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BackgroundHIV differentiated service delivery (DSD) models are scaling up in resource-limited settings for stable patients; less is known about DSD outcomes for patients with viremia. We evaluated the effect on viral suppression (VS) of a streamlined care DSD model implemented in the SEARCH randomized universal test and treat trial in rural Uganda and Kenya (NCT:01864603).MethodsWe included HIV-infected adults at baseline (2013) who were country guideline antiretroviral therapy (ART) eligible (prior ART experience or CD4 ≤ 350) with ≥1 HIV clinic visit between 2013 and 2017 in SEARCH communities randomized to intervention (N = 16) or control (N = 16). We assessed the effect of streamlined care in intervention community clinics (patient-centered care, increased appointment spacing, improved clinic access, reminders, and tracking) on VS at 3 years. Analysis was stratified by the baseline care status: ART-experienced with viremia, ART-naïve with CD4 ≤ 350, or ART-experienced with VS.ResultsAmong 6190 ART-eligible persons in care, year 3 VS was 90% in intervention and 87% in control arms (RR 1.03, 95% CI: 1.01 to 1.06). Among ART-experienced persons with baseline viremia, streamlined care was associated with higher VS (67% vs 47%, RR 1.41, 95% CI: 1.05 to 1.91). Among ART-naïve persons, VS was not significantly higher with streamlined care (83% vs 79%, RR 1.05, 95% CI: 0.95 to 1.16). Among ART-experienced persons with baseline VS, nearly all remained virally suppressed in both arms (97% vs 95%, RR 1.01, 95% CI: 1.00 to 1.03).ConclusionsStreamlined care was associated with higher viral suppression among ART-experienced patients with viremia in this randomized evaluation of ART-eligible patients who were in care after universal HIV testing.

ObjectivesIn high-income countries, hazardous alcohol use is associated with reduced receipt of antiretroviral therapy (ART) and viral suppression among people living with HIV (PLHIV) who inject drugs. These associations are less understood in lower middle-income countries (LMIC) and upper middle-income countries.DesignWe examined associations between hazardous alcohol use, ART receipt, and viral suppression among PLHIV who reported current or former injection drug use. Participants were from nine studies in the United States (high-income country), India (LMIC), Russia (upper middle-income country), and Vietnam (LMIC).MethodsHazardous alcohol use was measured via Alcohol Use Disorders Identification Test. Outcomes were HIV viral suppression (viral load of

There is limited research on the effects of stigma on health outcomes among new-to-HIV care individuals. We examined the effect of changes in internalized stigma over time on health behaviors and outcomes such as viral suppression, antiretroviral therapy (ART) adherence, and visit adherence among new-to-HIV care individuals. We also analyzed the mediating effects of adherence self-efficacy and depressive symptoms in these associations. Participants were 186 persons living with HIV who initiated care at four HIV clinical sites in the United States and had diverse geographical and ethnic backgrounds. Baseline and 48-week follow-up assessments included measures of internalized stigma, ART adherence, depressive symptoms, and adherence self-efficacy. HIV visit adherence and viral load data were extracted from clinic records. Age, race, gender, insurance status, and site were controlled in all analyses. Logistic regression analyses were used to examine predictors of adherence and viral suppression. Change (decrease) in internalized stigma was calculated by subtracting follow-up internalized stigma scores from baseline scores and served as the main predictor. Mediation analyses included calculation of 95% confidence intervals for the indirect effects using bootstrapping. Decreases in internalized stigma over time were positively associated with viral suppression, ART adherence, and visit adherence. Adherence self-efficacy significantly mediated these effects of decrease in internalized stigma on all outcomes. Depressive symptoms only mediated the association between decrease in internalized stigma and ART adherence. Interventions that address internalized stigma and depressive symptoms, as well as adherence self-efficacy, may significantly improve adherence and viral suppression outcomes for individuals new to HIV care.

ObjectiveWe sought to examine the prospective association between internalized HIV stigma and unsuppressed viral load and to investigate whether this relationship was sequentially mediated by depressive symptoms and antiretroviral (ART) adherence.DesignLongitudinal study in a multi-site observational clinical cohort.MethodsThe Center for AIDS Research Network of Integrated Clinical Systems (CNICS) Patient-Reported Outcomes (PROs) survey measures internalized HIV stigma yearly using a 4-item assessment (response scale 1 = strongly disagree to 5 = strongly agree). We obtained PRO, lab, and appointment data from six CNICS sites. We used multivariable logistic regression to examine the association between mean stigma and subsequent viremia. We then used Bayesian sequential mediation to fit a longitudinal sequential path model spanning four time points to test if depressive symptoms at T1 and ART adherence at T2 mediated the effect of stigma at T0 on viral load at T3, adjusting for baseline covariates.ResultsBetween February 2016 - November 2018, 6,859 patients underwent stigma assessment and were 81% cis-men, 38% Black, 16% Latinx, 32% heterosexual-identified, and 49% ≥50 years of age. Mean stigma level was 2.00 (SD 1.08). Stigma was significantly associated with subsequent viremia (aOR = 1.16, 95% CI: 1.05-1.28, p 0.004), as were younger age and Black race. The chained indirect effect from stigma to unsuppressed viral load through depressive symptoms and then adherence was significant (standardized β = 0.002; SD = 0.001).ConclusionsInternalized HIV stigma positively predicts subsequent viremia through depressive symptoms and ART adherence. Addressing the link between stigma and depressive symptoms could help improve viral suppression.

Youth and young adults living with HIV (YYALH) are less likely to be engaged in HIV care, adhere to their medications, and achieve viral suppression compared to older adult populations. In the United States, the majority of YYALH belong to racial/ethnic, sexual, and gender minority groups. HIV care interventions are needed that specifically target YYALH and that exploit the use of social media and mobile technology (SMMT) platforms, where youth and young adults have a ubiquitous presence. We conducted a qualitative evaluation of SMMT interventions included in a Health Resources and Services Administration Special Projects of National Significance initiative designed to improve medical care engagement, retention, and medication adherence to achieve viral suppression among YYALH. However, in this study, only young adults living with HIV (YALH) ages 18 to 34 years participated. A total of 48 YALH were interviewed. The data were analyzed using thematic analysis and revealed three main themes supporting the usefulness of the SMMT interventions, which included (1) acceptability of SMMT interventions in managing HIV care with subthemes of medical information accessibility, reminders, and self-efficacy; (2) feelings of support and personal connection afforded by SMMT interventions; and (3) SMMT interventions help to alleviate negative feelings about status and mitigate HIV-related stigma. A few participants identified problems with using their respective intervention, primarily related to the functionality of the technologies. Overall, findings from our qualitative evaluation suggest that SMMT-based interventions have the potential to increase engagement and retention in care, support YALH in adhering to medication, and help them adjust to their diagnosis.

BackgroundIn March of 2013, the Los Angeles County (LAC) Division of HIV and STD Programs implemented a clinic-based Medical Care Coordination (MCC) Program to increase viral suppression (VS) (

The success of antiretroviral therapy (ART) has led to both extended life expectancy and improved quality of life among people living with HIV (PLWH). To maximize the efficacy of first line ART regimens in low- and middle-income countries (LMIC), we need culturally-relevant interventions that empower participants to reduce barriers to long-term uninterrupted adherence. The Chetana adherence intervention trial was designed in collaboration with local community groups as a comprehensive wellness program for adherence-challenged PLWH and included peer-led adherence support, yoga, nutrition, information about local resources, and individual counseling using motivational interviewing techniques. Intervention arm participants were almost twice as likely to be virally suppressed at their 12-month follow-up visit (AOR = 1.98; 95% CI [1.2, 3.23]) as were participants in the active control arm. They were also about twice as likely as control arm participants to self-report ≥ 95% adherence (AOR = 1.86, 95% CI [1.09, 3.15]), and as having eliminated individual adherence barriers (AOR = 2.33, 95% CI [1.51, 3.62]) and clinic attendance barriers (AOR = 2.01, 95% CI [1.20, 3.38]) These low-cost strategies can be implemented by local NGOs, making it both scalable and sustainable in this and similar settings.

