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Background: Optimum adherence to antiretroviral therapy (ART) is crucial in managing HIV. However, some people's religious beliefs can influence how they deal with HIV and the psychosocial factors influencing their adherence to ART, such as disclosure, acceptance of HIV status, belief in ART, and depression. In sub-Saharan Africa (SSA), the role of religious beliefs in ART adherence is underexplored. We aimed to identify and conceptualize the literature on religious beliefs concerning ART adherence among Pentecostal Christians living with HIV in SSA. Methods: We conducted a scoping review of the literature on religious beliefs and ART adherence. We searched papers from PubMed, Web of Science, Medline, Sabinet, Academic Search Complete, CINAHL Plus, Health Source/Nursing Academic, Scopus, and Google Scholar and published papers from conference proceedings and dissertations. Data were extracted according to a predetermined population, concept, context framework, and eligibility criteria for selecting or rejecting studies. We used a narrative synthesis to summarize the data on evidence and the impact of religious beliefs on ART adherence. Results: Seven papers published between January 2010 and February 2022 met the inclusion criteria. Nineteen aspects of religious beliefs were identified as negatively influencing ART adherence, while eight aspects facilitated optimal adherence. "Being saved" or "born again" enhanced coping strategies for optimal adherence through actions such as less alcohol use, fidelity to a sexual partner(s), disclosure, acceptance of HIV status, reduced depression, and facilitated PLHIV to access social support from church members or other institutions. Conclusion: Religious beliefs are integral to Pentecostal Christians living with HIV and affect their adherence to ART. While some Pentecostal Christians living with HIV on ART use their religious beliefs and practices to access psychosocial support from other church members or organizations and achieve good clinical outcomes, others apply their religious beliefs and practices differently and compromise their commitments to taking ART as prescribed, thus experiencing poor viral suppression and clinical outcomes. However, more research is required to understand and theorize how religious beliefs impact ART adherence among Pentecostals living with HIV to inform guidelines for practitioners. [ABSTRACT FROM AUTHOR]

Background: In 2020, the Health Resources and Services Administration's HIV/AIDS Bureau funded an initiative to promote implementation of rapid antiretroviral therapy initiation in 14 HIV treatment settings across the U.S. The goal of this initiative is to accelerate uptake of this evidence-based strategy and provide an implementation blueprint for other HIV care settings to reduce the time from HIV diagnosis to entry into care, for re-engagement in care for those out of care, initiation of treatment, and viral suppression. As part of the effort, an evaluation and technical assistance provider (ETAP) was funded to study implementation of the model in the 14 implementation sites. Method: The ETAP has used implementation science methods framed by the Dynamic Capabilities Model integrated with the Conceptual Model of Implementation Research to develop a Hybrid Type II, multi-site mixed-methods evaluation, described in this paper. The results of the evaluation will describe strategies associated with uptake, implementation outcomes, and HIV-related health outcomes for patients. Discussion: This approach will allow us to understand in detail the processes that sites to implement and integrate rapid initiation of antiretroviral therapy as standard of care as a means of achieving equity in HIV care. [ABSTRACT FROM AUTHOR]

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

Background: Many people are now living longer with HIV due to access to antiretroviral treatment. In turn, there has been an increase in the burden of hypertension and diabetes. The paucity of data on the burden of hypertension and diabetes in adults living with HIV in South Africa is a public health concern. The paper aimed to describe the prevalence and factors associated with hypertension and diabetes among adults living with HIV (ALHIV).Methods: This was a secondary data analysis of the population based on the South African National HIV Prevalence, Incidence, Behaviour and Communication surveys for 2005, 2008 and 2017. Descriptive statistics were used to summarise the characteristics of the study sample. Bivariate and multivariate logistic regression analyses were used to determine factors associated with hypertension and diabetes.Results: The total study population of ALHIV aged 25 years and older was 978, 1023 and 2483 for 2005, 2008 and 2017. The prevalence of hypertension showed an increasing trend at 11.8% in 2005, 9.5% in 2008 and 14.3% in 2017. The prevalence of diabetes was 3.3% in 2005, 2.8% in 2008 and 3.2% in 2017. Increased odds of hypertension among adults living with HIV were consistently associated with being female and the age group 45 years older across all the survey years, including pensioners and the sick, living in urban areas, high risk of hazardous alcohol consumption, diabetes and heart disease. Increased odds of diabetes were consistently associated with hypertension across all the survey years, including age group 45 years and older, and poor health. While having a secondary level of education and above was protective against diabetes.Conclusion: The study showed that the prevalence of hypertension is high and has increased over time among adults living with HIV while the prevalence of diabetes has remained constant. Findings identified factors consistently associated with the prevalence of both diseases overtime, including contemporary risk factors that should be targeted in the integrated management of chronic disease and HIV care model. [ABSTRACT FROM AUTHOR]

