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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.

ABSTRACT BACKGROUND Food insecurity— lack of dependable access to adequate food—may play a role in poor diabetes control. OBJECTIVE We aimed to determine the relationship between food security status and depression, diabetes distress, medication adherence and glycemic control. DESIGN Secondary analysis of baseline data from Peer Support for Achieving Independence in Diabetes, a randomized controlled trial that enrolled patients from November 2011 to October 2013. PARTICIPANTS Participants had poorly controlled type 2 diabetes (A1c ≥ 8.0 % on eligibility screen), household income < 250 % of the federal poverty level, were 30–70 years old, and were recruited from a large public hospital, a VA medical center and a community-health center in King County, Washington. MAIN MEASURES We measured food insecurity determined by the Department of Agriculture’s 6-Item Food Security Module. Depression, diabetes distress and medication adherence measured by PHQ-8, Diabetes Distress Scale and Morisky Medication Adherence Scale, respectively. Diet was assessed through Summary of Diabetes Self-Care Activities and Starting the Conversation tool. Incidence of hypoglycemic episodes was by patient report. Glycemic control was assessed with glycosylated hemoglobin (A1c) values from fingerstick blood sample. KEY RESULTS The prevalence of food insecurity was 47.4 %. Chi-square tests revealed participants with food insecurity were more likely to be depressed (40.7 % vs. 15.4 %, p < 0.001), report diabetes distress (55.2 % vs. 33.8 %, p < 0.001) and have low medication adherence (52.9 % vs. 37.2 %, p = 0.02). Based on linear regression modeling, those with food insecurity had significantly higher mean A1c levels (β = 0.51; p = 0.02) after adjusting for sex, age, race/ethnicity, language, education, marital status, BMI, insulin use, depression, diabetes distress and low medication adherence. CONCLUSIONS Almost half of participants had food insecurity. Food insecurity was associated with depression, diabetes distress, low medication adherence and worse glycemic control. Even with adjustment, people with food insecurity had higher mean A1c levels than their food-secure counterparts, suggesting there may be other mediating factors, such as diet, that explain the relationship between food security status and diabetes control.

Expedited partner therapy (EPT), the practice of treating the sex partners of persons with sexually transmitted infections without their medical evaluation, increases partner treatment and decreases gonorrhea and chlamydia reinfection rates. We conducted a stepped-wedge, community-level randomized trial to determine whether a public health intervention promoting EPT could increase its use and decrease chlamydia test positivity and gonorrhea incidence in women. The trial randomly assigned local health jurisdictions (LHJs) in Washington State, US, into four study waves. Waves instituted the intervention in randomly assigned order at intervals of 6-8 mo. Of the state's 25 LHJs, 24 were eligible and 23 participated. Heterosexual individuals with gonorrhea or chlamydial infection were eligible for the intervention. The study made free patient-delivered partner therapy (PDPT) available to clinicians, and provided public health partner services based on clinician referral. The main study outcomes were chlamydia test positivity among women ages 14-25 y in 219 sentinel clinics, and incidence of reported gonorrhea in women, both measured at the community level. Receipt of PDPT from clinicians was evaluated among randomly selected patients. 23 and 22 LHJs provided data on gonorrhea and chlamydia outcomes, respectively. The intervention increased the percentage of persons receiving PDPT from clinicians (from 18% to 34%, p < 0.001) and the percentage receiving partner services (from 25% to 45%, p < 0.001). Chlamydia test positivity and gonorrhea incidence in women decreased over the study period, from 8.2% to 6.5% and from 59.6 to 26.4 per 100,000, respectively. After adjusting for temporal trends, the intervention was associated with an approximately 10% reduction in both chlamydia positivity and gonorrhea incidence, though the confidence bounds on these outcomes both crossed one (chlamydia positivity prevalence ratio = 0.89, 95% CI 0.77-1.04, p = 0.15; gonorrhea incidence rate ratio = 0.91, 95% CI .71-1.16, p = 0.45). Study findings were potentially limited by inadequate statistical power, by the institution of some aspects of the study intervention outside of the research randomization sequence, and by the fact that LHJs did not constitute truly isolated sexual networks. A public health intervention promoting the use of free PDPT substantially increased its use and may have resulted in decreased chlamydial and gonococcal infections at the population level. ClinicalTrials.gov NCT01665690.