BACKGROUND:Even with antiretroviral therapy (ART), persons with HIV (PWH) experience increased morbidity/mortality. Cytomegalovirus (CMV) and Epstein-Barr-Virus (EBV) co-infections likely exacerbate inflammatory-related diseases. OBJECTIVE:To determine if presence of detectable CMV or EBV DNA in peripheral blood mononuclear cells (PBMC) is associated with non-AIDS events among PWH receiving modern ART. DESIGN:We performed a case-control study of PWH starting ART and HIV-suppressed at year 1 and thereafter, 140 cases who experienced non-AIDS events and 305 matched controls. Events included myocardial infarction, stroke, malignancy, serious bacterial infection or death. METHODS:Blood samples were studied pre-ART, 1-year post-ART and pre-event. Controls had an event-free follow-up equal or greater than cases. CMV and EBV levels were measured in PBMC. Conditional logistic regression analysis assessed associations and adjusted for relevant covariates; Spearman's correlations compared CMV and EBV levels with other biomarkers. RESULTS:CMV was detected in PBMC of 25% of participants, EBV was detected in > 90%. Higher EBV levels were associated with increased risk of events at all time points (odds ratio (OR) per one IQR = 1.5-1.7, all p

BACKGROUND:Understanding factors driving virological failure, including the contribution of HIV drug resistance mutations (DRM), is critical to ensuring HIV treatment remains effective. We examine the contribution of drug resistance mutations for low viral suppression in HIV-positive participants in a population-based sero-prevalence survey in rural South Africa. METHODS:We conducted HIV drug resistance genotyping and ART analyte testing on dried blood spots (DBS) from HIV-positive adults participating in a 2014 survey in North West Province. Among those with virologic failure (> 5000 copies/mL), we describe frequency of DRM to protease inhibitors (PI), nucleoside reverse transcriptase inhibitors (NRTI), and non-nucleoside reverse transcriptase inhibitors (NNRTI), report association of resistance with antiretroviral therapy (ART) status, and assess resistance to first and second line therapy. Analyses are weighted to account for sampling design. RESULTS:Overall 170 DBS samples were assayed for viral load and ART analytes; 78.4% of men and 50.0% of women had evidence of virologic failure and were assessed for drug resistance, with successful sequencing of 76/107 samples. We found ≥1 DRM in 22% of participants; 47% were from samples with detectable analyte (efavirenz, nevirapine or lopinavir). Of those with DRM and detectable analyte, 60% showed high-level resistance and reduced predicted virologic response to ≥1 NRTI/NNRTI typically used in first and second-line regimens. CONCLUSIONS:DRM and predicted reduced susceptibility to first and second-line regimens were common among adults with ART exposure in a rural South African population-based sample. Results underscore the importance of ongoing virologic monitoring, regimen optimization and adherence counseling to optimize durable virologic suppression.

BackgroundSubstance use is common among people living with human immunodeficiency virus (PLWH) and a barrier to achieving viral suppression. Among PLWH who report illicit drug use, we evaluated associations between HIV viral load (VL) and reduced use of illicit opioids, methamphetamine/crystal, cocaine/crack, and marijuana, regardless of whether or not abstinence was achieved.MethodsThis was a longitudinal cohort study of PLWH from 7 HIV clinics or 4 clinical studies. We used joint longitudinal and survival models to examine the impact of decreasing drug use and of abstinence for each drug on viral suppression. We repeated analyses using linear mixed models to examine associations between change in frequency of drug use and VL.ResultsThe number of PLWH who were using each drug at baseline ranged from n = 568 (illicit opioids) to n = 4272 (marijuana). Abstinence was associated with higher odds of viral suppression (odds ratio [OR], 1.4-2.2) and lower relative VL (ranging from 21% to 42% by drug) for all 4 drug categories. Reducing frequency of illicit opioid or methamphetamine/crystal use without abstinence was associated with VL suppression (OR, 2.2, 1.6, respectively). Reducing frequency of illicit opioid or methamphetamine/crystal use without abstinence was associated with lower relative VL (47%, 38%, respectively).ConclusionsAbstinence was associated with viral suppression. In addition, reducing use of illicit opioids or methamphetamine/crystal, even without abstinence, was also associated with viral suppression. Our findings highlight the impact of reducing substance use, even when abstinence is not achieved, and the potential benefits of medications, behavioral interventions, and harm-reduction interventions.

Abstract Introduction Monitoring HIV viral load (HVL) in people living with HIV (PLHIV) on antiretroviral therapy (ART) is recommended by the World Health Organization. Implementation of HVL testing programs have been affected by logistic and organizational challenges. Here we describe the HVL monitoring cascade in a rural setting in Tanzania and compare turnaround times (TAT) between an on-site and a referral laboratory. Methods In a nested study of the prospective Kilombero and Ulanga Antiretroviral Cohort (KIULARCO) we included PLHIV aged ≥ 15 years, on ART for ≥ 6 months after implementation of routine HVL monitoring in 2017. We assessed proportions of PLHIV with a blood sample taken for HVL, whose results came back, and who were virally suppressed (HVL

Abstract Background Suubi is an evidenced based multi-component intervention that targets psychosocial and economic hardships to improve ART adherence, viral suppression, mental health, family financial stability, and family cohesion for adolescents living with HIV (ALHIV) in Uganda. Suubi was originally tested as a combined package of four components: 1) Financial Literacy Training; 2) incentivized matched Youth Savings Accounts with income-generating activities; 3) a manualized and visual-based intervention for ART adherence and stigma reduction; and 4) engagement with HIV treatment-experienced role models. However, it is unknown if each component in Suubi had a positive effect, how the components interacted, or if fewer components could have produced equivalent effects. Hence, the overall goal of this new study is to identify the most impactful and sustainable economic and psychosocial components across 48 health clinics in Uganda. Methods A total of 576 ALHIV (aged 11–17 years at enrollment) will be recruited from 48 clinics and each clinic will be randomized to one of 16 study conditions. Each condition represents every possible combination of the 4 components noted above. Assessments will be conducted at baseline, 12, 24, 36 and 48- months post-intervention initiation. Using the multi-phase optimization strategy (MOST), we will identify the optimal combination of components and associated costs for viral suppression, as well as test key mediators and moderators of the component-viral suppression relationship. Discussion The study is a shift in the paradigm of research to use new thinking to build/un-pack highly efficacious interventions that lead to new scientific knowledge in terms of understanding what drives an intervention’s success and how to iterate on them in ways that are more efficient, affordable and scalable. The study advances intervention science for HIV care outcomes globally. Trial Registration This project was registered at clinicaltrials.gov (NCT05600621) on October, 31, 2022. https://clinicaltrials.gov/ct2/show/NCT05600621

Abstract Background In 2014, the Joint United Nations Programme on HIV/AIDS (UNAIDS) and partners launched the 90-90-90 targets. These were further updated to correspond to 95-95-95 by the year 2025. We present an overview of the progress made by Gulf Cooperated Council (GCC) countries towards meeting the global targets. Methods We extracted data from Global AIDS Monitoring (GAM), UNAIDS AIDS Info, HIV case reporting database, and the WHO global policy uptake for six countries: Bahrain, Kuwait, Oman, Qatar, Saudi Arabia and the United Arab of Emirates (UAE) to assess the HIV/AIDS burden in the six GCC countries, and the progress towards achieving the 95-95-95 goal. Results By the end of 2021, an estimated 42,015 people living with HIV (PLHIV) were residing in the GCC countries with prevalence levels below 0.01%. Data from four GCC countries, Bahrain, Oman, Qatar and UAE, indicated that by 2021, 94%, 80%, 66%, and 85% of HIV-positive population knew their status, respectively. 68%, 93% (2020 data), 65%, 58% and 85% of PLHIV in Bahrain, Kuwait, Oman, Qatar and UAE who knew their status were on anti-retroviral therapy (ART), respectively, and 55%, 92%, 58% and 90% (2020 data) among those who were on ART had viral suppression in Bahrain, Kuwait, Oman and KSA, respectively. Conclusion The GCC countries have made great strides toward fulfilling the 95-95-95 targets, but the interim 2025 overall UNAIDS targets remain unmet. The GCC countries must strive diligently to accomplish the targets by emphasising early identification of the cases by enhanced screening and testing, as well as prompt commencement of ART therapy with viral load suppression.

