No abstract

Objectives To determine the safety of the candidate vaginal microbicide SPL7013 Gel (VivaGel®) when applied to the penis. Methods A randomized, double blind, placebo controlled study. Thirty-six healthy men (18 circumcised, 18 uncircumcised), were randomized in a 2:1 ratio and treated with 3% SPL7013 Gel (N=24) or placebo gel (N=12), applied once daily for 7 days. Genital toxicity was determined by interview, diary, and examination. Results There were 10 genital adverse events (AEs) in 6 men (25%) receiving SPL7013 Gel, and 5 genital AEs in 4 men (33%) receiving the placebo that were possibly or probably related to the study product (difference of −8%, 95% CI: −40% to 23%, p=0.70). The most common genital AEs were genital pruritus and application site erythema. All genital AEs were mild (grade 1), and all but one, in the placebo group, were transient. Analysis of vital signs, non-genital AEs, and laboratory results indicated no safety or tolerability issues with SPL7013 Gel, irrespective of circumcision status. There was no detectable absorption of SPL7013 into the plasma. Conclusions 3% SPL7013 Gel was safe and well tolerated, and comparable with placebo, when administered to the penis of both circumcised and uncircumcised men once daily for 7 days, with no evidence of systemic absorption or toxicity.

Our findings highlight the profiles of current PEP users: men in HIV-serodiscordant relationships, and men having high numbers of casual partners and unprotected anal intercourse with them. These men are in need of effective HIV prevention strategies and may be receptive to preexposure prophylaxis in the future. Presently, targeted HIV education to improve risk assessment skills may prevent some seroconversions through the appropriate use of PEP.

NCT02007421.

Objective: Human papillomavirus-related anal cancer rates are increasing and are particularly high in gay, bisexual and other men who have sex with men (GBM/MSM), especially HIV-positive individuals. Although screening programs for high-risk populations have been advocated, concerns about possible adverse psychological consequences exist. This study aimed to investigate GBM/MSM's experience, understanding and emotional response to screening techniques for anal cancer to determine how best to minimise psychological distress in future programs. Methods:In-depth qualitative face-to-face interviews were conducted with 21 GBM/MSM participating in the "Study of the Prevention of Anal Cancer" in Sydney, Australia, between June 2013 and June 2014. Nonrandom, purposive sampling was used to ensure heterogeneity with respect to HIV status and screening test results. Framework analysis method was used to organise the data and identify emerging themes.Results: Knowledge about anal cancer, human papillomavirus and the link between them was limited. Abnormal screening results affected participants' sense of well-being and were associated with anxiety and concern about developing anal cancer. HIV-negative men receiving abnormal results showed higher levels of distress compared to their HIV-positive counterparts. Consultations with general practitioners about abnormal results had an important role in increasing participants' understanding and in moderating their anxiety.Conclusion: Anal cancer screening should be accompanied by health education around anal cancer, its aetiology and the meaning of associated test results. Simple and effective communication strategies should be encouraged. Collaboration with general practitioners could assist the process of education and reporting test results. Recent works showed that GBM are largely unaware of the link between HPV and anal cancer, with HIV-negative men having lower awareness. 6 Lack of knowledge and recommendations from doctors are the greatest barriers to screening for HIV-positive men. The present study is explorative and pursues potentially fruitful lines of research rather than an overall explanation of the phenomenon. | Sample and recruitmentApproximately 600 men from community-based settings took part to SPANC study. 18 To be eligible, men were aged 35 years or over and reported sex with another man in their lifetime. 18 This age limit was based on the distribution of anal cancer among different age-groups and on the evidence that incidence of anal cancer increases exponentially with age. 19Among SPANC participants, men were purposively selected based on HIV status (positive and negative), age (>50 years and <50 years) and severity of screening results (normal, presence of LSIL or HSIL). Eligible participants were recruited via letter or e-mail by a SPANC research officer who had access to participants' information and contact details. The recruiting process was arm's length from the interviewer.Those who agreed to be contacted were telephoned by the interviewer t...