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Research

Research Involving FHI Collaboration Produces Change

Network: Vol. 23, No. 1

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FHI has recently participated in three research projects that are changing contraceptive service provision and recommendations.

  • Vasectomy: Interim results from a seven-country vasectomy study by FHI and New York-based EngenderHealth have shown that ligation and excision vasectomy is more effective when it includes fascial interposition (a technique in which the fascial sheath covering the vas is pulled over one of the cut ends and the end is sewn shut).1Analysis of data from some 800 men in the study is nearly complete, and final results are expected by the end of 2003.

    In the meantime, EngenderHealth is integrating fascial interposition into its training materials. The third edition of its training resource No-Scalpel Vasectomy: An Illustrated Guide for Surgeons, published in March 2003, contains an expanded description of the steps for performing ligation and excision plus fascial interposition.2 Also in March 2003, the organization held a training exercise in New Delhi, India, during which 10 key trainers from India, Nepal, Bangladesh, Cambodia, the Philippines, and Kenya standardized their fascial interposition techniques and were oriented to EngenderHealth's revised vasectomy-training curriculum. "Fascial interposition is no longer an option for our trainers," says John Pile, senior manager of family planning services at EngenderHealth. "It is a necessity."

    Based on a recent study of the time and number of ejaculations before reaching azoospermia (the absence of sperm in the ejaculate) after ligation and excision vasectomy,3 the illustrated guide and new curriculum also recommend a follow-up visit 12 weeks (three months) after vasectomy. This is considered a more reliable way to confirm success than giving clients the option of returning after 20 ejaculations. The guide and curriculum also highlight the importance of providers counseling their clients about the small possibility of vasectomy failure.

  • Pregnancy Checklist: Using guidelines prepared by the U.S. Agency for International Development (USAID), FHI has developed a six-question checklist that health care providers can use to help rule out pregnancy in nonmenstruating clients who request contraceptives. This simple and low-cost job aid, which is available in English, French, and Spanish, has been shown in a Kenyan study to be more than 99 percent effective at identifying nonpregnant women.4 The checklist has also been translated into Creole, Hindi, Khmer, Kiswahili, and Nepali. An extensive dissemination campaign has targeted USAID missions and cooperating agencies, and the checklist is being disseminated nationally in Kenya, Mali, and Nepal and in selected settings in Cambodia, Guatemala, India, Jordan, Senegal, and Zimbabwe.

  • Nonoxynol-9: After studies by FHI, the Joint United Nations Programme on HIV/AIDS (UNAIDS), and others revealed that the spermicide nonoxynol-9 (N-9) does not protect against HIV, gonorrhea, and chlamydial infection,5 international organizations moved quickly to begin putting these findings into practice. In October 2001, experts convened by the World Health Organization (WHO) and the U.S.-based CONRAD Program concluded that while N-9 remains a contraceptive option for women at low risk of HIV infection, it may increase the risk of HIV infection among women already at high risk for HIV.6 A note advising such women to avoid using N-9 alone or products containing N-9 was added to WHO's Selected Practice Recommendations for Contraceptive Use.7 In March 2003, WHO also published interim recommendations on the use of N-9 spermicides in an on-line update to its medical eligibility criteria for contraceptive use.

In January 2003, the U.S. Food and Drug Administration proposed new warnings for the labels of over-the-counter vaginal contraceptives containing N-9, stating that their use does not protect against infection with HIV or other sexually transmitted pathogens. The label would also advise consumers that using such contraceptives can increase vaginal irritation, which is thought to be the reason why N-9 may actually increase the possibility of acquiring HIV.8

— Kerry L. Wright and Kathleen Henry Shears

References

  1. Chen-Mok M, Bangdiwala SI, Dominik R, et al. Termination of a randomized controlled trial of two vasectomy techniques. Control Clin Trials 2003;24(1):78-84.
  2. EngenderHealth. No-Scalpel Vasectomy: An Illustrated Guide for Surgeons. Third Edition. New York, NY: EngenderHealth, 2003.
  3. Barone MA, Nazerali H, Cortes M, et al. A prospective study of time and number of ejaculations to azoospermia after vasectomy by ligation and excision. J Urol 2003;170(3):892-96.
  4. Stanback J, Qureshi Z, Sekadde-Kigondu C, et al. Checklist for ruling out pregnancy among family-planning clients in primary care [letter]. Lancet 1999;354(9178):566-67.
  5. Van Damme L, Ramjee G, Alary M, et al. Effectiveness of COL-1492, a nonoyxnol-9 vaginal gel, on HIV-1 transmission in female sex workers: a randomized controlled trial. Lancet 2002;360(9338):971-77; Roddy RE, Zekeng L, Ryan KA, et al. Effect of nonoxynol-9 gel on urogenital gonorrhea and chlamydia infection: a randomized controlled trial. JAMA 2002;287(9):1117-22; Roddy RE, Zekeng L, Ryan KA, et al. A controlled trial of nonoxynol 9 film to reduce male-to-female transmission of sexually transmitted diseases. N Engl J Med 1998;339(8):504-10.
  6. World Health Organization, CONRAD Program. Safety of Nonoxynol-9 When Used for Contraception: Report from WHO/CONRAD Technical Consultation, October 2001. Geneva, Switzerland: World Health Organization and CONRAD Program, 2002. Available online.
  7. World Health Organization. Selected Practice Recommendations for Contraceptive Use, Question 20. Geneva, Switzerland: World Health Organization, 2002: Available online.
  8. Over-the-counter vaginal contraceptive drug products containing nonoxynol 9: required labeling (proposed rule). Federal Regist 2003;68(11):2254-62. Available online.