Characteristics of male perpetrators of intimate partner violence and implications for women's HIV status: A pooled analysis of cohabiting couples from 27 countries in Africa (2000-2020).

Intimate partner violence (IPV) may increase women's HIV acquisition risk. Still, knowledge on pathways through which IPV exacerbates HIV burden is emerging. We examined the individual and partnership-level characteristics of male perpetrators of physical and/or sexual IPV and considered their implications for women's HIV status. We pooled individual-level data from nationally representative, cross-sectional surveys in 27 countries in Africa (2000-2020) with information on past-year physical and/or sexual IPV and HIV serology among cohabiting couples (≥15 years). Current partners of women experiencing past-year IPV were assumed to be IPV perpetrators. We used Poisson regression, based on Generalized Estimating Equations, to estimate prevalence ratios (PR) for male partner and partnership-level factors associated with perpetration of IPV, and men's HIV status. We used marginal standardization to estimate the adjusted risk differences (aRD) quantifying the incremental effect of IPV on women's risk of living with HIV, beyond the risk from their partners' HIV status. Models were adjusted for survey fixed effects and potential confounders. In the 48 surveys available from 27 countries (N = 111,659 couples), one-fifth of women reported that their partner had perpetrated IPV in the past year. Men who perpetrated IPV were more likely to be living with HIV (aPR = 1.09; 95%CI: 1.01-1.16). The aRD for living with HIV among women aged 15-24 whose partners were HIV seropositive and perpetrated past-year IPV was 30% (95%CI: 26%-35%), compared to women whose partners were HIV seronegative and did not perpetrate IPV. Compared to the same group, aRD among women whose partner was HIV seropositive without perpetrating IPV was 27% (95%CI: 23%-30%). Men who perpetrated IPV are more likely to be living with HIV. IPV is associated with a slight increase in young women's risk of living with HIV beyond the risk of having an HIV seropositive partner, which suggests the mutually reinforcing effects of HIV/IPV.

Economic evaluation of a cluster randomized, non-inferiority trial of differentiated service delivery models of HIV treatment in Zimbabwe.

About 85% of Zimbabwe's >1.4 million people living with HIV are on antiretroviral treatment (ART). Further expansion of its treatment program will require more efficient use of existing resources. Two promising strategies for reducing resource utilization per patient are multi-month medication dispensing and community-based service delivery. We evaluated the costs to providers and patients of community-based, multi-month ART delivery models in Zimbabwe. We used resource and outcome data from a cluster-randomized non-inferiority trial of three differentiated service delivery (DSD) models targeted to patients stable on ART: 3-month facility-based care (3MF), community ART refill groups (CAGs) with 3-month dispensing (3MC), and CAGs with 6-month dispensing (6MC). Using local unit costs, we estimated the annual cost in 2020 USD of providing HIV treatment per patient from the provider and patient perspectives. In the trial, retention at 12 months was 93.0% in the 3MF, 94.8% in the 3MC, and 95.5% in the 6MC arms. The total average annual cost of HIV treatment per patient was $187 (standard deviation $39), $178 ($30), and $167 ($39) in each of the three arms, respectively. The annual cost/patient was dominated by ART medications (79% in 3MF, 87% in 3MC; 92% in 6MC), followed by facility visits (12%, 5%, 5%, respectively) and viral load (8%, 8%, 2%, respectively). When costs were stratified by district, DSD models cost slightly less, with 6MC the least expensive in all districts. Savings were driven by differences in the number of facility visits made/year, as expected, and low uptake of annual viral load tests in the 6-month arm. The total annual cost to patients to obtain HIV care was $10.03 ($2) in the 3MF arm, $5.12 ($0.41) in the 3MC arm, and $4.40 ($0.39) in the 6MF arm. For stable ART patients in Zimbabwe, 3- and 6-month community-based multi-month dispensing models cost less for both providers and patients than 3-month facility-based care and had non-inferior outcomes.

The effects of intimate partner violence on women's risk of HIV acquisition and engagement in the HIV treatment and care cascade: a pooled analysis of nationally representative surveys in sub-Saharan Africa.

