Publications by authors named "Joseph B Babigumira"

54 Publications

Understanding how social norms affect modern contraceptive use.

BMC Public Health 2021 06 4;21(1):1061. Epub 2021 Jun 4.

The University of Washington, Seattle, USA.

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 < 0.001). The analysis found that the negative association between social norms and contraceptive use remained statistically significant after controlling for motivation but did not remain statistically significant after controlling for ability.

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.
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http://dx.doi.org/10.1186/s12889-021-11110-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8178889PMC
June 2021

Utilization of a mobile phone application to increase access to sexual and reproductive health information, goods, and services among university students in Uganda.

Reprod Health 2021 May 17;18(1):95. Epub 2021 May 17.

Saw Swee Hock School of Public Health, National University of Singapore , Block MD1, 12 Science Drive 2, Tahir Foundation Building, #09-03M, Singapore, 117549, Singapore.

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.
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http://dx.doi.org/10.1186/s12978-020-01037-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8127235PMC
May 2021

Analysis of the gap in PCR monitoring availability for patients with chronic myeloid leukemia in 60 low- and middle-income countries.

Cost Eff Resour Alloc 2021 Mar 12;19(1):18. Epub 2021 Mar 12.

Global Medicines Program, Department of Global Health, School of Public Health, University of Washington, Seattle, USA.

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® 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.
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http://dx.doi.org/10.1186/s12962-021-00271-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7953726PMC
March 2021

A systematic literature review of economic evaluations of pneumococcal conjugate vaccines in east and southeast Asia (2006-2019).

Expert Rev Vaccines 2021 Mar 22:1-14. Epub 2021 Mar 22.

Health Economics and Outcomes Research, Pfizer Inc, New York, NY, USA.

Introduction: 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 and serotype 3, were the main drivers of cost-effectiveness.
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http://dx.doi.org/10.1080/14760584.2021.1894933DOI Listing
March 2021

Effectiveness of a mobile phone application to increase access to sexual and reproductive health information, goods, and services among university students in Uganda: a randomized controlled trial.

Contracept Reprod Med 2020 Oct 31;5(1):31. Epub 2020 Oct 31.

Department of Community Medicine and Public Health, Sahlgrenska Academy, University of Gothenburg, P. O Box 414, 40530, Gothenburg, Sweden.

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 < 0.001), contraceptive use (DID = 6.6%, P < 0.001), HIV Voluntary testing and counselling (DID = 17.2%, P < 0.001), STI diagnosis and treatment (DID = 12.9%, P < 0.001), and condom use at last sex (DID = 4%,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 < 0.001), a significant 1.6-fold increase in odds of contraceptive use (adjusted coefficient = 1.6, P = 0.04), a significant 3.5-fold increase in HIV VCT (adjusted coefficient = 3.5, P < 0.001), and a significant 2-fold increase in odds of STI testing and treatment (adjusted coefficient = 1.9, P < 0.001) after adjusting for demographic characteristics among APP users compared to the control group.

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.
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http://dx.doi.org/10.1186/s40834-020-00134-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7603751PMC
October 2020

Financial incentives to increase pediatric HIV testing: a randomized trial.

AIDS 2021 01;35(1):125-130

Department of Epidemiology.

Background: Financial incentives can motivate desirable health behaviors, including adult HIV testing. Data regarding the effectiveness of financial incentives for HIV testing in children, who require urgent testing to prevent mortality, are lacking.

Methods: In a five-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 with 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 with 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 < 0.001, respectively).

Conclusion: Financial incentives are effective in improving pediatric HIV testing among caregivers living with HIV.

Registration: NCT03049917.
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http://dx.doi.org/10.1097/QAD.0000000000002720DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7791594PMC
January 2021

Cost-effectiveness analysis of two-way texting for post-operative follow-up in Zimbabwe's voluntary medical male circumcision program.

PLoS One 2020 30;15(9):e0239915. Epub 2020 Sep 30.

Department of Global Health, University of Washington, Seattle, WA, United States of America.

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.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0239915PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7526887PMC
December 2020

A Novel HIV-1 RNA Testing Intervention to Detect Acute and Prevalent HIV Infection in Young Adults and Reduce HIV Transmission in Kenya: Protocol for a Randomized Controlled Trial.

