Midterm follow-up after computed tomography angiography planned left atrial appendage closure.

BACKGROUND: While studies have shown the advantages of computed tomography angiography (CTA) over transesophageal echocardiography (TEE) in left atrial appendage closure (LAAC) preprocedural planning for WATCHMAN™ legacy and FLX devices, there has been no reported long-term data for this approach. OBJECTIVES: We sought to evaluate long-term outcomes using CTA-based preprocedural planning for LAAC using the WATCHMAN™ device. METHODS: A prospective analysis of 231 consecutive patients who underwent LAAC in a single, large academic hospital in the United States was conducted over a 5-year period. CTA-guided preprocedural planning was performed in all. Procedural success, adverse events, length of procedure, number of devices used, and length of stay were evaluated. Rates of death, cerebral embolism, systemic embolism, and major and minor bleeding were recorded. Adjusted predicted stroke and major bleeding rates were derived from CHA2DS2-Vasc and HAS-BLED scores, respectively. RESULTS: From January 26, 2017, to November 23, 2021, 231 patients underwent LAAC with CTA preprocedural planning by two operating physicians. The mean age of patients was 76.5 ± 8.4. 59.7% of patients were male. Mean CHA2DS2VASc and HAS-BLED scores were 4.5 ± 1.4 and 3.9 ± 0.9, respectively. All procedures were performed with intracardiac echo (100%). The procedural success rate was 99.1%. The CTA sizing strategy accurately predicted the implant size in 93.5% of patients. Mean number of devices used was 1.10 ± 0.3. Peri-procedural complication rate was 2.2%. 6 patients were lost to follow-up. Mean follow-up was 608.94 days with a total of 377.04 patient years. Median follow-up period of 368 days (interquartile range: 209-1067 days). There were 51 deaths from all causes (13.52 per 100 patient-years), 10 cases of cerebral embolism (2.65 per 100 patient-years), 2 cases of systemic embolism (0.53 per 100 patient-years), 17 cases of major bleeding (4.50 per 100 patient-years), and 31 cases of minor bleeding (8.2 per 100 patient-years). All-cause mortality at 1, 2, and 3 years was 12.7%, 20.9%, and 29.2%, respectively. CV event rates at 1, 2, and 3 years were 2.1%, 6.6%, and 10.5%, respectively. CONCLUSIONS: CTA-based preprocedural planning is accurate in predicting device size for LAAC and associated with excellent clinical outcomes at 5 years.

Building an HIV Learning Health Care Community for Youth in Florida: Opportunities and Challenges.

In Florida, 33% of new HIV infections among men and 21% of new infections among women are among those younger than 29 years of age. We describe the development of a Learning Health Care Community for youth (Y-LHCC) in Orange County, FL. Its core implementation team (iTeam) was composed of representatives from community agencies and academics, whose work was informed by data from the Florida Department of Health (FDOH) and regional research, in-depth interviews (IDIs) with agency representatives, and a pilot implementation of Tailored Motivational Interviewing (TMI) to improve service provision. IDIs revealed limited programming specifically for youth, significant structural challenges providing them with PrEP, and differences in use of evidence-based behavioral interventions to improve HIV services. FDOH provided data on new HIV infections, linkage to care, viral suppression, and PrEP coverage, however, limitations such as minimal data on PrEP referrals and use, agency level data, and inability to generate data quarterly (which would facilitate program improvement) were encountered. Thirty staff members from five agencies serving youth in Orange County participated in TMI training. About half the agency staff (n = 16) completed at least three of the four online training sessions. MI skills improved from pre- (n = 28; M = 1.96) to post TMI training (n = 11; M = 2.48, SD = 0.57); (t(37) = - 3.14, p = 0.0033). The iTeam held seven remote meetings and two in-person half-day meetings at the end of the study, during which they reassessed areas of focus for improving youth services. They also reiterated their commitment to continuing to meet beyond the study period and to engage other agencies in the newly established coalition. Findings highlight the potential of creating a Y-LHCC in Florida as well as some of the challenges that will need to be overcome to achieve ending the HIV Epidemic goals for young people in the region.

