A health decision analytical model to evaluate the cost-effectiveness of female genital schistosomiasis screening strategies: The female genital schistosomiasis SCREEN framework.

Female genital schistosomiasis is a chronic gynaecological disease caused by the waterborne parasite Schistosoma (S.) haematobium. It affects an estimated 30-56 million girls and women globally, mostly in sub-Saharan Africa where it is endemic, and negatively impacts their sexual and reproductive life. Recent studies found evidence of an association between female genital schistosomiasis and increased prevalence of HIV and cervical precancer lesions. Despite the large population at risk, the burden and impact of female genital schistosomiasis are scarcely documented, resulting in neglect and insufficient resource allocation. There is currently no standardised method for individual or population-based female genital schistosomiasis screening and diagnosis which hinders accurate assessment of disease burden in endemic countries. To optimise financial allocations for female genital schistosomiasis screening, it is necessary to explore the cost-effectiveness of different strategies by combining cost and impact estimates. Yet, no economic evaluation has explored the value for money of alternative screening methods. This paper describes a novel application of health decision analytical modelling to evaluate the cost-effectiveness of different female genital schistosomiasis screening strategies across endemic settings. The model combines a decision tree for female genital schistosomiasis screening strategies, and a Markov model for the natural history of cervical cancer to estimate the cost per disability-adjusted life-years averted for different screening strategies, stratified by HIV status. It is a starting point for discussion and for supporting priority setting in a data-sparse environment.

Cost-effectiveness analysis of community-led HIV self-testing among key populations in Côte d'Ivoire, Mali, and Senegal.

INTRODUCTION: HIV self-testing (HIVST) is a promising strategy to improve diagnosis coverage among key populations (KP). The ATLAS (Auto Test VIH, Libre d'Accéder à la connaissance de son Statut) programme implemented HIVST in three West African countries, distributing over 380,000 kits up between 2019 and 2021, focussing on community-led distribution by KP to their peers and subsequent secondary distribution to their partners and clients. We aim to evaluate the cost-effectiveness of community-led HIVST in Côte d'Ivoire, Mali and Senegal. METHODS: An HIV transmission dynamics model was adapted and calibrated to country-specific epidemiological data and used to predict the impact of HIVST. We considered the distribution of HIVST among two KP-female sex workers (FSW), and men who have sex with men (MSM)-and their sexual partners and clients. We compared the cost-effectiveness of two scenarios against a counterfactual without HIVST over a 20-year horizon (2019-2039). The ATLAS-only scenario mimicked the 2-year implemented ATLAS programme, whereas the ATLAS-scale-up scenario achieved 95% coverage of HIVST distribution among FSW and MSM by 2025 onwards. The primary outcome is the number of disability-adjusted life-years (DALY) averted. Scenarios were compared using incremental cost-effectiveness ratios (ICERs). Costing was performed using a healthcare provider's perspective. Costs were discounted at 4%, converted to $USD 2022 and estimated using a cost-function to accommodate economies of scale. RESULTS: The ATLAS-only scenario was highly cost-effective over 20 years, even at low willingness-to-pay thresholds. The median ICERs were $126 ($88-$210) per DALY averted in Côte d'Ivoire, $92 ($88-$210) in Mali and 27$ ($88-$210) in Senegal. Scaling-up the ATLAS programme would also be cost-effective, and substantial epidemiological impacts would be achieved. The ICERs for the scale-up scenario were $199 ($122-$338) per DALY averted in Côte d'Ivoire, $224 ($118-$415) in Mali and $61 ($18-$128) in Senegal. CONCLUSIONS: Both the implemented and the potential scale-up of community-led HIVST programmes in West Africa, where KP are important to overall transmission dynamics, have the potential to be highly cost-effective, as compared to a scenario without HIVST. These findings support the scale-up of community-led HIVST to reach populations that otherwise may not access conventional testing services.

Zipime-Weka-Schista study protocol: a longitudinal cohort study and economic evaluation of an integrated home-based approach for genital multipathogen screening in women, including female genital schistosomiasis, human papillomavirus, Trichomonas and HIV in Zambia.