JMIR Res Protoc 2020 Aug 7;9(8):e16198. Epub 2020 Aug 7.

Kenya Medical Research Institute - Wellcome Trust Research Programme, Kilifi, Kenya.

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.

Trial Registration: ClinicalTrials.gov NCT03508908; https://clinicaltrials.gov/ct2/show/NCT03508908.

International Registered Report Identifier (irrid): DERR1-10.2196/16198.
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http://dx.doi.org/10.2196/16198DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7442943PMC
August 2020

Cost-effectiveness analysis of pre-ART HIV drug resistance testing in Kenyan women.

EClinicalMedicine 2020 May 22;22:100355. Epub 2020 May 22.

Department of Medicine, Stanford University, Stanford, CA, United States.

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.
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http://dx.doi.org/10.1016/j.eclinm.2020.100355DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7256304PMC
May 2020

Implementation strategy and cost of Mozambique's HPV vaccine demonstration project.

BMC Public Health 2019 Oct 29;19(1):1406. Epub 2019 Oct 29.

Department of Global Health, Harris Hydraulics Laboratory, University of Washington, 1510 San Juan Road, Seattle, WA, 98195, USA.

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.
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http://dx.doi.org/10.1186/s12889-019-7793-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6819423PMC
October 2019

Cost-Effectiveness Analysis of Adjuvant Neratinib Following Trastuzumab in Early-Stage HER2-Positive Breast Cancer.

J Manag Care Spec Pharm 2019 Oct;25(10):1133-1139

Fred Hutchinson Cancer Research Center, Seattle, Washington.

Background: 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.

Objective: To evaluate clinical and economic implications of adding neratinib after adjuvant trastuzumab based on results from the phase III ExteNET trial.

Methods: 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.

Results: 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.

Conclusions: 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.

Disclosures: 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.
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http://dx.doi.org/10.18553/jmcp.2019.25.10.1133DOI Listing
October 2019

Acceptability and utilization of family planning benefits cards by youth in slums in Kampala, Uganda.

Contracept Reprod Med 2019 5;4:10. Epub 2019 Aug 5.

2Department of Global Health, University of Washington, 1959 NE Pacific Street, Health Sciences Building F-151-B, Box 357630, Seattle, WA 98195 USA.

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,  = 0.011). Participants in professional/managerial employment were 30 times more likely to discontinue compared to the unemployed (adjusted OR = 30.3,  = 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,  = 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.
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http://dx.doi.org/10.1186/s40834-019-0092-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6681485PMC
August 2019

Estimating the costs of HIV clinic integrated versus non-integrated treatment of pre-cancerous cervical lesions and costs of cervical cancer treatment in Kenya.

PLoS One 2019 6;14(6):e0217331. Epub 2019 Jun 6.

University of Washington, Seattle, Washington, United States of America.

Objectives: To 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 Methods: A 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.

Results: Patients 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.

Conclusions: Integrating 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.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0217331PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6553698PMC
February 2020

Use of the Fogg Behavior Model to Assess the Impact of a Social Marketing Campaign on Condom Use in Pakistan.

J Health Commun 2019 4;24(3):284-292. Epub 2019 Apr 4.

b University of Washington, Strategic Analysis, Research, and Training (START) Center , Seattle , WA , USA.

The Fogg Behavior Model (FBM) is a new framework which posits that behavior happens when three factors - motivation, ability, and a prompt - occur in the same moment. The FBM categorizes people into four groups based on motivation and ability and posits that those with high motivation and high ability will adopt a behavior when prompted. Two rounds of panel survey data from 617 married men in urban Pakistan were used to test this hypothesis. Multilevel mixed-effects logistic regression was used for the analysis. The results show the relationships between ability, motivation, the prompt and condom use to be as hypothesized by the FBM. After adjustment for a range of variables including fertility desires, education, and household wealth, the odds of condom use among men with high motivation and high ability were 34 times higher than the odds of condom use among men with low motivation and low ability. Moreover, the association between the prompt and condom use operated through increased motivation and ability. The FBM has potential for use in the design and evaluation of behavior change interventions in developing countries.
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http://dx.doi.org/10.1080/10810730.2019.1597952DOI Listing
March 2020

Study protocol: using a mobile phone-based application to increase awareness and uptake of sexual and reproductive health services among the youth in Uganda. A randomized controlled trial.

