Preparing for PrEP; the cost of delaying universal access in England.

OBJECTIVES: Pre-exposure prophylaxis (PrEP) is not commissioned within National Health Service (NHS) England. Individuals can access it privately online or by enrolment into a clinical trial. We established a list of individuals not enrolled in trials, awaiting PrEP. In response to the observation that patients awaiting PrEP trials were being referred with newly diagnosed HIV, we aimed to measure attendance, incident HIV, STI acquisition and missed opportunities for prevention. METHODS: The search was conducted for patients on the list from November 2017 to November 2019. We examined the electronic clinical records of those on the list and extracted demographic information, STI and HIV diagnoses. In addition, for those diagnosed with HIV, we reviewed risk factors including chemsex and prior postexposure prophylaxis. RESULTS: There were 1073 patients on list, and 520 (48.6%) were still awaiting recruitment in a PrEP trial. Eight (0.75%) had an enrolment appointment booked while 200 (18.64%) had been contacted and deemed ineligible according to PrEP trial criteria. 45 (32.15%) had not responded to contact. We identified 15 new HIV infections in patients awaiting PrEP. Of these, 9/15 (60.00%) did not meet eligibility criteria at point of contact, though had been eligible at first referral. CONCLUSION: It is unacceptable that 15 patients acquired HIV while waiting. The individual lifetime cost of treating HIV is estimated at £360 800(1). This equals £5 412 000 for these 15 infections notwithstanding the psychological and physical burden. We advocate the immediate role out of universal PrEP for those who need it on the NHS. While this decision is delayed, harm is coming to those waiting. Wider provision of PrEP may encourage increased attendance, but must consider additional resources to accommodate added visits. We are relieved that at the point of final submission (21 March 2020) NHS England have recently announced funding of PrEP for eligible patients from, further details are pending.

Integrated care experiences and out-of-pocket expenditures: a cross-sectional survey of adults receiving treatment for HIV and hypertension in Malawi.

OBJECTIVES: As HIV-positive individuals' life expectancy extends, there is an urgent need to manage other chronic conditions during HIV care. We assessed the care-seeking experiences and costs of adults receiving treatment for both HIV and hypertension in Malawi. DESIGN, SETTING AND PARTICIPANTS: A cross-sectional survey was conducted with HIV-positive adults with hypertension at a health facility in Lilongwe that offers free HIV care and free hypertension screening, with antihypertensives available for purchase (n=199). Questions included locations and costs of all medication refills and preferences for these refill locations. Respondents were classified as using 'integrated care' if they refilled HIV and antihypertensive medications simultaneously. Data were collected between June and December 2017. RESULTS: Only half of respondents reported using the integrated care offered at the study site. Among individuals using different locations for antihypertensive medication refills, the most frequent locations were drug stores and public sector health facilities which were commonly selected due to greater convenience and lower medication costs. Although the number of antihypertensive medications was equivalent between the integrated and non-integrated care groups, the annual total cost of care differed substantially (approximately US$21 in integrated care vs US$90 for non-integrated care)-mainly attributable to differences in other visit costs for non-integrated care (transportation, lost wages, childcare). One-third of those in the non-integrated care group reported no expenditure for antihypertensive medication, and six people in each group reported no annual hypertension care-seeking costs at all. CONCLUSIONS: Individuals using integrated care saw efficiencies because, although they were more likely to pay for antihypertensive medications, they did not incur additional costs. These results suggest that preferences and experiences must be better understood to design effective policies and programmes for integrated care among adults on antiretroviral therapy.

Estimating HIV Management and Comorbidity Costs Among Aging HIV Patients in the United States: A Systematic Review.