INTRODUCTION: Multiplathogen home-based self-sampling offers an opportunity to increase access to screening and treatment in endemic settings with high coinfection prevalence of sexually transmitted (HIV, Trichomonas vaginalis (Tv), human papillomavirus (HPV)) and non-sexually transmitted pathogens (Schistosoma haematobium (Sh)). Chronic coinfections may lead to disability (female genital schistosomiasis) and death (cervical cancer). The Zipime-Weka-Schista (Do self-testing sister!) study aims to evaluate the validity, acceptability, uptake, impact and cost-effectiveness of multipathogen self-sampling for genital infections among women in Zambia. METHODS AND ANALYSIS: This is a longitudinal cohort study aiming to enrol 2500 non-pregnant, sexually active and non-menstruating women aged 15-50 years from two districts in Zambia with 2-year follow-up. During home visits, community health workers offer HIV and Tv self-testing and cervicovaginal self-swabs for (1) HPV by GeneXpert and, (2) Sh DNA detection by conventional (PCR)and isothermal (recombinase polymerase assay) molecular methods. Schistosoma ova and circulating anodic antigen are detected in urine. At a clinic follow-up, midwives perform the same procedures and obtain hand-held colposcopic images. High-risk HPV positive women are referred for a two-quadrant cervical biopsy according to age and HIV status. A cost-effectiveness analysis is conducted in parallel. ETHICS AND DISSEMINATION: The University of Zambia Biomedical Research Ethics Committee (UNZABREC) (reference: 1858-2021), the London School of Hygiene and Tropical Medicine (reference: 25258), Ministry of Health and local superintendents approved the study in September 2021.Written informed consent was obtained from all participants prior to enrolment. Identifiable data collected are stored securely and their confidentiality is protected in accordance with the Data Protection Act 1998.

Ignored and undervalued in public health: a systematic review of health state utility values associated with syphilis infection.

BACKGROUND: Syphilis is a sexually transmitted infection causing significant global morbidity and mortality. To inform policymaking and economic evaluation studies for syphilis, we summarised utility and disability weights for health states associated with syphilis. METHODS: We conducted a systematic review, searching six databases for economic evaluations and primary valuation studies related to syphilis from January 2000 to February 2022. We extracted health state utility values or disability weights, including identification of how these were derived. The study was registered in the international prospective register of systematic reviews (PROSPERO, CRD42021230035). FINDINGS: Of 3401 studies screened, 22 economic evaluations, two primary studies providing condition-specific measures, and 13 burden of disease studies were included. Fifteen economic evaluations reported outcomes as disability-adjusted life years (DALYs) and seven reported quality-adjusted life years (QALYs). Fourteen of 15 economic evaluations that used DALYS based their values on the original Global Burden of Disease (GBD) study from 1990 (published in 1996). For the seven QALY-related economic evaluations, the methodology varied between studies, with some studies using assumptions and others creating utility weights or converting them from disability weights. INTERPRETATION: We found a limited evidence base for the valuation of health states for syphilis, a lack of transparency for the development of existing health state utility values, and inconsistencies in the application of these values to estimate DALYs and QALYs. Further research is required to expand the evidence base so that policymakers can access accurate and well-informed economic evaluations to allocate resources to address syphilis and implement syphilis programs that are cost-effective.

Provider and female client economic costs of integrated sexual and reproductive health and HIV services in Zimbabwe.

A retrospective facility-based costing study was undertaken to estimate the comparative cost per visit of five integrated sexual and reproductive health and HIV (human immuno-deficiency virus) services (provider perspective) within five clinic sites. These five clinics were part of four service delivery models: Non-governmental-organisation (NGO) directly managed model (Chitungwiza and New Africa House sites), NGO partner managed site (Mutare site), private-public-partnership (PPP) model (Chitungwiza Profam Clinic), and NGO directly managed outreach (operating from New Africa House site. In addition client cost exit interviews (client perspective) were conducted among 856 female clients exiting integrated services at three of the sites. Our costing approach involved first a facility bottom-up costing exercise (February to April 2015), conducted to quantify and value each resource input required to provide individual SRH and HIV services. Secondly overhead financial expenditures were allocated top-down from central office to sites and then respective integrated service based on pre-defined allocation factors derived from both the site facility observations and programme data for the prior 12 months. Costs were assessed in 2015 United States dollars (USD). Costs were assessed for HIV testing and counselling, screening and treatment of sexually transmitted infections, tuberculosis screening with smear microscopy, family planning, and cervical cancer screening and treatment employing visual inspection with acetic acid and cervicography and cryotherapy. Variability in costs per visit was evident across the models being highest for cervical cancer screening and cryotherapy (range: US$6.98-US$49.66). HIV testing and counselling showed least variability (range; US$10.96-US$16.28). In general the PPP model offered integrated services at the lowest unit costs whereas the partner managed site was highest. Significant client costs remain despite availability of integrated sexual and reproductive health and HIV services free of charge in our Zimbabwe study setting. Situating services closer to communities, incentives, transport reimbursements, reducing waiting times and co-location of sexual and reproductive health and HIV services may help minimise impact of client costs.