Chronic hepatitis B remains a major public health concern and a leading cause of morbidity and mortality worldwide, specifically through its causative role in chronic liver disease and hepatocellular carcinoma. Worldwide, it affects up to 292 million people. In this paper, we review the historic discovery of the hepatitis B virus and chronicle the significant advances in our understanding of the virus and its interactions with the human host to cause disease. We also overview advancements in therapies for hepatitis B virus and the current absence of curative therapies and highlight on-going therapeutic efforts in search of curative therapies to control transmission and eradicate hepatitis B virus.

Abstract Background The healthcare transition (HCT) from pediatric to adult HIV care can be disruptive to HIV care engagement and viral suppression for youth living with HIV (YLH). Methods We performed qualitative interviews with 20 YLH who experienced HCT and with 20 multidisciplinary pediatric and adult HIV clinicians to assess and rank barriers and facilitators to HCT and obtain their perspectives on strategies to improve the HCT process. We used the Exploration Preparation Implementation Sustainment Framework to guide this qualitative inquiry. Results The most impactful barriers identified by YLH and clinicians focused on issues affecting the patient-clinician relationship, including building trust, and accessibility of clinicians. Both groups reported that having to leave the pediatric team was a significant barrier (ranked #1 for clinicians and #2 for YLH). The most impactful facilitator included having a social worker or case manager to navigate the HCT (listed #1 by clinicians and #2 by YLH); case managers were also identified as the individual most suited to support HCT. While YLH reported difficulty building trust with their new clinician as their #1 barrier, they also ranked the trust they ultimately built with a new clinician as their #1 facilitator. Factors reported to bridge pediatric and adult care included providing a warm handoff, medical record transfer, developing relationships between pediatric clinics and a network of youth-friendly adult clinics, and having the pediatric case manager attend the first adult appointment. Longer new patient visits, increased health communication between YLH and clinicians and sharing vetted clinician profiles with YLH were identified as innovative strategies. Conclusion In this multi-disciplinary contextual inquiry, we have identified several determinants that may be targeted to improve HCT for YLH.

Abstract Background The Joint United Nations Programme on HIV/AIDS through the 95-95-95 target requires 95% of people living with HIV (PLHIV) on antiretroviral treatment (ART) to be virally suppressed. Viral Load (VL) non-suppression has been found to be associated with suboptimal ART adherence, and Intensive Adherence Counselling (IAC) has been shown to lead to VL re-suppression by over 70% in PLHIV on ART. Currently, there is data paucity on VL suppression after IAC in adult PLHIV in Uganda. This study aimed to evaluate the proportion of VL suppression after IAC and associated factors among adult PLHIV on ART at Kiswa Health Centre in Kampala, Uganda. Methods Study was a retrospective cohort design and employed secondary data analysis to review routine program data. Medical records of adult PLHIV on ART for at least six months with VL non-suppression from January 2018 to June 2020 at Kiswa HIV clinic were examined in May 2021. Descriptive statistics were applied to determine sample characteristics and study outcome proportions. Multivariable modified Poisson regression analysis was employed to assess predictors of VL suppression after IAC. Results Analysis included 323 study participants of whom 204 (63.2%) were female, 137 (42.4%) were between the age of 30 and 39 years; and median age was 35 years (interquartile range [IQR] 29–42). Participant linkage to IAC was 100%. Participants who received the first IAC session within 30 days or less after unsuppressed VL result were 48.6% (157/323). Participants who received recommended three or more IAC sessions and achieved VL suppression were 66.4% (202/304). The percentage of participants who completed three IAC sessions in recommended 12 weeks was 34%. Receipt of three IAC sessions (ARR = 1.33, 95%CI: 1.15–1.53, p

Abstract Introduction Key and priority populations (with risk behaviours and health inequities) are disproportionately affected by HIV in Uganda. We evaluated the impact of an intensive case management intervention on HIV treatment outcomes in Kalangala District, predominantly inhabited by fisher folk and female sex workers. Methods This quasi-experimental pre-post intervention evaluation included antiretroviral therapy naïve adults aged ≥ 18 years from six health facilities in the pre-intervention (Jan 1, 2017–December 31, 2017) and intervention phase (June 13, 2018–June 30, 2019). The primary outcomes were 6-month retention and viral suppression (VS) before and after implementation of the intervention involving facility and community case managers who supported participants through at least the first three months of ART. We used descriptive statistics to compared the characteristics, overall outcomes (i.e., retention, lost to follow up, died), and VS of participants by phase, and used mixed-effects logistic regression models to determine factors associated with 6-month retention in care. Marginal (averaging over facilities) probabilities of retention were computed from the final multivariable model. Results We enrolled 606 and 405 participants in the pre-intervention and intervention phases respectively. Approximately 75% of participants were aged 25–44 years, with similar age and gender distributions among phases. Approximately 46% of participants in the intervention were fisher folk and 9% were female sex workers. The adjusted probability of 6-month retention was higher in the intervention phase, 0.83 (95% CI: 0.77–0.90) versus pre-intervention phase, 0.73 (95% CI: 0.69–0.77, p = 0.03). The retention probability increased from 0.59 (0.49–0.68) to 0.73 (0.59–0.86), p = 0.03 among participants aged 18–24 years, and from 0.75 (0.71–0.78) to 0.85 (0.78–0.91), p = 0.03 among participants aged ≥ 25 years. VS (

Abstract Introduction Incident syphilis leads to changes in plasma HIV-1 RNA and CD4 + T-cell level in people with HIV (PWH) with viraemia. Its effect in PWH on suppressive antiretroviral therapy (ART) is less clear. Methods PWH on suppressive ART (plasma HIV-1 RNA

Abstract Background Viral suppression (VS) is a marker of effective HIV therapy, and viral load (VL) testing is critical for treatment monitoring, especially in high-risk groups such as children and pregnant/postpartum women. Although routine VL testing, via centralized laboratory networks, was implemented in Kenya starting in 2014, optimization and sustainable scale up of VL testing are still needed. Methods We conducted a mixed methods study to evaluate the impact of higher frequency, point-of-care (POC) VL testing in optimizing VS among children and pregnant/postpartum women on antiretroviral treatment (ART) in five HIV treatment facilities in western Kenya in the Opt4Kids and Opt4Mamas studies. We conducted 68 key informant interviews (KIIs) from December 2019 to December 2020 with children and pregnant women living with HIV, child caregivers, providers, laboratory/facility leadership, and county- or national-level policymakers. Our KII guide covered the following domains: (1) barriers and facilitators to ART use and VS, (2) literacy and experiences with VL in routine care and via study, and (3) opinions on how to scale up VL testing for optimal programmatic use. We used inductive coding and thematic analysis to identify dominant themes with convergent and divergent subthemes. Results Three main themes regarding VL testing emerged from our analysis. (1) Key informants uniformly contrasted POC VL testing’s faster results turnaround, higher accessibility, and likely cost-effectiveness against centralized VL testing. (2) Key informants also identified areas of improvement for POC VL testing in Kenya, such as quality control, human resource and infrastructure capacity, supply chain management, and integration of VL testing systems. (3) To enable successful scale-up of VL testing, key informants proposed expanding the POC VL testing scheme, electronic medical records systems, conducting quality checks locally, capacity building and developing strong partnerships between key stakeholders. Conclusion The more accessible, decentralized model of POC VL testing was deemed capable of overcoming critical challenges associated with centralized VL testing and was considered highly desirable for optimizing VS for children and pregnant/postpartum women living with HIV. While POC VL testing has the potential to improve VS rates among these populations, additional research is needed to develop strategies for ensuring the sustainability of POC VL testing programs. Trial registration NCT03820323, 29/01/2019

