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The HIV/AIDS pandemic is a global issue that has unequally affected several countries. Due to the complexity of this condition and the human drama it represents to those most affected by it, several fields have contributed to solving or at least alleviating this situation, and the information systems (IS) field has not been absent from these efforts. With the importance of antiretroviral therapy (ART) as a starting point, several initiatives in the IS field have focused on ways to improve the adherence and effectiveness of this therapy: mobile phone reminders (for pill intake and appointments), and mobile interfaces between patients and health workers are popular contributions. However, many of these solutions have been difficult to implement or deploy in some countries in the Global South, which are among the most affected by this pandemic. This paper presents one such case. Using a case‐study approach with an extreme‐case selection technique, the paper studies an m‐health system for HIV patients in the Kalangala region of Uganda. Using Heeks' design—reality gap model for data analysis, the paper shows that the rich interaction between social context and technology should be considered a central concern when designing or deploying such systems. [ABSTRACT FROM AUTHOR]

We report on the highlights ofthe 24th International AIDS Conference, held in Montreal in 2022. We address three main themes: human immunodeficiency virus (HIV) targets and cascades, HIV and sexually transmitted infection prophylaxis, and HIV treatment, including the use of antiretroviral therapy in pregnancy. [ABSTRACT FROM AUTHOR]

The Research Agenda generated by the 7th World Workshop on Oral Health and Disease in AIDS (WW7) is delivered in this paper. Panels of international experts presided over nine workshops that constituted the conference held in November 2014 in Hyderabad, India. The main goal of the Workshop was to bring together clinician and scientists interested in the subject to debate with world-wide perspectives current issues related to the oral manifestations in HIV/AIDS. The workshops were structured around three themes; basic science, clinical/translational science and social science and were attended by 135 participants from 31 countries. The research questions debated at the workshops are presented in nine consensus papers published in this issue and are summarised in this paper along with an outline of the identified research needs in the field. [ABSTRACT FROM AUTHOR]

Human immunodeficiency virus (HIV)‐positive women can breastfeed with minimal risk of mother‐to‐child transmission if taking antiretrovirals. Guidelines surrounding infant feeding for HIV‐positive women have evolved several times over the last two decades. Our review aimed to explore perspectives of breastfeeding with antiretrovirals from HIV‐positive women since the World Health Organization (2010) infant feeding and antiretroviral guidelines. HIV‐positive pregnant and postnatal women from all countries/settings were eligible. HIV‐positive women were either on an antiretroviral regimen at the time of the study, previously on an antiretroviral regimen, not initiated on a regimen yet, or enrolled in prevention of mother‐to‐child transmission (PMTCT) care. Quality assessment of all included studies were conducted. Four databases (CINAHL, EMBASE, MEDLINE and PsycINFO) were searched for studies conducted from January 2010 to October 2020. Nine papers were included in the review, of which two presented findings from the same study. Five analytical themes were developed via thematic synthesis: (1) awareness of breastfeeding with antiretrovirals, (2) turmoil of emotions, (3) coping mechanisms, (4) the intertwining of secret, stigma and support and (5) support needed. Support from family and health care professionals and coping approaches were important to overcome stigma and the emotional challenges of breastfeeding with antiretrovirals. Health care professionals should be familiar with the most updated national and local guidance surrounding infant feeding and antiretrovirals. Further research into interventions to encourage HIV‐positive women to adhere and commit to lifelong antiretroviral treatment (Option B+) for breastfeeding is required. [ABSTRACT FROM AUTHOR]

Introduction: In 2004, the US government began to utilize the Food and Drug Administration's (USFDA) tentative approval process (tFDA) as a basis to determine which HIV drugs are appropriate to be purchased and used in resource-constrained settings. This process permits products that are not approved for marketing in the US, including medicines with active patents or marketing restrictions in the US, to be purchased and distributed in resource-constrained settings. Although the tFDA was originally intended to support the United States' President's Emergency Plan for AIDS Relief (PEPFAR), the USFDA list has become a cornerstone of international HIV programmes that support procurement of ARVs, such as the World Health Organization and the Global Fund to Fight AIDS, Tuberculosis, and Malaria. Our objective in this article is to help the global HIV policy makers and implementers of HIV programmes better understand the benefits and limitations of the tFDA by providing an in-depth review of the relevant legal and regulatory processes. Discussion: USFDA's dedicated tFDA process for ARVs used by the PEPFAR programme has a wide impact globally; however, the implementation and the regulatory processes governing the programme have not been thoroughly described in the medical literature. This paper seeks to help stakeholders better understand the legal and regulatory aspects associated with review of ARVs under the tFDA by describing the following: (1) the tFDA and its importance to global ARV procurement; (2) the regulatory pathways for applications under tFDA for the PEPFAR programme, including modifications to applications, review timelines and costs; (3) the role of US patents, US marketing exclusivity rights, and the Medicines Patents Pool in tFDA; and (4) an overview of how applications for PEPFAR programme are processed through the USFDA. We also provide a case study of a new ARV, tenofovir alafenamide fumarate (TAF), not yet reviewed by USFDA for PEPFAR use. Conclusions: In this paper, we describe the importance and implementation of USFDA's tentative approval process to review ARVs for resource-constrained settings. We also highlight the impact of patents and exclusivities on review of HIV drugs under tFDA and illustrate the concepts using a new HIV drug as an example. [ABSTRACT FROM AUTHOR]