RESUMEN: En Florida, el 33% y 21% de las nuevas infecciones del VIH entre hombres y mujeres, respectivamente, fueron entre personas menores de 29 años de edad. Describimos el desarrollo de una Comunidad de Aprendizaje de Atención Médica para jóvenes (Y-LHCC) en el Condado de Orange, FL. Su equipo central de implementación (iTeam) estuvo compuesto de representantes de agencias comunitarias y académicos, cuyo trabajo se basó en datos del Departamento de Salud de Florida (FDOH) e investigaciones regionales, entrevistas en profundidad con representantes de agencias y un programa piloto de implementación de la Entrevista Motivacional a la Medida (TMI) para mejorar la prestación de servicios. Las entrevistas revelaron poca programación específica para los jóvenes, desafíos estructurales significativos para proporcionarles PrEP, y diferencias en el uso de intervenciones conductuales basadas en evidencia para mejorar los servicios de VIH. El FDOH proporcionó datos sobre nuevas infecciones por el VIH, vinculación con la atención médica, supresión viral y cobertura de PrEP. Sin embargo, se encontraron limitaciones en la data, tales como datos limitados sobre derivaciones u uso de PrEP, falta de datos a nivel de agencia, e incapacidad para generar datos trimestrales (lo que facilitaría la mejora de programas en la agencia). Treinta miembros del personal de cinco agencias que atienden a jóvenes en el Condado de Orange participaron en la capacitación de TMI. Aproximadamente la mitad del personal de la agencia (n = 16) completó al menos tres de las cuatro sesiones de capacitación remota. Las habilidades de MI mejoraron desde antes (n = 28; M = 1.96, SD = .042) hasta después del entrenamiento de TMI (n = 11; M = 2.48, SD = 0.57); (t(37) = − 3.14, p = 0.0033). El iTeam realizó siete reuniones remotas y dos reuniones en persona de medio día al final del estudio, durante las cuales reevaluaron las áreas de enfoque para mejorar los servicios para jóvenes. También reiteraron su compromiso de continuar reuniéndose más allá del período de estudio y de involucrar a otras agencias en la coalición recién establecida. Los hallazgos destacan el potencial de crear un Y-LHCC en Florida, así como algunos de los desafíos que deberán superarse para lograr los objetivos de terminar con la epidemia de VIH para los jóvenes de la región.

Device therapy with interatrial shunt devices for heart failure with preserved ejection fraction.

Heart failure with preserved ejection fraction is responsible for half of all heart failure and confers substantial morbidity and mortality, and yet to date, there have been no effective pharmacologic interventions. Although the pathophysiology is complex, the primary aetiology of exercise intolerance is due to an elevated left atrial pressure, particularly with exercise. In this context, device-based therapy has become a focus. Several companies have developed techniques to percutaneously create an iatrogenic left to right shunt at the atrial level, thereby reducing left atrial pressure and reducing transmitted pressures to the pulmonary circulation and reducing pulmonary congestion. In this review, we explore the pathophysiology, evidence base, benefits, and considerations of these devices and their place in the therapeutic landscape of heart failure with preserved ejection fraction.

An agent-based model of binge drinking, inequitable gender norms and their contribution to HIV transmission, with application to South Africa.

BACKGROUND: Binge drinking, inequitable gender norms and sexual risk behaviour are closely interlinked. This study aims to model the potential effect of alcohol counselling interventions (in men and women) and gender-transformative interventions (in men) as strategies to reduce HIV transmission. METHODS: We developed an agent-based model of HIV and other sexually transmitted infections, allowing for effects of binge drinking on sexual risk behaviour, and effects of inequitable gender norms (in men) on sexual risk behaviour and binge drinking. The model was applied to South Africa and was calibrated using data from randomized controlled trials of alcohol counselling interventions (n = 9) and gender-transformative interventions (n = 4) in sub-Saharan Africa. The model was also calibrated to South African data on alcohol consumption and acceptance of inequitable gender norms. Binge drinking was defined as five or more drinks on a single day, in the last month. RESULTS: Binge drinking is estimated to be highly prevalent in South Africa (54% in men and 35% in women, in 2021), and over the 2000-2021 period 54% (95% CI: 34-74%) of new HIV infections occurred in binge drinkers. Binge drinking accounted for 6.8% of new HIV infections (0.0-32.1%) over the same period, which was mediated mainly by an effect of binge drinking in women on engaging in casual sex. Inequitable gender norms accounted for 17.5% of incident HIV infections (0.0-68.3%), which was mediated mainly by an effect of inequitable gender norms on male partner concurrency. A multi-session alcohol counselling intervention that reaches all binge drinkers would reduce HIV incidence by 1.2% (0.0-2.5%) over a 5-year period, while a community-based gender-transformative intervention would reduce incidence by 3.2% (0.8-7.2%) or by 7.3% (0.6-21.2%) if there was no waning of intervention impact. CONCLUSIONS: Although binge drinking and inequitable gender norms contribute substantially to HIV transmission in South Africa, recently-trialled alcohol counselling and gender-transformative interventions are likely to have only modest effects on HIV incidence. Further innovation in developing locally-relevant interventions to address binge drinking and inequitable gender norms is needed.