BACKGROUND: As life expectancy of patients infected with human immunodeficiency virus (HIV) approaches that of the general population, the composition of HIV management costs is likely to change. OBJECTIVES: To (a) review treatment and disease management costs in HIV, including costs of adverse events (AEs) related to antiretroviral therapy (ART) and long-term toxicities, and (b) explore the evolving cost drivers. METHODS: A targeted literature review between January 2012 and November 2017 was conducted using PubMed and major conferences. Articles reporting U.S. costs of HIV management, acquired immunodeficiency syndrome (AIDS)-defining events, end of life care, and ART-associated comorbidities such as cardiovascular disease (CVD), chronic kidney disease (CKD), and osteoporosis were included. All costs were inflated to 2017 U.S. dollars. A Markov model-based analysis was conducted to estimate the effect of increased life expectancy on costs associated with HIV treatment and management. RESULTS: 22 studies describing HIV costs in the United States were identified, comprising 16 cost-effectiveness analysis studies, 5 retrospective analyses of health care utilization, and 1 cost analysis in a resource-limited setting. Management costs per patient per month, including routine care costs (on/off ART), non-HIV medication, opportunistic infection prophylaxis, inpatient utilization, outpatient utilization, and emergency department utilization were reported as CD4+ cell-based health state costs ranging from $1,192 for patients with CD4 > 500 cells/mm3 to $2,873 for patients with CD4 < 50 cells/mm3. Event costs for AEs ranged from $0 for headache, pain, vomiting, and lipodystrophy to $31,545 for myocardial infarction. The mean monthly per-patient costs for CVD management, CKD management, and osteoporosis were $5,898, $6,108, and $4,365, respectively. Improvements in life expectancy, approaching that of the general population in 2018, are projected to increase ART-related and AE costs by 35.4% and comorbidity costs by 175.8% compared with estimated costs with HIV life expectancy observed in 1996. CONCLUSIONS: This study identified and summarized holistic cost estimates appropriate for use within U.S. HIV cost-effectiveness analyses and demonstrates an increasing contribution of comorbidity outcomes, primarily associated with aging in addition to long-term treatment with ART, not typically evaluated in contemporary HIV cost-effectiveness analyses. DISCLOSURES: This analysis was sponsored by ViiV Healthcare, which had no role in the analyses and interpretation of study results. Ward, Sugrue, Hayward, and McEwan are employees of HEOR Ltd, which received funding from ViiV Healthcare to conduct this study. Anderson is an employee of GlaxoSmithKline and holds shares in the company. Punekar and Oglesby are employees of ViiV Healthcare and hold shares in GlaxoSmithKline. Lopes was employed by ViiV Healthcare at the time of the study and holds shares in GlaxoSmithKline.

A systematic review of adherence to oral pre-exposure prophylaxis for HIV - how can we improve uptake and adherence?

INTRODUCTION: Oral pre-exposure prophylaxis (PrEP) is an effective strategy to reduce the risk of HIV transmission in high risk individuals. However, the effectiveness of oral pre-exposure prophylaxis is highly dependent on user adherence, which some previous trials have struggled to optimise particularly in low and middle income settings. This systematic review aims to ascertain the reasons for non-adherence to pre-exposure prophylaxis to guide future implementation. METHODS: We performed structured literature searches of online databases and conference archives between August 8, 2016 and September 16, 2017. In total, 18 prospective randomized control trials and implementation studies investigating oral pre-exposure prophylaxis were reviewed. A structured form was used for data extraction and findings summarized regarding efficacy, effectiveness, adherence and possible reasons for non-adherence. RESULTS: Adherence varied between differing populations both geographically and socioeconomically. Common reasons for non-adherence reported over multiple studies were; social factors such as stigma, low risk perception, low decision making power, an unacceptable dosing regimen, side effects, and the logistics of daily life. Oral pre-exposure prophylaxis with included antiviral regimens was not associated with a high risk of antiviral resistance development in the reviewed studies. CONCLUSION: Our findings indicate that oral pre-exposure prophylaxis should be delivered within a holistic intervention, acknowledging the other needs of the targeted demographic in order to maximise acceptability. Socioeconomic factors and poor governmental policy remain major barriers to widespread implementation of pre-exposure prophylaxis.

Evaluating the integration of HIV self-testing into low-resource health systems: study protocol for a cluster-randomized control trial from EQUIP Innovations.

