Cost-effectiveness and budget impact of decentralising childhood tuberculosis diagnosis in six high tuberculosis incidence countries: a mathematical modelling study.

Background: The burden of childhood tuberculosis remains high globally, largely due to under-diagnosis. Decentralising childhood tuberculosis diagnosis services to lower health system levels could improve case detection, but there is little empirically based evidence on cost-effectiveness or budget impact. Methods: In this mathematical modelling study, we assessed the cost-effectiveness and budget impact of decentralising a comprehensive diagnosis package for childhood tuberculosis to district hospitals (DH-focused) or primary health centres (PHC-focused) compared to standard of care (SOC). The project was conducted in Cambodia, Cameroon, Côte d'Ivoire, Mozambique, Sierra Leone, and Uganda between August 1st, 2018 and September 30th, 2021. A mathematical model was developed to assess the health and economic outcomes of the intervention from a health system perspective. Estimated outcomes were tuberculosis cases, deaths, disability-adjusted life years (DALYs) and incremental cost-effectiveness ratios (ICERs). We also calculated the budget impact of nationwide implementation. The TB-Speed Decentralization study is registered with ClinicalTrials.gov, NCT04038632. Findings: For the DH-focused strategy versus SOC, ICERs ranged between $263 (Cambodia) and $342 (Côte d'Ivoire) per DALY averted. For the PHC-focused strategy versus SOC, ICERs ranged between $477 (Cambodia) and $599 (Côte d'Ivoire) per DALY averted. Results were sensitive to TB prevalence and the discount rate used. The additional costs of implementing the DH-focused strategy ranged between $12.8 M (range 10.8-16.4) (Cambodia) and $50.4 M (36.5-74.4) (Mozambique), and between $13.9 M (12.6-15.6) (Sierra Leone) and $134.6 M (127.1-143.0) (Uganda) for the PHC-focused strategy. Interpretation: The DH-focused strategy may be cost-effective in some countries, depending on the cost-effectiveness threshold used for policy making. Either intervention would require substantial early investment. Funding: Unitaid.

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.

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.

Is it possible to recruit HIV self-test users for an anonymous phone-based survey using passive recruitment without financial incentives? Lessons learned from a pilot study in Côte d'Ivoire.

BACKGROUND: Due to the discreet and private nature of HIV self-testing (HIVST), it is particularly challenging to monitor and assess the impacts of this testing strategy. To overcome this challenge, we conducted a study in Côte d'Ivoire to characterize the profile of end users of HIVST kits distributed through the ATLAS project (AutoTest VIH, Libre d'Accéder à la connaissance de son Statut). Feasibility was assessed using a pilot phone-based survey. METHODS: The ATLAS project aims to distribute 221300 HIVST kits in Côte d'Ivoire from 2019 to 2021 through both primary (e.g., direct distribution to primary users) and secondary distribution (e.g., for partner testing). The pilot survey used a passive recruitment strategy-whereby participants voluntarily called a toll-free survey phone number-to enrol participants. The survey was promoted through a sticker on the HIVST instruction leaflet and hotline invitations and informal promotion by HIVST kit-dispensing agents. Importantly, participation was not financially incentivized, even though surveys focussed on key populations usually use incentives in this context. RESULTS: After a 7-month period in which 25,000 HIVST kits were distributed, only 42 questionnaires were completed. Nevertheless, the survey collected data from users receiving HIVST kits via both primary and secondary distribution (69% and 31%, respectively). CONCLUSION: This paper provides guidance on how to improve the design of future surveys of this type. It discusses the need to financial incentivize participation, to reorganize the questionnaire, the importance of better informing and training stakeholders involved in the distribution of HIVST, and the use of flyers to increase the enrolment of users reached through secondary distribution.

Economic Analysis of Low Volume Interventions Using Real-World Data: Costs of HIV Self-Testing Distribution and HIV Testing Services in West Africa From the ATLAS Project.