This paper discusses some of the forms and consequences of HIV-related stigma in a community living in KTC, an informal settlement in South Africa, drawing on ethnographic research findings. The first section presents a dynamic form of stigma sign language that is used to label the HIV-positive ‘other’ in this community. The second section highlights some of the pernicious consequences of HIV-related stigma, including fear of disclosure and downward social mobility, and the way in which these prompt some HIV-positive people to avoid local clinics and treatment altogether, and drive others to mask or hide the fact that they are receiving medical treatment, such as antiretroviral drugs. Copyright © 2006 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

Background and aims Pre-exposure prophylaxis for HIV, or 'PrEP', is the use of antiretroviral medicines by people who are HIV-negative to protect themselves against acquiring HIV. PrEP has shown efficacy for preventing HIV acquisition. Despite the potential, many concerns have been voiced by people who inject drugs (PWID) and their organizations. There is a need to engage with these views and ensure their integration in to policy and strategy. This paper presents PWID views on PrEP to foster the uptake of these opinions into scientific and policy debate around PrEP Methods Critical analysis of a report of a community consultation led by the International Network of People who Use Drugs (INPUD). Results The INPUD report highlights enthusiasm from PWID for PrEP, but also three main concerns: the feasibility and ethics of PrEP, its potential use as a substitute for other harm reduction strategies and how a focus on PrEP heralds a re-medicalization of HIV. Each concern relates to evidenced gaps in essential services or opposition to harm reduction and PWID human rights. Conclusions People who use drugs have fundamental concerns about the potential impacts of pre-exposure prophylaxis for HIV which reflect a 'fault line' in HIV prevention: a predominance of biomedical approaches over community perspectives. Greater community engagement in HIV prevention strategy is needed, or we risk continuing to ignore the need for action on the underlying structural drivers and social context of the HIV epidemic. [ABSTRACT FROM AUTHOR]

The interplay between HIV-1 and epithelial cells represents a critical aspect in mucosal HIV-1 transmission. Epithelial cells lining the oral cavity cover subepithelial tissues, which contain virus-susceptible host cells including CD4+ T lymphocytes, monocytes/macrophages, and dendritic cells. Oral epithelia are among the sites of first exposure to both cell-free and cell-associated virus HIV-1 through breast-feeding and oral-genital contact. However, oral mucosa is considered to be naturally resistant to HIV-1 transmission. Oral epithelial cells have been shown to play a crucial role in innate host defense. Nevertheless, it is not clear to what degree these local innate immune factors contribute to HIV-1 resistance of the oral mucosa. This review paper addressed the following issues that were discussed at the 7th World Workshop on Oral Health and Disease in AIDS held in Hyderabad, India, during November 6-9, 2014: (i) What is the fate of HIV-1 after interactions with oral epithelial cells?; (ii) What are the keratinocyte and other anti- HIV effector oral factors, and how do they contribute to mucosal protection?; (iii) How can HIV-1 interactions with oral epithelium affect activation and populations of local immune cells?; (iv) How can HIV-1 interactions alter functions of oral epithelial cells? [ABSTRACT FROM AUTHOR]

Introduction The extraordinary feat of proving the effectiveness of oral pre-exposure prophylaxis (PrEP) in clinical trials in different populations in a variety of settings may prove to have been easier than ensuring it is used well. Decision-makers must make difficult choices to realize the promise of antiretroviral prophylaxis for their countries. This paper outlines key economic, regulatory and distributive justice issues that must be addressed for effective and acceptable PrEP implementation. Discussion In considering the role that PrEP can play in combination prevention programmes, decision-makers must determine who can benefit most from PrEP, how PrEP can be provided safely and efficiently, and what kind of health system support will ensure successful implementation. To do this, they need contextualized information on disease burden by population, analyses of how PrEP services might best be delivered, and projections of the human resource and infrastructure requirements for each potential delivery model. There are cost considerations, varying cost-effectiveness results and regulatory challenges. The principles of ethics can inform thorny discussions about who should be prioritized for oral PrEP and how best to introduce it fairly. We describe the cost-effectiveness of PrEP in different populations at higher risk of HIV exposure, its price in low- and middle-income countries, and the current regulatory situation. We explore the principles of ethics that can inform resource allocation decision-making about PrEP anchored in distributive justice, at a time when universal access to antiretroviral treatment remains to be assured. We then highlight the role of advocacy in moving the PrEP agenda forward. Conclusions The time is ripe now for decisions about whether, how and for whom PrEP should be introduced into a country's HIV response. It has the potential to contribute significantly to high impact HIV prevention if it is tailored to those who can most benefit from it and if current regulatory and pricing barriers can be overcome. Advocacy at all levels can help inform decision-making and push the access agenda to avert HIV infections among those at highest risk of HIV exposure. The benefits will accrue beyond the individual level to slow HIV transmission at the population level. [ABSTRACT FROM AUTHOR]

The article discusses research which examined the role of pre-exposure prophylaxis (PrEP) in addressing the global HIV/AIDS epidemic. Topics discussed include the papers on the PrEP implementation, potential impact and efficiency, social science concerns and the study of modern PrEP implementation and cost-effectiveness analysis targeting PrEP and antiretroviral (ART).