Mild traumatic brain injury (mTBI) is a common injury for service members in recent military conflicts. There is insufficient evidence of how best to treat the consequences of mTBI. In a randomized, clinical trial, we evaluated the efficacy of telephone-delivered problem-solving treatment (PST) on psychological and physical symptoms in 356 post-deployment active duty service members from Joint Base Lewis McChord, Washington, and Fort Bragg, North Carolina. Members with medically confirmed mTBI sustained during deployment to Iraq and Afghanistan within the previous 24 months received PST or education-only (EO) interventions. The PST group received up to 12 biweekly telephone calls from a counselor for subject-selected problems. Both groups received 12 educational brochures describing common mTBI and post-deployment problems, with follow-up for all at 6 months (end of PST), and at 12 months. At 6 months, the PST group significantly improved on a measure of psychological distress (Brief Symptom Inventory; BSI-18) compared to the EO group (p = 0.005), but not on post-concussion symptoms (Rivermead Post-Concussion Symptoms Questionnaire [RPQ]; p = 0.19), the two primary endpoints. However, these effects did not persist at 12-month follow-up (BSI, p = 0.54; RPQ, p = 0.45). The PST group also had significant short-term improvement on secondary endpoints, including sleep (p = 0.01), depression (p = 0.03), post-traumatic stress disorder (p = 0.04), and physical functioning (p = 0.03). Participants preferred PST over EO (p < 0.001). Telephone-delivered PST appears to be a well-accepted treatment that offers promise for reducing psychological distress after combat-related mTBI and could be a useful adjunct treatment post-mTBI. Further studies are required to determine how to sustain its effects. (Trial registration: ClinicalTrials.gov Identifier: NCT01387490 https://clinicaltrials.gov)

Reported relationships between frequency, type, and timing of eating occasions and obesity-risk among adults are mixed while associations with obesogenic eating behaviors remain unexplored. The Physical Activity and Changes in Eating (PACE) study was a group-randomized controlled trial to prevent weight gain among 34 small worksites in Seattle from 2005–2009. Baseline surveys assessed body mass index (BMI), obesogenic eating behaviors (e.g., fast food and distracted-eating), and eating occasions (i.e., snacks and meals) among 2265 employees. BMI and waist circumference were measured on a subset (n = 567). Time-periods for analyses included: morning (12:00 a.m. to 10:59 a.m.), mid-day (11:00 a.m. to 4:29 p.m.), and evening (4:30 p.m. to 11:59 p.m.). Multilevel linear models estimated associations between snack timing, obesity, and related behaviors while adjusting for meal timing, gender, and worksite random effects. Greater morning snacking was associated with increased fruit and vegetable consumption, while greater evening snacking was associated with higher BMI, higher obesogenic dietary index (intake of fast food, French fries, and soft drinks), and higher percent time eating while distracted. Associations with mid-day snacking were mixed. Patterns of association were consistent across repeated and objective measures. Findings suggest that evening snacking is more detrimental to healthy weight compared to snacking at other times of day. Reducing evening snacks may be an important and simple message for population-level obesity prevention efforts.

