Utility of a US Food and Drug Administration (FDA) label indication for condoms for anal sex.

Condoms are highly effective for HIV prevention, yet are not currently indicated by the US Food and Drug Administration (FDA) for anal sex. We surveyed a national sample of men who have sex with men to assess whether FDA label indication could affect anticipated condom use, and to determine levels of perceived condom failure for anal sex. We found that 69% of respondents anticipated that a label indication change would increase their likelihood of condom use. Median perceived failure was 15%. We anticipate that these results may aid the FDA in developing standards for a label indication for anal sex.

[Natural Latex Rubber Condom Inspection and Exploratory Research Analysis].

According to the situation of 34 batches of natural rubber latex condoms tested by our center in 2018, the unqualified items in the product inspection items and the exploratory research results of D4 and D5 content in silicone oil lubricants are analyzed. We make recommendations on product technical requirements or standards to strengthen the quality supervision of products.

Evidence for behavioural interventions addressing condom use fit and feel issues to improve condom use: a systematic review.

Continuing high rates of sexually transmissible infections (STIs) in many countries highlight the need to identify effective behavioural interventions. Consistent and correct use of male condoms is a key strategy for the prevention of STIs. However, some men report problems with condom fit (e.g. the size and shape of the condom) and feel (e.g. tightness, irritation, sensitivity), which inhibits their use. We conducted a systematic review to identify existing interventions addressing condom use fit and feel problems. We searched electronic databases for peer-reviewed articles and searched reference lists of retrieved studies. Five studies met the inclusion criteria. These were generally small-scale pilot studies evaluating behavioural interventions to promote safer sex with men aged under 30 years, addressing, among other things, barriers to condom use relating to fit and feel. There were significant increases in the reported use of condoms, including condom use with no errors and problems. Improvements in some condom use mediators were reported, such as condom use self-efficacy, knowledge, intentions and condom use experience. There were mixed findings in terms of the ability of interventions to reduce STI acquisition. Behavioural interventions addressing condom fit and feel are promising in terms of effectiveness but require further evaluation.

Evaluation of the Condom Barriers Scale for Young Black Men Who Have Sex With Men: Reliability and Validity of 3 Subscales.

BACKGROUND: Reliable and valid scale measures of barriers to condom use are not available for young black men who have sex with men (YBMSM). The purpose of this study was to evaluate the Condom Barriers Scales for application with YBMSM. METHODS: A clinic-based sample of 600 YBMSM completed a computer-assisted self-interview. The primary measure was a 14-item abbreviated version of the Condom Barriers Scale. Reliability and criterion validity were assessed. RESULTS: All 3 subscales were reliable: partner-related barriers (Cronbach α=0.73), sensation-related barriers (α=0.70), and motivation-related barriers (α =0.81). A complete absence of barriers was common: 47.0% (partner-related), 30.7% (sensation-related), and 46.5% (motivation-related). Dichotomized subscales were significantly associated with reporting any condomless insertive anal sex (all Ps < 0.001) and any condomless receptive anal sex (all Ps < 0.001). The subscales were significantly associated with these measures of condomless sex preserved at a continuous level (all Ps <0.001, except for sensation barriers associated with condomless receptive anal sex = 0.03). Further, the subscales were significantly associated with reporting any condom use problems (all Ps <0.001) and a measure of condomless oral sex (all Ps <0.001, except for partner-related barriers=0.31). Finally, the sensation-related barriers subscale was significantly associated with testing positive for Chlamydia and/or gonorrhea (P=0.049). CONCLUSIONS: The 3 identified subscales yielded adequate reliability and strong evidence of validity, thereby suggesting the utility of these brief measures for use in observational and experimental research with YBMSM.

"But the moment they find out that you are MSM ": a qualitative investigation of HIV prevention experiences among men who have sex with men (MSM) in Ghana's health care system.

