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BackgroundDetection and management of acute HIV infection (AHI) is a clinical and public health priority, and HIV infections diagnosed among young adults aged 18 to 39 years are usually recent. Young adults with recent HIV acquisition frequently seek care for symptoms and could potentially be diagnosed through the health care system. Early recognition of HIV infection provides considerable individual and public health benefits, including linkage to treatment as prevention, access to risk reduction counseling and treatment, and notification of partners in need of HIV testing. ObjectiveThe Tambua Mapema Plus study aims to (1) test 1500 young adults (aged 18-39 years) identified by an AHI screening algorithm for acute and prevalent (ie, seropositive) HIV, linking all newly diagnosed HIV-infected patients to care and offering immediate treatment; (2) offer assisted HIV partner notification services to all patients with HIV, testing partners for acute and prevalent HIV infection and identifying local sexual networks; and (3) model the potential impact of these two interventions on the Kenyan HIV epidemic, estimating incremental costs per HIV infection averted, death averted, and disability-adjusted life year averted using data on study outcomes. MethodsA modified stepped-wedge design is evaluating the yield of this HIV testing intervention at 4 public and 2 private health facilities in coastal Kenya before and after intervention delivery. The intervention uses point-of-care HIV-1 RNA testing combined with standard rapid antibody tests to diagnose AHI and prevalent HIV among young adults presenting for care, employs HIV partner notification services to identify linked acute and prevalent infections, and follows all newly diagnosed patients and their partners for 12 months to ascertain clinical outcomes, including linkage to care, antiretroviral therapy (ART) initiation and virologic suppression in HIV-infected patients, and pre-exposure prophylaxis uptake in uninfected individuals in discordant partnerships. ResultsEnrollment started in December 2017. As of April 2020, 1374 participants have been enrolled in the observation period and 1500 participants have been enrolled in the intervention period, with 13 new diagnoses (0.95%) in the observation period and 37 new diagnoses (2.47%), including 2 AHI diagnoses, in the intervention period. Analysis is ongoing and will include adjusted comparisons of the odds of the following outcomes in the observation and intervention periods: being tested for HIV infection, newly diagnosed with prevalent or acute HIV infection, linked to care, and starting ART by week 6 following HIV diagnosis. Participants newly diagnosed with acute or prevalent HIV infection in the intervention period are being followed for outcomes, including viral suppression by month 6 and month 12 following ART initiation and partner testing outcomes. ConclusionsThe Tambua Mapema Plus study will provide foundational data on the potential of this novel combination HIV prevention intervention to reduce ongoing HIV transmission in Kenya and other high-prevalence African settings. Trial RegistrationClinicalTrials.gov NCT03508908; https://clinicaltrials.gov/ct2/show/NCT03508908 International Registered Report Identifier (IRRID)DERR1-10.2196/16198

BackgroundHIV infection leads to endothelial activation, promoting platelet adhesion, and accelerating atherosclerosis. Our goal was to determine whether biomarkers of endothelial activation and hemostasis/thrombosis were elevated in people with treated HIV (PWH) before myocardial infarction (MI).MethodsIn a case-control study nested within the CFAR Network of Integrated Clinical Systems (CNICS) cohort, we compared 69 adjudicated cases with type 1 MI with 138 controls matched for antiretroviral therapy regimen. We measured angiopoietin-1, angiopoietin-2 (ANG-2), intercellular adhesion molecule 1 (ICAM-1), vascular cell adhesion molecule 1 (VCAM-1), a disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13 (ADAMTS13), von Willebrand factor, C-reactive protein (CRP), interleukin-6 (IL-6), plasminogen activation inhibitor-1, P-selectin, serum amyloid-A, soluble CD14, and apolipoprotein A1 in stored plasma. Conditional logistic regression identified associations with subsequent MI, with and without adjustment for Atherosclerotic Cardiovascular Disease (ASCVD) and Veterans Aging Cohort Study (VACS) scores.ResultsHigher IL-6 was associated with MI after adjustment for ASCVD score (adjusted odds ratio [AOR] 1.51, 95% confidence interval [95% CI]: 1.05 to 2.17 per standard-deviation-scaled log 2 increment). In a separate model adjusting for VACS score, higher ANG-2 (AOR 1.49, 95% CI: 1.04 to 2.14), higher CRP (AOR 1.45, 95% CI: 1.06 to 2.00), and higher IL-6 (AOR 1.68, 95% CI: 1.17 to 2.41) were associated with MI. In a sensitivity analysis excluding PWH with viral load ≥400 copies/mL, higher IL-6 remained associated with MI after adjustment for ASCVD score and after adjustment for VACS score.ConclusionsAmong PWH, higher levels of plasma IL-6, CRP, and ANG-2 predict subsequent type 1 MI, independent of conventional risk scores. IL-6 had the most consistent associations with type 1 MI, regardless of viral load suppression.

