The effect of treatment on work productivity in patients with bladder cancer.

OBJECTIVE: To describe the impact of bladder-preserving treatment vs. cystectomy on work productivity and activity impairment (WPAI) among patients with bladder cancer. METHODS: Using cross-sectional survey data, we constructed 2-part models involving both logistic and linear prediction to describe the relationship between WPAI and treatment modality among patients with non-muscle-invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC). RESULTS: A total of 848 patients were included in the analysis. Patients with NMIBC who had cystectomy were more likely to experience activity impairment compared with those receiving bladder-preserving treatment (OR: 4.25, 95% CI: 2.28-7.93). Among patients with MIBC, cystectomy was protective against increasing presenteeism (e^ß: 0.41, 95% CI: 0.23-0.71) and productivity loss (e^ß: 0.44, 95% CI: 0.21-0.88); however, the opposite effect was seen for absenteeism treatment (e^ß: 4.82, 95% CI: 1.72-13.49). CONCLUSION: Cystectomy increased the odds of experiencing activity impairment for patients with NMIBC. However, for patients with MIBC, cystectomy appears to be protective for presenteeism and productivity loss. Further work is needed in order to better understand these important relationships and improve both patient counseling and shared decision-making.

Quality of Life and Health State Utilities in Bladder Cancer.

BACKGROUND: Bladder cancer treatments may variably impact health-related quality of life (QOL). OBJECTIVE: To characterize the quality of life of patients with bladder cancer at various time points across the continuum of bladder cancer care from non-muscle-invasive disease to metastatic bladder cancer and develop utility scores to inform cost-effective analyses. METHODS: We performed a cross-sectional survey of bladder cancer patients in the Bladder Cancer Advocacy Network Patient Survey Network. Participants were classified into mutually exclusive health states based upon non-muscle invasive (NMIBC), muscle-invasive (MIBC), or metastatic bladder cancer and completed surveys of generic cancer and bladder cancer-specific quality of life, financial toxicity, and work impairment. We constructed generalized linear mixed models to identify patient, clinical, and treatment factors associated with quality of life over time and derived health state utilities. RESULTS: Among 911 self-identified patients with bladder cancer, overall QOL scores and function domains were worse among those with advanced cancer. Financial toxicity was similar among non-metastatic disease states. Work and activity impairment increased with advancing disease (13%and 12%among non-recurrent NMIBC to 63%and 31%for metastatic disease respectively; p < 0.01). On multivariable analysis, bowel-related QOL was diminished among patients with MIBC, with urinary symptoms and physical function most diminished among patients with metastatic disease. Patients with metastatic and MIBC experienced worse emotional functioning (p = 0.04; p = 0.048). Health state utilities were calculated, highest among those with non-recurrent NMIBC and lowest among those with metastatic disease. CONCLUSION: Generic and bladder cancer-specific QOL diminishes with advancing disease. Health state utility estimates derived from this study can inform shared decision making with patients and may be used to inform future cost-effective analyses.

The elusive diagnosis and emergent management of a late-presenting ruptured interstitial pregnancy: a case report.

BACKGROUND: Interstitial pregnancies are rare and often difficult to diagnose given their proximal position to the uterine cavity, however most are identified by 12 weeks gestation. Delayed or missed diagnosis contributes to heightened incidence of poor outcomes including hemorrhage and death. CASE PRESENTATION: A 35-year-old woman at 15 weeks gestation with confirmed intrauterine pregnancy on first trimester ultrasound and prior negative MRI presented in hemorrhagic shock and was found to have a ruptured interstitial pregnancy. Exploratory laparotomy revealed the fetus to be in the abdomen as well as a large cornual defect and abnormal placentation that resulted in supracervical hysterectomy. CONCLUSIONS: Interstitial pregnancy should be considered in a patient presenting with symptoms consistent with ectopic rupture, especially in the setting of equivocal or suboptimal prior imaging. Earlier diagnosis may allow for fertility-sparing intervention and decreased risk of morbidity and mortality.

Utility of a US Food and Drug Administration (FDA) label indication for condoms for anal sex.

Condoms are highly effective for HIV prevention, yet are not currently indicated by the US Food and Drug Administration (FDA) for anal sex. We surveyed a national sample of men who have sex with men to assess whether FDA label indication could affect anticipated condom use, and to determine levels of perceived condom failure for anal sex. We found that 69% of respondents anticipated that a label indication change would increase their likelihood of condom use. Median perceived failure was 15%. We anticipate that these results may aid the FDA in developing standards for a label indication for anal sex.

An Electronic Pre-Exposure Prophylaxis Initiation and Maintenance Home Care System for Nonurban Young Men Who Have Sex With Men: Protocol for a Randomized Controlled Trial.

