Behaviour changes following HIV diagnosis among men who have sex with men in the era of treatment as prevention: data from a prospective study.

We described the longitudinal changes in sexual behaviour and associated factors among newly diagnosed with HIV men who have sex with men participating in a prospective observational study from a London HIV clinic (2015-2018). Participants self-completed questionnaires at baseline, months 3 and 12. Information collected included socio-demographic, sexual behaviour, health, lifestyle and social support. Trends in sexual behaviours over one year following diagnosis and associated factors were assessed using generalized estimating equations with logit link. Condomless sex (CLS) dropped from 62.2% at baseline to 47.6% at month-three but increased again to 61.8% at month-12 (p-trend = 0.790). Serodiscordant-CLS increased between month-three and month-12 (from 13.1% to 35.6%, p-trend < 0.001). The prevalence of serodiscordant-CLS with high risk of transmitting to their partners at month-three was 10.7%. CLS was higher among men who reported recreational drug use (adjusted Odds Ratio (aOR) 3.03, 95%CI 1.47-6.24, p = 0.003), those with undetectable viral load (aOR 2.17, 95%CI 1.22-3.84, p = 0.008) and those who agreed with a statement "condoms are not necessary when HIV viral load is undetectable" (aOR 3.41, 95%CI 1.58-7.38, p = 0.002). MSM continued to engage in CLS after HIV diagnosis, which coincided with U = U publications and increased throughout the study.

The cost of care for people living with stable HIV in Croatia and the efficiency of EmERGE.

AIM: To estimate the cost-effectiveness of the EmERGE Pathway of Care for medically stable people living with HIV (PLHIV) at the University Hospital for Infectious Diseases (UHID), Zagreb. The Pathway includes a mobile application enabling individuals to communicate with their caregivers. METHODS: This study involving 293 participants collected data on the use of HIV outpatient services one year before and after EmERGE implementation. In departments supporting HIV outpatients, a micro-costing exercise was performed to calculate unit costs. These were combined with mean use of HIV services per patient year (MPPY) to estimate average annual costs. Primary outcomes were CD4 count, viral load, and secondary outcomes were patient activation, PAM13; and quality of life, PROQOL-HIV. Information on out-of-pocket expenditures was also collected. RESULTS: Outpatient visits decreased by 17%, from 4.0 (95% CI 3.8-4.3) to 3.3 MPPY (95% CI 3.1-3.5). Tests, including CD4 count, decreased, all contributing to a 33% reduction of annual costs: 7139 HRK (95% CI 6766-7528) to 4781 HRK (95% CI 4504-5072). Annual costs including anti-retroviral drugs (ARVs) decreased by 5%: 43101 HRK (95% CI 42728-43,490) to 40 743 HRK (95% CI 40466-41,034). ARVs remain the main cost driver in stable PLHIV. Primary and secondary outcomes did not change substantially between periods. CONCLUSION: EmERGE Pathway was a cost-saving intervention associated with changes in management, and a reduction in outpatient visits, tests, and costs. ARV costs dominated costs. Future efficiencies are possible if EmERGE is introduced to other PLHIV across the UHID and if ARV prices are reduced.

Global Burden of Atherosclerotic Cardiovascular Disease in People Living With HIV: Systematic Review and Meta-Analysis.

