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Abstract Background Uganda has a high population growth rate of 3%, partly due to limited access to and low usage of contraception. This study assessed the cost-effectiveness of the family planning benefits cards (FPBC) program compared to standard of care (SOC). The FPBC program was initiated to increase access to modern contraception among young women in slums in Kampala, Uganda. Methods We developed a decision-analytic model (decision tree) and parameterized it using primary intervention data together with previously published data. In the base case, a sexually active woman from an urban slum, aged 18 to 30 years, was modelled over a one-year time horizon from both the modified societal and provider perspectives. The main model outcomes included the probability of unintended conception, costs, and incremental cost-effectiveness ratio (ICER) in terms of cost per unwanted pregnancy averted. Both deterministic and probabilistic sensitivity analyses were conducted to assess the robustness of the modelling results. All costs were reported in 2022 US dollars, and analyses were conducted in Microsoft Excel. Results In the base case analysis, the FPBC was superior to the SOC in outcomes. The probability of conception was lower in the FPBC than in the SOC (0.20 vs. 0.44). The average societal and provider costs were higher in the FPBC than in the SOC, i.e., $195 vs. $164 and $193 vs. $163, respectively. The ICER comparing the FPBC to the SOC was $125 per percentage reduction in the probability of unwanted conception from the societal perspective and $121 from the provider perspective. The results were robust to sensitivity analyses. Conclusion Given Uganda’s GDP per capita of $1046 in 2022, the FPBC is highly cost-effective compared to the SOC in reducing unintended pregnancies among young women in low-income settings. It can even get cheaper in the long run due to the low marginal costs of deploying additional FPBCs. Trial registration MUREC1/7 No. 10/05-17. Registered on July 19, 2017.

ABSTRACTIntroduction Pneumococcal infections can lead to serious invasive diseases such as meningitis, septicemia and pneumonia, as well as milder but more common illnesses such as sinusitis and otitis media. The World Health Organization (WHO) recommends the inclusion of pneumococcal conjugate vaccines (PCVs) in infant National Immunization Program (NIP) programs worldwide. Decision-makers in Asian countries planning to introduce PCVs in their respective NIP will need a comprehensive evidence of effectiveness of PCVs at the population level and economic evidence including cost-effectiveness.Areas Covered A systematic literature review (from 1/1/2016 to 10/11/2019) of PCVs in East and Southeast Asia to understand (1) the contributing factors to cost-effectiveness results of PCVs and (2) whether gaps in evidence exist suggesting why the region may have yet to implement full NIPs.Expert Opinion In East and Southeast Asia, vaccination with PCVs was found to significantly reduce the mortality and morbidity of pneumococcal diseases and was cost-effective compared to no vaccination. Study assumptions, specifically vaccine local acquisition, the inclusion or exclusion of indirect effects (serotype replacement and herd effect), cross-protection, and protection against nontypeable haemophilus influenzae and serotype 3, were the main drivers of cost-effectiveness.

Abstract Objectives To estimate the cost of six different techniques used to treat Genital Warts and the annual average cost of treating a typical GW patient in Peru. To estimate the annual economic burden diagnosing and treating GW in the Peruvian public healthcare system. Methods We developed a prevalence-based, cost-of-illness study from the provider’s perspective, the healthcare facilities under the purview of Peruvian Ministry of Health. We used an activity-based costing approach. We conducted primary data collection in three regions in Peru and supplemented it with governmental data. Uncertainty of the costing estimates was assessed via Monte Carlo simulations. We estimated the average cost and associated confidence intervals for six treatment options – three topical and three surgical – and the overall cost per patient. Results The average treatment cost per patient was 59.9USD (95 %CI 45.5, 77.6). Given a population of 18.4 million adults between 18 and 60 years of age and a GW prevalence of 2.28 %, the annual cost of treating GW was 25.1 million USD (uncertainty interval 16.9, 36.6). Conclusions This study provides the first quantification of the economic burden of treating genital warts in Peru and one of the few in Latin America. The costing data did not include other healthcare providers or out-of-pocket expenditures, and hence we present a conservative estimate of the COI of GW in Peru. Our findings bring attention to the financial burden of treating GW, a vaccine-preventable disease.

