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The varied nature of the US HIV/AIDS epidemic: what makes the South so different?

27 Feb, 15 | by Leslie Goode, Blogmaster

As of 2011, 38% of all US citizens diagnosed with HIV were from a block of nine states in the south-east, sometimes referred to as “the South”: Louisiana, Alabama, Florida, N. and S. Carolina, Georgia, Texas, Mississippi and Tennessee. Death rates among those living with HIV in this region were, by far, the highest of any US region.  A recent study (Reif & Wilson) uses CDC HIV surveillance data to seek to assign characteristics to the large number of persons in that region diagnosed with, and frequently failing to survive, HIV/AIDS, in order to determine what it is about this region of the US that makes it peculiarly vulnerable to the epidemic.

A number of these characteristics were not specific to the South, but shared by all the southern states: the high proportion of those diagnosed who are female (27%: US average 20.9%), who have contracted HIV through hetero-sexual relations (14.5%: US average 11.7%) and who fall in the 13-24 yr age group. What differentiates the South more particularly, is the considerably higher percentages of diagnoses among those living in rural (11%) and suburban (17%) areas, though even urban rates (29.6 per 100,000) are higher in the South than in other regions.  Five-year survival following AIDS diagnosis, at 73%, is considerably lower than the US average (77%), and lower than for any other region. Survival rates following HIV diagnosis were considerably lower for rural (82%) than for urban (86%) areas.  Above all, the death, rate at 27.3 per 1000, was considerably higher than in any other region of the US. (HIV mortality in the UK fell from 21.8 to 8.2 per 1000 over the years 1997-2008 (Smith & Delpech (STI))).

The high death rates for the South suggest, the authors claim, a fundamental “disconnect” between diagnosis and maintenance of care in the region. Moreover, when the figures are adjusted to take account of characteristics of individuals living with HIV, including sex, race, mode of transmission etc., the disparity remains substantively unchanged or accentuated. This likely indicates underlying structural factors affecting the states of the South.  Obvious candidates would be lower insurance coverage, lower levels of income and education. On the basis of the convergence of high death rates and the high proportion of rural and suburban HIV cases in the region, the authors also evoke, more speculatively, the “class system unique to the US South” which has traditionally allowed little social mobility.  They argue this may have contributed towards a social environment among lower strata characterized by a combination of stigmatization and distrust of medical services, which is very unconducive to retention in care.

Trialling innovative approaches to STI partner services: Partner-Delivered vv. Accelerated Partner Therapy

26 Feb, 15 | by Leslie Goode, Blogmaster

It is vital to treat partners of patients with curable STIs as quickly as possible.  But the effectiveness of interventions to achieve this proves hard to measure – and the case for increasing resources correspondingly difficult to make.  The inadequacy of the resources available to existing partner services has led some investigators in the US and UK to seek out innovative approaches to ensuring the treatment of partners which are less expensive.  One option – Patient-Delivered Partner Therapy (PDPT) – is to provide treatment for partners via the patient and without prior medical assessment of the partner.  The problems with this are: first, that PDPT may not conform to legal (Cramer & Leichliter (STI)) or professional guidelines; second, that concomitant infections (e.g. HIV) in the partner may go undiagnosed and untreated. An alternative solution – Accelerated Partner Therapy (APT) – is to treat the partner via the patient, but only after a medical assessment conducted by telephone or with a pharmacist (Golden & Estcourt (STI); Dombrowski & Golden (STI)).

The option of PDPT has been trialled in various US clinics (Mickievicz & Rietmeijer (STI); Sanchez & Schillinger (STI); but its impact is difficult to evaluate on a local level. Now, for the first time, Golden & Holmes have attempted a population-level randomized control trial of uptake and impact across 23 out of the 25 counties of Washington State.  This impressively large-scale operation had two elements.  The first was the provision of free PDPT, and involved: 1. informing all clinicians about the programme; 2. making stocks of free PDPT available to clinicians who had reported ≥ one case of Chlamydia or Gonorrhoea, and to certain large pharmaceutical chains; 3. visiting clinicians reporting frequent cases for the purpose of educating staff about the programme.  The second element was the possibility offered to diagnosing practitioners via routine report forms of having the provision of partner services handled by the state public health department. This intervention was rolled out in four successive waves to different counties in turn, thus enabling the impact of the intervention to be controlled against the default situation in the counties of each wave.

