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Background: An increasing number of HIV cure trials involve combining multiple potentially curative interventions. Until now, considerations for designing and implementing complex combination HIV cure trials have not been thoroughly considered. Methods: We used a purposive method to select key informants for our study. Informants included biomedical HIV cure researchers, regulators, policy makers, bioethicists, and community members. We used in-depth interviews to generate ethical and practical considerations to guide the design and implementation of combination HIV cure research. We analyzed the qualitative data using conventional content analysis focused on inductive reasoning. Results: We interviewed 11 biomedical researchers, 4 community members, 2 regulators, 1 policy researcher, and 1 bioethicist. Informants generated considerations for designing and implementing combination interventions towards an HIV cure, focused on ethical aspects, as well as considerations to guide trial design, benefit/risk determinations, regulatory requirements, prioritization and sequencing and timing of interventions, among others. Informants also provided considerations related to combining specific HIV cure research modalities, such as broadly neutralizing antibodies (bNAbs), cell and gene modification products, latency-reversing agents and immune-based interventions. Finally, informants provided suggestions to ensure meaningful therapeutic improvements over standard antiretroviral therapy, overcome challenges of designing combination approaches, and engage communities around combination HIV cure research. Conclusion: The increasing number of combination HIV cure trials brings with them a host of ethical and practical challenges. We hope our paper will inform meaningful stakeholder dialogue around the use of combinatorial HIV cure research approaches. To protect the public trust in HIV cure research, considerations should be periodically revisited and updated with key stakeholder input as the science continues to advance. [ABSTRACT FROM AUTHOR]

Engagement in HIV care and a high level of antiretroviral therapy (ART) adherence for people living with HIV is crucial to treatment success and can minimize the population burden of the disease. Despite this, there is a critical gap in HIV prevention science around the development of interventions for serodiscordant male couples. This paper reports on the results of a randomized controlled trial to assess the efficacy of Stronger Together, a dyadic counseling intervention aimed at increasing engagement in and optimizing HIV care among serodiscordant male couples in Atlanta, GA, Boston, MA, and Chicago, IL. Between 2014 and 2017, 159 male serodiscordant couples (total N = 318) in Atlanta, GA, Boston, MA, and Chicago, IL were enrolled and equally randomized to either the Stronger Together intervention arm (a three-session dyadic intervention involving HIV testing and adherence counseling) or a standard of care (SOC) control arm. Couples completed individual study assessments via an audio computer assisted self-interviewing (ACASI) system at baseline, 6, 12 and 18 months. Primary outcomes included being prescribed and currently taking ART, and fewer missed doses of ART in the past 30 days; because the trial was not powered to examine viral suppression, we examined this as an exploratory outcome. Longitudinal data analysis was by an intention-to-treat approach. Participants ages ranged from 18 to 69 (mean = 35.9), and are predominantly white (77.5%), and college educated (68.4% earned a college degree or higher). Participants randomized to the Stronger Together arm had a significantly greater odds of being prescribed and currently taking ART over time than those in the SOC arm (at 12 months OR 2.75, 95%CI 1.35–4.67, p-value 0.020, and at 18 months OR 2.91, 95%CI 1.61–4.88, p-value 0.013). Similarly, those in the Stronger Together arm had a significantly lower odds of missing a dose of ART in the past 30 days over time compared to those in the SOC arm (at 12 months OR 0.28, 95%CI 0.09–0.81, p-value 0.019, and at 18 months OR 0.25, 95%CI 0.07–0.82, p-value 0.023). Among male couples in serodiscordant relationships, the Stronger Together intervention resulted in significantly improved HIV treatment outcomes at both 12 and 18 months of follow-up. This trial is the first to date to demonstrate evidence of efficacy for a dyadic counseling intervention and has the potential to fill a critical gap in secondary HIV prevention interventions for serodiscordant male couples. [ABSTRACT FROM AUTHOR]

