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: Introduction: Implementation science (IS) offers methods to systematically achieve the Ending the HIV Epidemic goals in the United States, as well as the global UNAIDS targets. Federal funders such as the National Institutes of Mental Health (NIMH) have invested in implementation research to achieve these goals, including supporting the AIDS Research Centres (ARCs), which focus on high‐impact science in HIV and mental health (MH). To facilitate capacity building for the HIV/MH research workforce in IS, “grey areas,” or areas of IS that are confusing, particularly for new investigators, should be addressed in the context of HIV/MH research. Discussion: A group of IS experts affiliated with NIMH‐funded ARCs convened to identify common and challenging grey areas. The group generated a preliminary list of 19 grey areas in HIV/MH‐related IS. From the list, the authors developed a survey which was distributed to all ARCs to prioritize grey areas to address in this paper. ARC members across the United States (N = 60) identified priority grey areas requiring clarification. This commentary discusses topics with 40% or more endorsement. The top grey areas that ARC members identified were: (1) Differentiating implementation strategies from interventions; (2) Determining when an intervention has sufficient evidence for adaptation; (3) Integrating recipient perspectives into HIV/MH implementation research; (4) Evaluating whether an implementation strategy is evidence‐based; (5) Identifying rigorous approaches for evaluating the impact of implementation strategies in the absence of a control group or randomization; and (6) Addressing innovation in HIV/MH IS grants. The commentary addresses each grey area by drawing from the existing literature (when available), providing expert guidance on addressing each in the context of HIV/MH research, and providing domestic and global HIV and HIV/MH case examples that address these grey areas. Conclusions: HIV/MH IS is key to achieving domestic and international goals for ending HIV transmission and mitigating its impact. Guidance offered in this paper can help to overcome challenges to rigorous and high‐impact HIV/MH implementation research., INTRODUCTION Implementation science (IS), defined by the National Institutes of Health (NIH) as “the scientific study of the use of strategies to adopt and integrate evidence‐based health interventions (EBIs),” offers [...]

Prospective studies on the association between depression and telomere length have produced mixed results and have been largely limited to European ancestry populations. We examined the associations between depression and telomere length, and the modifying influence of religion and spirituality, in four cohorts, each representing a different race/ethnic population. Relative leukocyte telomere length (RTL) was measured by a quantitative polymerase chain reaction. Our result showed that depression was not associated with RTL (percent difference: 3.0 95% CI: -3.9, 10.5; p = 0.41; p-heterogeneity across studies = 0.67) overall or in cohort-specific analyses. However, in cohort-specific analyses, there was some evidence of effect modification by the extent of religiosity or spirituality, religious congregation membership, and group prayer. Further research is needed to investigate prospective associations between depression and telomere length, and the resources of resilience including dimensions of religion and spirituality that may impact such dynamics in diverse racial/ethnic populations.

PURPOSE: Current tools in predicting survival outcomes for patients with colon cancer predominantly rely on clinical and pathologic characteristics, but increasing evidence suggests that diet and lifestyle habits are associated with patient outcomes and should be considered to enhance model accuracy. METHODS: Using an adjuvant chemotherapy trial for stage III colon cancer (CALGB 89803), we developed prediction models of disease-free survival (DFS) and overall survival by additionally incorporating self-reported nine diet and lifestyle factors. Both models were assessed by multivariable Cox proportional hazards regression and externally validated using another trial for stage III colon cancer (CALGB/SWOG 80702), and visual nomograms of prediction models were constructed accordingly. We also proposed three hypothetical scenarios for patients with (1) good-risk, (2) average-risk, and (3) poor-risk clinical and pathologic features, and estimated their predictive survival by considering clinical and pathologic features with or without adding self-reported diet and lifestyle factors. RESULTS: Among 1,024 patients (median age 60.0 years, 43.8% female), we observed 394 DFS events and 311 deaths after median follow-up of 7.3 years. Adding self-reported diet and lifestyle factors to clinical and pathologic characteristics meaningfully improved performance of prediction models (c-index from 0.64 [95% CI, 0.62 to 0.67] to 0.69 [95% CI, 0.67 to 0.72] for DFS, and from 0.67 [95% CI, 0.64 to 0.70] to 0.71 [95% CI, 0.69 to 0.75] for overall survival). External validation also indicated good performance of discrimination and calibration. Adding most self-reported favorable diet and lifestyle exposures to multivariate modeling improved 5-year DFS of all patients and by 6.3% for good-risk, 21.4% for average-risk, and 42.6% for poor-risk clinical and pathologic features. CONCLUSION: Diet and lifestyle factors further inform current recurrence and survival prediction models for patients with stage III colon cancer.

