Estimating the costs and cost-effectiveness of HIV self-testing among men who have sex with men, United States.

INTRODUCTION: HIV testing is an essential prerequisite for accessing treatment with antiretroviral therapy or prevention using pre-exposure prophylaxis. Internet distribution of HIV self-tests is a novel approach, and data on the programmatic cost of this approach are limited. We analyse the costs and cost-effectiveness of a self-testing programme. METHODS: Men who have sex with men (MSM) reporting unknown or negative HIV status were enrolled from March to August 2015 into a 12-month trial of HIV self-testing in the United States. Participants were randomly assigned either to the self-testing arm or the control arm. All participants received information on HIV testing services and locations in their community. Self-testing participants received up to four self-tests each quarter, which they could use themselves or distribute to their social network associates. Quarterly follow-up surveys collected testing outcomes, including number of tests used and new HIV diagnoses. Using trial expenditure data, we estimated the cost of implementing a self-testing programme. Primary outcomes of this analysis included total programme implementation costs, cost per self-test completed, cost per person tested, cost per new HIV diagnosis among those self-tested and cost per quality adjusted life year (QALY) saved. RESULTS: A total of 2665 men were assigned either to the self-testing arm (n = 1325) or the control arm (n = 1340). HIV testing was reported by 971 self-testing participants who completed a total of 5368 tests. In the control arm, 619 participants completed 1463 HIV tests. The self-testing participants additionally distributed 2864 self-tests to 2152 social network associates. Testing during the trial identified 59 participants and social network associates with newly diagnosed HIV infection in the self-testing arm; 11 control participants were newly diagnosed with HIV. The implementation cost of the HIV self-testing programme was $449,510. The cost per self-test completed, cost per person tested at least once, and incremental cost per new HIV diagnosis was $61, $145 and $9365 respectively. We estimated that self-testing programme potentially averted 3.34 transmissions, saved 14.86 QALYs and nearly $1.6 million lifetime HIV treatment costs. CONCLUSIONS: The HIV self-testing programme identified persons with newly diagnosed HIV infection at low cost, and the programme is cost saving.

Assessing HIV acquisition risks among men who have sex with men in the United States of America / Evaluación del riesgo de transmisión del VIH entre hombres que tienen relaciones sexuales con otros hombres en los Estados Unidos de América

ABSTRACT Men who have sex with men (MSM) can reduce their risk of acquiring human immunodeficiency virus (HIV) by using various prevention strategies and by understanding the effectiveness of each option over the short- and long-term. Strategies examined were: circumcision; insertive anal sex only; consistent, 100% self-reported condom use; and pre-exposure prophylaxis (PrEP). PrEP efficacy was based on three levels of adherence. The cumulative HIV acquisition risk among MSM over periods of 1 year and 10 years were estimated with and without single and combinations of prevention strategies. A Bernoulli process model was used to estimate risk. In the base case with no prevention strategies, the 1-year risk of HIV acquisition among MSM was 8.8%. In contrast, the 1-year risk associated with circumcision alone was 6.9%; with insertive sex only, 5.5%; with 100% self-reported condom use, 2.7%; and with average, high, and very high PrEP adherence, 5.1%, 2.5%, and 0.7%, respectively. The 10-year risk of HIV acquisition among MSM with no prevention strategy was 60.3%. In contrast, that associated with circumcision alone was 51.1%; with insertive sex only, 43.1%; with 100% self-reported condom use, 24.0%; and with average, high, and very high PrEP adherence, 40.5%, 22.2%, and 7.2%, respectively. While MSM face substantial risk of HIV, there are now a number of prevention strategies that reduce risk. Very high adherence to PrEP alone or with other strategies appears to be the most powerful tool for HIV prevention.(AU)

RESUMEN Los hombres que tienen relaciones sexuales con otros hombres (HSH) pueden reducir su riesgo de contraer el virus de la inmunodeficiencia humana (VIH) si utilizan diversas estrategias de prevención y comprenden la eficacia de cada opción a corto y largo plazo. Las estrategias examinadas fueron: la circuncisión; las relaciones anales insertivas solamente; el 100% de uso sostenido y autonotificado de condones; y la profilaxis preexposición (PrEP). La eficacia de la PrEP se basó en tres niveles de adherencia. Se calculó el riesgo acumulativo de la transmisión del VIH entre los HSH en períodos de 1 y 10 años con a) una única estrategia de prevención, b) sin estrategia de prevención y c) con combinaciones de estrategias de prevención. Se usó un modelo del proceso de Bernoulli para calcular el riesgo. En el caso base sin estrategias de prevención, el riesgo de transmisión del VIH a 1 año entre HSH fue 8,8%. En contraste, el riesgo de 1 año asociado a la circuncisión solamente fue de 6,9%; a las relaciones insertivas solamente fue de 5,5%; al 100% de uso autonotificado de condón, 2,7%; y a la adherencia media, alta y muy alta a la PrEP, 5,1%, 2,5% y 0,7%, respectivamente. El riesgo de transmisión del VIH a los 10 años entre HSH sin estrategia de prevención fue de 60,3%. En contraste, la transmisión asociada a la circuncisión solamente fue de 51,1%; a las relaciones insertivas solamente, 43,1%; al 100% de uso autonotificado de condón, 24,0%; y a la adherencia media, alta y muy alta a la PrEP, 40,5%, 22,2% y 7,2%, respectivamente. Si bien los HSH enfrentan un riesgo sustancial de contraer el VIH, existen ahora varias estrategias de prevención que reducen dicho riesgo. Una adherencia muy alta a la PrEP sola o en combinación con otras estrategias parece ser la herramienta más potente para la prevención de la infección por el VIH.(AU)