Costs of distributing HIV self-testing kits in Eswatini through community and workplace models.

BACKGROUND: This study evaluates the implementation and running costs of an HIV self-testing (HIVST) distribution program in Eswatini. HIVST kits were delivered through community-based and workplace models using primary and secondary distribution. Primary clients could self-test onsite or offsite. This study presents total running economic costs of kit distribution per model between April 2019 and March 2020, and estimates average cost per HIVST kit distributed, per client self-tested, per client self-tested reactive, per client confirmed positive, and per client initiating antiretroviral therapy (ART). METHODS: Distribution data and follow-up phone interviews were analysed to estimate implementation outcomes. Results were presented for each step of the care cascade using best-case and worst-case scenarios. A top-down incremental cost-analysis was conducted from the provider perspective using project expenditures. Sensitivity and scenario analyses explored effects of economic and epidemiological parameters on average costs. RESULTS: Nineteen thousand one hundred fifty-five HIVST kits were distributed to 13,031 individuals over a 12-month period, averaging 1.5 kits per recipient. 83% and 17% of kits were distributed via the community and workplace models, respectively. Clients reached via the workplace model were less likely to opt for onsite testing than clients in the community model (8% vs 29%). 6% of onsite workplace testers tested reactive compared to 2% of onsite community testers. Best-case scenario estimated 17,458 (91%) clients self-tested, 633 (4%) received reactive-test results, 606 (96%) linked to confirmatory testing, and 505 (83%) initiated ART. Personnel and HIVST kits represented 60% and 32% of total costs, respectively. Average costs were: per kit distributed US$17.23, per client tested US$18.91, per client with a reactive test US$521.54, per client confirmed positive US$550.83, and per client initiating ART US$708.60. Lower rates for testing, reactivity, and linkage to care in the worst-case scenario resulted in higher average costs along the treatment cascade. CONCLUSION: This study fills a significant evidence gap regarding costs of HIVST provision along the client care cascade in Eswatini. Workplace and community-based distribution of HIVST accompanied with effective linkage to care strategies can support countries to reach cascade objectives.

Unit costs of needle and syringe program provision: a global systematic review and cost extrapolation.

BACKGROUND: Needle and syringe programs (NSPs) are effective at preventing HIV and hepatitis C virus (HCV) among people who inject drugs (PWID), yet global coverage is low, partly because governments lack data on the cost and cost-effectiveness of NSP in their countries to plan and fund their responses. We conducted a global systematic review of unit costs of NSP provision to inform estimation of cost drivers and extrapolated costs to other countries. METHODS: We conducted a systematic review to extract data on the cost per syringe distributed and its cost drivers. We estimated the impact of country-level and program-level variables on the cost per syringe distributed using linear mixed-effects models. These models were used to predict unit costs of NSP provision, with the best performing model used to extrapolate the cost per syringe distributed for 137 countries. The total cost for a comprehensive NSP (200 syringes per PWID/year) was also estimated for 68 countries with PWID population size estimates. RESULTS: We identified 55 estimates of the unit cost per syringe distributed from 14 countries. Unit costs were extrapolated for 137 countries, ranging from $0.08 to $20.77 (2020 USD) per syringe distributed. The total estimated spend for a high-coverage, comprehensive NSP across 68 countries with PWID size estimates is $5 035 902 000 for 10 887 500 PWID, 2.1-times higher than current spend. CONCLUSION: Our review identified cost estimates from high-income, upper-middle-income, and lower-middle-income countries. Regression models may be useful for estimating NSP costs in countries without data to inform HIV/HCV prevention programming and policy.

Feasibility and economic costs of syphilis self-testing to expand test uptake among gay, bisexual and transgender men: results from a randomised controlled trial in Zimbabwe.

BACKGROUND: Access to syphilis testing and treatment is frequently limited for men who have sex with men (MSM). A two-armed randomised controlled trial compared feasibility and costs of facility-based syphilis testing with self-testing among MSM in Zimbabwe. METHODS: This randomised controlled trial was conducted in Harare, with participants randomised 1:1. Syphilis self-testing was offered in community-based settings. The primary outcome was the relative proportion of individuals taking up testing. Total incremental economic provider and user costs, and cost per client tested, diagnosed and treated were assessed using ingredients-based costing in 2020US$. RESULTS: A total of 100 men were enrolled. The two groups were similar in demographics. The mean age was 26years. Overall, 58% (29/50) and 74% (37/50) of facility- and self-testing arm participants, respectively, completed syphilis testing. A total of 28% of facility arm participants had a reactive test, with 50% of them returning for confirmatory testing yielding 28% reactivity. In the self-testing arm, 67% returned for confirmatory testing, with a reactivity of 16%. Total provider costs were US$859 and US$736, and cost per test US$30 and US$15 for respective arms. Cost per reactive test was US$107 and US$123, and per client treated US$215 and US$184, respectively. The syphilis test kit was the largest cost component. Total user cost per client per visit was US$9. CONCLUSION: Syphilis self-testing may increase test uptake among MSM in Zimbabwe. However, some barriers limit uptake including lack of self-testing and poor service access. Bringing syphilis testing services to communities, simplifying service delivery and increasing self-testing access through community-based organisations are useful strategies to promote health-seeking behaviours among MSM.

