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Up to 69% of adults who acquire HIV in Kenya seek care before seroconversion, providing an important opportunity for early diagnosis and treatment. The Tambua Mapema Plus (TMP) trial tested a combined HIV-1 nucleic acid testing, linkage, treatment, and partner notification intervention for adults aged 18-39 years with symptoms of acute HIV infection presenting to health facilities in coastal Kenya. We estimated the potential impact of TMP on the Kenyan HIV epidemic.We developed an agent-based network model of HIV-1 transmission using TMP data and Kenyan statistics to estimate potential population-level impact of targeted facility-based testing over 10 years. Three scenarios were modeled: standard care [current use of provider-initiated testing and counseling (PITC)], standard HIV rapid testing scaled to higher coverage obtained in TMP (scaled-up PITC), and the TMP intervention.Standard care resulted in 90.7% of persons living with HIV (PLWH) knowing their status, with 67.5% of those diagnosed on treatment. Scaled-up PITC resulted in 94.4% of PLWH knowing their status and 70.4% of those diagnosed on treatment. The TMP intervention achieved 97.5% of PLWH knowing their status and 80.6% of those diagnosed on treatment. The percentage of infections averted was 1.0% (95% simulation intervals: -19.2% to 19.9%) for scaled-up PITC and 9.4% (95% simulation intervals: -8.1% to 24.5%) for TMP.Our study suggests that leveraging new technologies to identify acute HIV infection among symptomatic outpatients is superior to scaled-up PITC in this population, resulting in95% knowledge of HIV status, and would reduce new HIV infections in Kenya.

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.

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 Conclusion These findings suggest that social norms may affect contraceptive use in Nigeria through ability rather than motivation. In terms of programmatic implications, these finding suggest that public health interventions may be able to counter the negative effects of social norms that discourage contraceptive use by increasing women’s ability to practice contraception.

BackgroundInnovations 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.MethodsWe 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.ResultsIn 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.ConclusionA 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 RegistrationMUREC1/7 No. 07/05-18. Registered; June 29, 2018.

ObjectivesPakistan 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 designWe used a decision tree-analytic model from a governmental (formal healthcare sector) perspective.Study settingIndividuals 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.ParticipantsWe included the general testing population for chronic HCV in Pakistan.InterventionScreening 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.MeasuresOutcome 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.ResultsAt 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).ConclusionsAnti-HCV-CEN would provide the best value for money when scaling up HCV testing in Pakistan.

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.

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 P P = 0.02) among students who used the APP. There was a significant 0.98 unit increase in knowledge score (adjusted coefficient = 0.98, P P = 0.04), a significant 3.5-fold increase in HIV VCT (adjusted coefficient = 3.5, P Conclusion A mobile phone application increased sexual and reproductive health information (knowledge score), access to goods (contraceptives), and services (HIV voluntary testing and counseling and sexually transmitted infection diagnosis and management) among sexually active university students in Uganda. Further technical development, including the refinement of youth-friendly attributes, extending access to the app with other platforms besides android which was pilot tested, as well as further research into potential economic impact and paths to sustainability, is needed before the app is deployed to the general youth population in Uganda and other low-income settings. Trial registration MUREC1/7 No. 07/05–18. Registered on June 29, 2018.

Can Adolescents and Young Adults in Kenya Afford Free HIV Testing Services? Anjuli Wagner;Kate Wilson;Joseph Babigumira;Cyrus Mugo;Peter Mutiti;Jillian Neary;Dalton Wamalwa;David Bukusi;Grace John-Stewart;Pamela Kohler;Jennifer Slyker; Journal of the Association of Nurses in AIDS Care