Abstract Background Multi-assay algorithms (MAAs) are used to estimate population-level HIV incidence and identify individuals with recent infection. Many MAAs use low viral load (VL) as a biomarker for long-term infection. This could impact incidence estimates in settings with high rates of early HIV treatment initiation. We evaluated the performance of two MAAs that do not include VL. Methods Samples were collected from 219 seroconverters (infected 1 year) in the HPTN 071 (PopART) trial; 28.8% of seroconverter samples and 73.2% of non-seroconverter samples had VLs ≤ 400 copies/mL. Samples were tested with the Limiting Antigen Avidity assay (LAg) and JHU BioRad-Avidity assays. Antibody reactivity to two HIV peptides was measured using the MSD U-PLEX assay. Two MAAs were evaluated that do not include VL: a MAA that includes the LAg-Avidity assay and BioRad-Avidity assay (LAg + BR) and a MAA that includes the LAg-Avidity assay and two peptide biomarkers (LAg + PepPair). Performance of these MAAs was compared to a widely used MAA that includes LAg and VL (LAg + VL). Results The incidence estimate for LAg + VL (1.29%, 95% CI: 0.97–1.62) was close to the observed longitudinal incidence (1.34% 95% CI: 1.17–1.53). The incidence estimates for the other two MAAs were higher (LAg + BR: 2.56%, 95% CI 2.01–3.11; LAg + PepPair: 2.84%, 95% CI: 1.36–4.32). LAg + BR and LAg + PepPair also misclassified more individuals infected > 2 years as recently infected than LAg + VL (1.2% [42/3483 and 1.5% [51/3483], respectively, vs. 0.2% [6/3483]). LAg + BR classified more seroconverters as recently infected than LAg + VL or LAg + PepPair (80 vs. 58 and 50, respectively) and identified ~ 25% of virally suppressed seroconverters as recently infected. Conclusions The LAg + VL MAA produced a cross-sectional incidence estimate that was closer to the longitudinal estimate than two MAAs that did not include VL. The LAg + BR MAA classified the greatest number of individual seroconverters as recently infected but had a higher false recent rate.

Abstract Introduction Achieving sustained HIV viral suppression is a key strategy to optimize the health and wellbeing of those living with HIV. Sub‐optimal adherence to antiretroviral therapy (ART) in adolescents and young people living with HIV (AYPLHIV) in Southern Africa, due to a range of social and contextual factors, including poor mental health, has presented a substantial challenge to meeting targets aimed towards improving treatment outcomes and reducing transmission. With the increasing availability of viral load (VL) testing in Southern Africa, there is an opportunity to better understand the relationship between VL literacy, wellbeing and adherence among adolescents. Methods We conducted qualitative interviews with 45 AYPLHIV aged 10–24 years in three districts (urban, peri‐urban and rural) in Zimbabwe between March and August 2021. The sample was purposively selected to represent a range of experiences related to HIV status disclosure, gender, marital status and treatment experience. Separate workshops were conducted with 18 healthcare workers (HCWs) and 20 caregivers to better understand existing support mechanisms to AYPLHIV accessing ART. We used thematic analysis to examine adolescent VL literacy, treatment support networks, experiences of clinic interactions, VL testing procedures and barriers to adherence. Results VL literacy was consistently under‐developed among participants. Comprehension of phrases commonly heard during clinic visits, such as TND (target not detected) and “high” and “low” VL, were better understood by older participants. VL testing was predominantly understood as a clinical procedure that enables HCWs to monitor treatment adherence. Absent throughout the interviews were descriptions of how viral suppression improves health and quality of life, likely fosters wellbeing and enhances self‐esteem, enables participation in education and social activities, and eliminates the risk of onward transmission. Conclusions It is imperative that we reconsider how routine VL monitoring is communicated to and understood by AYPLHIV. Reframing ART, including VL test results, in terms of the psychosocial benefits that viral suppression can generate is likely to be crucial to motivating AYPLHIV to maintain optimal treatment engagement and develop self‐management approaches as they move into adulthood. Access to accurate information tailored to individual concerns and circumstances can support AYPLHIV to achieve wellbeing.

Background The approval of long-acting injectable cabotegravir/rilpivirine (LAI CAB/RPV) heightened the urgency of ensuring effective implementation. Our study assesses readiness and barriers to implement LAI CAB/RPV across Ryan White–funded clinics in the United States. Methods We conducted a cross-sectional survey between December 2020 and January 2021 using validated 4-item measures: acceptability of intervention measure (AIM), intervention appropriateness measure (IAM), and feasibility of intervention measure (FIM). Associations between measures and clinic characteristics were evaluated via Spearman rank correlations. A 5-point Likert scale ranked potential barriers of implementation responses. Open-ended questions were analyzed through a thematic approach. Results Of 270 clinics, 44 (16%) completed the survey: 38% federally qualified health centers, 36% academic, 20% community-based organizations, 14% hospital outpatient, and 9% nonprofit. Means (SD; range) were as follows: AIM, 17.6 (2.4; 12–20); IAM, 17.6 (2.4; 13–20); and FIM, 16.8 (2.9; 7–20). Twenty percent were not at all ready to implement LAI CAB/RPV, and 52% were slightly or somewhat ready. There was a significant association between AIM and the proportion of Medicaid patients (AIM, rho = 0.312, P =.050). Community-based organizations scored the highest readiness measures (mean [SD]: AIM, 19.50 [1.41]; IAM, 19.25 [1.49]; FIM, 19.13 [1.36]) as compared with other clinics. Implementation barriers were cost and patients' nonadherence to visits. Conclusions There is variability of readiness yet high levels of perceived acceptability and appropriateness of implementing LAI CAB/RPV among Ryan White clinics, necessitating tailored interventions for successful implementation. A special focus on addressing the barriers of adherence and the cost of implementation is needed. [ABSTRACT FROM AUTHOR]

Introduction: There is little data on long‐term implementation and outcomes for people living with HIV (PLHIV) in differentiated antiretroviral therapy (ART) delivery programmes. We aimed to analyse usage patterns of and associated treatment outcomes in a community ART programme, within the Centralized Chronic Medicines Dispensing and Distribution programme, in South Africa over 3.5 years. Methods: We performed a retrospective cohort study among PLHIV on first‐line ART who were eligible for community ART delivery between October 2016 and March 2019, from 56 urban clinics in KwaZulu‐Natal, South Africa. Follow‐up ended in March 2020. We measured referral rates and, among those referred, we characterized patterns of community ART usage using group‐based trajectory modelling following referral. We used survival analysis to measure the association between community ART usage and loss‐to‐care (no visit for ≥365 days) and logistic regression to measure the association between community ART usage and viraemia (≥50 copies/ml). Results: Among the 80,801 patients eligible for community ART, the median age was 36 years, 69.8% were female and the median (interquartile range [IQR]) follow‐up time was 22 (13–31) months. In total, 49,961 (61.8%) were referred after a median of 6 (IQR 2–13) months from first eligibility. After referral, time spent in community ART varied; 42% remained consistently in community ART, 15% returned to consistent clinic‐based care and the remaining 43% oscillated between community ART and clinic‐based care. Following referral, the incidence of loss‐to‐care was 3.93 (95% confidence interval [CI]: 3.71–4.15) per 100 person‐years during periods of community ART usage compared to 5.75 (95% CI: 5.28–6.25) during clinic‐based care. In multivariable models, community ART usage was associated with a 36% reduction in the hazards of loss‐to‐care (adjusted hazard ratio: 0.64 [95% CI: 0.57–0.72]). The proportion of patients who became viraemic after first community ART referral was 5.2% and a 10% increase in time in community ART was associated with a 3% reduction in odds of viraemia (adjusted odds ratio: 0.97 [95% CI: 0.95–0.99]). Conclusions: Community ART usage patterns vary considerably, while clinical outcomes were good. Promoting consistent community ART usage may reduce clinic burden and the likelihood of patients being lost to care, while sustaining viral suppression. [ABSTRACT FROM AUTHOR]

