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Doxycycline post-exposure prophylaxis (doxy-PEP) is a promising intervention to reduce bacterial sexually transmitted infections (STIs). We evaluated the effect of doxy-PEP on STI incidence and antimicrobial resistance in men who have sex with men and transgender women for up to 12 months of follow-up, inlcuding an open-label extension. DoxyPEP, an open-label trial in Seattle (WA, USA) and San Francisco (CA, USA) among men who have sex with men and transgender women with at least one bacterial STI in the past year, randomly assigned participants by clinic (with computer-generated variable block sizes) 2:1 to doxy-PEP (200 mg doxycycline delayed-release tablets 24–72 h after condomless sex) or standard care. The independent endpoint adjudication committee was masked to group assignment. The primary outcome was presence of one or more bacterial STIs (Neisseria gonorrhoeae, Chlamydia trachomatis, or early syphilis) each quarter. This outcome was assessed in the modified intention-to-treat cohort, which included participants with at least one follow-up quarter (ie, ∼3 months) in their as-randomised assignment. After early termination of the randomised phase for efficacy, all participants still enrolled were offered doxy-PEP in an open-label extension (OLE). We report quarterly incidence of bacterial STIs for the as-randomised and OLE periods. Safety was assessed in all participants with any follow-up data. The trial was registered with ClinicalTrials.gov (NCT03980223) and is completed. From Aug 19, 2020, to May 13, 2022, we enrolled 637 participants; 592 participants completed at least one follow-up quarter in the randomised phase (411 in the doxy-PEP group and 181 in the standard-care group) and 282 in the OLE phase (207 in the doxy-PEP group and 82 in the standard-care group). STIs were present in 129 (12·0%) of 1077 quarters in the doxy-PEP group versus 139 (30·5%) of 455 quarters in the standard-care group during the as-randomised period, showing an absolute difference of 19 percentage points and a relative risk of 0·39 (95% CI 0·31–0·49, p<0·0001). During the OLE, STIs were diagnosed in 51 (13%) of 388 quarters among those continuing doxy-PEP and 25 (17%) of 145 quarters among standard-care participants who initiated doxy-PEP. Throughout all quarters for participants on doxy-PEP, there was one grade 2 laboratory abnormality and five grade 3 adverse events that were possibly or probably related to doxy-PEP. No serious adverse events were attributed by site investigators to doxycycline. Of participants with positive gonorrhoea cultures during the study, eight (27%) of 29 taking doxy-PEP versus five (24%) of 21 not taking doxy-PEP had tetracycline resistance (minimum inhibitory concentration ≥2 μg/mL). Doxy-PEP was effective in reducing bacterial STIs in this population of men who have sex with men and transgender women, including during an open-label extension when doxy-PEP efficacy was known. Doxy-PEP was well tolerated, highly acceptable, and with no new safety signals. US National Institutes of Health.

Troubling disparities in viral suppression persist among transgender (trans) women living with HIV in the US. We utilized baseline data from a randomized controlled trial of a behavioral intervention among trans women living with HIV in San Francisco and Los Angeles, to identify the socio-ecological correlates of biologically confirmed viral suppression (< 200 HIV-1 RNA copies/mL). Among 253 participants, the mean age was 43 (SD = 11), 46% identified as Black or African American and 35% were virally non-suppressed. In adjusted Poisson regression models, the following barriers to viral suppression were identified: injection drug use [adjusted risk ratio (aRR) 0.78, 95% CI 0.65–0.93, Z = − 2.64, p = 0.008], methamphetamine use (aRR 0.65, 95% CI 0.51–0.83, Z = − 3.45, p = 0.001), amphetamine use (aRR 0.62, 95% CI 0.44–0.87, Z = − 2.75, p = 0.006), homelessness (aRR 0.79, 95% CI 0.63–0.98, Z = − 2.06, p = 0.039), and sex work (aRR 0.60, 95% CI 0.41–0.86, Z = − 2.77, p = 0.009). These findings underscore the importance of interventions that address the socio-ecological barriers to viral suppression among trans women in urban settings.