BACKGROUND: The prevalence of HIV in Ghana is 1.3%, compared to 17% among men who have sex with men (MSM). There is limited empirical data on the current health care climate and its impact on HIV prevention services for Ghanaian MSM. The purposes of this study were to investigate (1) MSM's experiences using HIV prevention resources, (2) what factors, including health care climate factors, influenced MSM's use of prevention resources and (3) MSM self-identified strategies for improving HIV/sexually transmitted infection (STI) prevention among MSM in Ghanaian communities. METHODS: We conducted 22 focus groups (n = 137) with peer social networks of MSM drawn from three geographic communities in Ghana (Accra, Kumasi, Manya Krobo). The data were examined using qualitative content analysis. Interviews with individual health care providers were also conducted to supplement the analysis of focus group findings to provide more nuanced illuminations of the experiences reported by MSM. RESULTS: There were four major findings related to MSM experiences using HIV prevention resources: (1) condom quality is low, condom access is poor, and condom use is disruptive, (2) inaccurate information undermines HIV testing (3), stigma undermines HIV testing, and (4) positive attitudes towards HIV prevention exist among MSM. The main healthcare climate factors that affected prevention were that MSM were not free to be themselves, MSM were not understood by healthcare providers, and that MSM did not feel that healthcare providers cared about them. To improve HIV prevention MSM suggested increased education tailored to MSM should be provided to enable self-advocacy and that education and awareness are needed to protect human rights of MSM in Ghana. CONCLUSION: MSM in Ghana are exposed to negative health care climates. Health care spaces that are unsupportive of MSM's autonomy undermine the uptake of prevention measures such as condoms, HIV testing, and accurate sexual health education. These findings contribute to knowledge to inform development of HIV prevention interventions for MSM in Ghana, such as culturally appropriate sexual health education, and digital technology to connect individuals with resources supportive of MSM.

Quality evaluation of commercially available male condoms in Rio de Janeiro, Brazil, 2009-2011.

BACKGROUND: The increased incidence of sexually transmitted infections (STIs) in Brazil represents a significant public health issue. This issue has raised awareness among health authorities regarding the quality of condoms. In Brazil, male condoms need to be certified. The certification process evaluates in detail the manufacturing and quality of the final product; however, post-market surveillance is not part of the normal certification practice. METHODS: From 2009 to 2011, we evaluated 20 male condoms brands per lot of 8 manufactures-both domestic and imported-marketed in Rio de Janeiro, Brazil. Sampling was performed per ISO 2859-1, and the condoms were evaluated on length, width, thickness, holes, integrity of primary packaging, bursting volume, bursting pressure, label and secondary packaging, following the criteria established in the Brazilian National Health Oversight Agency Resolution no. RDC 62/2008. RESULTS: Of the 20 evaluated brands, 17 brands were found to be noncompliant with the guidelines of the Brazilian National Health Oversight Agency Resolution no. RDC 62/2008 in at least one of the analyses performed. CONCLUSIONS: Any nonconforming unit has serious public health implications.

Men who have sex with mens' exposure to, use of, and subjective experiences with the 'NYC Condom'.

In 2007, the New York City (NYC) Department of Health introduced the 'NYC Condom'--a Lifestyles® condom with a 'NYC' logo. Few studies have evaluated attitudes toward or distribution of the 'NYC Condom' among men who have sex with men (MSM)--a population at increased risk for HIV/STIs. 148 MSM completed a survey about their exposure to, use of, and experiences using the 'NYC Condom.' The majority (93.2 %) had seen the 'NYC Condom;' 82.4 % of said men had used it. Among MSM who used it, 82.1 % rated it average or above. Exposure did not statistically differ by race/ethnicity, HIV status, gay or barebacker identification, or sex role. Use was neither significantly associated with demographic characteristics nor recruitment source, suggesting distributional success in reaching various sub-populations of MSM. Among those who had not used the 'NYC Condom,' 22.2 % reported size or quality concerns, suggesting a demand for alternative prevention campaigns.

Perspectives on condom breakage: a qualitative study of female sex workers in Bangalore, India.