BackgroundPakistan has a hepatitis C virus (HCV) infection prevalence of 6–9% and aims to achieve World Health Organization (WHO) targets for elimination of HCV by the year 2030 through scaling HCV diagnosis and accelerating access to care. The clinical and economic benefits of various HCV testing strategies have not yet been evaluated in Pakistan.ObjectiveTo evaluate the potential cost-effectiveness of a reference laboratory-based (CEN) confirmatory testing approach vs a molecular near-patient point-of-care (POC) confirmatory approach to screen the general population for HCV in Pakistan.MethodsWe developed a decision-analytic model comparing HCV testing under two scenarios: screening with an anti-HCV antibody test (Anti-HCV) followed by either POC nucleic acid testing (NAT) (Anti-HCV-POC), or reference laboratory NAT (Anti-HCV-CEN), using data from published literature, the Pakistan Ministry of Health, and expert judgment. 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. Sensitivity analysis was also performed.ResultsAt a national level for a tested population of 25 million, the Anti-HCV-CEN strategy would identify 142,406 more HCV infections in one 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 $7.68 million ($0.31 per person). Thus, incrementally, the Anti-HCV-CEN strategy costs less and identifies more HCV infections than Anti-HCV-POC.ConclusionsAnti-HCV-CEN would provide the best value for money when scaling up HCV testing in Pakistan.Significance statementHepatitis C virus (HCV) infection constitutes a major medical and public health burden in PakistanWidespread testing is important to identify those that are chronically infected in order to link them to treatment servicesThe optimal and most cost-effective testing approach to scale up HCV testing to support elimination efforts in Pakistan has not been establishedHigh throughput reference laboratory testing would provide the best value for money when scaling-up HCV testing in Pakistan

Background: Prior reviews argue that unsafe sexual behaviors and poor HIV knowledge significantly increase the probability of acquiring HIV infections among adolescents. This study assessed the predictors of HIV prevention knowledge and sexual behaviors among Makerere university students in Uganda. Methods: We performed a cross-sectional survey. We performed a normality test using Shapiro Wilk test on knowledge score. Results revealed that knowledge score was not normally distributed. The study used two sample Wilcoxon Rank Sum and Kruskal Wallis Rank tests to assess the effect of HIV knowledge on demographic characteristics and sexual behaviors. Post-hoc tests were conducted using Bonferroni correction. Spearman rank correlation test was used for continuous variables while Chi-square and Fisher’s tests were used for categorical variables to assess the relationship between demographic characteristics and sexual behaviors. Results: We report results for 1337 students. The mean age was 21.2SD (1.6) and more than half 700(52.4%) were male students. The median HIV prevention knowledge score of students was 13 IQR (11-15) in the range of 0 to 18. Males significantly scored higher than females (13.0 IQR (12-15) vs. 12.0 IQR (10-14) p=0.000), an increase in age was associated with higher knowledge scores (Rho = 0.101, p = 0.000). Students in the third year of study significantly scored higher than those in the first year, and government-sponsored students scored higher than the privately sponsored students. HIV knowledge was also significantly associated with sexual experience, and condom use at univariate level but insignificant at multiple level analysis. Males were more likely to have ever had sex (31.7% vs. 12.7%) and ever used a condom (63% vs. 55%) than females respectively Conclusion: Our findings suggest that Makerere University students possessed good knowledge on HIV. There is evidence of an association between student’s knowledge, and demographic characteristics and a few sexual behaviors. Future behavioral and educational programs that target both sexually and non-sexually experienced students should address the gender differences.

Disease-free survival (DFS) in early-stage human epidermal growth factor receptor 2 (HER2)-positive breast cancer is significantly greater with the addition of neratinib after adjuvant trastuzumab versus no additional therapy. However, it remains uncertain whether these survival gains represent good value for the money, given the substantial cost of neratinib.To evaluate clinical and economic implications of adding neratinib after adjuvant trastuzumab based on results from the phase III ExteNET trial.A 3-state Markov model was developed to estimate the cost-effectiveness of neratinib for women with early-stage (I-III) HER2-positive breast cancer. Five-year recurrence rates were derived from the ExteNET trial. Mortality and recurrence rates after 5 years were derived from the HERceptin Adjuvant (HERA) trial. Outcomes included life-years, quality-adjusted life-years (QALYs), and direct medical expenditures. The analysis was performed from a payer perspective over a lifetime horizon. One-way sensitivity and probabilistic analyses were conducted to evaluate uncertainty.Total cost of neratinib following adjuvant trastuzumab was $317,619 versus $152,812 for adjuvant trastuzumab alone. A gain of 0.4 QALYs (15.7 vs. 15.3) and 0.1 years of projected life expectancy (18.3 vs. 18.2) favored neratinib after trastuzumab versus trastuzumab alone. The neratinib cost per QALY gained was $416,106. At standard willingness-to-pay thresholds of $50,000, $100,000, and $200,000 per QALY gained, neratinib has a probability of 2.8%, 16.7%, and 33.9% of cost-effectiveness, respectively. The cost per QALY gained in a scenario analysis only including patients with hormone-receptor positive disease was $275,311.Based on 5-year data from ExteNET, neratinib following adjuvant trastuzumab is not projected to be cost-effective, even among those patients shown to derive the greatest clinical benefit. Future analyses should reassess the cost-effectiveness associated with neratinib treatment as trial data mature.No outside funding supported this study. Roth reports consulting fees from Genentech. Steuten reports grants from AstraZeneca, EMD Serono, and Genomic Health, along with personal fees from Agendia, unrelated to this study. The other authors have no conflicts of interest in connection with this study.

