HIV Research & Clinical Practice最新文献

Introduction: The BIC-T&T study aimed to determine the efficacy of bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF) and darunavir/cobicistat/emtricitabine/tenofovir alafenamide (DRV/c/F/TAF) at suppressing viral load in a two-arm, open-label, multi-centre, randomised trial under a UK test-and-treat setting. This sub-study aimed to evaluate potential off-target cardiovascular impact by examining ex vivo platelet function.

Methods: Platelets were isolated by centrifugation of citrated blood from participants attending Chelsea and Westminster Hospital or St Mary's Hospital at Week 48 following enrolment. Platelet activation was assessed by real-time flow cytometry to examine integrin activation and granule release and platelet aggregation was evaluated by light transmission aggregometry. Statistical significance was determined by 2-way ANOVA with a Šidák's multiple comparisons post-test.

Results: An analysis of 21 participants was performed at Week 48 (96% male and 48% white; mean (range) age was 37 (23-78) years). No difference between arms was observed in ADP-, collagen- or thrombin receptor activator for peptide (TRAP)-6-evoked platelet α_IIbβ₃ integrin activation, granule release or platelet aggregation in response to any of the agonists tested. Despite differences in the demographics between treatment arms, the presence of an unboosted integrase inhibitor or boosted protease inhibitor in a test-and-treat setting did not impact platelet function.

Conclusions: Our study provides no evidence of differences in downstream platelet responses between participants taking BIC/F/TAF compared to DRV/c/F/TAF following 48 wk of treatment. Further data are required to explore whether there are biologically significant off-target effects, including effects on platelets and other components of the cardiovascular system between these two test-and-treat regimens.

Clinical trial number: NCT04653194.

Background: BICtegravir Single Tablet Regimen (BICSTaR) is an observational cohort study evaluating the effectiveness and safety of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in treatment-naïve (TN) and treatment-experienced (TE) people with HIV.

Objective: To present final pooled 24-month outcomes for the full cohort.

Methods: Prospective data were pooled from TN and TE adults with HIV initiating B/F/TAF in routine clinical practice across 14 countries (data collection: 25/06/2018-29/12/2023). Outcomes at 24 months included virologic suppression (HIV-1 RNA <50 copies/mL), immunologic effectiveness (change in CD4 cell count and CD4/CD8 ratio), persistence, and safety. Outcomes were also analysed in key populations.

Results: Of 2,074 (483 TN, 1,591 TE) participants included, most were male (85%), White (70%), and had ≥1 comorbidity (66%). Median (Q1, Q3) age was 45 (35, 54) years. At 24 months, 94% of TN and 96% of TE participants had HIV-1 RNA <50 copies/mL (missing = excluded analysis). These values were 88% and 86%, respectively, in a discontinuation = failure analysis. Effectiveness remained high across all key populations at 24 months. Median (Q1, Q3) CD4 count increased by 257 (127, 447) cells/µL in TN and 40 (-70, 153) cells/µL in TE participants (both p < 0.001). There was no reported treatment-emergent resistance to B/F/TAF. Persistence was high at 24 months (TN, 95%; TE, 91%). Drug-related adverse events occurred in 11% of TN and 12% of TE participants, leading to B/F/TAF discontinuation in 5%.

Conclusions: B/F/TAF was generally well tolerated over 24 months, with high effectiveness and persistence observed among a broad range of people with HIV.

Background: Despite advances in HIV treatment, gaps in care retention threaten the individual health of people with HIV (people) and public health efforts to end the HIV epidemic.

Objective: This project aimed to identify and address gaps in retention and support re-engagement in care.

Methods: A multipronged initiative at five community HIV clinics and community-based organizations (CBOs) included patient, healthcare professional (HCP), and community-focused interventions. Patient-oriented interventions included instructional videos for patients to view before appointments and conversation guides about barriers to care for patients to use with staff during appointments. HCP-oriented interventions included baseline surveys assessing clinic practices and challenges and audit-feedback sessions to review survey findings and devise plans to improve retention strategies. Community-oriented interventions included education sessions co-led by clinics and CBOs, micro-learning engagements at community events, and social media campaigns covering topics related to HIV care. Data were collected through surveys administered before and after patient- and HCP-oriented interventions and community education sessions, follow-up surveys administered after micro-learning engagements, and reach of social media campaigns.

Results: Patient-oriented interventions led to improvements in patient-reported empowerment and confidence in their ability to remain in care. HCPs also reported improvements in patient intake and follow-up processes after audit-feedback sessions. Community interventions reached over 1,000 community members combined, with education sessions and micro-learning engagements uncovering key barriers to HIV care and leading to improvements in knowledge and awareness of local HIV services.

Conclusion: This multipronged initiative demonstrates how patient, HCP, and community-oriented education can support retention and re-engagement in care.