BackgroundWe assessed whether key biomarkers of endothelial activation and hemostasis/thrombosis were elevated in individuals receiving effective antiretroviral therapy (ART) in the year before ischemic stroke.MethodsWe conducted a case-control study nested in the CFAR Network of Integrated Clinical Systems cohort, comparing 42 adjudicated cases with ischemic stroke with 83 controls matched for ART regimen. Angiopoietin-1, angiopoietin-2, C-reactive protein, interleukin-6, plasminogen activation inhibitor-1, P-selectin, serum amyloid-A, soluble CD14, ICAM-1, VCAM-1, apolipoprotein A1, ADAMTS13, and von Willebrand factor (VWF) were measured in stored plasma collected before the stroke event. We used conditional logistic regression to identify associations with ischemic stroke, with and without adjustment for Atherosclerotic Cardiovascular Disease (ASCVD) and Veterans Aging Cohort Study (VACS) scores.ResultsAfter adjustment for age and sex, higher plasma viral load and higher angiopoeitin-2, soluble CD14, and VWF were associated with increased odds of ischemic stroke; higher nadir CD4 count was associated with decreased odds of ischemic stroke. VWF remained associated with subsequent ischemic stroke after adjustment for ASCVD score (adjusted odds, 1.74; 95% CI, 1.01-2.98 per log2 increment). In a separate model adjusting for VACS score, only VWF (adjusted odds, 1.80; 95% CI, 1.04-3.12 per log2 increment) was associated with subsequent ischemic stroke. In a sensitivity analysis excluding participants with viral load ≥400 copies/mL, associations between VWF and ischemic stroke were attenuated, with risk estimates ranging from 1.59 to 1.64 per log2 increment.ConclusionsEndothelial activation and related release and attachment of VWF may play an important role in ischemic stroke among persons with treated HIV infection.

Background. People living with HIV (PWH) frequently have co-morbid substance use disorders that may have been impacted by the COVID-19 pandemic. This study examined associations between COVID-related stress and increased substance use among PWH in Washington State. Methods. Between August 2020 and March 2021, we conducted an online survey of 397 PWH in western Washington. Logistic regression was used to analyze associations between a COVID-19 stress score and four self-reported outcomes: increased alcohol use, increased cigarette smoking, increased marijuana use, and increased use of illicit substances. Results. Thirty-five (38.0%) of 92 participants who smoked, 61 (23.4%) of 261 participants who used alcohol, 15 (14.6%) of 103 participants who used marijuana, and 35 (33.0%) of 102 participants who used illicit substances reported increased use of these substances. Higher COVID-19 stress scores were associated with higher odds of increased cigarette smoking (adjusted odds ratio [aOR] = 1.15, 95% confidence interval [CI]: 1.04–1.27), even after adjustment for anxiety and depressive symptoms (aOR 1.14, 95%CI: 1.03–1.27). COVID-19 stress was not associated with an increased use of alcohol, marijuana, or illicit substances. Conclusions. COVID-19-related stress was associated with self-reported increased cigarette smoking among PWH in western Washington during the pandemic. [ABSTRACT FROM AUTHOR]