Novel computed tomography angiography-based sizing methodology for WATCHMAN FLX device in left atrial appendage closure.

BACKGROUND: While there is recent data suggesting an advantage of computed tomography angiography (CTA) over transesophageal echocardiography (TEE) for preprocedural left atrial appendage closure (LAAC) planning, there is limited published experience for sizing strategies. Device sizing for LAAC may be challenging and noninvasive algorithms that improve this selection process are warranted. OBJECTIVES: We sought to evaluate the safety and the feasibility for the implementation of a novel CTA-based sizing methodology for WATCHMAN™ FLX device in a series of patients undergoing LAAC using the TruPlan™ software package. METHODS: A prospective analysis of 136 consecutive patients who underwent LAAC over a 12-month period in a single, large academic hospital in the United States was conducted. CTA-guided preprocedural planning and intracardiac echocardiography (ICE) was performed in all. Procedural success, adverse events, length of procedure, number of devices used, and length of stay were evaluated. RESULTS: A total of 136 patients who underwent LAAC procedure with WATCHMAN™ FLX platform between October 1, 2020 until September 30, 2021 were included. The pre-specified protocol using CTA and ICE was implemented in all patients (100%). Mean CHA2 DS2 VASc score was 4.4 ± 1.3 and the mean HAS-BLED score was 3.9 ± 0.8. ICE-guided 100% transseptal puncture success rate was 100% with 98.5% of overall procedural success rate. Preprocedural CTA sizing strategy accurately predicted the implanted size in 91.1% of patients. Ten patients (7.4%) required another sized device and 2 cases were aborted. At 45-day follow-up, only 1 patient (0.7%) had significant peri-device leak (≥5 mm) on TEE. CONCLUSIONS: CTA-based preprocedural sizing methodology for WATCHMAN™ FLX in LAAC was safe, feasible and associated with excellent procedural outcomes. Further studies are warranted to confirm if the features specific to TruPlan™ may reduce the number of deployment attempts, the number of devices utilized in the procedure, and the risk of complications.

Predictors of successful same-day discharge and 1-year outcomes after left atrial appendage closure.

BACKGROUND: Same-day discharge (SDD) following left atrial appendage closure (LAAC) is increasingly common but predictors of successful SDD and 1-year clinical outcomes have not been described. OBJECTIVE: The purpose of this study was to explore predictors of successful SDD and report 1-year outcomes in patients undergoing LAAC with SDD. METHODS: A prospective analysis was performed over a 20-month period of 225 consecutive patients that underwent LAAC in a large, academic hospital. All patients included in the study underwent a SDD protocol. Baseline characteristics and 1-year outcomes of patients discharged same day of the procedure versus those that required at least one overnight stay were compared. Adverse events, procedural success, and procedure times were evaluated. RESULTS: One hundred and sixty-one patients (72%) of patients were discharged the same day and 64 patients (28%) required at least an overnight stay (non-SDD: NSDD). NSDD patients were older and more often female. Procedure time was also longer in the NSDD group than in the SDD (63.4 vs. 55.1 min; p = 0.01). While overall procedural success rates were similar between the SDD and NSDD groups (99.4% vs. 98.4%; p = 0.39), NSDD patients had more complications (9.4% vs. 0%; p = 0.01) and higher number of devices per procedure (1.2 vs. 1.0; p = 0.01) as compared to SDD. At 1 year, there were no significant difference between the SDD and NSDD groups in stroke (1.1% vs. 0%; log-rank p = 0.44) and all-cause mortality (3.9% vs. 4.7%; log-rank p = 0.70). CONCLUSION: In this single-center LAAC experience, female sex, older age, and longer procedure duration were associated with higher likelihood for need of overnight stay. At 1-year follow-up, there were no significant differences in stroke events and death rates between SDD and NSDD groups.

Sexual health communication between sex worker mothers and their children in India.