A qualitative study was conducted to obtain a detailed understanding of two key determinants of condom breakage - 'rough sex' and poor condom fit - identified in a recent telephone survey of female sex workers, in Bangalore, India. Transcripts from six focus-group discussions involving 35 female sex workers who reported condom breakage during the telephone survey were analysed. Rough sex in different forms, from over-exuberance to violence, was often described by sex workers as a result of clients' inebriation and use of sexual stimulants, which, they report, cause tumescence, excessive thrusting and sex that lasts longer than usual, thereby increasing the risk of condom breakage. Condom breakage in this setting is the result of a complex set of social situations involving client behaviours and power dynamics that has the potential to put the health and personal lives of sex workers at risk. These findings and their implications for programme development are discussed.

State of condom use in HIV prevention science and practice.

Condom use remains as the frontline defense against the HIV/AIDS pandemic. Fortunately, an ever-expanding body of empirical literature is currently guiding improvements in use of this prevention strategy. Recent advances include improved measurement of condom use behaviors, advances in condom effectiveness research, innovations in the design of condoms, and greater intervention efficiency for high-risk populations. After reviewing each of these four areas of research, this article will offer speculation about the future of condom use for HIV prevention.

Female sex worker client behaviors lead to condom breakage: a prospective telephone-based survey in Bangalore, South India.

We examined condom breakage rates and predictors of breakage in a prospective telephone-based study of female sex workers (FSWs) in Bangalore, India. We obtained data on 3,257 condom-use sex acts, and breakage occurred in 2.1 % of these. Situational factors, especially those associated with male clients' behaviors, were the most important predictors of breakage, including sexual inexperience, roughness and violence. Breakage was also associated with having vaginal and anal sex at the same encounter and with poor-fitting condoms. Despite lower than expected breakage rates, the high client volume of FSWs means that there are many unprotected sex acts caused by breakage. Discussions should be held around new education messages, and how programs can respond quickly when sex workers encounter clients who are inebriated, violent or unusually sexually charged. More work is urgently needed with police, and on FSW empowerment, the use of help lines, and counseling for the most vulnerable women.

A prospective event-level analysis of condom use experiences following STI testing among patients in three US cities.

BACKGROUND: This study prospectively assessed and compared the incidence of condom use errors/problems among clinic patients testing positive for one or more of 3 sexually transmitted diseases (STDs) and those testing negative. The study also identified event-level condom use errors associated with condom breakage and slippage during sex. METHODS: Enrolled clinic patients (N = 928) were tested for 3 STDs, then patients electronically recorded sexual intercourse and condom use behaviors daily for up to 6 months. Data were available on condom use errors and problems for the >10,000 sex events involving condoms. Assessed errors/problems were as follows: (1) not using a new condom, (2) allowing condoms to contact sharp objects, (3) not using condoms from start to finish of sex, (4) condoms drying out, (5) erection loss during condom use, (6) breakage, (7) slippage during sex, and (8) slippage after sex. Because the event-level measures were correlated within individual, generalized estimation equation models were used for analyses. RESULTS: All 8 forms of errors/problems with condom use occurred, with varying levels of frequency, without significant differences by baseline STD status for either men or women. Condom breakage was associated with contact with sharp objects (P < 0.0001) and drying out (P < 0.0001). Slippage during sex was associated with erection loss (P < 0.0001) and drying out (P < 0.0001). CONCLUSION: Subsequent to STD evaluation, much of the sex occurring with the use of a condom may not confer adequate protection. Problems found to be associated with condom breakage and slippage are potentially amenable to counseling interventions.

Assessing male condom failure and incorrect use.