Background: Mental health concerns among youth living with HIV are well documented. Given the interconnection between physical and mental health, behavioral health screening in medical settings is recommended to ensure patients are linked to mental health services. Unfortunately, COVID-19 disrupted medical and mental health services for people living with HIV, including youth. However, the extent of this disruption and its impact are not entirely known.

Objective: We aimed to explore the impact of COVID-19 on psychosocial screening practices and outcomes among youth living with HIV aged 12-25 in an integrated care setting in the southeastern United States.

Methods: Using existing program evaluation and continuous quality improvement data, we examined psychosocial screenings before and after the onset of COVID-19 (2019-2022).

Results: Findings revealed decreased psychosocial screening of eligible youth living with HIV between 2019 and 2021, but an increase in 2022. The percentage of positive depression and anxiety screeners decreased between 2019 and 2020, increased in 2021, and decreased again in 2022. However, positive post-traumatic stress screeners increased between 2019 and 2020, decreased in 2021, and increased again in 2022. Substance use screening indicated a steady increase in alcohol and tobacco use between 2019 and 2021. In 2022, alcohol continued to increase, but tobacco use decreased.

Conclusions: Findings underscore the critical need for robust, adaptable psychosocial screening practices in integrated care settings to address the evolving mental health and substance use needs of youth living with HIV, especially during and after major public health disruptions.

Objective: Treatment, adherence and linkage to care are lower in Black African and Black Caribbean heritage women living with HIV, affected by significant psychosocial challenges compared to other groups. The COVID-19 lockdowns further amplified these inequalities. We aimed to assess its impact on this population across Chelsea and Westminster Hospitals NHS Foundation Trust.

Methods: We used an online survey and in-depth interviews to collect data between 01-10-2022 and 01-06-2023. Descriptive statistics were used to summarize the survey data and thematic analysis was adopted to analyze the qualitative data.

Results: Of 393 women contacted, 36 completed the survey and 22 took part in interviews. The survey found that COVID-19 lockdown restrictions worsened anxiety (48%) and low mood (45%). 54% reported that the experience of COVID-19 triggered the trauma of their initial HIV diagnosis. Interviewed participants discussed how their psychological issues and co-morbidities were not always addressed by their care system. Stigma and being forced to share their HIV information were also prominent issues.

Conclusions: There is continued institutional stigma and discrimination in health care settings for women living with HIV of African or Caribbean heritage, and there is an urgent need to address the inequity in care to improve patients' experience post-pandemic.

Background: HIV remains a major challenge in KwaZulu-Natal, South Africa, particularly for young women who face disproportionate risks and barriers to prevention and treatment. Most HIV cure trials, however, occur in high-income countries.

Objective: To examine the perspectives of young women diagnosed with acute HIV in a longitudinal study, focusing on their perceptions on ATI-inclusive HIV cure trials and the barriers and facilitators to participation.

Materials and methods: Between October 2022 and February 2024, we conducted closed-ended surveys and in-depth interviews with 20 women aged 19-33 living with HIV, who were willing but ineligible or unable to participate in an HIV cure trial.

Results: Many participants reported mental health challenges, including major depression (40%), moderate to severe anxiety (35%), and low self-esteem (35%). While women diagnosed during acute HIV supported pausing antiretroviral treatment (ART) during analytical treatment interruption (ATI) to advance HIV cure research, concerns about health risks and HIV-related stigma were significant barriers to enrollment. Trust in the research team and close monitoring were seen as positive factors, while fears around sharing of HIV/ATI status and transmission to sex partners complicated decision-making. Participants expressed a need for psychological counseling and access to community resources to manage ATI-related stressors.

Conclusions: Understanding women's perspectives on HIV cure research, especially ATI trials, is vital. Building trust and addressing psychosocial challenges through a healing-centered approach can facilitate trial participation. Socio-behavioral research before and during HIV cure trials will be essential to inform participant-centered protocol design.

Background: In Trinidad and Tobago, high HIV prevalence among key populations necessitates studying factors that impact durable viral suppression (DVS), crucial for effective HIV management and reducing transmission among at-risk networks. This study investigates these factors using clinical data from a major HIV care clinic in the Caribbean.

Methods: A retrospective analysis of 533 adult people with HIV (people) at MRFTT from 2017 to 2021 assessed the proportion achieving DVS, defined as a sustained viral load <200 copies/ml over one year. Initial univariate analysis characterized individuals with DVS, followed by bivariate analysis to explore socio-demographic differences. Significant variables from bivariate analysis were examined in a regression model to identify DVS covariates.