BACKGROUND: With advances in antiretroviral therapy, most deaths in people with HIV are now attributable to noncommunicable illnesses, especially cardiovascular disease. We determine the association between HIV and cardiovascular disease, and estimate the national, regional, and global burden of cardiovascular disease attributable to HIV. METHODS: We conducted a systematic review across 5 databases from inception to August 2016 for longitudinal studies of cardiovascular disease in HIV infection. A random-effects meta-analysis across 80 studies was used to derive the pooled rate and risk of cardiovascular disease in people living with HIV. We then estimated the temporal changes in the population-attributable fraction and disability-adjusted life-years (DALYs) from HIV-associated cardiovascular disease from 1990 to 2015 at a regional and global level. National cardiovascular DALYs associated with HIV for 2015 were derived for 154 of the 193 United Nations member states. The main outcome measure was the pooled estimate of the rate and risk of cardiovascular disease in people living with HIV and the national, regional, and global estimates of DALYs from cardiovascular disease associated with HIV. RESULTS: In 793 635 people living with HIV and a total follow-up of 3.5 million person-years, the crude rate of cardiovascular disease was 61.8 (95% CI, 45.8-83.4) per 10 000 person-years. In comparison with individuals without HIV, the risk ratio for cardiovascular disease was 2.16 (95% CI, 1.68-2.77). Over the past 26 years, the global population-attributable fraction from cardiovascular disease attributable to HIV increased from 0.36% (95% CI, 0.21%-0.56%) to 0.92% (95% CI, 0.55%-1.41%), and DALYs increased from 0.74 (95% CI, 0.44-1.16) to 2.57 (95% CI, 1.53-3.92) million. There was marked regional variation with most DALYs lost in sub-Saharan Africa (0.87 million, 95% CI, 0.43-1.70) and the Asia Pacific (0.39 million, 95% CI, 0.23-0.62) regions. The highest population-attributable fraction and burden were observed in Swaziland, Botswana, and Lesotho. CONCLUSIONS: People living with HIV are twice as likely to develop cardiovascular disease. The global burden of HIV-associated cardiovascular disease has tripled over the past 2 decades and is now responsible for 2.6 million DALYs per annum with the greatest impact in sub-Saharan Africa and the Asia Pacific regions. CLINICAL TRIAL REGISTRATION: URL: https://www.crd.york.ac.uk/prospero . Unique identifier: CRD42016048257.

Attitudes towards homosexuals in seven Caribbean countries: implications for an effective HIV response.

Between 2000 and 2015, the number of people newly infected with HIV in the Caribbean decreased by 76% and HIV-related deaths by 42%. The number of people living with HIV (PLHIV) on anti-retroviral therapy (ART) increased from near zero to 50% (44% to 57%) in 2015. In many Caribbean countries communities of men-who-have-sex-with-other-men (MSM) have higher incidence and prevalence of HIV. They are often stigmatized and subjected to both social and institutional discrimination. This study compared attitudes of the general public obtained through public opinion polls 2013-2014 towards homosexuals and willingness to socialize with them in seven Caribbean countries. Informants were asked if they "hate, tolerate or accept" homosexuals and if they would socialize with them. In St. Vincent 53% indicated they "hate" homosexuals, compared with 12% in Suriname; the converse was observed for those who "accept" homosexuals; 63% of St. Vincent informants would not socialize with homosexuals, compared with 25% in Suriname. Findings for the other 5 countries fell within these ranges. Women were more likely to accept and socialize with homosexuals, as were informants with a tertiary education and "passive" religious believers. These groups are less likely to adhere to a culture of "compulsory heterosexuality" or "hyper-masculinity" dominant among Caribbean men. The homophobic views expressed by these cultures result in stigma and discrimination by members of the "general" public towards MSM. This negatively affects the involvement of MSM in successful national HIV responses. Public messaging, communications campaigns and educational measures need to be employed to change the culture of "compulsory heterosexuality" or "hyper-masculinity" that result in stigma and discrimination of homosexuals to improve early access to services by MSM. Repeat use of well performed opinion polls is one method that can be employed to monitor progress over time in "key" and "general" populations.

The efficiency of the EmERGE platform for medically stable people living with HIV in Portugal.

Background: The aim of this study was to calculate the cost-effectiveness of the EmERGE Pathway of Care for medically stable people living with HIV in the Hospital Capuchos, Centro Hospitalar Universitário de Lisboa Central (HC-CHLC). The app enables individuals to receive HIV treatment information and communicate with caregivers. Methods: This before-and-after study collected the use of services data 1 year before implementation and after implementation of EmERGE from November 1, 2016, to October 30, 2019. Departmental unit costs were calculated and linked to mean use of outpatient services per patient-year (MPPY). Annual costs per patient-year were combined with primary (CD4 count; viral load) and secondary outcomes (PAM-13; PROQOL-HIV). Results: Five hundred eighty-six EmERGE participants used HIV outpatient services. Annual outpatient visits decreased by 35% from 3.1 MPPY (95% confidence interval [CI]: 3.0-3.3) to 2.0 (95% CI: 1.9-2.1) as did annual costs per patient-year from €301 (95% CI: €288-€316) to €193 (95% CI: €182-€204). Laboratory tests and costs increased by 2%, and radiology investigations decreased by 40% as did costs. Overall annual cost for HIV outpatient services decreased by 5% from €2093 (95% CI: €2071-€2112) to €1984 (95% CI: €1968-€2001); annual outpatient costs decreased from €12,069 (95% CI: €12,047-€12,088) to €11,960 (95% CI: €11,944-€11,977), with 83% of annual cost because of antiretroviral therapy (ART). Primary and secondary outcome measures did not differ substantially between periods. Conclusions: The EmERGE Pathway produced cost savings after implementation-extended to all people living with HIV additional savings are likely to be produced, which can be used to address other needs. Antiretroviral drugs (ARVs) were the main cost drivers and more expensive in Portugal compared with ARV costs in the other EmERGE sites.

