choices (pre-exposure prophylaxis [PrEP]/post-exposure prophylaxis [PEP], clinic vs. off-site visits and self- or clinician-based HIV testing) (enabling); and client and staff feedback (reinforcing). All clients received a structured assessment of barriers with personalized plans to address them, mobile phone access to clinicians (24 hours/7 days/week) and integrated reproductive health services. In this interim analysis, we describe the uptake of choices of product, location and testing during the first 24 weeks of follow-up (April 2021-March 2022).ResultsA total of 612 (203 ANC, 197 OPD and 212 community) participants were randomized to the person-centred DCP intervention. We delivered the DCP intervention in all three settings with diverse populations: ANC: 39% pregnant; median age: 24 years; OPD: 39% male, median age 27 years; and community: 42% male, median age: 29 years. Baseline choice of PrEP was highest in ANC (98%) vs. OPD (84%) and community (40%); whereas the proportion of adults selecting PEP was higher in the community (46%) vs. OPD (8%) and ANC (1%). Personal preference for off-site visits increased over time (65% at week 24 vs. 35%

BackgroundAlthough unhealthy alcohol use is associated with increased morbidity and mortality among people with HIV (PWH), many are ambivalent about engaging in treatment and experience variable responses to treatment. We describe the rationale, aims, and study design for the Financial Incentives, Randomization, with Stepped Treatment (FIRST) Trial, a multi-site randomized controlled efficacy trial.MethodsPWH in care recruited from clinics across the United States who reported unhealthy alcohol use, had a phosphatidylethanol (PEth) >20 ng/mL, and were not engaged in formal alcohol treatment were randomized to integrated contingency management with stepped care versus treatment as usual. The intervention involved two steps; Step 1: Contingency management (n = 5 sessions) with potential rewards based on 1) short-term abstinence; 2) longer-term abstinence; and 3) completion of healthy activities to promote progress in addressing alcohol consumption or conditions potentially impacted by alcohol; Step 2: Addiction physician management (n = 6 sessions) plus motivational enhancement therapy (n = 4 sessions). Participants' treatment was stepped up at week 12 if they lacked evidence of longer-term abstinence. Primary outcome was abstinence at week 24. Secondary outcomes included alcohol consumption (assessed by TLFB and PEth) and the Veterans Aging Cohort Study (VACS) Index 2.0 scores; exploratory outcomes included progress in addressing medical conditions potentially impacted by alcohol. Protocol adaptations due to the COVID-19 pandemic are described.ConclusionsThe FIRST Trial is anticipated to yield insights on the feasibility and preliminary efficacy of integrated contingency management with stepped care to address unhealthy alcohol use among PWH.Clinicaltrialsgov identifier: NCT03089320.

BackgroundThe SARS-CoV-2 pandemic has resulted in an increase in telemedicine utilization for routine HIV care. However, there is limited information on perceptions of and experiences with telemedicine from United States (U.S.) federally qualified health centers (FQHCs) offering HIV care. We sought to understand telemedicine experiences of stakeholders with various roles: people living with HIV (PLHIV), clinical (clinicians and case managers), programmatic (clinic administrators), and policy (policymakers).MethodsQualitative interviews about benefits and challenges of telemedicine (telephone and video) for HIV care were conducted with 31 PLHIV and 23 other stakeholders (clinicians, case managers, clinic administrators, and policymakers). Interviews were transcribed, translated to English if conducted in Spanish, coded, and analyzed for major themes.ResultsAlmost all PLHIV felt capable of engaging in telephone visits, with some expressing interest in learning how to use video visits as well. Nearly all PLHIV wanted to continue telemedicine as part of their routine HIV care, and this was also endorsed by clinical, programmatic and policy stakeholders. Interviewees agreed that telemedicine for HIV care has benefits for PLHIV, especially savings of time and transportation costs, which also reduced stress. Clinical, programmatic, and policy stakeholders expressed concerns around patients' technological literacy and resources, as well as their access to privacy, and some felt that PLHIV strongly preferred in-person visits. These stakeholders also commonly reported clinic-level implementation challenges, including integrating telephone and video telemedicine into workflows and difficulty with video visit platforms.ConclusionsTelemedicine for HIV care, largely delivered via telephone (audio-only), was highly acceptable and feasible for both PLHIV, clinicians, and other stakeholders. Addressing barriers for stakeholders in incorporating video visits will be important fo

IntroductionThe COVID-19 pandemic has required a shift of many routine primary care visits to telemedicine, potentially widening disparities in care access among vulnerable populations. In a publicly-funded HIV clinic, we aimed to evaluate a pre-visit phone-based planning intervention to address anticipated barriers to telemedicine.MethodsWe conducted a pragmatic randomized controlled trial of patients scheduled for a phone-based HIV primary care visit at the Ward 86 HIV clinic in San Francisco from 15 April to 15 May 2020. Once reached by phone, patients were randomized to either have a structured pre-visit planning intervention to address barriers to an upcoming telemedicine visit versus a standard reminder call. The primary outcome was telemedicine visit attendance.ResultsOf 476 scheduled telemedicine visits, 280 patients were reached by a pre-visit call to offer enrollment. Patients were less likely to be reached if virally unsuppressed (odds ratio (OR) 0.11, 95% confidence intervals (CI) 0.03-0.48), CD4 < 200 (OR 0.24, 95% CI 0.07-0.85), or were homeless (OR 0.24, 95% CI 0.07-0.87). There was no difference between intervention and control in scheduled visit attendance (83% v. 78%, OR 1.38, 95% CI 0.67-2.81).ConclusionsA structured phone-based planning call to address barriers to telemedicine in a public HIV clinic was less likely to reach patients with poorly-controlled HIV and patients experiencing homelessness, suggesting additional interventions may be needed in this population to ensure access to telemedicine-based care. Among patients reachable by phone, telemedicine visit attendance was high and not improved with a structured pre-visit intervention, suggesting that standard reminders may be adequate in this population.

Few studies have researched young adults' experiences taking HIV pre-exposure prophylaxis (PrEP) after the start of California's COVID-19 shelter-in-place (SIP) orders. The purpose of this study was to examine the experiences of young adults with sex, dating, and PrEP use during SIP and their perceptions on how to improve PrEP care in this age group. In this mixed-methods study, PrEP users ages 18-29 living in California between April 2020 and June 2021 completed a quantitative survey (N = 37) and one-on-one qualitative interviews (N = 18). Over half of survey participants reported trouble accessing PrEP care during SIP, citing difficulty obtaining medication refills, clinic appointments, and access to completing lab work. In qualitative interviews, participants expressed their preferences for more accessible PrEP service delivery across the PrEP care continuum. Despite pandemic SIP orders and trouble accessing PrEP services, young adults continued to engage in sexual behaviors.