In India, relatively little is known about sex worker mothers' beliefs regarding sexual health communication with their children. Using qualitative data collected in Kolkata, India, this study used the Parent Expansion of the Theory of Planned Behaviour to examine sex worker mothers' beliefs about sexual health communication and factors shaping these beliefs. Sex worker mothers' beliefs about sexual health communication were shaped by societal norms and collectivising processes often driven by Durbar Mahila Samanwaya Committee (DMSC), a sex workers' collective in Kolkata, India. Specifically, we found that challenging stigma, assuming ownership over one's body and health, and making relevant material resources and knowledge accessible and meaningful were key in supporting mothers to overcome barriers around sexual health communication. These collectivising processes shaped mothers' beliefs about sexual health communication and facilitated their ability to engage in it. Future research, policies and programmes should consider the far-reaching impact of community-led structural interventions on sex worker mothers and their children.

Evaluation of Translife Care: An Intervention to Address Social Determinants of Engagement in HIV Care Among Transgender Women of Color.

The TransLife Care (TLC) project was developed to address the structural factors that act as barriers to HIV care among transgender women of color. The purpose of this study was to evaluate the feasibility and initial efficacy of the TLC project; primary HIV care outcomes included linkage to HIV care, engagement in care, retention in care, use of ART and viral suppression among N = 120 participants. In multivariable analysis, receipt of the intervention (versus none), was associated with any HIV care visit (aOR 2.05; 95% CI 1.25-3.37; p = 0.005), more total HIV care visits (aRR 1.45; 95% CI 1.09-1.94; p = 0.011), being retained in care (aOR 1.58; 95% CI 1.03-2.44; p = 0.038), and having a viral load test done (aOR 1.95; 95% CI 1.23-3.09; p = 0.004). We conclude that a structural intervention, designed and delivered by the focus population, that directly addresses social determinants, is feasible and efficacious to promote HIV care engagement among transgender women of color.

RESUMEN: El proyecto TransLife Care (TLC) se desarrolló para abordar los factores estructurales que actúan como barreras para la atención médica del VIH entre las mujeres transgénero de color. El propósito de este estudio fue evaluar la viabilidad y la eficacia inicial del proyecto TLC; los resultados primarios de la atención médica del VIH incluyeron el vínculo con la atención médica del VIH, la retención en la atención médica, el uso de ART y la supresión viral entre N = 120 participantes. En el análisis multivariable, la recepción de la intervención (versus ninguna) se asoció con la participación en la atención médica (aOR 2.05, IC 95% 1.25­3.37, p = 0.005), más visitas totales al VIH (aRR 1.45, IC 95% 1.09­1.94, p = 0.011), se mantuvo en la atención médica (aOR 1.58; IC 95%: 1.03 - 2.44; p = 0.038) y se realizó una prueba de carga viral (aOR 1.95; IC 95%: 1.23 - 3.09; p = 0.004). Concluimos que una intervención estructural, diseñada y ejecutada por la población de enfoque, que aborda directamente los determinantes sociales, es factible y eficaz para promover el compromiso de la atención del VIH entre las mujeres transgénero de color.

Breaking Down Barriers to HIV Care for Gay and Bisexual Men and Transgender Women: The Advocacy and Other Community Tactics (ACT) Project.

Despite the prevailing consensus on the role that stigma and discrimination play in limiting access to HIV prevention technology, discouraging HIV testing, and impeding access to HIV care, studies that focus on structural interventions to address stigma and discrimination for gay, bisexual, and other men who have sex with men and transgender women are surprisingly uncommon. We aimed to identify the outcomes from a coordinated set of community-led advocacy initiatives targeting structural changes that might eliminate barriers to HIV care for gay and bisexual men and transgender women in five African and two Caribbean countries. We conducted a prospective evaluation that included repeated site visits and in-depth semi-structured interviews with 112 people with direct knowledge of project activities, accomplishments, failures, and challenges. Using outcome harvesting and qualitative analysis methods, we observed that over the 18-month implementation period, local advocacy efforts contributed to enhanced political will on the part of duty bearers for ensuring equitable access to HIV care, increases in the availability of affirming resources, improved access to existing resources, and changes in normative institutional practices to enable access to HIV care. Evidence on Project ACT points to the vital role community-led advocacy plays in addressing stigma and discrimination as structural barriers to HIV care.