As regards uptake, percentage of persons receiving PDPT from clinicians rose in intervention periods from 18% to 34%, and percentage receiving partner services from 25% to 45%.  This is broadly comparable with what has been achieved by more local interventions in the US.  Unfortunately, it is one thing for a pack to be accepted by the index patient, another for a partner to be successfully treated.  Hence the interest of G&S’s attempt to evaluate population-level impact – through testing in sentinel clinics in the case of Chlamydia, and through incidence of reported infection in the case of Gonorrhoea. It was undoubtedly ambitious of G&S to seek an indicator of population level impact for a comparatively brief intervention.  It is no surprise that the results are less than overwhelming. Chlamydia test positivity and gonorrhoea incidence in women declined respectively from 8.2% to 6.5% and from 59.6 to 26.4 per 100,000. The latter more impressive reduction is unfortunately hard to distinguish from a strong secular trend in the same direction in various states.

There are more general problems, however – such as knowing whether the handing over of PDPT packs is resulting in the successful treatment of disease, or whether it may even be contributing to an ongoing failure to diagnose concomitant partner infections.  These might weigh in favour of the alternative approach recently developed in UK clinics: APT.  Estcourt & Johnson (STI) report uptakes of 66% and 59% for versions of APT as against 36% for conventional PS.  Sending a treatment pack following a telephone interview would seem to offer a better guarantee of partner treatment, than offering a pack on the basis of nothing more than a stated willingness of the index patient to deliver it.  At the same time, interviewing the partner averts the risk of doing harm by pre-empting consultations at which a fuller diagnosis of the partner’s condition would have been possible.  A population-level trial of the impact of APT has yet to be undertaken.

ChemSex and HCV transmission among UK MSM

2 Feb, 15 | by Leslie Goode, Blogmaster

Reports of substantial rises in the incidence of HCV among MSM populations in the UK  (STI/Yaphe & KleinSTI/Ghosn & Chaix) have attracted some attention in STI journal.  Not least because intravenous drug use is the most obvious mode of transmission for this blood-borne virus, and MSM have in the past tended not to use this route of administration.  The question then arises what specific factors in the environment of these MSM populations are increasing their risk?  The question is all the more urgent as – whatever those factors may be – MSM populations seem as yet largely incapable of reducing them – to judge by the large proportion of successfully treated MSM who become re-infected within two years (40% according to a N. London hospital). A number of recent contributions to STI journal consider the role of MSM sex in HCV transmission (STI/Stall & McFarland; STI/Valencia & Salas), and what it is in the practices or lifestyle of MSM that puts them at particular risk. Associations have been identified with number of partners, casual anal sex, sex parties (STI/Marcellin & Spire): specific practices such as fisting, rimming, recreational use of intra-nasal drugs (STIs/Turner & Stephenson): interactions between these practices and certain self-described MSM lifestyle groups such as “leather”, or “lycra & rubber” (STI/Matser & van der Loeff).

A recently published guide for health professionals (ChemSex & Hepatitis C), claiming to be based on c.500 conversations with MSM clients, offers an illuminating, ground-level account of one risk environment: events involving “ChemSex”, or the collective use of recreational drugs to enhance sexual experience. The authors claim that ChemSex parties are a growing HCV risk for MSM for three reasons: greater availability of certain non-injection drugs; increased injecting drug use; more widespread use of smartphone Apps and online “hooking-up” sites.  MSM involved in Chemsex, they claim, are a particularly hard-to-reach group for health professionals because of their use of informal private venues (rather than clubs, or the street), and a lack of exposure and openness to IDU service messages owing to a past preference among MSM for non-intravenous drugs.

Before health professionals can communicate effectively with these clients about the potentially stigma-laden issue of HCV they need to develop an awareness of the various elements of risk in the ChemSex environment.     The booklet aims to guide health professionals on this path. This it is does by means of an illustrative “case study”, as well as by a systematic itemization of potential risk factors in the ChemSex environment, including some less obvious transmission routes  – such as blood on douching tools or shower hoses, or blood on the lube pump, or snorting straw.   Language, of course, is at the heart of communication.  The booket, therefore, includes a handy list of current popular terms, as well as suggested  questions to ask at consultations.