Efficiency of the EmERGE Pathway of Care in Five European HIV Centres.

OBJECTIVE: We aimed to calculate the efficiency of the EmERGE Pathway of Care in five European HIV clinics, developed and implemented for medically stable people living with HIV. METHODS: Participants were followed up for 1 year before and after implementation of EmERGE, between April 2016 and October 2019. Micro-costing studies were performed in the outpatient services of the clinics. Unit costs for outpatient services were calculated in national currencies and converted to US$ 2018 OECD purchasing parity prices to enable between clinic comparisons in terms of outcomes and costs. Unit costs were linked to the mean use of services for medically stable people living with HIV,  before and after implementation of EmERGE. Primary outcome measures were CD4 count and viral load; secondary outcomes were patient activation (PAM13) and quality of life (PROQOL-HIV). Out-of-pocket expenditure data were collected. RESULTS: There were 2251 participants: 87-93% were male, mean age at entry was 41-47 years. Medically stable people living with HIV had outpatient visits in four sites which decreased by 9-31% and costs by 5-33%; visits and costs increased by 8% in one site, which had to revert back to face-to-face visits. Antiretroviral drugs comprised 83-91% of annual costs: the Portuguese site had the highest antiretroviral drug costs in US$ purchasing parity prices. Primary and secondary outcome measures of participants did not change during the study. CONCLUSIONS: EmERGE is acceptable and provided cost savings in different socio-economic settings. Antiretroviral drug costs remain the main cost drivers in medically stable people living with HIV. While antiretroviral drug prices in local currencies did not differ that much between countries, conversion to US$ purchasing parity prices revealed antiretroviral drugs were more expensive in the least wealthy countries. This needs to be taken into consideration when countries negotiate drug prices with pharmaceutical vendors. Greater efficiencies can be anticipated by extending the use of the EmERGE Pathway to people with complex HIV infection or other chronic diseases. Extending such use should be systematically monitored, implementation should be evaluated and funding should be provided to monitor and evaluate future changes in service provision.

Does the political will exist to bring quality-assured and affordable drugs to low- and middle-income countries?

BACKGROUND: Increased coverage with antiretroviral therapy for people living with HIV in low- and middle-income countries has increased their life expectancy associated with non-HIV comorbidities and the need for quality-assured and affordable non-communicable diseases drugs . Funders are leaving many middle-income countries that will have to pay and provide quality-assured and affordable HIV and non-HIV drugs, including for non-communicable diseases. OBJECTIVE: To estimate costs for originator and generic antiretroviral therapy as the number of people living with HIV are projected to increase between 2016 and 2026, and discuss country, regional and global factors associated with increased access to generic drugs. METHODS: Based on estimates of annual demand and prices, annual cost estimates were produced for generic and originator antiretroviral drug prices in low- and middle-income countries and projected for 2016-2026. RESULTS: Drug costs varied between US$1.5 billion and US$4.8 billion for generic drugs and US$ 8.2 billion and US$16.5 billion for originator drugs between 2016 and 2026. DISCUSSION: The global HIV response increased access to affordable generic drugs in low- and middle-income countries. Cheaper active pharmaceutical ingredients and market competition were responsible for reduced drug costs. The development and implementation of regulatory changes at country, regional and global levels, covering intellectual property rights and public health, and flexibilities in patent laws enabled prices to be reduced. These changes have not yet been applied in many low- and middle-income countries for HIV, nor for other infectious and non-communicable diseases, that lack the profile and political attention of HIV. Licensing backed up with Trade-Related Aspects of Intellectual Property Rights safeguards should become the norm to provide quality-assured and affordable drugs within competitive generic markets. CONCLUSION: Does the political will exist among policymakers and other stakeholders to develop and implement these country, regional and global frameworks for non-HIV drugs as they did for antiretroviral drugs?