Introduction: An appropriate economic evaluation of post-exposure prophylaxis (PEP) should consider the effectiveness of different regimens prescribed for patients. Studies have not evaluated the comparative effectiveness of different PEP antiretrovirals (ARVs) based on their costs. Therefore, the aim of the present study was to determine the cost-effectiveness of ARVs regimens used for PEP in Nigerian tertiary hospitals. Material and methods: This cross-sectional study collated patients' demographic and clinical data from PEP databases of United States' President Emergency Plan for AIDS Relief - AIDS Prevention Initiative in Nigeria hospitals. Costs of ARVs were obtained from donors' price list. Effectiveness was measured as the percentage of human immunodeficiency virus (HIV)-negative patients one-month post-PEP. Average cost-effectiveness ratios (ACERs) were computed as the unit cost of the regimens/HIV infection averted (HIA). Probabilistic sensitivity analysis was conducted using 1,000 iterations using Monte-Carlo simulation. Results: Out of 575 patients identified, 198 (34.4%) had non-occupational exposure. Of the 14 regimens, tenofovir (TDF) + lamivudine (3TC) + ritonavir-boosted atazanavir (ATV/r) was prescribed for 230 (40.00%) patients. HIV-negative results were documented in 129 (22.4%) of the 185 patients with post-PEP test. Zidovudine (AZT) + 3TC + ATV-r was the most effective (95.5%, n = 63 of 66) regimen, while TDF + emtricitabine (FTC) + ritonavir-boosted lopinavir (LPV/r) was the most expensive ($23.66). With an ACER of $8.110/HIV infection prevented (95% CI: $8.052-$8.168), TDF + 3TC + efavirenz (EFV) was the most cost-effective regimen. Conclusions: AZT + 3TC + LPV/r was the most effective regimen, while TDF + FTC + ATV/r was the most expensive. However, TDF + 3TC + EFV combination was the most cost-effective regimen used in providing PEP service to HIV patients in Nigerian hospitals. [ABSTRACT FROM AUTHOR]

This study aims to describe and understand the relationship between sociodemographic factors and PrEP awareness, and willingness to use a PrEP modality (oral or injectable).Despite the availability of effective prevention tools such as HIV preexposure prophylaxis (PrEP), African immigrants in the United States are disproportionately affected by HIV. Although PrEP can significantly reduce HIV infection in this population, research evidence on PrEP outcomes, such as awareness, knowledge, and willingness to use, is extremely limited. Between April and May 2022, 92 participants completed an online survey assessing their awareness, knowledge, and willingness to use oral or injectable PrEP. The association between sociodemographic characteristics and PrEP-related measures was examined using descriptive and Pearson's chi-squared or Fisher's exact tests. Participants (N = 92) were born between 1990 and 1999 (46.7%), female (70.76%) and highly educated (59.6%). About 52.2% were unaware of PrEP, and 65.6% were willing to use a PrEP modality. Findings indicate that individuals who reported being aware of PrEP demonstrated a high level of knowledge regarding the medication. Having a healthcare provider was associated with PrEP awareness and willingness to use, while educational status was associated with PrEP awareness. 51.1% of participants were willing to use an oral pill for prevention and 47.8% were willing to use injectable PrEP. Our findings highlight the need for PrEP-related research and interventions for African immigrants to increase awareness and provide options for HIV prevention, as African immigrants are currently not well-represented in PrEP delivery systems in the US. [ABSTRACT FROM AUTHOR]

Improved life expectancy from advances in antiretroviral therapy (ART) has been followed by a rise in comorbidities and polypharmacy in this aging population. Historically, polypharmacy has been associated with suboptimal virologic outcomes in persons with HIV, although data in the current ART era and among historically marginalized populations in the United States are limited. We measured the prevalence of comorbidities and polypharmacy, evaluating their impact on virologic suppression. This retrospective IRB-approved cross-sectional study reviewed health records of adults with HIV on ART and receiving care (≥2 visits) in 2019 at a single center in a historically minoritized community. Virologic suppression (HIV RNA <200 copies/mL) based on polypharmacy (≥5 non-HIV medications) or multimorbidity (≥2 chronic conditions) was evaluated. Logistic regression analyses were performed to identify factors associated with virologic suppression, with age, race/ethnicity, and CD4 < 200 cells/mm3 as covariates. Of the 963 individuals that met the criteria, 67%, 47%, and 34% had ≥1 comorbidity, multimorbidity, and polypharmacy, respectively. The cohort demographics were: mean of 49 years (range, 18–81), 40% cisgender women, 46% Latinx individuals, 45% Black individuals, 8% White individuals. Virologic suppression rates were 95% among patients with polypharmacy compared with 86% in those with a lower pill burden (p = 0.0001). The odds of virologic success were higher for individuals with polypharmacy [adjusted odds ratio, aOR = 2.3 (95% confidence interval, CI: 1.2–4.4)] and Latinx identity [aOR = 2.4 (95% CI: 1.5–3.8)], but lower if a CD4 count <200 cells/mm3 [aOR = 0.07 (95% CI: 0.04–0.1)]. The comorbidity burden was higher than previously described, which are driving polypharmacy rates. In the current ART era, polypharmacy is not inherently associated with worse virologic outcomes. [ABSTRACT FROM AUTHOR]