Should the Faculty of Sexual and Reproductive Health and Keele University Postgraduate Award in Medical Education be compulsory for GUM trainees?

30 Jan, 15 | by Leslie Goode, Blogmaster

Author: Dr Zana Ladipo, New Croft Sexual Health Centre, The Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle, UK

Sexual Health services in the United Kingdom are changing from separate Genitourinary Medicine (GUM) clinics and Faculty of Sexual and Reproductive Health (FSRH) clinics to a more integrated Sexual Health service, a one-stop shop for patients. There is now a debate as to whether this may lead to a loss of expertise1 and whether it will improve patient care2 -3 and provide more career opportunities for staff.1 Of particular concern is a difference between the two career tracks in the respective opportunities they offer to acquire teaching training skills.

On the FSRH side, trainees are required to have passed their Diploma in FSRH (DFSRH) and their membership exams, and, with the planned merging of the services, are increasingly being advised to obtain the Diploma in GUM. But they have also been required to do the FSRH & Keele University Post Graduate Award in medical education (PGA Med Ed).

On the GUM side, trainees are required to achieve the GUM, HIV and FSRH diplomas.  But only some pursue a qualification in medical education, e.g. the Royal College of Physicians Certificate in Medical Education.  This represents a significant disadvantage for GUM trainees. It isn’t just that the PGA Med Ed improves teaching and feedback skills: it also enables the graduate to become a Faculty Registered Trainer (FRT) and train others towards obtaining the DFSRH, which is a compulsory qualification for both GUM and FSRH trainees. Doctors and nurses in all specialities are required to take on roles involving increasing amounts of medical education.4 Most have little formal training in this area.  In these times of austerity and budget cuts, offering training towards the DFSRH can be a useful way for a clinic to generate revenue by attracting external paying candidates as well as providing local training.

Most importantly, however, without the PGA Med Ed, GUM trainees cannot obtain FRT status. I have spoken about the PGA Med Ed to other GUM trainees, all of whom were unaware of this. Only one other GUM doctor and I attended the course in March 2014, and I think this may be due more to lack of knowledge about the course among GUM trainees rather than a lack of interest. I do not feel it should be compulsory for GUM trainees, but simply aim to increase awareness of its availability and usefulness. Information on the course can be found at the FSRH website (http://www.fsrh.org/) under ‘Training’. I hope that after reading this letter you agree that the PGA Med Ed is a worthwhile qualification for GUM specialists working in or starting an integrated service.

Dr Zana Ladipo

 

REFERENCE LIST

  1. French RS, Coope CM, Graham A, et al. One stop shop versus collaborative integration: what is the best way of delivering sexual health services?  Sex Transm Infect 2006,82;3:202-6 (STIs/French&Graham)
  2. Dawson, SG, Callander N, Roche C, et al. Integrated sexual health care: the development and review of one model of service delivery. Int J STD AIDS 2000;11:428-34 (Dawson&Roche)
  3. Kinn S, MacDonald C, Hinks S, et al. Clients and staff views on facilities and services, before and after the convergence of sexual, reproductive and women’s services. Eur J Contracept Reprod Health Care 2003;8:65-74 (Kinn&Hinks)
  4. Hutchinson, L. ABC of learning and teaching: Educational environment. BMJ 2003;326:810 (Hutchinson)

 

 

Population-based study concludes: HPV vaccination does not cause sexual disinhibition

19 Jan, 15 | by Leslie Goode, Blogmaster

HPV is known to be the cause of various types of cancer, including cervical cancer. Routine vaccination before the onset of sexual activity ought therefore to be effective in reducing the incidence of these cancers, and has been adopted by many countries.  The impact of such programmes will not be apparent for years; but the sharp reduction of cases of genital warts in several countries where vaccination has been introduced, is an encouraging indicator of the likely effectiveness of cancer prevention over the longer term (STI/blog/Smith & Canfell).  Unfortunately, however, vaccination coverage has often been sub-optimal ( STI/Sacks & Robinson).  A number of recent contributions to STIs have attempted to identify parental (and provider) concerns that may be responsible for poor uptake of vaccination (STI/Schuler & Brewer; STI/Javanbakht & Guerry;  STI/Krupp & Madhivanan).