Women continue to be at special risk for HIV acquisition due to a complex mix of biological, behavioural, structural, cultural and social factors, with unacceptable rates of new infection. Scientific advances over the past decade have highlighted the use of antiretroviral (ARV) drugs as pre-exposure prophylaxis (PrEP) to prevent HIV acquisition (sexually, parenterally and vertically) and ARV treatment (ART) for HIV-positive patients to prevent onward transmission (treatment as prevention - TasP). This paper reviews the evidence base for PrEP and TasP, describes new products in development and the need to translate research findings into programmes with impact at the population level. [ABSTRACT FROM AUTHOR]

Aims Adherence to highly active antiretroviral therapy (HAART) is a key predictor of survival for human immunodeficiency virus (HIV)-infected people. Suboptimal adherence among marginalized populations such as HIV-positive drug users could be associated with clinical failure and the emergence of viral resistance. Objective To conduct a systematic review of studies assessing adherence to HAART among HIV-positive drug users (DU) and identify factors associated with non-adherence to HIV treatment. Data sources Seven electronic databases were searched for peer-reviewed papers published in English, French, Spanish or Portuguese, from 1996 to 2007. Study selection and data abstraction Studies were excluded if they presented only qualitative data, were reviews themselves or assessed other populations without disaggregating data on DU. Findings on adherence were extracted and summarized. Data synthesis Forty-one studies were considered, which studied a total of 15 194 patients, the majority of whom were HIV-positive DU ( n = 11 628, 76.5%). Twenty-two studies assessed adherence using patient self-reports, eight used pharmacy records, three used electronic monitoring [i.e. Medication Event Monitoring Systems (MEMS) caps], six studies used a combination of patient self-report, clinical data and MEMS-caps, and two analyzed secondary data. Overall, active substance use was associated with poor adherence, as well as depression and low social support. Higher adherence was found in patents receiving care in structured settings (e.g. directly observed therapy) and/or drug addiction treatment (especially substitution therapy). Conclusion While lower than other populations—especially among users of stimulants, incarcerated DU and patients with psychiatric comorbidities—adherence to HAART among HIV-positive DU can be achieved. Better adherence was identified among those engaged in comprehensive services providing HIV and addiction treatment with psychosocial support. [ABSTRACT FROM AUTHOR]

Aim. This paper is a report of a study to map care pathways, examine the approach of different treatment advisors and explore the acceptability of a nurse- and pharmacistled treatment advice clinic in order to aid decision-making for the future development and evaluation of the clinic. Background. High levels of adherence to antiretroviral drugs are a prerequisite for a successful and durable virological and immunological response to HIV. Treatment guidelines acknowledge that adherence is a process, not a single event, and that adherence support must be integrated into clinical follow-up for all patients receiving these drugs. Method. Data were collected between September 2004 and January 2005 through 17 consultation observations and 10 patient interviews in a specialist treatment advice clinic located within a central London HIV outpatient clinic providing care for over 2200 patients, of whom more than 1300 are taking highly active antiretroviral therapy. Findings. The nurses and pharmacist had similar consultation approaches, although follow-up care varied in extent. Benefits of the clinic approach included permitting patients to observe real tablets, tailoring regimens to lifestyles and telephone followup. These factors, particularly telephone support, were perceived by patients to assist with adherence. Conclusion. The role of telephone support, perceived to assist with initial adherence, requires further investigation. Future work is also needed to explore the health economics of this approach and to determine the actual impact of the clinic on clinical and adherence outcomes. [ABSTRACT FROM AUTHOR]

Background: Patients with human immunodeficiency virus (HIV) are at a significantly higher risk of cardiovascular disease (CVD) compared to HIV‐negative people. Left heart dysfunction is the most common cardiac complication in people living with HIV/acquired immune deficiency syndrome (PLWHA), and diastolic dysfunction is an important predictor of cardiovascular events. The aims of this study were (1) to detect changes in left cardiac structure and function in antiretroviral therapy (ART)‐naive PLWHA using echocardiography; and (2) to investigate the risk factors for the development of left ventricular diastolic dysfunction (LVDD) in ART‐naive PLWHA. Methods: We retrospectively included 105 ART‐naïve PLWHA and included 90 healthy subjects as controls to compare the differences in left heart structure and function between the two groups. Univariate and multifactorial logistic regression were employed to explore the risk factors of the development of LVDD in ART‐naive PLWHA. Results: The left ventricular end‐diastolic internal diameter (LVEDD), left ventricular mass index (LVMI), and left atrial volume index (LAVI) were significantly greater in PLWHA than in controls (p <.05). The E/A ratio, lateral e′ velocity, and mitral deceleration time were significantly lower in PLWHA than in controls (p <.05). Average E/e′ ratio was significantly higher in PLWHA than in controls (p <.05). Left ventricular ejection fraction (LVEF) and left ventricular fractional shortening (LVFS) were not significantly different between PLWHA and controls (p >.05). Multifactorial logistic regression analysis showed that age, body mass index (BMI), and CD4+ count <200 cells/μL were independent risk factors for LVDD in ART‐naive PLWHA (OR = 1.781, 1.228, 3.683, p <.05). Conclusions: Left ventricular systolic function did not differ between PLWHA and controls, and left ventricular diastolic function was lower in PLWHA than in controls. Age, BMI, and CD4+ count were independent factors affecting LVDD in ART‐naive PLWHA. [ABSTRACT FROM AUTHOR]