RESUMEN: Estudios cual centran en intervenciones estructurales para abordar el estigma y la discriminación de los hombres gay, bisexuales y otros hombres que tienen sexo con hombres y mujeres transgénero son sorprendentemente poco comunes, a pesar del consenso prevaleciente sobre el rol que desempeñan el estigma y la discriminación al limitar el acceso a la tecnología de prevención del VIH, desalentar las pruebas del VIH e impedir el acceso a la atención del VIH. Nuestro objetivo era identificar los resultados de un conjunto coordinado de iniciativas de incidencia política dirigidas por la comunidad que apuntan a cambios estructurales que podrían eliminar las barreras a la atención del VIH para hombres gay y bisexuales y mujeres transgénero en cinco países de África y dos del Caribe. Realizamos una evaluación prospectiva que incluyó visitas repetidas al sitio y entrevistas profundas semiestructuradas con 112 personas con conocimiento directo de las actividades, logros, fracasos y desafíos del proyecto. Utilizando métodos de recolección de resultados y análisis cualitativo, observamos que durante el período de implementación de 18 meses, los esfuerzos de promoción local contribuyeron a una mayor voluntad política por parte de los titulares de deberes para garantizar el acceso equitativo a la atención del VIH, aumentos en la disponibilidad de recursos afirmativos, mejoras al acceso a los recursos existentes y cambios en las prácticas institucionales normativas para permitir el acceso a la atención del VIH. La evidencia sobre el Proyecto ACT apunta al papel vital que desempeñan las iniciativas de incidencia política liderada por la comunidad para abordar el estigma y la discriminación como barreras estructurales para la atención del VIH.

The effects of interventional mitral valve repair using the MitraClip System on the results of pulmonary function testing, pulmonary pressure and diffusing capacity of the lung.

BACKGROUND: The study analyzes changes in lung function, pulmonary pressure and diffusing capacity of the lung in patients with mitral valve regurgitation (MR) treated by MitraClip implantation. METHODS: A total of 43 patients (19 women and 24 men with an average age of 78.0 ± 6.6 years) who were able to perform pulmonary function testing including diffusing capacity of the lung for carbon monoxide (DLCO), vital capacity (VC), total lung capacity (TLC), residual volume (RV) and forced expiratory volume in 1 s (FEV1) before and 6 weeks after MitraClip implantation participated in this study. Furthermore, clinical and echocardiographic parameters including systolic pulmonary artery pressure (sPAP), left ventricular ejection fraction (LVEF) and left atrial diameter (LAD) measurements were recorded in all patients. RESULTS: The procedure was performed successfully in all 43 patients leading to a reduction of MR in 97.7% of cases. One patient died on day 4 after the intervention most likely due to pulmonary artery embolism. Six weeks after the implantation 79.1% of patients showed a MR of at most mild to moderate. Furthermore, we could demonstrate a significant reduction of systolic pulmonary artery pressure during follow-up (from 48.8 ± 11.4 mmHg to 42.9 ± 9.0 mmHg (t(41) = - 2.6, p = 0.01). However, no changes in LVEF were detected. Comparing pre and post implant lung function tests, no significant alterations were seen for VC, TLC, DLCO and FEV1. Though, in a subgroup of patients with moderate to severe preexisting deterioration of DLCO at the baseline (max. 50%) the MitraClip procedure resulted in a significant improvement in DLCO (37.8% ± 9.0 to 41.6% ± 10.0, p < 0.001). CONCLUSIONS: Treatment of MR with the MitraClip system successfully reduces MR severity in the vast majority of patients. Consecutively, a reduction in pulmonary pressure could be observed, however no changes in LVEF were obvious. Lung function tests remained unaltered during follow-up. However, in a subgroup of patients with severe preexisting deterioration of DLCO the MitraClip procedure resulted in a significant improvement in DLCO. TRIAL REGISTRATION: Name of the registry: Die Auswirkung der interventionellen Mitralklappenreparatur mit MitraClip-System auf die Ergebnisse der Lungenfunktionsmessung. TRIAL REGISTRATION NUMBER: DRKS00022435; Date of registration: 09/07/2020 'Retrospectively registered'; URL of trial registry record: https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00022435 .

A Systematic Review of HIV Interventions for Young Women in Sub-Saharan Africa.

