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Rapid Responses: Rapid Responses published:
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The Evidence Speaks for Itself
- Ali M. Khan (16 August 2007)
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Sexual abstinence education. What is the evidence we need?
- Jokin De Irala (20 August 2007)
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Not the last word on abstinence education
- Trevor Stammers (23 August 2007)
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Sex education programme that teach abstenism, safe sex had very little impact on adolescence behavior & role of Microbicide in prevention of HIV in Rich countries
- Professor pranab Kumar Bhattacharya MD(cal) FIcPath(ind), Bhattacharya Rupak Bsc(cal) MSc(JU) Purbapalli, Sodepur, Bhattacharya Upasana DPS Kolkata, Chakraborty Srabani MD Asst Prof Patho,BhattacharyaPalash MD(PGT) Patho, Dutta Pradip MD(Medicine) Assoc. Prof. Medicine, Roy Arnab HIV clinic IPGMER KOl-20,W.B Ind (26 August 2007)
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Ali M. Khan, Medical Student Virginia Commonwealth University School of Medicine, Richmond, VA 23298 USA
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To the Editor: Re: Sexual abstinence only programmes to prevent HIV infection in high income countries: systematic review, 4 August 2007, BMJ 2007;335:248-52. Evidence-based and translational medicine--the idea that health care delivery should incorporate best practices culled from medical literature--is the current rage in the U.S. health care system. This "bench to bedside" model operates on a basic principle: that discoveries made in the scientific research arena should be quickly applied to the everyday practice of medicine, allowing the benefits of those findings to be felt as early as possible. In theory, the United States' health care policy, whether domestic or international in focus, also operates on this principle. When it comes to U.S. efforts to address the global AIDS pandemic, however, we all too often ignore science in the name of ideology. The Bush administration has made considerable progress in the war on AIDS through the President's Emergency Plan for AIDS Relief (PEPFAR), domestic programs and support of the Global Fund. By requiring one-third of all spending on AIDS prevention to go toward the promotion of abstinence-only educational programming, however, the administration puts valuable resources toward initiatives that are proven to be ineffective in industrialized and developing countries alike, as indicated by the results of the Underhill study. President Bush should take a page out of our national health care primer when developing future plans to combat AIDS, focusing on evidence- based prevention programs (such as needle exhange programs and condom distribution) that have a proven track record of success. For all the current outcry on the state of American health care, relying on the evidence is one example of where we're doing something right. Ali Khan
Competing interests: None declared |
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Jokin De Irala, Professor of Epidemiology, Preventive Medicine and Public Health School of Medicine, University of Navarre, 31080 Spain
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Articles such as the one published by Underhill and colleagues (1),
where sex education programmes are reviewed, tend to be picked up by the
news media and make headlines. The problem is that conclusions are too
often made hastily in spite of complex data and analyses. Underhill and
colleagues have reviewed 13 trials of abstinence only programmes and have
done a great job putting together and summarising very heterogeneous
studies. Indeed, the methodological pitfalls they have encountered within
all studies are a sign of how difficult it is to achieve well designed
studies for evaluating the effect of educational programmes on human
behaviour, and/or to implement such studies. Most of the methodological
problems cited by Underhill and colleagues are crucial:
What puzzles me most, however, is the conclusion drawn by the authors after such a meticulous job reviewing the trials. They bluntly state that programmes that exclusively encourage abstinence are ineffective for preventing HIV and, by implication, generally ineffective. This conclusion is furthermore corroborated by the friendly editorial of Hawes and colleagues (2) who speak of the studies being “remarkably consistent” in suggesting that abstinence only programmes increased neither primary nor secondary abstinence. The editorialists takes the opportunity to suggest that “In contrast to abstinence only programmes, programmes that promote the use of condoms greatly reduce the risk of acquiring HIV”, citing three papers, two of which are from the late 1990s. The editorial finally argues that money should not be spent on abstinence only programmes but rather on condom promotion programmes. I am not sure under what criteria other studies showing the contrary are being excluded before such statements are made. For example, a trial found an increase in HIV risky behaviours in the intervention group where condom use and supply was promoted (3). And a meta-analysis by Dicenso and colleagues showed programmes, including