16 May, 12 | by Leslie Goode, Blogmaster
We’re inviting contributions for two special themed issues:
Trichomonas vaginalis - deadline 31st October 2012
Further information >>
Criminalizing contagion - deadline 14th December 2012
Further information >>
31 Jan, 12 | by Jackie Cassell, Editor of STI
The BMJ Group journals Sexually Transmitted Infections (impact factor 3.029) and the Journal of Medical Ethics (impact factor 1.391), in conjunction with academics at the Centre for Social Ethics and Policy (University of Manchester) and the Health Ethics and Law Network (University of Southampton), would like to publish a collection of articles on the criminalization of disease and sexually transmitted infections. We invite article contributions to be published as part of this themed collection.[1]
Themes
The use of criminal law to respond to infectious disease transmission has far-reaching implications for law, policy and practice. It presupposes co-operation between clinicians and criminal justice professionals, and that people who infect others can be effectively and fairly identified and brought to justice. There is a potentially difficult relationship between criminal justice and public health bodies, whose priorities do not necessarily coincide. We are interested in receiving papers of broad interest to an international readership of medical ethics scholars and practicing clinicians on any of the following topics:
Publication
1. Up to eight articles will published in a special section in an issue of Sexually Transmitted Infections in 2013.
2. Two articles will be published in a special section in an issue of Journal of Medical Ethics in 2013.
All articles will be blind peer reviewed according to each individual journal’s editorial policies. Final publication decisions will rest with the Editors in Chief: Professor Jackie Cassell (STI) and Professor Julian Savulescu (JME).
Important Dates
Please submit your article to either journal no later than December 14th 2012.
Submission Instructions
For Sexually Transmitted Infections:
Articles for STI should be a maximum of 2,500 words and submitted via the journal’s website: http://sti.bmj.com/. Please choose the special issue ‘Criminalizing Contagion’ during the submission process.
For Journal of Medical Ethics:
Articles for JME should be a maximum of 3,500 words, and submitted via the journal’s website: http://jme.bmj.com/. Please choose the special issue ‘Criminalizing Contagion’ during the submission process.
Further submission instructions are on the journals’ respective websites. If you would like to discuss any aspect of your submission, including possible topics and the journals involved, please contact the guest editors in the first instance: Dr David Gurnham (David.Gurnham@manchester.ac.uk), Dr Catherine Stanton (Catherine.Stanton@manchester.ac.uk) or Dr Hannah Quirk (Hannah.Quirk@manchester.ac.uk).
11 Dec, 11 | by Jackie Cassell, Editor of STI
We are seeking contributions on clinical topics of interest to our readers, for the “How To” series, edited by Dr Sarah Edwards. Could you write for your colleagues on a topic of practical relevance to clinicians? Perhaps a common clinical conundrum, or an area not covered by guidelines where evidence is lacking?
If you would like to propose a topic, please send the following information to Sarah at sarah.edwards@wsh.nhs.uk
* What is the topic?
* Why is it of interest to clinical readers?
* Explain why you are well placed to write this article.
* Who will write it (this may be a less experienced clinician, supervised by a senior mentor)?
* Your suggested deadline for submitting a first draft.
15 May, 11 | by Jackie Cassell, Editor of STI
This week saw the British Association of Sexual Health and HIV (BASHH) descend on Newcastle, in the North East of England, and not far from the Angel of the North, one of the wonders of Britain. This meeting, attended by over 500 sexual health clinicians, always provides an impressive array of research studies from small centres and large teaching hospitals alike.
Last year, we reported in our blog a 10 top papers session in which Steve Taylor voted best paper of the year an STI paper from Australia, reporting a decline in HPV vaccination his top paper of 2010. The audience was fascinated this year by Professor Kit Fairley’s presentation of recent Australian data from the same centre, where the 4-valent vaccine Gardasil appears to have had a dramatic effect on genital warts in the youngest cohort of women vaccinated before they became sexually active. We look forward to hearing more.
We were delighted that this year’s BASHH conference again voted an STI published initiative as a winner – this time of a prize for service innovation. Gary Brook described his team’s experience of using electronic health records to reduce time to treatment, and to improve partner notification outcomes, in two STI papers (see below). Though many clinics now use electronic records to some degree, few have used them with such an effective and determined focus on their potential to improve clinical outcomes. For this, the team was awarded the Cathy Harman memorial prize – STI is delighted to have published this research, demonstrating real benefit for patients. You might like to listen to the podcast on this research, at STI.bmj.com
9 Apr, 11 | by Leslie Goode, Blogmaster
At the same time as the release of depressing figures by the UK Health Protection Agency (HPA) showing a doubling of the annual rate of fresh HIV diagnoses in the UK, the National Institute for Health and Clinical Excellence (NICE) has just issued two sets of recommendations on HIV prevention.