Adolescent girls and young women (AGYW) ages (15-24 years old) in Southern and Eastern Africa account for nearly 30% of all new HIV infections. We conducted a systematic review of studies examining the effectiveness of behavioral, structural, and combined (behavioral + structural) interventions on HIV incidence and risky sexual behaviors among AGYW. Following PRISMA guidelines, we searched PubMed, CINAHL, Web of Science, and Global Health. Twenty-two studies met inclusion criteria conducted in Eastern and Southern Africa and comprised behavioral, structural, or combined (behavioral and structural) interventions. All findings are based on 22 studies. HIV incidence was significantly reduced by one structural intervention. All three types of interventions improved condom use among AGYW. Evidence suggests that structural interventions can reduce HIV incidence, while behavioral and combined interventions require further investigation.

Pharmacy PEP Access Intervention Among Persons Who Use Drugs in New York City: iPEPcare Study-Rethinking Biomedical HIV Prevention Strategies.

Biomedical HIV prevention uptake has not taken hold among Black and Latinx populations who use street-marketed drugs. A pilot intervention providing a PEP informational video and direct pharmacy access to a PEP starter dose was conducted among this population. Four study pharmacies were selected to help facilitate syringe customer recruitment (2012-2016). Baseline, post-video, and 3-month ACASI captured demographic, risk behavior, and psychosocial factors associated with PEP willingness, and willingness to access PEP in a pharmacy. A non-experimental study design revealed baseline PEP willingness to be associated with PEP awareness, health insurance, being female, and having a high-risk partner (n = 454). Three-month PEP willingness was associated with lower HIV stigma (APR = 0.95). Using a pre-post approach, PEP knowledge (p < 0.001) and willingness (p < 0.001) increased overtime; however, only three participants requested PEP during the study. In-depth interviews (n = 15) identified lack of a deeper understanding of PEP, and contextualized perceptions of HIV risk as PEP access barriers. Pharmacy PEP access shows promise but further research on perceived risk and HIV stigma is warranted.

Day-case percutaneous left atrial appendage occlusion-Safety and efficacy.

OBJECTIVES: We evaluated the safety and efficacy of percutaneous left atrial appendage (LAA) occlusion performed as a day case procedure. BACKGROUND: LAA occlusion has been shown to be safe and effective for stroke prevention in patients with atrial fibrillation. It has not been shown if the procedure can safely be performed on a day-case basis. METHODS: Retrospective analysis was made of 117 LAA occlusion procedures in a single large teaching hospital in the UK. Procedural success, procedural complications, length of stay, and readmission data were examined. RESULTS: Successful deployment of a device was possible in all but one patient (whose appendage was too large). Major in-hospital complications occurred in 1.7% of patients (both femoral vascular). Same-day discharge was made in 66% of patients overall. Since January 2016, only 3 of 59 patients (5%) have remained in hospital overnight following LAAO. Echocardiography 2-4 hr postprocedure was undertaken prior to discharge. One patient was readmitted within 7 days but this readmission would not have been prevented by overnight stay. CONCLUSIONS: LAA occlusion can be safely performed as a day case procedure with acceptable complication rates and no increment of complications related to the lack of routine overnight stay.

Enhancing LPG adoption in Ghana (ELAG): a factorial cluster-randomized controlled trial to Enhance LPG Adoption & Sustained use.

BACKGROUND: Three billion individuals worldwide rely on biomass fuel [dung, wood, crops] for cooking and heating. Further, health conditions resulting from household air pollution (HAP) are responsible for approximately 3.9 million premature deaths each year. Though transition away from traditional biomass stoves is projected curb the health effects of HAP by mitigating exposure, the benefits of newer clean cookstove technologies can only be fully realized if use of these new stoves is exclusive and sustained. However, the conditions under which individuals adopt and sustain use of clean cookstoves is not well understood. METHODS: The Enhancing LPG Adoption in Ghana (ELAG) study is a cluster-randomized controlled trial employing a factorial intervention design. The first component is a behavior change intervention based on the Risks, Attitudes, Norms, Abilities, and Self-regulation (RANAS) model. This intervention seeks to align these five behavioral factors with clean cookstove adoption and sustained use. A second intervention is access-related and will improve LPG availability by offering a direct-delivery refueling service. These two interventions will be integrated via a factorial design whereby 27 communities are assigned to one of the following: the control arm, the educational intervention, the delivery, or a combined intervention. Intervention allocation is determined by a covariate-constrained randomization approach. After intervention, approximately 900 households' individual fuel use is tracked for 12 months via iButton stove use monitors. Analysis will include hierarchical linear models used to compare intervention households' fuel use to control households. DISCUSSION: Literature to-date demonstrates that recipients of improved cookstoves rarely completely adopt the new technology. Instead, they often practice partial adoption (fuel stacking). Consequently, interventions are needed to influence adoption patterns and simultaneously to understand drivers of fuel adoption. Ensuring uptake, adoption, and sustained use of improved cookstove technologies can then lead to HAP-reductions and consequent improvements in public health. TRIAL REGISTRATION: NCT03352830 (November 24, 2017).