Objective: Viral load suppression (VLS) is critical in reducing morbidity and mortality associated with HIV as well as minimizing the likelihood of HIV transmission to uninfected persons. The objective of this study was to identify factors associated with VLS among people living with HIV (PLWH) on antiretroviral (ARV) therapy to inform HIV programme strategies in Nigeria. Methods: Adult participants, aged 15–64 years, from the 2018 Nigeria HIV/AIDS Indicator and Impact Survey (NAIIS), who self‐reported to be a PLWH or had detectable ARVs, were analysed to examine factors associated with VLS defined as HIV RNA <1000 copies/mL. NAIIS measured HIV prevalence, viral load, ARV and hepatitis B in PLWH. Logistic regression models were used and reported weighted prevalence. Results: Of 1322 participants, 949 (68.25%) were women and 1287 (96.82%) had detectable ARVs. The median age was 39.31 [interquartile range (IQR): 31.47–47.63] years. Prevalence of VLS was 80.88%. Compared with participants with detectable ARVs, those with undetectable ARVs in their blood specimens had lower odds of VLS [adjusted odds ratio (aOR) = 0.24, 95% confidence interval (CI): 0.08–0.64). Coinfection with hepatitis B and nonnucleoside reverse transcriptase inhibitor metabolites were also associated with lower odds of VLS. Older people (45–54 vs 15–24 years) had increased odds of VLS (aOR = 2.81, 95% CI: 1.14–6.90). Conclusion: Young people and those with undetectable ARVs had lower odds of virological suppression. Targeted interventions focusing on young people and adherence to medication are needed to achieve the UNAIDS 95–95‐95 goals for HIV epidemic control. [ABSTRACT FROM AUTHOR]

Levels of adherence to antiretroviral therapy (ART) can affect the likelihood of viral suppression differentially among ART regimens. In this prospective cohort conducted in Belo Horizonte, Brazil, we included 354 individuals who initiated ART containing tenofovir disoproxil fumarate/lamivudine/efavirenz in fixed-dose combination (TDF/3TC/EFV) or tenofovir disoproxil fumarate/lamivudine associated with dolutegravir (TDF/3TC + DTG). Viral suppression (viral load <50 copies/mL) was evaluated within six months of follow-up at different adherence levels and by therapeutic regimen. Adherence was measured by the Proportion of Days Covered (PDC) and classified into low (≤84%), intermediate (85-89%) or high (≥90%). The association between viral suppression, adherence levels, and other explanatory variables was analyzed using chi-square and multivariable logistic regression. Viral suppression was achieved by 76.0% of individuals and was more frequent among those who achieved higher levels of adherence (high adherence: 79.3%, intermediate: 71.4% and low: 45.2%), those on TDF/3TC + DTG, and those who had viral load ≤100,000 copies/mL at the onset of treatment (p < 0.05). Moreover, individuals on TDF/3TC + DTG had an approximately 90% probability of achieving viral suppression at intermediate adherence levels. These results add new insights on the possibility of lower adherence levels for contemporary antiretroviral regimens currently used as first-line therapy worldwide. [ABSTRACT FROM AUTHOR]

Despite effectiveness and accessibility of combined anti-retroviral therapy (cART), only 85% of people living with HIV (PLHIV) in the United States are virologically suppressed. Improving suppression is complex. Our objective was to consider unique factors in PLHIV with non-suppressed viral loads in clinic and improve the percentage of suppressed patients by implementing a "Suppression Bundle" consisting of three to five bundled interventions with the goal of improved suppression. Prior to the study, there were 567 HIV-positive patients receiving care in clinic. Of those, 89 had a measurable viral load (>40 copies/mL). In this pilot pre-post implementation, we focused on the 89 non-suppressed patients to (1) determine feasibility of implementing bundles and (2) increase the number of patients with suppressed viral loads pre- to post-intervention. Of non-suppressed patients, 65 were active in care immediately pre-intervention and participated in the pilot. At the completion of the 9-month intervention, 46 had viral loads <40 copies/mL, demonstrating substantial improvement with 70.1% of the previously non-suppressed patients achieving suppression. By considering unique patient factors, an individualized Suppression Bundle is acceptable, feasible, and may increase virally suppressed patients in an outpatient clinic. Next steps include determining whether suppression bundles can be implemented in differing practices. [ABSTRACT FROM AUTHOR]

Background. Little is known about the effects of disclosure of HIV-serodiscordant relationships on clinical outcomes. We aimed to evaluate the effect of relationship disclosure on HIV viral suppression, and hypothesized that disclosure by HIV-positive and HIV-negative partners would be associated with viral suppression in the HIV-positive partner. Methods. We conducted a Canadian national online and telephone-administered survey of HIV-positive and HIV-negative partners in serodiscordant relationships. The primary outcome was self-reported viral suppression. Multivariable analyses were undertaken using Firth logistic regression. Results. We recruited 540 participants in current serodiscordant relationships (n = 228 HIV-negative; n = 312 HIV-positive). Similar proportions of HIV-positive and HIV-negative partners disclosed their relationship to healthcare professionals (82% v. 76%, p = 0.13). Among HIV-positive partners, disclosure of the relationship to healthcare professionals increased the odds of viral suppression (aOR = 4.7; CI: 2.13, 10.51) after adjusting for age, education, and relationship turmoil due to HIV. Increasing age (aOR = 1.28; 95% CI = 1.07, 1.55) and education (aOR = 2.43; 95% CI = 1.15, 5.26) were also associated with viral suppression. Among HIV-negative partners, relationship disclosure was not associated with viral suppression and HIV-negative heterosexual men were less likely to report that their HIV-positive partners were virally suppressed (aOR = 0.24; CI: 0.09, 0.61). Conclusions. Disclosure of HIV-serodiscordant status by HIV-positive participants to healthcare professionals was associated with increased odds of viral suppression. Similar effects were not evident among HIV-negative participants. Future work should explore factors that empower relationship disclosure and incorporate them into supportive services for HIV-serodiscordant relationships. [ABSTRACT FROM AUTHOR]

Supplemental Digital Content is Available in the Text. Background: Few studies in sub-Saharan Africa have assessed the impact of multimonth dispensing (MMD) of antiretroviral therapy (ART) and dolutegravir (DTG) beyond clinical trials among children with HIV (CWHIV). We assessed the effect of the 2 interventions on achieving undetectable viral load (VL) among CWHIV in the age group of 0–15 years in Nigeria. Methods: We used longitudinal routine records and cross-sectional survey data from caregivers of a subsample of children. VLs were considered suppressed at <1000 copies/mL and undetectable at <50 copies/mL. Multimonth dispensing (MMD) was defined as ART refill for >84 days. The effect of MMD and DTG on VL levels and associations between social factors and VL were estimated using generalized linear models, reporting adjusted relative risks/prevalence ratios and 95% confidence intervals (CIs). Results: Of 2490 CWHIV, 52% were male, with a median age of 10 years (interquartile ranges: 6–13) and a median duration on ART of 4.6 years (interquartile ranges: 2.8–7.1). Overall, 73% were on DTG and 55% received MMD. At baseline, 63% were suppressed, while 79% and 56% were suppressed and undetectable in their last VL, respectively. We found no differences in undetectable VL between those on MMD and not on MMD (adjusted relative risks: 1.05 [95% CI: 0.94–1.18]) and between those on DTG and not on DTG (1.07 [0.92–1.25]). In secondary analyses, poor adherence and being in a support group were associated with a lower likelihood of undetectable VL (adjusted prevalence ratios: 0.85 [95% CI: 0.74–0.96] and 0.81 [0.68–0.96], respectively). Conclusion: MMD did not compromise treatment outcomes for CWHIV. Poor adherence, however, remains a barrier to achieving treatment targets. [ABSTRACT FROM AUTHOR]