BACKGROUND: Throughout sub-Saharan Africa HIV-testing rates remain low. Barriers to testing, such as inconvenient service hours and long wait times, lack of privacy, and fear of unwanted disclosure, continue to impede service utilization. HIV self-testing (HIVST) is one strategy that addresses these barriers and has been shown to increase use of HIV-testing when distributed through community-based settings. However, the scalability of HIVST is limited because it has yet to be fully integrated into existing health systems and routine care. To address this gap, we designed a study to test the effect of offering HIVST to routine outpatient department (OPD) clients on uptake of HIV-testing as compared to standard of care and optimized standard of care. METHODS/DESIGN: This is a non-blinded, multi-site, cluster-randomized control trial. The health facility is the unit of randomization (cluster). Fifteen facilities were randomized to one of three arms: (1) Standard of care using routine provider-initiated testing and counseling (PITC); (2) Optimized standard of care using optimized PITC defined by additional training, job aids, and monitoring of PITC strategies with OPD providers and support staff; and (3) HIVST defined by HIVST demonstrations for OPD clients, HIVST kit distribution, and private spaces for HIVST kit use and/or interpretation. The primary outcome is the proportion of OPD clients tested for HIV on the day that they accessed OPD services. Secondary outcome measures are the proportion of OPD clients newly identified as HIV-positive and antiretroviral therapy (ART) initiation. Costs and cost-effectiveness will be evaluated. Nested studies will determine the acceptability of facility-based HIVST among OPD clients and health care providers, the presence of adverse events, such as coercion to test or unwanted status disclosure, and a process evaluation to determine feasibility and scale-up of facility-based HIVST for the future. DISCUSSION: This study protocol tests whether facility-based HIVST can positively contribute to HIV-testing among OPD clients in resource-limited settings. This will be one of the first studies to test the integration of HIVST into facility-based, primary health services in sub-Saharan Africa. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT03271307 . Registered on 31 August 2017. Pan African Clinical Trials: PACTR201711002697316 . Registered on 1 November 2017.

Understanding the persistence of vertical (stand-alone) HIV clinics in the health system in Uganda: a qualitative synthesis of patient and provider perspectives.

BACKGROUND: Although there is mounting evidence and policy guidance urging the integration of HIV services into general health systems in countries with a high HIV burden, vertical (stand-alone) HIV clinics are still common in Uganda. We sought to describe the specific contexts underpinning the endurance of vertical HIV clinics in Uganda. METHODS: A qualitative research design was adopted. Semi-structured interviews were conducted with the heads of HIV clinics, clinicians and facility in-charges (n = 78), coupled with eight focus group discussions (64 participants) with patients from 16 health facilities purposively selected, from a nationally-representative sample of 195 health facilities across Uganda, because they run stand-alone HIV clinics. Data were analyzed by thematic approach as guided by the theory proposed by Shediac-Rizkallah & Bone (1998) which identifies; Intervention characteristics, organizational context, and broader environment factors as potentially influential on health programme sustainability. RESULTS: Intervention characteristics: Provider stigma was reported to have been widespread in the integrated care experience of participating health facilities which necessitated the establishment of stand-alone HIV clinics. HIV disease management was described as highly specialized which necessitated a dedicated workforce and vertical HIV infrastructure such as counselling rooms. Organizational context: Participating health facilities reported health-system capacity constraints in implementing integrated systems of care due to a shortage of ART-proficient personnel and physical space, a lack of laboratory capacity to concurrently conduct HIV and non-HIV tests and increased workloads associated with implementing integrated care. Broader environment factors: Escalating HIV client loads and external HIV funding architectures were perceived to have perpetuated verticalized HIV programming over the past decade. CONCLUSION: Our study offers in-depth, contextualized insights into the factors contributing to the endurance of vertical HIV clinics in Uganda. Our analysis suggests that there is a complex interaction in supply-side constraints (shortage of ART-proficient personnel, increased workloads, laboratory capacity deficiencies) and demand-side factors (escalating demand for HIV services, psychosocial barriers to HIV care) as well as the specialized nature of HIV disease management which pose challenges to the integrated-health services agenda.

Healthcare and economic impact. / Atención sanitaria e impacto económico.

This chapter reviews the current model of HIV patient care and its economic impact. There are clinical and geographical differences in the care HIV patients receive and a need to develop new models of comprehen-sive HIV care has been identified. HIV infection in Spain is an important and expensive public health problem. The main costs are due to an-tiretroviral therapy, indirect costs and the cost of admission, consultation and diagnostic testing. A strong correlation between severity and cost has been identified. Patients diagnosed late have a poorer clinical course, increased mortality and require more medical and therapeutic resources. Early detection of the disease significantly improves the clinical outcomes of patients. The increased number of patients receiving treatment and their progressive ageing will increase costs of HIV healthcare in the coming years.

Household contact non-attendance of clinical evaluation for tuberculosis: a pilot study in a high burden district in South Africa.