BACKGROUND: Pre-exposure prophylaxis (PrEP) is highly efficacious for preventing HIV but has not yet been brought to scale among at-risk persons. In several clinical trials in urban areas, technology-based interventions have shown a positive impact on PrEP adherence. In rural and small-town areas in the United States, which often do not have geographically proximal access to PrEP providers, additional support may be needed. This may be particularly true for younger persons who are more likely to face multiple barriers to accessing PrEP services. Home-based care, accomplished through a tailored mobile phone app, specimen self-collection (SSC), and interactive video consultations, could increase both PrEP initiation and persistence in care. OBJECTIVE: The goal of this study is to assess the initiation and persistence in PrEP care for those randomized to a home-care intervention (electronic PrEP, ePrEP) relative to those assigned to the standard of care (control) condition. We will conduct additional assessments, including quantitative and qualitative analyses, to contextualize trial results and facilitate scale-up. METHODS: This 2-arm, randomized controlled trial will enroll young men who have sex with men (YMSM) aged between 18 and 24 years from rural areas of Georgia, Mississippi, and North Carolina. The trial will seek to recruit a diverse sample, targeting 50% participation among highly impacted groups of black or Latino men who have sex with men. Intervention participants will receive a study app that incorporates a messaging platform, a scheduling and milestone-based tracking system for PrEP care progress, electronic behavioral surveys, and interactive video consultations with a clinician. Complemented by SSC kits mailed to laboratories for standard PrEP-related monitoring, the ePrEP system will allow participants to access PrEP care without leaving their homes. YMSM randomized to the control condition will receive a listing of nearest local PrEP providers to receive standard PrEP care. Both groups will complete quarterly electronic surveys. The primary outcome, assessed at 6 and 12 months after randomization, will be the difference in the proportion of intervention versus control participants that achieve protective levels of the active metabolite of oral PrEP (tenofovir diphosphate in dried blood spots). RESULTS: Enrollment will begin in May 2019, with study completion in 2022. CONCLUSIONS: This trial will determine whether home PrEP care provided through an app-based platform is an efficacious means of expanding access to PrEP care for a diverse group of YMSM in rural and small-town areas of the United States. TRIAL REGISTRATION: ClinicalTrials.gov NCT03729570; https://clinicaltrials.gov/ct2/show/NCT03729570 (Archived by WebCite at http://www.webcitation.org/78RE2Qizf). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/13982.

Double-Blind, Single-Center, Randomized Three-Way Crossover Trial of Fitted, Thin, and Standard Condoms for Vaginal and Anal Sex: C-PLEASURE Study Protocol and Baseline Data.

BACKGROUND: Male condoms are underused despite their ability to prevent transmission of HIV and other sexually transmitted infections. The perception of decreased sexual pleasure and poor condom fit are major contributors to condom nonuse. OBJECTIVE: The purpose of this study was to compare event-level performance and pleasure using fitted, thin, and standard condoms among men who have sex with men (MSM) and men who have sex with women (MSW). We also sought to assess condom type preference. We present the study design and enrollment data from the trial. METHODS: This study recruited sexually active men aged 18 to 54 years in Atlanta, Georgia, United States. We enrolled 252 MSM and 252 MSW in a double-blind, 3-way randomized crossover trial with conditions of fitted, thin, and standard condoms. A permuted block randomization scheme was used to assign each participant to the sequence in which they received each type of study condom. After a baseline screening and enrollment visit, randomized participants were followed for at least 6 and up to 12 weeks depending on their use of study condoms in each 2-week period between scheduled, in-person study visits. Participants were instructed to complete mobile-optimized coital logs as soon as possible after using condoms for anal or vaginal sex acts. The logs collected event-level pleasure and performance measures for the study condoms as well as other relevant data. A questionnaire was administered at the final study visit to assess overall study condom preference. RESULTS: The study enrolled 252 MSM and 252 MSW, a total of 504 participants. MSM and MSW study arms were similar for a number of key traits including race and ethnicity, marital status, self-rated condom experience, and recent experience of condom failure. Men in the MSM arm were older, however, and fewer MSM were students. The majority of participants in both arms rated themselves as very experienced with using condoms, and the majority had used condoms recently. Over one-third of participants in each arm reported experiencing condom failure in the last 6 months. CONCLUSIONS: This is the first condom trial to compare the performance of standard, thin, and fitted condoms and to use pleasure and preference as primary outcomes. Given the disparate impact of HIV on MSM, equal enrollment of MSM and MSW was a key feature of this study. Trial results may inform an FDA label indication for anal sex and provide new information regarding the relative performance of different types of condoms. TRIAL REGISTRATION: ClinicalTrials.gov NCT02753842; https://clinicaltrials.gov/ct2/show/NCT02753842 (Archived by WebCite at http://www.webcitation.org/76RLTFyf0). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/12205.

