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Circumcision

Location of HIV-2 emergence determined by distribution of indigenous cultural practices of male circumcision

16 Jan, 17 | by Leslie Goode, Blogmaster

Sousa & Vandamme demonstrate a robust correlation between HIV-2 prevalence at the time of the 1980s surveys and the absence of indigenous practices of male circumcision earlier in the century.  This is a complex and interdisciplinary study, involving some of the earliest large-scale, West African serological surveys of HIV-2 (1980s) and extensive ethnography of the region throughout the twentieth century.

HIV-2 seems to have crossed the species barrier into humans from a primate called the ‘sooty mangabey’.  The two epicentres of the 1980s HIV-2 epidemic – south-west Côte I’Ivoire and Guinea Bissau – correspond to the two points along the band of sooty mangabey territory where ethnic groups were to be found who did not practice circumcision (Côte I’Ivoire), or performed it only late in life or very intermittently (Guinea Bissau).  The complexity of this study arises from the fact that, thanks to waves of islamicization, male circumcision has been widely adopted across the region even in areas where it was traditionally prohibited.  Hence investigation of the correlation with HIV-2 emergence, probably in the 1940s, required the authors to go back to ethnographic accounts preceding islamicization.

Of course, the certainty of a causal link cannot be established.  But Sousa & Vandamme discover a strong negative correlation between male circumcision and HIV-2 (Spearman rho = -0.546).  Their results are supported by studies that establish the same negative relationship with HIV-1, both in sub-Saharan Africa (Moses and Plummer) and, more recently in Papua New Guinea (MacLaren & Vallely/STIs).  A likely causative mechanism might be the prevalence of ulcerative sexually transmitted infections (Weiss & Hayes/STIs).

So Sousa & Vandamme offer an additional ‘ecological’ reinforcement of the public health rationale for encouraging voluntary male medical circumcision (VMMC).  Yet what is also interesting, from a public health perspective, is the importance their study attributes to culture in the adoption of a practice like male circumcision.  In the present case, for once, the impact would appear to have been very positive from the medical point of view. The authors speak, for example, of islamicization, along with ethnic intermarriage in the cities, as having given rise to ‘social pressure to be circumcised in order to be accepted by women’, and the ‘abandonment of traditional prohibitions of male circumcision’. Of course, the impact of indigenous culture may often be less benign from a medical point of view – as the source of conservative attitudes that tend to hold back and limit the uptake of VMMC.  As, for example, where males have seen male circumcision as the practice of potentially hostile neighbouring groups (Cultural constraints on uptake of circumcision/STI/blogs), or as a practice uniquely suited to those younger age groups on whom it was traditionally performed (Mbabazi/STIs).  But, either way, it is noteworthy that the influence of local culture would often seem to be so decisive.  So there may be an argument, for electing to promote infant circumcision, as an evidently medical practice that runs less risk of falling foul of prevailing cultural attitudes that restrict ‘demand’ (Gray & Kigozi/STIs; Feasibility of infant circumcision/STIs/blogs).

 

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Feasibility of infant circumcision as an HIV prevention tool

31 Oct, 16 | by Leslie Goode, Blogmaster

Recent trials have shown male circumcision (MC) to be associated with a reduced HIV incidence of up to 60%. For this reason UNAIDS has included ambitious goals for circumcision (20 millions MCs) as a major component of its HIV prevention strategies for 14 priority countries in sub-Saharan Africa (STI/blogs/Roll-out of UNAIDS voluntary male circumcision).  The achievement of this objective has met with considerable obstacles on the supply side – for instance, the lack of trained practitioners (STI/blogs/Roll-out of UNAIDS voluntary male circumcision; Kaufman & Ross/STIs); but constraints on the demand for MC have, if anything, proved still harder to surmount (STIs/blogs/cultural constraints on uptake of circumcision). The existence of circumcision as a traditional cultural practice amongst some populations can lead to its perception in other cultures as alien and externally imposed – even  hostile to one’s own tradition (David/STIs; Madhivanan & Klausner/STIs; STIs/blogs/cultural constraints on uptake of circumcision). Also, its traditional association with a certain phase in the life cycle can give rise to the feeling among older members of the community that it is inappropriate for people of their age (Mbabazi/STIs).