Pay-it-forward influenza vaccination among older adults and children: A cost-effectiveness analysis in China.

A quasi-experimental study was conducted to evaluate the effectiveness of a pay-it-forward strategy for increasing influenza vaccination among children and older adults compared to a self-paid vaccination strategy in China. Pay-it-forward is an innovative community-engaged intervention in which participants receive a free influenza vaccination and are then asked if they would like to donate or create a message to support subsequent vaccinations. This economic evaluation used a decision-tree model to compare pay-it-forward to a standard of care arm in which patients had to pay for their own influenza vaccine. The analysis was performed from the healthcare provider perspective and costs were calculated with 2020 United States dollars. The time horizon was one year. In the base case analysis, pay-it-forward was more effective (111 vs 55 people vaccinated) but more costly than standard-of-care ($4477 vs $2725). Pay-it-forward spurred 96.4% (107/111) of individuals to voluntarily donate to support influenza vaccination for high-risk groups in China. Further costing and implementation research is needed to inform scale up.

The role of syphilis self-testing as an additional syphilis testing approach in key populations: a systematic review and meta-analysis.

BACKGROUND: Syphilis is causing epidemics in many countries. Syphilis self-testing (SST) has potential to increase testing and treatment coverage in the same manner as documented for self-testing of, for example, HIV, hepatitis C virus, and COVID-19. We aimed to synthesise current evidence on the utility of SST. METHODS: We conducted a systematic review and, where possible, meta-analysis. We searched MEDLINE, Embase, CINAHL, Scopus, and Web of Science for publications published from Jan 1, 2000, to Oct 13, 2022. We included publications with original data on any syphilis rapid tests, including dual HIV-syphilis tests. Study populations were not restricted. We used random-effects meta-analysis to calculate the pooled proportion of people offered SST who undertook the test. The systematic review was registered in PROSPERO (CRD42022302129). FINDINGS: In total, 40 499 citations were identified. 11 publications from seven studies from the USA, Zimbabwe, and China met eligibility criteria. Of those, four studies reported data from men who have sex with men and five studies used dual HIV-SST. Using data from one randomised controlled trial and three observational studies, the pooled proportion of people who received SST kits who undertook the test was 88% (95% CI 85-91). No studies provided data on the sensitivity or specificity of SST. Overall, user and provider preference for SST was high, with participants reporting convenience, privacy, rapid results, autonomy, trust in blood-based tests, decreased facility contact, and time savings, with individuals being able to correctly self-test. Publications from China reported that SST had lower costs per person tested than existing facility-based testing options. INTERPRETATION: Our review builds on the literature for self-testing across different disease areas and demonstrates that SST has the potential to reach underserved populations. As this review found that SST use was acceptable and feasible to implement, SST can be used as an additional syphilis testing approach. Since no data on the sensitivity and specificity of SST were found, further implementation research will be required to guide the best strategies for SST service delivery and future scale-up. FUNDING: WHO, Australian National Health and Medical Research Council, and Unitaid.

Implementation and resource needs for long-acting PrEP in low- and middle-income countries: a scoping review.