Notification following new positive HIV test results.

Client notification of a new HIV diagnosis is critical for timely access to treatment and reduction in behaviours associated with HIV infection. It is also an important input in HIV transmission and disease progression models. We used national, Centers for Disease Control and Prevention-funded HIV testing events data collected through the National HIV Prevention Program Monitoring and Evaluation system to update estimates of the proportion of newly identified HIV-positives notified of their status. We compared estimates from 2008 to 2010 across test technologies, settings, and HIV risk groups. In 2010, notification following a positive rapid test was 99.6% compared with 99.3% in 2008. Notification following a positive conventional test was 81.5% in 2010 compared with 80.8% in 2008. To realise the full promise of early HIV diagnosis and treatment for the prevention of additional HIV cases, efforts to ensure prompt notification following a new HIV diagnosis will be crucial.

How much should we pay for a new HIV diagnosis? A mathematical model of HIV screening in US clinical settings.

OBJECTIVE: To develop a model to assist clinical setting decision makers in determining how much they can spend on human immunodeficiency virus (HIV) screening and still be cost-effective. DESIGN: The authors developed a simple mathematical model relating the program cost per new HIV diagnosis to the cost per HIV infection averted and the cost per quality-adjusted life year (QALY) saved by screening. They estimated outcomes based on behavioral changes associated with awareness of HIV infection and applied the model to US sexually transmitted disease clinics. METHODS: The authors based the cost per new HIV diagnosis (2009 US dollars) on the costs of testing and the proportion of persons who tested positive. Infections averted were calculated from the reduction in annual transmission rates between persons aware and unaware of their infections. The authors defined program costs from the sexually transmitted disease clinic perspective and treatment costs and QALYs saved from the societal perspective. They undertook numerous sensitivity analyses to determine the robustness of the base case results. RESULTS: In the base case, the cost per new HIV diagnosis was $2528, the cost per infection averted was $40,516, and the cost per QALY saved was less than zero, or cost-saving. Given the model inputs, the cost per new diagnosis could increase to $22,909 to reach the cost-saving threshold and to $63,053 for the cost-effectiveness threshold. All sensitivity analyses showed that the cost-effectiveness results were consistent for extensive variation in the values of model inputs. CONCLUSIONS: HIV screening in a clinical setting is cost-effective for a wide range of testing costs, variations in positivity rates, reductions in HIV transmissions, and variation in the receipt of test results.

Return on public health investment: CDC's Expanded HIV Testing Initiative.

BACKGROUND: Over a 3-year period, the Centers for Disease Control and Prevention invested $102.3 million in a large-scale HIV testing program, the Expanded HIV Testing Initiative for populations disproportionally affected by HIV. Policy makers, who must optimize public health given a set budget, are interested in the financial return on investment (ROI) of large-scale HIV testing. METHODS: We conducted an ROI analysis using expenditure and outcome data from the program. A health system perspective was used that included all program expenditures including medical costs of treating newly diagnosed patients. We incorporated benefits of HIV transmissions averted from persons diagnosed of their infection through the Initiative compared with when, on average, those persons would have been diagnosed without the Initiative (3 years later in the base case). HIV transmissions were derived from a published mathematical model of HIV transmission. In sensitivity analysis, we tested the effect of 1-year to 5-year alternate testing intervals and differences in the prevalence of undiagnosed HIV infection. RESULTS: Under the Initiative, 2.7 million persons were tested for HIV, there was a newly diagnosed HIV positivity rate of 0.7%, and an estimated 3381 HIV infections were averted. It achieved a return of $1.95 for every dollar invested. ROI ranged from $1.46 to $2.01 for alternative testing intervals of 1-5 years and remained above $1 (positive return on investment) with a prevalence of undiagnosed HIV infection as low as 0.12%. CONCLUSIONS: The expanded testing Initiative yielded ROI values of >$1 under a broad range of sensitivity analyses and provides further support for large-scale HIV testing programs.

Cost-effectiveness of HIV screening in STD clinics, emergency departments, and inpatient units: a model-based analysis.

