Periodical Presumptive Treatment for the Control of Gonococcal Infections Among Sex Workers
Status:
Completed
Trial end date:
2002-04-01
Target enrollment:
Participant gender:
Summary
In the early years of the HIV epidemic in Africa, female sex workers (FSWs) were identified
as a high-prevalence, high-incidence, core group among whom the extraordinary prevalence of
other sexually transmitted infections (STIs) facilitated transmission of the virus to their
clients, who then infected low-risk women not involved in the sex trade. In resource-poor
settings, control of Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT) among FSWs is
difficult. The purpose of this study is to determine whether periodical antibiotic treatment
(PAT) is effective in controlling these infections among West African FSWs.
The study is designed as a cluster-randomized double-blind placebo-controlled trial conducted
in West Africa. The study population consists of "seaters" FSWs who work from their homes in
well-defined areas. Clusters will be paired according to their size and demographic
characteristics of FSWs and clients. Within each pair, one cluster will be randomly allocated
to the intervention and the other to the placebo group.
At enrollment, participants will be interviewed, a pelvic examination performed, cervical
swabs obtained for NG and CT polymerase chain reaction (PCR), and current cervicitis or
vaginitis managed syndromically. Blood specimens will be obtained for HIV testing. All
participants will be given free condoms and counseled on risk reduction.
Monthly follow-up will be conducted within FSW communities, alternating with clinic visits
where cervical samples will be collected. Study drugs (azithromycin 1 g and ciprofloxacin 500
mg, and their identical placebos) will be distributed every month according to a predefined
schedule: directly-observed intake of azithromycin at months 1, 4 and 7, and ciprofloxacin at
months 2, 3, 5, 6, 8 and 9.
Data will be analyzed with SAS. The investigators will assess the time trends in NG and CT
prevalence separately in both study groups using χ2-for-trend.
Phase:
Phase 4
Details
Lead Sponsor:
Centre Hospitalier Universitaire de Québec, CHU de Québec CHU de Quebec-Universite Laval
Collaborators:
Centre de recherche du Centre hospitalier universitaire de Sherbrooke Maisonneuve-Rosemont Hospital Ministry of Health, Benin