Summary: Background: Sabes, a treatment-as-prevention intervention among men who have sex with men and transgender women in Lima, Peru, was developed to identify HIV during early primary infection (

Abstract Background An aim of this study is to introduce a practitioner-friendly behavior model. Few theories of health behavior explicitly take the effect of social norms on behavior into account. Generally, theories that do take social norms into account assume that the effect of social norms on behavior operates through motivation. We use the Fogg Behavior Model (FBM), a behavior model that is new to public health, to explore whether social norms are associated with modern contraceptive use among Nigerian women, and whether they affect behavior through motivation or through ability. In other words, do social norms that discourage contraception lower women’s motivation to use contraception or do they lower women’s ability to use contraception. Methods This study uses data from a cross-sectional household survey of Nigerian women, ages 14–24. The survey collected data on socio-economic and demographic characteristics of women, whether they were sexually experienced, and whether they used contraception. Modern contraceptive use was the outcome of interest for the study. The survey also collected data on social norms around premarital sex and contraceptive use. Multivariate logistic regression was used for the analysis. Results After adjusting for a range of socio-economic and demographic variables, we found that social norms that discourage contraception had a statistically significant negative association with contraceptive use (aOR = 0.90, p

Abstract Background Innovations to increase access to sexual and reproductive health (SRH) information, goods, and services are needed, particularly in low-income settings. This study assessed the utilization of a mobile phone application (MPA) to increase access to SRH information, goods, and services among university students in Uganda. Methods We conducted a cross-sectional analysis of data from: (1) an endline survey performed as a consequence of a randomized controlled trial (RCT) of the effectiveness of the MPA, and (2) data from use of the MPA for accessing information, goods, and services over the 6-month time period of the RCT, obtained from in-MPA data collection service providers. We performed descriptive analysis of participant characteristics and their association with the utilization of the MPA using logistic regression; analyses of MPA use for accessing different types of information, goods, and services by gender; and analyses of functionality attributes of the MPA and related services. Results In the study population of young (median 22 years) predominantly female (61%) students, the utilization of the MPA by those who downloaded it was high (81% overall, 82% female, and 82% male). The most popular information portal was the frequently asked questions (71% utilization); the most popular goods were condoms for males (77% utilization) and sanitary pads for females (94% utilization); and the most popular service was HIV testing and counseling (60% utilization). The MPA demonstrated predominantly positive (responsiveness, non-distracting in-app advertisements, and ease of use) attributes. Conclusion A mobile phone app to increase access to SRH information, goods, and services among university students in Uganda demonstrated high utilization. The results of this study support ongoing and future technical improvement efforts and research on effectiveness, economic efficiency, and scalability, along the continuum of activities to scale this intervention in order to improve SRH in low-income settings. Trial Registration MUREC1/7 No. 07/05-18. Registered; June 29, 2018.

Abstract Purpose To estimate the resource gap in the polymerase chain reaction (PCR) monitoring for patients with chronic myeloid leukemia (CML) in low- and middle-income countries (LMICs). Methods We developed a model of demand and supply of PCR monitoring of CML patients in 60 LMICs. PCR testing was assumed to use Cepheid’s GeneXpert® IV system. We included costs of GeneXpert® instruments, uninterrupted power supplies, warranties, calibration kits, test cartridges, and shipping. We calculated the country-specific monetary gap in PCR monitoring, stratified by country priority defined as the availability of tyrosine kinase inhibitors (TKIs) through The Max Foundation initiatives. Results The 5-year gap in PCR monitoring was $29.1 million across all countries, 22% ($6.4 million) in countries with all five TKIs available, 20% ($5.7 million) in countries with four TKIs available, 50% ($14.5 million) in countries with three TKIs available, 8% ($2.2 million) in countries with two TKIs available, and 1% ($0.3 million) in countries with one TKI available. The gap was highest in South Asia (52%; $15.1 million) and lowest in Latin America (6%; $1.9 million). Excluding labor costs, the bulk of the resource needs (86%; $25.2 million) were for procurement of BCR-ABL cartridges. Conclusion Removing the 5-year gap in PCR monitoring capacity for CML in LMICs will require the mobilization of significant resources and will likely lead to better treatment outcomes and reduced treatment costs through optimization of treatment, discontinuation of therapy in appropriate patients, and facilitation of clinical research. Development of streamlined monitoring guidelines for resource-limited countries should be considered.

Abstract Background University students are one of the most vulnerable groups to sexual reproductive health [SRH] threats like sexually transmitted infections [STIs], unwanted pregnancies, and unsafe abortions and often have limited access to SRH information, goods, and services. This study assessed the effectiveness of using a mobile phone application (APP) to increase access to SRH information, goods, and services among university students in Uganda. Methods Using data from a double-blinded randomized controlled trial, participants were randomly assigned to both the intervention (APP) and control (standard of care) arms. We executed descriptive analyses for baseline demographic characteristics by intervention, difference in difference (DID), and quantile regression analyses for both primary and secondary outcomes. Results The median age of participants was 21 years of age, and the majority were female (over 60%), unemployed (over 85%) and Christian (90%). Over 50% were resident in off-campus hostels and in a relationship. Between baseline and end-line, there was a significant increase in SRH knowledge score (DID = 2, P

