Cervical cancer kills over a quarter of a million women worldwide on an annual basis, with 80% of these deaths occurring in developing countries. Cytology-based screening programs, widely used in industrialized countries, are difficult to implement in low-resource settings. Non-cytological methods for screening and treatment have been developed and studied over the last decade. Given the barriers to widespread, good quality screening and early treatment, the most promising new prevention strategy will be the introduction of a vaccine to prevent human papillomavirus infection, the cause of cervical cancer. Understanding women's health-seeking behaviors is critical to successful dissemination and uptake of both screening and vaccine prevention strategies.

Historical progress in the reduction of morbidity and mortality from cervical cancer has been attributed to systematic screening programs in wealthy countries—an option that has long seemed out of reach for poorer countries. Recent developments suggest, however, that there is new hope for bringing cervical cancer under control, even in countries with limited financial and infrastructural resources. References to cervical cancer appear as early as the fifth century BC, in Greek and Hindu texts, but more complete descriptions of the disease and its treatment first appear in various medical texts in the 19th century [1]. In 1900, Cullen introduced the concept that precursor lesions were harbingers of cancer of the cervix [2]. Over the course of the next 60 years, further investigation led to a description of the natural history of the disease and to our current understanding of its infectious nature and its slow growth, both of which supported the evolution of prevention strategies. Cytologic methods of screening for cervical cancer and its precursors have become the mainstay of population-based prevention programs, resulting in substantial reduction of disease in countries such as Canada and Finland, where mass screening is systematic, rather than opportunistic [3], [4]. In today's world, cervical cancer is primarily a disease found in low-income countries. Of the nearly 500,000 new cases that occur annually, 83% are in the developing world, as are 85% of the 274,000 deaths associated with cervical cancer [5]. This disease burden is primarily the result of weak national health care infrastructures that cannot establish or sustain well-organized screening programs using the comprehensive, multi-visit, regularly repeated, cytology-based protocol used successfully by many well-resourced countries. Key program factors needed for a population-based decrease in disease, including maximization of program coverage and targeted screening for appropriate at-risk age groups, add to the difficulty of implementing effective screening and treatment programs in environments where populations and economies are unstable and diverse. There is, in fact, scant evidence that a cytology-based screening program in a low-resource country has successfully reduced cervical cancer mortality. Because of the technical and programmatic challenges inherent in instituting a standard cytology-based screening program, national and international efforts to identify cost-effective alternatives have been ongoing for more than 15 years. However, conclusions from various small studies or pilot projects have, until recently, been difficult to consolidate into an evidence base that supports conclusions with adequate strength to influence policy and practice on a national scale. Clearly, secondary prevention of cervical cancer should be complemented by a longer-term strategy to develop and implement primary prevention through use of an HPV vaccine. Even with a vaccine on the 5-year horizon, modeling shows that both primary and secondary prevention will be necessary indefinitely in order to make a significant impact on disease burden globally [6]-[8]. In 1999, generous 5-year funding from the Bill and Melinda Gates Foundation supported the combination of the experience and capabilities of five international agencies—EngenderHealth, the International Agency for Research on Cancer (IARC), JHPIEGO, the Pan American Health Organization (PAHO), and Program for Appropriate Technology in Health (PATH)—in the coordinated effort of the Alliance for Cervical Cancer Prevention (ACCP). First and foremost, members of the ACCP recognized that noncytologic methods of screening for cervical cancer and its precursor lesions were the most likely large-scale solution to the problem of high cervical cancer mortality rates in low-resource settings. They were charged by the Gates Foundation to answer important questions about screening and treatment approaches, the related service-delivery needs of low-resource settings, and ways to involve women and their communities in the design and implementation of acceptable, high-quality cervical cancer prevention programs. The ACCP partners believed that targeting as-yet-unanswered questions about the performance, safety, and effectiveness of promising screening and treatment technologies, ways to enhance service-delivery efficiency and effectiveness, and strategies for community outreach and adding their findings to existing and evolving experience and data would bring solutions into clearer focus. At the same time, communicating what was already known