"End of AIDS" requires ambitious testing, treatment, and adherence benchmarks, like UNAIDS' "90‐90‐90 by 2020." Mozambique's efforts to improve essential maternal/infant antiretroviral treatment (ART) exposes how austerity‐related health system short‐falls impede public HIV/AIDS service‐delivery and hinder effective maternal ART and adherence. In therapeutic borderlands—where household impoverishment intersects with health‐system impoverishment—HIV+ women and over‐worked care‐providers circumnavigate scarcity and stigma. Worrisome patterns of precarious use emerge—perinatal ART under‐utilization, delayed initiation, intermittent adherence, and low retention. Ending HIV/AIDS requires ending austerity and reinvesting in a public sector health workforce to ensure universal health coverage as household and community safety nets. [ABSTRACT FROM AUTHOR]

Objectives: Significant pain from HIV‐associated sensory neuropathy (HIV‐SN) affects 40% of HIV‐infected individuals treated with antiretroviral therapy (ART). The most salient symptom of the neuropathy is pain, which frequently is moderate‐to‐severe intensity, associated with reduced activities and physical function, sleep disruption, increased severity of depression, and anxiety. Yet, evidence for managing painful HIV‐SN is poor. The purpose of this study was to verify by scientific evidence the neuropathy complication in HIV/AIDS patients to develop effective pain management strategies. Methods: Design: Systematic review. Data sources: PubMed (MEDLINE), Cochrane, www.controlled-trials.com. Selection criteria: the filter "English" was used, timeframed searched was 2009–2019, randomized controlled trials (RCT). Keywords were verified in MeSH "Peripheral Nervous System Disease" and "Antiretroviral Agents" or "Antiretroviral therapy." Review method: the PRISMA flowchart was used. Result: A systematic search following PRISMA guidelines was carried out, and 12 specific articles/studies on the subject were selected. The results revealed that HIV therapy, aging, body mass index, height, and systemic conditions influence neuropathy conditions in HIV/AIDS patients. The multistudies focused on pain management approaches such as administration of pain medication, drug combination to prevent side effects, or ART with minimal side effects. Conclusion: Sensory neuropathy is a frequent complication of HIV infection and ART. An understanding of the mechanism and pathophysiology of neuropathy in HIV is urgently required to develop alternative treatment modalities and to evaluate preventive strategies. [ABSTRACT FROM AUTHOR]

The EuroSIDA study was initiated in 1994 and follows adult people living with HIV (PLHIV) in 100 collaborating clinics across 35 countries covering all European regions, Israel and Argentina. The study aims to study the long‐term virological, immunological and clinical outcomes of PLHIV and to monitor temporal changes and regional differences in outcomes across Europe. Annually collected data include basic demographic characteristics, information on AIDS‐ and non‐AIDS‐related clinical events, and details about antiretroviral therapy (ART), hepatitis C treatment and other medications, in addition to a range of laboratory values. The summer 2016 data set held data from a total of 23 071 individuals contributing 174 481 person‐years of follow‐up, while EuroSIDA's unique plasma repository held over 160 000 samples. Over the past 25 years, close to 300 articles have been published in peer‐reviewed journals (h‐index 52), covering a range of scientific focus areas, including monitoring of clinical and virological outcomes, ART uptake, efficacy and adverse events, the influence of hepatitis virus coinfection, variation in the quality of HIV care and management across settings and regions, and biomarker research. Recognizing that there remain unresolved issues in the clinical care and management of PLHIV in Europe, EuroSIDA was one of the cohorts to found The International Cohort Consortium of Infectious Disease (RESPOND) cohort consortium on infectious diseases in 2017. In celebration of the EuroSIDA study's 25th anniversary, this article aims to summarize key scientific findings and outline current and future scientific focus areas. [ABSTRACT FROM AUTHOR]