Global and regional trends of people living with HIV aged 50 and over: Estimates and projections for 2000-2020.

BACKGROUND: The increasing numbers of people living with HIV (PLHIV) who are receiving antiretroviral therapy (ART) have near normal life-expectancy, resulting in more people living with HIV over the age of 50 years (PLHIV50+). Estimates of the number of PLHIV50+ are needed for the development of tailored therapeutic and prevention interventions at country, regional and global level. METHODS: The AIDS Impact Module of the Spectrum software was used to compute the numbers of PLHIV, new infections, and AIDS-related deaths for PLHIV50+ for the years 2000-2016. Projections until 2020 were calculated based on an assumed ART scale-up to 81% coverage by 2020, consistent with the UNAIDS 90-90-90 treatment targets. RESULTS: Globally, there were 5.7 million [4.7 million- 6.6 million] PLHIV50+ in 2016. The proportion of PLHIV50+ increased substantially from 8% in 2000 to 16% in 2016 and is expected to increase to 21% by 2020. In 2016, 80% of PLHIV50+ lived in low- and middle-income countries (LMICs), with Eastern and Southern Africa containing the largest number of PLHIV50+. While the proportion of PLHIV50+ was greater in high income countries, LMICs have higher numbers of PLHIV50+ that are expected to continue to increase by 2020. CONCLUSIONS: The number of PLHIV50+ has increased dramatically since 2000 and this is expected to continue by 2020, especially in LMICs. HIV prevention campaigns, testing and treatment programs should also focus on the specific needs of PLHIV50+. Integrated health and social services should be developed to cater for the changing physical, psychological and social needs of PLHIV50+, many of whom will need to use HIV and non-HIV services.

Developing and implementing national health identifiers in resource limited countries: why, what, who, when and how?

Many resource-limited countries are scaling up health services and health-information systems (HISs). The HIV Cascade framework aims to link treatment services and programs to improve outcomes and impact. It has been adapted to HIV prevention services, other infectious and non-communicable diseases, and programs for specific populations. Where successful, it links the use of health services by individuals across different disease categories, time and space. This allows for the development of longitudinal health records for individuals and de-identified individual level information is used to monitor and evaluate the use, cost, outcome and impact of health services. Contemporary digital technology enables countries to develop and implement integrated HIS to support person centred services, a major aim of the Sustainable Development Goals. The key to link the diverse sources of information together is a national health identifier (NHID). In a country with robust civil protections, this should be given at birth, be unique to the individual, linked to vital registration services and recorded every time that an individual uses health services anywhere in the country: it is more than just a number as it is part of a wider system. Many countries would benefit from practical guidance on developing and implementing NHIDs. Organizations such as ASTM and ISO, describe the technical requirements for the NHID system, but few countries have received little practical guidance. A WHO/UNAIDS stake-holders workshop was held in Geneva, Switzerland in July 2016, to provide a 'road map' for countries and included policy-makers, information and healthcare professionals, and members of civil society. As part of any NHID system, countries need to strengthen and secure the protection of personal health information. While often the technology is available, the solution is not just technical. It requires political will and collaboration among all stakeholders to be successful.

Are there sex-related differences in specialized, multidisciplinary congestive heart failure clinics?

BACKGROUND: Specialized, multidisciplinary clinics improve service provision and reduce morbidity for patients with congestive heart failure (CHF). Although sex-related differences in access to cardiac health services have been reported, it remains unclear whether there are sex-related differences in the use of these specialized services. OBJECTIVES: To evaluate possible sex-related differences in severity at entry into specialized, multidisciplinary clinics, and compare prescription patterns between male and female patients at these clinics. METHODS: Data were obtained from the electronic clinical files of 765 CHF patients newly admitted to any of three main CHF clinics in Montreal, Quebec. Univariate and multivariate models were used to compare differences between sexes. RESULTS: Only 27.1% of patients were female. The mean age (+/- SD) of the women in the present study was similar to that of the men (64+/-16 years versus 65+/-13 years, respectively). Left ventricular ejection fraction at entry for patients with reduced systolic function was comparable between sexes. The New York Heart Association functional class at entry was similar among men and women with systolic dysfunction. However, among patients with preserved systolic function, women were more symptomatic, with a higher functional class at entry (adjusted OR 2.52, 95% CI 1.18 to 5.38). Prescription profiles were similar for men and women. CONCLUSION: Entry into a clinic may be delayed for women with preserved systolic function CHF. However, clinic referral patterns and disease management appeared to be similar among both men and women with systolic dysfunction CHF.