Abstract Introduction This study examined changes in biomarkers of exposure (BoE) after 5 days of nicotine-salt pod system (NSPS) use, compared with continuation of usual-cigarette smoking and cigarette abstinence, among adult combustible cigarette smokers. Aims and Methods A randomized, open-label, parallel-cohort, confinement study of healthy adult smokers, naive to NSPS use, was conducted. Participants (N = 90) were randomized to six cohorts (n = 15 each): exclusive ad libitum use of NSPS (four flavors: Virginia Tobacco, Mint, Mango, Creme), continuation of usual-brand cigarette smoking, or cigarette abstinence. Total nicotine equivalents and BoE (NNN, NNAL, 3-HPMA, MHBMA, S-PMA, HMPMA, CEMA, 1-OHP, and COHb) were measured. Results Eight non-nicotine BoEs, measured in urine, were reduced by an aggregate of 85.0% in the pooled NSPS cohort; increased by 14.4% in the cigarette cohort (p < .001 for pooled NSPS vs. cigarette); and reduced by 85.3% in the abstinence cohort (p > .05; 99.6% relative reduction between pooled NSPS vs. abstinence). Similar changes in individual BoEs were also observed (p < .001 for each BoE between pooled NSPS vs. cigarettes; and abstinence vs. pooled NSPS; p > .05 for each BoE between pooled NSPS vs. abstinence). Blood COHb decreased by 71.8% in the pooled NSPS cohort and 69.1% in the abstinence cohort (p > .05) and increased by 13.3% in the cigarette cohort (p < .001). Mean total urine nicotine equivalents increased in the pooled NSPS and cigarette cohorts by 9% and 26%, respectively, and did not significantly differ (p > .05). Conclusion Complete switching from cigarettes to NSPS produced significant reductions in key non-nicotine BoEs associated with cigarette smoking. Implications The results of this study concorded with evidence that complete switching from combustible cigarettes to tobacco and nontobacco-flavored vapor products may reduce exposure to key carcinogens and other toxicants known to be associated with tobacco-related diseases. Future research is needed to assess the long-term health effects of NSPS use. These results should not be interpreted to mean that the use of NSPS is without any risk, particularly for nonusers of tobacco products.

The advent of direct-acting antivirals for hepatitis C virus (HCV) and limited effectiveness of prevention have generated interest in \"Treatment as Prevention\" (TasP), in which those most likely to transmit HCV (i.e. people who inject drugs [PWID]) are treated to reduced secondary transmission. However, there are scant data regarding the feasibility of treating PWID at high risk for secondary transmission or the optimal approach to treatment delivery. We conducted a 2:1 randomized trial of modified directly-observed (mDOT) versus unobserved HCV treatment with ledipasvir-sofosbuvir daily for 8 weeks among PWID with 36 weeks of follow-up in San Francisco from 2015-2017. We evaluated recruitment-enrollment, treatment completion, end-of-treatment and 12-week response, and reinfection rate. Of 83 individuals eligible for screening, 72 (87.6%) attended the screening visit, 33 were eligible, and 31 enrolled; mean age was 42 years, 81% were male, 74% white. All but one participant (in the mDOT arm) completed treatment and 89.4% of mDOT and 96.6% of unobserved arm visits were attended. HCV was undetectable for 96.8% (30/31) at end of treatment and 89.7% (26/29) 12 weeks later (1 relapse, 1 reinfection), with no differences by arm. Two additional reinfections were subsequently identified, for a reinfection rate of 16.3 (95% CI 5.3-50.5) per 100 person-years of observation. It was feasible to recruit active PWID for HCV treatment and achieve high retention, viral response, and satisfaction with either mDOT or unobserved protocols, supporting treatment of PWID at risk of transmitting HCV to others. The reinfection rate suggests we successfully reached a high-risk population and that successful HCV TasP initiatives may aim to be sufficient in scope to significantly lower prevalence in the community. clinicaltrials.gov NCT02609893.

Pre-exposure prophylaxis (PrEP) trials are evaluating regimens containing tenofovir-disoproxil fumarate (TDF) for HIV prevention. We determined the baseline prevalence of low bone mineral density (BMD) and the effect of TDF on BMD in men who have sex with men (MSM) in a PrEP trial in San Francisco. We evaluated 1) the prevalence of low BMD using Dual Energy X-ray Absorptiometry (DEXA) in a baseline cohort of 210 HIV-uninfected MSM who screened for a randomized clinical trial of daily TDF vs. placebo, and 2) the effects of TDF on BMD in a longitudinal cohort of 184 enrolled men. Half began study drug after a 9-month delay to evaluate changes in risk behavior associated with pill-use. At baseline, 20 participants (10%) had low BMD (Z score≤-2.0 at the L2-L4 spine, total hip, or femoral neck). Low BMD was associated with amphetamine (OR = 5.86, 95% CI 1.70-20.20) and inhalant (OR = 4.57, 95% CI 1.32-15.81) use; men taking multivitamins, calcium, or vitamin D were less likely to have low BMD at baseline (OR = 0.26, 95% CI 0.10-0.71). In the longitudinal analysis, there was a 1.1% net decrease in mean BMD in the TDF vs. the pre-treatment/placebo group at the femoral neck (95% CI 0.4-1.9%), 0.8% net decline at the total hip (95% CI 0.3-1.3%), and 0.7% at the L2-L4 spine (95% CI -0.1-1.5%). At 24 months, 13% vs. 6% of participants experienced >5% BMD loss at the femoral neck in the TDF vs. placebo groups (p = 0.13). Ten percent of HIV-negative MSM had low BMD at baseline. TDF use resulted in a small but statistically significant decline in BMD at the total hip and femoral neck. Larger studies with longer follow-up are needed to determine the trajectory of BMD changes and any association with clinical fractures. ClinicalTrials.gov: NCT00131677.