Objectives: Since 2013, the London HIV Mortality Review Group has conducted annual reviews of deaths among people with HIV to reduce avoidable mortality. Methods: All London HIV care Trusts reported data on 2016 patient deaths in 2017. Deaths were submitted using a modified Causes of Death in HIV reporting form and categorized by a specialist HIV pathologist and two HIV clinicians. Results: There were 206 deaths reported; 77% were among men. Median age at death was 56 years. Cause was established for 82% of deaths, with non‐AIDS‐related malignancies and AIDS‐defining illnesses being the most common causes reported. Risk factors in the year before death included: tobacco smoking (37%), excessive alcohol consumption (19%), non‐injecting drug use (10%), injecting drug use (7%) and opioid substitution therapy (6%). Thirty‐nine per cent of patients had a history of depression, 33% chronic hypertension, 27% dyslipidaemia, 17% coinfection with hepatitis B virus and/or hepatitis C virus and 14% diabetes mellitus. At the time of death, 81% of patients were on antiretroviral therapy (ART), 61% had a CD4 count < 350 cells/μL, and 24% had a viral load ≥ 200 HIV‐1 RNA copies/mL. Thirty‐six per cent of deaths were unexpected; 61% of expected deaths were in hospital. Two‐thirds of expected deaths had a prior end‐of‐life care discussion documented. Conclusions: In 2016, most deaths were attributable to non‐AIDS‐related conditions and the majority of patients were on ART and virally suppressed. However, several potentially preventable deaths were identified and underlying risk factors were common. As London HIV patients are not representative of people with HIV in the UK, a national mortality review is warranted. [ABSTRACT FROM AUTHOR]

Objectives: Reliable and timely HIV care cost estimates are important for policy option appraisals of HIV treatment and prevention strategies. As HIV clinical management and outcomes have changed, we aimed to update profiles of antiretroviral (ARV) usage pattern, patent/market exclusivity details and management costs in adults (≥ 18 years old) accessing HIV specialist care in England. Methods: The data reported quarterly to the HIV and AIDS Reporting System in England was used to identify ARV usage pattern, and were combined with British National Formulary (BNF) prices, non‐ARV care costs and patent/market exclusivity information to generate average survival‐adjusted lifetime care costs. The cumulative budget impact from 2018 to the year in which all current ARVs were expected to lose market exclusivity was calculated for a hypothetical 85 000 (± 5000) person cohort, which provided an illustration of potential financial savings afforded by bioequivalent generic switches. Price scenarios explored BNF70 (September 2015) prices and generics at 10/20/30/50% of proprietary prices. The analyses took National Health Service (NHS) England's perspective (as the payer), and results are presented in 2016/2017 British pounds. Results: By 2033, most currently available ARVs would lose market exclusivity; that is, generics could be available. Average per person lifetime HIV cost was ~£200 000 (3.5% annual discount) or ~£400 000 (undiscounted), reducing to ~£70 000 (3.5% annual discount; ~£120 000 undiscounted) with the use of generics (assuming that generics cost 10% of proprietary prices). The cumulative budget to cover 85 000 (± 5000) persons for 16 years (2018–2033) was £10.5 (± 0.6) billion, reducing to £3.6 (± 0.2) billion with the use of generics. Conclusions: HIV management costs are high but financial efficiency could be improved by optimizing generic use for treatment and prevention to mitigate the high cost of lifelong HIV treatment. Earlier implementation of generics as they become available offers the potential to maximize the scale of the financial savings. [ABSTRACT FROM AUTHOR]

Objectives: To observe relationships between oral Candida status and salivary human beta‐defensin 2 and 3 (hBD‐2 and hBD‐3) levels in HIV/AIDS patients of Guangxi, China during the first year of antiretroviral therapy (ART) dynamically, and to understand the influence of ART on oral Candida status and salivary hBDs expressions. Methods: A prospective self‐controlled study was carried to observe the dynamic changes of CD4+ T cell counts, oral Candida carriages and salivary hBD‐2,3 expressions in HIV/AIDS patients during the first year of ART. A total of 90 HIV/AIDS patients were enrolled and were examined at the baseline, 3rd, 6th, 12th month of ART. Thirty healthy individuals were enrolled as control. Peripheral blood, oral rinse sample, and unstimulated whole saliva were collected to test CD4+ T cell counts, oral Candida carriages, and hBD‐2,3 expressions. Results: In the first year of ART, CD4+ T cell counts increased significantly. However, oral Candida carriages and oral candidiasis decreased significantly, and salivary hBD‐2 expressions in HIV/AIDS patients decreased gradually, salivary hBD‐3 levels were highly variable. Salivary hBD‐2 concentrations were positively related to oral Candida carriages. Conclusions: The incidence of oral candidiasis among HIV/AIDS patients gradually decreased due to the immune reconstruction of ART. Salivary defensins might play an important role in Candida‐host interaction in HIV/AIDS patients. [ABSTRACT FROM AUTHOR]