The cultural problems affecting demand have led some to reconsider the possible contribution of early infant circumcision (EIC) as a prevention tool – albeit on a longer view that the one envisaged by existing UNAIDS targets (Gray & Kigozi/STIs).  Kankaka & Gray (K&S), in a recent paper reporting a trial of such an intervention in Rakai Uganda, seem to corroborate (largely) positive findings of earlier investigations of EIC in other sub-Saharan countries (Young & Nordstrom (Y&N) (Kenya); Plank & Lockman (Botswana); Bowa & Stringer (Zambia)) that would indicate EIC could ultimately prove a highly effective form of prevention.  Of course, supply side problems with the recruitment and retention of adequately trained personnel remain.  For this reason, K&S – as indeed Y&N before them – investigated the impact of task-shifting from physicians to less highly trained practitioners; in the Uganda study, infants were randomly assigned to either ‘clinical officers’ (i.e. assistant physicians) or registered nurse midwives (RNMWs). Another feature of this study geared to testing the feasibility of the extension of EIS to remote areas was the decision to substitute topical analgesia for the dorsal penile nerve block used in earlier studies.  The trial assessed the safety of EIS (Mogen Clamp) as performed by more junior cadres of medical staff, and rated the degree of pain/discomfort experienced by the infants in terms of Neonatal Infant Pain scores (NIPS) – as well as testing out, in some rudimentary way, the acceptability of the intervention to mothers.

On all accounts, the trial produced very satisfactory results.  The rate of adverse events with RNMWs was low, and indeed comparable to rates that might be expected with physicians (1.6%), and the NIPS scores suggested that 76% of infants experienced mild pain or less, and only 1.6% experienced severe pain.  So far as the supply-side difficulties are concerned, these results are encouraging.  There could, of course, also be demand-side constraints with EIS, equivalent to those observed with adult circumcision.  Yet, of the 701 infant-mother pairs registered as potential participants, 74% (no.= 525) consented (as compared to 60% in the Botswana study (Plank & Lockman), but only 11% in the Zambia study (Bowa & Stringer)).  Maternal satisfaction rates were 99.6% for clinical officers, and 100% for RNMWs.  The cultural acceptability may vary somewhat between populations – yet, to the extent that EIS remains distinct from cultural practices, its dissemination may be less at risk of being perceived in non-medical terms as an alien or hostile cultural imposition.  Moreover the evidence suggests that experience of pain increases with age.

 

First study of population-level preventative impact of Medical Male Circumcision and ART on HIV incidence in a country of sub-Saharan Africa

14 Sep, 16 | by Leslie Goode, Blogmaster

Clinical studies have demonstrated the potential effectiveness of ART (HPTN 052) and Voluntary Medical Male Circumcision (VMMC) (Gray & Kigozi/STIs) as preventative measures against HIV.  This led WHO/UNAIDS to launch a Joint Strategic Action Framework (JSAF) setting a target in 14 priority sub-Saharan countries of 80% VMMC by 2016.

What, then, are the potential gains of ART and VMMC interventions in these countries?  Comparative ecological studies have shown the population-level impact of male circumcision as a cultural practice (MacLaren & Vallely/STIs). Various mathematical modelling studies have sought to quantify that potential effect of interventions both in the realm of VMMC (Jenness & Cassels/STIs) and ART (Shafer & White/STIs)  (though other studies have highlighted the challenges that scale-up of these interventions is likely to present (Kaufman & Ross/STIs)).

Now, for the first time, a study has sought to quantify the real-life population-level impact of these interventions.  Kong & Gray (K&G) base their study on data from the 1999-2013 Rakai Community Cohort Study (Uganda)).  Among the 45 Rakai communities (44,688 participants surveyed over 24.6 years), VMMC coverage had, by 2013, increased from 19% to 39%, and ART had risen, in males, from 0% to 21%, and, in females, from 0% to 26% – and HIV incidence had fallen, concurrently, from 1.25 per 100 person-years to 0.84 per 100 person-years in males, and from 1.25 to 0.99 in females.  As regards VMMR, each 10% increase in the rate was associated amongst males with a decline in incidence that could be quantified, on multivariate analysis, at 0.87 – though, in females, the reduction was statistically insignificant.  As for ART, the decline attributable was not statistically significant in either case, but, when ART coverage was modelled as a categorical variable, and coverage of over 20% was compared with coverage of under 20%, a decline in HIV incidence was observed in the former group of the order of 0.86 among males, and 0.77 among females.