We sought to leverage the strengths of time location sampling (TLS) and respondent-driven sampling (RDS) for surveys of hidden populations by combing elements of both methods in a new approach we call “starfish sampling.” Starfish sampling entails random selection of venue-day-time units from a mapping of the locations where the population can be found, combined with short chains of peer referrals from their social networks at the venue or presenting to the study site later. Using the population of transmen in San Francisco as a case example, we recruited 122 eligible participants using starfish sampling: 79 at randomly selected venues, 11 on dating applications, and 32 by referral. Starfish sampling produced one of the largest community-recruited samples specifically for transmen to date. Starfish sampling is a flexibility method to recruit and sample hidden populations for whom conventional TLS and RDS may not work in theory or practice.

Objective To evaluate trochlear morphology as a potential risk factor for patellofemoral osteoarthritis, determined by morphological and quantitative measurements of cartilage degeneration using 3-T magnetic resonance imaging (MRI) of the knee. Materials and methods MRI of the right knees of 304 randomly selected subjects, aged 45–60 years, from the Osteoarthritis Initiative (OAI) progression cohort were screened for trochlear dysplasia, defined by an abnormal trochlear depth. Out of 304 subjects, n  = 85 demonstrated a shallow trochlea (depth ≤3 mm; 28 %). In these, and also in a random sample of controls with normal trochlear depth ( n  = 50), the facet ratio and the sulcus angle were calculated and knee structural abnormalities were assessed by using a modified Whole Organ MR Imaging Score (WORMS). Cartilage segmentation was performed and T 2 relaxation times and patellar cartilage volume were determined. ANOVA and multivariate regression models were used for statistical analysis of the association of MRI structural measures and trochlear morphology. Results Knees with a shallow trochlea showed higher patellofemoral degeneration (WORMS mean ± standard deviation, 11.2 ± 0.5 versus 5.7 ± 0.6; multivariate regression, P  < 0.001) and lower patellar cartilage volume than controls (900 ± 664 mm 3 versus 1,671 ± 671 mm 3 ; P  < 0.001). Knees with an abnormal medial-to-lateral facet ratio (<0.4) showed increased patellofemoral WORMS scores (12.3 ± 0.9 versus 8.3 ± 0.5; P  < 0.001). Knees with an abnormal sulcus angle (>170°) also showed increased WORMS scores (12.2 ± 1.1 versus 8.6 ± 0.6; P  = 0.003). T 2 values at the patella were significantly lower in the dysplasia group with a shallow trochlea. However, significance was lost after adjustment for cartilage volume ( P  = 0.673). Conclusion Trochlear dysplasia, defined by a shallow trochlea, was associated with higher WORMS scores and lower cartilage volume, indicating more advanced osteoarthritis at the patellofemoral joint.

Objectives Inaccuracies in cause-of-death information in death certificates can reduce the validity of national death statistics and result in poor targeting of resources to reduce morbidity and mortality in people with HIV. Our objective was to measure the sensitivity, specificity, and agreement between multiple causes of deaths from death certificates obtained from the National Death Index (NDI) and causes determined by expert physician review. Methods Physician specialists determined the cause of death using information collected from the medical records of 50 randomly selected HIV-infected people who died in San Francisco from July 1, 2016, through May 31, 2017. Using expert review as the gold standard, we measured sensitivity, specificity, and agreement. Results The NDI had a sensitivity of 53.9% and a specificity of 66.7% for HIV deaths. The NDI had a moderate sensitivity for non–AIDS-related infectious diseases and non–AIDS-related cancers (70.6% and 75.0%, respectively) and high specificity for these causes (100.0% and 94.7%, respectively). The NDI had low sensitivity and high specificity for substance abuse (27.3% and 100.0%, respectively), heart disease (58.3% and 86.8%, respectively), hepatitis B/C (33.3% and 97.7%, respectively), and mental illness (50.0% and 97.8%, respectively). The measure of agreement between expert review and the NDI was lowest for HIV (κ = 0.20); moderate for heart disease (κ = 0.45) and hepatitis B/C (κ = 0.40); high for non–AIDS-related infectious diseases (κ = 0.76) and non–AIDS-related cancers (κ = 0.72); and low for all other causes of death (κ < 0.35). Conclusions Our findings support education and training of health care providers to improve the accuracy of cause-of-death information on death certificates.