Reprod Health 2018 Dec 22;15(1):216. Epub 2018 Dec 22.

Global Medicines Program, Department of Global Health, University of Washington, P.O. Box 357630, Seattle, WA, 98195, USA.

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.
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http://dx.doi.org/10.1186/s12978-018-0642-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6303874PMC
December 2018

Expanding global access to essential medicines: investment priorities for sustainably strengthening medical product regulatory systems.

Global Health 2018 11 1;14(1):102. Epub 2018 Nov 1.

Promoting the Quality of Medicines program, United States Pharmacopeia, Rockville, USA.

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.
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http://dx.doi.org/10.1186/s12992-018-0421-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6211488PMC
November 2018

Financial Incentives for Pediatric HIV Testing in Kenya.

Pediatr Infect Dis J 2018 11;37(11):1142-1144

From the Department of Global Health, University of Washington, Seattle, WA.

The acceptability of financial incentives for pediatric HIV testing was evaluated in Kenya. Sixty HIV-positive women with children of unknown status were randomized to receive $5, $10 or $15 conditional upon HIV testing. Forty-four (73%) completed child testing, with similar rates across arms. Uptake was significantly higher than a cohort with similar procedures but no incentives (73% vs. 14%, P < 0.001).
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http://dx.doi.org/10.1097/INF.0000000000002035DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6153083PMC
November 2018

Azithromycin to prevent post-discharge morbidity and mortality in Kenyan children: a protocol for a randomised, double-blind, placebo-controlled trial (the Toto Bora trial).

BMJ Open 2017 12 29;7(12):e019170. Epub 2017 Dec 29.

Department of Global Health, University of Washington, Seattle, Washington, USA.

Introduction: Child mortality due to infectious diseases remains unacceptably high in much of sub-Saharan Africa. Children who are hospitalised represent an accessible population at particularly high risk of death, both during and following hospitalisation. Hospital discharge may be a critical time point at which targeted use of antibiotics could reduce morbidity and mortality in high-risk children.

Methods And Analysis: In this randomised, double-blind, placebo-controlled trial (Toto Bora Trial), 1400 children aged 1-59 months discharged from hospitals in Western Kenya, in Kisii and Homa Bay, will be randomised to either a 5-day course of azithromycin or placebo to determine whether a short course of azithromycin reduces rates of rehospitalisation and/or death in the subsequent 6-month period. The primary analysis will be modified intention-to-treat and will compare the rates of rehospitalisation or death in children treated with azithromycin or placebo using Cox proportional hazard regression. The trial will also evaluate the effect of a short course of azithromycin on enteric and nasopharyngeal infections and cause-specific morbidities. We will also identify risk factors for postdischarge morbidity and mortality and subpopulations most likely to benefit from postdischarge antibiotic use. Antibiotic resistance in and among enrolled children and their primary caregivers will also be assessed, and cost-effectiveness analyses will be performed to inform policy decisions.

Ethics And Dissemination: Study procedures were reviewed and approved by the institutional review boards of the Kenya Medical Research Institute, the University of Washington and the Kenyan Pharmacy and Poisons Board. The study is being externally monitored, and a data safety and monitoring committee has been assembled to monitor patient safety and to evaluate the efficacy of the intervention. The results of this trial will be published in peer-reviewed scientific journals and presented at relevant academic conferences and to key stakeholders.

Trial Registration Number: NCT02414399.
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http://dx.doi.org/10.1136/bmjopen-2017-019170DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5778294PMC
December 2017

Simulated patient encounters to improve adolescent retention in HIV care in Kenya: study protocol of a stepped-wedge randomized controlled trial.

Trials 2017 Dec 28;18(1):619. Epub 2017 Dec 28.

Department of Global Health, University of Washington, 325 9th Avenue, Box 359932, Seattle, WA, 98104, USA.

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.
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http://dx.doi.org/10.1186/s13063-017-2266-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5745919PMC
December 2017

Acceptability of cervical cancer screening using visual inspection among women attending a childhood immunization clinic in Uganda.