in understandable and persuasive terms would heighten awareness of the pressing problem of cervical cancer and of the feasibility of control. Ultimately, the ACCP planned to combine an adequate evidence base with heightened awareness and commitment among communities and policymakers to bring about a paradigm shift in global thinking—to move from the previously accepted wisdom that cervical cancer was not a high priority and that no feasible solutions were available to poor countries to a new understanding that prevention was not only possible but imperative. The overriding goal of the ACCP over the past 5 years has been to improve women's health and save women's lives through cervical cancer prevention programs in developing countries. The four main objectives of the ACCP have been to: Assess (qualitatively and quantitatively) the safety and effectiveness of selected screening and treatment technologies and protocols in low-resource settings. Develop appropriate service-delivery algorithms and guidelines for using these technologies and protocols in various settings, ensuring consideration of training needs, follow-up systems, quality of services, and the needs of women with invasive cancer. Ensure that client/provider perspectives and needs are incorporated into the design and evaluation of program strategies—in particular, development of information, education, and communication approaches within and outside the clinical context. Heighten the awareness of cervical cancer and rational prevention strategies among policymakers, providers, and communities to ensure adequate funding for, support of, and use of newly available services. The ACCP members have summarized their experiences in pursuing the above objectives in seven articles presented in this special supplement of International Journal of Gynecology and Obstetrics. The first two articles present the results of ACCP research on innovative approaches to screening and treatment in the developing world. The next three articles highlight ACCP experiences with and perspectives on broader programmatic issues related to organization of service delivery, clinical training, and community involvement. The sixth article emphasizes the critical role of broad-based advocacy efforts at the international, regional, national, and local levels for gaining prevention program policy support. The final paper considers the implications of ACCP work for future policy and program development. These articles cannot fully reflect the comprehensive body of work accomplished by the ACCP. More than 50 publications have been produced elsewhere that assess cervical cancer needs, programs, and efforts in developing countries, such as underserved populations in Ghana, South Africa, and Peru; the safety and acceptability of low-cost treatment with cryotherapy in Thailand; strategies for cervical cancer prevention in Bolivia and Kenya; and large-scale comparative trials in India. Some of the articles have investigated decision-modeling constructs for cervical cancer detection and prevention, analyzed the cost-effectiveness of visual and human papillomavirus (HPV) screening and an HPV vaccine, and reviewed the broader public health impact of cervical cancer in the developing world. All of these articles are listed, and some are available for download, at our website (www.alliance-cxca.org). The ACCP has developed numerous education and training tools, which can also be found on our website. These include fact sheets in English, French, and Spanish on topics ranging from the natural history of cervical cancer to HPV testing, visual screening methods, and meeting women's needs. Additionally, numerous presentations, planning guides, training materials, and technical reports have been prepared to assist in training providers, educating clients, and developing screening programs. The ACCP has also provided funding for 42 projects in 31 countries through its Small Grants Program. Projects have included: Extending coverage of cervical screening among rural women of Albania. Analyzing current practices of health professionals and beliefs of the public concerning cervical cancer prevention in Argentina. Conducting a needs assessment of cervical cancer prevention in Kazakhstan. Launching a pilot project that initiated a cervical cancer screening program using visual inspection with acetic acid for screening and cryotherapy for precancerous lesions in Sudan. Studying the incidence of invasive cervical cancer among women in El Salvador. Establishing a cervical cancer prevention and control unit in Nicaragua in which health promoters made house visits and distributed brochures. The ACCP has attempted to address a broad array of issues specific to the needs and challenges of low-resource countries. Although significant advances have been made and recognized over the course of the last 5 years, unanswered questions remain. We recognize that the topic is broad and spans public health, as well as social, cultural, economic, and political issues. The articles in this supplement cannot cover all of these aspects, but the ACCP work presented here, in conjunction with the work of others in the field, strengthens the body of evidence that will enable low-resource countries to develop effective and efficient cervical cancer prevention efforts and make the possible a reality.