BACKGROUND: It has not been well established whether common indices of male condom failure are valid predictors of biologically meaningful exposure during condom use. METHODS: To address this gap, the authors compared self-reported condom malfunctions (i.e., breakage and slippage) and incorrect condom practices to 2 following objective measures of failure: prostate-specific antigen (PSA) detected in vaginal swabs collected after condom use and structural integrity of used condoms. The study, conducted in 2000-2001, evaluated 635 male condoms used by 77 women attending an outpatient, reproductive-health clinic in Birmingham, AL. RESULTS: Women reported breakage or slippage for 7.9% of condoms; 3.5% of postcoital swabs had moderate or high levels of PSA; and laboratory testing of used condoms revealed breaks (1.1%) and leaks (2.0%). Self-reported breakage and slippage was associated with moderate/high PSA concentrations in postcoital swabs only when the malfunctions were not accompanied by reports of corrective actions to reduce exposure (adjusted odds ratio [aOR], 6.9; 95% confidence interval [CI], 1.8-26.2). Defects observed in postcoital laboratory testing were related to PSA detection (aOR, 8.0; 95% CI, 1.5-42.6). Incorrect practices defined on the condom label were frequent, but not all types were associated with semen exposure. Furthermore, other practices not currently label-defined were associated with semen exposure: touching the tip of the penis with his hands (aOR, 6.2; 95% CI, 2.3-17.0) or with her hands (aOR, 2.8; 95% CI, 1.1-72) before donning the condom. CONCLUSIONS: Used correctly, male condoms afforded good protection based on objective measures of failure.

Determinants of condom breakage among female sex workers in Karnataka, India.

BACKGROUND: Condoms are effective in preventing the transmission of HIV and other sexually transmitted infections, when properly used. However, recent data from surveys of female sex workers (FSWs) in Karnataka in south India, suggest that condom breakage rates may be quite high. It is important therefore to quantify condom breakage rates, and examine what factors might precipitate condom breakage, so that programmers can identify those at risk, and develop appropriate interventions. METHODS: We explored determinants of reported condom breakage in the previous month among 1,928 female sex workers in four districts of Karnataka using data from cross-sectional surveys undertaken from July 2008 to February 2009. Using stepwise multivariate logistic regression, we examined the possible determinants of condom breakage, controlling for several independent variables including the district and client load. RESULTS: Overall, 11.4% of FSWs reported at least one condom break in the previous month. FSWs were much more likely to report breakage if under 20 years of age (AOR 3.43, p = 0.005); if divorced/ separated/widowed (AOR 1.52, p = 0.012); if they were regular alcohol users (AOR 1.63, p = 0.005); if they mostly entertained clients in lodges/rented rooms (AOR 2.99, p = 0.029) or brothels (AOR 4.77, p = 0.003), compared to street based sex workers; if they had ever had anal sex (AOR 2.03, p = 0.006); if the sex worker herself (as opposed to the client) applied the condom at last use (AOR 1.90, p < 0.001); if they were inconsistent condom users (AOR 2.77, p < 0.001); and if they had never seen a condom demonstration (AOR 2.37, p < 0.001). CONCLUSIONS: The reported incidence of condom breakage was high in this study, and this is a major concern for HIV/STI prevention programs, for which condom use is a key prevention tool. Younger and more marginalized female sex workers were most vulnerable to condom breakage. Special effort is therefore required to seek out such women and to provide information and skills on correct condom use. More research is also needed on what specific situational parameters might be important in predisposing women to condom breakage.

[The consideration and several suggestions on the national standard GB 7544 natural latex rubber condoms--requirements and test methods].

It was found that several problems exist in the implementation of GB 7544-2004 in the aspects of requirements of natural latex materials and safety of rubber condom products, microorganisms to be controlled and the packaging and label. As a result, the suggestions were put forward.

What predicts self-efficacy? Understanding the role of sociodemographic, behavioural and parental factors on condom use self-efficacy among university students in Nigeria.