Papillomavirus Res 2017 12 8;4:17-21. Epub 2017 Jun 8.

Pharmaceutical Outcomes Research and Policy Program, Department of Pharmacy, University of Washington, Seattle, WA, USA; Global Medicines Program, Department of Global Health, University of Washington, Seattle, WA, USA.

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<0.001) and employment status (OR 2.00; p-value=0.019) were significantly associated with acceptance of VIA screening. In the multivariate model, no characteristic was independently associated with acceptance of VIA screening after adjusting for other factors. Compared to reference Pap smear, CC screening with VIA had a sensitivity of 50% and a specificity of 97.7%.

Conclusions: CC screening with VIA is highly acceptable in the setting of rural immunization clinics in Uganda. Studies to assess which screening method would be the most effective and cost-effective are needed before stakeholders can consider adopting screening programs at scale.
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http://dx.doi.org/10.1016/j.pvr.2017.06.004DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5883247PMC
December 2017

Study protocol: incentives for increased access to comprehensive family planning for urban youth using a benefits card in Uganda. A quasi-experimental study.

Reprod Health 2017 Oct 27;14(1):140. Epub 2017 Oct 27.

Pharmaceutical Outcomes Research and Policy Program, Department of Pharmacy, University of Washington, P.O. Box 357630, Seattle, WA, 98195, USA.

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.
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http://dx.doi.org/10.1186/s12978-017-0400-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5659021PMC
October 2017

Projecting the potential impact of the Cap-Score™ on clinical pregnancy, live births, and medical costs in couples with unexplained infertility.

J Assist Reprod Genet 2018 Jan 23;35(1):99-106. Epub 2017 Sep 23.

Global Medicines Program, Department of Global Health, University of Washington, 1510 San Juan Road, Box 357965, Seattle, WA, 98092, USA.

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.
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http://dx.doi.org/10.1007/s10815-017-1021-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5758457PMC
January 2018

Impact of pharmacy worker training and deployment on access to essential medicines for children under five in Malawi: a cluster quasi-experimental evaluation.

BMC Health Serv Res 2017 Sep 11;17(1):638. Epub 2017 Sep 11.

Global Medicines Program, Departments of Global Health and Pharmacy, University of Washington, Harris Hydraulics Building 1510 San Juan Road, Box 357965, Seattle, WA, 98195, USA.

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.
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http://dx.doi.org/10.1186/s12913-017-2530-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5594492PMC
September 2017

Cost-effectiveness of cervical cancer screening and preventative cryotherapy at an HIV treatment clinic in Kenya.

Cost Eff Resour Alloc 2017 14;15:13. Epub 2017 Jul 14.

Department of Global Health, University of Washington, 325 Ninth Avenue, Box 359909, Seattle, WA 98104 USA.

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.
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http://dx.doi.org/10.1186/s12962-017-0075-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5513032PMC
July 2017

Costs of integrating cervical cancer screening at an HIV clinic in Kenya.

Int J Gynaecol Obstet 2017 Feb 21;136(2):220-228. Epub 2016 Nov 21.

University of Washington, Seattle, WA, USA.

Objective: To estimate the societal-level costs of integrating cervical cancer screening into HIV clinics in Nairobi, Kenya.

Methods: A cross-sectional micro-costing study was performed at Coptic Hope Center for Infectious Diseases and Kenyatta National Hospital, Kenya, between July 1 and October 31, 2014. To estimate direct medical, non-medical, and indirect costs associated with screening, a time-and-motion study was performed, and semi-structured interviews were conducted with women aged at least 18 years attending the clinic for screening during the study period and with clinic staff who had experience relevant to cervical cancer screening.

Results: There were 148 patients and 23 clinic staff who participated in interviews. Visual inspection with acetic acid was associated with the lowest estimated marginal per-screening costs ($3.30), followed by careHPV ($18.28), Papanicolaou ($24.59), and Hybrid Capture 2 screening ($31.15). Laboratory expenses were the main cost drivers for Papanicolaou and Hybrid Capture 2 testing ($11.61 and $16.41, respectively). Overhead and patient transportation affected the costs of all methods. Indirect costs were cheaper for single-visit screening methods ($0.43 per screening) than two-visit screening methods ($2.88 per screening).