The Alliance for Cervical Cancer Prevention (ACCP) came together in 1999 to answer key research questions and to advocate for greater global and national interest in reducing the heavy burden of morbidity and mortality caused by this preventable disease. Visual inspection with acetic acid (VIA), visual inspection with Lugol's iodine (VILI), and human papillomavirus (HPV) tests have been shown to be viable alternatives to traditional cytology. ACCP experience confirmed that cryotherapy is a safe and effective method that is acceptable to women and can be delivered by a range of health providers, including nonphysicians. Programs can maximize coverage by accommodating local needs and involving community leaders and women in planning and implementation. Advocacy efforts have led to significant policy changes and galvanized support for cervical cancer prevention. Despite the prospect of new HPV vaccines, screening wilt be needed for at least the next 30-40 years. Our experience has shown that with creativity, flexibility, and well-focused use of resources, the inequitable burden of cervical cancer borne by women in poor countries can be sharply reduced. (c) 2005 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

CONTEXT Non-cytology-based screen-and-treat approaches for cervical cancer prevention have been developed for low-resource settings, but few have directly addressed efficacy. OBJECTIVE To determine the safety and efficacy of 2 screen-and-treat approaches for cervical cancer prevention that were designed to be more resource-appropriate than conventional cytology-based screening programs. DESIGN, SETTING, AND PATIENTS Randomized clinical trial of 6555 nonpregnant women, aged 35 to 65 years, recruited through community outreach and conducted between June 2000 and December 2002 at ambulatory women's health clinics in Khayelitsha, South Africa. INTERVENTIONS All patients were screened using human papillomavirus (HPV) DNA testing and visual inspection with acetic acid (VIA). Women were subsequently randomized to 1 of 3 groups: cryotherapy if she had a positive HPV DNA test result; cryotherapy if she had a positive VIA test result; or to delayed evaluation. MAIN OUTCOME MEASURES Biopsy-confirmed high-grade cervical cancer precursor lesions and cancer at 6 and 12 months in the HPV DNA and VIA groups compared with the delayed evaluation (control) group; complications after cryotherapy. RESULTS The prevalence of high-grade cervical intraepithelial neoplasia and cancer (CIN 2+) was significantly lower in the 2 screen-and-treat groups at 6 months after randomization than in the delayed evaluation group. At 6 months, CIN 2+ was diagnosed in 0.80% (95% confidence interval [CI], 0.40%-1.20%) of the women in the HPV DNA group and 2.23% (95% CI, 1.57%-2.89%) in the VIA group compared with 3.55% (95% CI, 2.71%-4.39%) in the delayed evaluation group (P<.001 and P = .02 for the HPV DNA and VIA groups, respectively). A subset of women underwent a second colposcopy 12 months after enrollment. At 12 months the cumulative detection of CIN 2+ among women in the HPV DNA group was 1.42% (95% CI, 0.88%-1.97%), 2.91% (95% CI, 2.12%-3.69%) in the VIA group, and 5.41% (95% CI, 4.32%-6.50%) in the delayed evaluation group. Although minor complaints, such as discharge and bleeding, were common after cryotherapy, major complications were rare. CONCLUSION Both screen-and-treat approaches are safe and result in a lower prevalence of high-grade cervical cancer precursor lesions compared with delayed evaluation at both 6 and 12 months. Trial Registration http://clinicaltrials.gov Identifier: NCT00233727.

In your Nov 8 Editorial addressing the US abortion divide you call on US policymakers to stop waging “war over abortion” and instead “provide comprehensive contraceptive services to the poor” asserting that “it would do more to reduce abortion than passing bans”. The same suggestion holds for the White House itself which 3 years ago reimposed the “global gag rule” banning abortion counselling and referral in US-subsidised nongovernmental family planning clinics around the world. But in the developing world unlike in the USA such bans do more than restrict access to abortion services. Indeed a new report Access Denied: U.S. Restrictions on International Family Planning shows that the global gag rule jeopardises the health of women and their families by impeding access to a wide array of life-affecting reproductive health services. Aimed at abortion the gag rule eliminates access to family planning AIDS-related services and maternal care. (excerpt)