The extended lifespan of people living with human immunodeficiency (HIV) and acquired immune deficiency syndrome (AIDS) (PLWHA) has increased the potential for ICU admissions unrelated to HIV infection. The objective of this review is to guide continued management of antiretroviral therapy (ART) recommended by the United States Department of Health and Human Services Antiretroviral Guidelines in critically ill adult PLWHA admitted to the intensive care unit (ICU). Pharmacists are uniquely positioned to mitigate these concerns, including whether to continue ART in the ICU, drug interactions with common ICU drugs, renal and hepatic dosing considerations, and alternative methods of administration. Despite these concerns, the original ART regimen should be continued or modified in conjunction with an HIV specialist. Discontinuation greater than 2 weeks should be avoided due to potential resistance and future HIV treatment failure. Use of ART in critically ill patients presents challenges that pharmacists are best equipped to address to prevent adverse events, administration errors, and treatment failure. [ABSTRACT FROM AUTHOR]

We examined associations between COVID-19 conspiracy beliefs and HIV status neutral care engagement among Black cisgender sexual minority men (BCSMM) and Black transgender women (BTW). Throughout April–July 2020, a total of 226 (222 in the current analysis: 196 BCSMM, 20 BTW, and 6 other) participants in Chicago's Neighborhoods and Networks (N2) cohort study completed virtual assessments. Participants reported their HIV status, changes in the frequency of PrEP/ART use, and COVID-19 conspiracy beliefs. Three-quarters of the sample believed at least one conspiracy theory that COVID-19 was either government-created or lab-created accidentally or purposefully. Believing one or more COVID-19 conspiracy theories was significantly associated with better PrEP or ART engagement (using PrEP more frequently or continuously using PrEP/Missing ART less or continuously using ART) (aPR = 0.75 [95% CI 0.56–0.99], p < 0.05). Believing COVID-19 came about naturally was strongly associated with worse PrEP engagement (i.e., use PrEP less or not on PrEP) or worse ART engagement (i.e., missed ART more or not on ART) (aPR = 1.56 [95% CI 1.23, 1.98], p < 0.001). Findings suggested substantial COVID-19 conspiracies among BCSMM and BTW, and this was associated with HIV care engagement. [ABSTRACT FROM AUTHOR]

Improving adherence to antiretroviral therapy (ART) is essential for limiting HIV disease progression among young sexual minority men living with HIV. Daily diaries allow for a detailed examination of how fluctuations in psychosocial factors are associated with adherence over time. Across three cities in the United States, this study collected 60 days of quantitative data from 44 young men (between 16 and 24 years of age) living with HIV who have sex with men. Lagged transition models explored the associations of mood, stress, social support, substance use, and condomless intercourse with daily ART adherence. Baseline levels of illicit substance use and condomless intercourse, and a higher proportion of days with stress or marijuana use, were associated with lower ART adherence. Lapses in adherence predicted non-adherence the following day. Findings suggest prospective data collection may identify different predictors of adherence compared to retrospective recall. Lapse-management strategies are needed to improve adherence following a missed dose. [ABSTRACT FROM AUTHOR]

Long-acting injectable (LAI) modalities have been developed for ART and PrEP. Women face unique barriers to LAI use yet little research has examined women's perceptions of potential LAI HIV therapy candidates. We conducted 89 in-depth interviews at six Women's Interagency HIV Study (WIHS) sites with women living with HIV (n = 59) and HIV-negative women (n = 30) from 2017 to 2018. Interviews were recorded, transcribed, and analyzed using thematic content analysis. Participants identified specific sub-populations who could most benefit from LAI over daily pills: (1) young people; (2) women with childcare responsibilities; (3) people with adherence-related psychological distress; (4) individuals with multiple sex partners; and (5) people facing structural insecurities such as homelessness. Women are underserved by current HIV care options and their perspectives are imperative to ensure a successful scale-up of LAI PrEP and LAI ART that prioritizes equitable access and benefit for all individuals. [ABSTRACT FROM AUTHOR]