National adult antiretroviral therapy guidelines in resource-limited countries: concordance with 2003 WHO guidelines?

AIMS: To investigate the existence of national adult antiretroviral therapy (ART) guidelines in 43 World Health Organization (WHO) '3 by 5' focus countries and compare their content with the 2003 WHO ART guidelines. METHODS: Questionnaires covered initiation of ART, selection of first or second-line ART, monitoring treatment response and toxicity and dissemination of national guidelines. Weighted concordance scores were created and country scores correlated with national indicators and WHO recommendations. RESULTS: Thirty-nine (91%) countries returned questionnaires, three of which had no national ART guidelines. Of the 36, 16 (44%) recommended to start ART based on WHO clinical staging criteria and CD4 cell count or T-lymphocyte count, 12 (33%) WHO clinical staging criteria and CD4 cell count, four (11%) only CD4 cell counts. 35 (97%) recommended a standard first-line regimen and 24 (67%) preferred stavudine + lamivudine + nevirapine; 33 (92%) recommended second-line regimens, and 24 (60%) preferred abacavir + didanosine + lopinavir/ritonavir. Thirty-one (94%) recommended CD4 cell count, possibly combined with other indicators, to monitor ART. Concordance scores were higher in countries with lower health expenditure per capita (P = 0.009) and lower GDP per capita (P < 0.03). Median concordance scores for starting ART was 100 [interquartile range (IQR), 67 to 100]; first line therapy, 70 (IQR, 60 to 80); second-line regimens, 45 (IQR, 27 to 55) and for laboratory investigations, 80 (IQR, 80 to 100). CONCLUSIONS: Most countries had developed national ART guidelines as part of a comprehensive national HIV program. Concordance with WHO recommendations was strong on starting first-line ART regimens and routine monitoring but lower for second-line recommendations.

Cost-effectiveness of highly active antiretroviral therapy in South Africa.

BACKGROUND: Little information exists on the impact of highly active antiretroviral therapy (HAART) on health-care provision in South Africa despite increasing scale-up of access to HAART and gradual reduction in HAART prices. METHODS AND FINDINGS: Use and cost of services for 265 HIV-infected adults without AIDS (World Health Organization [WHO] stage 1, 2, or 3) and 27 with AIDS (WHO stage 4) receiving HAART between 1995 and 2000 in Cape Town were compared with HIV-infected controls matched for baseline WHO stage, CD4 count, age, and socioeconomic status, who did not receive antiretroviral therapy (ART; No-ART group). Costs of service provision (January 2004 prices, USD 1 = 7.6 Rand) included local unit costs, and two scenarios for HAART prices for WHO recommended first-line regimens: scenario 1 used current South African public-sector ART drug prices of $730 per patient-year (PPY), whereas scenario 2 was based on the anticipated public-sector price for locally manufactured drug of $181 PPY. All analyses are presented in terms of patients without AIDS and patients with AIDS. For patients without AIDS, the mean number of inpatient days PPY was 1.08 (95% confidence interval [CI]: 0.97-1.19) for the HAART group versus 3.73 (95% CI: 3.55-3.97) for the No-ART group, and 8.71 (95% CI: 8.40-9.03) versus 4.35 (95% CI: 4.12-5.61), respectively, for mean number of outpatient visits PPY. Average service provision PPY was $950 for the No-ART group versus $1,342 and $793 PPY for the HAART group for scenario 1 and 2, respectively, whereas the incremental cost per life-year gained (LYG) was $1,622 for scenario 1 and $675 for scenario 2. For patients with AIDS, mean inpatients days PPY was 2.04 (95% CI: 1.63-2.52) for the HAART versus 15.36 (95% CI: 13.97-16.85) for the No-ART group. Mean outpatient visits PPY was 7.62 (95% CI: 6.81-8.49) compared with 6.60 (95% CI: 5.69-7.62) respectively. Average service provision PPY was $3,520 for the No-ART group versus $1,513 and $964 for the HAART group for scenario 1 and 2, respectively, whereas the incremental cost per LYG was cost saving for both scenarios. In a sensitivity analysis based on the lower (25%) and upper (75%) interquartile range survival percentiles, the incremental cost per LYG ranged from $1,557 to $1,772 for the group without AIDS and from cost saving to $111 for patients with AIDS. CONCLUSION: HAART is a cost-effective intervention in South Africa, and cost saving when HAART prices are further reduced. Our estimates, however, were based on direct costs, and as such the actual cost saving might have been underestimated if indirect costs were also included.