PURPOSEWe obtained detailed information on the time and number of ejaculations to azoospermia after vasectomy by ligation and excision.MATERIALS AND METHODSMen seeking vasectomy at 3 public clinics in Mexico City were invited to participate in this prospective noncomparative study. Vasectomy was performed using the no-scalpel technique. The vas was occluded using 2 silk sutures and the segment of vas between the ligatures was excised. Men were followed biweekly up to 24 weeks after vasectomy or until azoospermia was confirmed. Semen was examined at each visit for sperm concentration and motility. The main outcome measure was azoospermia in uncentrifuged semen samples.RESULTSThe life table rate for time to azoospermia was 81.5/100 men (95% CI 76.2 to 86.9) by the end of the study. Cumulative Kaplan-Meier event probability attained a maximum of 79.5/100 men (95% CI 73.7 to 85.2) at 70 ejaculations. Only 60/100 and 27.9/100 men were azoospermic by 12 weeks and 20 ejaculations, respectively. These end points are the commonly recommended waiting periods when semen analysis is unavailable. Of the 217 men 36 (16.6%) did not achieve azoospermia by 24 weeks, of whom 25 (11.5% of all participants) were considered to have vasectomy failure.CONCLUSIONSOur results suggest that it is not possible to develop guidelines for clearance based only on the time or number of ejaculations when ligation and excision are performed. In addition, of the methods for vas occlusion during vasectomy ligation and excision may not provide the best success rates.

International experience compels us to revisit how we define and assess the safety and efficacy of medical abortifacients such as misoprostol. In some countries where safe abortion is neither accessible nor legal, even unsupervised, off-protocol use of misoprostol can provide women with a means to safely terminate pregnancy. This is due primarily to misoprostol-induced uterine contractions that cause bleeding, which in turn provides access to existing reasonable quality health services that would otherwise be unavailable. Several studies have suggested that an increase in the underground use of misoprostol in Brazil has already reduced serious complications from unsafe abortion. Thus, the availability of medical abortifacients combined with strengthened postabortion care services can legitimately be considered a public health success in countries in which safe abortion services do not exist and law reform is unlikely.

Quinacrine has been one focus of the search for a safe and effective method of nonsurgical female sterilization. Questions about its safety and efficacy as well as about ethics, policy, rights, and the prioritization of resources have been raised by women's health advocates and agencies concerned with public health. Nevertheless, interest in the method by researchers and donors has continued. Yet, global experience shows that the users of contraceptive technologies possess perspectives necessary to successful and ethical research and introduction of any new method into general service. Without an inclusive process for discussing and resolving the many questions that continue to surround Quinacrine, the method is likely to face an embattled future and its pursuit may jeopardize other important efforts to make quality family planning and sterilization services available. (C) 2000 International Federation of Gynecology and Obstetrics.

Ethical guidelines require that study participants be informed of alternative procedures or treatment that might be as advantageous as the one being tested. In the case of microbicide testing Dr. Potts challenges the agreed-on principle that condom counseling must be offered to participants in microbicide research. He suggests dispensing with beneficence to the study participants in order to hasten delivery of a long-term beneficence in the form of a safe and effective microbicide to the general population. In doing so he presupposes that the individual autonomy of study participants could be preserved in such a trial an assertion with which the authors of this letter do not agree. The authors argue that condom counseling is not simply a beneficent offer of an otherwise discretionary good to microbicide-testing participants. Counseling on condom use is an ethical imperative under the obligation to preserve individual autonomy through informed consent. Condoms are an alternative to microbicide use that any primary care physician should discuss with a client. In choosing to rely on a microbicide alone an individual should be made aware of the protective attributes of condoms in order to make an informed choice. In addition unlike beneficence autonomy can be considered a human right under treaties that recognize rights to consent to experimentation and to security of the person in the health care context.