BACKGROUND: Risky sexual behaviours are not uncommon among young adults particularly those in the higher levels of education. It is known that higher self-efficacy could contribute to better sexual and reproductive health outcomes including the use of condoms. However, there is limited research on the role of socio-demographic, behavioural and parental factors as predictors of condom-use self-efficacy. As a result, this exploratory study was designed to assess the predictors of self-efficacy for condom use among university students in Nigeria. METHODS: A cross-sectional survey was conducted with 755 university students in Nigeria from February to April 2018. Self-efficacy for condom use was assessed by combining responses to 11-items measures of condom self-efficacy drawn from the work of Barkley and colleagues. We fitted a structural equation model to identify the pathways through which socio-demographic, behavioural and parental factors predict two constructs of condom-use self-efficacy (self-efficacy for condom purchase and use and partner communication self-efficacy) in the sample. RESULTS: Demographic factors such as age (ß = -0.29, p<0.05) and sex (ß = 0.42, p<0.05), as well as ratings on religious importance (ß = -0.08, p<0.05) were directly associated with self-efficacy for condom purchase and use. These factors showed significantly mediated effects through sexual experience which also had a direct positive relationship (ß = 0.73, p<0.05) with self-efficacy for condom purchase and use. The receipt of parental support, on the other hand, was directly associated with higher partner communication efficacy for condom use (ß = 0.07, p<0.05). We found no evidence that the level of partner communication efficacy was directly associated with any of the behavioural, demographic or parental factors. CONCLUSION: The findings of this study affirm that sex, or age or having higher ratings on religious importance alone does not increases self-efficacy but also exposure to sexual activity through which these factors affect self-efficacy for condom purchase and use. These findings also highlight the need to address and strengthen condom use self-efficacy among young adults, particularly the sexually inexperienced, highly religious and young adults with limited support from their parent.

Poor quality male latex condoms found in Dominican Republic: Quality assurance evaluation and public health impact.

Male condoms are important to prevent transmission of HIV (and other STIs) and unwanted pregnancies. Research was conducted to evaluate the quality of male condoms available in the Dominican Republic market based on preliminary concerns of suspect product. Based on international testing standards (ISO 4074 and ASTM D 3492-08), condoms were sampled across ten prominent brands within the market and evaluated for airburst pressure / volume, freedom from holes, visual defects, package seal integrity, packaging and marking, lubricant quantity, and dimensions. Five of the brands were found to have extensive quality problems, where holes were found in 5.7% to 17.5% of the condoms (depending on the brand). Between 5.1% and 30.5% of these condoms failed to meet the requirements for airburst properties, and violations in regulatory labeling where observed. Three additional brands were compliant for the other tests, but were found to have the same challenges with labeling violations as the previous five brands. Two brands were found to be fully compliant with all aspects of the evaluation. The level of defects observed in these samples would greatly increase the risk of HIV transmission (and other STIs) and unwanted pregnancies. When projected on the annual market of male condoms sold in the Dominican Republic (~26 million), potentially over 1 million condoms could be estimated to adversely impact the health risk of the end-user. These results prompted action by the Dominican Republic regulatory authorities to investigate and remove poor quality product from the market. This research study emphasizes the need for continued vigilance towards increased regulatory and market surveillance efforts to better protect public health interests.

Management of Urethritis: Is It Still the Time for Empirical Antibiotic Treatments?