Viewpoint: a pragmatic approach to constructing a minimum data set for care of patients with HIV in developing countries.

Providing quality health care requires access to continuous patient data that developing countries often lack. A panel of medical informatics specialists, clinical human immunodeficiency virus (HIV) specialists, and program managers suggests a minimum data set for supporting the management and monitoring of patients with HIV and their care programs in developing countries. The proposed minimum data set consists of data for registration and scheduling, monitoring and improving practice management, and describing clinical encounters and clinical care. Data should be numeric or coded using standard definitions and minimal free text. To enhance accuracy, efficiency, and availability, data should be recorded electronically by those generating them. Data elements must be sufficiently detailed to support clinical algorithms/guidelines and aggregation into broader categories for consumption by higher level users (e.g., national and international health care agencies). The proposed minimum data set will evolve over time as funding increases, care protocols change, and additional tests and treatments become available for HIV-infected patients in developing countries.

Cost and cost-effectiveness of antiretroviral therapy for HIV infection in Singapore.

The objective of this study was to determine the cost and cost-effectiveness of antiretroviral therapy (ART) in Singapore. The use and cost of HIV services was calculated for patients managed at the national HIV referral centre in Singapore between 1996 and 2001 from a hospital perspective. Three groups of patients were compared by Centers for Disease Control and Prevention (CDC) stage of HIV infection: those who had never received ART; those who had received only dual therapy; and those who had only received highly active antiretroviral therapy (HAART). Hospital charges were used to estimate the average hospital inpatient and outpatient care costs. Life years gained (LYG) were calculated for different stages of HIV infection and the incremental costs per LYG were calculated comparing those on dual ART and HAART with those who did not receive ART. Patients on ART progressed less rapidly across all CDC stages. For CDC stage A, the incremental cost per LYG was 17,007 dollars (Singaporean dollar) (interquartile range [IQR] 7963-25,113 dollars ) and 22,511 dollars (IQR 11,299-33,724 dollars) for those on dual therapy and HAART, respectively. The incremental cost per LYG in stage B was 10,868 dollars (IQR 4506-17,239 dollars) and 21,094 dollars (IQR 7774-34,431 dollars) for patients on dual therapy and HAART, respectively, while the incremental cost per LYG for stage C patients was 9,848 dollars (IQR 5256-14,419 dollars ) and 16,513 dollars (IQR 8677-24,337 dollars) for dual therapy and HAART, respectively. Dual ART therapy and HAART were cost-effective interventions in Singapore. Cost-effectiveness is likely to improve if drug prices continue to decrease.

Protecting the confidentiality and security of personal health information in low- and middle-income countries in the era of SDGs and Big Data.