BACKGROUND: Achieving the 95-95-95 targets for HIV diagnosis, treatment, and viral load suppression to end the HIV epidemic hinges on eliminating structural inequalities, including intimate partner violence (IPV). Sub-Saharan Africa has among the highest prevalence of IPV and HIV worldwide. We aimed to examine the effects of IPV on recent HIV infection and women's engagement in the HIV care cascade in sub-Saharan Africa. METHODS: We did a retrospective pooled analysis of data from nationally representative, cross-sectional surveys with information on physical or sexual IPV (or both) and HIV testing, from Jan 1, 2000, to Dec 31, 2020. Relevant surveys were identified from data catalogues and previous large-scale reviews, and included the Demographic and Health Survey, the AIDS Indicator Survey, the Population-based HIV Impact Assessment, and the South Africa National HIV Prevalence, Incidence, Behavior and Communication Survey. Individual-level data on all female respondents who were ever-partnered (currently or formerly married or cohabiting) and aged 15 years or older were included. We used Poisson regression to estimate crude and adjusted prevalence ratios (PRs) for the association between past-year experience of physical or sexual IPV (or both), as the primary exposure, and recent HIV infection (measured with recency assays), as the primary outcome. We also assessed associations of past-year IPV with self-reported HIV testing (also in the past year), and antiretroviral therapy (ART) uptake and viral load suppression at the time of surveying. Models were adjusted for participant age, age at sexual debut (HIV recency analysis), urban or rural residency, partnership status, education, and survey-level fixed effects. FINDINGS: 57 surveys with data on self-reported HIV testing and past-year physical or sexual IPV were available from 30 countries, encompassing 280 259 ever-partnered women aged 15-64 years. 59 456 (21·2%) women had experienced physical or sexual IPV in the past year. Six surveys had information on recent HIV infection and seven had data on ART uptake and viral load suppression. The crude PR for recent HIV infection among women who had experienced past-year physical or sexual IPV, versus those who had not, was 3·51 (95% CI 1·64-7·51; n=19 179). The adjusted PR was 3·22 (1·51-6·85). Past-year physical or sexual IPV had minimal effect on self-reported HIV testing in the past year in crude analysis (PR 0·97 [0·96-0·98]; n=274 506) and adjusted analysis (adjusted PR 0·99 [0·98-1·01]). Results were inconclusive for the association of ART uptake with past-year IPV among women living with HIV (crude PR 0·90 [0·85-0·96], adjusted PR 0·96 [0·90-1·02]; n=5629). Women living with HIV who had experienced physical or sexual IPV in the past year were less likely to achieve viral load suppression than those who had not experienced past-year IPV (crude PR 0·85 [0·79-0·91], adjusted PR 0·91 [0·84-0·98], n=5627). INTERPRETATION: Past-year physical or sexual IPV was associated with recent HIV acquisition and less frequent viral load suppression. Preventing IPV is inherently imperative but eliminating IPV could contribute to ending the HIV epidemic. FUNDING: Canadian Institutes of Health Research, the Canada Research Chairs Program, and Fonds de recherche du Québec-Santé. TRANSLATIONS: For the French, Spanish and Portuguese translations of the abstract see Supplementary Materials section.

Prevalence and risk factors of unsuppressed viral load among pregnant and breastfeeding women in sub-Saharan Africa: analysis from population-based surveys.