One concern frequently mentioned by these studies is that HPV vaccination could lead to sexual disinhibition.  The results of a large population-based cohort study in Canada (Smith & Levesque (S&M)), where HPV vaccination was introduced in 2006, may help to offer some assurance on this matter.  The study was based on administrative health data relating to a cohort of 260,493 girls, of whom approximately half were in the first two school year-groups offered the vaccine (2006-7; 2007-8), and the other half in the previous two year groups (2004-5;2005-6). The study compared data from the two groups in respect to the incidence of pregnancy and non-HPV-related STIs over the four years following vaccination.  Earlier studies addressing the question of vaccination-related disinhibition have focussed on risk perception or reported sexual behaviour.   S&M use objective medical outcomes – pregnancy and STi diagnoses.  Moreover, the definition of the groups on the basis of eligibility for vaccination, as opposed to vaccination itself, circumvents the potential confounding bias which might have been expected to arise from the fact that the same beliefs and behaviours influencing the decision to vaccinate would likely also have affected the outcome of pregnancy and STI infection.

The results are entirely reassuring.  In respect to pregnancy they show precisely no difference between the eligible as opposed to ineligible girls (RR = 1.0 0); in regard to non-HPV related STI diagnoses, they show a small reduction among eligible girls, which the authors plausibly attribute to the likely eventuality of some HPV-related warts having being categorized in the data as non-HPV-related.  These findings corroborate, on a population wide basis, those of earlier studies (e.g. Bednarczyk & Omer) which indicate that fears of vaccination-related disinhibition are unwarranted.

 

Living dangerously in the Dominican Republic and Mexico City: can cash transfer payments be used to counteract the “risk premium”?

17 Dec, 14 | by Leslie Goode, Blogmaster

The Caribbean has the highest levels of HIV outside sub-Saharan Africa – and the Dominican Republic (DR), which together with Haiti accounts for 70% of all people living with HIV in the Caribbean region, is a hotspot.  While there has been a 73% reduction in the rate of new infections in the DR between 2001 and 2011, prevalence of HIV remains high among key populations of MSM (6%) and female sex-workers (3%).  A recent qualitative study has sought to investigate the relations between the drug trade, sex tourism, and risk taking which may hold the secret of the obstinately high-levels of HIV in these key populations (Guillamo-Ramos & Robles).  In-depth interviews, along with drug screening, were conducted with 30 local drug users in Sosua, known for its tourist sex industry.

Three major themes emerge.  First, drugs are freely available as a result of diversion from the major drug routes running from N to S America through the DR.  Second, they have become integral to the local tourist industry – specifically as a vital component of sex work.  Third, the engagement of locals, along with tourists, in commercial sex fuelled by drug use gives rise to the kind high-risk behaviours that sustain the spread of HIV in the local population.

What, from the public health angle, seems particularly challenging in this situation is that the element of risk-taking isn’t merely an incidental effect of the sexual activity; it is precisely the element that makes that activity attractive, and – from the locals’ point of view – lucrative.  Participants associate sex work and drug use with improved livelihood, and describe how risk behaviours are part of the economic negotiating process.

This is the same general kind of problem described in the reported base-line study of a pilot trial of an intervention among male sex workers in Mexico City (STI/Galarraga & Sosa-Rubi).  These male sex-workers are at particular risk of infection because they receive market-based inducements from clients to engage in condomless sex.  It is not simply that MSW are neglecting to take precautions; the average price for a sex transaction is 35% higher for condomless sex – and, given MSW may be unemployed (16%), or dependent for their income on sex work (37%), the economic pressures to engage in unsafe practices are considerable.

The Punto Seguro pilot trial, based at the Clinica Condesa, an HIV centre in Mexico City, is considering as a potential solution the idea of a conditional cash transfer (CCT) whereby MSW are rewarded for keeping themselves free of curable STIs over a six-month period.  Within Mexico CCT has been employed, since the 1990s to provide incentives for poor people to keep their children in school, and to attend preventative check-ups, though not apparently in the sphere of HIV.  In the US, however, it has been used to prevent persistent STIs and pregnancy amongst the Latino population (STI/Minnis & Padian), in Pakistan to encourage infected men to disclose to their wives, and have them tested (STI/Khan & Khan).