Abstract Background Cost is an important determinant of health program implementation. In this study, we conducted a comprehensive evaluation of the implementation strategy of Mozambique’s school-based HPV vaccine demonstration project. We sought to estimate the total costs for the program, cost per fully immunized girl (FIG), and compute projections for the total cost of implementing a similar national level vaccination program. Methods We collected primary data through document review, participatory observation, and key informant interviews at all levels of the national health system and Ministry of Education. We used a combination of micro-costing methods—identification and measurement of resource quantities and valuation by application of unit costs, and gross costing—for consideration of resource bundles as they apply to the number of vaccinated girls. We extrapolated the cost per FIG to the HPV-vaccine-eligible population of Mozambique, to demonstrate the projected total annual cost for two scenarios of a similarly executed HPV vaccine program. Results The total cost of the Mozambique HPV vaccine demonstration project was $523,602. The mean cost per FIG was $72 (Credibility Intervals (CI): $62 - $83) in year one, $38 (CI: $37 - $40) in year two, and $54 CI: $49 - $61) for years one and two. The mean cost per FIG with the third HPV vaccine dose excluded from consideration was $60 (CI: $50 - $72) in year one, $38 (CI: $31 - $46) in year two, and $48 (CI: $42 - $55) for years one and two. The mean cost per FIG when only one HPV vaccine dose is considered was $30 (CI: $27 - $33)) in year one, $19 (CI: $15–$23) in year two, and $24 (CI: $22–$27) for both years. The projected annual cost of a two-and one-dose vaccine program targeting all 10-year-old girls in the country was $18.2 m (CI: $15.9 m - $20.7 m) and $9 m (CI: $8 m - $10 m) respectively. Conclusion National adaptation and scale-up of Mozambique’s school-based HPV vaccine strategy may result in substantial costs depending on dosing. For sustainability, stakeholders will need to negotiate vaccine price and achieve higher efficiency in startup activities and demand creation.

Abstract Background This study was conducted to test the acceptability and utilization of family planning benefits cards (FPBCs) as incentives to increase family planning uptake among youth living in urban slums in Uganda. Methods We conducted a one-year pilot study with two sub-studies on acceptability and utilization of FPBCs. The acceptability study utilized a quantitative cross-sectional design and was part of a baseline household survey while the utilization study was a primary analysis of claims and clinic data. We performed descriptive analyses and analyses of the association between different variables using binary logistic regression. Results The acceptability study included 280 eligible females. The majority were married (52%), Christian (87%), and aged 20 and above (84%). Acceptability of the program was high (93%). Seventy-two percent of females used the card at least once to access reproductive health services. Twenty-seven percent of female users discontinued family planning and 14% changed family planning methods during the study. Female users of short-term contraceptive methods were 11 times more likely to discontinue use of FPBCs compared to those who used long-term methods (adjusted OR = 10.9, P = 0.011). Participants in professional/managerial employment were 30 times more likely to discontinue compared to the unemployed (adjusted OR = 30.3, P = 0.015). Participants of parity equal to two were 89% less likely to discontinue use of FPBCs compared to those of parity equal to zero (adjusted OR = 0.1, P = 0.019). Conclusion Family planning benefits cards, deployed as incentives to increase uptake of family planning, exhibited high acceptability and utilization by youth in urban slums in Uganda. There was evidence that use of short-term contraception methods, professional employment, and lower parity were associated with discontinuation of modern family planning methods after initial enrolment. Trial registration MUREC1/7 No. 10/05–17. Registered 19th, July 2017.

Background: The prevalence of pre-treatment drug resistance (PDR) to non-nucleoside reverse-transcriptase inhibitor (NNRTI) agents is increasing in sub-Saharan Africa, which may decrease the effectiveness of efavirenz-based antiretroviral therapy (ART) programs. However, due to recent safety concerns, there has been hesitancy to replace efavirenz-based ART with dolutegravir in women of reproductive potential. Our objective was to evaluate whether PDR testing for women not initiating dolutegravir-based ART would be a cost-effective strategy to address the challenges posed by PDR. Methods: We developed an HIV drug resistance model that simulates the emergence and transmission of resistance mutations, calibrated to the Kenyan epidemic. We modeled three care strategies for PDR testing among women not initiating dolutegravir-based ART: no PDR testing, PDR testing with a low-cost point mutation assay, known as oligonucleotide ligation assay (OLA), and PDR testing with consensus sequencing. Using a health sector perspective, this model was used to evaluate the health outcomes, lifetime costs, and cost-effectiveness under each strategy over a 15-year time horizon starting in 2019. Findings: OLA and CS PDR testing were projected to have incremental cost-effectiveness ratios (ICER) of $10,741/QALY gained and $134,396/QALY gained, respectively, which are not cost-effective by national income standards. Viral suppression rates among women at 12 months after ART initiation were 87·8%, 89·0%, and 89·3% with no testing, OLA testing, and CS testing, respectively. PDR testing with OLA and CS were associated with a 0.5% and 0.6% reduction in incidence rate compared to no PDR testing. Initial PDR prevalence among women was 13.1% in 2019. By 2034, this prevalence was 17·6%, 17·4%, and 17·3% with no testing, OLA testing, and CS testing, respectively. Interpretation: PDR testing for women is unlikely to be cost-effective in Kenya whether one uses a low-cost assay, such as OLA, or consensus sequencing. Funding: National Institutes of Health, Gilead Sciences.