OBJECTIVE: To examine the prevalence of viral suppression and risk factors for unsuppressed viral load among pregnant and breastfeeding women living with HIV (WLH). DESIGN: Pooled analysis among pregnant and breastfeeding WLH from Population-Based HIV Impact Assessment (PHIA) cross-sectional surveys from 10 sub-Saharan African countries. METHODS: Questionnaires included sociodemographic, relationship-related, and HIV-related items, while blood tests examined HIV serostatus and viral load (data collected 2015-2018). The weighted prevalence of viral suppression was calculated. Logistic regression was used to examine risk factors for unsuppressed viral load (≥1000 copies/ml). RESULTS: Of 1685 pregnant or breastfeeding WLH with viral load results, 63.8% (95% confidence interval (CI): 60.8-66.7%) were virally suppressed at the study visit. Among all included women, adolescence (adjusted odds ratio (aOR): 4.85, 95% CI: 2.58-9.14, P  < 0.001) and nondisclosure of HIV status to partner (aOR: 1.48, 95% CI: 1.02-2.14, P  = 0.04) were associated with unsuppressed viral load. Among only partnered women, adolescence (aOR: 7.95, 95% CI: 3.32-19.06, P  < 0.001), and lack of paid employment (aOR: 0.67, 95% CI: 0.47-0.94, P  = 0.02) were associated with unsuppressed viral load. Examining only women on ART, nondisclosure of HIV status to partner (aOR: 1.85, 95% CI: 1.19-2.88, P  = 0.006) was associated with unsuppressed viral load. CONCLUSION: Viral suppression among pregnant and breastfeeding WLH in sub-Saharan Africa remains suboptimal. Relationship dynamics around nondisclosure of HIV-positive status to partners was an important risk factor for unsuppressed viral load. Improving HIV care via sensitive discussions around partner dynamics in pregnant and breastfeeding women could improve maternal HIV outcomes and prevention of mother-to-child transmission of HIV (PMTCT).

Population sizes, HIV prevalence, and HIV prevention among men who paid for sex in sub-Saharan Africa (2000-2020): A meta-analysis of 87 population-based surveys.

BACKGROUND: Key populations, including sex workers, are at high risk of HIV acquisition and transmission. Men who pay for sex can contribute to HIV transmission through sexual relationships with both sex workers and their other partners. To characterize the population of men who pay for sex in sub-Saharan Africa (SSA), we analyzed population size, HIV prevalence, and use of HIV prevention and treatment. METHODS AND FINDINGS: We performed random-effects meta-analyses of population-based surveys conducted in SSA from 2000 to 2020 with information on paid sex by men. We extracted population size, lifetime number of sexual partners, condom use, HIV prevalence, HIV testing, antiretroviral (ARV) use, and viral load suppression (VLS) among sexually active men. We pooled by regions and time periods, and assessed time trends using meta-regressions. We included 87 surveys, totaling over 368,000 male respondents (15-54 years old), from 35 countries representing 95% of men in SSA. Eight percent (95% CI 6%-10%; number of surveys [Ns] = 87) of sexually active men reported ever paying for sex. Condom use at last paid sex increased over time and was 68% (95% CI 64%-71%; Ns = 61) in surveys conducted from 2010 onwards. Men who paid for sex had higher HIV prevalence (prevalence ratio [PR] = 1.50; 95% CI 1.31-1.72; Ns = 52) and were more likely to have ever tested for HIV (PR = 1.14; 95% CI 1.06-1.24; Ns = 81) than men who had not paid for sex. Men living with HIV who paid for sex had similar levels of lifetime HIV testing (PR = 0.96; 95% CI 0.88-1.05; Ns = 18), ARV use (PR = 1.01; 95% CI 0.86-1.18; Ns = 8), and VLS (PR = 1.00; 95% CI 0.86-1.17; Ns = 9) as those living with HIV who did not pay for sex. Study limitations include a reliance on self-report of sensitive behaviors and the small number of surveys with information on ARV use and VLS. CONCLUSIONS: Paying for sex is prevalent, and men who ever paid for sex were 50% more likely to be living with HIV compared to other men in these 35 countries. Further prevention efforts are needed for this vulnerable population, including improved access to HIV testing and condom use initiatives. Men who pay for sex should be recognized as a priority population for HIV prevention.

Differentiated Service Delivery Models for HIV Treatment in Malawi, South Africa, and Zambia: A Landscape Analysis.