These results are not surprising.  VMMC is, in the first instance, protective of men – though, of course, in the longer term women too will benefit from any population-level effect. (There is, in fact, a worrying possibility, investigated by Maughan-Brown & Thornton/STIs, that men could incorrectly assume that their VMMC will be directly protective of their partners, and modify their behaviour accordingly.)  As for ART, here too the (as yet) limited impact in Rakai is what we might have expected.  Tanser & Newell, in a South Africa-based study only observed significant association when ART coverage was over 30%.  However, population level decline in incidence – especially that associated with VMMC – is encouraging.  The results of this study allow us to predict that increasing VMMC coverage more than 40% could reduce male incidence by approximately 39% at population level.   A major limitation of the study, of course, is its assumption that sexual networks, and hence HIV transmissions, are internal to the community. However, a recent study by Chemaitelly & Abu-Raddad/STIs would seem to indicate that, in a context like sub-Saharan Africa the contribution of networks going beyond the wider community is likely to be limited.

Does risk compensation behaviour neutralize the benefits of voluntary medical male circumcision?

18 Aug, 14 | by Leslie Goode, Blogmaster

The effectiveness and feasibility of voluntary medical male circumcision (VMMC) as a preventative intervention against HIV has been demonstrated in a variety of non-circumcising African communities.  The WHO has designated 14 countries in southern and eastern Africa as priority areas for VMMC scale-up.  Attempts to model the progress of the epidemic have long sought to factor in the potential contribution of VMMC (STIs/Hallett & Abu-Raddad).  However, the possibility of risk-compensation remains an ongoing concern (i.e. that the known preventative effects of VMMC will lead to increased sexual risk-taking).  Current evidence has been largely limited to behavioural evaluations and extended follow-up in populations where RCTs of VMMC were being conducted (e.g. Rakai, Uganda; Orange Farm, South Africa; Kisumu, Kenya).  The evidence has been reassuring, by and large.  Yet it is also inconclusive – for two reasons: first, on account of the rigorous risk reduction counselling invariably provided by these trials, which is far in excess of what would be offered in operational settings; second, due to the lack of certainty as to the preventative effectiveness of VMMC that prevailed at the time when these RCTs were being conducted.  These are precisely the issues that bedevil studies seeking to evaluate risk compensation in the context of pre-exposure prophylaxis (PrEP): see STIs/blog/Marcus & Grant; STIs/blogs/Mugwanya & Baeten.

A recent prospective, longitudinal study conducted in Nyanza Province, Kenya (Westercamp & Bailey) claims to mark an important step forward towards understanding the relation between VMMC and sexual risk-taking in everyday operational settings.  Participants in the study were not exposed to unrealistic levels of risk reduction counselling, and the preventative efficacy of VMMC had already been well established prior to commencement of the study.  Participants were followed up, at six monthly intervals over a two year period, having assigned themselves either to a circumcision (1,5888) or a control (1,599) group, using (as far as possible) audio computer-assisted self-interview questionnaires to investigate sexual behaviour.

The result?  No risk-compensation, apparently.  In fact, the findings show an increase of 30%/6% in condom use at last sex (for the circumcised/control group), and a broadly comparable decline for both groups across a range of indicators, including transactional sex in the last six months (26-12%), most recent sex with a casual partner (20-12%), and having multiple partners in the last six months (26-16%).  The only adverse finding was an increase in sexual activity for both groups among the younger participants – but this seems to be largely explained by transition to married status.

The decline might be due to some limited exposure to HIV education through participation, or reflect “cognitive dissonance” – i.e. the re-evaluation of behaviours in the light of the personal investment involved in getting circumcised.  But there is evidence it might be part and parcel of a decrease in sexual risk-taking in the community at large due to the implementation of the VMMC programme over the period of the study 2008-2011.  A curious finding was the greatly reduced perception of high HIV risk among the “cross-over group” of those 20% of the control group who subsequently chose to be circumcised, as against the perceptions of those who initially assigned themselves to the circumcision group.  This, according to the authors, suggests that men motivated to early adoption of VMMC may represent a higher risk group.  When this finding is taken together with recent evidence of high (90%) acceptance of VTC services among men undergoing circumcision, the case stacks up for ensuring the provision of high-quality counselling as a priority throughout the commencement and rapid initial sale up of VMMC services.