: Introduction: Recent advances in long‐acting antiretroviral therapy (LA‐ART) could provide new options for HIV treatment and reduce adherence barriers, if regimens are acceptable to patients. We elicited preferences for key attributes of potential LA‐ART regimens among people with HIV (PWH) in the United States, focusing on four treatment modes (oral tablets, subcutaneous injections, intramuscular injections, and implants), product characteristics and location of administration. Methods: A discrete choice experiment was conducted among PWH aged ≥18 years recruited from HIV clinics in Washington State and Atlanta, Georgia from March 2021 to June 2022. Participants responded to 17 choice scenarios, each with three options: two systematically generated hypothetical LA‐ART regimens and a constant opt‐out (their current daily oral treatment). LA‐ART regimen descriptions included treatment mode, pain, dosing frequency, location, pre‐treatment time with undetectable viral load, pre‐treatment negative reaction testing and “late‐dose leeway” (i.e. flexibility or forgiveness in timing the next dose). We used conditional logistic regression, with an interaction between treatment mode and pain, to estimate preference weights for all attribute levels. Results: Seven hundred participants (350 at each site) enrolled, with median age 51 years (range 18–73); 70% identified as cisgender male, 24% as cisgender female and 6% as non‐binary or transgender. LA oral tablets were the only mode preferred over current daily oral treatment, with annual implants and injections the next most preferred LA‐ART option. Longer time between doses was preferred, and administration at home was preferred to clinics, which were preferred to pharmacies. Attributes with less impact on preferences included oral lead‐in treatment to achieve viral suppression or test for negative reactions and late‐dose leeway around the prescribed dosing interval. Participants in Atlanta were more likely to prefer their current daily oral ART than participants from Seattle. Conclusions: PWH in the United States may soon have several options for LA‐ART. Our results suggest that LA oral tablets will be preferred by many patients over their current daily oral treatment, while implants and injections with longer duration may be acceptable to some. Future research should investigate sources of preference heterogeneity and actual uptake of and adherence to LA‐ART products, when available., INTRODUCTION In 2020, the Centers for Disease Control and Prevention estimated that for every 100 people who were diagnosed with HIV, only 74 had received HIV care and 65 were [...]

Sexual minority men (SMM) experience intimate partner violence (IPV) at a substantially high rate and also bear high burdens of adverse mental health outcomes. This systematic review and meta-analysis aimed to consolidate existing evidence on the associations between experiencing IPV and adverse mental health outcomes (depressive symptoms, anxiety, stress, etc.) among SMM. Following the Preferred Reporting Items For Systematic Reviews and Meta-Analyses guideline, we identified 22 published studies encompassing data from 18,454 individuals, all of which were cross-sectional in design and half of which were conducted in the U.S. We found that experiencing IPV was associated with an increased risk of depressive symptoms and anxiety with a pooled Adjusted Odds Ratios (AORs) of 1.71 (95% CI [1.43, 2.05]) and 1.89 (95% CI [1.46, 2.43]), respective. Studies also found that IPV was positively associated with suicide-related risk (AOR = 2.71, 95% CI [2.21, 3.32] and perceived loneliness. Studies varied in their IPV measures and recall periods and used diverse mental health measurement tools like PHQ-9/GAD-7, Perceived Stress Scale, and the Suicide Behaviors Questionnaire-Revised. This systematic review and meta-analysis revealed an urgent need to examine the effects of IPV on SMM's mental well-being in low- and middle-income countries using standardized IPV measurement tools. Future research should employ a longitudinal design to track the long-term effects of IPV on the mental well-being of SMM and explore potential interventions for mitigating these impacts over time. These insights are crucial for enhancing IPV screening within healthcare settings and identifying key intervention targets aimed at improving the mental health of SMM. [ABSTRACT FROM AUTHOR]

