The Mental Health Burden of Patients with Colorectal Cancer Receiving Care during the COVID-19 Pandemic: Results of the PICO-SM Study.

The COVID-19 pandemic has resulted in unprecedented changes to the lives of patients with cancer. To evaluate the impact of the COVID-19 pandemic on the mental health and well-being of patients with colorectal cancer, we conducted a prospective longitudinal questionnaire study at a UK tertiary cancer centre. In total, 216 participants were included: mean age 65 years, 57% (n = 122) male, 92% (n = 198) of white ethnicity. Amongst participants who completed the screening psychometric questionnaire, 24% (n = 48/203) reported anxiety (GAD-7 ≥ 5), 15% (n = 31/204) depressive symptoms (PHQ-9 ≥ 10), 3% (n = 5/190) probable post-traumatic stress disorder (PC-PTSD-5 ≥ 4), and 31% (n = 66/213) poor well-being (WHO-5 < 50). In the subgroup (n = 95/216, 44%) who consented to and completed a follow-up survey 6 months later, there was a significant increase in the number of participants at risk of depression (4% vs. 13%, p = 0.021). Self-reported concern about the COVID-19 pandemic impacting one's mental health is associated with increased likelihood of anxiety, depression, and poor well-being, in respective multivariate analyses. In conclusion, screening for the mental health impact of the COVID-19 pandemic is essential to ensure timely action from all key stakeholders and to avoid potentially longer-term detrimental consequences.

The Impact of Changes in Service Delivery in Patients With Colorectal Cancer During the Initial Phase of the COVID-19 Pandemic.

BACKGROUND: The Coronavirus disease 2019 (COVID-19) pandemic has imposed significant changes in cancer service delivery resulting in increased anxiety and distress in both patients and clinicians. We aimed to investigate how these changes have been perceived by patients diagnosed with colorectal cancer and identify determinants of increased anxiety. PATIENTS AND METHODS: An anonymized 32-item survey in the specialized lower gastrointestinal cancer outpatient clinics at a tertiary cancer center in North West England between May 18 and July 1, 2020. Self-reported anxiety was based on the General Anxiety Disorder-7 screening tool. RESULTS: Of 143 participants who completed the survey (response rate, 67%), 115 (82%) were male, and the median age group was 61 to 70 years. A total of 112 (78%) participants had telephone consultation (83% met needs), and 57 (40%) had radiologic scan results discussed over the phone (96% met needs). In total, 23 (18%) participants were considered to have anxiety (General Anxiety Disorder-7 score ≥ 5), with 7 (5.5%) scoring for moderate or severe anxiety. Those concerned about getting COVID-19 infection, and worried COVID-19 would have effect on their mental health, and affect their experience of cancer care, were most likely to have anxiety (P < .05, multivariate analysis). The majority did not feel they needed support during this phase of the pandemic. Participants felt that friends and family had been very supportive, but less so the primary care services (P < .05). CONCLUSIONS: The findings of this survey suggest that some of the service changes implemented may have already improved the overall experience of cancer care among patients with colorectal cancer at our institute. Reassuringly, the incidence of participants with moderate to severe anxiety levels during the peak of COVID-19 in the United Kingdom was much lower than anticipated. Importantly, patients were much more concerned about their cancer treatment than COVID-19, emphasizing the need to continue to provide comprehensive cancer care even with a "second wave" of COVID-19.

Requiring help injecting independently predicts incident HIV infection among injection drug users.