Cultural constraints on the uptake of voluntary medical male circumcision in Eastern and Southern Africa

23 Jun, 14 | by Leslie Goode, Blogmaster

My previous blog spoke of the recent PLoS-Medicine Collection on the progress of a UNAIDS initiative for a five-year scale-up of Voluntary Male Medical Circumcision (VMMC) for HIV prevention in 14 high priority Eastern and Southern African countries.  Among the papers, Ashengo & Njeuhmeli (A&N) and Macintyre & Bertrand (M&B) deal with what the authors of the Collection Review identify as one of the two major obstacles to deployment of the initiative: the insufficiency of demand, especially amongst older (aged 25+) men.  They consider the cultural and social constraints on demand, as these are reflected in the very different cultural contexts of Zimbabwe and Tanzania/Iringa Province (A&N) and Kenya/Turkana County (M&B).

In Tanzania, where circumcision as a cultural practice is widespread, A&N’s figures show a proportion of older men presenting for VMMC through to 2013 of c.6%.  Very few of these were reached through campaigns, as opposed to routine services.  In Zimbabwe, by contrast, where circumcision is not widely practised, the proportion of aged 25+ circumcised through the program was c.33%.  There was much less difference in the age profiles of those accessed by campaign and routine service modalities.  Whereas, in Tanzania there is a cultural perception “that male circumcision is most appropriate before or during puberty” (and older men do not come to VMMC services in a setting that includes mostly adolescent clients) – in Zimbabwe there is less difference between age groups, either in respect to numbers circumcised or preferred mode of access.  Intriguingly, this suggests that the existence of a cultural norm of circumcision may be more of an obstacle than an asset where older clients are concerned.  Of course, this contrast has to be set in the context of the overall advantage in terms of HIV/AIDS prevention conferred on countries like Tanzania by the existence of the cultural norm.  On difficulties of demand in Zimbabwe specifically, see STI/Kaufman & Ross.

A further insight into the potentially negative impact of existing cultural practice is cast by M&B.  Focus group discussions and in-depth interviews in the rural, traditionally non-circumcising area of Turkana County, Kenya, draw attention to perceptions of circumcision amongst older men that are not favourable to their widespread up-take, especially by the older age-group.  The first is the identification of circumcision with the cultural values of other (potentially hostile) groups.  Interestingly, the negative impact of the perception of the practice as imposed from outside, or else non-traditional, has been demonstrated in other non-circumcising cultures (STI/David; STI/Madhivanan & Klausner). The second is the understandable perception that HIV/AIDS is a “new” problem among young urban dwellers (most Turkana sufferers belong in this category) and that circumcision, as a response to this “new” problem, is appropriate for the young, not for older, rural people (see also responses in a study on the acceptability of VMMC in Rwanda: STI/Mbabazi).

The impression that emerges from both studies is that the existence of a cultural practice of circumcision amongst certain groups in a region does not always confer an advantage where potential clients for VMMC are in the older age groups (25+).  In particular, good uptake of VMMC services by adolescents may actually prove an obstacle for older men, reinforcing the cultural perception of VMMC as primarily for younger men.  In this situation service providers may face a choice between strategies that yield the greatest number of circumcisions through an exclusive focus on the younger age-group, and strategies designed to attract a wider diversity of age-groups.

 

The roll-out of UNAIDS voluntary medical male circumcision programmes in sub-Saharan Africa: Is it working?

18 Jun, 14 | by Leslie Goode, Blogmaster

Voluntary medical male circumcision (VMMC) has been demonstrated to reduce HIV acquisition by 60% or more.  WHO and UNAIDS have recommended that VMMC form a part of comprehensive HIV prevention programming in regions of high prevalence, such as sub-Saharan Africa.  Mathematical modelling suggests that the achievement of 80% VMMC coverage within 5 years in 14 countries in Eastern and Southern Africa would avert 3.36m new HIV infections. In the light of this the UNAIDS Joint Strategic Action Framework (JSAF) has set out the goal of circumcising 20.2 million men in five years across these countries. The challenges this represents on both the supply and the demand side are comprehensively discussed by STI/Gray & Kigozi.