CONTEXT: Urethritis prevalence in Europe changed in the last years due to both the increase of migratory streams from North Africa and the more frequent exposition of males to relevant risk factors. Owing to these reasons, urethritis treatment should be optimized by accurate microbiological investigations to avoid the risk of persistence, recurrence, or reinfection. OBJECTIVE: The aim of this systematic review is to optimize the treatments for urethritis and investigate the applicability of nucleic acid amplification test (NAAT) as the primary microbiological investigation. EVIDENCE ACQUISITION: A literature search in Medline, Cochrane, and Google Scholar databases was conducted up to June 2018. Subject headings were selected as follows: Urethritis OR gonococcal urethritis OR non-gonococcal urethritis AND Antibiotics OR Recurrence. A total of 528 abstracts were identified and selected. Finally, 12 full-text articles were selected for a qualitative synthesis. The Preferred Reported Items for Systematic Reviews and Meta-Analyses statement was used to perform an accurate research checklist and report. EVIDENCE SYNTHESIS: Empirical treatments are no more recommended, although a broad spectrum of antibiotic therapy may be initiated while awaiting the results from pathogens' microbiological characterization. First-line treatment for gonococcal urethritis consists of a single dose of ceftriaxone/azithromycin combined therapy. Specific therapies should be initiated for nongonococcal urethritis according to each single pathogen involved in the infection process. Owing to this reason, NAAT is mandatory in the clinical approach to the disease, although the Gram stain of urethral discharge or smear remains applicable for some less frequent nongonococcal urethritis. Moreover, the urethritis "modern view" also includes noninfectious etiologies that occurred after traumas or injection of irritating compounds. Sexual abstinence of at least 7 d should be observed from the start of treatment to avoid reinfection, while sexual partners should evenly be treated. CONCLUSIONS: The treatment of urethritis implies accurate determination of pathogens involved in the infection process by NAAT with subsequent appropriate antibiotic therapy, thus avoiding the risk of antibiotic resistance and overuse of antibiotics indicated for empirical treatments. The population exposed to relevant risk factors should be adequately informed about the increased risk of developing infections and motivated toward the intensive use of condoms during sexual intercourses. PATIENT SUMMARY: Urethritis is a sexually transmitted disease generally characterized by urethral discharge or other symptoms such as itching, tingling, and apparent difficulties in having a regular urinary flow. Microbiological investigations are mandatory to obtain satisfactory results from the treatment. Multiple antibiotic treatments are often necessary due to the high risk of multiple pathogens responsible for the disease. Similarly, sexual partners should be investigated and treated in the same way. Several risk factors such as immunodeficiency, multiple sexual partners, homo- and bisexuality, and alcohol abuse may be related to the disease. In these cases, the use of condom is strongly recommended.

Breakage, slippage and acceptability outcomes of a condom fitted to penile dimensions.

OBJECTIVE: This study compared failure rates of a standard-sized condom and a condom fitted to a man's penile length and circumference and assessed users' perceptions of condom acceptability and confidence in the efficacy of both condoms. METHOD: Using an experimental crossover design with Internet-based daily diaries, 820 men who wore at least one of each condom type reported outcomes and perceptions of condoms used during vaginal and anal intercourse events for which they were the insertive partner. RESULTS: Breakage for fitted condoms (0.7%) was significantly less than for standard-sized condoms (1.4%). When assessed by penile dimensions, significantly less breakage of fitted condoms than standard-sized condoms was observed among men in the middle circumference category (12-13 cm) during anal intercourse (1.2% versus 5.6%), men in the larger circumference category (> or =14 cm) during vaginal intercourse (0.6% versus 2.6%), and men in the longer length category (> or =16 cm) for both vaginal (0.5% versus 2.5%) and anal (3.0% versus 9.8%) intercourse. More slippage upon withdrawal after vaginal intercourse occurred with fitted condoms among men in the middle penile length (1.9% versus 0.9%) and circumference (2.2% versus 0.7%) categories. CONCLUSIONS: Fitted condoms may be valuable to sexually transmitted infection prevention efforts, particularly for men with larger penile dimensions. That fitted condoms slipped more for some men provides insights into the need for unique educational materials to accompany such products. Findings also highlight the need for participatory approaches between public health, condom manufacturers, and the retail industry to integrate fitted products into our work successfully.

Slips, breaks and 'falls': condom errors and problems reported by men attending an STD clinic.

The objective was to comprehensively assess the prevalence of condom-use errors and problems among male clients attending a public sexually transmitted disease (STD) clinic. Men (n = 278) attending an STD clinic completed an anonymous questionnaire. Seven errors and six problems were assessed. Summative scores were tested for associations with three key variables. Of 834 condom-protected events: 19% were associated with 'fit and feel' problems, 15% involved breakage, 14% involved lost erection, 9% were associated with lost erection while applying condoms, 8% involved slippage during withdrawal and 7% involved slippage during sex. A mean of 6.4 errors/problems were observed. None of these summative variables (total errors, total problems or total of errors and problems) were significantly associated with age, minority status or whether men indicated they had ever been taught how to use condoms. Multiple types of condom-use errors and problems may be highly prevalent among high-risk men attending public STD clinics.