The Inter-ministerial National Structural Intervention trial (INSTRUCT): protocol for a parallel group cluster randomised controlled trial of a structural intervention to reduce HIV infection among young women in Botswana.

BACKGROUND: Wide recognition that structural factors are important in the HIV epidemic has not generated much evidence of impact of structural interventions. Few randomised controlled trials of structural interventions for HIV prevention have an HIV endpoint, and most of those did not show a significant impact. It has proved difficult to prevent new HIV infections in Botswana, especially among young women, many of whom are unable to act on HIV preventive choices. Proposed by a government think tank in Botswana, the Inter-ministerial National Structural Intervention trial (INSTRUCT) tests whether addressing social and economic factors, including gender inequality, gender violence, poverty, and poor access to education, can lower HIV infection rates among young women. Focussed on increasing access by marginalised young women to government support programs, the intervention seeks to change their structural position, reducing their vulnerability to transactional sex, and thus to HIV infection. METHODS: This parallel group cluster randomised controlled trial compares HIV rates among young women in districts with and without the structural interventions. The 30 administrative districts in the country, stratified by HIV prevalence and development status, will be randomly assigned to 5-district implementation waves. The intervention in the first-wave districts will include: (i) recruiting and preparing vulnerable young women to apply to government support programs, (ii) making the support programs more accessible to young women by engaging local program officers and young women in co-evaluation of programs and co-design of solutions; and (iii) generating an enabling environment for change in communities through an audio-drama edutainment program. In year five, an impact survey will measure HIV rates among vulnerable young women (15-29 years) in a random sample of communities in the five intervention districts and in the five second-wave (control) districts. Fieldworkers will undertake rapid HIV screening and interview young women and young men, collecting information on secondary outcomes of attitudes and behaviours. DISCUSSION: This is the first step in a planned stepped-wedge design that will roll out the intervention, modified as necessary, to all districts. Strong government commitment provides an important opportunity to reduce new HIV cases in Botswana, and guide prevention efforts in other countries. TRIAL REGISTRATION: Registration number: ISRCTN 54878784 . Registry: ISRCTN. Date of registration: 11 June 2013.

Left atrial pressure and predictors of survival after percutaneous mitral paravalvular leak closure.

BACKGROUND: Data on the clinical utility of left atrial (LA) hemodynamic monitoring during percutaneous mitral interventions are limited. OBJECTIVES: To evaluate the association between intraprocedural LA pressures during percutaneous mitral paravalvular leak (PVL) closure and long term survival. METHODS: Patients who underwent mitral PVL repair with invasive LA pressure monitoring were divided at baseline to three tertiles based on their mean final LA pressure (<25%; 25-30%; >30% of mean systolic blood pressure). Primary outcome was all-cause mortality. RESULTS: 134 patients (mean age 68 ± 12 years) were studied. Over 3 year mean follow-up, 81 (38%) patients died. The cumulative probability of death at 3 years was significantly higher among patients in the highest LA pressure tertile (56 ± 8% vs. 28 ± 5%, log rank P < 0.001). More than mild residual mitral regurgitation (MR) by transesophageal echocardiography (TEE) was associated with a 2.5-fold increased risk of death and patients in the highest LA pressure tertile had 2.2-fold higher mortality (P < 0.001 and = 0.003 respectively). After adjustment for residual MR by TEE, each 10% acute procedural reduction in LA pressures was associated with a significant 9% reduced risk of death (P = 0.023). Multivariate Cox regression with adjustment for multiple predictors of death showed that patients in lower LA pressure tertiles had 59% lower mortality (P = 0.003). CONCLUSION: Lower LA pressure following mitral PVL closure is an independent predictor of improved survival, even after adjustment for residual MR. LA pressure monitoring may be a useful tool for procedural guidance during mitral PVL closure.

Impact of a Structural Intervention to Address Alcohol Use Among Gay Bar Patrons in San Francisco: The PACE Study.

