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Chaykowski, S.

Handbook of Economic Evaluation of HIV Prevention Programs

Shortt, F. St-Hilaire, and A. Sweetman eds. American Journal of Public Health. Masotti P. Fick R, Johnson-Masotti A.

Alaska Medicine. Journal of Primary Prevention. Acta Orthopaedica. Medical Decision Making. Johnson-Masotti AP. Expert Review. Pharmacoeconomics Outcomes Research. Ethical Issues in Cost-Effectiveness Analysis. Evaluation and Program Planning. American Journal of Obstetrics and Gynecology. Ethnicity and Disease. Synthesizing outcomes of economic evaluations can be challenging because there are many approaches to the evaluations—each with its strengths and limitations and often driven by data availability, the perspectives under which strategies are evaluated, and the research question and outcomes of interest [ 11 , 12 ].

However, there are no guidelines for synthesizing the results of economic evaluations.

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There exist several recommendations for the conduct and reporting of individual economic evaluations [ 11 , 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 ]. Most recommendations focus on health technology assessments [ 11 , 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 ]—for example, comparison of PrEP regimens. Yet a comparison of PrEP implementation strategies may extend beyond assessing the usual data and modeling decisions needed for health technology assessments.

For example, an assessment of PrEP economic evaluations would involve examining whether processes such as the downstream benefits of HIV testing during eligibility screening for PrEP were included in the model [ 22 ]; how the fraction of undiagnosed HIV or antiretroviral treatment coverage in persons living with HIV influenced outcomes [ 23 ]; how potential ascertainment biases in identifying individuals deemed eligible for PrEP were addressed [ 24 , 25 ]; and whether the model was calibrated to, and thus reproduced, key epidemiological features of the HIV epidemic pertinent to the strategies evaluated.

An example of the latter includes the calibration of high- and lower-risk subgroups in comparisons of PrEP implementation strategies prioritized to subgroups at higher risk of HIV. The methods, inputs, and assumptions in existing PrEP economic evaluations and their influence on outcomes have yet to be assessed with a systematic review. One systematic review summarized findings from 13 economic evaluations of PrEP that used transmission dynamic models published before [ 26 ].

The review provided a detailed and narrative synthesis of each study stratified by epidemic context high-prevalence generalized epidemics vs. However, the review was restricted to transmission dynamic models and did not describe the methodological strengths and limitations nor how assumptions may have influenced the results [ 26 ].

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Another systematic review of pre studies identified only two economic evaluations and briefly summarized their main results [ 27 ]. In , an expert review described in narrative detail the methods and findings from the seven most recent published after cost-effectiveness studies of introducing PrEP [ 28 ]. The findings were stratified by geography, and authors outlined an in-depth discussion of how model parameters may influence outcomes—noting that conditions such as high baseline HIV incidence and PrEP adherence led to cost savings [ 28 ]. The expert review also identified key gaps, including a need to understand how real-world PrEP implementation factors influence cost-effectiveness and budgetary impact [ 28 ].

However, the two reviews did not examine every single scenario simulated in each primary study nor the various perspectives and funding systems for PrEP. Thus, the reviews could not quantitatively explore potential sources of variability in the projected outcomes [ 26 , 28 ].

We aim to estimate the cost-effectiveness of all PrEP and PrEP implementation strategies evaluated to date in the published literature and systematically appraise and quantify the methodological and other sources of heterogeneity in outcomes. We will conduct a systematic review of economic evaluation studies comparing PrEP to placebo, the status quo no placebo, no PrEP , or other HIV prevention interventions and studies comparing different types of PrEP implementation strategies. To estimate the incremental cost per health outcome of different types of PrEP implementation strategies.

To quantify the potential sources of heterogeneity data, assumptions, methodological in the cost-effectiveness of PrEP implementation strategies.

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Our primary outcomes are incremental cost-effectiveness ratios, such as incremental cost per HIV infection averted; incremental cost per death averted; incremental cost per life year saved, or quality-adjusted life years QALY , or disability-adjusted life year DALY ; and incremental net monetary benefit.