Objective To evaluate the effectiveness of integrated care for chronic physical diseases and depression in reducing disability and improving quality of life.Design A randomised controlled trial of multi-condition collaborative care for depression and poorly controlled diabetes and/or risk factors for coronary heart disease compared with usual care among middle aged and elderly people Setting Fourteen primary care clinics in Seattle, Washington.Participants Patients with diabetes or coronary heart disease, or both, and blood pressure above 140/90 mm Hg, low density lipoprotein concentration >3.37 mmol/L, or glycated haemoglobin 8.5% or higher, and PHQ-9 depression scores of ≥10. Intervention A 12 month intervention to improve depression, glycaemic control, blood pressure, and lipid control by integrating a “treat to target” programme for diabetes and risk factors for coronary heart disease with collaborative care for depression. The intervention combined self management support, monitoring of disease control, and pharmacotherapy to control depression, hyperglycaemia, hypertension, and hyperlipidaemia.Main outcome measures Social role disability (Sheehan disability scale), global quality of life rating, and World Health Organization disability assessment schedule (WHODAS-2) scales to measure disabilities in activities of daily living (mobility, self care, household maintenance).Results Of 214 patients enrolled (106 intervention and 108 usual care), disability and quality of life measures were obtained for 97 intervention patients at six months (92%) and 92 at 12 months (87%), and for 96 usual care patients at six months (89%) and 92 at 12 months (85%). Improvements from baseline on the Sheehan disability scale (−0.9, 95% confidence interval −1.5 to −0.2; P=0.006) and global quality of life rating (0.7, 0.2 to 1.2; P=0.005) were significantly greater at six and 12 months in patients in the intervention group. There was a trend toward greater improvement in disabilities in activities of daily living (−1.5, −3.3 to 0.4; P=0.10).Conclusions Integrated care that covers chronic physical disease and comorbid depression can reduce social role disability and enhance global quality of life.Trial registration Clinical Trials NCT00468676.

Comorbid nongastrointestinal symptoms account for two-thirds of excess health-care costs in irritable bowel syndrome (IBS). To determine whether IBS patients are at greater risk for specific comorbid disorders versus showing a general tendency to overreport symptoms; whether patients with inflammatory bowel disease (IBD) show patterns of comorbidity similar to IBS; whether comorbidity is explained by psychiatric disease; and whether excess comorbidity occurs in all IBS patients. All 3,153 patients in a health maintenance organization with a diagnosis of IBS in 1994-1995 were compared to 3,153 age- and gender-matched controls, and to 571 IBD patients. All diagnoses in a 4-yr period beginning 1 yr before their index visit were categorized as gastrointestinal, psychiatric, or nongastrointestinal somatic. Nongastrointestinal somatic diagnoses were further divided into symptom-based versus biological marker-based diagnoses. Forty-eight of 51 symptom-based and 16 of 25 biomarker-based diagnoses were significantly more common in IBS versus controls. However, there were no unique associations. Bacterial, viral, and fungal infections and stroke were among diagnoses made more frequently in IBS. IBD patients were similar to controls. Greater somatic comorbidity was associated with concurrent psychiatric diagnosis. Only 16% of IBS patients had abnormally high numbers of comorbid diagnoses. Comorbidity in IBS is due to a general amplification of symptom reporting and physician consultation rather than a few unique associations; this suggests biased symptom perception rather than shared pathophysiology. Comorbidity is influenced by, but is not explained by, psychiatric illness. Excess comorbidity is present in only a subset of IBS patients.

Background Obesity is associated with clinical depression among women. However, depressed women are often excluded from weight loss trials. Purpose This study examined treatment outcomes among women with comorbid obesity and depression. Methods Two hundred three (203) women were randomized to behavioral weight loss ( n  = 102) or behavioral weight loss combined with cognitive-behavioral depression management ( n  = 101). Results Average participant age was 52 years; mean baseline body mass index was 39 kg/m 2 . Mean Patient Health Questionnaire and Hopkins Symptom Checklist (SCL-20) scores indicated moderate to severe baseline depression. Weight loss and SCL-20 changes did not differ between groups at 6 or 12 months in intent-to-treat analyses ( p  = 0.26 and 0.55 for weight, p  = 0.70 and 0.25 for depressive symptoms). Conclusions Depressed obese women lost weight and demonstrated improved mood in both treatment programs. Future weight loss trials are encouraged to enroll depressed women.