While pre-exposure prophylaxis (PrEP) has demonstrated efficacy in preventing HIV transmission, disparities in access persist in the United States, especially among Hispanic/Latinx sexual minority men (SMM). Language barriers and differences in how Latinx SMM obtain information may impact access to PrEP and HIV prevention. This study used data from the 2021 American Men's Internet Survey (AMIS) to examine differences in communication networks and PrEP use among Latinx SMM by primary language (Spanish vs. English). We examined the associations between Latinx SMM's individual- and meso-level communication networks and PrEP-related outcomes using modified Poisson regression with robust variances. Spanish-speaking Latinx SMM in the study were less likely to test for HIV, be aware of PrEP, and use daily PrEP, compared to English-speaking participants. Sexuality disclosure to a healthcare provider was positively associated with PrEP uptake among all participants and predicted STI testing over the past 12 months among English-speaking Latinx SMM. Findings highlight disparities in PrEP awareness and uptake among Latinx SMM, especially among those whose primary language is Spanish. Addressing these disparities through targeted interventions, including improved communication with healthcare providers, may help facilitate PrEP access and use in this population. [ABSTRACT FROM AUTHOR]

Introduction: HIV healthcare services for men who have sex with men (MSM) in Kenya have not been openly provided because of persistent stigma and lack of healthcare capacity within Kenya's decentralized health sector. Building on an evaluation of a developed online MSM sensitivity training programme offered to East and South African healthcare providers, this study assessed views and responses to strengthen HIV healthcare services for MSM in Kenya. Methods: The study was conducted between January and July 2017 in Kilifi County coastal Kenya. Seventeen policymakers participated in an in-depth interview and 59 stakeholders, who were purposively selected from three key groups (i.e. healthcare providers, implementing partners and members of MSM-led community-based organizations) took part in eight focus group discussions. Discussions aimed to understand gaps in service provision to MSM from different perspectives, to identify potential misconceptions, and to explore opportunities to improve MSM HIV healthcare services. Interviews and focus group discussions were recorded, transcribed verbatim and analysed using Braun and Clarke's thematic analysis. Results: Participants' responses revealed that all key groups navigated diverse challenges related to MSM HIV health services. Specific challenges included priority-setting by county government staff; preparedness of leadership and management on MSM HIV issues at the facility level; data reporting at the implementation level and advocacy for MSM health equity. Strong power inequities were observed between policy leadership, healthcare providers and MSM, with MSM feeling blamed for their sexua orientation. MSM agency, as expressed in their actions to access HIV services, was significantly constrained by county context, but can potentially be improved by political will, professional support and a human rights approach. Conclusions: To strengthen HIV healthcare for MSM within a decentralized Kenyan health system, a more responsive, multi-pronged strategy adaptable and relevant to MSM's healthcare needs is required. Continued engagement with policy leadership, collaboration with health facilities, and partnerships with different community stakeholders are critical to improve HIV healthcare services for MSM. Keywords: HIV healthcare services; MSM; Kenya; decentralization; health equity, 1 | INTRODUCTION Kenya has among the largest HIV epidemics in the world with an estimated 1.6 million people living with HIV, 46,000 new infections, and 25,000 AIDS-related deaths in [...]

Introduction: Most gay, bisexual and other men who have sex with men (GBMSM) live in rights-constrained environments making retaining them in research to be as hard as recruiting them. To evaluate Anza Mapema, an HIV risk-reduction programme in Kisumu, Kenya, we examined the enrolment sociodemographic, behavioural, psychosocial and clinical factors associated with missing two or more follow-up visits for GBMSM participating in Anza Mapema. Methods: Between August 2015 and November 2017, GBMSM were enrolled and followed in a prospective cohort study with quarterly visits over 12 months. At enrolment, men were tested for HIV and sexually transmitted infections and completed questionnaires via audio computer-assisted self-interview. Because the Kenya Ministry of Health recommends HIV testing every three to six months for GBMSM, the retention outcome in this cross sectional analysis was defined as missing two consecutive follow-up visits (vs. not missing two or more consecutive visits). Multivariable logistic regression estimated the adjusted odds ratios (aOR) and 95% confidence intervals (CI) for the associations of the enrolment characteristics with the binary outcome of retention. Results and discussion: Among 609 enrolled HIV-negative GBMSM, the median age was 23 years (interquartile range, 21 to 28 years), 19.0% had completed Conclusions: One in five men missed two consecutive follow-up visits during this HIV prevention study despite intensive retention efforts and compensation for travel and participation. Participants with recent community arrival may require specia support to optimize their retention in HIV prevention activities. Live-in partners of participants may be enlisted to support greater engagement in prevention programmes, and men who engage in transactional sex will need enhanced counselling and support to stay in longitudinal studies. Keywords: gay and bisexual men who have sex with men; GBMSM; care and treatment; cohort study; missed follow-up visits; retention; HIV; HIV negative; Kenya, 1 | INTRODUCTION Studies conducted throughout sub-Saharan Africa demonstrate that gay, bisexual and other men who have sex with men (GBMSM) have HIV prevalence rates two to four times higher [...]