Objective The APHINITY trial assessed the effectiveness and the safety of adding pertuzumab to trastuzumab and chemotherapy (THP) compared to trastuzumab and chemotherapy (TH) in the adjuvant management of human epidermal growth factor 2-positive (HER2+) breast cancer. We performed a study to project the potential cost-effectiveness of THP vs. TH. Study Design Trial-based cost-utility modeling analysis. Methods We performed an economic evaluation from a payer perspective using a Markov model with six health states: invasive disease-free survival, non-metastatic recurrence, remission, first-line metastatic, subsequent line metastatic, and death. We parameterized the model using data from both arms in APHINITY extrapolated to a patient’s lifetime horizon. Estimates of health state utilities were based on EQ-5D trial data and the literature, and costs were estimated from government sources and the published literature. The primary outcomes of the model were life-years (LYs), quality-adjusted LYs (QALYs), costs, and incremental cost-effectiveness ratios (ICERs). Uncertainty was addressed via univariate and probabilistic sensitivity analyses. Results For the intention-to-treat population, the model projected improved outcomes (by 0.50 LYs and 0.45 QALYs) and increased costs (by $74 420) for ICERs of $147 774/LY gained and $167 185/QALY gained for PHT vs. HT patients. In the node-positive patient population, the model projected improved outcomes (by 0.86 LYs and 0.76 QALYs) and increased costs (by $66 647) for ICERs of $77 684/LY gained and $87 929/QALY gained. For the hormone-receptor-negative patient population, the model projected health gains, increased costs, and ICERs of $147 022/LY gained and $166 518/QALY gained. The results were sensitive to changes in the model time horizon. Conclusion The addition of pertuzumab to the available regimens for HER2+ early breast cancer is likely to be cost-effective for patients in the U.S. at high risk of recurrence.

BackgroundDetection 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.MethodsWe 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.ResultsAfter 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.ConclusionPOC-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 numberTambua Mapema (“Discover Early”) Plus study (NCT03508908) conducted in Kenya (2017–2020) i.e., Post-results.

Background Improving maternal health has been a primary goal of international health agencies for many years, with the aim of reducing maternal and child deaths and improving access to antenatal care (ANC) services, particularly in low-and-middle-income countries (LMICs). Health interventions with these aims have received more attention from a clinical effectiveness perspective than for cost impact and economic efficiency. Methods We collected data on resource use and costs as part of a large, multi-country study assessing the use of routine antenatal screening ultrasound (US) with the aim of considering the implications for economic efficiency. We assessed typical antenatal outpatient and hospital-based (facility) care for pregnant women, in general, with selective complication-related data collection in women participating in a large maternal health registry and clinical trial in five LMICs. We estimated average costs from a facility/health system perspective for outpatient and inpatient services. We converted all country-level currency cost estimates to 2015 United States dollars (USD). We compared average costs across countries for ANC visits, deliveries, higher-risk pregnancies, and complications, and conducted sensitivity analyses. Results Our study included sites in five countries representing different regions. Overall, the relative cost of individual ANC and delivery-related healthcare use was consistent among countries, generally corresponding to country-specific income levels. ANC outpatient visit cost estimates per patient among countries ranged from 15 to 30 USD, based on average counts for visits with and without US. Estimates for antenatal screening US visits were more costly than non-US visits. Costs associated with higher-risk pregnancies were influenced by rates of hospital delivery by cesarean section (mean per person delivery cost estimate range: 25–65 USD). Conclusions Despite substantial differences among countries in infrastructures and health system capacity, there were similarities in resource allocation, delivery location, and country-level challenges. Overall, there was no clear suggestion that adding antenatal screening US would result in either major cost savings or major cost increases. However, antenatal screening US would have higher training and maintenance costs. Given the lack of clinical effectiveness evidence and greater resource constraints of LMICs, it is unlikely that introducing antenatal screening US would be economically efficient in these settings--on the demand side (i.e., patients) or supply side (i.e., healthcare providers). Trial registration Trial number: NCT01990625 (First posted: November 21, 2013 on https://clinicaltrials.gov).