BACKGROUND: In 2012, the World Health Organization launched guidelines for systematically investigating contacts of persons with infectious tuberculosis (TB) in low- and middle-income countries. As such, it is necessary to understand factors that would influence successful scale-up. This study targeted household contacts of newly-diagnosed infectious TB patients in the Mangaung Metropolitan district to explore factors associated with non-attendance of clinical evaluation. METHOD: In September-October 2016, a pilot study of household contacts was conducted. At each of the 40 primary health care (PHC) facilities in the district, at least one out of four types of TB index cases were purposefully selected. These included children <5 years, smear-positive cases, HIV co-infected cases, and multidrug-resistant TB (MDR-TB) cases. Trained fieldworkers administered questionnaires and screened contacts for TB symptoms. Those with TB symptoms as well as children <5 years were referred for clinical evaluation at the nearest PHC facility. Contacts' socio-demographic and clinical characteristics, TB knowledge and perception about TB-related discrimination are described. Logistic regression analysis was used to investigate factors associated with non-attendance of clinical evaluation. RESULTS: Out of the 259 participants, approximately three in every five (59.5%) were female. The median age was 20 (interquartile range: 8-41) years. While the large majority (87.3%) of adult contacts correctly described TB aetiology, almost three in every five (59.9%) thought that it was hereditary, and almost two-thirds (65.5%) believed that it could be cured by herbal medicine. About one-fifth (22.9%) of contacts believed that TB patients were subjected to discrimination. Two in every five (39.4%) contacts were referred for clinical evaluation of whom more than half (52.9%) did not attend the clinic. Non-attendance was significantly associated with inter alia male gender (AOR: 3.4; CI: 1.11-10.24), prior TB diagnosis (AOR: 5.6; CI: 1.13-27.90) and sharing of a bedroom with the index case (AOR: 3.4: CI: 1.07-10.59). CONCLUSION: The pilot study identified gaps in household contacts' knowledge of TB. Further research on important individual, clinical and structural factors that can influence and should be considered in the planning, implementation and scale-up of household contact TB investigation is warranted.

Noncommunicable diseases in adolescents with perinatally acquired HIV-1 infection in high-income and low-income settings.

PURPOSE OF REVIEW: Perinatally HIV-infected adolescents may be at increased risk of noninfectious comorbidities later in life. This review summarizes recent advances in the understanding of noncommunicable diseases (NCD) among HIV-infected adolescents in high-income and lower middle-income countries, and identifies key questions that remain unanswered. We review atherosclerotic vascular disease (AVD), chronic bone disease (CBD), chronic kidney disease (CKD), and chronic lung disease (CLD). RECENT FINDINGS: Persistent immune activation and inflammation underlie the pathogenesis of AVD, highlighting the importance of treatment adherence and maintenance of viral suppression, and the need to evaluate interventions to decrease risk. Tenofovir disoproxil fumarate (TDF) and trials of vitamin D supplementation have been the focus of recent studies of CBD with limited studies to date evaluating tenofovir alafenamide as an alternative to TDF for decreasing risk for bone and renal adverse effects among HIV-infected adolescents. Recent studies of CKD have focused primarily on estimating prevalence in different settings whereas studies of CLD are limited. SUMMARY: As perinatally HIV-infected children age into adolescence and adulthood with effective long-term ART, it is necessary to continue to evaluate their risks for noninfectious comorbidities and complications, understand mechanisms underlying their risks, and identify and evaluate interventions specifically in this population.

Economic evaluation of weekends-off antiretroviral therapy for young people in 11 countries.

OBJECTIVES: To analyze the cost effectiveness of short-cycle therapy (SCT), where patients take antiretroviral (ARV) drugs 5 consecutive days a week and have 2 days off, as an alternative to continuous ARV therapy for young people infected with human immunodeficiency virus (HIV) and taking efavirenz-based first-line ARV drugs. METHODS: We conduct a hierarchical cost-effectiveness analysis based on data on clinical outcomes and resource use from the BREATHER trial. BREATHER is a randomized trial investigating the effectiveness of SCT and continuous therapy in 199 participants aged 8 to 24 years and taking efavirenz-based first-line ARV drugs in 11 countries worldwide. Alongside nationally representative unit costs/prices, these data were used to estimate costs and quality adjusted life years (QALYs). An incremental cost-effectiveness comparison was performed using a multilevel bivariate regression approach for total costs and QALYs. Further analyses explored cost-effectiveness in low- and middle-income countries with access to low-cost generic ARV drugs and high-income countries purchasing branded ARV drugs, respectively. RESULTS: At 48 weeks, SCT offered significant total cost savings over continuous therapy of US dollar (USD) 41 per patient in countries using generic drugs and USD 4346 per patient in countries using branded ARV drugs, while accruing nonsignificant total health benefits of 0.008 and 0.009 QALYs, respectively. Cost-effectiveness estimates were similar across settings with access to generic ARV drugs but showed significant variation among high-income countries where branded ARV drugs are purchased. CONCLUSION: SCT is a cost-effective treatment alternative to continuous therapy for young people infected with HIV in countries where viral load monitoring is available.