family planning clinics, were actually not impressively effective improving contraceptive use, delaying sexual debut nor avoiding unwanted pregnancies (4). No one then requested the elimination of funding to family planning clinics. In addition to the summary of problems stated above, the statistical adjustment for possible confounding in these studies is by no means clearly described. The reviewers strongly feel that “Internal and external validity are further restricted by limitations in the primary trials, lack of intention to treat analysis, and incomplete reporting of program implementation”. In the absence of internal validity, extreme caution should be exercised when interpreting any epidemiological results, even if reviewers collect data using: “prereviewed Cochrane protocol”. What is most worrisome, because it is not sufficiently described in the review, is to what extent the attrition rates were differentially distributed between the groups compared and to what extent this hinders any valid interpretation. Furthermore, in the light of: (a) the statistical adjustments likely performed, (b) some of the sample sizes described and (c) the probable scarcity of outcomes in some age groups, either in the intervention or in the control group, non-significant results can be interpreted in different ways. Non significant results can suggest “absence of differences” (which is what reviewers argue), only when the study design and the statistical power of such studies are appropriate. However, non-significant results may also suggest there is no evidence for, or against, an existing difference due to lack of statistical power. Among all comparisons made in the 13 studies reviewed what is remarkable is that most studies find non-significant results. When this happens, we epidemiologists usually have a look on whether non-significant differences between groups favour the control or the intervention group. In the paper of Underhill and colleagues, approximately half of the effect measures they present tend to favour the control groups whereas the other half tend to favour intervention groups. I see no clear connection between the results of the 13 studies with their numerous and severe methodological problems and the reviewers’ clear-cut conclusion that programmes that exclusively encourage abstinence are ineffective. I contend that other interpretations are as plausible. For example, we could also conclude that abstinence only programmes seem to be “at least as good” as their alternatives. One could similarly argue that money could be allocated to any of the alternative programmes tested in the trials, given they presented similar results; or, conversely, that neither abstinence only nor their alternatives (some of which promoted condoms) should receive money at all in the USA. Another plausible conclusion is that the situation could have been worse had neither the abstinence only programmes nor their alternatives been implemented. Finally, it is very misleading and not methodologically sound, to sum up the sample sizes of the trials reviewed and to speak of “more than 15900 participants” included in the studies, as both the reviewers and the editorialists state on several occasions. If the data are not valid for a proper meta-analysis, then no aggregate measure should be used to convey any quantitative information. A smaller well-designed trial can be more informative than an aggregate of studies presenting serious methodological problems even if, overall, they have thousands of participants. In the light of such data it might be safer to say there is no evidence that these 13 particular abstinence only programmes reviewed have done any better than the alternatives evaluated. This does not mean “abstinence promotion does not work”, which is what some are trying to convey to the public. For example, the Spanish paper “El País”, on August 12th, 2007. But, irrespective of whether these programmes actually worked or not, the problem with this controversial issue is that we might not be asking ourselves the right questions, or we might not be looking for the right evidence. Does any body really believe it is possible to change any human behaviour with a dozen sessions in schools, if parents at home, television programmes, movies, youth magazines, health and educational authorities and society at large convey the opposite message? Think of gender violence, sexism, discrimination, academic failure, lack of exercise, unhealthy eating, the problem of drinking and driving, smoking and other drug taking. Would a dozen of classes at school suffice to change these behaviours if everywhere else the message was different? The question for these issues is “how” can we convey the right message and not “whether” we should convey them. If a programme aiming to prevent gender violence does not succeed, it would be a terrible mistake to conclude that: “the education against violence is not effective”. We would rather have to think of a way to do it better given that this particular programme had failed, or we would have to think of how we could help this program to succeed. Let us not forget many anti-smoking programmes have little success and no one doubts we should prevent smoking in youth. Do we really expect that “abstinence promotion” during a few school