Background: Following the World Health Organization's (WHO) 2015 guidelines recommending initiation of antiretroviral therapy (ART) irrespective of CD4 count for all people living with HIV (PLHIV), many countries in sub-Saharan Africa have adopted this strategy to reach epidemic control. As the number of PLHIV on ART rises, maintenance of viral suppression on ART for over 90% of PLHIV remains a challenge to government health systems in resource-limited high HIV burden settings. Non facility-based antiretroviral therapy (ART) delivery for stable HIV+ patients may increase sustainable ART coverage in resource-limited settings. Within the HPTN 071 (PopART) trial, two models, home-based delivery (HBD) or adherence clubs (AC), were offered to assess whether they achieved similar viral load suppression (VLS) to standard of care (SoC). In this paper, we describe the trial design and discuss the methodological issues and challenges.Methods: A three-arm cluster randomized non-inferiority trial, nested in two urban HPTN 071 trial communities in Zambia, randomly allocated 104 zones to SoC (35), HBD (35), or AC (34). ART and adherence support were delivered 3-monthly at home (HBD), adherence clubs (AC), or clinic (SoC). Adult HIV+ patients defined as "stable" on ART were eligible for inclusion. The primary endpoint was the proportion of PLHIV with virological suppression (≤ 1000 copies HIV RNA/ml) at 12 months (± 3months) after study entry across all three arms. Viral load measurement was done at the routine government laboratories in accordance with national guidelines, annually. The study was powered to determine if either of the community-based interventions would yield a viral suppression rate drop compared to SoC of no more than 5% in its absolute value. Both community-based interventions were delivered by community HIV providers (CHiPs). An additional qualitative study using observations, interviews with PLHIV, and FGDs with community HIV providers was nested in this study to complement the quantitative data.Discussion: This trial was designed to provide rigorous randomized evidence of safety and efficacy of non-facility-based delivery of ART for stable PLHIV in high-burden resource-limited settings. This trial will inform policy regarding best practices and what is needed to strengthen scale-up of differentiated models of ART delivery in resource-limited settings.Trial Registration: ClinicalTrials.gov NCT03025165 . Registered on 19 January 2017. [ABSTRACT FROM AUTHOR]

Background: We sought to describe linkage to care, ART continuity, and factors associated with linkage to care among people with HIV following release from incarceration in South Africa.Methods: We conducted a study of South African correctional service community reentrants who were receiving ART at the time of release. The study was implemented in three of 46 correctional service management areas. Participants were enrolled prior to corrections release and followed up to 90 days post-release to obtain self-reported linkage to care status and number of days of ART provided at corrections release. Clinic electronic and paper charts were sought and abstracted to verify self-reported linkage to care. Log-binomial regression, adjusted for facility, was used to identify associations with post-release linkage to care (self-reported and verified). We sought to specifically assess for associations with HIV diagnosis during index incarceration, ART initiation during index incarceration, and duration of incarceration.Results: From May 2014 to December 2016, 554 inmates met eligibility and 516 (93%) consented to participate; 391 were released on ART, 40 of whom were excluded from analysis post-release. Of the remaining 351, 301 (86%) were men and the median age was 35 years (interquartile range 30, 40). Linkage to care was self-reported by 227 (64%) and linkage to care could be verified for 121 (34%). At most, 47% of participants had no lapse in ART supply. Initiating ART during the index incarceration showed a trend toward increased self-reported post-release linkage to care. Age > 35 years was associated with increased verified linkage to care while HIV diagnosis outside of a correctional setting and ART initiation during the index incarceration showed trends toward association with increased verified linkage to care.Discussion: The results of our study are the first description of retention in care following correctional facility release from an African setting and indicate high levels of attrition during the transition from correctional facility to community care. Initiating ART within a correctional facility did not impair post-release linkage to care. [ABSTRACT FROM AUTHOR]