Objectives To determine the efficacy, evaluate the safety and assess side-effects (swelling, haematoma and pain) of percutaneous vas occlusion compared with vasectomy in Dutch men.Patients and methods Vas occlusion and vasectomy procedures (attempted in 58 and 50 men, respectively) were conducted at the University Hospital Maastricht. The men returned 1 week after the procedure, underwent a clinical examination and completed a questionnaire assessing subjectively any pain, swelling and haematoma. The men were asked to return for semen analysis at 6 and 12 weeks and, if necessary, for additional analyses until they were azoospermic.Results The vas occlusion procedure was completed on both vasa in 49 of the 58 men (84%) in whom it was attempted. Significantly more (P < 0.001) men were azoospermic after vasectomy (48 of 50) than after vas occlusion (only four). Men undergoing vas occlusion reported significantly less pain (P = 0.02), swelling (P = 0.01) and haematoma (P = 0.04) after the procedure than did men undergoing vasectomy.Conclusion Men undergoing vas occlusion would not have been able to rely on the method for contraception. From this study, vas occlusion, at least in its current form, is an unsuitable method of male contraception. Not only was the efficacy poor, but constraints in delivering the method in its current state would probably limit its utility, especially in situations where resources are limited.

OBJECTIVES:This study sought to assess whether the controversy surrounding publications linking vasectomy and prostate cancer has had an effect on vasectomy acceptance and practice in the United States.METHODS:National probability surveys of urology, general surgery, and family practices were undertaken in 1992 and 1996.RESULTS:Estimates of the total number of vasectomies performed, population rate, and proportion of practices performing vasectomy were not significantly different in 1991 and 1995.CONCLUSIONS:This study provides no solid evidence that the recent controversy over prostate cancer has influenced vasectomy acceptance or practice in the United States. However, the use of vasectomy appears to have leveled off in the 1990s.

Associations between Depo-Provera® (injectable, progesterone-only contraceptive) use and visible disruption of cervical epithelium and cervical ectopy were investigated using data collected as part of a cervical cancer screening study in periurban Cape Town, South Africa. Women were interviewed about their contraceptive use, and underwent a gynecologic examination that included two 35-mm photographs of the cervix after application of 5% acetic acid. Photographs of 723 subjects were reviewed (blind to clinical information and using systematic criteria developed before review) for evidence of atrophy and epithelial disruption, including inflammation and ulceration. The percentage of the cervix covered with columnar epithelium (ectopy) was also estimated from the photographs. A random sample of 85 photographs was reviewed again for reliability. A total of 121 current users of Depo-Provera were no more likely to have evidence of epithelial disruption (38%) than 574 nonusers (39%), odds ratio (OR) = 1.37, 95% CI: 0.89–2.11 adjusting for age and parity. The prevalence of significant ectopy (columnar epithelium covering >10% of the cervix) was also no different among current Depo-Provera users (OR = 1.22, 95% CI: 0.80–1.86 adjusting for age and parity). Reliability of visual scoring of epithelial disruption and ectopy was excellent (κ = 0.8). Although the underlying prevalence of visible disruption of cervical epithelium was very high, current use of Depo-Provera was not associated with increased prevalence of visible disruption of the cervical epithelium or with ectopy in this sample of African women.

OBJECTIVES:Currently, no surveillance system collects data on the numbers and characteristics of vasectomies performed annually in the United States. This study provides nationwide data on the numbers of vasectomies and the use of no-scalpel vasectomy, various occlusion methods, fascial interposition, and protocols for analyzing semen after vasectomy.METHODS:A retrospective mail survey (with telephone follow-up) was conducted of 1800 urology, family practice, and general surgery practices drawn from the American Medical Association's Physician Master File and stratified by specialty and census region. Mail survey and telephone follow-up yielded an 88% response rate.RESULTS:In 1995, approximately 494,000 vasectomies are estimated to have been performed by 15,800 physicians in the United States. Urologists performed 76% of all vasectomies, and nearly all (93%) urology practices performed vasectomies in 1995. Nearly one third (29%) of vasectomies in 1995 were no-scalpel vasectomies, and 37% of physicians performing no-scalpel vasectomies taught themselves the procedure. The most common occlusion method in 1995 (used for 38% of all vasectomies) was concurrent use of ligation and cautery. In 1995, slightly less than half (48%) of all physicians surveyed interposed the fascial sheath over one end of the vas when performing a vasectomy. Protocols for ensuring azoospermia varied: 56% of physicians required one postvasectomy semen specimen; 39% required two, and 5%, three or more.CONCLUSIONS:No-scalpel vasectomy, used by nearly one third of U.S. physicians, has become an accepted part of urologic care. Physicians' variations in occlusion methods, use of fascial interposition, and postvasectomy protocols underscore the need for large scale, controlled, and statistically valid studies to determine the efficacy of occlusion methods and fascial interposition, as well as whether azoospermia is the only determination of a successful vasectomy.