Optimal adherence to HIV antiretroviral therapy (ART) is challenging, and racial/ethnic disparities in adherence rates are substantial. The most common reason persons living with HIV (PLWH) give for missed ART doses is forgetting. We took a qualitative exploratory approach to describe, from the perspectives of African American/Black and Hispanic/Latino PLWH, what it means to forget to take ART and factors that influence forgetting. Participants (N = 18) were purposively sampled for maximum variability and engaged in semi-structured/in-depth interviews on HIV/ART management. The analysis took a directed content analysis approach. Participants were mostly male (56%) and African American/Black (79%), between 50 and 69 years old, and had lived with HIV for an average of 21 years. Findings were organised into six inter-related themes: (1) forgetting to take ART was a shorthand description of a complex phenomenon, but rarely a simple lapse of memory; (2) 'forgetting' was means of managing negative emotions associated with HIV; (3) life events triggered mental health distress/substance use which disrupted adherence; (4) historical traumatic events (including AZT monotherapy) and recent trauma/loss contributed to forgetting; (5) patient-provider interactions could support or impede adherence; and (6) intrinsic motivation was fundamental. Implications for HIV social service and health care settings are described. [ABSTRACT FROM AUTHOR]

Research suggests that language barriers in health care settings may adversely affect clinical outcomes and patient satisfaction. We describe the characteristics of adults with limited English proficiency (LEP) and diagnosed HIV in the United States. The Medical Monitoring Project is a complex sample survey of adults with diagnosed HIV in the United States that uses two-stage, probability-proportional-to-size sampling. We analyzed weighted interview and medical record data collected from June 2015–May 2018. The prevalence of LEP among adults with HIV was 10%. Higher percentages of adults with LEP, compared with adults with English proficiency (EP), were female, Hispanic/Latino, less educated and poor, only had Ryan White HIV/AIDS Program (RWHAP) health care coverage, attended RWHAP-funded facilities, were satisfied with their HIV medical care, were prescribed antiretroviral therapy (ART), were virally suppressed and received testing for sexually transmitted diseases. We found no statistical difference in ART adherence among adults with LEP and EP. Despite the association between LEP and the risk for health disparities, more persons with LEP were virally suppressed compared with persons with EP. One possible explanation is attendance at RWHAP-funded facilities by adults with LEP; however, future studies are needed to explore other possible explanations. [ABSTRACT FROM AUTHOR]

A large proportion of HIV infections among men who have sex with men occur within primary partnerships, however, there is a lack of research focused on serodiscordant male couples. We used baseline data collected as part of Project Stronger Together—a randomized controlled trial to improve treatment outcomes among 155 serodiscordant male couples. We described engagement in HIV care/prevention using the HIV treatment cascade and PrEP care continuum. Among partners living with HIV, 86.5% were linked to care, 77.4% retained in care, 81.3% prescribed ART, 60.7% adherent, and 67.7%virally suppressed. Among HIV-negative partners, 62.6% were willing to take PrEP, 48.4% had ever taken PrEP, and 26.5% were adherent to PrEP. Black partners living with HIV had lower odds of being virally suppressed compared to White partners. Our findings provide evidence to suggest designing programs to address the racial disparities in viral suppression, addressing barriers to HIV prevention/treatment, and improving PrEP education. [ABSTRACT FROM AUTHOR]