The paper sets out the procedures and the baseline data for investigating the effectiveness of a form of this kind of intervention.  The 267 participants have been randomized to four groups: control; medium conditional incentive ($50); high conditional incentive ($75); unconditional incentive ($50). Previous formative work established the incentive levels necessary for behaviour change ($156 per year).  It is also hoped that CCT interventions may benefit participants by helping to link them into care – since of the participants in the trial who knew they were infected with HIV, only 40% were on treated, and of these, only 61% had achieved viral suppression.

Heterosexual transmission of HPV to male oral tract via oral/genital route indicated by partner data

15 Dec, 14 | by Leslie Goode, Blogmaster

The UK Joint Committee for Vaccination and Immunization (JCVI) has not so far decided to extend HPV vaccination to boys, but this possibility remains under consideration (Public Health England Guidance on HPV 2014-15). The potential benefit of protecting males from face and neck cancer will be an important consideration, both in the UK and in other countries contemplating this extension of HPV vaccination programs (STI/Conway & Adams).  Some have attributed the recent tripling in number of cases of these cancers to oral HPV, thus transforming what was formerly a smokers’ disease into an STI outcome.  A figure of 2,000.has been placed on the total of HPV attributable cases in UK males.  Such claims – and their public health policy implications – confer a new importance on research into the risk factors of oral HPV infection among young men.

A recently reported sub-study taking place in the framework of the Montreal based HPV Infection and Transmission among Couples through Heterosexual Activity (HITCH) cohort study claims to be the first to have established the association of oral infection in males with sexual behaviour, not just on the basis of their reported sexual behaviour, but through the collection of data from their partners (Dahlstrom & Franco).   The study administered questionnaires and tests to 222 young men and their partners at baseline and four-months.

Prevalence of oral HPV among male study participants was 7.2%.  Of these 28.6% (2) were found to have a partner with oral HPV infection, and 11.5% (15) to have a partner with genital infection.  The study also investigated type-specific HPV prevalences.  The prevalence among the young men of oral HPV16 (especially associated with head and neck cancer) was 2.3% (5); among the 33 men who had a partner with genital HPV, prevalence was (6.1%) (2/33).  In a rough and ready way, this study also establishes a correlation of oral HPV prevalence in males with frequency of oral sex (RR 1.47 as between rarely/sometimes having oral sex & rarely/never having oral sex).  The potential advance on previous studies is that this correlation is seen to hold only where the partner is genital HPV positive.

The importance of these findings is, first, to corroborate, on the basis of partner data, the conclusion drawn by earlier studies of the relation of oral HPV with reported oral sex, that there is indeed transmission of HPV from the female partner to the male partner’s oral tract, whether through oral or genital routes.  Second, the association of deep kissing with oral HPV infection seen in earlier studies would seem to be confirmed by the higher prevalence among men with oral HPV of female partners with oral HPV.  However, the alternative explanation of auto-inoculation, indicated in the study data by the high prevalence of genital HPV in self, cannot be excluded (STI/Hernandez & Ning).  Third, the possibility of oral sex as a route of transmission is suggested by the increased prevalence of oral HPV among men with a genital HPV partner, and its relationship to frequency of oral sex.

 

Obituary of Denis Lambert Sugrue

27 Nov, 14 | by Leslie Goode, Blogmaster

Denis Lambert Sugrue

Dr D Sugrue photo

Denis Sugrue was born in Dublin on 10th March 1927. He had a happy childhood in Dublin with his parents, older sister and half-brother. He had a tremendous affection and pride for his father who was a decorated soldier of the First World War.

He was educated at the Catholic University School and Blackrock College. He commenced his medical studies in University College Dublin (UCD) in 1944. The following year he was awarded a Kitchener Scholarship. He qualified MB, BAO, Bch in 1950. He came to England to pursue postgraduate training in ENT. He obtained the DLORCS Eng. in 1953 and the MCH, National University of Ireland in 1954.

Having completed his postgraduate training studies, Denis decided to explore the field of plastic surgery and applied for the post of registrar at Rooksdown House. Three happy and instructive years were spent there, before Denis returned to Ireland. (His famous interview by Sir Harold Giles was recounted in the BMJ volume 314, 11th January 1997). He was appointed consultant plastic surgeon to the Children Hospital, Temple Street, Dublin and to the International Missionary Training Hospital, Drogheda where he pioneered plastic surgery and his work was recognised and published internationally.