Achieving the first 95 of the UNAIDS targets requires the implementation of innovative approaches to knowing one's HIV status. Among these innovations is the provision of HIV self-testing (HIVST) kits in west Africa by the international partner organization Solthis (IPO). In order to provide guidance for the optimal use of financial resources, this study aims to estimate the program and site level costs of dispensing HIVST as well as HIV testing services (HTS)-excluding HIVST-in health facilities in Côte d'Ivoire, Mali and Senegal as part of the ATLAS project. We estimated from the provider's perspective, HIVST and HTS incremental costs using top-down and bottom-up costing approaches and conducted a time and motion study. We identified costs at the program level for HIVST (including IPO central costs) and at the site level for HIVST and HTS. The economic costs of distributing HIVST kits were assessed in 37 health facilities between July 2019 and March 2021 (21 months). Sensitivity analyses were also performed on unit costs to examine the robustness of our estimates related to key assumptions. In total, 16,001 HIVST kits were dispensed for 32,194 HTS sessions carried out. Program level HIVST average costs ranged $12-286, whereas site level costs ranged $4-26 across distribution channels and countries. Site level HTS costs ranged $7-8 per testing session, and ranged $72-705 per HIV diagnosis. Across countries and channels, HIVST costs were driven by personnel (27-68%) and HIVST kits (32-73%) costs. The drivers of HTS costs were personnel costs ranging between 65 and 71% of total costs across distribution channels and countries, followed by supplies costs between 21 and 30%. While program level HIVST average costs were high, site level HIVST average costs remained comparable to HTS costs in all countries. Health facility-based distribution channels operating at low volume exhibit high proportion of central costs which should be considered carefully for financial planning when run alongside high volumes mobile outreach distribution channels. HIVST can diversify the HIV testing offer at health facilities, thus improving access to screening for target populations not reached by HTS services.

The cost and intermediary cost-effectiveness of oral HIV self-test kit distribution across 11 distribution models in South Africa.

BACKGROUND: Countries around the world seek innovative ways of closing their remaining gaps towards the target of 95% of people living with HIV (PLHIV) knowing their status by 2030. Offering kits allowing HIV self-testing (HIVST) in private might help close these gaps. METHODS: We analysed the cost, use and linkage to onward care of 11 HIVST kit distribution models alongside the Self-Testing AfRica Initiative's distribution of 2.2 million HIVST kits in South Africa in 2018/2019. Outcomes were based on telephonic surveys of 4% of recipients; costs on a combination of micro-costing, time-and-motion and expenditure analysis. Costs were calculated from the provider perspective in 2019 US$, as incremental costs in integrated and full costs in standalone models. RESULTS: HIV positivity among kit recipients was 4%-23%, with most models achieving 5%-6%. Linkage to confirmatory testing and antiretroviral therapy (ART) initiation for those screening positive was 19%-78% and 2%-72% across models. Average costs per HIVST kit distributed varied between $4.87 (sex worker model) and $18.07 (mobile integration model), with differences largely driven by kit volumes. HIVST kit costs (at $2.88 per kit) and personnel costs were the largest cost items throughout. Average costs per outcome increased along the care cascade, with the sex worker network model being the most cost-effective model across metrics used (cost per kit distributed/recipient screening positive/confirmed positive/initiating ART). Cost per person confirmed positive for HIVST was higher than standard HIV testing. CONCLUSION: HIV self-test distribution models in South Africa varied widely along four characteristics: distribution volume, HIV positivity, linkage to care and cost. Volume was highest in models that targeted public spaces with high footfall (flexible community, fixed point and transport hub distribution), followed by workplace models. Transport hub, workplace and sex worker models distributed kits in the least costly way. Distribution via index cases at facility as well as sex worker network distribution identified the highest number of PLHIV at lowest cost.

Costs of integrating HIV self-testing in public health facilities in Malawi, South Africa, Zambia and Zimbabwe.