Objectives: Only one community-based study has assessed religious group involvement and health outcomes among South Asians in the U.S., with mixed results. Here, using a large, South Asian community-based sample, the effects of six religious group involvement predictors - religious tradition, attendance, group prayer, giving/receiving congregational emotional support, congregational neglect, and congregational criticism - were examined in relation to four health outcomes: self-rated health, positive mental health functioning, trait anxiety, and trait anger.Design: The study used a new religion/spirituality questionnaire in the Mediators of Atherosclerosis Among South Asians Living in America (MASALA), the largest study of mental and physical well-being among U.S. South Asians. Associations were assessed cross-sectionally using OLS regression in both the full sample (N = 928) and a subsample of congregation members (N = 312).Results: Jains reported better self-rated health compared to Hindus and Muslims. Group prayer involvement, when measured ordinally, was positively associated with self-rated health and mental health functioning. In reference group comparisons, individuals who participated in group prayer once/day or more had lower levels of anxiety and anger compared to several comparison groups in which individuals prayed less than once a day. Religious service attendance was associated with higher levels of anxiety. Giving/receiving congregational emotional support was positively associated with self-rated health and mental health functioning, and inversely associated with anxiety. Congregational criticism was associated with higher levels of anger and anxiety.Conclusions: This study provided a new assessment of religious group involvement and health in the U.S. South Asian population. Religious group participation was associated with mental and self-rated health in well-controlled models, indicating this is a fruitful area for further research. Group religious involvement may be a health-promoting resource for U.S. South Asians who are religiously active, but it is not an unalloyed boon.

Background: Little is known about improving physical activity (PA) and diet during and after chemotherapy for breast cancer. This secondary analysis examines changes in PA and diet quality during a yearlong intervention for patients with breast cancer undergoing chemotherapy and evaluates factors associated with these changes. Methods: Newly diagnosed patients with breast cancer (N = 173) undergoing chemotherapy were randomized to a year‐long nutrition and exercise intervention (n = 87) or usual care (UC, n = 86). Mixed models compared 1‐year changes in PA and diet quality via the Healthy Eating Index (HEI)‐2015 by study arm. Among the intervention group, baseline factors associated with change in PA and diet were assessed with multivariable linear and logistic regression. Results: At 1 year, compared with UC, the intervention arm increased PA more (mean difference = 136.1 minutes/week; 95% CI, 90.2–182.0), participated in more strength training (56% vs. 15%; p <.001), and had suggestive improvements in HEI‐2015 (mean difference = 2.5; 95% CI, –0.3 to 5.3; p =.08). In the intervention arm, lower fatigue was associated with improved PA (p =.04) and higher education was associated with improved HEI‐2015 (p =.001) at 1 year. Higher HEI‐2015 (p =.04) and married/living with someone (p =.05) were associated with higher odds of participating in strength training at 1 year. Conclusions: This year‐long lifestyle intervention for patients with breast cancer undergoing chemotherapy resulted in increases in PA and suggestive improvements in diet quality. Behavior change was associated with baseline fatigue, diet quality, education, and married/living with someone. Addressing these factors in interventions may improve uptake of lifestyle behaviors in trials during and after chemotherapy. This secondary analysis of the Lifestyle, Exercise, and Nutrition Early After Diagnosis trial explored changes in physical activity and diet quality during a year‐long lifestyle intervention for patients with breast cancer that started at the beginning of chemotherapy and evaluated baseline factors associated with behavior change. Although women enrolled in the trial improved their physical activity and had suggestive improvements in diet quality from the start of chemotherapy through 1 year, considering sociodemographic factors including education, being married/living with someone, as well as baseline levels of fatigue may be important for future interventions seeking to achieve maximum positive behavior change during and after chemotherapy. [ABSTRACT FROM AUTHOR]

Background: Intervention packages may result in a greater public health impact than single interventions. Understanding the separate impact of each component on the overall package effectiveness can improve intervention delivery. Methods: We adapted an approach to evaluate the effects of a time-varying intervention package in a network-randomized study. In some network-randomized studies, only a subset of participants in exposed networks receive the intervention themselves. The spillover effect contrasts average potential outcomes if a person was not exposed to themselves under intervention in the network versus no intervention in a control network. We estimated the effects of components of the intervention package in HIV Prevention Trials Network 037, a Phase III network-randomized HIV prevention trial among people who inject drugs and their risk networks using marginal structural models to adjust for time-varying confounding. The index participant in an intervention network received a peer education intervention initially at baseline, then boosters at 6 and 12 months. All participants were followed to ascertain HIV risk behaviors. Results: There were 560 participants with at least one follow-up visit, 48% of whom were randomized to the intervention, and 1,598 participant visits were observed. The spillover effect of the boosters in the presence of initial peer education training was a 39% rate reduction (rate ratio = 0.61; 95% confidence interval = 0.43, 0.87). Conclusions: These methods will be useful for evaluating intervention packages in studies with network features. [ABSTRACT FROM AUTHOR]