sessions will work in a society where the media are conveying exactly the opposite message? (5). The question is: do we really believe abstinence is a good choice for our youth and do we really want to promote abstinence? I am not necessarily a defender of “abstinence only” programmes, at least not for older adolescent age groups. I personally believe the whole truth is the best we can give to our youth in order to help them make better and healthier choices. But we should empower youth, to make the best choices and, when behaviours are involved, this includes character education. It is always best to “avoid risks” rather than to “reduce risks” and messages should be tailored to specific target groups. There is sound epidemiological evidence in favour of the ABC strategy of prevention. Abstinence and being mutually faithful are best for avoiding risk whereas condoms reduce risks in people who choose not to avoid risks with “A” nor “B”. The 2004 Lancet consensus (6) emphasised the importance of prioritising messages by calling for a delay of sexual debut in youth or for the return to abstinence in those who are having casual sex. When having sex is chosen, the consensus prioritised the message of mutual monogamy. Those who choose not to accept “A” nor “B”, should be advised they can reduce, albeit never totally eliminate, the risk of infection. The Lancet consensus signers do not believe it is sound public health policy to give the exact same priority to one message (condom use) to teens who have not began to be sexually active and to persons working in commercial sex. All the truth should be conveyed but “abstinence plus” programmes have to be “abstinence centred” and not just programs that add condom information to abstinence promotion at the same level. This is crucial to avoid the slippery slope of risk compensation (7, 8). There is evidence showing such programs are helpful (9). No African country has succeeded in reducing HIV incidence with programmes which relied exclusively on condom promotion whereas the countries which have reduced HIV incidence have integrated “A” and “B” in comprehensive national programmes (10). Our major problem is to decide what we want to convey to our youth. It is unlikely any limited and/or short programme will help change any risky behaviour unless youth are given truthful information, and unless they are empowered with life skills such as character education. This can hardly be achieved, unless society at large and especially educational and health authorities make the right effort to convey consistent messages to specific target groups, thus helping parents do their job at home as well. Are we ready to convey what is best for our children and rely on their capability of making right decisions? Or, should we pessimistically and patronisingly decide for them that they can not achieve risk avoidance and that they have no other choice rather than reducing risks? Jokin de Irala MD
References (1) Underhill K, Montgomery P, Operando D. Sexual abstinence only programmes to prevent HIV infection in high income countries: systematic review. BMJ2007;335:248- (2) Hawes S, Sow PS, Kiviat NB. Is there a role for abstinence only programmes for HIV prevention in high income countries? BMJ 2007;335:217- 218 (3) Kajubi P, Kamya MR, Kamya S, Chen S, McFarland W, Hearst N. Increasing condom use without reducing HIV risk: results of a controlled community trial in Uganda. J Acquir Immune Defic Syndr 2005; 40: 77-82. (4) DiCenso A, Guyatt G, Willan A, GriffithL. Interventions to reduce unintended pregnancies among adolescents: systematic review of randomized controlled trials. BMJ 2002;324:1426-1435 (5) Collins RL, Elliott MN, Berry SH, Kanouse DE, Kunkel D, Hunter SB, Miu A. Watching sex on television predicts adolescent initiation of sexual behavior. Pediatrics 2004;114:280 (6) Haleprin D, Steiner M, Cassel M, Green E, Hearts N, Kirby D, et al. The time has come for common ground on preventing sexual transmission of HIV. Lancet 2004; 364: 1913-1915. (7) De Irala J, Alonso A. Changes in sexual behaviours to prevent HIV. Lancet. 2006;368:1749-50. (8) Cassell MM, Halperin DT, Shelton JD, Stanton D. Risk compensation: the Achilles' heel of innovations in HIV prevention? BMJ 2006; 332: 605-7. (9) Cabezon C, Vigil P, Rojas I, Leiva ME, Riquelme R, Aranda W, Garcia C. Adolescent pregnancy prevention: An abstinence-centered randomized controlled intervention in a Chilean public high school. J Adolesc Health. 2005;36:64-9. (10) Stoneburner RL, Green T, Hearst N, McIlhaney J. Evidence that Demands Action; Comparing Risk Avoidance and Risk Reduction Strategies for HIV Prevention. In: Edited by Patricia Thickstun KH, editor: The Medical Institute, 2004. Competing interests: None declared |
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Trevor Stammers, Lecturer In Healthcare Ethics St Mary's University College, TW1