Abstract Background Several cost-effective programs are being implemented around the world that use mobile technology to improve Sexual and Reproductive Health (SRH) uptake and awareness among youth. Mobile phone applications are a viable and effective means of increasing access to SRH services and tools in low and middle-income countries. This paper presents a protocol for a pilot study of a novel program, a mobile phone-based sexual and reproductive health services awareness and delivery application with the objective of increasing the demand for SRH services amongst the youth in Uganda. Methods The study employs rigorous evaluation methods to ascertain the impact of the mobile application. We propose a randomized control trial study to determine the causal effect of the mobile phone app in creating awareness and increasing uptake of sexual and reproductive health services in Uganda. The main outcome of the impact evaluation is the percentage change in the SRH services and tools uptake, SRH knowledge and sexual behavior. We will also conduct a model-based incremental cost-effectiveness analysis (CEA) and budget impact analysis (BIA). The main outcomes of the economic evaluation will be the average cost per app user, cost per app service and tool provided. We will also test the in-app advertising model as a way to generate revenue to sustain the program subsidies and related costs. Discussion The study seeks to establish the proof of concept of using a mobile application to increase create awareness and increase uptake of SRH tools and services among youth in Uganda. The study results will lead to the development of a demand-driven, culturally-relevant, and easy-to-use mobile app to enhance the uptake of SRH services among the youth in Uganda and globally. Trial registration MUREC1/7 No. 07/05–18. Registered 29th June 2018.

Abstract Access to quality-assured medical products improves health and save lives. However, one third of the world’s population lacks timely access to quality-assured medicines while estimates indicate that at least 10% of medicine in low- and middle-income countries (LMICs) are substandard or falsified (SF), costing approximately US$ 31 billion annually. National regulatory authorities are the key government institutions that promote access to quality-assured medicines and combat SF medical products but despite progress, regulatory capacity in LMICs is still insufficient. Continued and increased investment in regulatory system strengthening (RSS) is needed. We have therefore reviewed existing global normative documents and resources and engaged with our networks of global partners and stakeholders to identify three critical challenges being faced by NRAs in LMICs that are limiting access to medical products and impeding detection of and response to SF medicines. The challenges are; implementing value-added regulatory practices that best utilize available resources, a lack of timely access to new, quality medical products, and limited evidence-based data to support post-marketing regulatory actions. To address these challenges, we have identified seven focused strategies; advancing and leveraging convergence and reliance initiatives, institutionalizing sustainability, utilizing risk-based approaches for resource allocation, strengthening registration efficiency and timeliness, strengthening inspection capacity and effectiveness, developing and implementing risk-based post-marketing quality surveillance systems, and strengthening regulatory management of manufacturing variations. These proposed solutions are underpinned by 13 focused recommendations, which we believe, if financed, technically supported and implemented, will lead to stronger health system and as a consequence, positive health outcomes.

Abstract Background Adolescent-friendly policies aim to tailor HIV services for adolescents and young adults aged 10–24 years (AYA) to promote health outcomes and improve retention in HIV care and treatment. However, few interventions focus on improving healthcare worker (HCW) competencies and skills for provision of high-quality adolescent care. Standardized patients (SPs) are trained actors who work with HCWs in mock clinical encounters to improve clinical assessment, communication, and empathy skills. This stepped-wedge randomized controlled trial will evaluate a clinical training intervention utilizing SPs to improve HCW skills in caring for HIV-positive AYA, resulting in increased retention in care. Methods/design The trial will utilize a stepped-wedge design to evaluate a training intervention using SPs to train HCWs in assessment, communication, and empathy skills for AYA HIV care. We will recruit 24 clinics in Kenya with an active electronic medical record (EMR) system and at least 40 adolescents enrolled in HIV care per site. Stratified randomization by county will be used to assign clinics to one of four waves – time periods when they receive the intervention – with each wave including six clinics. From each clinic, up to 10 HCWs will participate in the training intervention. SP training includes didactic sessions in adolescent health, current guidelines, communication skills, and motivational interviewing techniques. HCW participants will rotate through seven standardized SP scenarios, followed by SP feedback, group debriefing, and remote expert evaluation. AYA outcomes will be assessed using routine clinic data. The primary outcome is AYA retention in HIV care, defined as returning for first follow-up visit within 6 months of presenting to care, or returning for a first follow-up visit after re-engagement in care in AYA with a previous history of being lost to follow-up. Secondary outcomes include HCW competency scores, AYA satisfaction with care, and AYA clinical outcomes including CD4 and viral load. Additional analyses will determine cost-effectiveness of the intervention. Discussion This trial will contribute valuable information to HIV programs in Kenya and other low-resource settings, providing a potentially scalable strategy to improve quality of care and retention in critical HIV services in this population. Trial registration ClinicalTrials.gov, ID: NCT02928900. Registered 26 August 2016.