INTRODUCTION: Many countries in Africa are scaling up differentiated service delivery (DSD) models for HIV treatment, but most existing data systems do not describe the models in use. We surveyed organizations that were supporting DSD models in 2019 in Malawi, South Africa, and Zambia to describe the diversity of DSD models being implemented at that time. METHODS: We interviewed DSD model implementing organizations for descriptive information about each of the organization's models of care. We described the key characteristics of each model, including population of patients served, location of service delivery, frequency of interactions with patients, duration of dispensing, and cadre(s) of provider involved. To facilitate analysis, we refer to 1 organization supporting 1 model of care as an "organization-model." RESULTS: The 34 respondents (8 in Malawi, 16 in South Africa, 10 in Zambia) interviewed described a total of 110 organization-models, which included 19 facility-based individual models, 21 out-of-facility-based individual models, 14 health care worker-led groups, and 3 client-led groups; jointly, these encompassed 12 specific service delivery strategies, such as multimonth dispensing, adherence clubs, home delivery, and changes to facility hours. Over two-thirds (n=78) of the organization-models were limited to clinically stable patients. Almost all organization-models (n=96) continued to provide clinical care at established health care facilities; medication pickup took place at facilities, external pickup points, and adherence clubs. Required numbers of provider interactions per year varied widely, from 2 to 12. Dispensing intervals were typically 3 or 6 months in Malawi and Zambia and 2 months in South Africa. Individual models relied more on clinical staff, while group models made greater use of lay personnel. CONCLUSIONS: As of 2019, there was a large variety of differentiated service models being offered for HIV treatment in Malawi, South Africa, and Zambia, serving diverse patient populations.

Outcomes of a multicomponent safe surgery intervention in Tanzania's Lake Zone: a prospective, longitudinal study.

BACKGROUND: Evidence-based strategies for improving surgical quality and patient outcomes in low-resource settings are a priority. OBJECTIVE: To evaluate the impact of a multicomponent safe surgery intervention (Safe Surgery 2020) on (1) adherence to safety practices, teamwork and communication, and documentation in patient files, and (2) incidence of maternal sepsis, postoperative sepsis, and surgical site infection. METHODS: We conducted a prospective, longitudinal study in 10 intervention and 10 control facilities in Tanzania's Lake Zone, across a 3-month pre-intervention period in 2018 and 3-month post-intervention period in 2019. SS2020 is a multicomponent intervention to support four surgical quality areas: (i) leadership and teamwork, (ii) evidence-based surgery, anesthesia and equipment sterilization practices, (iii) data completeness and (iv) infrastructure. Surgical team members received training and mentorship, and each facility received up to a $10 000 infrastructure grant. Inpatients undergoing major surgery and postpartum women were followed during their stay up to 30 days. We assessed adherence to 14 safety and teamwork and communication measures through direct observation in the operating room. We identified maternal sepsis (vaginal or cesarean delivery), postoperative sepsis and SSIs prospectively through daily surveillance and assessed medical record completeness retrospectively through chart review. We compared changes in surgical quality outcomes between intervention and control facilities using difference-in-differences analyses to determine areas of impact. RESULTS: Safety practices improved significantly by an additional 20.5% (95% confidence interval (CI), 7.2-33.7%; P = 0.003) and teamwork and communication conversations by 33.3% (95% CI, 5.7-60.8%; P = 0.02) in intervention facilities compared to control facilities. Maternal sepsis rates reduced significantly by 1% (95% CI, 0.1-1.9%; P = 0.02). Documentation completeness improved by 41.8% (95% CI, 27.4-56.1%; P < 0.001) for sepsis and 22.3% (95% CI, 4.7-39.8%; P = 0.01) for SSIs. CONCLUSION: Our findings demonstrate the benefit of the SS2020 approach. Improvement was observed in adherence to safety practices, teamwork and communication, and data quality, and there was a reduction in maternal sepsis rates. Our results support the emerging evidence that improving surgical quality in a low-resource setting requires a focus on the surgical system and culture. Investigation in diverse contexts is necessary to confirm and generalize our results and to understand how to adapt the intervention for different settings. Further work is also necessary to assess the long-term effect and sustainability of such interventions.

Improving surgical quality in low-income and middle-income countries: why do some health facilities perform better than others?