Results: The average age of the sample was 45 years (SD = 10.88), with 52.0% male and 72.1% of African descent. 31.5% achieved durable viral suppression (DVS). Those with DVS were predominantly women (54.1%), older (mean age 45, SD = 11.32), with more frequent clinic visits over five years (mean = 101, SD = 33.26). Regression analysis showed that women (OR = 1.43, 95% CI 0.99-2.07), individuals on long-term antiretroviral therapy (ART) (>5 years) (OR = 1.66, 95% CI 1.03-2.66), and those with extended clinic enrolment (>5 years) (OR = 1.82, 95% CI 1.08-3.06) had higher odds of achieving DVS.

Conclusions: Only a third of the study sample achieved DVS, with men less likely to reach this goal. Lesser engagement in care correlated with lower DVS rates. Further research into social and structural barriers to clinic attendance, particularly among younger men, is recommended.

Introduction: Sex influences the presentation and progression of various diseases. Studies regarding the impact of sex on the course and outcome of HIV may be biased due to differences in socioeconomic status between women and men and uneven sex representation, among other factors, resulting in conflicting data. Thus, this study compared men and women of similar ethnicity and social class who were diagnosed with HIV in two Israeli HIV care centers to minimize the effect of non-biological elements in this study cohort.

Methods: A retrospective HIV cohort of 334 women and 223 men diagnosed from 2000 to 2015. All patients were immigrants from Ethiopia who acquired HIV heterosexually and were of a similar socioeconomic status. Data regarding demographics, clinical status, virological (viral load [VL]) and immunological (CD4) status, and treatment modalities were collected for each patient.

Results: At HIV diagnosis, male were older than female (43.2 ± 13.2 vs. 35.4 ± 11.95 years; p < 0.0001) with a higher VL (372,086 ± 757,366 vs. 237,442 ± 756,371 copies/mL; p = 0.0443) and lower CD4 cell counts (240.74 ± 178 vs. 302.54 ± 218.89 cells/µL; p = 0.0006). Mean follow-up (9.94 ± 4.11 years) was similar between sexes. Women demonstrated significantly higher CD4 cell counts (492.6 ± 267.2 vs. 382.4 ± 214.7 cells/µL; p = 0.0001), lower AIDS rates (13.47% vs. 21.97%; p = 0.0147), and reduced mortality (6.29% vs. 16.59%; p = 0.0002) then men. These differences persisted in subgroup analyses stratified by age and immunological status at diagnosis (measured by CD4 cell counts and VL). In a multivariate analysis male sex emerged as an independent risk factor for death, AIDS, and low CD4 cell counts.

Conclusions: The clinical course and outcome of HIV infected women compared to men were more favorable, with lower rates of immunological impairment, AIDS, and mortality.

People with HIV are at increased risk of cardiovascular events; thus, care delivery strategies that increase access to comprehensive cardiovascular disease (CVD) risk management are a priority. We report the results of a multi-component telemedicine-based strategy to improve blood pressure control among people with HIV-Assess and Adapt to the Impact of COVID-19 on CVD Self-Management and Prevention Care in Adults Living with HIV (AAIM-High). The AAIM High strategy is a virtual adaptation of our previously published EXTRA-CVD strategy and consisted of hypertension education and six components: nurse-led care coordination (delivered by teleconference or telephone), home systolic blood pressure (SBP) monitoring, evidence-based treatment algorithms, electronic health records tools, technology coach, and communication preferences assessment. People with HIV (n = 74) with comorbid hypertension at three academic medical centers were enrolled in a single arm implementation study from January 2021 to December 2022. Over 12 months, the average patient-performed home SBP decreased by 7.7 mmHg (95% CI -11.5, -3.9). The percentage of patients at treatment goal, defined as average SBP <130 mmHg, increased from 46.0% to 72.5% at 12 months. By adapting to the growing use of telemedicine in healthcare delivery, our study effectively improved hypertension control in people with HIV through a virtual, nurse-led intervention.

Purpose: Men and women of transgender experience encounter HIV-related health inequities based on race across the HIV care continua. We explored HIV prevention and care needs via focus groups, surveys, and Sexually Transmitted Infection (STI) testing experiences (N = 40); we supplemented this data via in-depth interviews with peer navigators.

Methods: This study was conducted from 2020 to 2022. Analyses included coding and descriptive statistics. Nearly 63% identified as Black, and 20% identified as Latinx. Nearly 90% of participants reported ever having HIV tests; 10% of participants tested positive for other STIs.

Results: Qualitative analyses yielded three core intervention components for men and women of transgender experience: (1) Comprehensive Trans Care; (2) Community, Mentorship, and Support; and (3) Life Skills and Professional Development. Study participants, community and scientific advisory board members agreed on the need for a peer-led, group-level intervention in English and Spanish.

Conclusion: These needs and priorities are conducive to future interventions which build community agency, structural approaches, and health equity centered on men and women of transgender experience of color.