A recent PLoS – Medicine Collection considers the progress thus far, and through to 2016, of this initiative.  The Collection Review (Sgaier & Njeuhmeli (S&G)) offers a useful survey. The year preceding the JSAF and the first two years of the initiative have seen yearly VMMC of 0.88m, 1.7m, and 2.9m respectively. If we assume current rates of growth, this would give a cumulative total of 17.5m circumcisions by 2016 – about 3m short of the 20.2m target; if we assume no growth, the cumulative total for this period would be 13.7m.  The scale-up of VMMC over the last three years has been impressive. Still, rates of year-on-year growth have fallen from 109% (2011) to 72% (2013).  S&G identify two factors impeding the achievement of the JSAF goal: first, insufficient funding, largely as a result of the failure of international donors to step in alongside the US President’s Emergency Plan for AIDS Relief (PEPFAR) (which currently bears 80% of the cost); second, the lack of – or failure to create – sufficient demand for VMMC in the targeted countries, especially amongst the older element (i.e. aged 25+) of the population.

The 13 papers in the collection deal with issues around supply of VMMC – such as maintaining quality of service during scale-up (Jennings & Njeuhmeli; Rech & Bertrand; Rech & Njeuhmeli) and optimizing efficiency in service delivery (Rech & Njeuhmeli;  Mahvu & Bertrand; Perry & Bertrand).  But, more interestingly, they also deal with the problem that S&G identify as one of the two main obstacles to achieving the JSAF goal – that of creation of demand (Macintyre & Bertrand; Ashengo & Njeuhmeli).  This important issue will be covered in my next blog.

To circumcise or not to circumcise? Continued US debate on the benefits of infant male circumcision as an STI prevention tool

24 Sep, 12 | by Leslie Goode, Blogmaster

Last month saw two further developments in the ongoing US debate over infant male circumcision (MC).  European readers may be surprised to discover that infant MC has traditionally been widely practised in the US – for complex historical reasons (http://blogs.bmj.com/sti/2011/10/15/to-circumcise-or-not-to-circumcise/?preview=true&preview_id=509&preview_nonce=9ecb80c216 ).  MC has shown a sharp decline in the US from around 79% some twenty years ago to 56% as of 2008, with the doubts widely expressed as to its medical justification, and insurance cover withdrawn in 18 US states; yet some paediatricians are making a last-ditch effort to halt the trend, drawing attention to medical benefits of MC as a prevention tool that have been highlighted by recent African studies (e.g. http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(07)60313-4/abstract).

At the end of August came first, on the 20th, the publication in the Archives of Pediatrics and Adolescent Medicine of an editorial and associated paper seeking to place a speculative figure on the potential health cost to the US of infant MC declining to European levels of 10% (http://archpedi.jamanetwork.com.libproxy.ucl.ac.uk/issue.aspx): then, on the 27th, a long-awaited policy statement on infant MC by the American Association of Paediatrics (http://www.aap.org/en-us/about-the-aap/aap-press-room/pages/Newborn-Male-Circumcision.aspx?nfstatus=401&nftoken=00000000-0000-0000-0000-000000000000&nfstatusdescription=ERROR%3a+No+local+token).

The paper (Kacker and Tobian) takes into account the health costs not only of increased heterosexual HIV, but of other STI problems in men and women (HPV, HSV-2, bacterial vaginosis) as well as infant male UTIs.  Their model claims to demonstrate a net increased health expenditure of $313 per forgone MC procedure, amounting to a net additional annual health care cost of $505 million, largely driven by male HIV, infant UTIs and high-risk HPV in women.  An associated editorial (http://archpedi.jamanetwork.com.libproxy.ucl.ac.uk/article.aspx?articleid=1352168) reminds us that State Medicaid plans have covered two fifths of infant MCs in the past, but are currently in the process of dropping their coverage.  It also argues that the sectors of US society most affected by the abandonment of insurance cover for MC are precisely the sectors that experience highest levels of STIs and are most likely to benefit from MC.

The policy statement by the AAP, however, declares that, while the benefits of infant MC outweigh the risks, those benefits are not “great enough to recommend universal male newborn circumcision”.  What are we to make of the apparent discrepancy between the conclusions of Kacker & Tobian and the recommendations of the AAP?