Background In sub-Saharan Africa, adult outpatients with symptoms of acute infectious illness are not routinely tested for prevalent or acute HIV infection (AHI) when seeking healthcare. Methods Adult symptomatic outpatients aged 18-39 years were evaluated by a consensus AHI risk score. Patients with a risk score ≥ 2 and no previous HIV diagnosis were enrolled in a stepped-wedge trial of opt-out delivery of point-of-care (POC) HIV-1 nucleic acid testing (NAAT), compared with standard provider-initiated HIV testing using rapid tests in the observation period. The primary outcome was the number of new diagnoses in each study period. Generalized estimating equations with a log-binomial link and robust variance estimates were used to account for clustering by health facility. The trial is registered with ClinicalTrials.gov NCT03508908. Results Between 2017 and 2020, 13 (0.9%) out of 1374 participants in the observation period and 37 (2.5%) out of 1500 participants in the intervention period were diagnosed with HIV infection. Of the 37 newly diagnosed cases in the intervention period, two (5.4%) had AHI. Participants in the opt-out intervention had a two-fold greater odds of being diagnosed with HIV (odds ratio = 2.2, 95% confidence interval: 1.39-3.51) after adjustment for factors imbalanced across study periods. Conclusions Among symptomatic adults aged 18-39 years targeted by our POC NAAT intervention, we identified one chronic HIV infection for every 40 patients and one AHI patient for every 750 patients tested. Although AHI yield was low in this population, routinely offered opt-out testing could diagnose twice as many patients as an approach relying on provider discretion.

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.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.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

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.

BACKGROUND: Financial incentives (FI) can motivate desirable health behaviors, including adult HIV testing. Data regarding the effectiveness of FI for HIV testing in children, who require urgent testing to prevent mortality, are lacking. METHODS: In a 5-arm unblinded randomized controlled trial, adults living with HIV attending 19 HIV clinics in Western Kenya, with children 0-12 years of unknown HIV status, were randomized with equal allocation to $0, $1.25, $2.50, $5 or $10. Payment was conditional on child HIV testing within 2 months. Block randomization with fixed block sizes was used; participants and study staff were unblinded at randomization. Primary analysis was intent-to-treat, with predefined primary outcomes of completing child HIV testing and time to testing. RESULTS: Of 452 caregivers, 90, 89, 93, 92 and 88 were randomized to $0, $1.25, $2.50, $5.00, and $10.00, respectively. Of those, 31 (34%), 31 (35%), 44 (47%), 51 (55%), and 54 (61%) in the $0, $1.25, $2.50, $5.00, and $10.00 arms, respectively, completed child testing. Compared to the $0 arm, and adjusted for site, caregivers in the $10.00 arm had significantly higher uptake of testing (Relative risk: 1.80 [95%CI 1.15, 2.80] p=0.010). Compared to the $0 arm, and adjusted for site, time to testing was significantly faster in the $5.00 and $10.00 arms (Hazard ratio: 1.95 [95%CI 1.24, 3.07] p=0.004, 2.42 [95%CI 1.55, 3.79] p