Background: HIV/AIDS patients who fail to respond to first-line treatment protocols are switched to second-line ART. Identifying factors that influence effective second-line treatment can improve utilization of limited medical resources. We investigated the efficacy of long-term second-line anti-retroviral therapy (ART) after first-line virologic failure as well as the impact of non-nucleotide reverse transcriptase inhibitor (NNRTI), nucleotide reverse transcriptase inhibitor (NRTI), and protease inhibitor (PI) resistance mutations and medication adherence on ineffective viral suppression.Methods: A total of 120 patients were evaluated at 6, 12, 18, 24, and 48 months after initiation of second-line ART; a paper questionnaire was administered via a face-to-face interview and venous blood samples were collected. CD4+ T cell count, viral load, and drug resistance genotypes were quantified.Results: CD4+ T cell counts increased from 170 cells/μL (IQR 100-272) at baseline to 359 cells/μL (IQR 236-501) after 48 months of second-line treatment. Viral load (log10) decreased from 4.58 copies/mL (IQR 3.96-5.17) to 1.00 copies/mL (IQR 1.00-3.15). After switching to second-line ART, nine patients newly acquired the NRTI drug-resistant mutation, M184 V/I. No major PI resistance mutations were detected. Logistical regression analysis indicated that medication adherence < 90% in the previous month was associated with ineffective viral suppression; baseline high/low/moderate level resistance to 3TC/TDF was protective towards effective viral suppression.Conclusions: Long-term second line ART was effective in the Henan region of China. Drug resistance mutations to NRTIs were detected in patients receiving second-line ART, suggesting that drug resistance surveillance should be continued to prevent the spread of resistant strains. Patient medication adherence supervision and management should be strengthened to improve the efficacy of antiviral treatment. [ABSTRACT FROM AUTHOR]

Background: Timely and enduring access to antiretroviral therapy (ART) by HIV-infected individuals has been shown to substantially reduce HIV transmission risk, HIV-related morbidity and mortality. However, there is evidence that in addition to limited supply of antiretrovirals (ARVs) and linkage to ART in many low-income countries, HIV+ persons often encounter barriers in accessing ART-related services even in contexts where these services are freely available. In Ghana, limited research evidence exists regarding the barriers HIV+ persons already linked to ART face. This paper explores ART access-related barriers that HIV+ persons linked to care in southern Ghana face. Methods: A mixed method study design, involving a cross-sectional survey and qualitative in-depth interviews, was conducted to collect data from four healthcare providers and a total of 540 adult HIV+ persons receiving ART at four treatment centres in Ghana. We used univariate analysis to generate descriptive tabulations for key variables from the survey. Data from qualitative in-depth interviews were thematically analysed. Results from the survey and in-depth interviews were brought together to illuminate the challenges of the HIV+ persons. Results: All (100%) the HIV+ persons interviewed were ARV-exposed and linked to ART. Reasons for taking ARVs ranged from beliefs that they will suppress the HIV virus, desire to maintain good health and prolong life, and desire to prevent infection in unborn children, desire both to avoid death and to become good therapeutic citizens (abide by doctors' advice). Despite this, more than half of the study participants (63.3%) reported seven major factors as barriers hindering access to ART. These were high financial costs associated with accessing and receiving ART (26%), delays associated with receiving care from treatment centres (24%), shortage of drugs and other commodities (23%), stigma (8.8%), fear of side effects of taking ARVs (7.9%), job insecurity arising from regular leave of absence to receive ART (5.3%), and long distance to treatment centres (4.9%). Conclusions: The results in this study suggest that efforts to provide and scale-up ART to all HIV+ persons must be accompanied by interventions that address structural and individual level access barriers. [ABSTRACT FROM AUTHOR]

Background: Utility estimates are important health outcomes for economic evaluation of care and treatment interventions for patients with HIV/AIDS. We conducted a systematic review and meta-analysis of utility measurements to examine the performance of preference-based instruments, estimate health utility of patients with HIV/AIDS by disease stages, and investigate changes in their health utility over the course of antiretroviral treatment. Methods: We searched PubMed/Medline, Cochrane Database of Systematic Review, NHS Economic Evaluation Database and Web of Science for English-language peer-reviewed papers published during 2000-2013. We selected 49 studies that used 3 direct and 6 indirect preference based instruments to make a total of 218 utility measurements. Random effect models with robust estimation of standard errors and multivariate fractional polynomial regression were used to obtain the pooled estimates of utility and model their trends. Results: Reliability of direct-preference measures tended to be lower than other types of measures. Utility elicited by two of the indirect preference measures - SF-6D (0.171) and EQ-5D (0.114), and that of Time-Trade off (TTO) (0.151) was significantly different than utility elicited by Standard Gamble (SG). Compared to asymptomatic HIV patients, symptomatic and AIDS patients reported a decrement of 0.025 (p = 0.40) and 0.176 (p = 0.001) in utility scores, adjusting for method of assessment. In longitudinal studies, the pooled health utility of HIV/AIDS patients significantly decreased in the first 3 months of treatment, and rapidly increased afterwards. Magnitude of change varied depending on the method of assessment and length of antiretroviral treatment. Conclusion: The study provides an accumulation of evidence on measurement properties of health utility estimates that can help inform the selection of instruments for future studies. The pooled estimates of health utilities and their trends are useful in economic evaluation and policy modelling of HIV/AIDS treatment strategies. [ABSTRACT FROM AUTHOR]