Background To evaluate the frequency and associated characteristics of chronic comorbid conditions and obstetrical complications among pregnant women with human immunodeficiency virus (HIV) and receiving antiretroviral therapy (ART) in comparison to those without HIV. Methods We compared 2 independent concurrent US pregnancy cohorts: (1) with HIV (International Maternal Pediatric Adolescent AIDS Clinical Trials Protocol P1025, 2002–2013) and (2) without HIV (Consortium for Safe Labor Study, 2002–2007). Outcomes were ≥2 chronic comorbid conditions and obstetrical complications. For women with HIV, we assessed whether late prenatal care (≥14 weeks), starting ART in an earlier era (2002–2008), and a detectable viral load at delivery (≥400 copies/mL) were associated with study outcomes. Results We assessed 2868 deliveries (n = 2574 women) with HIV and receiving ART and 211 910 deliveries (n = 193 170 women) without HIV. Women with HIV were more likely to have ≥2 chronic comorbid conditions versus those without HIV (10 vs 3%; adjusted OR [AOR]: 2.96; 95% CI: 2.58–3.41). Women with HIV were slightly less likely to have obstetrical complications versus those without HIV (both 17%; AOR:.84; 95% CI:.75–.94), but secondarily, higher odds of preterm birth <37 weeks. Late entry to prenatal care and starting ART in an earlier era were associated with a lower likelihood of ≥2 chronic comorbidities and obstetrical complications; detectable viral load at delivery was associated with a higher likelihood of obstetric complications. Conclusions Pregnant women with HIV receiving ART have more chronic comorbid conditions, but not necessarily obstetrical complications, than their peers without HIV. [ABSTRACT FROM AUTHOR]

Introduction: Although individual antiretroviral drugs have been shown to be associated with elevated cardiovascular disease (CVD) risk, data are limited on the role of antiretroviral drug combinations. Therefore, we sought to investigate CVD risk associated with antiretroviral drug combinations. Methods: Using an administrative health-plan dataset, risk of acute myocardial infarction (AMI) associated with current exposure to antiretroviral drug combinations was assessed among persons living with HIV receiving antiretroviral therapy (ART) across the U.S. from October 2009 through December 2014. To account for confounding-by-indication and for factors simultaneously acting as causal mediators and confounders, we applied inverse probability of treatment weighted marginal structural models to longitudinal data of patients. Results: Over 114,417 person-years (n = 73,071 persons) of ART exposure, 602 cases of AMI occurred at an event rate of 5.26 (95% CI: 4.86, 5.70)/1000 person-years. Of the 14 antiretroviral drug combinations studied, persons taking abacavir-lamivudine-darunavir had the highest incidence rate (IR: 11/1000; 95% CI: 7.4–16.0) of AMI. Risk (HR; 95% CI) of AMI was elevated for current exposure to abacavir-lamivudine-darunavir (1.91; 1.27–2.88), abacavir-lamivudine-atazanavir (1.58; 1.08–2.31), and tenofovir-emtricitabine-raltegravir (1.35; 1.07–1.71). Tenofovir-emtricitabine-efavirenz was associated with reduced risk (0.65; 0.54–0.78). Abacavir-lamivudine-darunavir was associated with increased risk of AMI beyond that expected of abacavir alone, likely attributable to darunavir co-administration. We did not find an elevated risk of AMI when abacavir-lamivudine was combined with efavirenz or raltegravir. Conclusion: The antiretroviral drug combinations abacavir-lamivudine-darunavir, abacavir-lamivudine-atazanavir and tenofovir-emtricitabine-raltegravir were found to be associated with elevated risk of AMI, while tenofovir-emtricitabine-efavirenz was associated with a lower risk. The AMI risk associated with abacavir-lamivudine-darunavir was greater than what was previously described for abacavir, which could suggest an added risk from darunavir. The results should be confirmed in additional studies. [ABSTRACT FROM AUTHOR]

Background: Despite remarkable achievements in antiretroviral therapy (ART), losses to follow-up (LTFU) might prevent the long-term success of HIV treatment and might delay the achievement of the 90-90-90 objectives. This scoping review is aimed at the description and analysis of the strategies used in high-income countries to reengage LTFU in HIV care, their implementation and impact.Methods: A scoping review was done following Arksey & O'Malley's methodological framework and recommendations from Joanna Briggs Institute. Peer reviewed articles were searched for in Pubmed, Scopus and Web of Science; and grey literature was searched for in Google and other sources of information. Documents were charted according to the information presented on LTFU, the reengagement procedures used in HIV units in high-income countries, published during the last 15 years. In addition, bibliographies of chosen articles were reviewed for additional articles.Results: Twenty-eight documents were finally included, over 80% of them published in the United States later than 2015. Database searches, phone calls and/or mail contacts were the most common strategies used to locate and track LTFU, while motivational interviews and strengths-based techniques were used most often during reengagement visits. Outcomes like tracing activities efficacy, rates of reengagement and viral load reduction were reported as outcome measures.Conclusions: This review shows a recent and growing trend in developing and implementing patient reengagement strategies in HIV care. However, most of these strategies have been implemented in the United States and little information is available for other high-income countries. The procedures used to trace and contact LTFU are similar across reviewed studies, but their impact and sustainability are widely different depending on the country studied. [ABSTRACT FROM AUTHOR]