Background: Few theories of health behavior explicitly take the effect of social norms on behavior into account. The ones that do assume that the effect of norms on behavior operates through motivation. We use a behavior model that is new to public health to test whether norms affect behavior through motivation or ability. Methods: This study uses data from a 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. The survey also collected data on descriptive and injunctive norms around premarital sex and contraceptive use. Multivariate logistic regression was used to test whether the effect of unfavorable social norms on modern contraceptive use operates through motivation or ability. Results: The data was used to construct variables measuring unfavorable social norms, motivation, ability, and modern contraceptive use. After adjusting for a range of socio-economic and demographic variables, we found that unfavorable social norms had a statistically significant negative effect on contraceptive use. The analysis suggests that the effect of unfavorable social norms on contraceptive use operates through ability.Conclusion: This study sheds light on the pathway through which social norms affect contraceptive use. The findings suggest that public health interventions may be able to counter the negative effects of unfavorable social norms on modern contraceptive use by increasing women’s ability to practice contraception. These findings have important implications for the design of interventions that aim to increase contraceptive use among young women in Nigeria. The study also demonstrates the utility of the FBM, a practitioner-friendly, behavior change model, in examining the relationship between norms and behavior.

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 five-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 five-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.

Background: University students are one of the most vulnerable groups to sexual and reproductive health (SRH) threats, yet they often have limited access to SRH tools, services and information. This study explored university students’ perceptions of SRH, their source of SRH information and how they authenticated such information in Uganda. Methods: Data were collected from 40 students of Kyambogo university—20 males and 20 females through 4 gender-classified Focus Group Discussions (FGDs). Atlas ti 8 software was used to analyse the data and generate themes from interview transcripts.Results: Many students perceived SRH to be about sexual intercourse and its related consequences. Perceived risky behaviours included mainly having multiple sexual partners. The students identified the reduced sexual sensitivity, struggle to bear children in the future, as the myths and misconceptions about different SRH goods and services in addition to the uncertainty over safe days. The various sources of SRH information included Google, social media, health centres, friends, parents and government and non-government organizations. The main barriers to accessing SRH information included lack of finances, inadequate or few medical personnel, and service provider bias. Many of them authenticated the SRH information from the internet through their friends. Conclusion: New approaches and interventions should target both students and their parents, as this multifaceted approach will reduce the societal stigma, bias, ignorance, negative attitudes, and exposure to risky sexual behaviours among such youth populations.

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. 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. 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. MUREC1/7 No. 07/05–18 . Registered 29th June 2018.

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

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.

Purpose The Cap-Score™ was developed to assess the capacitation status of men, thereby enabling personalized management of unexplained infertility by choosing timed intrauterine insemination (IUI), versus immediate in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) in individuals with a low Cap-Score™. The objective of this study was to estimate the differences in outcomes and costs comparing the use of the Cap-Score™ with timed IUI (CS-TI) and the standard of care (SOC), which was assumed to be three IUI cycles followed by three IVF-ICSI cycles. Methods We developed and parameterized a decision-analytic model of management of unexplained infertility for women based on data from the published literature. We calculated the clinical pregnancy rates, live birth rates, and medical costs comparing CS-TI and SOC. We used Monte Carlo simulation to quantify uncertainty in projected estimates and performed univariate sensitivity analysis. Results Compared to SOC, CS-TI was projected to increase the pregnancy rate by 1–26%, marginally reduce live birth rates by 1–3% in couples with women below 40 years, increase live birth rates by 3–7% in couples with women over 40 years, reduce mean medical costs by $4000–$19,200, reduce IUI costs by $600–$1370, and reduce IVF costs by $3400–$17,800, depending on the woman’s age. Conclusion The Cap-Score™ is a potentially valuable clinical tool for management of unexplained infertility because it is projected to improve clinical pregnancy rates, save money, and, depending on the price of the test, increase access to treatment for infertility.

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.