BACKGROUND: Requiring help injecting has been associated with syringe sharing among injection drug users (IDUs). No prospective study has fully examined this risk factor and its relation to rates of HIV infection. We investigated whether requiring help injecting illicit drugs was a predictor of HIV infection among a prospective cohort of IDUs. METHODS: The Vancouver Injection Drug User Study is a prospective study of more than 1500 IDUs who have been recruited from the Downtown Eastside of Vancouver since May 1996. At baseline and semiannually, subjects provided blood samples and completed an interviewer-administered questionnaire. The questionnaire elicits demographic data as well as information about drug use, HIV risk behavior, and drug treatment. HIV incidence rates were calculated using Kaplan-Meier methods, and Cox regression determined independent predictors of seroconversion. RESULTS: A total of 1013 baseline HIV-negative participants were eligible for this study. Within this population, 418 (41.3%) participants had required help injecting during the last 6 months at baseline. Participants requiring help injecting were more likely to be female (odds ratio = 2.3, 95% confidence interval [CI]: 1.8-3.0; P < 0.001), were slightly younger (33.5 vs. 34.9 years of age; P = 0.014), and had fewer years of experience injecting drugs (7 vs. 11 years; P < or = 0.001). Among participants who required help injecting at baseline, cumulative HIV incidence at 36 months was 16.1% compared with 8.8% among participants who did not require help injecting (log-rank, P < 0.001). In an adjusted model controlling for potential confounding variables, being aboriginal (relative hazard [RH] = 1.68, 95% CI: 1.15-2.48), injecting cocaine daily (RH = 2.71, 95% CI: 1.87-3.95), and requiring help injecting (RH = 1.79, 95% CI: 1.23-2.62) remained independent predictors of HIV seroconversion. CONCLUSIONS: These data demonstrate the need for interventions to reduce the risk of HIV infection among IDUs who require help injecting.

Back to work: correlates of employment among persons receiving highly active antiretroviral therapy.

The aim of this study was to quantify the level of employment at one-year and to determine potential predictors of future employment among HIV-positive persons on highly active antiretroviral therapy (HAART) in the province of British Columbia. Of the 392 individuals that were initially unemployed at baseline 63 (16.1%) found a job over the subsequent year. Factors associated with becoming employed included a baseline income over 10,000 dollars, having long-term disability or unemployment insurance as an income source, having higher CD4 cell counts, and better physical, social, and role functioning. Factors negatively associated with finding employment included having provincial assistance as an income source and having ever been an injection drug user (IDU). In multivariate analyses, not using provincial assistance as a source of income (Odds Ratio [OR] = 7.39; 95% CI: 3.26-16.7; p < 0.001) and higher MOS-SF role functioning (OR = 1.12 per 10 point increment; 95% CI: 1.03-1.21; p = 0.005) were independent predictors of becoming employed. In conclusion, our study demonstrates that while significant advances have been made in the reduction of HIV-related mortality, the majority of HIV-infected individuals on adequate treatment are still unable to be gainfully employed.

Gender differences in HIV-1 RNA rebound attributed to incomplete antiretroviral adherence among HIV-Infected patients in a population-based cohort.

BACKGROUND: There have been growing concerns about possible gender-related differences in rates of responses to highly active antiretroviral therapy (HAART). We therefore examined the association between gender and time to HIV-1 RNA rebound in antiretroviral-naive HIV-infected patients initiating HAART in a population-based setting. METHODS: We evaluated all antiretroviral-naive HIV-infected men and women who achieved HIV-1 RNA suppression at least once (HIV RNA <500 copies/mL) after initiating HAART between August 1, 1996 and July 31, 2000 and who were followed until March 31, 2002 in a province-wide HIV treatment program. We evaluated time to HIV-1 RNA rebound (> or =500 copies/mL) using Kaplan-Meier methods and Cox proportional hazards regression. RESULTS: In total, 844 (87.0%) men and 126 (13.0%) women initiated HAART during the study period and achieved HIV-1 RNA suppression at least once. Overall rates of rebound were 47.4% and 34.0% for women and men, respectively (log-rank, P < 0.021). Women were less likely to be > or =95% adherent (P = 0.001) and more likely to have a history of injection drug use (P = 0.001). In multivariate analysis, incomplete adherence was found to be highly predictive of HIV-1 RNA rebound (adjusted relative hazard [ARH] = 4.00, 95% confidence interval [CI]: 3.33-5.00). Although female patients had higher rates of HIV-1 RNA rebound in univariate analysis (relative hazard [RH] = 1.39, 95% CI: 1.05-1.82), this was no longer statistically significant once other known confounders such as adherence and injection drug use were adjusted for (RH = 0.95, 95% CI: 0.71-1.28). When the analyses were stratified based on history of injection drug use, we found that rates of rebound were higher among injection drug-using women than among injection drug-using men (P = 0.048), whereas there was no gender difference among non-injection drug users with respect to rebound (P = 0.345). CONCLUSIONS: We found that higher rates of HIV-1 RNA rebound among women were primarily explained by incomplete adherence, which was more prevalent among women in this cohort. Our findings suggest that psychosocial factors such as drug use and incomplete adherence predict HIV-1 RNA rebound and that gender differences in time to rebound can be largely attributed to a disproportionate prevalence of these factors among women in this population.