BACKGROUND: As increasing amounts of personal information are being collected through a plethora of electronic modalities by statutory and non-statutory organizations, ensuring the confidentiality and security of such information has become a major issue globally. While the use of many of these media can be beneficial to individuals or populations, they can also be open to abuse by individuals or statutory and non-statutory organizations. Recent examples include collection of personal information by national security systems and the development of national programs like the Chinese Social Credit System. In many low- and middle-income countries, an increasing amount of personal health information is being collected. The collection of personal health information is necessary, in order to develop longitudinal medical records and to monitor and evaluate the use, cost, outcome, and impact of health services at facility, sub-national, and national levels. However, if personal health information is not held confidentially and securely, individuals with communicable or non-communicable diseases (NCDs) may be reluctant to use preventive or therapeutic health services, due to fear of being stigmatized or discriminated against. While policymakers and other stakeholders in these countries recognize the need to develop and implement policies for protecting the privacy, confidentiality and security of personal health information, to date few of these countries have developed, let alone implemented, coherent policies. The global HIV response continues to emphasize the importance of collecting HIV-health information, recently re-iterated by the Fast Track to End AIDS by 2030 program and the recent changes in the Guidelines on When to Start Antiretroviral Therapy and on Pre-exposure Prophylaxis for HIV. The success of developing HIV treatment cascades in low- and middle-income countries will require the development of National Health Identification Systems. The success of programs like Universal Health Coverage, under the recently ratified Sustainable Development Goals is also contingent on the availability of personal health information for communicable and non-communicable diseases. DESIGN: Guidance for countries to develop and implement their own guidelines for protecting HIV-information formed the basis of identifying a number of fundamental principles, governing the areas of privacy, confidentiality and security. The use of individual-level data must balance maximizing the benefits from their most effective and fullest use, and minimizing harm resulting from their malicious or inadvertent release. DISCUSSION: These general principles are described in this paper, as along with a bibliography referring to more detailed technical information. A country assessment tool and user's manual, based on these principles, have been developed to support countries to assess the privacy, confidentiality, and security of personal health information at facility, data warehouse/repository, and national levels. The successful development and implementation of national guidance will require strong collaboration at local, regional, and national levels, and this is a pre-condition for the successful implementation of a range of national and global programs. CONCLUSION: This paper is a call for action for stakeholders in low- and middle-income countries to develop and implement such coherent policies and provides fundamental principles governing the areas of privacy, confidentiality, and security of personal health information being collected in low- and middle-income countries.

The cost-effectiveness of highly active antiretroviral therapy, Canada 1991-2001.

AIM: To estimate the cost-effectiveness ratio of highly-active antiretroviral therapy (HAART) in Canada. DESIGN: A before-and-after analysis to calculate incremental cost of life year gained (LYG) between 1991 and 1995 (pre-HAART period) and between 1997 and 2001 (HAART period) for non-AIDS and AIDS groups (CDC stage of HIV infection). METHODS: For two Quebec HIV hospital clinics, mean inpatient (IP) days, outpatient (OP) visits and direct health care costs per patient-year (PPY) were calculated. Cox's proportional hazards models calculated disease progression, stratified by study periods and adjusted for gender, age at cohort entry, sexual orientation, injecting drug use and baseline CD4 cell count. RESULTS: For non-AIDS patients, mean IP days was 1.6 (pre-HAART period) compared with 0.8 PPY (HAART period); mean OP visits increased from 2.8 to 5.5 PPY. Total cost was US$ 4265 (pre-HAART period) and US$ 9445 PPY (HAART period) of which 66 and 84%, respectively were spent on antiretroviral drugs. Median progression time was 6.3 years in the pre-HAART period compared with 12.5 years in HAART period (log rank chi = 270, P < 0.0001). Incremental cost per LYG between periods was US$ 14 587. For AIDS patients, mean IP days decreased from 13.3 to 4.4 PPY between periods; OP visits increased from 8.3 to 9.2 PPY. Total costs increased from US$ 9099 to US$ 11 754 PPY, while expenditure on antiretroviral drugs increased from 29 to 72% of total cost. Median progression time was 3.8 years in the pre-HAART period, which increased to 13.3 years in the HAART period (log rank chi = 158, P < 0.0001); incremental cost per LYG between periods was US$ 12 813. CONCLUSION: HAART appeared a cost-effective intervention in Canada.

Cost-effectiveness of antenatal HIV-testing: reviewing its pharmaceutical and methodological aspects.