Background: Across Sub-Saharan Africa, the roll-out of antiretroviral treatment (ART) has contributed to shifting HIV care towards the management of a chronic health condition. While the balance of professional and lay tasks in HIV caregiving has been significantly altered due to changing skills requirements and task-shifting initiatives, little attention has been given to the effects of these changes on health workers' motivation and existing care relations. Methods: This paper draws on a cross-sectional, qualitative study that explored changes in home-based care (HBC) in the light of widespread ART rollout in the Lusaka and Kabwe districts of Zambia. Methods included observation of HBC daily activities, key informant interviews with programme staff from three local HBC organisations (n = 17) and ART clinic staff (n = 8), as well as in-depth interviews with home-based caregivers (n = 48) and HBC clients (n = 31). Results: Since the roll-out of ART, home-based caregivers spend less time on hands-on physical care and support in the household, and are increasingly involved in specialised tasks supporting their clients' access and adherence to ART. Despite their pride in gaining technical care skills, caregivers lament their lack of formal recognition through training, remuneration or mobility within the health system. Care relations within homes have also been altered as caregivers' newly acquired functions of monitoring their clients while on ART are met with some ambivalence. Caregivers are under pressure to meet clients and their families' demands, although they are no longer able to provide material support formerly associated with donor funding for HBC. Conclusions: As their responsibilities and working environments are rapidly evolving, caregivers' motivations are changing. It is essential to identify and address the growing tensions between an idealized rhetoric of altruistic volunteerism in home-based care, and the realities of lay worker deployment in HIV care interventions that not only shift tasks, but transform social and professional relations in ways that may profoundly influence caregivers' motivation and quality of care. [ABSTRACT FROM AUTHOR]

Background Utility estimates are important health outcomes for economic evaluation of care and treatment interventions for patients with HIV/AIDS. We conducted a systematic review and meta-analysis of utility measurements to examine the performance of preference-based instruments, estimate health utility of patients with HIV/AIDS by disease stages, and investigate changes in their health utility over the course of antiretroviral treatment. Methods We searched PubMed/Medline, Cochrane Database of Systematic Review, NHS Economic Evaluation Database and Web of Science for English-language peer-reviewed papers published during 2000-2013. We selected 49 studies that used 3 direct and 6 indirect preference based instruments to make a total of 218 utility measurements. Random effect models with robust estimation of standard errors and multivariate fractional polynomial regression were used to obtain the pooled estimates of utility and model their trends. Results Reliability of direct-preference measures tended to be lower than other types of measures. Utility elicited by two of the indirect preference measures - SF-6D (0.171) and EQ-5D (0.114), and that of Time-Trade off (TTO) (0.151) was significantly different than utility elicited by Standard Gamble (SG). Compared to asymptomatic HIV patients, symptomatic and AIDS patients reported a decrement of 0.025 (p = 0.40) and 0.176 (p = 0.001) in utility scores, adjusting for method of assessment. In longitudinal studies, the pooled health utility of HIV/AIDS patients significantly decreased in the first 3 months of treatment, and rapidly increased afterwards. Magnitude of change varied depending on the method of assessment and length of antiretroviral treatment. Conclusion The study provides an accumulation of evidence on measurement properties of health utility estimates that can help inform the selection of instruments for future studies. The pooled estimates of health utilities and their trends are useful in economic evaluation and policy modelling of HIV/AIDS treatment strategies. [ABSTRACT FROM AUTHOR]

Background Global Health Initiatives (GHIs), aiming at reducing the impact of specific diseases such as Human Immunodeficiency Virus (HIV), have flourished since 2000. Amongst these, PEPFAR and GFATM have provided a substantial amount of funding to countries affected by HIV, predominantly for delivery of antiretroviral therapy (ARV) and prevention strategies. Since the need for additional human resources for health (HRH) was not initially considered by GHIs, countries, to allow ARV scale-up, implemented short-term HRH strategies, adapted to GHI-funding conditionality. Such strategies differed from one country to another and slowly evolved to long-term HRH policies. The processes and content of HRH policy shifts in 5 countries in Sub-Saharan Africa were examined. Methods A multi-country study was conducted from 2007 to 2011 in 5 countries (Angola, Burundi, Lesotho, Mozambique and South Africa), to assess the impact of GHIs on the health system, using a mixed methods design. This paper focuses on the impact of GFATM and PEPFAR on HRH policies. Qualitative data consisted of semi-structured interviews undertaken at national and sub-national levels and analysis of secondary data from national reports. Data were analysed in order to extract countries' responses to HRH challenges posed by implementation of HIV-related activities. Common themes across the 5 countries were selected and compared in light of each country context. Results In all countries successful ARV roll-out was observed, despite HRH shortages. This was a result of mostly short-term emergency response by GHI-funded Non-Governmental Organizations (NGOs) and to a lesser extent by governments, consisting of using and increasing available HRH for HIV tasks. As challenges and limits of short-term HRH strategies were revealed and HIV became a chronic disease, the 5 countries slowly implemented mid to long-term HRH strategies, such as formalisation of pilot initiatives, increase in HRH production and mitigation of internal migration of HRH, sometimes in collaboration with GHIs. Conclusion Sustainable HRH strengthening is a complex process, depending mostly on HRH production and retention factors, these factors being country-specific. GHIs could assist in these strategies, provided that they are flexible enough to incorporate country-specific needs in terms of funding, that they coordinate at global-level and minimise conditionality for countries. [ABSTRACT FROM AUTHOR]