INTRODUCTION: Several low- and middle-income countries (LMICs) are preparing to introduce long-acting pre-exposure prophylaxis (LAP). Amid multiple pre-exposure prophylaxis (PrEP) options and constrained funding, decision-makers could benefit from systematic implementation planning and aligned costs. We reviewed national costed implementation plans (CIPs) to describe relevant implementation inputs and activities (domains) for informing the costed rollout of LAP. We assessed how primary costing evidence aligned with those domains. METHODS: We conducted a rapid review of CIPs for oral PrEP and family planning (FP) to develop a consensus of implementation domains, and a scoping review across nine electronic databases for publications on PrEP costing in LMICs between January 2010 and June 2022. We extracted cost data and assessed alignment with the implementation domains and the Global Health Costing Consortium principles. RESULTS: We identified 15 implementation domains from four national PrEP plans and FP-CIP template; only six were in all sources. We included 66 full-text manuscripts, 10 reported LAP, 13 (20%) were primary cost studies-representing seven countries, and none of the 13 included LAP. The 13 primary cost studies included PrEP commodities (n = 12), human resources (n = 11), indirect costs (n = 11), other commodities (n = 10), demand creation (n = 9) and counselling (n = 9). Few studies costed integration into non-HIV services (n = 5), above site costs (n = 3), supply chains and logistics (n = 3) or policy and planning (n = 2), and none included the costs of target setting, health information system adaptations or implementation research. Cost units and outcomes were variable (e.g. average per person-year). DISCUSSION: LAP planning will require updating HIV prevention policies, technical assistance for logistical and clinical support, expanding beyond HIV platforms, setting PrEP achievement targets overall and disaggregated by method, extensive supply chain and logistics planning and support, as well as updating health information systems to monitor multiple PrEP methods with different visit schedules. The 15 implementation domains were variable in reviewed studies. PrEP primary cost and budget data are necessary for new product introduction and should match implementation plans with financing. CONCLUSIONS: As PrEP services expand to include LAP, decision-makers need a framework, tools and a process to support countries in planning the systematic rollout and costing for LAP.

Estimating health care costs at scale in low- and middle-income countries: Mathematical notations and frameworks for the application of cost functions.

Appropriate costing and economic modeling are major factors for the successful scale-up of health interventions. Various cost functions are currently being used to estimate costs of health interventions at scale in low- and middle-income countries (LMICs) potentially resulting in disparate cost projections. The aim of this study is to gain understanding of current methods used and provide guidance to inform the use of cost functions that is fit for purpose. We reviewed seven databases covering the economic and global health literature to identify studies reporting a quantitative analysis of costs informing the projected scale-up of a health intervention in LMICs between 2003 and 2019. Of the 8725 articles identified, 40 met the inclusion criteria. We classified studies according to the type of cost functions applied-accounting or econometric-and described the intended use of cost projections. Based on these findings, we developed new mathematical notations and cost function frameworks for the analysis of healthcare costs at scale in LMICs setting. These notations estimate variable returns to scale in cost projection methods, which is currently ignored in most studies. The frameworks help to balance simplicity versus accuracy and increase the overall transparency in reporting of methods.

Secondary distribution of HIV self-test kits by HIV index and antenatal care clients: implementation and costing results from the STAR Initiative in South Africa.

BACKGROUND: Partner-delivered HIV self-testing kits has previously been highlighted as a safe, acceptable and effective approach to reach men. However, less is known about its real-world implementation in reaching partners of people living with HIV. We evaluated programmatic implementation of partner-delivered self-testing through antenatal care (ANC) attendees and people newly diagnosed with HIV by assessing use, positivity, linkage and cost per kit distributed. METHODS: Between April 2018 and December 2019, antenatal care (ANC) clinic attendees and people or those newly diagnosed with HIV clients across twelve clinics in three cities in South Africa were given HIVST kits (OraQuick Rapid HIV-1/2 Antibody Test, OraSure Technologies) to distribute to their sexual partners. A follow-up telephonic survey was administered to all prior consenting clients who were successfully reached by telephone to assess primary outcomes. Incremental economic costs of the implementation were estimated from the provider's perspective. RESULTS: Fourteen thousand four hundred seventy-three HIVST kits were distributed - 10,319 (71%) to ANC clients for their male partner and 29% to people newly diagnosed with HIV for their partners. Of the 4,235 ANC clients successfully followed-up, 82.1% (3,475) reportedly offered HIVST kits to their male partner with 98.1% (3,409) accepting and 97.6% (3,328) using the kit. Among ANC partners self-testing, 159 (4.8%) reported reactive HIVST results, of which 127 (79.9%) received further testing; 116 (91.3%) were diagnosed with HIV and 114 (98.3%) initiated antiretroviral therapy (ART). Of the 1,649 people newly diagnosed with HIV successfully followed-up; 1,312 (79.6%) reportedly offered HIVST kits to their partners with 95.8% (1,257) of the partners accepting and 95.9% (1,206) reported that their partners used the kit. Among these index partners, 297 (24.6%) reported reactive HIVST results of which 261 (87.9%) received further testing; 260 (99.6%) were diagnosed with HIV and 258 (99.2%) initiated ART. The average cost per HIVST distributed in the three cities was US$7.90, US$11.98, and US$14.81, respectively. CONCLUSIONS: Partner-delivered HIVST in real world implementation was able to affordably reach many male partners of ANC attendees and index partners of people newly diagnosed with HIV in South Africa. Given recent COVID-19 related restrictions, partner-delivered HIVST provides an important strategy to maintain essential testing services.