Objectives We sought to compare all-cause mortality of people living with HIV and accessing care in Canada and the UK. Methods Individuals from the Canadian Observational Cohort ( CANOC) collaboration and UK Collaborative HIV Cohort ( UK CHIC) study who were aged ≥ 18 years, had initiated antiretroviral therapy ( ART) for the first time between 2000 and 2012 and who had acquired HIV through sexual transmission were included in the analysis. Cox regression was used to investigate the difference in mortality risk between the two cohort collaborations, accounting for loss to follow-up as a competing risk. Results A total of 19 960 participants were included in the analysis ( CANOC, 4137; UK CHIC, 15 823). CANOC participants were more likely to be older [median age 39 years (interquartile range ( IQR): 33, 46 years) vs. 36 years ( IQR: 31, 43 years) for UK CHIC participants], to be male (86 vs. 73%, respectively), and to report men who have sex with men ( MSM) sexual transmission risk (72 vs. 56%, respectively) (all P < 0.001). Overall, 762 deaths occurred during 98 798 person-years ( PY) of follow-up, giving a crude mortality rate of 7.7 per 1000 PY [95% confidence interval ( CI): 7.1, 8.3 per 1000 PY]. The crude mortality rates were 8.6 (95% CI: 7.4, 10.0) and 7.5 (95% CI: 6.9, 8.1) per 1000 PY among CANOC and UK CHIC study participants, respectively. No statistically significant difference in mortality risk was observed between the cohort collaborations in Cox regression accounting for loss to follow-up as a competing risk (adjusted hazard ratio 0.86; 95% CI: 0.72-1.03). Conclusions Despite differences in national HIV care provision and treatment guidelines, mortality risk did not differ between CANOC and UK CHIC study participants who acquired HIV through sexual transmission. [ABSTRACT FROM AUTHOR]

Introduction: Successful population-level antiretroviral therapy (ART) adherence will be necessary to realize both the clinical and prevention benefits of antiretroviral scale-up and, ultimately, the end of AIDS. Although many people living with HIV are adhering well, others struggle and most are likely to experience challenges in adherence that may threaten virologic suppression at some point during lifelong therapy. Despite the importance of ART adherence, supportive interventions have generally not been implemented at scale. The objective of this review is to summarize the recommendations of clinical, research, and public health experts for scalable ART adherence interventions in resource-limited settings. Methods: In July 2015, the Bill and Melinda Gates Foundation convened a meeting to discuss the most promising ART adherence interventions for use at scale in resource-limited settings. This article summarizes that discussion with recent updates. It is not a systematic review, but rather provides practical considerations for programme implementation based on evidence from individual studies, systematic reviews, meta-analyses, and the World Health Organization Consolidated Guidelines for HIV, which include evidence from randomized controlled trials in low- and middle-income countries. Interventions are categorized broadly as education and counselling; information and communication technology-enhanced solutions; healthcare delivery restructuring; and economic incentives and social protection interventions. Each category is discussed, including descriptions of interventions, current evidence for effectiveness, and what appears promising for the near future. Approaches to intervention implementation and impact assessment are then described. Results and discussion: The evidence base is promising for currently available, effective, and scalable ART adherence interventions for resource-limited settings. Numerous interventions build on existing health care infrastructure and leverage available resources. Those most widely studied and implemented to date involve peer counselling, adherence clubs, and short message service (SMS). Many additional interventions could have an important impact on ART adherence with further development, including standardized counselling through multi-media technology, electronic dose monitoring, decentralized and differentiated models of care, and livelihood interventions. Optimal targeting and tailoring of interventions will require improved adherence measurement. Conclusions: The opportunity exists today to address and resolve many of the challenges to effective ART adherence, so that they do not limit the potential of ART to help bring about the end of AIDS. [ABSTRACT FROM AUTHOR]

Introduction: Low bone mass is prevalent in HIV-positive patients. However, compared to Western countries, less is known about HIV-associated osteopenia in Asian populations. Methods: We performed a cross-sectional survey in Seoul National University Hospital from December 2011 to May 2012. We measured bone mineral density using central dual energy X-ray absorptiometry, with consent, in male HIV-positive patients, aged 40 years and older. Diagnosis of low bone mass was made using International Society for Clinical Densitometry Z-score criteria in the 40-49 years age group and World Health Organization T-score criteria in the >50-year age group. The data were compared with those of a community-based cohort in Korea. Results: Eighty-four HIV-positive male patients were included in this study. Median age was 49 (interquartile range [IQR], 45-56) years, and median body mass index (BMI) was 22.6 (IQR, 20.9-24.4). Viral suppression was achieved in 75 (89.3%) patients and median duration of antiretroviral therapy was 71 (IQR, 36-120) months. The overall prevalence of low bone mass was 16.7% in the 40-49 years age group and 54.8% in the>50 years age group. Our cohort had significantly lower bone mass at the femur neck and total hip than HIV-negative Koreans in the 40-49 years age group. Low bone mass was significantly associated with low BMI, and a high level of serum carboxy-terminal collagen crosslinks, but was not associated with antiretroviral regimen or duration of antiretroviral therapy. Conclusions: Low bone mass is prevalent in Korean HIV-positive males undergoing antiretroviral therapy, and may be associated with increased bone resorption. [ABSTRACT FROM AUTHOR]

An editorial is presented on HIV Medicine highlighting the current progress in the management of and clinical research on HIV/AIDS in China. Topics include Chinese authorities making several efforts regarding the prevention and treatment of AIDS; HIV infections transmitted by illegal blood transfusions being eradicated; and reducing due to the implementation of a needle and syringe exchange programme.