Background: While combination antiretroviral therapy has extended the life expectancy of those infected with human immunodeficiency virus (HIV), there is a high prevalence of comorbidities that increase the risk of cardiovascular morbidity and mortality among people living with HIV/AIDS (PLWHA). The side effects associated with antiretroviral therapy (ART) lead to multiple metabolic disorders, making the management of these metabolic issues and risk of cardiovascular disease (CVD) in those treated with ART a critical issue. Clinical research trials, primarily clinical exercise, rarely include this population due to unique challenges in research methods with underserved minority populations living with a life threatening illness like HIV/AIDS. This paper describes the rationale and design of a randomized clinical trial evaluating the feasibility of a home-based exercise program designed to increase physical activity (PA) and reduce the risk of CVD in PLWHA. Methods/design: PLWHA being treated with ART will be randomly assigned to one of two groups: a home-based PA intervention or standard care. All participants will receive an educational weight loss workbook and pedometer for self-monitoring of PA. Only those in the intervention group will receive additional elastic Thera-bands® for strength training and behavioral telephone based coaching. Discussion: This study will evaluate the feasibility of a home-based program designed to increase PA among PLWHA. Further, it will evaluate the effectiveness of such a program to decrease modifiable risk factors for CVD as a secondary outcome. This study was funded by the NIH/NINR R21 Grant 1R21NRO11281. [ABSTRACT FROM AUTHOR]

Background: The prevention of intimate partner transmission of HIV remains an important component of comprehensive HIV prevention strategies. In this paper we examine the sexual practices of people living with HIV on antiretroviral therapy (ART) in Papua New Guinea (PNG). Method: In 2008, a total of 374 HIV-positive people over the age of 16 and on ART for more than two weeks were recruited using a non-probability, convenience sampling methodology. This accounted for around 18% of adults on ART at the time. A further 36 people participated in semi-structured interviews. All interviews were thematically analysed using NVivo qualitative data analysis software. Results: Less than forty per cent (38%) of participants reported having had sexual intercourse in the six months prior to the survey. Marital status was by far the most important factor in determining sexual activity, but consistent condom use during vaginal intercourse with a regular partner was low. Only 46% reported consistent condom use during vaginal intercourse with a regular partner in the last six months, despite 77% of all participants reporting that consistent condom use can prevent HIV transmission. Consistent condom use was lowest amongst married couples and those in seroconcordant relationships. The vast majority (91.8%) of all participants with a regular heterosexual partner had disclosed their status to their partner. Qualitative data reinforced low rates of sexual activity and provided important insights into sexual abstinence and condom use. Conclusions: Considering the importance of intimate partner transmission of HIV, these results on the sexual practices of people with HIV on ART in PNG suggest that one-dimensional HIV prevention messages focussing solely on condom use fail to account for the current practices and needs of HIV-positive people, especially those who are married and know their partners' HIV status. [ABSTRACT FROM AUTHOR]

This paper describes the clinical features of a series of patients admitted to the specialist HIV/AIDS unit (Jagori) of the Dhaka Hospital, ICDDR,B (International Centre for Diarrhoeal Disease Research, Bangladesh) during May 2008-February 2010. Data were collected from a review of documents and electronic case-records and collation of laboratory results with respect to CD4 counts. One hundred and nine patients were admitted during this period. Their mean age was 33.4 years, and 62% were male. On admission, the mean CD4 count±standard deviation (SD) was 244±245 (range 2-1,549). The death rate was 12%. The patients were classified as World Health Organization clinical stage 1: 23%, stage 2: 30%, stage 3: 23%, and stage 4: 24% during the admission. The commonest diagnosis recorded was tuberculosis (TB) (23%), which was also the commonest cause of death (38%). Even for those clinicians with limited experience of managing AIDS cases, the commonest problem encountered in this patient group was TB, reflecting the continued high burden of TB on health services in Bangladesh. Additional challenges to managing TB/HIV co-infection include atypical presentations in HIV-infected persons and the complex drug interaction with antiretroviral therapy. [ABSTRACT FROM AUTHOR]