BACKGROUND Detection and management of acute HIV infection (AHI) is a clinical and public health priority, and HIV infections diagnosed among young adults aged 18 to 39 years are usually recent. Young adults with recent HIV acquisition frequently seek care for symptoms and could potentially be diagnosed through the health care system. Early recognition of HIV infection provides considerable individual and public health benefits, including linkage to treatment as prevention, access to risk reduction counseling and treatment, and notification of partners in need of HIV testing. OBJECTIVE The Tambua Mapema Plus study aims to (1) test 1500 young adults (aged 18-39 years) identified by an AHI screening algorithm for acute and prevalent (ie, seropositive) HIV, linking all newly diagnosed HIV-infected patients to care and offering immediate treatment; (2) offer assisted HIV partner notification services to all patients with HIV, testing partners for acute and prevalent HIV infection and identifying local sexual networks; and (3) model the potential impact of these two interventions on the Kenyan HIV epidemic, estimating incremental costs per HIV infection averted, death averted, and disability-adjusted life year averted using data on study outcomes. METHODS A modified stepped-wedge design is evaluating the yield of this HIV testing intervention at 4 public and 2 private health facilities in coastal Kenya before and after intervention delivery. The intervention uses point-of-care HIV-1 RNA testing combined with standard rapid antibody tests to diagnose AHI and prevalent HIV among young adults presenting for care, employs HIV partner notification services to identify linked acute and prevalent infections, and follows all newly diagnosed patients and their partners for 12 months to ascertain clinical outcomes, including linkage to care, antiretroviral therapy (ART) initiation and virologic suppression in HIV-infected patients, and pre-exposure prophylaxis uptake in uninfected individuals in discordant partnerships. RESULTS Enrollment started in December 2017. As of April 2020, 1374 participants have been enrolled in the observation period and 1500 participants have been enrolled in the intervention period, with 13 new diagnoses (0.95%) in the observation period and 37 new diagnoses (2.47%), including 2 AHI diagnoses, in the intervention period. Analysis is ongoing and will include adjusted comparisons of the odds of the following outcomes in the observation and intervention periods: being tested for HIV infection, newly diagnosed with prevalent or acute HIV infection, linked to care, and starting ART by week 6 following HIV diagnosis. Participants newly diagnosed with acute or prevalent HIV infection in the intervention period are being followed for outcomes, including viral suppression by month 6 and month 12 following ART initiation and partner testing outcomes. CONCLUSIONS The Tambua Mapema Plus study will provide foundational data on the potential of this novel combination HIV prevention intervention to reduce ongoing HIV transmission in Kenya and other high-prevalence African settings. CLINICALTRIAL ClinicalTrials.gov NCT03508908; https://clinicaltrials.gov/ct2/show/NCT03508908 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/16198

Background HIV viral load (VL) monitoring informs antiretroviral therapy failure and helps to guide regimen changes. Typically, VL monitoring is performed using dried blood spot (DBS) samples transported and tested in a centralized laboratory. Novel sample collection technologies based on dried plasma stored on a plasma separation card (PSC) have become available. The cost-effectiveness of these different testing approaches to monitor VL is uncertain, especially in resource-limited settings. The objective of this study is to evaluate the potential cost-effectiveness of HIV VL testing approaches with PSC samples compared to DBS samples in Malawi. Methods We developed a decision-tree model to evaluate the cost-effectiveness of two different sample collection and testing methods—DBS and PSC samples transported and tested at central laboratories. The analysis used data from the published literature and was performed from the Malawi Ministry of Health perspective. We estimated costs of sample collection, transportation, and testing. The primary clinical outcome was test accuracy (proportion of patients correctly classified with or without treatment failure). Sensitivity analysis was performed to assess the robustness of results. Results The estimated test accuracy for a DBS testing approach was 87.5% compared to 97.4% for an approach with PSC. The estimated total cost per patient of a DBS testing approach was $19.39 compared to $17.73 for a PSC approach. Based on this, a PSC-based testing approach “dominates” a DBS-based testing approach (i.e., lower cost and higher accuracy). Conclusion The base-case analysis shows that a testing approach using PSC sample is less costly and more accurate (correctly classifies more patients with or without treatment failure) than with a DBS approach. Our study suggests that a PSC testing approach is likely an optimal strategy for routine HIV VL monitoring in Malawi. However, given the limited data regarding sample viability, additional real-world data are needed to validate the results.

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 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.