Objective: To evaluate the acceptability and performance of cervical cancer (CC) screening using visual inspection with acetic acid (VIA) integrated into a rural immunization clinic in Uganda. Methods/materials: We conducted a cross-sectional pilot study in rural Uganda. We explored associations between women's characteristics and acceptance of VIA testing. We collected samples for Papanicolaou (Pap) smear testing in a random subset of women and used results from this test as a comparator for assessing VIA performance. Results: We enrolled 625 women of whom 571 (91.4%) accepted and 54 (8.6%) refused CC screening. In the univariate model, age (Odds Ratio (OR)=1.10; p-value

Abstract Background The use of contraception is one of the most cost-effective public health interventions and has the potential to prevent about 30% of maternal and 10% of child deaths in developing countries. Voucher-based initiatives for family planning are an effective and viable means of increasing contraceptive use. In this paper, we present a protocol for a pilot study of a novel incentive, a family planning benefits card (FPBC) program to increase uptake of family planning services among urban poor youth in Uganda while leveraging private sector funding. Methods The study employs both impact and health economic evaluation methods to assess the effect of the FPBC program. We propose a quasi-experimental study design with two separate pre- and post-samples to measure program effectiveness. The main outcome of the impact evaluation is the percentage change in the prevalence of modern contraceptive use and unmet need for contraception. We will also conduct model-based incremental cost-effectiveness and budget impact analyses. The main outcomes of the economic evaluation are the cost per enrolled youth and cost per pregnancy averted, and cost per disability-adjusted life-year (DALY) averted. We will also pilot a corporate social responsibility model of sponsorship for the FPBC program in partnership with local corporations. Budget impact analysis will examine the potential affordability of scaling up the FPBC program and the fiscal implications of this scale up to the corporate social responsibility (CSR) budgets of partner corporations, the government, and the individual taxpayer. Discussion In this study, we propose an impact and economic evaluation to establish the proof concept of using a FPBC program to increase uptake of family planning services among urban poor youth in Uganda. The results of this study will present stakeholders in Uganda and internationally with a potentially viable option for corporate-sponsored access to family planning in urban poor communities. Trial registration MUREC1/7 No. 10/05-17. Registered 19th July 2017.

Abstract Background Poor access to essential medicines is common in many low- and middle-income countries, partly due to an insufficient and inadequately trained workforce to manage the medicines supply chain. We conducted a prospective impact evaluation of the training and deployment of pharmacy assistants (PAs) to rural health centers in Malawi. Methods A quasi-experimental design was used to compare access to medicines in two districts where newly trained PAs were deployed to health centers (intervention) and two districts with no trained PAs at health centers (comparison). A baseline household survey and two annual post-intervention household surveys were conducted. We studied children under five years with a history of fever, cough and difficulty in breathing, and diarrhea in the previous two weeks. We collected data on access to antimalarials, antibiotics and oral rehydration salts (ORS) during the childrens’ symptomatic periods. We used difference-in-differences regression models to estimate the impact of PA training and deployment on access to medicines. Results We included 3974 children across the three rounds of annual surveys: 1840 (46%) in the districts with PAs deployed at health centers and 2096 (53%) in districts with no PAs deployed at health centers. Approximately 80% of children had a fever, nearly 30% had a cough, and 43% had diarrhea in the previous two weeks. In the first year of the program, the presence of a PA led to a significant 74% increase in the odds of access to any antimalarial, and a significant 49% increase in the odds of access to artemisinin combination therapies. This effect was restricted to the first year post-intervention. There was no effect of presence of a PA on access to antibiotics or ORS. Conclusion The training and deployment of pharmacy assistants to rural health centers in Malawi increased access to antimalarial medications over the first year, but the effect was attenuated over the second year. Pharmacy assistants training and deployment demonstrated no impact on access to antibiotics for pneumonia or oral rehydration salts for diarrhea.