Background: In 2003, the Ethiopian Ministry of Health (MOH) started to implement a national antiretroviral treatment (ART) program. Using data in the monthly HIV/AIDS Updates issued by the MOH, this paper examines the spatial and temporal distribution of ART on a population basis for Ethiopian towns and administrative zones and regions for the period February to December 2006. Results: The 101 public ART hospitals treated 44,446 patients and the 91 ART health centers treated 1,599 patients in December 2006. The number of patients currently receiving ART doubled between February and December 2006 and the number of female patients aged 15 years and older surpassed male patients, apparently due to increased awareness and provision of free ART. Of 58,405 patients who ever started ART in December 2006, 46,045 (78.8%) were adhering to treatment during that month. Population coverage of ART was highest in the three urban administrative regions of Addis Ababa, Harari and Dire Dawa, in regional centers with referral hospitals, and in several small road side towns that had former mission or other NGO-operated hospitals. Hospitals in Addis Ababa had the largest patient loads (on average 850 patients) and those in SNNPR (Southern Nations and Nationalities Peoples Republic) (212 patients) and Somali (130 patients) regions the fewest patients. In bivariate tests, number of patients receiving treatment was significantly correlated with population size of towns, urban population per zone, number of hospitals per zone, and duration of ART services in 2006 (all p < 0.001). The stronger relationship with urban than total zonal populations (p < 0.001 versus p = 0.014) and the positive correlation between distance from 44 health centers to the nearest ART hospital and patients receiving treatment at these health centers may be due to a combination of differential accessibility of ART sites, patient knowledge and health-seeking behavior. Conclusion: The sharp increase in ART uptake in 2006 is largely due to the rapid increase in the provision of free treatment at more sites. The marked variation in ART utilization patterns between urban and rural communities and among zones and regions requires further studies. Recommendations are made for further expansion and sustainability of the ART scale-up. [ABSTRACT FROM AUTHOR]

Background: Following the World Health Organization's (WHO) 2015 guidelines recommending initiation of antiretroviral therapy (ART) irrespective of CD4 count for all people living with HIV (PLHIV), many countries in sub-Saharan Africa have adopted this strategy to reach epidemic control. As the number of PLHIV on ART rises, maintenance of viral suppression on ART for over 90% of PLHIV remains a challenge to government health systems in resource-limited high HIV burden settings. Non facility-based antiretroviral therapy (ART) delivery for stable HIV+ patients may increase sustainable ART coverage in resource-limited settings. Within the HPTN 071 (PopART) trial, two models, home-based delivery (HBD) or adherence clubs (AC), were offered to assess whether they achieved similar viral load suppression (VLS) to standard of care (SoC). In this paper, we describe the trial design and discuss the methodological issues and challenges. Methods: A three-arm cluster randomized non-inferiority trial, nested in two urban HPTN 071 trial communities in Zambia, randomly allocated 104 zones to SoC (35), HBD (35), or AC (34). ART and adherence support were delivered 3-monthly at home (HBD), adherence clubs (AC), or clinic (SoC). Adult HIV+ patients defined as "stable" on ART were eligible for inclusion. The primary endpoint was the proportion of PLHIV with virological suppression (≤ 1000 copies HIV RNA/ml) at 12 months (± 3months) after study entry across all three arms. Viral load measurement was done at the routine government laboratories in accordance with national guidelines, annually. The study was powered to determine if either of the community-based interventions would yield a viral suppression rate drop compared to SoC of no more than 5% in its absolute value. Both community-based interventions were delivered by community HIV providers (CHiPs). An additional qualitative study using observations, interviews with PLHIV, and FGDs with community HIV providers was nested in this study to complement the quantitative data. Discussion: This trial was designed to provide rigorous randomized evidence of safety and efficacy of non-facility-based delivery of ART for stable PLHIV in high-burden resource-limited settings. This trial will inform policy regarding best practices and what is needed to strengthen scale-up of differentiated models of ART delivery in resource-limited settings. Trial registration: ClinicalTrials.gov NCT03025165. Registered on 19 January 2017 [ABSTRACT FROM AUTHOR]