INTRODUCTION: As countries approach the UNAIDS 95-95-95 targets, there is a need for innovative and cost-saving HIV testing approaches that can increase testing coverage in hard-to-reach populations. The HIV Self-Testing Africa-Initiative distributed HIV self-test (HIVST) kits using unincentivised HIV testing counsellors across 31 public facilities in Malawi, South Africa, Zambia and Zimbabwe. HIVST was distributed either through secondary (partner's use) distribution alone or primary (own use) and secondary distribution approaches. METHODS: We evaluated the costs of adding HIVST to existing HIV testing from the providers' perspective in the 31 public health facilities across the four countries between 2018 and 2019. We combined expenditure analysis and bottom-up costing approaches. We also carried out time-and-motion studies on the counsellors to estimate the human resource costs of introducing and demonstrating how to use HIVST for primary and secondary use. RESULTS: A total of 41 720 kits were distributed during the analysis period, ranging from 1254 in Zimbabwe to 27 678 in Zambia. The cost per kit distributed through the primary distribution approach was $4.27 in Zambia and $9.24 in Zimbabwe. The cost per kit distributed through the secondary distribution approach ranged from $6.46 in Zambia to $13.42 in South Africa, with a wider variation in the average cost at facility-level. From the time-and-motion observations, the counsellors spent between 20% and 44% of the observed workday on HIVST. Overall, personnel and test kit costs were the main cost drivers. CONCLUSION: The average costs of distributing HIVST kits were comparable across the four countries in our analysis despite wide cost variability within countries. We recommend context-specific exploration of potential efficiency gains from these facility-level cost variations and demand creation activities to ensure continued affordability at scale.

Modelling costs of community-based HIV self-testing programmes in Southern Africa at scale: an econometric cost function analysis across five countries.

BACKGROUND: Following success demonstrated with the HIV Self-Testing AfRica Initiative, HIV self-testing (HIVST) is being added to national HIV testing strategies in Southern Africa. An analysis of the costs of scaling up HIVST is needed to inform national plans, but there is a dearth of evidence on methods for forecasting costs at scale from pilot projects. Econometric cost functions (ECFs) apply statistical inference to predict costs; however, we often do not have the luxury of collecting large amounts of location-specific data. We fit an ECF to identify key drivers of costs, then use a simpler model to guide cost projections at scale. METHODS: We estimated the full economic costs of community-based HIVST distribution in 92 locales across Malawi, Zambia, Zimbabwe, South Africa and Lesotho between June 2016 and June 2019. We fitted a cost function with determinants related to scale, locales organisational and environmental characteristics, target populations, and per capita Growth Domestic Product (GDP). We used models differing in data intensity to predict costs at scale. We compared predicted estimates with scale-up costs in Lesotho observed over a 2-year period. RESULTS: The scale of distribution, type of community-based intervention, percentage of kits distributed to men, distance from implementer's warehouse and per capita GDP predicted average costs per HIVST kit distributed. Our model simplification approach showed that a parsimonious model could predict costs without losing accuracy. Overall, ECF showed a good predictive capacity, that is, forecast costs were close to observed costs. However, at larger scale, variations of programme efficiency over time (number of kits distributed per agent monthly) could potentially influence cost predictions. DISCUSSION: Our empirical cost function can inform community-based HIVST scale-up in Southern African countries. Our findings suggest that a parsimonious ECF can be used to forecast costs at scale in the context of financial planning and budgeting.

The cost effectiveness and optimal configuration of HIV self-test distribution in South Africa: a model analysis.