The probable role of male circumcision in limiting HIV transmission in African contexts has been recognized (http://sti.bmj.com/content/87/7/640.abstract?sid=3c2776bf-91df-4443-b45c-d91cccd67208), along with its preventative benefits where other STIs are concerned (e.g. chancroid and syphilis (http://sti.bmj.com/content/82/2/101.abstract?sid=4e861499-e57a-40b3-833f-1c3a03449ee8); trichomonas (http://sti.bmj.com/content/85/2/116.abstract?sid=4e861499-e57a-40b3-833f-1c3a03449ee8).  Its effectiveness and acceptability as a prevention tool have been positively evaluated in some cultural contexts (http://sti.bmj.comcontent/79/3/214.abstract?sid=4e861499-e57a-40b3-833f-1c3a03449ee8; http://sti.bmj.com/content/87/Suppl_1/A319.1.abstract?sid=4e861499-e57a-40b3-833f-1c3a03449ee8). In others, however, a link between circumcision and reduced HIV prevalence is not evident, and MC would not be acceptable (http://sti.bmj.com/content/84/1/49.abstract?sid=4e861499-e57a-40b3-833f-1c3a03449ee8 and http://sti.bmj.com/content/86/5/404.abstract?sid=4e861499-e57a-40b3-833f-1c3a03449ee8).

Clearly the feasibility of MC as a prevention tool is highly culture-specific.  This aspect may be  undervalued by Kacker & Tobian, who, in reference to European contexts,  assume a link between low rates of MC and the absence of insurance cover for the procedure – as though, but for insurance, a practice of infant MC would be universally adopted by everybody in the interests of sexual health!  This makes light of the element of culture and tradition.  From an outsider perspective, history would appear to have delivered the US, the shape of infant MS, a fortuitous cultural advantage which it would seem all the more misguided to squander, as it is not something that any rationally-directed health strategy could have delivered to order.  This perspective, which seems a very persuasive one, is as absent from Kacker & Tobian’s paper as it from the AAP recommendation that the authorities proceed on the basis of a calculation of individual benefit and risk.

Bloodless circumcision procedure opens the way to HIV prevention in Rwanda

19 Jan, 12 | by Leslie Goode, Blogmaster

As three recent randomized control trials undertaken in Africa have shown, male circumcision can reduce risk of HIV transmission by 53-60%.  But sub-Saharan African countries will need to scale up voluntary male medical circumcision (VMMC) hugely if they are to achieve these preventative benefits.  (See our earlier blog: Costing the Scale-Up of Voluntary Male Medical Circumcision).  In these settings the availability and deployment of the necessary resources poses a great challenge.

The development of new medical technologies adapted to resource-limited settings may be the way to make such a scale-up achievable.  Last month saw the successful completion of safety and efficacy trials in Rwanda on a device – the Prepex – designed to achieve circumcision by non-surgical means.  This certainly brings Rwanda’s goal of circumcising 2 million men over the next two years a step closer (and with it the goal of reducing HIV transmission by a half); but is also good news for other sub-Saharan countries facing similar challenges.  Results of the three trials on the Prepex were presented to the 16th International  Conference on Aids and Sexually Transmitted Infections in Africa (ICASA) at Addis Ababa.  The importance of non-surgical circumcision can be imagined in a country with only 300 trained physicians for a population of 10 million, and 90% of them living in rural areas remote from surgical facilities. But such conditions are replicated in other sub-Saharan countries which share Rwanda’s ambition to achieve HIV reduction through circumcision, and the challenge which this poses for the availability and deployment of resources.

The device itself operates by controlled radial elastic pressure so as to cut off circulation to the foreskin distally.  The necrotic foreskin can be removed bloodlessly from 4 days after the fitting of the device.  The Prepex offers a number of advantages over surgical circumcision that are particularly relevant to resource-limited settings.  The Prepex device does not require anaesthetic or sutures, may consequently be deployed in non-sterile conditions by non-medically trained staff.  Total time required for the procedure is just over 8 minutes, as opposed to the 25-36 minutes required for surgical circumcision.

Of the three Prepex trials successfully undertaken in Rwanda, the first was a non-controlled study of the feasibility of the procedure in 55 adult males; the second was a randomized controlled study comparing the non-surgical Prepex with surgical male circumcision; the third set out to demonstrate that the procedure could be performed safely and effectively by nurses.

