Prevalence and determinants of anal human papillomavirus infection in men who have sex with men and transgender women.

Human papillomavirus (HPV) prevalence varies by population. This study investigated anal HPV type detection risk by country in a population of men who have sex with men (MSM) and transgender women (TW) at risk of HIV. Sexually active HIV-1-uninfected MSM and TW were enrolled at eight sites: four in the United States (US), two in Thailand, one in Peru, and one in South Africa. Baseline anal HPV swabs were collected, and DNA typing was performed. One hundred and ninety-five participants, 76 (42%) from the US, had a mean age of 30.9 years (range 18-64). In 182 participants with results available, anal HPV infection was common with 169 (93%) with ≥1 type, 132 (73%) with ≥1 nine-valent vaccine types, and 66 (36%) with HPV 16. Participants in the US had a higher prevalence of HPV 16 (56%, p = 0.004) and HPV 6 (69%, p < 0.001) compared to the other regions. Stimulant drug use was significantly associated with HPV 6 detection. Anal HPV is highly prevalent in this population of MSM and TW sampled from four countries, with HPV 16 the most commonly detected type. The nine-valent HPV vaccine has the potential to provide significant protection if given prior to exposure.

A Randomized, Placebo-Controlled Trial of the Quadrivalent Human Papillomavirus Vaccine in Human Immunodeficiency Virus-Infected Adults Aged 27 Years or Older: AIDS Clinical Trials Group Protocol A5298.

Background: Adults living with human immunodeficiency virus (HIV) are at increased risk for anal and oropharyngeal cancer caused by human papillomavirus (HPV). The efficacy of HPV vaccines in this population is unknown. Methods: In this phase 3, double-blind, randomized, controlled trial, we assigned HIV-infected adults aged ≥27 years to the quadrivalent HPV (types 6, 11, 16, 18) vaccine or placebo (1:1) stratified by sex and presence of anal high-grade squamous intraepithelial lesions on biopsy (bHSIL). The primary endpoint was vaccine efficacy against incident persistent anal infection with quadrivalent vaccine types or single detection at the final visit that were not present at baseline. Secondary endpoints included vaccine efficacy for anal bHSIL after week 52, persistent oral HPV infection. Results: A total of 575 participants were randomized. The Data and Safety Monitoring Board stopped the study early due to futility. Vaccine efficacy was 22% (95.1% confidence interval [CI], -31%, 53%) for prevention of persistent anal infection or single detection at the final visit, 0% (95% CI -44%, 31%) for improving bHSIL outcomes and 88% (95.1% CI 2%, 98%) for preventing persistent oral HPV infection, but was 32% (95.1% CI -80%, 74%) for 6-month persistent oral HPV infection or single detection at the final visit. Conclusions: These results do not support HPV vaccination of HIV-infected adults aged ≥27 years to prevent new anal HPV infections or to improve anal HSIL outcomes. However, our data suggest a role for prevention of oral HPV infections, but this finding should be confirmed in future studies. Clinical Trials Registration: NCT01461096.

Acceptability of Three Novel HIV Prevention Methods Among Young Male and Transgender Female Sex Workers in Puerto Rico.

Sex workers need HIV-prevention methods they can control and incorporate easily in their work. We studied the acceptability of three methods: HIV self-test use with clients, oral pre-exposure prophylaxis (PrEP), and rectal microbicide gel. Four male and eight transgender female (TGF) sex workers in Puerto Rico completed a baseline survey with a quantitative measure of likelihood of use. From them, one male and four TGF also completed a 12-week study of rectal microbicide placebo gel use prior to receptive anal intercourse with male clients and evaluated via qualitative in-depth interviews and follow-up quantitative assessments how each method could be incorporated into their work. Most were interested in a rectal microbicide gel and able to use it covertly with clients. Challenges to using the HIV self-test with clients included the potential for both breach of confidentiality and confronting violent situations. Participants also expressed interest in oral PrEP, but raised concerns about side effects.

Influence of Partner Type on Acceptability and Likelihood of Use of a Rectal Microbicide Among Young Men Who Have Sex With Men in the United States and Puerto Rico.