An Illustration of the Potential Health and Economic Benefits of Combating Antibiotic-Resistant Gonorrhea.

Preventing the emergence of ceftriaxone-resistant Neisseria gonorrhoeae can potentially avert hundreds of millions of dollars in direct medical costs of gonorrhea and gonorrhea-attributable HIV infections. In the illustrative scenario we examined, emerging ceftriaxone resistance could lead to 1.2 million additional N. gonorrhoeae infections within 10 years, costing $378.2 million.

Funding antiretroviral treatment for HIV-positive temporary residents in Australia prevents transmission and is inexpensive.

Background The aim of this study is to estimate the reduction in new HIV infections and resultant cost outcomes of providing antiretroviral treatment (ART) through Australia's 'universal access' health scheme to all temporary residents with HIV infection living legally in Australia, but currently deemed ineligible to access subsidised ART via this scheme. METHODS: A mathematical model to estimate the number of new HIV infections averted and the associated lifetime costs over 5 years if all HIV-positive temporary residents in Australia had access to ART and subsidised medical care was developed. Input data came from a cohort of 180 HIV-positive temporary residents living in Australia who are receiving free ART donated by pharmaceutical companies for up to 4 years. RESULTS: Expanding ART access to an estimated total 450 HIV+ temporary residents in Australia for 5 years could avert 80 new infections. The model estimated the total median discounted (5%) cost for ART and associated care to be A$36million, while the total savings in lifetime-discounted costs for the new infections averted was A$22million. CONCLUSIONS: It is estimated that expanded access to ART for all HIV-positive temporary residents in Australia will substantially reduce HIV transmission to their sexual partners at little additional cost. In the context of Australia's National HIV strategy and Australia's endorsement of global goals to provide universal access to ART for all people with HIV, this is an important measure to remove inequities in the provision of HIV-related treatment and care.

Accommodating Indigenous Nurse-Initiated and Managed Antiretroviral Therapy (NIMART) Reporting in a Developing Country Context.

Financial reporting represents a critical tool in eliminating HIV across Papua New Guinea (PNG). Using the tenets of the theory of indigenous alternative reporting, this paper considers how the PNG Nursing Council may accommodate nurse-initiated and managed antiretroviral therapy (NIMART) reporting. Textual analysis of indigenous reporting expectations placed on the PNG Nursing Council are examined in a NIMART context to examine levels of reporting compliance exercised by council administrators from year-end reports (1980 to 2016) to accommodate NIMART reporting. The study revealed that the 2014 annual report of the PNG Nursing Council generated a 40% NIMART compliance rate, offering encouraging signs of financial reporting that could make room for NIMART reporting. The study suggested that local mechanisms could be used to meet local indigenous reporting expectations in order to adopt NIMART reporting. The study also has far-reaching implications for other developing country nursing councils wanting to develop NIMART reporting.

The Clinical and Economic Impact of Attaining National HIV/AIDS Strategy Treatment Targets in the United States.

Background: The US National HIV/AIDS Strategy (NHAS) aims for 72% (90% diagnosed times 80% of those virally suppressed) viral suppression among persons with human immunodeficiency virus (HIV) by 2020. We examined the clinical and economic impact of reaching this target, in the general US population and among black men who have sex with men (MSM), the group with the highest HIV prevalence. Methods: Using a mathematical simulation, we project the 5- and 20-year clinical outcomes, costs, and incremental cost-effectiveness ratios for (1) Current Pace of detection, linkage, retention, and virologic suppression and (2) NHAS investments in expanded testing ($24-$74 per test) and adherence ($400 per person-year), calibrated to achieve 72% suppression by 2020. We examined alternative rates of testing, retention, and suppression and the efficacy and cost of adherence interventions. Results: Compared with Current Pace over 20 years, NHAS averted 280000 HIV transmissions (80000 in black MSM) and 199000 (45000) deaths and saved 2138000 (453000) years of life, while increasing costs by 23%. The incremental cost-effectiveness ratio for NHAS compared with Current Pace was $68900 per quality-adjusted life-year ($38300 for black MSM) and was most sensitive to antiretroviral therapy costs. Conclusions: Reaching NHAS targets would yield substantial clinical benefits and be cost-effective in both the general US and black MSM populations.