Objectives: People living with HIV (PLWH) have increased risk of chronic disease and poor mental health. We aimed to explore HIV disease indicators, comorbidity, and risk behavior of recent antiretroviral therapy (ART) initiators to inform current needs of PLWH. Methods: Men who have sex with men (MSM) in the Multicenter AIDS Cohort Study (MACS) who initiated ART between 2010 and 2018 (recent initiators) were compared with age‐, race‐ and geographic location‐matched men who initiated ART during 2000–2009 (early initiators). Measures of HIV disease, behavior, comorbidity and mental health were collected prospectively every 6 months using standardized forms. Results: Recent initiators had higher current CD4 (median CD4 451 vs. 307 cells/μL, P < 0.0001) and nadir CD4 (451 vs. 300 cells/μL, P < 0.0001) than earlier initiators. The proportion achieving viral suppression within a year of starting ART was significantly higher in recent compared with earlier initiators (92% vs. 74%, P < 0.0001). Median [interquartile range (IQR)] time from HIV diagnosis to ART initiation was 5.4 (1.7–23.1) months in recent initiators. Comorbidity prevalence was high in recent initiators, including obesity (24%), hypertension (25%) and kidney disease (15%). Substance use continues to be common, including cigarette use (40%), daily alcohol use (88%) and marijuana use (46%). Conclusions: Improvements in getting individuals onto ART at an early stage have led to substantially higher CD4 cell counts at initiation. However, the high burden of comorbidity, substance use and poor mental health affecting MSM living with HIV in the US underscore ongoing challenges and our need to adapt and coordinate care. [ABSTRACT FROM AUTHOR]

Long-acting injectable antiretroviral therapy has been shown to be non-inferior to daily oral antiretroviral therapy in clinical trials and may soon become part of clinical care. While most trial participants to date have been men, approximately one quarter of ongoing Phase 3 trial participants are women offering an important opportunity to understand how long-acting antiretroviral therapy is perceived and experienced by women. We conducted in-depth interviews with 80 people living with HIV participating in Phase 2 and 3 clinical trials of long-acting antiretroviral therapy in the USA and Spain. Fifteen percent (12/80) of trial participants interviewed were women. Interviews were audio-recorded, transcribed and coded using content analysis, focused on gender-specific themes. Women shared many of the positive perceptions expressed by men but also had unique perspectives, including finding that long-acting antiretroviral therapy addressed the challenge of remembering pills amidst busy day-to-day realities including multiple roles and responsibilities, is less time consuming and creates less stress compared to oral antiretroviral therapy, and is emotionally freeing and empowering. The gendered nature of women's lives shaped why and how they were satisfied with long-acting antiretroviral therapy. Findings can inform interventions and support systems to facilitate uptake of and adherence to long-acting antiretroviral therapy in women. [ABSTRACT FROM AUTHOR]

HIV prevalence among transgender women of color (TWC) in the United States of America is high. We enrolled TWC living with HIV (N = 858) to evaluate 1nine HIV care interventions. We examined factors associated with four outcomes at enrollment: linkage to care, ever being on antiretroviral treatment, retention in care and viral suppression. The sample was 49% Hispanic/Latino, 42% Black; average age was 37 years; 77% were ever linked to care, 36% were ever on treatment, 22% were retained in care, and 36% were virally suppressed. Current hormone use was significantly associated with linkage, retention, and viral suppression (all aORs > 1.5), providing evidence for gender-affirming care as an important facilitator of engagement in HIV care. Greater health care empowerment was significantly associated with greater odds of all outcomes (aORs between 1.19 and 1.37). These findings identify potential intervention targets to improve the provision of care and treatment for TWC living with HIV. [ABSTRACT FROM AUTHOR]