Introduction: Retention in preventive care among at-risk men who have sex with men (MSM) is critical for successful prevention of HIV acquisition in Africa. We assessed loss to follow-up (LTFU) rates and factors associated with LTFU in an HIV vaccine feasibility cohort study following MSM with access to pre-exposure prophylaxis (PrEP) in coastal Kenya. Methods: Between June 2017 and June 2019, MSM cohort participants attending a research clinic 20 km north of Mombasa were offered daily PrEP and followed monthly for risk assessment, risk reduction counselling and HIV testing. Participants were defined as LTFU if they were late by >90 days for their scheduled appointment. Participants who acquired HIV were censored at diagnosis. Cox proportional hazards models were used to estimate adjusted Hazard Ratio (aHR) of risk factors for LTFU. Results and discussion: A total of 179 participants with a median age of 25.0 years (interquartile range [IQR]: 23.0 to 30.0) contributed a median follow-up time of 21.2 months (IQR: 6.5 to 22.1). Of these, 143 (79.9%) participants started PrEP and 76 (42.5%) MSM were LTFU, for an incidence rate of 33.7 (95% confidence interval [CI], 26.9 to 42.2) per 100 person-years. Disordered alcohol use (aHR: 2.3, 95% CI, 1.5 to 3.7), residence outside the immediate clinic catchment area (aHR: 2.5, 95% CI, 1.3 to 4.6 for Mombasa Island; aHR: 1.8, 95% CI, 1.0 to 3.3 for south coast), tertiary education level or higher (aHR: 2.3, 95% CI, 1.1 to 4.8) and less lead-in time in the cohort prior to 19 June 2017 (aHR: 3.1, 95% CI, 1.8 to 5.6 for zero to three months; aHR: 2.4, 95% CI, 1.2 to 4.7 for four to six months) were independent predictors of LTFU. PrEP use did not differ by LTFU status (HR: 1.0, 95% CI, 0.6 to 1.5). Psychosocial support for men reporting disordered alcohol use, strengthened engagement of recently enrolled participants and focusing recruitment on areas close to the research clinic may improve retention in HIV prevention studies involving MSM in coastal Kenya. Conclusions: About one in three participants became LTFU after one year of follow-up, irrespective of PrEP use. Research preparedness involving MSM should be strengthened for HIV prevention intervention evaluations in coastal Kenya. Keywords: MSM; attrition; pre-exposure prophylaxis; Kenya; LGBTQ; sub-Saharan Africa; HIV, 1 | INTRODUCTION Men who have sex with men (MSM) are among the populations at highest risk of HIV acquisition globally [1]. Incidence estimates of HIV in MSM in sub-Saharan [...]