BACKGROUND: Evidence on heterogeneity in outcomes of surgical quality interventions in low-income and middle-income countries is limited. We explored factors driving performance in the Safe Surgery 2020 intervention in Tanzania's Lake Zone to distil implementation lessons for low-resource settings. METHODS: We identified higher (n=3) and lower (n=3) performers from quantitative data on improvement from 14 safety and teamwork and communication indicators at 0 and 12 months from 10 intervention facilities, using a positive deviance framework. From 72 key informant interviews with surgical providers across facilities at 1, 6 and 12 months, we used a grounded theory approach to identify practices of higher and lower performers. RESULTS: Performance experiences of higher and lower performers differed on the following themes: (1) preintervention context, (2) engagement with Safe Surgery 2020 interventions, (3) teamwork and communication orientation, (4) collective learning orientation, (5) role of leadership, and (6) perceived impact of Safe Surgery 2020 and beyond. Higher performers had a culture of teamwork which helped them capitalise on Safe Surgery 2020 to improve surgical ecosystems holistically on safety practices, teamwork and communication. Lower performers prioritised overhauling safety practices and began considering organisational cultural changes much later. Thus, while also improving, lower performers prioritised different goals and trailed higher performers on the change continuum. CONCLUSION: Future interventions should be tailored to facility context and invest in strengthening teamwork, communication and collective learning and facilitate leadership engagement to build a receptive climate for successful implementation of safe surgery interventions.

Do differentiated service delivery models for HIV treatment in sub-Saharan Africa save money? Synthesis of evidence from field studies conducted in sub-Saharan Africa in 2017-2019.

Introduction: "Differentiated service delivery" (DSD) for antiretroviral therapy (ART) for HIV is rapidly being scaled up throughout sub-Saharan Africa, but only recently have data become available on the costs of DSD models to healthcare providers and to patients. We synthesized recent studies of DSD model costs in five African countries. Methods: The studies included cluster randomized trials in Lesotho, Malawi, Zambia, and Zimbabwe and observational studies in Uganda and Zambia. For 3-5 models per country, studies collected patient-level data on clinical outcomes and provider costs for 12 months. We compared costs of differentiated models to those of conventional care, identified drivers of cost differences, and summarized patient costs of seeking care. Results: The studies described 22 models, including conventional care. Of these, 13 were facility-based and 9 community-based models; 15 were individual and 7 group models. Average provider cost/patient/year ranged from $100 for conventional care in Zambia to $187 for conventional care with 3-month dispensing in Zimbabwe. Most DSD models had comparable costs to conventional care, with a difference in mean annual cost per patient ranging from 11.4% less to 9.2% more, though some models in Zambia cost substantially more. Compared to all other models, models incorporating 6-month dispensing were consistently slightly less expensive to the provider per patient treated. Savings to patients were substantial for most models, with patients' costs roughly halved. Conclusion: In five field studies of the costs of DSD models for HIV treatment, most models within each country had relatively similar costs to one another and to conventional care. 6-month dispensing models were slightly less expensive, and most models provided substantial savings to patients. Limitations of our analysis included differences in costs included in each study. Research is needed to understand the effect of DSD models on the costs of ART programmes as a whole.

Retention in care and viral suppression in differentiated service delivery models for HIV treatment delivery in sub-Saharan Africa: a rapid systematic review.