Abstract Objective This study evaluated the potential cost-effectiveness of cervical cancer screening in HIV treatment clinics in Nairobi, Kenya. Methods A Markov model was used to project health outcomes and costs of cervical cancer screening and cryotherapy at an HIV clinic in Kenya using cryotherapy without screening, visual inspection with acetic acid (VIA), Papanicolaou smear (Pap), and testing for human papillomavirus (HPV). Direct and indirect medical and non-medical costs were examined from societal and clinic perspectives. Results Costs of cryotherapy, VIA, Pap, and HPV for women with CD4 200–500 cells/mL were $99, $196, $219, and $223 from a societal perspective and $19, $94, $124, and $113 from a clinic perspective, with 17.3, 17.1, 17.1, and 17.1 years of life expectancy, respectively. Women at higher CD4 counts (>500 cells/mL) given cryotherapy VIA, Pap, and HPV resulted in better life expectancies (19.9+ years) and lower cost (societal: $49, $99, $115, and $102; clinic: $13, $51, $71, and $56). VIA was less expensive than HPV unless HPV screening could be reduced to a single visit. Conclusions Preventative cryotherapy was the least expensive strategy and resulted in highest projected life expectancy, while VIA was most cost-effective unless HPV could be reduced to a single visit.

Objective Although adverse events (AEs) following voluntary medical male circumcision (VMMC) are rare, their prompt ascertainment and management is a marker of quality care. The use of two-way text messaging (2wT) for client follow-up after VMMC reduces the need for clinic visits (standard of care (SoC)) without compromising safety. We compared the cost-effectiveness of 2wT to SoC for post-VMMC follow-up in two, high-volume, public VMMC sites in Zimbabwe. Materials and methods We developed a decision-analytic (decision tree) model of post-VMMC client follow-up at two high-volume sites. We parameterized the model using data from both a randomized controlled study of 2wT vs. SoC and from the routine VMMC program. The perspective of analysis was the Zimbabwe government (payer). The time horizon covered the time from VMMC to wound healing. Costs included text messaging; both in-person and outreach follow-up; and AE management. Costs were estimated in 2018 U.S. dollars. The outcome of analysis was AE yield relative to the globally accepted safety standard of a 2% AE rate. We estimated the incremental cost per percentage increase in AE ascertainment and the incremental cost per additional AE identified. We conducted univariate and probabilistic sensitivity analyses. Results 2wT increased the costs due to text messaging by $4.42 but reduced clinic visit costs by $2.92 and outreach costs by $3.61 –a net savings of $2.10. 2wT also increased AE ascertainment by 50% (92% AE yield in 2wT compared to 42% AE yield in SoC). Therefore, 2wT dominated SoC in the incremental analysis: 2wT was less costly and more effective. Results were generally robust to univariate and probabilistic sensitivity analysis. Conclusions 2wT is cost-effective for post-VMMC follow-up in Zimbabwe. Countries in which VMMC is a high-priority HIV prevention intervention should consider this mHealth intervention to reduce overall cost per VMMC, increasing the likelihood of current and future VMMC program sustainability.

IntroductionThe presence of hypertension could reduce the health-related quality of life (HRQoL) of people with HIV (PWH). Yet, literature describing the HRQoL of PWH who have hypertension in Uganda is scarce making the design of locally adapted interventions cumbersome. In our study, we compared HRQoL scores of people with HIV with and without hypertension on long term antiretroviral therapy (ART) in Uganda.MethodsWe recruited 149 PWH with hypertension and 159 PWH without hypertension in the long-term ART cohort at an urban clinic in Kampala, Uganda. Data on socio-demographics were collected using an interviewer designed questionnaire while data on the World Health Organisation clinical stage viral load and CD4 count as well as ART duration were extracted from clinic electronic database and a generic EuroQol -5D- 5L (EQ-5D- 5L) and Medical Outcome Study (MOS-HIV) questionnaire used to collect HRQoL data. Data were summarized using descriptive statistics while inferential statistics were used to determine associations between key variables and HRQoL. Mann-Whitney U tests were used to compare HRQoL between groups of interest.ResultsOne hundred ninety (61.7%) participants were female. PWH who had hypertension were older (Mean ± SD: 53.7 ± 8.3 vs 49.9 ± 8.6, p value 70,000 UGX, (p value = 0.044), disclosure of the HIV status of the participants to their partner (p value = 0.026), and current history of smoking (p value = 0.029) were associated with low HRQoL scores.ConclusionAmong people with HIV, those with hypertension had lower HRQoL compared to those without. This calls for inclusion of quality-of-life assessment in the management of PWH who have been diagnosed with hypertension to identify those at risk and plan early interventions.