This study examined how acceptability of placebo gel with receptive anal intercourse (RAI) and likelihood of future rectal microbicide use varied across partner types. Because no rectal microbicide is available yet, use of placebo permitted the study of gel use behavior in real-life circumstances. A total of 87 men who have sex with men (MSM) aged 18 to 30 years inserted placebo gel rectally before RAI during 12 weeks. Using mixed-methods design, participants completed a behavioral questionnaire and in-depth interview. In all, 62 men (71.3%) reported gel use with a lover (i.e., spouse equivalent, boyfriend), 32 (36.8%) with a one-night stand (i.e., man with whom you had sex once), and 29 (33.3%) with an "other" male partner. While gel acceptability was high across partner types, use with lovers was facilitated by trust and familiarity; yet trust made participants believe protection was less necessary. Conversely, participants expressed high likelihood of using gel with one-night stands, whom they perceived as riskier; yet they felt less comfortable discussing gel with them, often resorting to covert use or forgoing gel. A successful microbicide will be positioned as a sexual pleasure enhancer so that men can present it to their lovers and other partners as a gel that improves sex and secondarily prevents human immunodeficiency virus (HIV).

Awareness of Post-Exposure Prophylaxis (PEP) and Pre-Exposure Prophylaxis (PrEP) Is Low but Interest Is High Among Men Engaging in Condomless Anal Sex With Men in Boston, Pittsburgh, and San Juan.

This study examines awareness of and experiences with post-exposure prophylaxis (PEP) and pre-exposure prophylaxis (PrEP) among 228 men recruited in Boston, Pittsburgh, and San Juan between 12/2010 and 6/2012. All of them reported having condomless anal sex with a man in the prior year. Overall, 41% had heard of PEP, ranging from 16% in San Juan to 64% in Boston. Only 21% had heard of PrEP, ranging from 8% in San Juan to 36% in Boston. Three had used PEP, and none had used PrEP. After the methods were described to participants, interest in both was high, with intentions to use PEP and PrEP respectively at 9.1 and 7.7 (10-point scale). Increased public education is needed to raise awareness of these HIV prevention methods, especially among MSM who acknowledge potential risk behavior. It also seems likely that many such men would use these methods once they become aware of them.

Topical application of trichloroacetic acid is efficacious for the treatment of internal anal high-grade squamous intraepithelial lesions in HIV-positive men.

OBJECTIVES: To assess the efficacy of topical 80% trichloroacetic acid (TCA) to treat internal anal high-grade squamous intraepithelial lesions (HSILs) in HIV-positive individuals. METHODS: All patients who attended the University of Pittsburgh Anal Dysplasia Clinic for treatment of biopsy-proven internal anal HSIL with topical TCA between July 1, 2009, and June 30, 2012, and who had 1 or more follow-up visits to assess treatment efficacy were included in the analysis. Recurrence of HSIL was assessed in July 1, 2013. RESULTS: A total of 98 HSILs from 72 patients were treated, and 77 (78.6%) resolved to normal epithelium or low-grade SIL during follow-up. Forty-eight (49.0%) and 27 (27.6%) of lesions resolved with 1 and 2 TCA treatments, respectively, whereas 1 lesion (1%) each resolved with 3 and 4 TCA treatments. Twenty-one (21.4%) lesions in 20 patients remained without resolution after TCA treatments. These patients were offered an alternative treatment. During follow-up, 8 (15.1%) of 53 patients had a lesion that recurred at the index site (11/53 [20.8%], inclusive of adjacent lesions) and 17 patients had new lesions diagnosed. CONCLUSIONS: Topical TCA is an efficacious treatment of internal anal HSIL in an anal dysplasia clinic setting with high-resolution anoscopy capacity. Advantages of TCA for this recurrent disease process include the following: low cost, no requirement for special equipment beyond that for high-resolution anoscopy, and painless application procedure. A larger prospective comparative study would better define efficacy and patient acceptability between treatment methods.

Rectal-specific microbicide applicator: evaluation and comparison with a vaginal applicator used rectally.

An applicator designed for rectal delivery of microbicides was tested for acceptability by 95 young men who have sex with men, who self-administered 4 mL of placebo gel prior to receptive anal intercourse over 90 days. Subsequently, 24 of the participants self-administered rectally 4 mL of tenofovir or placebo gel over 7 days using a vaginal applicator, and compared both applicators on a Likert scale of 1-10, with 10 the highest rating. Participants reported high likelihood to use either applicator in the future (mean scores 9.3 and 8.8 respectively, p = ns). Those who tested both liked the vaginal applicator significantly more than the rectal applicator (7.8 vs. 5.2, p = 0.003). Improvements in portability, conspicuousness, aesthetics, tip comfort, product assembly and packaging were suggested for both. This rectal-specific applicator was not superior to a vaginal applicator. While likelihood of future use is reportedly high, factors that decrease acceptability may erode product use over time in clinical trials. Further attention is needed to develop user-friendly, quick-acting rectal microbicide delivery systems.