Annual figures for new diagnoses of UK-acquired HIV have risen steadily from 1,950 in 2001 to 3,780 in 2010. Three fifths of these diagnoses are “late” diagnoses (i.e. after the point treatment should have begun). The HPA places a figure of £32 million annually on the failure to prevent the 3,780 cases diagnosed this year.
Two documents have been issued by NICE containing detailed recommendations regarding the most at risk groups – respectively, men who have sex with men (MSM), and UK black Africans. The aim of both documents is to recommend a more proactive approach to HIV testing. The strategy builds on current UK guidelines (British HIV Association et al. 2008) advocating the “normalization” of HIV tests, and specifically recommending that in certain areas – e.g. where more than 2 in 1000 people have been diagnosed with HIV – tests be offered to everyone.
Specific guidance in the MSM document is directed to those capable of playing a role in different capacities. Specialist sexual health services should offer testing to all who attend. Primary and secondary care providers should recommend testing at registration or admission, not only to individuals at high risk, but to everyone in areas where there is high prevalence (more than 2 in 1000), or a large community of men having sex with men. Health care promoters are specifically urged to promote testing in their promotional literature. Finally, planning services should work in partnership with relevant local organizations to gather data, assess local need and develop a strategy in respect to both of these at risk groups.
The recommendations for black Africans, though complementary and covering some of the same ground, are differently structured and more complex. The failure of the two documents to dovetail is no doubt an unfortunate result of the differing needs of the respective groups. The latter document builds on current UK guidelines (British HIV Association 2008) recommending that HIV testing be offered to men and women from countries of high prevalence as well as the guidelines mentioned above. The different emphasis in the latter document, and the preponderance of recommendations addressed to directors and commissioners of public health, may reflect the smaller role of specialist sexual health services, on the one hand, and the real possibility (and challenge) of community engagement, on the other, with responsibility falling on public health commissioners to ensure that that the needs of high risk communities are met through the provision of primary and secondary health care services within their sphere of operation.
Recommendations to “collect information about current HIV diagnoses” may pose a challenge to public health services lacking the necessary epidemiological expertise.
http://www.nice.org.uk/
9 Apr, 11 | by Leslie Goode, Blogmaster
A recent article offers a systematic review of the literature concerning the influence of clinical characteristics (e.g. pregnancy or STI history) on female genital tract immunity to HIV. This review places itself against the background of an increasing shift in HIV research from systemic considerations relating to transmission of the infection – “the blood compartment” – to considerations to do with the female genital tract – “the genital compartment”. The current interest in microbicide products for vaginal use is an example. A difficulty encountered by research in this area is the way genital mucosal immunity can be expected to vary in response to a number of clinical characteristics – some of which relate to the patient, and others to the state of development of the HIV virus, where the patient is HIV infected. Failure to take proper account of this variation could, according to the authors, lead in certain cases to erroneous interpretation of results.
Patient clinical characteristics likely to impact on female genital immunity reviewed in this paper include: phase of menstrual cycle and menopause; pregnancy; methods of contraception, especially hormonal and combination hormonal; race; STI history. Impact of pregnancy has been shown to be important (incident rate ratio: 2.16%). Evidence on the impact of the menstrual cycle is inconclusive, though hormonal regulation causes many immunologic changes. Much the same can be said of the impact of hormonal contraception, which is an area which appears to be in particular need of further investigation. The importance of STI history is well established, though not all STI receive the same attention. Clinical characteristics deriving from HIV disease state include: marked viremia in new infections; the impact of prior HIV infection on acquisition of multiple strains; the mode of HIV infection (i.e. whether via genital tract of IVD use); the degree of penetration of ARV drugs into the lower genital tract. It emerges in the course of this review that some of these clinical parameters are understudied (e.g. hormonal contraceptives), or scarcely studied at all (e.g. menopause; combination hormonal contraceptives).
The main content of the article concerns clinical characteristics. This is preceded, however, by comments on the potential importance of sampling techniques and the assessment of mucosal immune responses, for which the authors refer the reader to Jespers V. Harandi et al., “Assessment of mucosal immunity to HIV-1”. The authors urge the importance of developing standard operating procedures in this area.
9 Apr, 11 | by Leslie Goode, Blogmaster
The American College of Obstretricians and Gynecologists has just published its updated schedule of recommended screenings, tests and immunizations for periodic assessments or “well woman exams”. These annual assessments of women aged 21 and above are a key instrument of primary care in the US. Their free provision is being considered for inclusion in the Obama health care law – i.e. under Mikuski’s amendment which requires all new health insurance plans to cover preventive services for women with no out-of-pocket cost to patients.