Objectives Pakistan has a hepatitis C virus (HCV) infection prevalence of 6%–9% and aims to achieve World Health Organisation (WHO) targets for elimination of HCV by the year 2030. We aim to evaluate the potential cost-effectiveness of a reference laboratory-based (centralised laboratory testing; CEN) confirmatory testing approach versus a molecular near-patient point-of-care (POC) confirmatory approach to screen the general population for HCV in Pakistan.Study design We used a decision tree-analytic model from a governmental (formal healthcare sector) perspective.Study setting Individuals were assumed to be initially screened with an anti-HCV test at home, followed by POC nucleic acid test (NAT) at nearby district hospitals or followed by NAT at centralised laboratories.Participants We included the general testing population for chronic HCV in Pakistan.Intervention Screening with an anti-HCV antibody test (Anti-HCV) followed by either POC NAT (Anti-HCV-POC), or reference laboratory NAT (Anti-HCV-CEN), was compared, using data from published literature and the Pakistan Ministry of Health.Measures Outcome measures included: number of HCV infections identified per year, percentage of individuals correctly classified, total costs, average costs per individual tested, and cost-effectiveness (assessed as cost per additional HCV infection identified). Sensitivity analysis was also performed.Results At a national level (25 million annual screening tests), the Anti-HCV-CEN strategy would identify 142 406 more HCV infections in 1 year and increase correct classification of individuals by 0.57% compared with the Anti-HCV-POC strategy. The total annual cost of HCV testing was reduced using the Anti-HCV-CEN strategy by US$7.68 million (US$0.31/person). Thus, incrementally, the Anti-HCV-CEN strategy costs less and identifies more HCV infections than Anti-HCV-POC. The incremental difference in HCV infections identified was most sensitive to the probability of loss to follow-up (for POC confirmatory NAT).Conclusions Anti-HCV-CEN would provide the best value for money when scaling up HCV testing in Pakistan.

Background Detection of acute and prevalent HIV infection using point-of-care nucleic acid amplification testing (POC-NAAT) among outpatients with symptoms compatible with acute HIV is critical to HIV prevention, but it is not clear if it is cost-effective compared with existing HIV testing strategies.Methods We developed and parametrised a decision tree to compare the cost-effectiveness of (1) provider-initiated testing and counselling (PITC) using rapid tests, the standard of care; (2) scaled-up provider-initiated testing and counselling (SU-PITC) in which all patients were tested with rapid tests unless they opted out; and (3) opt-out testing and counselling using POC-NAAT, which detects both acute and prevalent infection. The model-based analysis used data from the Tambua Mapema Plus randomised controlled trial of a POC-NAAT intervention in Kenya, supplemented with results from a stochastic, agent-based network model of HIV-1 transmission and data from published literature. The analysis was conducted from the perspective of the Kenyan government using a primary outcome of cost per disability-adjusted life-year (DALY) averted over a 10-year time horizon.Results After analysing the decision-analytical model, the average per patient cost of POC-NAAT was $214.9 compared with $173.6 for SU-PITC and $47.3 for PITC. The mean DALYs accumulated per patient for POC-NAAT were 0.160 compared with 0.176 for SU-PITC and 0.214 for PITC. In the incremental analysis, SU-PITC was eliminated due to extended dominance, and the incremental cost-effectiveness ratio (ICER) comparing POC-NAAT to PITC was $3098 per DALY averted. The ICER was sensitive to disability weights for HIV/AIDS and the costs of antiretroviral therapy.Conclusion POC-NAAT offered to adult outpatients in Kenya who present for care with symptoms compatible with AHI is cost-effective and should be considered for inclusion as the standard of HIV testing in this population.Trial registration number Tambua Mapema (“Discover Early”) Plus study (NCT03508908) conducted in Kenya (2017–2020) i.e., Post-results.