BACKGROUND: HIV self-testing (HIVST) has been shown to be acceptable, feasible and effective in increasing HIV testing uptake. Novel testing strategies are critical to achieving the UNAIDS target of 95% HIV-positive diagnosis by 2025 in South Africa and globally. METHODS: We modelled the impact of six HIVST kit distribution modalities (community fixed-point, taxi ranks, workplace, partners of primary healthcare (PHC) antiretroviral therapy (ART) patients), partners of pregnant women, primary PHC distribution) in South Africa over 20 years (2020-2039), using data collected alongside the Self-Testing AfRica Initiative. We modelled two annual distribution scenarios: (A) 1 million HIVST kits (current) or (B) up to 6.7 million kits. Incremental economic costs (2019 US$) were estimated from the provider perspective; assumptions on uptake and screening positivity were based on surveys of a subset of kit recipients and modelled using the Thembisa model. Cost-effectiveness of each distribution modality compared with the status-quo distribution configuration was estimated as cost per life year saved (estimated from life years lost due to AIDS) and optimised using a fractional factorial design. RESULTS: The largest impact resulted from secondary HIVST distribution to partners of ART patients at PHC (life years saved (LYS): 119 000 (scenario A); 393 000 (scenario B)). However, it was one of the least cost-effective modalities (A: $1394/LYS; B: $4162/LYS). Workplace distribution was cost-saving ($52-$76 million) and predicted to have a moderate epidemic impact (A: 40 000 LYS; B: 156 000 LYS). An optimised scale-up to 6.7 million tests would result in an almost threefold increase in LYS compared with a scale-up of status-quo distribution (216 000 vs 75 000 LYS). CONCLUSION: Optimisation-informed distribution has the potential to vastly improve the impact of HIVST. Using this approach, HIVST can play a key role in improving the long-term health impact of investment in HIVST.

Costs and Scale-Up Costs of Integrating HIV Self-Testing Into Civil Society Organisation-Led Programmes for Key Populations in Côte d'Ivoire, Senegal, and Mali.

Despite significant progress on the proportion of individuals who know their HIV status in 2020, Côte d'Ivoire (76%), Senegal (78%), and Mali (48%) remain far below, and key populations (KP) including female sex workers (FSW), men who have sex with men (MSM), and people who use drugs (PWUD) are the most vulnerable groups with a HIV prevalence at 5-30%. HIV self-testing (HIVST), a process where a person collects his/her own specimen, performs a test, and interprets the result, was introduced in 2019 as a new testing modality through the ATLAS project coordinated by the international partner organisation Solthis (IPO). We estimate the costs of implementing HIVST through 23 civil society organisations (CSO)-led models for KP in Côte d'Ivoire (N = 7), Senegal (N = 11), and Mali (N = 5). We modelled costs for programme transition (2021) and early scale-up (2022-2023). Between July 2019 and September 2020, a total of 51,028, 14,472, and 34,353 HIVST kits were distributed in Côte d'Ivoire, Senegal, and Mali, respectively. Across countries, 64-80% of HIVST kits were distributed to FSW, 20-31% to MSM, and 5-8% to PWUD. Average costs per HIVST kit distributed were $15 for FSW (Côte d'Ivoire: $13, Senegal: $17, Mali: $16), $23 for MSM (Côte d'Ivoire: $15, Senegal: $27, Mali: $28), and $80 for PWUD (Côte d'Ivoire: $16, Senegal: $144), driven by personnel costs (47-78% of total costs), and HIVST kits costs (2-20%). Average costs at scale-up were $11 for FSW (Côte d'Ivoire: $9, Senegal: $13, Mali: $10), $16 for MSM (Côte d'Ivoire: $9, Senegal: $23, Mali: $17), and $32 for PWUD (Côte d'Ivoire: $14, Senegal: $50). Cost reductions were mainly explained by the spreading of IPO costs over higher HIVST distribution volumes and progressive IPO withdrawal at scale-up. In all countries, CSO-led HIVST kit provision to KP showed relatively high costs during the study period related to the progressive integration of the programme to CSO activities and contextual challenges (COVID-19 pandemic, country safety concerns). In transition to scale-up and integration of the HIVST programme into CSO activities, this model shows large potential for substantial economies of scale. Further research will assess the overall cost-effectiveness of this model.

Using HIV self-testing to increase the affordability of community-based HIV testing services.

