Periodical Presumptive Treatment for the Control of Gonococcal Infections Among Sex Workers
1 other identifier
interventional
636
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2001
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2002
CompletedFirst Submitted
Initial submission to the registry
February 14, 2011
CompletedFirst Posted
Study publicly available on registry
April 6, 2011
CompletedFebruary 13, 2013
February 1, 2013
1.1 years
February 14, 2011
February 12, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Presence of gonococcal infection
Cervical samples for NG PCR will be collected at the clinic visit planned at months 3 (between 45-134 days after enrolment). Time trend in gonorrhoea prevalence will be analysed.
3 months
Presence of gonococcal infection
Cervical samples for NG PCR will be collected at the clinic visit planned at months 6 (between 135-224 days after enrolment). Time trend in gonorrhoea prevalence will be analysed.
6 months
Presence of gonococcal infection
Cervical samples for NG PCR will be collected at the clinic visit planned at months 9 (between 225-315 days after enrolment). Time trend in gonorrhoea prevalence will be analysed.
9 months
Secondary Outcomes (3)
Presence of chlamydia infection
3 months
Presence of chlamydia infection
6 months
Presence of chlamydia infection
9 months
Study Arms (2)
Sugar pill
PLACEBO COMPARATORTreatment arm
EXPERIMENTALInterventions
Azithromycin 1g per os once at months 1, 4 and 7 Ciprofloxacin 500 mg per os once at months 2, 3, 5, 6, 8 and 9
Azithromycin placebo (sugar pill) per os once at months 1, 4 and 7 Ciprofloxacin placebo (sugar pill) per os once at months 2, 3, 5, 6, 8 and 9
Eligibility Criteria
You may qualify if:
- Female sex worker (seater) from one of the selected clusters
You may not qualify if:
- Allergy to study drugs
- Pregnancy
- Intention to leave the city within the next 3 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CHU de Quebec-Universite Lavallead
- Maisonneuve-Rosemont Hospitalcollaborator
- Ministry of Health, Benincollaborator
- Centre de recherche du Centre hospitalier universitaire de Sherbrookecollaborator
Study Sites (1)
Dispensaire des infections sexuellement transmissibles
Cotonou, Benin
Related Publications (1)
Labbe AC, Pepin J, Khonde N, Dzokoto A, Meda H, Asamoah-Adu C, Mayaud P, Mabey D, Demers E, Alary M. Periodical antibiotic treatment for the control of gonococcal and chlamydial infections among sex workers in Benin and Ghana: a cluster-randomized placebo-controlled trial. Sex Transm Dis. 2012 Apr;39(4):253-9. doi: 10.1097/OLQ.0b013e318244aaa0.
PMID: 22421690DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michel Alary, MD, PhD
Centre de recherche, Centre hospitalier affilié universitaire de Québec
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 14, 2011
First Posted
April 6, 2011
Study Start
March 1, 2001
Primary Completion
April 1, 2002
Study Completion
April 1, 2002
Last Updated
February 13, 2013
Record last verified: 2013-02