Introduction: Shifting HIV treatment tasks from physicians to nurses and midwives is essential to scaling-up HIV services in sub-Saharan Africa. Updating nursing and midwifery regulations to include task shifting and pre-service education reform can help facilitate reaching new HIV targets. Donor-supported initiatives to update nursing and midwifery regulations are increasing. However, there are gaps in our knowledge of current practice and education regulations and a lack of information to target and implement regulation strengthening efforts. We conducted a survey of national nursing and midwifery councils to describe current nursing and midwifery regulations in 13 African countries. Methods: A 30-item survey was administered to a convenience sample of 13 national nursing and midwifery regulatory body leaders in attendance at the PEPFAR-supported African Health Profession Regulatory Collaborative meeting in Nairobi, Kenya on 28 February, 2011. The survey contained questions on task shifting and regulations such as registration, licensure, scope of practice, pre-service education accreditation, continuing professional development and use of international guidelines. Survey data were analyzed to present country-level, comparative and regional findings. Results: Task shifting to nurses and midwives was reported in 11 of the 13 countries. Eight countries updated their scope of practice within the last five years; only one reported their regulations to reflect task shifting. Countries vary with regard to licensure, pre-service accreditation and continuing professional development regulations in place. There was no consistency in terms of what standards were used to design national practice and education regulations. Discussion: Many opportunities exist to assist countries to modernise regulations to incorporate important advancements from task shifting and pre-service reform. Appropriate, revised regulations can help sustain successful health workforce strategies and contribute to further scale-up HIV services and other global health priorities. Conclusions: This study provides fundamental information from which to articulate goals and to measure the impact of regulation strengthening efforts [ABSTRACT FROM AUTHOR]

Introduction: Papulopruritic eruption (PPE) occurs in people living with HIV in India. Understanding the risk factors associated with this disease may help decrease the prevalence of PPE. Methods: This study was a case-control study performed at the Government Hospital of Thoracic Medicine, a tertiary care hospital in Chennai, India. Cases included HIV-positive, antiretroviral (ARV) therapy-naïve adults experiencing a pruritic skin eruption for longer than one month, with evidence of multiple papular or nodular lesions and biopsy consistent with arthropod bite. Controls included HIV-positive, ARV-naïve patients without active skin rash. Main outcome measures were CD4 cell count, histology, and environmental exposures. We performed statistical analysis using Epi Info version 3.5.1 and SPSS version 11.0 (SPSS Inc., Chicago, IL). Categorical variables such as gender, urban versus rural residence, occupation, treatment history, CD4 count, use of insect repellents, and environmental exposures were evaluated using the x2 test (or the Fisher exact test when an expected value for a category was less than 5). The t-test was used to evaluate differences in age and the duration since HIV diagnosis. The Mann-Whitney test was used to compare non-normally distributed values such as CD4 cell count. A p-value that was less than 0.05 was considered to be statistically significant. Results: Forty-one cases and 149 control subjects were included. Subjects with PPE had significantly lower CD4 cell counts compared to controls (225.5 cells/μL vs. 425 cells/μL; p=0.0001). Sixty-six percent of cases had a CD4 cell count less than 350 cells/μL. PPE cases were less likely to use mosquito repellent techniques (odds ratio 2.81, CI=1.45-5.45). Discussion: PPE may be an altered and exaggerated immune response to arthropod bites in HIV-positive patients. CD4 cell count is significantly lower in patients with PPE, and therefore it may be considered a qualifying clinical finding for ARV initiation in resource-poor settings. Protective measures against mosquito bites appeared to be important in preventing PPE in subjects at risk. [ABSTRACT FROM AUTHOR]

Objectives To present a simple method for estimating population-level anti-retroviral therapy (ART) need that does not rely on knowledge of past HIV incidence. Methods A new approach to estimating ART need is developed based on calculating age-specific proportions of HIV-infected adults expected to die within a fixed number of years in the absence of treatment. Mortality data for HIV-infected adults in the pre-treatment era from five African HIV cohort studies were combined to construct a life table, starting at age 15, smoothed with a Weibull model. Assuming that ART should be made available to anyone expected to die within 3 years, conditional 3-year survival probabilities were computed to represent proportions needing ART. The build-up of ART need in a successful programme continuously recruiting infected adults into treatment as they age to within 3 years of expected death was represented by annually extending the conditional survival range. Results The Weibull model: survival probability in the infected state from age 15 = exp(−0.0073 × (age − 15)1.69) fitted the pooled age-specific mortality data very closely. Initial treatment need for infected persons increased rapidly with age, from 15% at age 20-24 to 32% at age 40-44 and 42% at age 60-64. Overall need in the treatment of naïve population was 24%, doubling within 5 years in a programme continually recruiting patients entering the high-risk period for dying. Conclusion A reasonable projection of treatment need in an ART naive population can be made based on the age and gender profile of HIV-infected people. [ABSTRACT FROM AUTHOR]

