Which HIV-infected men who have sex with men in care are engaging in risky sex and acquiring sexually transmitted infections: findings from a Boston community health centre.

OBJECTIVES: The primary objective was to determine the prevalence of sexually transmitted infections (STI) in a cohort of HIV-infected men who have sex with men (MSM) in their primary care setting, and to identify the demographic and behavioural characteristics of those infected with STI and the correlates of sexual transmission risk behaviour. METHODS: At study entry, participants (n = 398) were tested for STI and their medical charts were reviewed for STI results in the previous year. Data on demographics, substance use, sexual behaviour and HIV disease characteristics were collected through a computer-assisted self-assessment and medical record extraction. Logistic regression analyses assessed characteristics of those with recent STI and recent transmission risk behaviour. RESULTS: The sample was predominantly white (74.6%) and college educated (51.7%). On average, participants were 41.5 years old (SD 8.4) and had been HIV infected for 8.6 years (SD 6.7); 9% of the sample had an STI, with 6.4% testing positive for syphilis, 3.1% for gonorrhoea and 0.25% for chlamydia. Age and years since HIV diagnosis were significantly associated with testing positive for an STI, as was engaging in transmission risk behaviour and using methamphetamine, ketamine and inhalants. Substance use, particularly methamphetamine use, and being more recently diagnosed with HIV were each uniquely associated with transmission risk behaviour in a multivariable model. CONCLUSIONS: These results underscore the need to develop more effective secondary prevention interventions for HIV-infected MSM, tailored to more recently diagnosed patients, particularly those who are younger and substance users.

Are informed consent forms that describe clinical oncology research protocols readable by most patients and their families?

PURPOSE: This study was conducted to assess the readability of informed consent forms that describe clinical oncology protocols. METHODS: One hundred thirty-seven consent forms from 88 protocols that accrued patients at The Johns Hopkins Oncology Center were quantitatively analyzed. These included 58 of 99 (59%) institutional protocols approved by The Johns Hopkins Oncology Center's Clinical Research Committee and the Institutional Review Board (IRB) over a 2-year period, and 30 active Eastern Cooperative Oncology Group (ECOG), Radiation Therapy Oncology Group (RTOG), and Pediatric Oncology Group (POG) trials. The consent forms described phase I (17%), phase I/II (36%), phase III (29%), and nontherapeutic (18%) studies. Each was optically scanned, checked for accuracy, and analyzed using readability software. The following three readability indices were obtained for each consent form: the Flesch Reading Ease Score, and grade level readability as determined by the Flesch-Kincaid Formula and the Gunning Fog Index. RESULTS: The mean +/- SD Flesch Reading Ease Score for the consent forms was 52.6 +/- 8.7 (range, 33 to 78). The mean grade level was 11.1 +/- 1.67 (range, 6 to 14) using the Flesch-Kincaid Formula and 14.1 +/- 1.8 (range, 8 to 17) using the Gunning Fog Index. Readability at or below an eighth-grade level was found in 6% of the consent forms using the Flesch-Kincaid Formula and in 1% using the Gunning Fog Index. Readability was similar for consent forms that described institutional, cooperative group, and phase I, II, and III protocols. CONCLUSION: Consent forms from clinical oncology protocols are written at a level that is difficult for most patients to read, despite national, cooperative group, institutional, and departmental review. The consent process, which is crucial to clinical research, should be strengthened by improving the readability of the consent forms.