Developing and Assessing the Feasibility of a Home-based Preexposure Prophylaxis Monitoring and Support Program.

We piloted PrEP@Home, a preexposure prophylaxis system of remote laboratory and behavioral monitoring designed to replace routine quarterly follow-up visits with home care to reduce the patient and provider burden. The system was highly acceptable and in-demand for future use, and more than one-third of participants reported greater likelihood of persisting in care if available.

Levels of clinical condom failure for anal sex: A randomized cross-over trial.

BACKGROUND: Men who have sex with men (MSM) face a 28-fold higher risk of HIV acquisition than men who have sex with women (MSW). Condoms are the most accessible prevention method, with billions produced annually. Due to potentially high clinical failure, international regulatory agencies do not approve condoms for anal sex. This trial sought to provide data regarding approval of condoms for anal sex. METHODS: We conducted a blinded, crossover randomized trial among MSM and MSW in Atlanta, Georgia, USA. Crossover conditions were standard condoms, thin condoms, and condoms fitted to each user's penile dimensions. The primary outcome was total clinical failure (slippage and/or breakage), assessed using an intention-to-treat analysis. A mixed methods model assessed differences in odds of failure. The study is registered with ClinicalTrials.gov, NCT02753842, and is completed. FINDINGS: We enrolled 252 MSM and 252 MSW between May 19, 2016 and May 2, 2017. Participants reported a total of 4884 anal or vaginal sex acts using study-provided condoms. For all crossover conditions, clinical failure was lower for anal sex (0•7%, 16/2351) than for vaginal sex (1•9%, 48/2533), (odds ratio 0•40, 95% confidence interval 0•21, 0•75, p < â€¢001)00. There was no difference in odds of failure for anal sex acts between the different types of condoms. Due to study design, nearly all anal sex acts used condom-compatible lubricant (98•3%), yet only a minority of vaginal sex acts (41•6%) used lubricant. Sex acts for which lubricant was used had lower failure for both anal and vaginal sex, with no difference in odds of failure between them. INTERPRETATION: In the largest trial of effectiveness of condoms for anal sex to date, we found remarkably low levels of failure. Condoms should be approved by regulatory agencies for anal sex. Clinicians may recommend condoms as a highly efficacious HIV and STD prevention tool for anal sex. Differences between failure for anal and vaginal sex were likely due to differential use of lubricant. Condom promotion programs should consider providing additional lubricant for all condoms distributed.

Location location location: an exploration of disparities in access to publicly listed pre-exposure prophylaxis clinics in the United States.

PURPOSE: HIV pre-exposure prophylaxis (PrEP) is highly effective in preventing HIV transmission. Finding a PrEP provider, however, can be a barrier to accessing care. This study explores the distribution of publicly listed PrEP-providing clinics in the United States. METHODS: Data regarding 2094 PrEP-providing clinics come from PrEP Locator, a national database of PrEP-providing clinics. We compared the distribution of these PrEP clinics to the distribution of new HIV diagnoses within various geographical areas and by key populations. RESULTS: Most (43/50) states had less than one PrEP-providing clinic per 100,000 population. Among states, the median was two clinics per 1000 PrEP-eligible men who have sex with men. Differences between disease burden and service provision were seen for counties with higher proportions of their residents living in poverty, lacking health insurance, identifying as African American, or identifying as Hispanic/Latino. The Southern region accounted for over half of all new HIV diagnoses but only one-quarter of PrEP-providing clinics. CONCLUSIONS: The current number of PrEP-providing clinics is not sufficient to meet needs. In addition, PrEP-providing clinics are unevenly distributed compared to disease burden, with poor coverage in the Southern divisions and areas with higher poverty, uninsured, and larger minority populations. PrEP services should be expanded and targeted to address disparities.

Rwandan stakeholder perspectives of integrated family planning and HIV services.

The purpose of this qualitative study was to understand the knowledge, attitudes, and practices among key Rwandan policymakers and stakeholders related to family planning (FP) and integrated HIV/FP services. Motivational in-depth interview format and content was developed after an extensive policy review. A convenience sample of 10 high-level HIV and FP Rwandan policymakers and stakeholders completed the interview. Stakeholders demonstrated strong foundational knowledge of HIV and FP. Given the choice, stakeholders would allocate more monies to FP and less to HIV than currently distributed. Respondents felt that improved FP method knowledge, especially long-acting reversible contraception, among clients/couples and providers, was needed to address myths, misconceptions, and biases. The most often cited way to integrate HIV/FP services was development of integrated tools (eg, training materials, data collection tools, and advocacy and policy guidance). We recommend strategies for policy advancement supportive of HIV/FP service integration inclusive of couples and long-acting reversible contraception methods.