INTRODUCTION: Differentiated service delivery (DSD) models for antiretroviral treatment (ART) for HIV are being scaled up in the expectation that they will better meet the needs of patients, improve the quality and efficiency of treatment delivery and reduce costs while maintaining at least equivalent clinical outcomes. We reviewed the recent literature on DSD models to describe what is known about clinical outcomes. METHODS: We conducted a rapid systematic review of peer-reviewed publications in PubMed, Embase and the Web of Science and major international conference abstracts that reported outcomes of DSD models for the provision of ART in sub-Saharan Africa from January 1, 2016 to September 12, 2019. Sources reporting standard clinical HIV treatment metrics, primarily retention in care and viral load suppression, were reviewed and categorized by DSD model and source quality assessed. RESULTS AND DISCUSSION: Twenty-nine papers and abstracts describing 37 DSD models and reporting 52 discrete outcomes met search inclusion criteria. Of the 37 models, 7 (19%) were facility-based individual models, 12 (32%) out-of-facility-based individual models, 5 (14%) client-led groups and 13 (35%) healthcare worker-led groups. Retention was reported for 29 (78%) of the models and viral suppression for 22 (59%). Where a comparison with conventional care was provided, retention in most DSD models was within 5% of that for conventional care; where no comparison was provided, retention generally exceeded 80% (range 47% to 100%). For viral suppression, all those with a comparison to conventional care reported a small increase in suppression in the DSD model; reported suppression exceeded 90% (range 77% to 98%) in 11/21 models. Analysis was limited by the extensive heterogeneity of study designs, outcomes, models and populations. Most sources did not provide comparisons with conventional care, and metrics for assessing outcomes varied widely and were in many cases poorly defined. CONCLUSIONS: Existing evidence on the clinical outcomes of DSD models for HIV treatment in sub-Saharan Africa is limited in both quantity and quality but suggests that retention in care and viral suppression are roughly equivalent to those in conventional models of care.

Assessing completeness of patient medical records of surgical and obstetric patients in Northern Tanzania.

BACKGROUND: Strengthening surgical services in resource-constrained settings is contingent on using high-quality data to inform decision making at clinical, facility, and policy levels. However, the evidence is sparse on gaps in paper-based medical record quality for surgical and obstetric patients in low-resource settings. OBJECTIVE: We aim to examine surgical and obstetric patient medical record data quality in health facilities as part of a surgical system strengthening initiative in northern Tanzania. METHODS: To measure the incidence of Surgical Site Infections (SSIs), sepsis and maternal sepsis surgical and obstetric inpatients were followed prospectively, over three months in ten primary, district, and regional health facilities in northern Tanzania. Between April 22nd to May 1st, 2018, we retrospectively reviewed paper-based medical records of surgical and obstetric patients diagnosed with SSIs, post-operative sepsis, and maternal sepsis in the three-month follow-up period. A data quality assessment tool with18 data elements related to documentation of SSIs and sepsis diagnosis, their respective symptoms and vital signs, inpatient daily monitoring indicators, and demographic information was developed and used to assess the completeness of patient medical records. RESULTS: Among the 157 patients diagnosed with SSI and sepsis, we found and reviewed 68% of all medical records. Among records reviewed, approximately one third (34%) and one quarter (23%) included documentation of SSI and sepsis diagnoses, respectively. 6% of reviewed records included documentation of all SSI and sepsis diagnoses, symptoms and vital signs, inpatient daily monitoring indicators, and demographic data. CONCLUSIONS: Strengthening data quality and record-keeping is essential for surgical team communication, continuity of care, and patient safety, especially in low resource settings where paper-based records are the primary means of data collection. High-quality primary health information provides facilities with actionable data for improving surgical and obstetric care quality at the facility level.

Differentiated models of service delivery for antiretroviral treatment of HIV in sub-Saharan Africa: a rapid review protocol.