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Prof. De Irala’s measured and detailed analysis of Underhill’s recent paper which purported to show that “abstinence doesn’t work”, does a very comprehensive job of stating why the paper is not, and should not, be the last word on the issue in the scientific community, even though the media have swallowed wholesale the spin given on it. One further point not raised by Prof. De Irala however is that, of the 13 interventions included, “No trial assessed or reported outcomes by sexual orientation” (1). In the USA and UK, in common with most Western nations, new HIV infections are still disproportionately acquired by men who have sex with men - nearly a third of new cases in 2005 for the UK (2). The proportion of new cases of HIV infection acquired in heterosexuals in the UK as the country of acquisition remains comparatively low at 15% (2). If these patterns are similar to those in the USA, then a statistically significant effect of any sex education programme on HIV infection rates, whether it was abstinence or condom-based, would be much more difficult to demonstrate when outcomes are not reported by sexual orientation. 1) Underhill K, Montgomery P, Operando D. Sexual abstinence only programmes to prevent HIV infection in high income countries: systematic review. BMJ2007;335:248-252 2)http://www.hpa.org.uk/publications/2006/hiv_sti_2006/part2hiv.htm Competing interests: Trevor Stammers is the author of "Saving Sex: Answers to Teenagers' Questions on Relationships and Sex" and is a consultant to www.loveforlife.org.uk |
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Professor pranab Kumar Bhattacharya MD(cal) FIcPath(ind), professor of pathology, Incharge unit, blood bank&Vctc,Malaria clinic, cytogenetics Institute of post graduate medical education & Research 244A AJC Bose Road, KOlkata-20, W.Bindia, Bhattacharya Rupak Bsc(cal) MSc(JU) Purbapalli, Sodepur, Bhattacharya Upasana DPS Kolkata, Chakraborty Srabani MD Asst Prof Patho,BhattacharyaPalash MD(PGT) Patho, Dutta Pradip MD(Medicine) Assoc. Prof. Medicine, Roy Arnab HIV clinic IPGMER KOl-20,W.B Ind
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India is in the midst of an HIV and AIDS crisis with over 3.6 million infected people up to August 2006 and 1,25,021 nos of full blown AIDS cases(Male 82,335 Female 36,786) ,the highest burden in world after south Africa[1]. The prevalence of HIV infection in India is heterogeneous, the epidemic being mostly concentrated in southern states , while most of the states has low rate of infection(<1% sero-prevalence). The states with highest prevalence (>1% women presenting for antenatal check up when found positive for HIV antibody ) are Mumbai, Tamilnadu, Maharastra, Karnataka, West Bengal, Andhrapradesh, Manipur, & Nagaland. The pattern of spread of HIV is also diverse & mostly heterosexual 86% in some areas while IV drug users 2.6% in some others[2]. Heterosexual routes of transmission of HIV is also increasing in rich countries and <10% i.e 1 in 10 people is infected with HIV through this route. The number of people with AIDS in UK also rose 144 in 1999 to 315 in 2003. Total nos of AIDs in England, Wales, & northern Ireland between 1985-2003 is 21115 through heterosexual route[5] So any attempt to reduce the heterosexual transmission of HIV infection are highly one of the affective intervention that should be widely implemented as measure for HIV/AIDs epidemic in a state/ country, be it developed or developing or resource less. But the question remains how? Reducing sexual transmission through change in sexual behavior of population is mere a challenge and dream in modern society. Sexual behavior is influenced by many factors and not always under an individual control and depends on gender ness, social, cultural and economic condition of an individual. Changing or maintaining of behavior results a risk avoidance and risk reduction which must be cover stone of HIV prevention. Abstainism, be faith full, reduce partner, use of condom approach should play role in reducing the prevalence of HIV epidemic. All these elements of the approach are essential to practice for reducing the incidence at least theoretically In the developing world( Indian scenario are different however) HIV rates are higher in younger women then in men of same age and social, cultural and economic factors compare the biological susceptibility to put women of reproductive age group at particular risk. So targeting the young population of abstainism or delay in sexual activity onset will emphasize risk avoidance to prevent HIV & other STI as well as unwanted pregnancy. But what the practical experience tell us? Sex education programme that teach abstainism ,safe sex had a very little impact on adolescence behavior neither in India nor in US. Current UNIAIDS estimation of adult HIV prevalence in India (0.5- 1.5%). Indian National Behavioral surveillances (NBSS) reported extramarital sexual contact raised within the previous years by 8.6% of men & 1.7% of married educated middle aged women[3] Further a randomized community based study of adults in 28 chennai slums found that 2.9% of men and less then 1% of women reported extramarital sexual contact on regular basis with 1% and 0.2% of HIV infected respectively[4] 1% increase in AIDS prevalence in adults results in an additional 5 million people infected with the virus. Abstinence only sex education had been federally funded in the US since 1999 and US congress did approve US $167 million for abstinence only programme promotion for 2005 year. Abstinence education evaluation phase 5 technical report from Texas health dept also tell us that numbers of adolescence who had sexual intercourse