The patient costs of care for those with TB and HIV: a cross-sectional study from South Africa.

BACKGROUND: This study describes the post-diagnosis care-seeking costs incurred by people living with TB and/or HIV and their households, in order to identify the potential benefits of integrated care. METHODS: We conducted a cross-sectional study with 454 participants with TB or HIV or both in public primary health care clinics in Ekurhuleni North Sub-District, South Africa. We collected information on visits to health facilities, direct and indirect costs for participants and for their guardians and caregivers. We define 'integration' as receipt of both TB and HIV services at the same facility, on the same day. Costs were presented and compared across participants with TB/HIV, TB-only and HIV-only. Costs exceeding 10% of participant income were considered catastrophic. RESULTS: Participants with both TB and HIV faced a greater economic burden (US$74/month) than those with TB-only (US$68/month) or HIV-only (US$40/month). On average, people with TB/HIV made 18.4 visits to health facilities, more than TB-only participants or HIV-only participants who made 16 and 5.1 visits, respectively. However, people with TB/HIV had fewer standalone TB (10.9) and HIV (2.2) visits than those with TB-only (14.5) or HIV-only (4.4). Although people with TB/HIV had access to 'integrated' services, their time loss was substantially higher than for other participants. Overall, 55% of participants encountered catastrophic costs. Access to official social protection schemes was minimal. CONCLUSIONS: People with TB/HIV in South Africa are at high risk of catastrophic costs. To some extent, integration of services reduces the number of standalone TB and HIV of visits to the health facility. It is however unlikely that catastrophic costs can be averted by service integration alone. Our results point to the need for timely social protection, particularly for HIV-positive people starting TB treatment.

Identifying social and economic barriers to regular care and treatment for Black men who have sex with men and women (BMSMW) and who are living with HIV: a qualitative study from the Bruthas cohort.

BACKGROUND: There is little research regarding the ability of Black men who have sex with men and women (BMSMW) to access and maintain HIV-related health care and treatment adherence. This population, who often insist on secrecy about their same-sex desire, may experience unique barriers to seeking regular care and treatment. METHODS: From March 2011-April 2014, we recruited 396 BMSMW in the San Francisco Bay Area to be enrolled in our randomized controlled trial. At baseline we administered a behavioral survey assessing: demographics, homelessness, employment, history of incarceration, HIV status and disclosure practices, care and treatment adherence. 64 men reported living with HIV at intake. To learn more about their experiences, we recruited N = 25 to participate in qualitative interviews, which were conducted April-December 2014. Topics included: current living situation, diagnosis story, disclosure practices, experiences of accessing and maintaining care and treatment, and HIV-related stigma. Recordings were transcribed and coded for major themes. RESULTS: Despite being located in an area where treatment is plentiful, men faced social and economic barriers to maintaining regular care and treatment adherence. Several findings emerged to shed light on this quandary: (1) Competing needs particularly around attaining stable housing, food security, and money created barriers to treatment and care; (2) Side effects of HIV medications discouraged men from adhering to treatment; (3) Provider and Institutional level characteristics influenced care engagement; (4) Disclosure and social support made a difference in care and treatment behaviors; and (5) Participants expressed a desire for group-based intervention activities to support treatment and care among HIV+ BMSMW. Inadequate engagement in the continuum of care for HIV was born out in the quantitative data where 28% of participants did not know their Viral Load. CONCLUSIONS: A holistic approach to HIV health for BMSMW would appear to translate to better outcomes for men living with HIV, where a goal of viral suppression must also include attending to their basic social and economic support needs.

The Cost-Effectiveness of Integrating HIV Counseling and Testing into Primary Health Care in the Ukraine.