Sexual risk profile of young men in Vancouver, British Columbia, who have sex with men and inject drugs.

We compared sexual risk behaviors of men who have sex with men and inject drugs (MSM/IDU) with those of other men who have sex with men (MSM). Of 910 MSM surveyed, 106 (12%) injected drugs in the previous year. MSM/IDU were younger than MSM and more likely to be HIV-seropositive, Aboriginal, economically disadvantaged, engaged in the trade of sex for money or drugs, and to report having female sexual partners. MSM/IDU reported more casual sexual partners and in multivariate analyses were twice as likely to report unprotected receptive anal intercourse with casual partners. These results, combined with those from previous analyses, suggest that the higher risk for HIV seroconversion among MSM/IDU in this cohort is attributable mainly to sexual rather than injection-related exposures. Controlled assessments are needed to identify optimal sexual risk reduction strategies for MSM/IDU.

Age, adherence and injection drug use predict virological suppression among men and women enrolled in a population-based antiretroviral drug treatment programme.

OBJECTIVES: To characterize 1-year virological response to antiretroviral therapy and its determinants by sex. METHODS: This is a population-based analysis of antiretroviral therapy naive HIV-positive adult men and women. Factors associated with sex and with plasma HIV RNA viral load suppression to below 500 copies/ml were examined using non-parametric tests and logistic regression analyses. RESULTS: A total of 739 subjects (92 women and 647 men) were eligible. Female participants were younger (34 vs 37 years; P < 0.001), less likely to have AIDS (6.5 vs 14.4%; P = 0.039), more frequently injection drug users (44.6 vs 25.2%; P = 0.001) and were less likely to be adherent to therapy (34.8 vs 62.9%; P < 0.001) than male participants. There was no difference in baseline median CD4 count (P = 0.424) or HIV RNA levels (P = 0.140), physician experience (P = 0.057), or with respect to antiretroviral regimens containing protease inhibitors or non-nucleoside reverse transcriptase inhibitors (P = 0.911). With treatment, 46.7% (43/92) of women and 64.8% (419/647) of men (P = 0.001) suppressed HIV RNA viral load to below 500 copies/ml at 1 year. In a multivariate analysis, the association of sex with HIV RNA response to antiretroviral therapy fell from statistical significance (odds ratio 1.18; 95% CI: 0.72-1.95) after adjusting for adherence, injection drug use and age. CONCLUSION: Our data indicate that in this population-based setting, sex differences in 1-year virological response to antiretroviral therapy are explained by age, adherence and injection drug use.

Willingness to participate and enroll in a phase 3 preventive HIV-1 vaccine trial.

OBJECTIVES: To assess the extent to which HIV-negative cohort study participants would be willing to participate (WTP) in future HIV vaccine trials, to explore enrollment into an ongoing phase 3 HIV vaccine trial, and to assess changing WTP in such trials over time. METHODS: The Vanguard Project is a prospective study of gay and bisexual men in the greater Vancouver region, British Columbia, Canada. Sociodemographic characteristics, sexual risk behavior, beliefs around HIV, and reasons for not participating in the AIDSVAX B/B trial were collected from self-administered questionnaires. Contingency table analysis compared subjects who were WTP with subjects who were not WTP. Logistic regression analyses identified possible predictors of WTP. A subset analysis was conducted to assess changes in WTP in 2001 versus 1997. RESULTS: Of 440 respondents, 214 (48.6%) were WTP, and 97 (22.0%) were not WTP. Those WTP were disadvantaged, sexually risky, and had a high-perceived HIV risk (all p <.05). Reasons for not participating in the AIDSVAX B/B trial included fear of health problems and having missed the deadline for enrollment (all p < 0.05). Multivariate analysis revealed that having had a regular sex partner (adjusted odds ratio, 0.48 [confidence interval, 0.25-0.92]) was a negative predictor whereas having a high-perceived HIV risk (adjusted odds ratio, 5.35 [confidence interval, 1.57-18.25]) was a positive predictor of WTP. Comparing WTP in 2001 with that in 1997, 24% of 100 participants who had been previously WTP were now not WTP. CONCLUSION: Improving community and participant knowledge about preventive HIV vaccine trials may help ensure informed consent. However, whether informing potential participants will reverse or contribute to the declining trend in WTP observed in this cohort warrants further investigation.