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Gender, age, and ethnicity in HIV vaccine-related research and clinical trials. Report from a WHO-UNAIDS consultation, 26-28 August 2004. Lausanne, Switzerland.
AIDS. 2005 Nov 18; 19(17):w7-w28.This report summarizes the presentations and recommendations from a consultation held in Lausanne, Switzerland (26–28 August 2004) organized by the joint World Health Organization (WHO) – United Nations Programme on HIV/AIDS (UNAIDS) HIV Vaccine Initiative. The consultation discussed issues related to gender, ethnicity, and age in HIV vaccine research and clinical trial recruitment. A special focus of the meeting was the participation of women and adolescents in clinical trials. Also discussed were the experiences and lessons from various research programs, trials, and studies in different countries. Implementing the recommendations from this meeting will require prioritization and active participation from the research community, funders of research, local and national governments, non-governmental organizations, and industry, as well as the individuals and communities participating in clinical trials. This report contains the collective views of an international group of experts, and does not necessarily represent the decisions or the stated policy of the WHO. The contribution of the co-chairs (R. Macklin and F. Mhalu) and the rapporteurs (H. Lasher, M. Klein, M. Ackers, N. Barsdorf, A. Smith Rogers, E. Levendal, T. Villafana and M. Warren) during the consultation and in the preparation of this report is much appreciated. S. Labelle and J. Otani are also acknowledged and thanked for their efficient assistance in the preparation of the consultation and the report. (author's)
CLINICAL REPRODUCTION AND FERTILITY. 1986 Dec; 4(6):393-4.Comments on the topic of selection of subjects for clinical trials of contraceptives, in response to a review on design of clinical trials, point out the inadvisability of restricting the study population to women of known high fertility. First, limiting the study group may make recruitment difficult. More important, however, most contraceptive trials look at other end point besides pregnancy: data are collected on use effectiveness, patient satisfaction and continuation rates. This information is best obtained from women representative of the whole community, such as those close to 45 years old. If a study group representative of the total population is used, results can be applied to field conditions with confidence.
OUTLOOK. 1990 Jun; 8(2):7-9.This article summarizes the most recent data on WHO's multicenter clinical trial test of the low dose progestin-releasing vaginal ring as an effective contraceptive for women. The study involved 1005 women aged 19-34 and was carried out from 1980-86 at 19 centers in 13 countries, including 9 developing countries. The overall findings on vaginal ring use included: the ring's effectiveness was comparable to oral contraceptive (OC) effectiveness, pregnancy rates increased with increasing body weight, about 1/2 of the users had discontinued the ring by 1 year, the ring disrupted menstrual bleeding patterns in about 1/2 of all users, and about 1/4 of all users expelled the ring at least once but most continued to use it. The irregular bleeding pattern was the main reason for discontinuation. Part of the reason for having different ring contraceptive effectiveness in different countries could be due to differing average weights of the women. Increasing risk of expulsion was directly related to increasing age by approximately 3% with each year of age. For effective use of 90-day low-dose levonorgestrel-releasing vaginal ring, appropriate clients should have the following: a dislike for inserting and removing vaginal devices, low weight, counselling on potentially irregular bleeding, and counseling on how to deal with an expulsion. (author's modified)