Background: As in non-infected subjects, statins and aspirin have a pivotal preventive role in reducing the cardiovascular related morbidity and mortality in HIV infected patients. The persistence of immune activation in these subjects, could contribute to accelerate atherosclerosis, therefore, these treatments that reduce inflammation could provide additional cardiovascular protection. However the current guidelines for the use of these drugs in general population are dissimilar, with important differences between American and European ones. Aim of the present position paper is to provide recommendations aimed to overcome the actual differences and limitations among the current ones and to adapt them to the needs of HIV infected patients. Results: We propose to adopt the new ACC/AHA guidelines, simple to use and cost effective, to use the ASCVD score that seems to estimate more accurately the cardiovascular risk among these patients. We suggest to start statin therapy in all patients with a calculated 10-year risk of a cardiovascular event of 10% or greater. Rosuvastatin and atorvastatin should be preferred. LDL-C target may be adopted. Aspirin should be always associated with a statin, in secondary prevention, while in primary prevention it should be reserved only to patients with ≥ 20% 10-year risk particularly adherent to treatments, and with low risk of bleeding. We suggest to start with a dose of 100 mg/day. Finally, management of antiplatelet agents or novel oral anticoagulants may include selecting antiretrovirals with a lower potential for drug interactions or choosing agents least likely to interact with antiretrovirals. Conclusions: As demonstrated in surveys, HIV physicians are generally highly committed regarding CVD and autonomous in prescribing statins and ASA. Consequently, in the light of the previously discussed discrepancies among the different guidelines and of the incomplete indications regarding HIV-positive persons, the present suggestions could overcome the actual differences and limitations among the current ones. [ABSTRACT FROM AUTHOR]

High medicines prices increasingly pose challenges for universal access to treatments of communicable and non-communicable diseases. New essential medicines are often patent-protected which sustains high prices in many countries, including in low- and middle-income countries. To respond to the HIV/AIDS crisis of the late nineties and to increase access to antiretroviral treatment, certain flexibilities contained in the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS flexibilities) have been clarified and in some respects strengthened at the global level. They have been applied by a number of countries to ensure access to lower-priced generic medicines to treat HIV/AIDS. Governments in the South African Development Community (SADC) have also used TRIPS flexibilities to gain access to lower-priced generic medicines. This paper documents 15 instances of the use of TRIPS flexibilities by eight SADC Member States during the period 2001–2016. Of those, six concerned least developed countries (LDCs) that declared non-enforcement of pharmaceutical patents pursuant to a new LDC transition provision. All instances occurred in the context of medicines procurement for HIV treatment. Such flexibilities can, however, also be used to overcome patent barriers to gain access to generic medicines for other diseases, including NCDs. The SADC, being a regional bloc with over 50% least developed country Members, can make use of the regional exception, a TRIPS flexibility that facilitates the production or procurement of generic medicines to the benefit of the entire region. SADC's Pharmaceutical Business Plan proposes strategies for increased collaboration and pooled procurement of medicines. [ABSTRACT FROM AUTHOR]

Background: Adolescents living with HIV experience worse HIV care outcomes compared to adults, especially during transition from pediatric to adult care. However, data regarding adolescents are limited. This paper describes and compares characteristics of male and female adolescents living with HIV preparing for transition from pediatric to adult care in Cambodia.Methods: This cross-sectional study was conducted in August 2016 among 328 adolescents aged 15-17, randomly selected from 11 antiretroviral therapy (ART) clinics. Data were collected using a structured questionnaire, and descriptive analyses were conducted to compare characteristics of male and female adolescents.Results: Of total, 55.2% were male, and 40.8% were living with parents. Majority (82.6%) got HIV infection from their mothers. Overall, adolescents had received ART for an average of 8.4 years, and HIV care for 9.5 years. Additionally, 82.4% were on first line ART regimen. Mean CD4 count from the most recent test was 672 cells/mm3, and viral load was 7686 copies/mL. Overall, 95.6% were adherent to ART on Visual Analogue Scale. About half (50.7%) had never disclosed their HIV status to anyone, while the remaining had disclosed it to their siblings (24.2%), friends (13.0%), schoolteachers (2.4%), or other (5.8%). A fifth reported having had boy or girlfriends, but few (2.1%) had ever had sexual intercourse. Females were more likely to have been engaged in sexual intercourse, and none reported having used a condom in their last intercourse. Few participants reported having ever used tobacco (1.8%), or any kind of illicit drugs (0.9%), but almost a fifth (20.7%) had a history of alcohol use. The majority (82.1%) were aware that they were receiving ART. HIV-related knowledge was suboptimal among the sample.Conclusions: This study provides a snapshot of immunological, virological, adherence, and disclosure outcomes that should be tracked during and following healthcare transition to evaluate the effectiveness of the transition program. Findings showed high ART adherence, low likelihood of disclosure outside of family circles, sub-optimal condom use, and poor knowledge of HIV. To provide individualized support for healthcare transition, pediatric and adult clinics need to ensure that these characteristics are taken into account. [ABSTRACT FROM AUTHOR]