The only results as yet published (JAIDS (15th December 2011) relate to the first of these trials. Following the procedure the 55 subjects were monitored regularly for signs of bleeding, oedema and infection.  Levels of pain experienced at each stage of the procedure were assessed using VAS scores.  The paper makes detailed comparisons between the Prepex device and another circumcision devise – the Shang Ring.  The latter removes the live distal foreskin immediately after placement, and consequently requires anaesthesia and a sterile setting.

The Prepex procedure achieved complete circumcision in all cases with a median healing time of 21 days following removal of the device.  The only adverse event was a case of diffused oedema as a result of chronic urethritis from a belatedly reported STI.  This compares favourably with the six mild adverse events observed in a trial of 40 patients circumcised with the Shang Ring (M.A. Barone & F. Ndede et al., “The Shang Ring device for adult male circumcision: a proof of concept study in Kenya”, JAICS 2011;57: E7-E12).  The most serious issue with the Prepex device appears to be the experience of considerable pain during device removal (mean VAS score 5.4) which was not alleviated by paracetemol.

http://www.prepex.com/Scientific.aspx

Jean Paul Bitega, Agnes Binagwaho et al., “Safety and Efficacy of the PrePex Device for Rapid Scale-Up of Male Circumcision for HIV Prevention in Resource-Limited Settings”, JAIDS, Vol. 58, no. 5, December 15 2011

http://journals.lww.com/jaids/Fulltext/2011/12150/Safety_and_Efficacy_of_the_PrePex_Device_for_Rapid.16.aspx

Costing the scale-up of voluntary medical male circumcision

11 Dec, 11 | by Leslie Goode, Blogmaster

The end of November saw the first in a series of nine new articles produced by researchers associated with the Joint United Nations Programme on HIV/AIDS (UNAIDS) and the United States President’s Emergency Plan of AIDS Relief (PEPFAR).  This article proposes a rapid (five-year) scale-up of voluntary medical male circumcision (VMMC) in 13 priority sub-Saharan countries, and its maintenance through to 2025. The ensuing eight papers will focus on the various factors that go into effective program expansion of VMMC, including data for decision making, policy and programmatic frameworks, logistics, demand creation, human resources, and translating research into services.

The paper argues that VMMC should be a vital element in the HIV prevention toolbox in view of its proven effectiveness, low relative  cost and cultural acceptability: three randomised control trials have demonstrated a 57% protective effect for males against HIV; mathematical modelling has shown it is cost-effective, with costs to avert on HIV infection ranging from US$150 to US$900; it is also a widely accepted practice, with 67% sub-Saharan males already circumcised.

Maximum impact will require coverage of 80% across the 13 countries – a target which is very much more ambitious for some countries than for others, given the very different levels of circumcision constituting their point of departure.  The number of circumcisions needed to reach this coverage is estimated at 20.3 million.

The cost of scaling up VMMC over the years 2011-2015 in order to reach this figure is estimated at US$1.5 billion, and a further 0.5 billion is allowed for the maintenance of this coverage from 2015 through to 2025. Given discounted individual lifetime cost of antiretroviral therapy of US$7,400, net saving from 2011-2015 due to averted treatment and care cost would be US$16.5 billion.  The scale-up of VMMC would therefore be not only cost-effective but highly cost-saving.  It would “create fiscal space” that would otherwise have been encumbered by treatment costs.

If implemented, the scale-up would avert 3.4 million HIV infections.  The paper gives estimated percentages for proportion of infections averted for each of the 13 countries.  The figures vary from 9.2% for Swaziland to 41.7% for Zambia, with a million infections averted in South Africa alone.  Initial impact would largely be among men, but the proportion of infections averted in women steadily increases over time until 2025 when nearly half the infections averted would have been among women.

According to the authors, it is the need for accountable leadership and vision on the part of government leaders, and not access to funding, that poses the greatest challenge to the success of VMMC scale-up.  They draw particular attention to the challenge of mobilising human resources, and refer to the work of Curran et al. which reviews the concepts of task shifting and task sharing and describes approaches to expanding the health sector workforce through redeployment of personnel and use of expatriate volunteers (“Voluntary medical male circumcision: strategies for meeting the human resource needs of scale-up in southern and eastern Africa”). PLoS Medicine (November 2011) 8: e1001129).