Summary: Background: Mass drug administration of azithromycin to children in sub-Saharan Africa has been shown to improve survival in high-mortality settings. The period after hospital discharge is a time of elevated risk unaddressed by current interventions and might provide an opportunity for targeting empirical azithromycin administration. We aimed to assess the efficacy of azithromycin administered at hospital discharge on risk of death and rehospitalisation in Kenyan children younger than 5 years. Methods: In this double-blind, placebo-controlled randomised trial, children were randomly assigned (1:1) to receive a 5-day course of azithromycin (oral suspension 10 mg/kg on day 1, followed by 5mg/kg per day on days 2–5) or identically appearing and tasting placebo at discharge from four hospitals in western Kenya. Children were eligible if they were aged 1–59 months at hospital discharge, weighed at least 2 kg, and had been admitted to hospital for any medical reason other than trauma, poisoning, or congenital anomaly. The primary outcome was death or rehospitalisation in the subsequent 6-month period in a modified intention-to-treat population, compared by randomisation group with Cox proportional hazards regression and Kaplan-Meier. Azithromycin resistance in Escherichia coli isolates from a random subset of children was compared by randomisation group with generalised estimating equations. This trial is registered with ClinicalTrials.gov, NCT02414399. Findings: Between June 28, 2016, and Nov 4, 2019, 1400 children were enrolled in the trial at discharge from hospital, with 703 (50·2%) randomly assigned to azithromycin and 697 (49·8%) to placebo. Among the 1398 children included in the modified intention-to-treat analysis (702 in the azithromycin group and 696 in the placebo group), the incidence of death or rehospitalisation was 20·4 per 100 child-years in the azithromycin group and 22·5 per 100 child-years in the placebo group (adjusted hazard ratio 0·91, 95·5% CI 0·64–1·29, p=0·58). Azithromycin resistance was common in commensal E coli isolates from enrolled children before randomisation (37·7% of 406 isolates) despite only 3·7% of children having received a macrolide antibiotic during the hospitalisation. Azithromycin resistance was slightly higher at 3 months after randomisation in the azithromycin group (26·9%) than in the placebo group (19·1%; adjusted prevalence ratio 1·41, 95% CI 0·95–2·09, p=0·088), with no difference observed at 6 months (1·17, 0·78–1·76, p=0·44). Interpretation: We did not observe a significant benefit of a 5-day course of azithromycin delivered to children younger than 5 years at hospital discharge despite the overall high risk of mortality and rehospitalisation. These findings highlight the need for more research into mechanisms and interventions for prevention of morbidity and mortality in the post-discharge period. Funding: Eunice Kennedy Shriver National Institute of Child Health & Human Development.

ObjectivesTo estimate the modified societal costs of cervical cancer treatment in Kenya; and to compare the modified societal costs of treatment for pre-cancerous cervical lesions integrated into same-day HIV care compared to "non-integrated" treatment when the services are not coordinated on the same day.Materials and methodsA micro-costing study was conducted at Coptic Hope Center for Infectious Diseases and Kenyatta National Hospital from July 1-October 31, 2014. Interviews were conducted with 54 patients and 23 staff. Direct medical, non-medical (e.g., overhead), and indirect (e.g., time) costs were calculated for colposcopy, cryotherapy, Loop Electrosurgical Excision Procedure (LEEP), and treatment of cancer. All costs are reported in 2017 US dollars.ResultsPatients had a mean age of 41 and daily earnings of $6; travel time to the facility averaged 2.8 hours. From the modified societal perspective, per-procedure costs of colposcopy were $41 (integrated) vs. $91 (non-integrated). Per-procedure costs of cryotherapy were $22 (integrated) vs. $46 (non-integrated), whereas costs of LEEP were $50 (integrated) and $99 (non-integrated). This represents cost savings of $25 for cryotherapy and $50 for colposcopy and LEEP when provided on the same day as an HIV-care visit. Treatment for cervical cancer cost $1,345-$6,514, depending on stage. Facility-based palliative care cost $59/day.ConclusionsIntegrating treatment of pre-cancerous lesions into HIV care is estimated to be cost-saving from a modified societal perspective. These costs can be applied to financial and economic evaluations in Kenya and similar urban settings in other low-income countries.

BACKGROUND:Rheumatic heart disease (RHD) prevalence and mortality rates remain especially high in many parts of Africa. While effective prevention and treatment exist, coverage rates of the various interventions are low. Little is known about the comparative cost-effectiveness of different RHD interventions in limited resource settings. We developed an economic evaluation tool to assist ministries of health in allocating resources and planning RHD control programs. METHODOLOGY/PRINCIPAL FINDINGS:We constructed a Markov model of the natural history of acute rheumatic fever (ARF) and RHD, taking transition probabilities and intervention effectiveness data from previously published studies and expert opinion. Our model estimates the incremental cost-effectiveness of scaling up coverage of primary prevention (PP), secondary prevention (SP) and heart valve surgery (VS) interventions for RHD. We take a healthcare system perspective on costs and measure outcomes as disability-adjusted life-years (DALYs), discounting both at 3%. Univariate and probabilistic sensitivity analyses are also built into the modeling tool. We illustrate the use of this model in a hypothetical low-income African country, drawing on available disease burden and cost data. We found that, in our hypothetical country, PP would be cost saving and SP would be very cost-effective. International referral for VS (e.g., to a country like India that has existing surgical capacity) would be cost-effective, but building in-country VS services would not be cost-effective at typical low-income country thresholds. CONCLUSIONS/SIGNIFICANCE:Our cost-effectiveness analysis tool is designed to inform priorities for ARF/RHD control programs in Africa at the national or subnational level. In contrast to previous literature, our preliminary findings suggest PP could be the most efficient and cheapest approach in poor countries. We provide our model for public use in the form of a Supplementary File. Our research has immediate policy relevance and calls for renewed efforts to scale up RHD prevention.