Preferences for accessing sexual health services among middle-aged and older adults in the UK: a study protocol for a discrete choice experiment using mixed methods.

INTRODUCTION: Sexual health is essential for general health and well-being. Sexual health services for middle-aged and older adults are not prioritised and optimising available services for this population is often overlooked. Not much is known about preferences for accessing sexual health services among middle-aged and older people or level of satisfaction with current services. The aim of this study is to explore preferences for seeking sexual health services among middle-aged and older adults in the UK. This study will use discrete choice experiments (DCEs) including initial qualitative interviews followed by the survey, which have been used as a tool to explore preferences in various health service delivery. METHODS AND ANALYSIS: The project will be carried out in two phases. First, we will conduct in-depth semi-structured interviews with 20-30 adults (aged 45+), including disabled people, and those from sexual minority groups resident in the UK. Interviews will explore indications, preferences and factors related to accessing sexual health services. Themes and subthemes emerging from the analysis of the interviews will then be used to design the choice sets and attribute level for the DCEs. For the second phase, for the DCEs, we will design choice sets composed of sexual health service delivery scenarios. The software Ngene will be used to develop the experimental design matrix for the DCE. We will use descriptive statistics to summarise the key sociodemographic characteristics of the study population. Multinomial logit, latent class and mixed logit models will be explored to assess sexual health service preferences and preference heterogeneity. ETHICS AND DISSEMINATION: Ethical approval for both parts of this study was granted by the Research and Ethics Committee at the London School of Hygiene & Tropical Medicine. Findings from this study will be disseminated widely to relevant stakeholders via scheduled meetings, webinars, presentations and journal publications.

Cost-effectiveness of Hepatitis C virus self-testing in four settings.

Globally, there are approximately 58 million people with chronic hepatitis C virus infection (HCV) but only 20% have been diagnosed. HCV self-testing (HCVST) could reach those who have never been tested and increase uptake of HCV testing services. We compared cost per HCV viraemic diagnosis or cure for HCVST versus facility-based HCV testing services. We used a decision analysis model with a one-year time horizon to examine the key drivers of economic cost per diagnosis or cure following the introduction of HCVST in China (men who have sex with men), Georgia (men 40-49 years), Viet Nam (people who inject drugs, PWID), and Kenya (PWID). HCV antibody (HCVAb) prevalence ranged from 1%-60% across settings. Model parameters in each setting were informed by HCV testing and treatment programmes, HIV self-testing programmes, and expert opinion. In the base case, we assume a reactive HCVST is followed by a facility-based rapid diagnostic test (RDT) and then nucleic acid testing (NAT). We assumed oral-fluid HCVST costs of $5.63/unit ($0.87-$21.43 for facility-based RDT), 62% increase in testing following HCVST introduction, 65% linkage following HCVST, and 10% replacement of facility-based testing with HCVST based on HIV studies. Parameters were varied in sensitivity analysis. Cost per HCV viraemic diagnosis without HCVST ranged from $35 2019 US dollars (Viet Nam) to $361 (Kenya). With HCVST, diagnosis increased resulting in incremental cost per diagnosis of $104 in Viet Nam, $163 in Georgia, $587 in Kenya, and $2,647 in China. Differences were driven by HCVAb prevalence. Switching to blood-based HCVST ($2.25/test), increasing uptake of HCVST and linkage to facility-based care and NAT testing, or proceeding directly to NAT testing following HCVST, reduced the cost per diagnosis. The baseline incremental cost per cure was lowest in Georgia ($1,418), similar in Viet Nam ($2,033), and Kenya ($2,566), and highest in China ($4,956). HCVST increased the number of people tested, diagnosed, and cured, but at higher cost. Introducing HCVST is more cost-effective in populations with high prevalence.

Assessing preferences for HIV pre-exposure prophylaxis (PrEP) delivery services via online pharmacies in Kenya: protocol for a discrete choice experiment.