As regards sexual health, these assessments are the locus for preventative interventions. What is particularly important about the latest recommendations (which replace those of December 2009) is the inclusion of detailed specifications of sexual health screenings and immunizations recommended for each age group. Annual chlamydia and gonorrhoea tests are routine for those aged 21-25, or younger than 21 where individuals are sexually active; for other age groups testing is recommended for individuals reckoned to be at high risk. Annual HIV tests are routine for ages 21-65; for over 65s, tests are recommended for those known to be at high risk. Human papillomavirus vaccination (one series) is recommended for those aged 26 years or less and not previously tested. For all age groups Hepatitis A and B vaccination and Hepatitis C testing are recommended for individuals known to be at high risk.
The fate of the Obama health care law remains to be determined. Those parts of the law concerned with provision of sexual and reproductive issues remain particularly controversial. But if preventative services for women are included in the provision of insurance plans with no out-of-pocket cost, what impact will this have on levels of STI screening in the US?
23 Mar, 11 | by Leslie Goode, Blogmaster
A recent laboratory study based on specimens from 766 US patients with vaginal symptoms evaluates the performance of the current US FDA (Federal Drugs Administration) approved diagnostic test for Trichomonas Vaginalis (BD Affirm VPIII hybridization) against a modern molecular amplification based test (Gen-Probe Aptima). The greater sensitivity of the new test emerges clearly in this paper (36.6% more positive patients) – along with a more general message taken up strongly in journalistic reporting of this paper: that the insensitivity of current tests has led to our ignorance of the prevalence and sequelae of Trichomonas, and that the new techniques will require new policies on testing.
Overall prevalence of Trichomonas as against Chlamydia and Gonorrhea turns out much as existing literature would have led us to expect: 5.1%, as opposed to 3.4% and 0.7% respectively. The real surprise comes with the results for age-specific prevalence that show the highest levels of trichomonas positivity (11.9%) occurring among 36-45 year old patents with 0% prevalence for Chlamydia and Gonorroea. The authors’ recommendations for trichomonas testing for age 30+ women along with cervical screening might seem premature at this stage! Nevertheless, the high prevalence among this older group calls for further investigation. The results of this study need replication in a study which gives due attention to considerations beyond those of diagnostic efficacy. Assuming these results to be replicable, and assuming the reliability of the molecular amplification assay with vaginal tissue, there is clearly a challenge here to the widely accepted idea that trichomonas spreads exclusively by sexual transmission. The issue of diagnostic efficacy will need to be integral to future studies, but so will the examination of the full range of epidemiological possibilities. Maybe it is time to dust down some those older theories of transmission via the toilet seat (J.A. Burgess, “Trichomonas Vaginalis Infection from Spashing in Water Closets”, British Journal of Venereal Disease, 39, 1963, pp. 248ff.)!
Sarah B. Andrea & Kimberle C. Chapin, “Comparison of Aptima Trichomonas vaginalis Transcription-Mediated Amplification Assay and BD Affirm VPIII for Detection of T. Vaginalis in Symptomatic Women: Performance Parameters and Epidemiological Implications”, Journal of Clinical Microbiology, made available in advance of publication
J.A. Burgess, “Trichomonas Vaginalis Infection from Splashing in Water Closets”, British Journal of Venereal Disease, 39, 196
23 Mar, 11 | by Leslie Goode, Blogmaster
At the recent Conference on Retroviruses and Opportunistic Infections (CROI), meeting in Boston (27th February – 2nd March) researchers reported results from two trials involving the use of antiretroviral drugs, currently used in therapy, for the prevention of HIV transmission. These trials (MTN 001 & RMP-02/MTN-006) are just two among a whole programme of HIV-related microbicide trials being currently undertaken by the Microbicide Trials Network (MTN) – an organisation established in 2006 by component institutions of the US National Institutes of Health (NIH) with a view to early licensing of products for widespread use. These trials are just a stage in the deployment of the wider MTN programme, but contribute important findings.
Recent years have seen increasing interest in the possibility of preventative regimes for individual use that could protect against HIV. A promising avenue currently very much under consideration is the prophylactic use of antiretroviral (ARV) drugs, either taken orally or applied topically to the vagina (or rectum in the case of homosexual transmission). Such an approach promises to place in the hands of women a means of protecting themselves against the virus, rather than having to rely on their male partners. This represents a considerable advantage, given the relative importance of heterosexual transmission in many places, and the greater vulnerability of women to acquiring HIV during sex (about double the probability).