Background: Pre-Exposure Prophylaxis (PrEP) has demonstrated efficacy in preventing HIV infection. Female Bar Workers (FBWs) often act as informal sex workers, placing them at risk of HIV infection. Despite expressing interest in PrEP, FBWs face barriers to accessing public-sector clinics where PrEP is delivered. We developed a study to compare the effectiveness of workplace-based PrEP provision to standard-of-care facility-based provision for PrEP initiation, retention and adherence among FBWs. Methods: In this double-randomized intervention study, FBWs aged 15 years and above will be screened, consented and initiated on PrEP (emtricitabine/tenofovir disoproxil), and followed for six months. Participants will be randomized at the bar level and offered PrEP at their workplace or at a health facility. Those who are initiated will be independently individually randomized to either receive or not receive an omni-channel PrEP champion intervention (support from an experienced PrEP user) to improve PrEP adherence. We expect to screen 1,205 FBWs to enroll at least 160 HIV negative women in the study. Follow-up visits will be scheduled monthly. HIV testing will be performed at baseline, month 1, 4 and 6; and TDF testing at months 2 and 6. Primary outcomes for this trial are: (1) initiation on PrEP (proportion of those offered PrEP directly observed to initiate PrEP); and (2) adherence to PrEP (detectable urine TDF drug level at 6-months post-enrollment). The primary outcomes will be analyzed using Intention-to-Treat (ITT) analyses. Discussion: Using a randomized trial design, we will evaluate two interventions aiming to reduce barriers to uptake and retention on PrEP among FBWs, a vulnerable population at risk of HIV acquisition and onward transmission. If these interventions prove effective in promoting PrEP among FBWs, they could assist in abating the HIV epidemic in Africa. Trial registration: Registered with German Clinical Trials Register (www.drks.de) on 29 April 2020; Registration number DRKS00018101. [ABSTRACT FROM AUTHOR]

Regression calibration as developed by Rosner, Spiegelman, and Willett is used to adjust the bias in effect estimates due to measurement error in continuous exposures. The method involves two models: a measurement error model relating the mismeasured exposure to the true (or gold-standard) exposure and an outcome model relating the mismeasured exposure to the outcome. However, no comprehensive guidance exists for determining which covariates should be included in each model. In this article, we investigate the selection of the minimal and most efficient covariate adjustment sets under a causal inference framework. We show that to address the measurement error, researchers must adjust for, in both measurement error and outcome models, any common causes (1) of true exposure and the outcome and (2) of measurement error and the outcome. We also show that adjusting for so-called prognostic variables that are independent of true exposure and measurement error in the outcome model, may increase efficiency, while adjusting for any covariates that are associated only with true exposure generally results in efficiency loss in realistic settings. We apply the proposed covariate selection approach to the Health Professional Follow-up Study dataset to study the effect of fiber intake on cardiovascular disease. Finally, we extend the originally proposed estimators to a nonparametric setting where effect modification by covariates is allowed. [ABSTRACT FROM AUTHOR]

Background: Worksite-based health programs have shown positive impacts on employee health and have led to significant improvements in cardiovascular risk factor profiles. We aimed to determine the effect of cafeteria intervention on cardio-metabolic risk factors diet in a worksite setting (Dhulikhel Hospital) in Nepal. Methods: In this one-arm pre-post intervention study, we recruited 277 non-pregnant hospital employees aged 18–60 with prediabetes or pre-hypertension. The study was registered in clinicaltrials.gov (NCT03447340; 2018/02/27). All four cafeterias in the hospital premises received cafeteria intervention encouraging healthy foods and discouraging unhealthy foods for six months. We measured blood pressure, fasting glucose level, glycated hemoglobin, cholesterol in the laboratory, and diet intake (in servings per week) using 24-hour recall before and six months after the intervention. The before and after measures were compared using paired-t tests. Results: After six months of cafeteria intervention, the median consumption of whole grains, mono/polyunsaturated fat, fruits, vegetable and nuts servings per week increased by 2.24(p<0.001), 2.88(p<0.001), 0.84(p<0.001) 2.25(p<0.001) and nuts 0.55 (p<0.001) servings per week respectively. The median consumption of refined grains decreased by 5.07 servings per week (p<0.001). Mean systolic and diastolic blood pressure decreased by 2 mmHg (SE = 0.6; p = 0.003) and 0.1 mmHg (SE = 0.6; p = 0.008), respectively. The low-density lipoprotein (LDL) was significantly reduced by 6 mg/dL (SE = 1.4; p<0.001). Conclusion: Overall, we found a decrease in consumption of refined grains and an increase in consumption of whole grains, unsaturated fats, fruits, and nuts observed a modest reduction in blood pressure and LDL cholesterol following a 6-month cafeteria-based worksite intervention incorporating access to healthy foods. [ABSTRACT FROM AUTHOR]