Describe health of transgender women (TW) with HIV vs. cisgender men and women (CM, CW) in a U.S. HIV care cohort. Data were from Centers for AIDS Research Network of Integrated Clinical Systems (CNICS), 2005–2022. TW were identified using clinical data/identity measures. PWH (n = 1285) were included in analyses (275 TW, 547 CM, 463 CW). Cross-sectional multivariable analyses compared HIV outcomes/co-morbidities between TW/CM and TW/CW, and adjusted odds ratios (aOR) and 95% confidence intervals (95% CI) were estimated. TW had poorer adherence (> 90% adherent; aOR 0.57; 95%CI 0.38, 0.87) and were more likely to miss ≥ 3 visits in the past year than CM (aOR 1.50, 95%CI 1.06, 2.10); indicated more anxiety compared to both CM and CW (p ≤ 0.001, p = 0.02); hepatitis C infection (p = 0.03) and past-year/lifetime substance treatment (p = 0.004/p = 0.001) compared to CM; and substance use relative to CW. TW with HIV differed in HIV clinical outcomes and co-morbidities from CM and CW. [ABSTRACT FROM AUTHOR]

Persons with HIV (PWH) who use illicit drugs are at elevated risk for neurocognitive impairment (NCI). This study investigated the effects of HIV disease and HIV viremia on NCI among adults who use cocaine. PWH who were not virologically suppressed showed greater global deficits compared to participants with HIV viral suppression and HIV-negative participants, but no differences emerged between the latter two groups. These findings highlight the adverse effects of poorly controlled HIV disease on NCI, beyond the independent effects of cocaine on cognition, and underscore the importance of strengthening the HIV care continuum for persons who use cocaine. [ABSTRACT FROM AUTHOR]

Background: To determine whether the Centralized Chronic Medication Dispensing and Distribution (CCMDD) program in South Africa's differentiated ART delivery model affects clinical outcomes, we assessed viral load (VL) suppression and retention in care between patients participating in the program and those receiving the clinic-based standard of care. Methods: Clinically stable people living with HIV (PLHIV) eligible for differentiated care were referred to the national CCMDD program and followed up for up to 6 months. In this secondary analysis of trial cohort data, we estimated the association between routine patient participation in the CCMDD program and their clinical outcomes of viral suppression (<200 copies/mL) and retention in care. Results: Among 390 PLHIV, 236 (61%) were assessed for CCMDD eligibility; 144 (37%) were eligible, and 116 (30%) participated in the CCMDD program. Participants obtained their ART in a timely manner at 93% (265/286) of CCMDD visits. VL suppression and retention in care was very similar among CCMDD-eligible patients who participated in the program compared with patients who did not participate in the program (aRR: 1.03; 95% CI: 0.94–1.12). VL suppression alone (aRR: 1.02; 95% CI: 0.97–1.08) and retention in care alone (aRR: 1.03; 95% CI: 0.95–1.12) were also similar between CCMDD-eligible PLHIV who participated in the program and those who did not. Conclusion: The CCMDD program successfully facilitated differentiated care among clinically stable participants. PLHIV participating in the CCMDD program maintained a high proportion of viral suppression and retention in care, indicating that community-based ART delivery model did not negatively affect their HIV care outcomes. [ABSTRACT FROM AUTHOR]

Background Achieving viral suppression (VS) for persons living with HIV is key to reaching epidemic control. We assessed the prevalence of VS and the frequency of HIV drug resistance mutations (HIVDRM) among children and adolescents living with HIV (CALHIV) in the Southern Highland zone of Tanzania. Methods From 2019 to 2021, we enrolled CALHIV aged 1–19 years on ART for >6 months in a cross-sectional study. Participants had viral load (VL) testing; those with VL ≥ 1000 copies/mL underwent HIVDRM testing. VS (<1000 copies/mL) prevalence estimates were calculated and robust Poisson regression was used to estimate prevalence ratios (PRs) and 95% confidence intervals (CIs) for associations with potential predictors of VS. Results Of 707 participants, 595 had VS (PR: 0.84, 95% CI: 0.81–0.87). Use of an integrase strand transfer inhibitor-containing regimen (aPR 1.15, 95% CI: 0.99–1.34), age 5–9 years (aPR 1.16, 95% CI: 1.07–1.26), and seeking care at a referral center (aPR 1.12, 95% CI: 1.04–1.21) were associated with VS. Factors inversely associated with VS included having one (aPR 0.82, 95% CI: 0.72–0.92) or two or more (aPR 0.79, 95% CI: 0.66–0.94) referrals for adherence counselling, and self-reporting missing one to two (aPR 0.88, 95% CI: 0.78–0.99) or three or more (aPR 0.77, 95% CI: 0.63–0.92) doses of ART in the past month. Of 74 participants with PRRT and INT sequencing done, 60 (81.1%) had HIVDRMs at the following frequencies: 71.6%, 67.6%, 1.4%, and 4.1% for major NNRTI, NRTI, PI, and INSTI respectively. Conclusions Higher rates of VS were observed in this cohort, and HIVDRMs were common in those without VS. This evidence supports ART optimization using dolutegravir-based regimens. However, better strategies to improve adherence are needed. [ABSTRACT FROM AUTHOR]

Background. Undetectable=Untransmittable (U=U) first emerged in 2016 as a health information campaign to promote rigorous scientific evidence that people living with HIV (PLHIV) on effective treatment who have reached an undetectable or suppressed viral load cannot pass on the virus sexually. Within 7 years, U=U underwent transformation from a global community-led, grassroots movement into a global HIV/AIDS health equity strategy and policy priority. Methods. For this narrative review, a targeted literature search on 'history' + 'Undetectable=Untransmittable' and/or 'U=U' on Google and Google Scholar, in addition to a search of online documents on the Prevention Access Campaign (PAC) website, was conducted. The article utilises an interdisciplinary policy studies approach that recognises the roles of multi-stakeholder, especially that of the community and civil society, to effect policy change. Results. The narrative review first provides a synopsis of the scientific origination of U=U. The second section highlights the progress and leadership on U=U led by the PAC and civil society partners and efforts of the PLHIV and ally communities in advocating for the broad recognition and dissemination of the evidence, which has proven to be a game-changer within the HIV/AIDS response. The third section spotlights the recent developments of U=U within the local, national, and multilateral spheres. Conclusion. The article ends with recommendations for community and HIV/AIDS multi-stakeholders on how they can further integrate, implement, and strategically utiliseU=U as an essential and complementary HIV/AIDS pillar to the current Global AIDS Strategy 2021-2026 to end inequalities to end AIDS by 2030. [ABSTRACT FROM AUTHOR]

The World Health Organization's (WHO) global public health mandate includes a focus on expanding access to HIV testing, antiretroviral therapy (ART) and treatment monitoring to improve the clinical management of HIV, achieve sustained viral suppression, and prevent HIV-related incidence, morbidity, and mortality. This article documents key moments in research and WHO policies that have informed how ART is applied within HIV programs, including as a prevention tool with the potential to support efforts to address HIV-related discrimination. For more than 20 years, WHO has promoted the benefits of HIV treatment including as part of the approach to prevent the mother-to-child transmission (vertical transmission) of HIV. WHO guidance has followed, and continues to follow, the evolving evidence. In 2023, WHO continues to clarify that there is zero risk of sexual HIV transmission when a person living with HIV has an undetectable viral load and an almost zero or negligible risk of sexual transmission when a person living with HIV has a viral load of =1000 copies/mL - helping to evolve the focus of community campaigns and health worker training to include a focus on 'virally suppressed' while also continuing to emphasise the ultimate goal of achieving an undetectable viral load. This evolution does two things: first, it strongly reasserts the evidence around there being no chance of transmission if a person has an undetectable viral load; and second, it provides an extremely strong degree of confidence that, similarly, individuals who are virally suppressed will not pass on the virus sexually. WHO is now encouraging positive and clear messaging to highlight that the consistent use of ART prevents onwards HIV transmission. [ABSTRACT FROM AUTHOR]