A program designed to improve the availability of vasectomy in public-sector clinics trained physicians at 43 facilities in no-scalpel vasectomy between 1993 and 1995. Among the 38 clinics that responded to a follow-up survey in 1996, the number of clinics providing vasectomies rose from 23 to 32, an increase of almost 40%, while the number of vasectomies performed rose by 18%. Seventeen of the 32 clinics performed more vasectomies after the training; 10 of the 17 had not previously provided the procedure. In-depth interviews with staff from seven sites that experienced large caseload increases and from seven that experienced decreases identified three elements for the successful establishment or expansion of vasectomy services-sufficient numbers of trained providers, funds to subsidize vasectomies for men who cannot afford them and activities to raise awareness about the availability of low-cost or free vasectomy.

In a joint pilot study by Family Health International (FHI), AVSC International, and the Institute Mexicano del Seguro Social (IMSS), information was gathered on the determinants of azoospermia following vasectomy on 38 healthy men who chose vasectomy for contraception. The time and number of ejaculations associated with loss of sperm motility and loss of sperm eosin vital staining were also evaluated.''Azoospermia'' was defined on the basis of two consecutive azoospermic semen samples collected at least 3 days apart. The single decrement life table method was used to calculate weekly gross cumulative life table rates for the time to azoospermia, zero motility, and zero viability. The Kaplan-Meier method was used to calculate the product-limit estimates of the cumulative rates for the total number of ejaculations to azoospermia, 0% motility and 0% viability. The median time to azoospermia was 10 weeks and at the end of week 20, the life table rate (+/- standard error) was 93.0 (+/- 6.30) weeks/100 men. The median number of ejaculations to azoospermia was between 25 and 30, and the cumulative rate (+/- standard error) at 60 ejaculations reached 94.5 (+/- 5.16)/100 men. (C) 1997 Elsevier Science Inc. All rights reserved.

Objective: To evaluate the ''U'' technique versus the manufacturer-recommended technique for Norplant removal. Methods: We conducted a randomized comparison of the manufacturer-recommended method of removal and the ''U'' technique. The latter involves an incision between and parallel to the third and fourth implants and uses a modified vasectomy clamp to remove the implants by pulling perpendicular to the implant's axis.Results: Twenty-one physicians (three experienced, 18 inexperienced) performed 200 Norplant removals. Inexperienced physicians took significantly less time for removal using the ''U'' technique than the standard technique (7.9 versus 10.5 minutes), even after controlling for other factors. Experienced physicians also required less time for removal using the ''U'' technique (3.1 versus 3.7 minutes), but the difference was not statistically significant after controlling for other factors. Both experienced and inexperienced physicians broke implants more frequently using the standard technique, although the difference was significant only for experienced physicians (relative risk 3.6, 95% confidence interval 1.2, 10.8). No differences were noted between the techniques with respect to tissue damage or patient reports of pain during or after removal.Conclusions: These results suggest that the ''U'' technique is an improvement over the standard technique, particularly for personnel who are not highly experienced in Norplant removal. (C) 1997 by The American College of Obstetrican and Gynecologists.

For many years, researchers have been seeking nonsurgical methods for female sterilization because these methods may be safer, simpler, cheaper, and quicker than conventional techniques, and may require a lower level of skill to deliver. Various investigators have explored using intrauterine instillation of quinacrine for tubal occlusion. Until recently, reports of quinacrine use for nonsurgical sterilization have been scarce and limited to data sets involving small numbers with very short-term follow-up. The July 24, 1993 issue of the Lancet reports on 31,781 cases of nonsurgical sterilization with quinacrine in a field trial from Vietnam. The present paper is written as a background review to assist family planning providers in the dialogue regarding the introduction and use of quinacrine. It attempts to answer questions regarding what is currently known about the safety and efficacy of quinacrine, and what the recent article published in the Lancet adds to our knowledge. It also raises the question of how quinacrine sterilization affects free and informed choice and the other interests of family planning clients.