Background: Unstable settings present challenges for the effective provision of antiretroviral treatment (ART). In this paper, we summarize the experience and results of providing ART and implementing contingency plans during acute instability in the Central African Republic (CAR) and Yemen. Case presentation: In CAR, MSF has provided HIV care in three conflict-affected rural regions; these were put on hold throughout the acute phase of violence. "Run-away bags" containing 3 or 4 months of ART were distributed to patients at MSF facilities. Among 1820 HIV patients enrolled into care, 1440 (79%) initiated ART. By December 2016, 782 (54%) patients were still under ART, 354 (25%) have been lost to follow up and 182 (13%) had died. In 2013, when violence disrupted services, 683 patients were receiving ART. Between September–December 2013, 594 (87%) patients received runaway bags and by February 2014, 313 (53%) of these patients returned to the clinic. In Yemen, when violence erupted, patients received a health card that included a helpline to call in case of drug shortages in admission to emergency stocks; this was not possible in CAR due to lack of a functioning telephone network. One thousand six hundred fifty-five PLWHA have been enrolled in care and 1470 (89%) initiated ART; 1056 (72%) are still followed on ART, 126 (9%) were lost to follow up, and 288 (20%) died. In January 2011 clashes began and by April 2011 MSF medical activities were interrupted. Of the 363 patients receiving ART, 363 (100%) received emergency bags to cover 9 months and by February 2012, 354 (98%) patients returned to care. In March 2015 a new wave of conflict affected Yemen, forcing HIV activities to revert to contingency planning. Conclusions: This experience provides further evidence that provision of HIV treatment and emergency drug stocks can be successfully provided to most patients in both conflict-affected settings. [ABSTRACT FROM AUTHOR]

Background: In 2011, a decision was made to scale up a pilot innovation involving 'adherence clubs' as a form of differentiated care for HIV positive people in the public sector antiretroviral therapy programme in the Western Cape Province of South Africa. In 2016 we were involved in the qualitative aspect of an evaluation of the adherence club model, the overall objective of which was to assess the health outcomes for patients accessing clubs through epidemiological analysis, and to conduct a health systems analysis to evaluate how the model of care performed at scale. In this paper we adopt a complex adaptive systems lens to analyse planned organisational change through intervention in a state health system. We explore the challenges associated with taking to scale a pilot that began as a relatively simple innovation by a non-governmental organisation.Results: Our analysis reveals how a programme initially representing a simple, unitary system in terms of management and clinical governance had evolved into a complex, differentiated care system. An innovation that was assessed as an excellent idea and received political backing, worked well whilst supported on a small scale. However, as scaling up progressed, challenges have emerged at the same time as support has waned. We identified a 'tipping point' at which the system was more likely to fail, as vulnerabilities magnified and the capacity for adaptation was exceeded. Yet the study also revealed the impressive capacity that a health system can have for catalysing novel approaches.Conclusions: We argue that innovation in largescale, complex programmes in health systems is a continuous process that requires ongoing support and attention to new innovation as challenges emerge. Rapid scaling up is also likely to require recourse to further resources, and a culture of iterative learning to address emerging challenges and mitigate complex system errors. These are necessary steps to the future success of adherence clubs as a cornerstone of differentiated care. Further research is needed to assess the equity and quality outcomes of a differentiated care model and to ensure the inclusive distribution of the benefits to all categories of people living with HIV. [ABSTRACT FROM AUTHOR]

Background: By 1990, 94 percent of the acquired immunodeficiency syndrome (AIDS) cases in Romania were in children less than 13 years of age. The majority of the cases were identified in the city of Constanta. The purpose of this paper was to describe the current burden of pediatric human immunodeficiency virus (HIV) infection in the Constanta county.Methods: A cross-sectional study was designed to address the primary objective. Between April 1999 and March 2000, all living cases of pediatric HIV infection in the Constanta county were identified from records at the HIV hospital clinic which serves the Constanta county. Standard demographic, social, clinical, treatment and hospitalization data were collected for each study subject. Data were analyzed according to cross-sectional study design methodology.Results: Of the 762 subjects, the majority were seven to 11 years of age, lived with their parents and attended school. Only 70% of the fathers and 13% of the mothers were employed. Horizontal transmission accounted for 90% of the cases. Most of the children had moderate to severe disease as indicated by their AIDS-defining signs; 40% had AIDS. Less than half of the children were receiving antiretroviral therapy (ART). ART and children of mothers with a high school or greater education were independent predictors of long-term non-progression of HIV disease.Conclusions: This cross-sectional study demonstrated that ten years after the HIV epidemic was identified in Romania, it remains a health and economic burden. The infected children are very ill, but ART is not available for all. The proportion with vertical transmission has increased from an estimated four % to nine %. Our findings support the need to get HIV therapy to economically challenged countries such as Romania. [ABSTRACT FROM AUTHOR]