Objective: Conducted a literature review to identify studies that reported on the oral manifestations in human immunodeficiency virus (HIV) infected children in highly active antiretrovial therapy (HAART) era. Methods: A search electronic data base were used and the terms used were ‘oral lesions’ and ‘oral manifestations’. The studies of prevalence of oral manifestation in children with HIV worldwide, descriptive studies, case reports, studies on the association of oral lesions and levels of immune suppression, use of HAART and transmission of HIV were included. Results: There have been substantial changes in the management of HIV disease, especially in the past decade because of the use of HAART. However, children are still being infected and present some peculiarities when compared with adults. Molecular epidemiology, transmission and therapy of the common opportunistic oral infections of HIV disease need to be better understood as a consequence of improved anti-HIV strategies. Treatment with HAART improves the immune function and decreases mortality, morbidity, and opportunistic infections in HIV-infected persons. Conclusion: The frequency and severity of oral disease associated with HIV infection have reduced considerably, although the use of HAART may be associated with an increased appearance of oral lesions associated with human papillomavirus and potentially increase the risk of later oral squamous cell carcinoma. [ABSTRACT FROM AUTHOR]

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Objective Governments, clinicians and drug-licensing bodies have adopted changes in CD4 cell counts and HIV-1 RNA levels as evidence of effectiveness for new therapeutic interventions. We aimed to determine the strength of the association between the magnitude of the effect of changes in CD4 cell count and HIV-1 RNA and progression to AIDS or death in the highly active antiretroviral therapy (HAART) era. Methods We identified all randomized clinical trials (RCTs) evaluating the effect of HAART on both clinical and surrogate endpoints (1994 to September 2006). We performed a meta-regression and weighted linear regression. We additionally estimated potential RCT sample sizes that would be required to assess the effectiveness of new interventions in terms of clinical endpoints. Results We included data from 178 RCTs. We were unable to demonstrate a strong relationship at any time-point. Specifically, this was the case when CD4 T-cell change and clinical outcomes were examined at week 24 [coefficient −0.01, 95% confidence interval (CI) −0.03 to 0.001, P=0.54], week 48 (coefficient −0.01, 95% CI −0.02 to 0.001, P=0.83) and week 96 (coefficient 0.00, 95% CI −0.03 to 0.04, P=0.76). This was also the case when viral load was examined as a surrogate marker. Given the small number of clinical events occurring in new interventional RCTs, any RCT aiming to evaluate clinical endpoints within these time-points would require an exceptionally large sample size. Conclusions Our findings indicate that, within short-term clinical trial settings, it is not possible to estimate the proportion of treatment effect associated with surrogate endpoints. [ABSTRACT FROM AUTHOR]

In the present era of increasing resistance of human immunodeficiency virus (HIV) to antiviral drugs, exploration of adjunct therapies directed at immune responses in combination with antiretroviral drugs may be of value for the treatment of acquired immunodeficiency syndrome. In this study, we designed a model for immune therapy using SIVmac251 infection in rhesus macaques. We explored the outcomes of primary infection on viral loads and the resulting T-cell immune responses in primates. The SIV-infected rhesus macaque model exhibited features similar to those observed in HIV-1 infection of humans. Major histocompatibility complex (MHC) segregation with viral loads were found to associate with viral containment and hence the duration of the disease-free latency period. Thus a better understanding of the relative roles of MHC class I allele in control of viral replication may provide important information for prophylactic or therapeutic vaccine designs. Mamu-A01 is significantly associated with higher immune response and control of viral replication. This allele is frequent in rhesus macaques of Indian origin (22%). Interestingly, Mamu-B01 (26% animals) was associated with lower immune responses and higher viral loads. Another allele, A08 was also predominantly present in 37% of the animals in this study. We observed higher viral replication in individual SIV-infected rhesus monkeys that did not demonstrate strong cellular immune responses. The results are important for understanding SIV disease progression in different MHC Mamu alleles and also for improving the interpretation and quality of pre-clinical studies in rhesus monkeys. [ABSTRACT FROM AUTHOR]

Sub-Saharan Africa carries the overwhelming share of the global burden of human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS) and of HIV-associated tuberculosis (TB). The impact of HIV on TB patients and programmes has implications for TB control policies. The impact on patients includes the effect of HIV on diagnosis and on the patterns of HIV-related TB, the response of HIV-infected TB patients to TB treatment, the benefits of antiretroviral therapy (ART), and the quality and continuity of care for TB patients. The impact on national TB programmes (NTPs) includes increased case load, impaired NTP performance, increased need for access to ART and difficulties in reaching TB control targets. Implications for policies include the need to promote TB and HIV/AIDS programme collaboration, aimed at improving NTP performance (TB case-finding and treatment outcomes), quality and continuity of care, and monitoring and interpretation of progress towards TB control targets. In order to provide the recommended international standard of care for TB patients, clinicians need to be aware of the impact of HIV on TB patients and programmes and the implications for the policies that provide the framework for this standard. Conversely, policy-makers need to understand the impact of HIV on TB patients and programmes. This can help to ensure a firm evidence base for TB control policies aiming at the high standard of patient care that is at the heart of TB and HIV programmes. [ABSTRACT FROM AUTHOR]