Conclusions: Integrating cervical cancer screening into HIV clinics would be cost-saving from a societal perspective compared with non-integrated screening. These findings could be used in cost-effectiveness analyses to assess incremental costs per clinical outcome in an integrated setting.
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http://dx.doi.org/10.1002/ijgo.12025DOI Listing
February 2017

Estimating the Cost of Illness of Giant Cell Arteritis in the United States.

Rheumatol Ther 2017 Jun 13;4(1):111-119. Epub 2017 Jan 13.

Global Medicines Program, Department of Global Health, University of Washington, Seattle, WA, USA.

Introduction: Giant cell arteritis (GCA) is a chronic vasculitis affecting approximately 230,000 Americans. Limited data exist on the healthcare resource utilization and costs attributable to GCA. The objective of this study was to estimate the cost of illness in patients with GCA in the US.

Methods: A cohort of patients with a new GCA diagnosis was identified from a large US claims database between 1 January 2008 and 31 December 2012. Newly diagnosed GCA patients were defined by two claims with GCA (ICD-9 446.5) as one of the listed diagnoses during the study period and no GCA diagnosis in the 12 months prior. Subjects without a GCA diagnosis were matched 5:1 to cases. One-year healthcare costs were compared among cases and controls, adjusting for covariates using generalized linear models.

Results: A cohort of 1293 GCA patients and 6465 controls was identified. The mean age was 73 years, and 69% were females. Mean Charlson Comorbidity Index was 1.9 for GCA patients and 1.0 for controls. Mean 1-year cost for GCA patients was $34,065 [standard deviation (SD) $52,411], and mean 1-year cost for controls was $12,890 (SD $37,345). After multivariate adjustment, the difference in 1-year cost between GCA patients and controls was $16,431 (95% CI $13,821-$19,041).

Conclusions: Patients with GCA experience substantially higher healthcare costs in the first year following diagnosis compared to patients without GCA. These results add to the limited evidence available to inform researchers, clinicians, and policymakers on the cost burden of GCA in the US.

Funding: Genentech Inc.
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http://dx.doi.org/10.1007/s40744-017-0052-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5443721PMC
June 2017

Cost-utility and budget impact of methylene blue-treated plasma compared to quarantine plasma.

Blood Transfus 2018 02 16;16(2):154-162. Epub 2016 Nov 16.

Blood Systems Research Institute, San Francisco, United States of America.

Background: Methylene blue and visible light treatment and quarantine are two methods used to reduce adverse events, mostly infections, associated with the transfusion of fresh-frozen plasma. The objective of this study was to estimate and compare the budget impact and cost-utility of these two methods from a payer's perspective.

Materials And Methods: A budget impact and cost-utility model simulating the risks of hepatitis B virus, hepatitis C virus, cytomegalovirus, a West Nile virus-like infection, allergic reactions and febrile non-haemolytic transfusion reactions achieved using plasma treated with methylene blue and visible light (MBP) and quarantine plasma (QP) was constructed for Spain. QP costs were estimated using data from one blood centre in Spain and published literature. The costs of producing fresh-frozen plasma from whole blood, apheresis plasma, and multicomponent apheresis, and separately for passive and active methods of donor recall for QP were included. Costs and outcomes over a 5-year and lifetime time horizon were estimated.

Results: Compared to passive QP, MBP led to a net increase of € 850,352, and compared to active QP, MBP led to a net saving of € 5,890,425 over a 5-year period. Compared to passive QP, MBP increased the cost of fresh-frozen plasma per patient by € 7.21 and had an incremental cost-utility ratio of € 705,126 per quality-adjusted life-year. Compared to active QP, MBP reduced cost by € 50.46 per patient and was more effective.

Discussion: Plasma collection method and quarantine approach had the strongest influence on the budget impact and cost-utility of MBP. If QP relies on plasma from whole blood collection and passive quarantine, it is less costly than MBP. However, MPB was estimated to be more effective than QP in all analyses.
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http://dx.doi.org/10.2450/2016.0130-16DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5839612PMC
February 2018
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