OBJECTIVES: This study estimates the costs of community-based HIV testing services (HTS) in Lesotho and assesses the potential efficiency gains achieved by adding HIV self-testing (HIVST) and then self-testing booths. DESIGN: Micro-costing analysis using longitudinal data from a real-world intervention. METHODS: We collected data prospectively on provider's costs and programmatic outcomes over three time periods of approximately 8 months each, between May 2017 and April 2019. The scope of services was extended during each period as follows: HTS only, HTS and HIVST, HTS and HIVST with individual HIVST booths wherein clients were encouraged to self-test on-site followed by on-site confirmative testing for those with reactive self-test. For each implementation period, we estimated the full financial and economic implementation costs, the incremental costs of adding HIVST onto conventional HTS and the cost per HIV positive case identified. RESULTS: Costs per HIV-positive case identified increased between period 1 (US$956) and period 2 (US$1249) then dropped in period 3 (US$813). Full versus incremental cost analyses resulted in large differences in the magnitude of costs, attributable to methods rather than resource use: for example, in period 3, the average full and incremental cost estimates for HTS were US$34.3 and US$23.5 per person tested, and for HIVST were US$37.7 and US$14.0 per kit provided, respectively. CONCLUSION: In Lesotho, adding HIVST to community-based HTS improves its overall affordability for HIV-positive case finding. The reporting of both full and incremental cost estimates increase transparency for use in priority setting, budgeting and financial planning for scale-up.

Economic cost analysis of door-to-door community-based distribution of HIV self-test kits in Malawi, Zambia and Zimbabwe.

INTRODUCTION: HIV self-testing (HIVST) is recommended by the World Health Organization in addition to other testing modalities to increase uptake of HIV testing, particularly among harder-to-reach populations. This study provides the first empirical evidence of the costs of door-to-door community-based HIVST distribution in Malawi, Zambia and Zimbabwe. METHODS: HIVST kits were distributed door-to-door in 71 sites across Malawi, Zambia and Zimbabwe from June 2016 to May 2017. Programme expenditures, supplemented by on-site observation and monitoring and evaluation data were used to estimate total economic and unit costs of HIVST distribution, by input and site. Inputs were categorized into start-up, capital and recurrent costs. Sensitivity and scenario analyses were performed to assess the impact of key parameters on unit costs. RESULTS: In total, 152,671, 103,589 and 93,459 HIVST kits were distributed in Malawi, Zambia and Zimbabwe over 12, 11 and 10 months respectively. Across these countries, 43% to 51% of HIVST kits were distributed to men. The average cost per HIVST kit distributed was US$8.15, US$16.42 and US$13.84 in Malawi, Zambia and Zimbabwe, respectively, with pronounced intersite variation within countries driven largely by site-level fixed costs. Site-level recurrent costs were 70% to 92% of full costs and 20% to 62% higher than routine HIV testing services (HTS) costs. Personnel costs contributed from 26% to 52% of total costs across countries reflecting differences in remuneration approaches and country GDP. CONCLUSIONS: These early door-to-door community HIVST distribution programmes show large potential, both for reaching untested populations and for substantial economies of scale as HIVST programmes scale-up and mature. From a societal perspective, the costs of HIVST appear similar to conventional HTS, with the higher providers' costs substantially offsetting user costs. Future approaches to minimizing cost and/or maximize testing coverage could include unpaid door-to-door community-led distribution to reach end-users and integrating HIVST into routine clinical services via direct or secondary distribution strategies with lower fixed costs.

The effectiveness and cost-effectiveness of community-based lay distribution of HIV self-tests in increasing uptake of HIV testing among adults in rural Malawi and rural and peri-urban Zambia: protocol for STAR (self-testing for Africa) cluster randomized evaluations.