At university Denis joined the Boat Club at UCD and he was most fortunate in being a participant in a successful era of UCD rowing, which culminated in 1948 with his selection to cox the Irish Olympic Eight in the London Olympic Games. In 2012 Denis was awarded the medal of honour from the Olympic Council of Ireland.

In 1968 Denis accepted the post of consultant plastic surgeon at the General Hospital in Tripoli, Kingdom of Libya, spending many months with the hospital architects and administrators planning a department of plastic surgery and a burns unit. Denis was invited to join the International Society of Burns Injuries. The work was challenging. He endeavoured to build a team of experts who could provide the appropriate reconstructive surgery. Unfortunately as a result of a radical change of regime, courtesy of Colonel Gaddafi, Denis found himself unceremoniously returned to England.

By now Denis had a wife and a young daughter, so it was urgent that he found employment and a consultant post as quickly as possible. To this end, he was advised to consider a change of speciality by a former mentor from Rooksdown House and thus an opportunity arose for an appointment at St Thomas’ Hospital in what was then classified as venereology. Subsequently, Denis was registrar and then senior registrar at Southampton for training in his new career. He was appointed as consultant venereologist to the North and Mid Staffordshire Hospitals in 1972.

The major task on his appointment was to upgrade the premises as a temporary measure, while pursuing a purpose built department within the main hospital complex, which was essential for recognition for higher training and recruitment. Nationally, there was a movement to change the image of the speciality of venereology which became genitourinary medicine. Denis was active in promoting this new vision and was a founder member as well as first president of the Midlands Society of Genitourinary Medicine.

Denis remained in his post in North Staffordshire Hospital until his retirement in 1992. He was dedicated to the care of his patients and only the best medical practice would suffice. He took delight in developing his staff and teaching his junior colleagues. He gave unflinching support, advice and friendship to his consultant colleagues; friendships that in many instances lasted his lifetime. He was considered by some as their godfather.

He found retirement very enjoyable and travelled frequently. His last trip was to Hong Kong to attend the wedding of his younger daughter in February 2012.

Denis was introduced to his wife Helen at the Hunter Trial held at Castletown House, Celbridge, Co. Kildare in March 1962 and they married in September that year.

Denis died peacefully on 23rd July 2014. He leaves his devoted wife Helen, two daughters, a granddaughter and a grandson.

 

Dr Taha Wanas FRCOG

Retired consultant in genitourinary medicine

The Royal Wolverhampton Hospitals NHS Trust

Tracking the origin, early spread, and ignition of pandemic #HIV-1 through new approaches to phylogenetic analysis

17 Nov, 14 | by Leslie Goode, Blogmaster

“Distribution of HIV-1 subtypes in a population”, state Mumtaz & Raddad (STI) in a study of the HIV pandemic in the Middle East, “tracks the spread and evolution of the epidemic”.  Various studies covered in our previous blogs have attempted to read the history of the progress of the HIV epidemic through the evidence of the distribution of HIV genetic sub-types: Tatem & Salemi (STI/blogs) have investigated its spread throughout Africa; Zhao & Roca (STI/blogs) pass beyond the human epidemic to consider the genetic evidence for repeated transmission from chimpanzees to humans.

Now Faria & Lemey (F&L), in a paper recently appearing in Science, offer an account of the critical early phase of limited spread within Central Africa and the ignition of pandemic HIV-1 around 1960, bringing statistical approaches to bear to HIV-1 sequence data.  F&L produce a time-scaled phylogenetic “tree” of HIV-1 group M lineages, matching these up in each case with the geographical location of their earliest manifestation.

This approach points to the very strong likelihood (PP = 0.99) of an origin of the HIV1 epidemic in Kinshasa around 1920. Study of lineage migration shows comparatively early spread from Kinshasa to Brazzaville (Republic of Congo (RC)), and Mbuji-Mayi and Lubumbashi (southern Democratic Republic of Congo (DRC)) along the railway network, and its arrival around a decade later in Bwamanda and Kisangani (northern DRC).  The crucial period around 1960 (1952-1968) sees, for group M HIV-1, an exponential growth in levels of M-group transmission, while growth in group O transmission remains at previous levels.