for more than once did not change their behavior or numbers increased after they had received abstinence only sex education[5] For the developed countries or rich coutries without an effective vaccine for HIV increasing attention should be paid to development of an effective microbiocide to prevent the spread of HIV. Microbicides are antimicrobials medications formulated for vaginal administration to prevent the transmission of HIV. Ideally they should also protect other sexually transmitted infections of STDS like gonorrhea, Chlamydia, HPV and genetic ulcers Although no microbicide has yet been proven to block the heterosexual transmission of HIV in humans but may be promising candidates to prevent infection in the laboratory set up only and a dozen or so are in advance stages of development. Several Microbiocide are today under development 1) Those inactivate HIV by destabilizing or damaging viral structure like SAVY-C31G -surfactants ,[surfactants ,disintegrates viral lipid envelope] cyclodeytrins[alters envelope structure of virus] Buffer gel and acid form lactobacillus suppositories[ Bacteria secrete bile acid and H2O2] 2) Present HIV form dockers popery with target cells[ These are various classes of lymphocytes that bear on their surface the virus primary receptor CD4 and co-receptor CCR5 or CxCR4. These agents are –carraguard, Pro 2000, Usher cell, anti HIV proteins Cynovirin N, Monoclonal antibodies against component of docking mechanism 3) Anti Retroviral drugs those prevents HIV from replicating inside the target cells like Tenofovir(NRTI); TMC-120, UC-781; MIV-150(N-NRTIS) The protective effectiveness and long term safety of these microbicides like SAVY, Buffered Gel; Carraguard: Usher cell Pro-2000 are now being assessed in large scale clinical trial in communities at high risk Of HIV infection[6] Phase I and Phase II study on safety and acceptability of Vaginal microbicide PRO-2000/5 was done for 14 days twice daily as intra- vaginal microbicide (0.5% PRO2000gel) in HIV infected women in pune, India. 42 eligible sero negative women ( 30 low risk and 12 in High risk) enrolled this study and was given the gel for use. Local safety was assessed via pelvic examination, colposcopy and laboratory monitoring and systemic toxicity was judged based on whole blood count, liver, renal function tests and plasma microbicide level. The Research findings suggest that the gel is safe[7]34 Reference 1) Bhattacharya pranab, Bhattacharya Rupak, Bhattacharya Ritwik, Bhattacharya Palash &Roy Arnab “HIV epidemic, &nature in West Bengal State; India,: Role of male Circumcision Possible amongst Hindus as additional preventive measure? Will state government start thinking of It?” Rapid Responses published in BMJ for news byPeter Moszynski Experts recommend circumcision to combat male HIV infections in Africa BMJ 2007; 334: 712-b-713-b (10 April 2007) 2)http://www.nacoonline.org/facts htm 3) National AIDS control organization, Government of India, National baseline general population behavioral surveillances survey 2001 htpp:// www naco online. Org/ publication htm 4) Srikrisnan AK, Sivram .S et al " The HIV epidemic in chennai 9 southern India remains concentrated in high risk groups. Xv International AIDS conference, Bangkok, Thailand, july11-16, 2004 MopeC3469 5) Hopkins. J BMJ.com news round up BMJ 330;12th feb 326;2005 6) Alan Stone, ShiboJiang “ Microbicides : Stopping HIv at the Gate- The Lancet 368;August 5;431-33;2006 7) Annual Report of Indian Council Medical Research, New Delhi 2004-05 Edited by Sudha Chauhan DDG(SG) ICMR ; in Communicable disease HIV?AIDS Page 75;2006 Authors-:1) Professor Pranab Kr Bhattacharya MD(Path) Cal, FIC path (Ind.), Professor, Dept. of pathology, In charge of Histopathology Unit, in charge of Cytogenetics, Ex-In charge of 24 hours Ronald Ross Malaria clinic, Technical Supervisor In charge of Blood Bank, Institute of Post Graduate Medical Education& Research (IPGMER) 244A AJC Bose Road, K0lkata-700020, West Bengal , India Email= profpkb@yahoo.co.in phone no- 91- 9231510435 2) Mr. Rupak Bhattacharya BSc(cal), MSc(JU) 7/51 Purbapalli Po= Sodepur ,Dist.- 24 parganas(North),West Bengal ,Pin 700110, India Email= profpkb@yahoo.co.in pranab@unipathos.com 3)Miss Upasana Bhattacharya Delhi Public School, Rubipark, Kolkata Email= profpkb@yahoo.co.in pranab@unipathos.com 4) Dr. Srabani Chakraborty MD(cal) Path, Assistant Professor, Pathology, Institute of Post Graduate Medical Education &Research, 244A AJC Bose Road, kOlkata-700020, India Email= banerjee.srabani@rediffmail Telphone= 254111111 5)Dr. Palash Bhattacharya MBBS(Cal), MD(PGT) Pathology Dept. Of Pathology Institute of Post Graduate Medical Education& Research (IPGMER) 244A AJC Bose Road, K0lkata-700020, West Bengal , India Email= Phone no=91-3212243308 6) Dr. Pradip Dutta MD(cal) Medicine Associate Professor, Dept of Medicine Institute of Post Graduate Medical Education& Research (IPGMER) 244A AJC Bose Road, K0lkata-700020, West Bengal , India 7) Dr. Arnab Roy MBBS(cal) Medical officer, HIV Clinic, Dept of Medicine Institute of Post Graduate Medical Education& Research (IPGMER) 244A AJC Bose Road, K0lkata-700020, West Bengal , India Email- arnray@yahoo.com Telephone=9433133621 Competing interests: None declared |
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