We estimate the number of HIV cases diagnosed, costs, and cost per HIV case detected associated with integrating HIV counseling and testing (HCT) into primary health care facilities in Ukraine. The study uses a difference-in-difference design with four districts implementing the intervention compared to 20 districts where HCT were offered only at specialized HIV clinics. There was a 2.01 (95 % CI: 1.12-3.61) times increase in the number of HIV cases detected per capita in intervention districts compared to other districts. The incremental cost of the intervention was $21,017 and the incremental cost per HIV case detected was $369. The average cost per HIV case detected before the intervention was $558. Engaging primary health care facilities to provide HCT is likely desirable from an efficiency point-of-view. However, the affordability of the intervention needs to be assessed because expansion will require additional investment.

The Cost and Threshold Analysis of Retention in Care (RiC): A Multi-Site National HIV Care Program.

Persons diagnosed with HIV but not retained in HIV medical care accounted for the majority of HIV transmissions in 2009 in the United States (US). There is an urgent need to implement and disseminate HIV retention in care programs; however little is known about the costs associated with implementing retention in care programs. We assessed the costs and cost-saving thresholds for seven Retention in Care (RiC) programs implemented in the US using standard methods recommended by the US Panel on Cost-effectiveness in Health and Medicine. Data were gathered from accounting and program implementation records, entered into a standardized RiC economic analysis spreadsheet, and standardized to a 12 month time frame. Total program costs for from the societal perspective ranged from $47,919 to $423,913 per year or $146 to $2,752 per participant. Cost-saving thresholds ranged from 0.13 HIV transmissions averted to 1.18 HIV transmission averted per year. We estimated that these cost-saving thresholds could be achieved through 1 to 16 additional person-years of viral suppression. Across a range of program models, retention in care interventions had highly achievable cost-saving thresholds, suggesting that retention in care programs are a judicious use of resources.

Outcomes and Cost-Effectiveness of Integrating HIV and Nutrition Service Delivery: Pilots in Malawi and Mozambique.

This paper provides the first estimates of impact and cost-effectiveness for integrated HIV and nutrition service delivery in sub-Saharan Africa. HIV and undernutrition are synergistic co-epidemics impacting millions of children throughout the region. To alleviate this co-epidemic, UNICEF supported small-scale pilot programs in Malawi and Mozambique that integrated HIV and nutrition service delivery. We use trends from integration sites and comparison sites to estimate the number of lives saved, infections averted and/or undernutrition cases cured due to programmatic activities, and to estimate cost-effectiveness. Results suggest that Malawi's program had a cost-effectiveness of $11-29/DALY, while Mozambique's was $16-59/DALY. Some components were more effective than others ($1-4/DALY for Malawi's Male motivators vs. $179/DALY for Mozambique's One stop shops). These results suggest that integrating HIV and nutrition programming leads to a positive impact on health outcomes and should motivate additional work to evaluate impact and determine cost-effectiveness using an appropriate research design.

HIV Clinical Pathway: A New Approach to Combine Guidelines and Sustainability of Anti-Retroviral Treatment in Italy.

The present article describes the case study of a "real world" HIV practice within the debate concerning the strategic role of Clinical Governance (CG) tools in the management of a National Healthcare System's sustainability. The study aimed at assessing the impact of a Clinical Pathway (CP) implementation, required by the Regional Healthcare Service, in terms of effectiveness (virological and immunological conditions) and efficiency (economic resources absorption), from the budget holder perspective. Data derived from a multi-centre cohort of patients treated in 6 Hospitals that provided care to approximately 42% of the total HIV+ patients, in Lombardy Region, Italy. Two phases were compared: Pre-CP (2009-2010) vs. Post-CP implementation (2011-2012). All HIV infected adults, observed in the participating hospitals during the study periods, were enrolled and stratified into the 3 categories defined by the Regional CP: first-line, switch for toxicity/other, and switch for failure. The study population was composed of 1,284 patients (Pre-CP phase) and 1,135 patients (Post-CP phase). The results showed that the same level of virological and immunological effectiveness was guaranteed to HIV+ patients: 81.2% of Pre-CP phase population and 83.2% of Post-CP phase population had undetectable HIV-RNA (defined as <50 copies/mL) at 12-month follow up. CD4+ cell counts increased by 28 ± 4 cells/mm3 in Pre-CP Phase and 39 ± 5 cells/mm3 in Post-CP Phase. From an economic point of view, the CP implementation led to a substantial advantage: the mean total costs related to the management of the HIV disease (ART, hospital admission and laboratory tests) decreased (-8.60%) in the Post-CP phase (p-value < 0.0001). Results confirmed that the CP provided appropriateness and quality of care, with a cost reduction for the budget holder.