Abstract Introduction Despite greater smoking prevalence among sexual minority (SM) individuals relative to non-SM individuals, minimal research has examined whether SM smokers have differential success at quitting, and no prior treatment studies have examined differences within SM subgroups. There is also limited knowledge of the psychosocial characteristics of treatment-seeking SM smokers, which could inform targeted treatments. To address these gaps, we compared treatment outcomes and baseline characteristics for SM and non-SM smokers and for bisexual versus lesbian or gay smokers in a large randomized controlled trial of two web-based cessation treatments. Methods Trial participants completed a survey to assess baseline characteristics, including self-identification as either SM (n = 253; lesbian or gay, n = 122; bisexual, n = 131) or non-SM (n = 2384). The primary cessation outcome was complete-case, self-reported 30-day abstinence at 12 months after randomization. Results Cessation outcomes did not differ significantly for SM versus non-SM smokers (24% vs. 25%, adjusted OR = 0.91, 95% CI = 0.65 to 1.28) or across SM subgroups (24% for bisexual vs. 23% for lesbian or gay, adjusted OR = 1.01, 95% CI = 0.51 to 2.00), and there were no interactions with treatment group assignment. At baseline, SM smokers differed from non-SM smokers on most demographics, were more likely to screen positive for all mental health conditions assessed, and had greater exposure to other smokers in the home. Conclusions Substantial differences in baseline characteristics of SM versus non-SM smokers and bisexual versus lesbian or gay smokers did not translate into differential treatment outcomes. Nonetheless, SM smokers’ willingness or ability to quit smoking could be enhanced by taking their unique psychosocial profile into account when designing targeted interventions. Implications The findings of this study, which included the largest sample of SM smokers in a prospective intervention trial to date, support those of a small extant body of literature showing no differences in treatment-assisted cessation outcomes between SM and non-SM smokers. Regardless of their quit rates relative to non-SM smokers, SM smokers’ willingness or ability to quit smoking could potentially be enhanced by taking their unique psychosocial profile into account in intervention design, including their younger age, lower socioeconomic status, greater likelihood of being racial or ethnic minorities, and greater prevalence of mental health symptoms.

BACKGROUNDMany US health departments have implemented Data to Care interventions, which use HIV surveillance data to identify persons who are inadequately engaged in HIV medical care and assist them with care reengagement, but the effectiveness of this strategy is uncertain. METHODSWe conducted a stepped-wedge, cluster-randomized evaluation of a Data to Care intervention in King County, Washington, 2011 to 2014. Persons diagnosed as having HIV for at least 6 months were eligible based on 1 of 2 criteria(1) viral load (VL) greater than 500 copies/mL and CD4 less than 350 cells/μL at the last report in the past 12 months or (2) no CD4 or VL reported to the health department for at least 12 months. The intervention included medical provider contact, patient contact, and a structured individual interview. Health department staff assisted patients with reengagement using health systems navigation, brief counseling, and referral to support services. We clustered all eligible cases in the county by the last known medical provider and randomized the order of clusters for intervention, creating contemporaneous intervention and control periods (cases in later clusters contributed person-time to the control period at the same time that cases in earlier clusters contributed person-time to the intervention period). We compared the time to viral suppression (VL <200 copies/mL) for individuals during intervention and control periods using a Cox proportional hazards model. RESULTSWe identified 997 persons (intention to treat [ITT]), 18% of whom had moved or died. Of the remaining 822 (modified ITT), 161 (20%) had an undetectable VL reported before contact and 164 (20%) completed the individual interview. The hazard ratio (HR) for time to viral suppression did not differ between the intervention and control periods in ITT (HR, 1.21 [95% confidence interval, 0.85–1.71]) or modified ITT (HR, 1.18 [95% confidence interval, 0.83–1.68]) analysis. CONCLUSIONSThe Data to Care intervention did not impact time to viral suppression.