BACKGROUND: To meet global targets for the treatment of HIV, high-prevalence countries are launching or expanding differentiated models of service delivery (DSD) for antiretroviral therapy (ART). Ongoing studies report on metrics specific to individual models of care, but little is known about the overall scale, impact, costs, and benefits of widespread implementation of DSD. We will conduct a rapid review of recent literature on DSD currently in use in sub-Saharan Africa and identify gaps in the literature with respect to the description of delivery models, coverage, effectiveness, and cost. METHODS: We will use an adapted version of the preferred reporting items for systematic reviews and meta-analysis protocols (PRISMA-P) for reporting. To avoid repeating earlier reviews, only sources reporting data on interventions conducted and/or patients starting antiretroviral treatment since 1 January 2016 will be included. Other inclusion criteria: must report on HIV-positive patients receiving antiretroviral therapy (ART) for the treatment of HIV/AIDS in sub-Saharan Africa; must describe an antiretroviral care intervention and identify the location, visit frequency, provider, patient group, and intervention intensity; and must report at least one of the following outcomes: population coverage, intervention uptake, treatment outcomes, cost or resource allocation, acceptability, or feasibility. EXCLUSION CRITERIA: receiving ART as part of prevention of mother-to-child transmission (PMTCT) program or receiving preventive ART (PEP or PrEP). This review will include peer-reviewed articles and conference abstracts. Publication databases to be searched include PubMed, EMBASE, and Web of Science. For analysis, where possible, we will group the DSD by key characteristics (e.g., population served, visit frequency, visit location) and then report means and/or medians of coverage and outcomes with confidence intervals or IQRs. We will also descriptively compare and contrast different models of care, implementation challenges, and other non-quantitative information. DISCUSSION: This review will provide an initial picture of the status quo for the implementation of DSD in sub-Saharan Africa and identify directions for research and implementation support in the future. This big-picture analysis will be useful for ministries of health, implementers, and donor agencies to inform decision-making on DSD scale-up. SYSTEMATIC REVIEW REGISTRATION: PROSPERO: CRD42019118230.

Effectiveness of a multicomponent safe surgery intervention on improving surgical quality in Tanzania's Lake Zone: protocol for a quasi-experimental study.

INTRODUCTION: Effective, scalable strategies for improving surgical quality are urgently needed in low-income and middle-income countries; however, there is a dearth of evidence about what strategies are most effective. This study aims to evaluate the effectiveness of Safe Surgery 2020, a multicomponent intervention focused on strengthening five areas: leadership and teamwork, safe surgical and anaesthesia practices, sterilisation, data quality and infrastructure to improve surgical quality in Tanzania. We hypothesise that Safe Surgery 2020 will (1) increase adherence to surgical quality processes around safety, teamwork and communication and data quality in the short term and (2) reduce complications from surgical site infections, postoperative sepsis and maternal sepsis in the medium term. METHODS AND ANALYSIS: Our design is a prospective, longitudinal, quasi-experimental study with 10 intervention and 10 control facilities in Tanzania's Lake Zone. Participants will be surgical providers, surgical patients and postnatal inpatients at study facilities. Trained Tanzanian medical data collectors will collect data over a 3-month preintervention and postintervention period. Adherence to safety as well as teamwork and communication processes will be measured through direct observation in the operating room. Surgical site infections, postoperative sepsis and maternal sepsis will be identified prospectively through daily surveillance and completeness of their patient files, retrospectively, through the chart review. We will use difference-in-differences to analyse the impact of the Safe Surgery 2020 intervention on surgical quality processes and complications. We will use interviews with leadership and surgical team members in intervention facilities to illuminate the factors that facilitate higher performance. ETHICS AND DISSEMINATION: The study has received ethical approval from Harvard Medical School and Tanzania's National Institute for Medical Research. We will report results in peer-reviewed publications and conference presentations. If effective, the Safe Surgery 2020 intervention could be a promising approach to improve surgical quality in Tanzania's Lake Zone region and other similar contexts.

Addressing the Financial Burden of Cancer Clinical Trial Participation: Longitudinal Effects of an Equity Intervention.