The MTN trials take place in the wake of earlier path-breaking studies which have suggested the preventative potential of ARVs. CAPRISA-004 (2010), a South African study of 889 women who applied the tenofovir gel before and after sex, showed the product reduced the risk of HIV by 39%; while iPrEx (2010), another study involving 2,500 gay men, found 44% fewer HIV infections among those assigned to daily use of Truvada, as against the placebo group. A further stage in determining the prophylactic efficacy of ARV drugs will be marked by the conclusion (hopefully early in 2013) of phase IIb MTN study, MTN-003 – or VOICE (Vaginal and Oral Interventions to Control the Epidemic). The latter will enrol 5,000 sexually active HIV-negative women in Zimbabwe, Uganda and South Africa and will evaluate the relative efficacy of regimes involving daily use of Tenofovir and Truvada tablets, as well as Tenofovir gel.
Of the two trials, reported on at the Conference (CROI), and discussed below, MTN-001 was designed to complement the VOICE study; MTN-006 further explores the prophylactic effect of Tenofovir for transmission via anal sex.
MTN-001
This Phase II trial, the results of which have been reported at CROI, claims to be the first head-to-head comparison between tenofovir gel and oral tenofovir for HIV pre-exposure prophylaxis. The issue of the relative efficacy of these regimes remains to be resolved by the VOICE (MTN-003) study; MTN-001 is concerned with: 1. How much active drug is taken up by the body in each case (pharmacodynamics); 2. The participants’ preferences as regards gel and an orally administered medication. 168 women were enrolled: 72 in the US; the rest at sites in Uganda and South Africa.
Use of the tablet was associated with 20-times higher concentration of active drug in the blood; the gel regimen with a 100-times higher concentration in vaginal tissue. The significance will become clear when these findings are complemented by findings from the VOICE study. As regards the response of participants, both regimens were well tolerated, and both won the preference of certain participants. There was, however, an interesting divergence between US and African participants. US women tended to prefer the tablet (72% as against 14%), while 87% claimed they would be prepared to use the tablet, as against 64% the gel. African women marginally favoured the gel (42% as against 40%), while 100% claimed they would be willing to accept either regimen.
RMP-02/MTN-006
This study breaks new ground as the first to investigate the safety and efficacy of tenofovir gel applied to the rectum as a means to protect against HIV during anal intercourse. The phase I trial involved rectal tissue biopsies sampled from 18 HIV-negative participants who applied either tenofovir gel or a placebo gel daily for the course of one week. HIV infection was found to be “significantly inhibited” among those using the gel daily. Only 25% of participants using the tenofovir gel claimed to like it, though 75% reported a high likelihood of future use. 2 of the 12 participants using tenofovir reported severe gastrointestinal side effects.
2 Mar, 11 | by Leslie Goode, Blogmaster
A recent paper gives details of an Internet-based self-screening programme for Chlamydia in Baltimore, Maryland, running since 2004. The web site was advertised on the radio and in free community magazines, and kits made available at community locations, or sent on the Internet or in response to phone request. Participants return a questionnaire with their kit.
Take-up of the programme seems to have been relatively modest, but consistent over time, with the Internet program accounting for 644 tests in Baltimore, as against 15,645 in family planning, and 526 in the rest of Maryland, as against 152,715 in family planning. This may be relevant to those planning future Internet-based self-screening programmes. Also relevant from this point of view: 1. the overwhelming preference of Internet-based self-screeners for email ordering (86.6%) – leading to an early discontinuation of the community pick-up sites; 2. the return rate, which has varied from 31% to 43% over the years that the programme has been running.
The paper itself is a study of age-specific prevalence in Internet self-screeners as compared with people screened in family planning. The results show a positivity that is (very approximately) double across age groups for self-screeners. Questionnaire responses corroborate the impression of a high-risk group. A major concern of the authors is clearly with “reaching a population that is different” from family-planning clinic users. The prevalence study seems to contribute little to our understanding of this population, and the relevance of its age-specific character is not clear to me. Whether self-screeners would have accessed services – or accessed them as early – without the Internet programme seems hard to gauge – and there is no discussion of the possible clinical disbenefits of accessing a Chlamydia test outside a clinic setting.
What this study may demonstrate is that Internet self-screening is a cost-effective way of reaching certain people – that, in the words of the authors, Internet-based self-screening should be “another tool in our tool box”.
Charlotte A. Gaydos et al., “Chlamydia trachomatis Age-Specific Prevalence in Women Who Used an Internet-Based Self-screening Program Compared to Women Who Were Screened in Family Planning Clinics”, Sexually Transmitted Diseases, Vol. 8 no. 2, February 2011