An experienced information specialist will produce and test the preliminary electronic search strategies using an iterative process in collaboration with the research team. We will evaluate the search strategy by ensuring it yields all of the primary studies identified from the three previously published systematic reviews [ 26 , 27 , 28 ]. We will include economic evaluations of PrEP provided to individuals at risk of HIV acquisition through sex or needle exchange.

PrEP regimens may involve any antiretroviral drug e. The regimens can be at any dose, formulation e. Studies may evaluate the use of PrEP alone, or in combination with other HIV prevention strategies, and any PrEP implementation strategy focused on specific subpopulations, scaled roll-out over time, adherence-support programs, etc.

HIV Cost-effectiveness

Eligible study designs comprise full economic evaluations comparing both costs and outcomes of PrEP including cost-minimization analyses, cost-benefit analyses, cost-effectiveness analyses, or cost-utility analyses, without restriction on the language of publication or year of study. We will exclude editorials, conference abstracts, and economic evaluations focused solely on parent-to-child transmission of HIV.

We will perform study selection in two stages. In stage 1, two reviewers will independently screen the titles and abstracts for eligibility. Upon completion of the dual screening, we will calculate the inter-rater agreement and resolve discrepancies through a third reviewer. Stage 2 will include a similar process for screening the full text of articles. Co-publications or multiple reports of the same study will be identified as such. We will record the type of economic evaluation e.

We will extract outcomes reported in the primary studies: incremental cost, incremental outcomes e. We will extract discounted and undiscounted values as reported.

Account Options

In cases where an incremental cost-effectiveness ratio is not explicitly provided in included studies, we will derive an incremental cost-effectiveness ratio from the reported findings. We will extract data on every scenario examined within a study, including sensitivity analyses. If results of sensitivity analyses are only available in figures, study authors will be contacted to request the numerical values. We will convert cost data to US dollars USD for comparison across study settings using annual exchange rates and consumer price index reported by the US Bureau of Labor Statistics [ 30 ].

The online database will be made open-access upon publication of the findings and will readily support future updates to the search and data extraction. The data input domain examines how input parameters are described and justified, and whether various types of uncertainties are adequately assessed and reported. The consistency domain examines whether the economic model and its results are compared with the results from other models. We will supplement the Phillips checklist with the good research practice recommendations from the International Society for Pharmacoeconomics and Outcomes Research ISPOR for decision analytic, cohort, discrete event, and transmission dynamics models [ 16 , 17 , 18 , 19 , 20 , 21 ].

The additional recommendations cover a fourth domain: model calibration and structural model assumptions such as heterogeneity in HIV acquisition risk and sexual mixing patterns, which can influence outcomes of prioritization strategies [ 31 ].

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Two team members KT and SM will independently appraise study methods across the four domains, using a categorical scale, and resolve conflicts through discussion and consensus. Results from the method assessment and the implications for generalizability akin to the risk of bias assessment will be presented in table format with shading for easy visualization. Study characteristics: study perspective and setting low-middle income vs. Data inputs and assumptions: baseline HIV epidemic pre-intervention HIV incidence and prevalence , baseline intervention context antiretroviral treatment coverage , and intervention costs e.

Methods: type of economic evaluation, modeling method, model structure e. Population subgroups need not be mutually exclusive and include gay, bisexual, and other men who have sex with men; sex workers; persons who inject drugs; serodiscordant partnerships; and transgender persons.

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To identify knowledge gaps, we will create a matrix with elements that count the number of studies and modeled scenarios that evaluated each PrEP regimen and each implementation strategy, stratified by study characteristics, data inputs and assumptions, methods, and by population subgroups who receive PrEP. The elements within the matrix will thus provide information about what has not been evaluated—and under which epidemic contexts—using which methods and in which subgroups.

We will include all possible combinations of PrEP regimens and implementation strategies in the matrix.