BACKGROUND: The financial burden experienced by patients with cancer represents a barrier to clinical trial participation, and interventions targeting patients' financial concerns are needed. We sought to assess the impact of an equity intervention on clinical trial patients' financial burden. MATERIALS AND METHODS: We developed an equity intervention to reimburse nonclinical expenses related to trials (e.g., travel and lodging). From July 2015 to July 2017, we surveyed intervention and comparison patients matched by age, sex, cancer type, specific trial, and trial phase. We longitudinally assessed financial burden (e.g., trial-related travel and lodging cost concerns, financial wellbeing [FWB] with the COmprehensive Score for financial Toxicity [COST] measure) at baseline, day 45, and day 90. We used longitudinal models to assess intervention effects over time. RESULTS: Among 260 participants, intervention patients were more likely than comparison patients to have incomes under $60,000 (52% vs. 24%, p < .001) and to report travel-related (41.0% vs. 6.8%, p < 0.001) and lodging-related (32.5% vs. 2.0%, p < .001) cost concerns at baseline. Intervention patients were more likely to report travel to appointments as their most significant financial concern (24.0% vs. 7.0%, p = .001), and they had worse FWB than comparison patients (COST score: 15.32 vs. 23.88, p < .001). Over time, intervention patients experienced greater improvements in their travel-related (-10.0% vs. +1.2%, p = .010) and lodging-related (-3.9% vs. +4.0%, p = .003) cost concerns. Improvements in patients reporting travel to appointments as their most significant financial concern and COST scores were not statistically significant. CONCLUSION: Cancer clinical trial participants may experience substantial financial issues, and this equity intervention demonstrates encouraging results for addressing these patients' longitudinal financial burden. IMPLICATIONS FOR PRACTICE: Clinical trials are critical for developing novel therapies for patients with cancer, yet financial barriers may discourage some patients from participating in cancer clinical trials. This study found that patients who received financial assistance from an equity intervention experienced significant improvements over time in their concerns about the cost of travel and lodging associated with clinical trials compared with comparison patients who did not receive financial assistance from the equity intervention. Among cancer clinical trial participants, an equity intervention shows potential for addressing patients' concerns regarding clinical trial-related travel and lodging expenses.

Barriers to and Interest in Lung Cancer Screening Among Latino and Non-Latino Current and Former Smokers.

Lung cancer is a leading cause of cancer death in Latinos. In a telephone survey, we assessed perceptions about lung cancer and awareness of, interest in, and barriers to lung screening among older current and former smokers. We compared Latino and non-Latino responses adjusting for age, sex, education, and smoking status using logistic regression models. Of the 460 patients who completed the survey (51.5% response rate), 58.0% were women, 49.3% former smokers, 15.7% Latino, with mean age 63.6 years. More Latinos believed that lung cancer could be prevented compared to non-Latinos (74.6% vs. 48.2%, OR 3.07, CI 1.89-5.01), and less worried about developing lung cancer (34.8% vs. 50.3%, OR 0.44, CI 0.27-0.72). Most participants were not aware of lung screening (44.1% Latinos vs. 34.3% Non-Latinos, OR 1.24, CI 0.79-1.94), but when informed, more Latinos wanted to be screened (90.7% vs. 67%, OR 4.58, CI 2.31-9.05). Latinos reported fewer barriers to lung screening.

Patient navigation for lung cancer screening among current smokers in community health centers a randomized controlled trial.

Annual chest computed tomography (CT) can decrease lung cancer mortality in high-risk individuals. Patient navigation improves cancer screening rates in underserved populations. Randomized controlled trial was conducted from February 2016 to January 2017 to evaluate the impact of a patient navigation program on lung cancer screening (LCS) among current smokers in five community health centers (CHCs) affiliated with an academic primary care network. We randomized 1200 smokers aged 55-77 years to intervention (n = 400) or usual care (n = 800). Navigators contacted patients to determine LCS eligibility, introduce shared decision making about screening, schedule appointments with primary care physicians (PCPs), and help overcome barriers to obtaining screening and follow-up. Control patients received usual care. The main outcome was the proportion of patients who had any chest CT. Secondary outcomes were the proportion of patients contacted, proportion receiving LCS CTs, screening results and number of lung cancers diagnosed. Of the 400 intervention patients, 335 were contacted and 76 refused participation. Of the 259 participants, 124 (48%) were ineligible for screening; 119 had smoked <30 pack-years, and five had competing comorbidities. Among the 135 eligible participants in the intervention group, 124 (92%) had any chest CT performed. In intention-to-treat analyses, 124 intervention patients (31%) had any chest CT versus 138 control patients (17.3%, P < 0.001). LCS CTs were performed in 94 intervention patients (23.5%) versus 69 controls (8.6%, P < 0.001). A total of 20% of screened patients required follow-up. Lung cancer was diagnosed in eight intervention (2%) and four control (0.5%) patients. A patient navigation program implemented in CHCs significantly increased LCS among high-risk current smokers.