INTRODUCTION: Pre-exposure prophylaxis (PrEP) is highly effective at preventing HIV acquisition, but coverage remains low in high prevalence settings. Initiating and continuing PrEP via online pharmacies is a promising strategy to expand PrEP uptake but little is known about user preferences for this strategy. We describe methods for a discrete choice experiment (DCE) to assess preferences for PrEP delivery from an online pharmacy. METHODS AND ANALYSIS: This cross-sectional study is conducted in Nairobi, Kenya, in partnership with MYDAWA, a private online pharmacy retailer with a planned sample size of >400 participants. Eligibility criteria are: ≥18 years, not known HIV-positive and interested in PrEP. Initial DCE attributes and levels were developed via literature review and stakeholder meetings. We conducted cognitive interviews to assess participant understanding of the DCE survey and refined the design. The final DCE used a D-efficient design and contained four attributes: PrEP eligibility assessment, HIV test type, clinical consultation type and user support options. Participants are presented with eight scenarios consisting of two hypothetical PrEP delivery services. The survey was piloted among 20 participants before being advertised on the MYDAWA website on pages displaying products indicating HIV risk (eg, HIV self-test kits). Interested participants call a study number and those screened eligible meet a research assistant in a convenient location to complete the survey. The DCE will be analysed using a conditional logit model to assess average preferences and mixed logit and latent class models to evaluate preference heterogeneity among subgroups. ETHICS AND DISSEMINATION: This study was approved by the University of Washington Human Research Ethics Committee (STUDY00014011), the Kenya Medical Research Institute, Nairobi County (EOP/NMS/HS/128) and the Scientific and Ethics Review Unit in Kenya (KEMRI/RES/7/3/1). Participation in the DCE is voluntary and subject to completion of an electronic informed consent. Findings will be shared at international conferences and peer-reviewed publications, and via engagement meetings with stakeholders.

Health Economics Research on Non-surgical Biomedical HIV Prevention: Identifying Gaps and Proposing a Way Forward.

BACKGROUND AND OBJECTIVE: Although HIV prevention science has advanced over the last four decades, evidence suggests that prevention technologies do not always reach their full potential. Critical health economics evidence at appropriate decision-making junctures, particularly early in the development process, could help identify and address potential barriers to the eventual uptake of future HIV prevention products. This paper aims to identify key evidence gaps and propose health economics research priorities for the field of HIV non-surgical biomedical prevention. METHODS: We used a mixed-methods approach with three distinct components: (i) three systematic literature reviews (costs and cost effectiveness, HIV transmission modelling and quantitative preference elicitation) to understand health economics evidence and gaps in the peer-reviewed literature; (ii) an online survey with researchers working in this field to capture gaps in yet-to-be published research (recently completed, ongoing and future); and (iii) a stakeholder meeting with key global and national players in HIV prevention, including experts in product development, health economics research and policy uptake, to uncover further gaps, as well as to elicit views on priorities and recommendations based on (i) and (ii). RESULTS: Gaps in the scope of available health economics evidence were identified. Little research has been carried out on certain key populations (e.g. transgender people and people who inject drugs) and other vulnerable groups (e.g. pregnant people and people who breastfeed). Research is also lacking on preferences of community actors who often influence or enable access to health services among priority populations. Oral pre-exposure prophylaxis, which has been rolled out in many settings, has been studied in depth. However, research on newer promising technologies, such as long-acting pre-exposure prophylaxis formulations, broadly neutralising antibodies and multipurpose prevention technologies, is lacking. Interventions focussing on reducing intravenous and vertical transmission are also understudied. A disproportionate amount of evidence on low- and middle-income countries comes from two countries (South Africa and Kenya); evidence from other countries in sub-Saharan Africa as well as other low- and middle-income countries is needed. Further, data are needed on non-facility-based service delivery modalities, integrated service delivery and ancillary services. Key methodological gaps were also identified. An emphasis on equity and representation of heterogeneous populations was lacking. Research rarely acknowledged the complex and dynamic use of prevention technologies over time. Greater efforts are needed to collect primary data, quantify uncertainty, systematically compare the full range of prevention options available, and validate pilot and modelling data once interventions are scaled up. Clarity on appropriate cost-effectiveness outcome measures and thresholds is also lacking. Lastly, research often fails to reflect policy-relevant questions and approaches. CONCLUSIONS: Despite a large body of health economics evidence on non-surgical biomedical HIV prevention technologies, important gaps in the scope of evidence and methodology remain. To ensure that high-quality research influences key decision-making junctures and facilitates the delivery of prevention products in a way that maximises impact, we make five broad recommendations related to: improved study design, an increased focus on service delivery, greater community and stakeholder engagement, the fostering of an active network of partners across sectors and an enhanced application of research.

Preferences for HIV prevention strategies among newly arrived Asian-born men who have sex with men living in Australia: A discrete choice experiment.

The HIV epidemic in Australia is changing with higher risk for HIV among newly-arrived Asian-born men who have sex with men (MSM) compared to Australian-born MSM. We evaluated the preferences for HIV prevention strategies among 286 Asian-born MSM living in Australia for <5 years. A latent class analysis uncovered three classes of respondents who were defined by their preferences: "PrEP" (52%), "Consistent condoms" (31%), and "No strategy" (17%). Compared to the "No strategy" class, men in the "PrEP" class were less likely to be a student or ask their partner for their HIV status. Men in the "Consistent condoms" class were more likely to get information about HIV from online, and less likely to ask their partner for their HIV status. Overall, PrEP was the preferred HIV prevention strategy for newly arrived migrants. Removing structural barriers to access PrEP can accelerate progress toward ending HIV transmission.