But the most interesting aspect of the study relates to conditions around the sudden surge in group M HIV-1 transmission, as indicated by the accelerated ramification of viral lineages during the crucial period.  The authors consider the hypothesis that associates this ramification with the geographic dispersal of the epidemic, with the lineages emerging in the more widely distributed populations now being infected.  They reject this hypothesis, however, on the grounds that, when the epidemic history of lineages maintaining ancestry within Kinshasa is constructed, these turn out to exhibit phylo-genetic characteristics that are comparable to those of lineages in central Africa.

They conclude that the crucial explosion of pandemic HIV-1 transmission probably occurred in Kinshasa as a result of a historic contingency affecting a particular population subgroup.  Prime contenders are iatrogenic transmission as a result of the administration of unsterilized injections at STI clinics, and/or post-independence changes in sexual behaviour e.g. among commercial sex-workers.  The authors find support for the iatrogenic hypothesis in a study of the hepatitis C virus in the DRC which shows that it exhibits an age cohort effect, and in reports of an epidemic of hepatitis B in Kinshasa around 1951-2.

Failed PrEP trial (VOICE) participants give reasons for their poor adherence

13 Nov, 14 | by Leslie Goode, Blogmaster

Despite indications of the acceptability of Pre-Exposure Prophylaxis (PrEP) among certain populations (MSM in London (STI/Aghaizu & Nardone) 2013, and Australia (STI/Holt & De Wit) 2012), the extremely varied results that have emanated from large studies seeking to determine its efficacy and effectiveness as a preventative intervention remain a concern.  To name the most important examples, levels of risk-reduction were estimated as follows: CAPRISA 004 – 39%; iPrEX – 44%; CDC TDF2 – 62%; Partners-PrEP – 75%; FEM-PrEP – 0%; VOICE– 0%.  The reasons for this variation have been the topic of a number of contributions to this blog (especially: STI/blogs/Hendrix & Bumpus; STI/blogs/Haberer & Bangsberg), with consensus tending towards the poor adherence of study participants.

Last week in Cape Town results were briefly reported from a sub-study (VOICE D) of one of the less successful of these trials (VOICE). Microbicide Trials Network’s (MTN) VOICE study, discontinued in 2011, trialled daily tenofovir, in the form of vaginal gel or tablet, in 5,029 (mostly young) women from a representative range of sub-Saharan countries – S. Africa, Zimbabwe and Uganda. On the basis of self-reporting measures in the original VOICE trial, levels of adherence to the tenofovir regime had been estimated at 90%.  However, blood samples taken from participants found evidence of the drug in less of a third of the participants in the tablet arm, and less of a quarter of the participants in the gel arm, of the study.

After the closure of the VOICE study itself, the sub-study, VOICE D, engaged 127 former VOICE participants in in-depth interviews at which they were challenged with evidence of their poor adherence – with a view to stimulating frank discussion. When confronted with the evidence of blood tests, poor adherers initially expressed surprise and disbelief. Yet, according to the report, the aim of engaging frank discussion would seem to have been met.  The reason most frequently given was fear of the side effects of the drug, fuelled by peer participants and relatives and by the negative attitudes of community members.

Current trials of PrEP have re-evaluated and strengthened efforts to enhance adherence in the light of previous failures.  These include: the Follow-on African Consortium for Tenofovir Studies’ FACTS 001 (tenofovir gel before and after sex), the MTN’s ASPIRE and the International Microbial Partnership’s Ring Study (both the latter of vaginal ring releasing the ARV drug dapivirine) (MTN Trials). It is interesting that the Partners-PrEP study incorporated intensive “adherence interventions” for participants whose adherence levels fell below 80% (STI/blogs/Haberer & Bangsberg).

However, the VOICE D results may have implications for the usefulness of PrEP interventions more generally. At the very least, they discredit any idea that PrEP is able to offer a panacea. The value of PrEP, relative to other preventative interventions, is a contentious issue.  STI/Mukandavire & Vickerman (2013), for example, conclude that a scale-up of condom use is in most circumstances likely to be more effective than PrEP, but that PrEP could have a specific application in the case of female sex workers. STI/Verguet & Walsh (2012) see a future for PrEP in sub-Saharan countries with high HIV prevalence and without circumcision practice, such as S. Africa.  STI/Ying & Barnabas (2013) see targeted PrEP as a cost-effective addition to ARV.

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