Chronic hepatitis B remains a major public health concern and a leading cause of morbidity and mortality worldwide, specifically through its causative role in chronic liver disease and hepatocellular carcinoma. Worldwide, it affects up to 292 million people. In this paper, we review the historic discovery of the hepatitis B virus and chronicle the significant advances in our understanding of the virus and its interactions with the human host to cause disease. We also overview advancements in therapies for hepatitis B virus and the current absence of curative therapies and highlight on-going therapeutic efforts in search of curative therapies to control transmission and eradicate hepatitis B virus. [ABSTRACT FROM AUTHOR]

HIV-related stigma is recognized as a top barrier to achieve viral suppression in the United States, but data describing who is most affected by HIV stigma is limited. The study sought to (1) identify the relationships between HIV-related stigma and unsuppressed viral load and (2) examine whether the association between HIV stigma subtypes and unsuppressed viral load differ by age group (i.e., 18–34, 35–49, and 50+ years-old) using surveillance data from the Florida Medical Monitoring Project (n = 1195). Most participants were 50+ years-old (55%), male (71%), and Black (51%). Enacted stigma was significantly associated with unsuppressed viral loads among the 18–34-year-old age group (OR 1.68, CI 1.09–2.60). After adjusting for potential confounders, only enacted stigma was independently associated with unsuppressed viral load in the 18–34-year-old age group. Results highlight the need for targeted interventions to reduce enacted stigma among younger persons with HIV to achieve viral suppression. [ABSTRACT FROM AUTHOR]

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Background: Mobile Health ("mHealth") interventions have shown promise in improving HIV treatment outcomes for stigmatized populations. This paper presents the findings from a randomized controlled trial to assess the efficacy, participant-level feasibility and acceptability of a theory-informed mHealth intervention, Motivation Matters!, designed to improve viral suppression and ART adherence among HIV-seropositive women who engage in sex work in Mombasa, Kenya. Methods: A total of 119 women were randomized between the intervention and standard of care control. The primary outcome examined viral suppression (≤ 30 copies/mL) six months following ART initiation. ART adherence was assessed monthly using a visual analogue scale. Participant-level feasibility was measured through response rates to study text messages. Acceptability was assessed through qualitative exit interviews. Results: Six months following treatment initiation, 69% of intervention and 63% of control participants were virally suppressed (Risk Ratio [RR] = 1.09, 95% Confidence Interval [95% CI] (0.83, 1.44). Among women who were viremic at baseline and endorsed engagement in sex work, 74% of women in the intervention arm compared with 46% of women in the control arm achieved viral suppression at month six RR = 1.61, 95% CI (1.02, 2.55). Adherence was higher in intervention versus control participants every month. All participants responded to at least one message, and there was a 55% overall response rate to intervention text messages. Qualitative exit interviews suggested high acceptability and perceived impact of the intervention. Conclusion: The improvements in ART adherence and viral suppression, combined with encouraging data on feasibility and acceptability, provides preliminary evidence that Motivation Matters! could support ART adherence and viral suppression in women who engage in sex work. Trial registration: This trial was registered with ClinicalTrials.gov (NCT02627365, 10/12/2015; http://clinicaltrials.gov). [ABSTRACT FROM AUTHOR]

Background Incomplete antiretroviral therapy (ART) adherence has been linked to deleterious immunologic, inflammatory, and clinical consequences, even among virally suppressed (<50 copies/mL) persons with human immunodeficiency virus (PWH). The impact of improving adherence in the risk of severe non-AIDS events (SNAEs) and death in this population is unknown. Methods We estimated the reduction in the risk of SNAEs or death resulting from an increase in ART adherence by (1) applying existing data on the association between adherence with high residual inflammation/coagulopathy in virally suppressed PWH, and (2) using a Cox proportional hazards model derived from changes in plasma interleukin 6 (IL-6) and D-dimer from 3 randomized clinical trials. Comparatively, assuming 100% ART adherence in a PWH who achieves viral suppression, we estimated the number of persons in whom a decrease in adherence to <100% would need to be observed for an additional SNAE or death event to occur during 3- and 5-year follow-up. Results Increasing ART adherence to 100% in PWH who are suppressed on ART despite imperfect adherence translated into a 6%–37% reduction in the risk of SNAEs or death. Comparatively, based on an anticipated 12% increase in IL-6, 254 and 165 PWH would need to decrease their adherence from 100% to <100% for an additional event to occur over 3- and 5-year follow-up, respectively. Conclusions Modest gains in ART adherence could have clinical benefits beyond virologic suppression. Increasing ART adherence (eg, via an intervention or switch to long-acting ART) in PWH who remain virally suppressed despite incomplete adherence should be evaluated. [ABSTRACT FROM AUTHOR]

The transmission dynamics of HIV are closely tied to the duration and overlap of sexual partnerships. We develop an autonomous population model that can account for the possibilities of an infection from either a casual sexual partner or a long-term partner who was either infected at the start of the partnership or has been newly infected since the onset of the partnership. The impact of the long-term partnerships on the rate of infection is captured by calculating the expected values of the rate of infection from these extended contacts. The model includes three stages of infectiousness: acute, chronic, and virally suppressed. We calculate HIV incidence and the fraction of new infections attributed to casual contacts and long-term partnerships allowing for variability in condom usage, the effect of achieving and maintaining viral suppression, and early intervention by beginning HAART during the acute phase of infection. We present our results using data on MSM HIV transmission from the CDC in the U.S. While the acute stage is the most infectious, the majority of the new infections will be transmitted by long-term partners in the chronic stage when condom use is infrequent as is common in long-term relationships. Time series analysis of the solution, as well as parameter sensitivity analysis, are used to determine effective intervention strategies. [ABSTRACT FROM AUTHOR]

Despite improved clinical outcomes of initiating antiretroviral therapy (ART) soon after diagnosis, conflicting evidence exists regarding the impact of same-day ART initiation on subsequent clinical outcomes. We aimed to characterize the associations of time to ART initiation with loss to care and viral suppression in a cohort of newly diagnosed people living with HIV (PLHIV) entering care after Rwanda implemented a national "Treat All" policy. We conducted a secondary analysis of routinely collected data of adult PLHIV enrolling in HIV care at 10 health facilities in Kigali, Rwanda. Time from enrollment to ART initiation was categorized as same day, 1–7 days, or >7 days. We examined associations between time to ART and loss to care (>120 days since last health facility visit) using Cox proportional hazards models, and between time to ART and viral suppression using logistic regression. Of 2,524 patients included in this analysis, 1,452 (57.5%) were women and the median age was 32 (interquartile range: 26–39). Loss to care was more frequent among patients who initiated ART on the same day (15.9%), compared with those initiating ART 1–7 days (12.3%) or >7 days (10.1%), p < .001. In multivariable analyses, same-day ART initiation was associated with a greater hazard of loss to care compared with initiating >7 days after enrollment (adjusted hazard ratio 1.39, 95% confidence interval: 1.04–1.85). A total of 1,698 (67.3%) had available data on viral load measured within 455 days after enrollment. Of these, 1,476 (87%) were virally suppressed. A higher proportion of patients initiating ART on the same day were virally suppressed (89%) compared with those initiating 1–7 days (84%) or >7 days (88%) after enrollment. This association was not statistically significant. Our findings suggest that ensuring adequate, early support for PLHIV initiating ART rapidly may be important to improve retention in care for newly diagnosed PLHIV in the era of Treat All. [ABSTRACT FROM AUTHOR]

In sub-Saharan Africa (SSA) the burden of non-nucleoside reverse transcriptase inhibitor (NNRTI) HIV drug resistance (HIVDR) has been high over the years. Therefore, in 2018 the World Health Organization (WHO) recommended a regimen based on a integrase strand transfer inhibitor (INSTI), dolutegravir, as the default first-line antiretroviral therapy (ART) in countries in SSA. The scale-up of DTG-based regimens in SSA has gained significant momentum since 2018 and has continued to expand across multiple countries in recent years. However, whether or not the DTG robustness experienced in the developed world will also be achieved in SSA settings is still an important question. Evidence generated from in vitro and in vivo studies suggests that the emergence of DTG HIVDR is HIV-1 subtype dependent. These findings demonstrate that the extensive HIV-1 diversity in SSA can influence DTG effectiveness and the emergence of drug resistance. In addition, the programmatic approach to the transition to DTG adopted by many countries in the SSA region potentially exposes individuals to DTG functional monotherapy, which is associated with the emergence of DTG resistance. In this mini review, we describe the current trends of the effectiveness of DTG as reflected by viral suppression and DTG resistance. Furthermore, we explore how HIV-1 diversity and the programmatic approach in SSA could shape DTG effectiveness and DTG HIVDR in the region.