This paper reviews the pharmacoeconomic aspects of antenatal testing for HIV. HIV is a retrovirus which is transmitted among humans through sexual contact, infected blood or blood products (needle sharing or percutaneous accidents) and from mother to child (vertical transmission). Vertical transmission from the HIV-infected mother can occur in utero during and after delivery, through breastfeeding. Effective interventions available to reduce the risk of vertical transmission include: pharmacotherapy prior, during and after delivery; voluntary caesarean section; and replacing breastfeeding by bottle-feeding [1,2]. The existence of these effective interventions underlies the need to detect yet undiagnosed HIV-infection in pregnancy through antenatal testing. Contemporary pharmacotherapy consists of a combination of three or more antiretroviral drugs, also referred to as highly-active antiretroviral therapy (HAART). For newly detected HIV-infected mothers, the Centers for Disease Control suggests the use of a zidovudine-comprising combination with one other nucleoside analogue reverse transcriptase inhibitor and a protease inhibitor (PI) [3]. As HIV in pregnancy may be asymptomatic, structured antenatal HIV-testing therefore seems to offer an attractive prevention strategy. Two broad types of approaches exist: selective or targeted testing versus universal testing. The availability of effective - but expensive - combination therapies since 1996 has greatly enhanced the importance of pharmacoeconomic assessments in the field of HIV-infection. Treatment of the mother will incur additional costs but will also make any programme more effective. Furthermore, avoiding children becoming infected with HIV will also incur monetary benefits, as children are also being treated with HAART. In summary, the background of antenatal HIV-testing has undergone major changes compared with the early 1990s. This review of the pharmacoeconomics of antenatal HIV-testing followed a systematic approach as it was performed according to prespecified criteria, allowing valid comparisons in methodologies and findings of those studies that have yet been conducted in this area.

HIV epidemic control-a model for optimal allocation of prevention and treatment resources.

With 33 million people living with human immunodeficiency virus (HIV) worldwide and 2.7 million new infections occurring annually, additional HIV prevention and treatment efforts are urgently needed. However, available resources for HIV control are limited and must be used efficiently to minimize the future spread of the epidemic. We develop a model to determine the appropriate resource allocation between expanded HIV prevention and treatment services. We create an epidemic model that incorporates multiple key populations with different transmission modes, as well as production functions that relate investment in prevention and treatment programs to changes in transmission and treatment rates. The goal is to allocate resources to minimize R 0, the reproductive rate of infection. We first develop a single-population model and determine the optimal resource allocation between HIV prevention and treatment. We extend the analysis to multiple independent populations, with resource allocation among interventions and populations. We then include the effects of HIV transmission between key populations. We apply our model to examine HIV epidemic control in two different settings, Uganda and Russia. As part of these applications, we develop a novel approach for estimating empirical HIV program production functions. Our study provides insights into the important question of resource allocation for a country's optimal response to its HIV epidemic and provides a practical approach for decision makers. Better decisions about allocating limited HIV resources can improve response to the epidemic and increase access to HIV prevention and treatment services for millions of people worldwide.

Expanded HIV testing in low-prevalence, high-income countries: a cost-effectiveness analysis for the United Kingdom.

OBJECTIVE: In many high-income countries with low HIV prevalence, significant numbers of persons living with HIV (PLHIV) remain undiagnosed. Identification of PLHIV via HIV testing offers timely access to lifesaving antiretroviral therapy (ART) and decreases HIV transmission. We estimated the effectiveness and cost-effectiveness of HIV testing in the United Kingdom (UK), where 25% of PLHIV are estimated to be undiagnosed. DESIGN: We developed a dynamic compartmental model to analyze strategies to expand HIV testing and treatment in the UK, with particular focus on men who have sex with men (MSM), people who inject drugs (PWID), and individuals from HIV-endemic countries. METHODS: We estimated HIV prevalence, incidence, quality-adjusted life years (QALYs), and health care costs over 10 years, and cost-effectiveness. RESULTS: Annual HIV testing of all adults could avert 5% of new infections, even with no behavior change following HIV diagnosis because of earlier ART initiation, or up to 18% if risky behavior is halved. This strategy costs £67,000-£106,000/QALY gained. Providing annual testing only to MSM, PWID, and people from HIV-endemic countries, and one-time testing for all other adults, prevents 4-15% of infections, requires one-fourth as many tests to diagnose each PLHIV, and costs £17,500/QALY gained. Augmenting this program with increased ART access could add 145,000 QALYs to the population over 10 years, at £26,800/QALY gained. CONCLUSIONS: Annual HIV testing of key populations in the UK is very cost-effective. Additional one-time testing of all other adults could identify the majority of undiagnosed PLHIV. These findings are potentially relevant to other low-prevalence, high-income countries.