BACKGROUND: Knowledge of HIV status remains below target in sub-Saharan Africa, especially among men and adolescents. HIV self-testing (HIVST) is a novel approach that enables unique distribution strategies, with potential to be highly decentralised and to provide complementary coverage to facility-based testing approaches. However, substantial gaps in evidence remain on the effectiveness and cost-effectiveness of HIVST, particularly in rural settings, and on approaches to facilitate linkage to confirmatory HIV testing, prevention, and treatment services. This protocol describes two cluster-randomized trials (CRT) included within the UNITAID/PSI HIV Self-Testing Africa (STAR) project. METHODS: Two independent CRTs were designed around existing reproductive health programmes in rural Malawi and rural/peri-urban Zambia. Common features include use of constrained randomisation to allocate health clinic catchment areas to either standard HIV testing (SOC) or SOC plus community-based distribution of OraQuick HIV Self Tests (Bethlehem, PA USA, assembled in Thailand) by trained lay distributors selected by the community. Community-based distribution agents will be trained (3-day curriculum) to provide brief demonstration of kit use and interpretation, information and encouragement to access follow up services, and management of social harm. The primary outcome of both CRTs is the proportion of the population aged 16 years and older who tested for HIV within the 12-month intervention period. Secondary outcomes in both trials include lifetime HIV testing, antiretroviral therapy (ART) initiation and ART use. Circumcision status among males will be a secondary outcome in Zambia and clinic-level demand for ART will be a secondary outcome in Malawi. Outcomes will be measured using cross-sectional household surveys, and routine data extraction from participating clinics. Costing studies will be used to evaluate the cost-effectiveness of the intervention arm. Qualitative research will be used to guide distribution and explore reasons for testing and linkage to onward care. DISCUSSION: The STAR-Malawi and STAR-Zambia trials will provide rigorous evidence of whether community-based lay HIVST distribution is an effective and cost-effective approach to increasing coverage of HIV testing and demand for follow-on HIV services in rural and peri-urban communities in sub-Saharan Africa. TRIAL REGISTRATION: Clinicaltrials.gov, Malawi: NCT02718274 , 18 March 2016; Zambia: NCT02793804 , 3 June 2016. Protocol date: 21 February 2018.

A socioecological measurement of homophobia for all countries and its public health impact.

Background: Measuring homophobia at country level is important to guide public health policy as reductions in stigma are associated with improved health outcomes among gay men and other men who have sex with men. Methods: We developed a Homophobic Climate Index incorporating institutional and social components of homophobia. Institutional homophobia was based on the level of enforcement of laws that criminalise, protect or recognise same-sex relations. Social homophobia was based on the level of acceptance and justifiability of homosexuality. We estimated the Index for 158 countries and assessed its robustness and validity. Results: Western Europe is the most inclusive region, followed by Latin America. Africa and the Middle East are home to the most homophobic countries with two exceptions: South Africa and Cabo Verde. We found that a 1% decrease in the level of homophobia is associated with a 10% increase in the gross domestic product per capita. Countries whose citizens face gender inequality, human rights abuses, low health expenditures and low life satisfaction are the ones with a higher homophobic climate. Moreover, a 10% increase in the level of homophobia at country level is associated with a 1.7-year loss in life expectancy for males. A higher level of homophobia is associated with increased AIDS-related death among HIV-positive men. Conclusion: The socioecological approach of this index demonstrates the negative social, economic and health consequences of homophobia in low- and middle-income countries. It provides sound evidence for public health policy in favour of the inclusion of sexual minorities.

Costs of facility-based HIV testing in Malawi, Zambia and Zimbabwe.

BACKGROUND: Providing HIV testing at health facilities remains the most common approach to ensuring access to HIV treatment and prevention services for the millions of undiagnosed HIV-infected individuals in sub-Saharan Africa. We sought to explore the costs of providing these services across three southern African countries with high HIV burden. METHODS: Primary costing studies were undertaken in 54 health facilities providing HIV testing services (HTS) in Malawi, Zambia and Zimbabwe. Routinely collected monitoring and evaluation data for the health facilities were extracted to estimate the costs per individual tested and costs per HIV-positive individual identified. Costs are presented in 2016 US dollars. Sensitivity analysis explored key drivers of costs. RESULTS: Health facilities were testing on average 2290 individuals annually, albeit with wide variations. The mean cost per individual tested was US$5.03.9 in Malawi, US$4.24 in Zambia and US$8.79 in Zimbabwe. The mean cost per HIV-positive individual identified was US$79.58, US$73.63 and US$178.92 in Malawi, Zambia and Zimbabwe respectively. Both cost estimates were sensitive to scale of testing, facility staffing levels and the costs of HIV test kits. CONCLUSIONS: Health facility based HIV testing remains an essential service to meet HIV universal access goals. The low costs and potential for economies of scale suggests an opportunity for further scale-up. However low uptake in many settings suggests that demand creation or alternative testing models may be needed to achieve economies of scale and reach populations less willing to attend facility based services.