Depression and diabetes are highly comorbid conditions and are significant causes of global disability, particularly among individuals with low income or those from racial or ethnic minority backgrounds. While digital interventions offer promise for managing these chronic conditions (such as via lifestyle modification), there is also emerging evidence suggesting that digital support may strengthen or complement existing health care relationships, particularly by improving patient perceptions of communication and connection with their health care providers. This study aimed to examine the impact of an adaptive mobile health (mHealth) texting-based intervention on patient ratings of communication with their health care providers among individuals with diabetes and depressive symptoms. This study used data from the DIAMANTE (Diabetes and Mental Health Adaptive Notification Tracking and Evaluation) trial, a prospective, randomized controlled trial that varied SMS text messaging strategies to encourage physical activity to support both mental and physical health for patients with diabetes and depression. Patients were recruited from safety-net clinics in San Francisco and through social media during the COVID-19 pandemic, and were randomized into three trial arms: (1) personalized SMS text messaging about physical activity via an adaptive learning algorithm, (2) randomly selected SMS text messaging about physical activity, and (3) a control group that received no SMS text messages. As a secondary outcome, we examined pre-post changes in patient-reported health care communication, assessed via surveys with the validated Consumer Assessment of Healthcare Providers and Systems (CAHPS) communication subscale. Bivariate comparisons examined changes in CAHPS scores, including age, gender, preferred language, race or ethnicity, nativity, marital status, and education. Our primary analysis used mixed-effects modeling within an intent-to-treat analysis to determine differences in CAHPS scores by trial arm. A total of 195 patients participated in the DIAMANTE trial from 2020 to 2022. After excluding patients who had incomplete or missing baseline or exit surveys, 156 patients were included in this secondary analysis. Overall, there was a substantive but nonsignificant decrease in the average CAHPS score over the 6-month trial period (-2.6; P=.11), with similar trends across patient demographic subgroups. Upon evaluating health care communication across the three randomized controlled trial (RCT) arms, there were no significant differences in patient-provider communication. Digital health interventions are rapidly increasing in clinical practice and have the ability to reach historically underserved communities by overcoming barriers such as language, geography, and time constraints. However, RCTs have primarily focused on the clinical impact of these tools, rather than how the tools may impact patients' perceptions of their relationships with providers. While our study found no significant changes in patient-provider communication by RCT arm, the temporal implications of the COVID-19 pandemic during the DIAMANTE study period remain unclear and should be further studied. This study is the first of its kind to examine the influence of an adaptive mHealth intervention on patient-reported health care communication, with insights that may be important as digitally-enabled chronic care management rapidly expands.

Background Few data exist on the use of text messaging as a tool to promote retention in HIV care and virologic suppression at the clinic level in the United States. We describe the protocol for a study designed to investigate whether a text messaging intervention that supports healthy behaviors, encourages consistent engagement with care, and promotes antiretroviral persistence can improve retention in care and virologic suppression among patients in an urban safety-net HIV clinic in San Francisco. Methods/Design Connect4Care (C4C) is a single-site, randomized year-long study of text message appointment reminders vs. text message appointment reminders plus thrice-weekly supportive, informational, and motivational text messages. Eligible consenting patients are allocated 1:1 to the two arms within strata defined by HIV diagnosis within the past 12 months (i.e. “newly diagnosed”) vs. earlier. Study participants must receive primary care at the San Francisco General Hospital HIV clinic, speak English, possess a cell phone and be willing to send/receive up to 25 text messages per month, a have viral load >200 copies/μL, and be either new to the clinic or have a history of poor retention. The primary efficacy outcome is virologic suppression at 12 months and the key secondary outcome, which will also be examined as a mediator of the primary outcome, is retention in HIV care, as operationalized by kept and missed primary care visits. Process outcomes include text message response rate and percent of time in study without cell phone service. Generalized estimating equation log-binomial models will be used for intent to treat, per protocol, and mediation analyses. An assessment of the cost and cost-effectiveness of the intervention is planned along with a qualitative evaluation of the intervention. Discussion Findings from this study will provide valuable information about the use of behavioral-theory based text messaging to promote retention in HIV care and virologic suppression, further elucidate the challenges of using texting technology with marginalized urban populations, and help guide the development of new mobile health strategies to improve HIV care cascade outcomes. Trial registration NCT01917994