Abstract Introduction There is an urgent need for more efficient models of differentiated antiretroviral therapy (ART) delivery for people living with HIV (PLHIV), with the World Health Organization calling for evidence to guide whether annual ART prescriptions and consultations (12M scripts) should be recommended in global guidelines. We assessed the association between 12M scripts (allowed temporarily during the COVID‐19 pandemic) versus standard 6‐month prescriptions and consultations (6M scripts) and clinical outcomes. Methods We performed a retrospective cohort study using routine, de‐identified data from 59 public clinics in KwaZulu‐Natal, South Africa. We included PLHIV aged ≥18 years with a recent suppressed viral load (VL) who had been referred for community ART delivery with 6M or 12M scripts. We used modified Poisson regression to compare 12‐month retention‐in‐care (≤90 days late for all visits) and viral suppression (

Summary: Background: Low rates of postnatal retention in HIV care and viral suppression have been reported in women living with HIV (WLWH) despite viral suppression at delivery. At the same time, postpartum follow-up is of crucial importance in light of the increasing support offered in many resource-rich countries including Switzerland to WLWH choosing to breastfeed their infant, if optimal scenario criteria are met. Methods: We longitudinally investigated retention in HIV care, viral suppression, and infant follow-up in a prospective multicentre HIV cohort study of WLWH in the optimal scenario who had a live birth between January 2000 and December 2018. Risk factors for adverse outcomes in the first year postpartum were assessed using logistic and proportional hazard models. Findings: Overall, WLWH were retained in HIV care for at least six months after 94.2% of the deliveries (694/737). Late start of combination antiretroviral therapy (cART) during the third trimester was found to be the main risk factor for failure of retention in HIV care (crude odds ratio [OR] 3.91; 95% confidence interval [CI], 1.50–10.22; p = 0.005). Among mothers on cART until at least one year after delivery, 4.4% (26/591) experienced viral failure, with illicit drugs use being the most important risk factor (hazard ratio [HR], 13.2; 95% CI, 2.35–73.6; p = 0.003). The main risk factors for not following the recommendations regarding infant follow-up was maternal depression (OR, 3.52; 95% CI, 1.18–10.52; p = 0.024). Interpretation: Although the results are reassuring, several modifiable risk factors for adverse postpartum outcome, such as late treatment initiation and depression, were identified. These factors should be addressed in HIV care of all WLWH, especially those opting to breastfeed in resource-rich countries. Funding: This study has been financed within the framework of the Swiss HIV Cohort Study, supported by the Swiss National Science Foundation (grant #201369), by SHCS project 850 and by the SHCS research foundation.

About 90% of new HIV-1 infections in children occur in sub-Saharan Africa, where treatment monitoring remains suboptimal. We sought to ascertain factors associated with immunovirological responses among an ART-experienced paediatric population in Cameroon. A laboratory-based and analytical study was conducted from January 2017 throughout December 2020 wherein plasma viral load (PVL) analyses and CD4 cell counts were performed. Viral suppression (VS) was defined as PVL < 1000 copies/mL and immunological failure (IF) as CD4 < 500 cells/µL for participants ≤5 years and CD4 < 250 cells/µL for those >5 years; p < 0.05 was considered statistically significant. Overall, 272 participants were enrolled (median age: 13 [9–15.5] years; 54% males); median ART duration 7 [3–10] years. Globally, VS was achieved in 54.41%. VS was 56.96% in urban versus 40.48% in rural areas (p = 0.04). IF was 22.43%, with 15.79% among participants ≤5 years and 22.92% among those >5 years (p = 0.66). IF was 20.43% in urban versus 33.33% in rural areas (p = 0.10). Following ART, IF was 25.82% on first-line (non-nucleoside reverse transcriptase inhibitors; NNRTI-based) versus 10.17% on second-line (protease inhibitor-based) regimens (p = 0.01). Interestingly, IF was 7.43% among virally suppressed versus 40.32% among virally unsuppressed participants (p < 0.0001). A low VS indicates major challenges in achieving AIDS’ elimination in this paediatric population, especially in rural settings and poor immune statuses. Scaling up NNRTI-sparing regimens alongside close monitoring would ensure optimal therapeutic outcomes.

BACKGROUND:Even with antiretroviral therapy (ART), persons with HIV (PWH) experience increased morbidity/mortality. Cytomegalovirus (CMV) and Epstein-Barr-Virus (EBV) co-infections likely exacerbate inflammatory-related diseases. OBJECTIVE:To determine if presence of detectable CMV or EBV DNA in peripheral blood mononuclear cells (PBMC) is associated with non-AIDS events among PWH receiving modern ART. DESIGN:We performed a case-control study of PWH starting ART and HIV-suppressed at year 1 and thereafter, 140 cases who experienced non-AIDS events and 305 matched controls. Events included myocardial infarction, stroke, malignancy, serious bacterial infection or death. METHODS:Blood samples were studied pre-ART, 1-year post-ART and pre-event. Controls had an event-free follow-up equal or greater than cases. CMV and EBV levels were measured in PBMC. Conditional logistic regression analysis assessed associations and adjusted for relevant covariates; Spearman's correlations compared CMV and EBV levels with other biomarkers. RESULTS:CMV was detected in PBMC of 25% of participants, EBV was detected in > 90%. Higher EBV levels were associated with increased risk of events at all time points (odds ratio (OR) per one IQR = 1.5-1.7, all p

Immunologic function is an important determinant of cognition. Here we examined the contribution of early immune signatures to cognitive performance among HIV-infected, virally suppressed women (HIV+VS) and in HIV-uninfected (HIV-) women. Specifically, we measured serum inflammatory markers, developed combinatory immune signatures, and evaluated their associations with cognition. Forty-nine HIV+VS women in the Women's Interagency HIV Study (WIHS) who achieved viral suppression shortly after effective antiretroviral therapy (ART) initiation, and 56 matched HIV- women were selected. Forty-two serum inflammatory markers were measured within 2 years of effective ART initiation for HIV+VS women, and at an initial timepoint for HIV- women. The same inflammatory markers were also measured approximately 1, 7, and 12 years later for all women. Of the 105 women with complete immune data, 83 (34 HIV+VS, 49 HIV-) also had cognitive data available 12 years later at ≥1 time points (median = 3.1). We searched for combinatory immune signatures by adapting a dynamic matrix factorization analytic method that builds upon Tucker decomposition followed by Ingenuity® Pathway Analysis to facilitate data interpretation. Seven combinatory immune signatures emerged based on the Frobenius residual. Three signatures were common between HIV+VS and HIV- women, while four signatures were unique. These inflammatory signatures predicted subsequent cognitive performance in both groups using mixed-effects modeling, but more domain-specific associations were significant in HIV+VS than HIV- women. Leukocyte influx into brain was a major contributor to cognitive function in HIV+VS women, while T cell exhaustion, inflammatory response indicative of depressive/psychiatric disorders, microglial activity, and cytokine signaling predicted both global and domain-specific performance for HIV- women. Our findings suggest that immune signatures may be useful diagnostic, prognostic, and immunotherapeutic targets predictive of subsequent cognitive performance. Importantly, they also provide insight into common and distinct inflammatory mechanisms underlying cognition in HIV- and HIV+VS women.