Infectious Disease Modelling of HIV Prevention Interventions: A Systematic Review and Narrative Synthesis of Compartmental Models.

BACKGROUND: The HIV epidemic remains a major public health problem. Critical to transmission control are HIV prevention strategies with new interventions continuing to be developed. Mathematical models are important for understanding the potential impact of these interventions and supporting policy decisions. This systematic review aims to answer the following question: when a new HIV prevention intervention is being considered or designed, what information regarding it is necessary to include in a compartmental model to provide useful insights to policy makers? The primary objective of this review is therefore to assess suitability of current compartmental HIV prevention models for informing policy development. METHODS: Articles published in EMBASE, Medline, Econlit, and Global Health were screened. Included studies were identified using permutations of (i) HIV, (ii) pre-exposure prophylaxis (PrEP), circumcision (both voluntary male circumcision [VMMC] and early-infant male circumcision [EIMC]), and vaccination, and (iii) modelling. Data extraction focused on study design, model structure, and intervention incorporation into models. Article quality was assessed using the TRACE (TRAnsparent and Comprehensive Ecological modelling documentation) criteria for mathematical models. RESULTS: Of 837 articles screened, 48 articles were included in the review, with 32 unique mathematical models identified. The substantial majority of studies included PrEP (83%), whilst fewer modelled circumcision (54%), and only a few focussed on vaccination (10%). Data evaluation, implementation verification, and model output corroboration were identified as areas of poorer model quality. Parameters commonly included in the mathematical models were intervention uptake and effectiveness, with additional intervention-specific common parameters identified. We identified key modelling gaps; critically, models insufficiently incorporate multiple interventions acting simultaneously. Additionally, population subgroups were generally poorly represented-with future models requiring improved incorporation of ethnicity and sexual risk group stratification-and many models contained inappropriate data in parameterisation which will affect output accuracy. CONCLUSIONS: This review identified gaps in compartmental models to date and suggests areas of improvement for models focusing on new prevention interventions. Resolution of such gaps within future models will ensure greater robustness and transparency, and enable more accurate assessment of the impact that new interventions may have, thereby providing more meaningful guidance to policy makers.

Costs and Cost-Effectiveness of Biomedical, Non-Surgical HIV Prevention Interventions: A Systematic Literature Review.

BACKGROUND: Considerable evidence on the costs and cost-effectiveness of biomedical, non-surgical interventions to prevent human immunodeficiency virus (HIV) transmission has been generated over the last decade. This study aims to synthesize findings and identify remaining knowledge gaps to suggest future research priorities. METHODS: A systematic literature review was carried out in August 2020 using the MEDLINE, Embase, Global Health and EconLit databases to retrieve economic evaluations and costing studies of oral pre-exposure prophylaxis (PrEP), injectable long-acting PrEP, vaginal microbicide rings and gels, HIV vaccines and broadly neutralizing antibodies. Studies reporting costs from the provider or societal perspective were included in the analysis. Those reporting on behavioural methods of prevention, condoms and surgical approaches (voluntary medical male circumcision) were excluded. The quality of reporting of the included studies was assessed using published checklists. RESULTS: We identified 3007 citations, of which 87 studies were retained. Most were set in low- and middle-income countries (LMICs; n = 53) and focused on the costs and/or cost-effectiveness of oral PrEP regimens (n = 70). Model-based economic evaluations were the most frequent study design; only two trial-based cost-effectiveness analyses and nine costing studies were found. Less than half of the studies provided practical details on how the intervention would be delivered by the health system, and only three of these, all in LMICs, explicitly focused on service integration and its implication for delivery costs. 'Real-world' programme delivery mechanisms and costs of intervention delivery were rarely considered. PrEP technologies were generally found to be cost-effective only when targeting high-risk subpopulations. Single-dose HIV vaccines are expected to be cost-effective for all groups despite substantial uncertainty around pricing. CONCLUSIONS: A lack of primary, detailed and updated cost data, including above-service level costs, from a variety of settings makes it difficult to evaluate the cost-effectiveness of specific delivery modes at scale, or to evaluate strategies for services integration. Closing this evidence gap around real-world implementation is vital, not least because the strategies targeting high-risk groups that are recommended by PrEP models may incur substantially higher costs and be of limited practical feasibility in some settings.