BACKGROUND: Identifying and treating persons with human immunodeficiency virus (HIV) infection early in their disease stage is considered an effective means of reducing the impact of the disease. We compared the cost-effectiveness of HIV screening in three settings, sexually transmitted disease (STD) clinics serving men who have sex with men, hospital emergency departments (EDs), settings where patients are likely to be diagnosed early, and inpatient diagnosis based on clinical manifestations. METHODS AND FINDINGS: We developed the Progression and Transmission of HIV/AIDS model, a health state transition model that tracks index patients and their infected partners from HIV infection to death. We used program characteristics for each setting to compare the incremental cost per quality-adjusted life year gained from early versus late diagnosis and treatment. We ran the model for 10,000 index patients for each setting, examining alternative scenarios, excluding and including transmission to partners, and assuming HAART was initiated at a CD4 count of either 350 or 500 cells/µL. Screening in STD clinics and EDs was cost-effective compared with diagnosing inpatients, even when including only the benefits to the index patients. Screening patients in STD clinics, who have less-advanced disease, was cost-effective compared with ED screening when treatment with HAART was initiated at a CD4 count of 500 cells/µL. When the benefits of reduced transmission to partners from early diagnosis were included, screening in settings with less-advanced disease stages was cost-saving compared with screening later in the course of infection. The study was limited by a small number of observations on CD4 count at diagnosis and by including transmission only to first generation partners of the index patients. CONCLUSIONS: HIV prevention efforts can be advanced by screening in settings where patients present with less-advanced stages of HIV infection and by initiating treatment with HAART earlier in the course of infection.

Cost-effectiveness of pooled nucleic acid amplification testing for acute HIV infection after third-generation HIV antibody screening and rapid testing in the United States: a comparison of three public health settings.

BACKGROUND: Detection of acute HIV infection (AHI) with pooled nucleic acid amplification testing (NAAT) following HIV testing is feasible. However, cost-effectiveness analyses to guide policy around AHI screening are lacking; particularly after more sensitive third-generation antibody screening and rapid testing. METHODS AND FINDINGS: We conducted a cost-effectiveness analysis of pooled NAAT screening that assessed the prevention benefits of identification and notification of persons with AHI and cases averted compared with repeat antibody testing at different intervals. Effectiveness data were derived from a Centers for Disease Control and Prevention AHI study conducted in three settings: municipal sexually transmitted disease (STD) clinics, a community clinic serving a population of men who have sex with men, and HIV counseling and testing sites. Our analysis included a micro-costing study of NAAT and a mathematical model of HIV transmission. Cost-effectiveness ratios are reported as costs per quality-adjusted life year (QALY) gained in US dollars from the societal perspective. Sensitivity analyses were conducted on key variables, including AHI positivity rates, antibody testing frequency, symptomatic detection of AHI, and costs. Pooled NAAT for AHI screening following annual antibody testing had cost-effectiveness ratios exceeding US$200,000 per QALY gained for the municipal STD clinics and HIV counseling and testing sites and was cost saving for the community clinic. Cost-effectiveness ratios increased substantially if the antibody testing interval decreased to every 6 months and decreased to cost-saving if the testing interval increased to every 5 years. NAAT was cost saving in the community clinic in all situations. Results were particularly sensitive to AHI screening yield. CONCLUSIONS: Pooled NAAT screening for AHI following negative third-generation antibody or rapid tests is not cost-effective at recommended antibody testing intervals for high-risk persons except in very high-incidence settings.

Comparing the costs of HIV screening strategies and technologies in health-care settings.

OBJECTIVES: In 2006, the Centers for Disease Control and Prevention (CDC) recommended routine human immunodeficiency virus (HIV) screening for people aged 13 to 64 years in all U.S. health-care settings. Earlier recommendations focused on those at high risk for HIV and included more extensive pretest counseling. HIV screening may also involve either rapid or conventional testing. The purpose of this research was to estimate the costs of these different testing procedures and the cost per HIV-infected patient correctly receiving test results in three health-care scenarios that illustrated these policy differences. METHODS: The study estimated the costs of rapid and conventional HIV testing in the following scenarios: (1) sexually transmitted disease (STD) clinic counseling and testing (CT), (2) STD clinic screening, and (3) emergency department (ED) screening. Costs were estimated from the provider perspective in 2006 dollars. A decision analytic model was developed to estimate the cost per HIV-infected patient notified of test results using the two testing procedures in the three scenarios. RESULTS: Although the complete rapid testing procedure was more expensive than conventional testing, the cost per HIV-infected patient receiving test results was lower for the rapid test compared with conventional testing in all scenarios. Per-patient costs of receiving results were lowest in the ED screening scenario and highest in the STD CT scenario. These costs were sensitive to changes in test costs, HIV prevalence, and return rates following conventional tests. CONCLUSION: HIV screening in general health-care settings is economically feasible, particularly with rapid tests that lower the cost of HIV-infected patients receiving their test results.