Catherine Hankins et al., “Voluntary Medical Male Circumcision: An Introduction to the Cost, Impact, and Challenges of Accelerated Scaling Up”, PLoS Medicine (November 2011) 8 e1001127

http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1001127

Curran et al., “Voluntary medical male circumcision: strategies for meeting the human resource needs of scale-up in southern and eastern Africa”). PLoS Medicine (2011) 8: e1001129 doi: 10.1371/journal.pmed.1001129

http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1001129

The unequal benefits of male circumcision against HIV

1 Nov, 11 | by Leslie Goode, Blogmaster

The publication last August in the Lancet (Aaron A R Tobian, Ronald H Gray et al.) of findings from one of the two randomized control studies undertaken 2004-9 by the Rakkai Health Sciences Program (RHSP), Uganda, on the health impacts of circumcision to reduce HIV/STI transmission, has generated further comment in the Lancet from researchers engaged in the South African context (A R Giuliano, A G Nyitray et al.).  The findings of the initial paper indicate the inefficacy of circumcision of HIV-infected males as means of preventing the transmission of Human Papilloma Virus (HPV) to long-term partners.  The issue of HPV transmission has its own importance, given high levels of oncogenic HPV in African countries (4 in 10,000).  But their public health significance becomes fully apparent when taken in conjunction with the findings of a parallel study within RHSP indicating the same inefficacy in relation to the transmission of HIV (by infected males to partners) (M J Wawer, F Makumbi  & G Kigozi).  Altogether, this amounts to indicating no discernible benefits in the case of HIV-infected males – a result which has to be viewed against the background of earlier studies demonstrating the efficacy of circumcision of non-HIV infected males.  So it seems the balance of benefits and disbenefits of circumcision could vary substantially for different groups of the population, with the net effect of circumcision of HIV-infected males being inefficacious, or even harmful.

The findings raise interesting issues for the circumcision programs now under way in Uganda (as from 2010) and elsewhere in sub-Saharan Africa.  The authors of the initial paper plainly envisage the possibility of HIV-infected males demanding circumcision in contexts where this intervention is being promoted as a means of HIV prevention.  Against whatever limited benefit – if any – circumcision may actually confer in such cases, there evidently needs to be balanced the possible impact on the sexual behaviour of HIV-infected males who believe that their circumcision will minimise the risk of their transmitting the infection.  So what if – as the study would suggest – circumcision confers little or no benefit?  Tobian & Gray recommend that circumcision should still not be refused – on the grounds that this might stigmatize.  But they emphasize that “wherever possible, circumcision should be offered with HIV counselling, condoms, and education about HIV prevention”.

The second issue concerns “the ideal time for male circumcision to optimise prevention of infection and disease”.  Here Giuliano & Nyitray corroborate the conclusion from the trial data that “the greatest population benefit is likely to be achieved if done before sexual debut and first exposure to HIV and HPV”.

These are clearly pressing issues in the context of government-backed HIV prevention through circumcision in Uganda and beyond.  The Rakkai Health Sciences Program, which is involved in the provision of circumcision and the training of circumcision providers who operate throughout Uganda, is well placed to conduct a range of research projects that may contribute to the formation of public policy.  Linked with John Hopkins Bloomberg School of Public Health, the program began in 1987 at the initiative of a group of scientists from Makerere University, Kampala.  It has benefited since then from US and International grants, and has hosted two major, randomized, control trials: one, funded by the NIH, to investigate the efficacy of circumcision for HIV prevention; the other, funded by the Gates Foundation, to investigate circumcision and its behavioural impact in men, women and communities.

A R Giuliano, A G Nyitray et al., “Circumcised HIV-infected men and HPV transmission”, The Lancet Infections Diseases, August 2011, vol 11

http://www.sciencedirect.com.libproxy.ucl.ac.uk/science/article/pii/S1473309911700731

A A R Tobian, Ronald H Gray et al., “Circumcision of HIV-infected men and transmission of human papillomavirus to female partners: analyses of data from a randomised trial in Rakai, Uganda”, The Lancet  Infectious Disease, August 2011, vol 11

http://www.sciencedirect.com.libproxy.ucl.ac.uk/science/article/pii/S147330991170038X

M J Wawer, G Kigozi et al., “Circumcision in HIV-infected men and its effect on HIV transmission to female partners in Rakai, Uganda: a randomised controlled trial”, The Lancet 2009: 374: 229-37

http://www.sciencedirect.com.libproxy.ucl.ac.uk/science/article/pii/S0140673609609983

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http://www.jhsph.edu/rakai/

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