Introduction: There is emerging data on HIV-1 incidence among MSM in sub-Saharan Africa (SSA), but no known estimate of HIV-1 incidence among transgender women (TGW) in the region has yet been reported. We assessed HIV-1 incidence and pre-exposure prophylaxis (PrEP) interest in men who have sex with men exclusively (MSME), men who have sex with men and women (MSMW) and TGW in coastal Kenya. Methods: HIV-1-seronegative individuals who had participated in an HIV testing study in 2016 were traced and retested in 2017 according to Kenyan guidelines. All participants were assigned male sex at birth and had male sex partners; additional data on gender identity and sexual orientation were obtained. We assessed the factors associated with HIV-1 acquisition using Poisson regression and calculated HIV-1 incidence in MSME, MSMW and TGW. PrEP interest was assessed through focus group discussions to characterize subcategories' perceived PrEP needs. Results: Of the 168 cohort participants, 42 were classified as MSME, 112 as MSMW and 14 as TGW. Overall, HIV-1 incidence was 5.1 (95% confidence interval (CI): 2.6 to 9.8) per 100 person-years (PY): 4.5 (95% CI: 1.1 to 17.8] per 100 PY among MSME, 3.4 (95% CI: 1.3 to 9.1) per 100 PY among MSMW and 20.6 (95% CI: 6.6 to 63.8] per 100 PY among TGW. HIV-1 acquisition was associated with exclusive receptive anal intercourse (aIRR 13.0, 95% CI 1.9 to 88.6), history of an STI in preceding six months (aIRR 10.3, 95% CI 2.2 to 49.4) and separated/divorced marital status (aIRR 8.2 (95%: 1.1 to 62.2). Almost all (98.8%) participants were interested in initiating PrEP. MSME and TGW felt that PrEP would lead to increases in condomless anal or group sex. Conclusions: TGW had a very high HIV-1 incidence compared with MSME and MSMW. Subcategories of MSM anticipated different PrEP needs and post-PrEP risk behaviour. Further studies should assess if TGW may have been wrongly categorized as MSM in other HIV-1 incidence studies in the region. Keywords: HIV-1 Incidence; transgender women; TGW; PrEP; men who have sex with men, 1 INTRODUCTION Globally, key populations including men who have sex with men (MSM) are at disproportionate risk for HIV-1 acquisition [1,2]. However, within populations categorized as MSM, there is important [...]

Background Evidence on the distribution of pre-treatment HIV-1 drug resistance (HIVDR) among risk groups is limited in Africa. We assessed the prevalence, trends and transmission dynamics of pre-treatment HIVDR within and between MSM, people who inject drugs (PWID), female sex workers (FSWs), heterosexuals (HETs) and perinatally infected children in Kenya. Methods HIV-1 partial pol sequences from antiretroviral-naive individuals collected from multiple sources between 1986 and 2020 were used. Pre-treatment reverse transcriptase inhibitor (RTI), PI and integrase inhibitor (INSTI) mutations were assessed using the Stanford HIVDR database. Phylogenetic methods were used to determine and date transmission clusters. Results Of 3567 sequences analysed, 550 (15.4%, 95% CI: 14.2–16.6) had at least one pre-treatment HIVDR mutation, which was most prevalent amongst children (41.3%), followed by PWID (31.0%), MSM (19.9%), FSWs (15.1%) and HETs (13.9%). Overall, pre-treatment HIVDR increased consistently, from 6.9% (before 2005) to 24.2% (2016–20). Among HETs, pre-treatment HIVDR increased from 6.6% (before 2005) to 20.2% (2011–15), but dropped to 6.5% (2016–20). Additionally, 32 clusters with shared pre-treatment HIVDR mutations were identified. The majority of clusters had R0 ≥ 1.0, indicating ongoing transmissions. The largest was a K103N cluster involving 16 MSM sequences sampled between 2010 and 2017, with an estimated time to the most recent common ancestor (tMRCA) of 2005 [95% higher posterior density (HPD), 2000–08], indicating propagation over 12 years. Conclusions Compared to HETs, children and key populations had higher levels of pre-treatment HIVDR. Introduction of INSTIs after 2017 may have abrogated the increase in pre-treatment RTI mutations, albeit in the HET population only. Taken together, our findings underscore the need for targeted efforts towards equitable access to ART for children and key populations in Kenya. [ABSTRACT FROM AUTHOR]