The Syndromic Management of Vaginal Discharge Using Single-Dose Treatments: A Randomized Controlled Trial in West Africa/Prise En Charge Syndromique De la Leucorrhee Par Des Traitements Sous Forme De Dose Unique: Essai Controle Randomise En Afrique De l'Ouest/Manejo Sindromico del Flujo Vaginal Mediante Tratamientos De Dosis Unica: Ensayo Controlado Aleatorizado En Africa Occidental

Introduction Despite the contradictory results of large trials in East Africa, the syndromic management of sexually transmitted infections (STI) remains a public health priority: whether or not it reduces transmission of human immunodeficiency virus (HIV), this intervention relieves patients' symptoms, lowers the risk of complications and reduces transmission of etiological agents. (1-5) Within core groups such as sex workers (SW) and their clients, STI could be important cofactors of HIV transmission even if this is less marked in the general adult population. (6) Furthermore, effective management of STI among SW can enhance the credibility and acceptability of interventions aimed primarily at increasing the use of condoms. Syndromic management implies the simultaneous treatment of two or more infections: the higher cost of drugs is more than compensated by savings on diagnostic assays, but adverse effects are more frequent and adherence to multiple-dose regimens can be suboptimal. (1,2) Whereas strategies for the syndromic management of STI in men are standardized and very effective, this is not yet the case for vaginal discharge, which is by far the most common STI syndrome among women. (1,2) In the majority of cases, this syndrome is caused by either bacterial vaginosis (BV), Trichomanas vaginalis (TV) vaginitis, vulvovaginal candidiasis (CA) or any combination thereof. In West Africa, classical agents of cervicitis (Neisseria gonarrhoeae (NG) or Chlamydia trachomatis (CT)) are found in only 5-10% of women who are not SW and 10-25% of SW seeking treatment for a vaginal discharge. (7-11) To these pathogens must be added Mycoplasma genitalium, recently identified as an agent of cervicitis in West Africa. (10) The emergence of a generic drug industry in the developing world has led to a significant reduction in the cost of STI syndromic management, even with single-dose drugs. (12-14) To determine whether single-dose therapy would be as effective as standard therapy in the context of African primary health care institutions providing care to populations with a relatively high prevalence of HIV, we conducted a randomized controlled trial comparing the effectiveness of single-dose tinidazole/fluconazole to that of a 7-day course of metronidazole plus intravaginal clotrimazole for 3 days. Methods Sites and data collection This multicentre study involved nine health-care facilities in four West African countries: * in Ghana, the STI clinics of Accra-Adabraka and Kumasi-Suntreso; * in Guinea, the Madina and Carriere health centres, Conakry; * in Mali, the Korofina and Soutoura health centres, Bamako; and * in Togo, the STI clinics of Amoutive and Agoe Nyive (Lome) and the health centre of Adakpame. The study protocol was approved by the national ethics committee of each country and by the institutional review board of the Centre Hospitalier Universitaire de Sherbrooke, Canada. It was designed as an effectiveness trial, done under conditions similar to those routinely seen in these facilities. Between January 2004 and April 2005, we recruited women who consulted the health centre for a vaginal discharge, regardless of HIV status or involvement in transactional sex, who were local residents and consented to participate. We excluded SW who sought active screening for STI, pregnant women, those whose main complaint was lower abdominal pain and those allergic to one of the study drugs. Women not eligible for the study were treated according to the algorithms routinely used in the health facility. At the initial visit, a questionnaire was used to gather information on demographic and behavioural characteristics, current complaints and the recent intake of antimicrobials. During gynaecological examination, the presence of vulvar inflammation, the characteristics of the discharge and signs of cervicitis (mucopurulent cervical discharge, pus on the swab, cervical bleeding after sampling and cervical inflammation) were noted. …