We evaluated the impact on alcohol intake and blood alcohol concentration (BAC) of a multi-level structural intervention to increase the availability of free water, coupled with messaging on pacing alcohol intake and normative feedback of blood alcohol concentration in a convenience sample of gay bars in San Francisco. Participants (n = 1,293) were recruited among exiting patrons of four gay bars (two intervention bars and two control bars). Participants were surveyed on alcohol intake and BAC was measured by breathalyzer. Prior to the intervention there were no significant differences in baseline alcohol measures between intervention and control bars. Post-intervention there were significant differences on objective and subjective measures of alcohol consumption: 30% of intervention bar participants had BAC% levels over the legal driving limit (0.08%) compared to 43% of control bar participants, p < 0.0001 and 78% of intervention bar participants were above the AUDIT-C cut-off for hazardous drinking compared to 87% in control bars, p < 0.001.

Mixed-Method Quasi-Experimental Study of Outcomes of a Large-Scale Multilevel Economic and Food Security Intervention on HIV Vulnerability in Rural Malawi.

The objective of the Savings, Agriculture, Governance, and Empowerment for Health (SAGE4Health) study was to evaluate the impact of a large-scale multi-level economic and food security intervention on health outcomes and HIV vulnerability in rural Malawi. The study employed a quasi-experimental non-equivalent control group design to compare intervention participants (n = 598) with people participating in unrelated programs in distinct but similar geographical areas (control, n = 301). We conducted participant interviews at baseline, 18-, and 36-months on HIV vulnerability and related health outcomes, food security, and economic vulnerability. Randomly selected households (n = 1002) were interviewed in the intervention and control areas at baseline and 36 months. Compared to the control group, the intervention led to increased HIV testing (OR 1.90; 95 % CI 1.29-2.78) and HIV case finding (OR = 2.13; 95 % CI 1.07-4.22); decreased food insecurity (OR = 0.74; 95 % CI 0.63-0.87), increased nutritional diversity, and improved economic resilience to shocks. Most effects were sustained over a 3-year period. Further, no significant differences in change were found over the 3-year study period on surveys of randomly selected households in the intervention and control areas. Although there were general trends toward improvement in the study area, only intervention participants' outcomes were significantly better. Results indicate the intervention can improve economic and food security and HIV vulnerability through increased testing and case finding. Leveraging the resources of economic development NGOs to deliver locally-developed programs with scientific funding to conduct controlled evaluations has the potential to accelerate the scientific evidence base for the effects of economic development programs on health.

Protocol of the impact of alternative social assistance disbursement on drug-related harm (TASA) study: a randomized controlled trial to evaluate changes to payment timing and frequency among people who use illicit drugs.

BACKGROUND: Government social assistance payments seek to alleviate poverty and address survival needs, but their monthly disbursement may cue increases in illicit drug use. This cue may be magnified when assistance is disbursed simultaneously across the population. Synchronized payments have been linked to escalations in drug use and unintended but severe drug-related harms, including overdose, as well as spikes in demand for health, social, financial and police services. METHODS/DESIGN: The TASA study examines whether changing payment timing and frequency can mitigate drug-related harm associated with synchronized social assistance disbursement. The study is a parallel arm multi-group randomized controlled trial in which 273 participants are randomly allocated for six assistance cycles to a control or one of two intervention arms on a 1:1:1 basis. Intervention arm participants receive their payments: (1) monthly; or (2) semi-monthly, in each case on days that are not during the week when cheques are normally issued. The study partners with a community-based credit union that has developed a system to vary social assistance payment timing. The primary outcome is a 40 % increase in drug use during the 3 days beginning with cheque issue day compared to other days of the month. Bi-weekly follow-up interviews collect participant information on this and secondary outcomes of interest, including drug-related harm (e.g. non-fatal overdose), exposure to violence and health service utilization. Self-reported data will be supplemented with participant information from health, financial, police and government administrative databases. A longitudinal, nested, qualitative parallel process evaluation explores participant experiences, and a cost-effectiveness evaluation of different disbursement scenarios will be undertaken. Outcomes will be compared between control and intervention arms to identify the impacts of alternative disbursement schedules on drug-related harm resulting from synchronized income assistance. DISCUSSION: This structural RCT benefits from strong community partnerships, highly detailed outcome measurement, robust methods of randomization and data triangulation with third party administrative databases. The study will provide evidence regarding the potential importance of social assistance program design as a lever to support population health outcomes and service provision for populations with a high prevalence of substance use. TRIAL REGISTRATION: NCT02457949 Registered 13 May 2015.