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Periodical Presumptive Treatment for the Control of Gonococcal Infections Among Sex Workers

This study has been completed.
Sponsor:
Collaborators:
Maisonneuve-Rosemont Hospital
Centre Hospitalier Universitaire de Sherbrooke
Ministry of Health, Benin
Information provided by:
Centre Hospitalier Universitaire de Québec, CHU de Québec
ClinicalTrials.gov Identifier:
NCT01329588
First received: February 14, 2011
Last updated: February 12, 2013
Last verified: February 2013

February 14, 2011
February 12, 2013
March 2001
April 2002   (final data collection date for primary outcome measure)
  • Presence of gonococcal infection [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.
  • Presence of gonococcal infection [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.
  • Presence of gonococcal infection [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    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.
Same as current
Complete list of historical versions of study NCT01329588 on ClinicalTrials.gov Archive Site
  • Presence of chlamydia infection [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Cervical samples for CT 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.
  • Presence of chlamydia infection [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Cervical samples for CT 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.
  • Presence of chlamydia infection [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Cervical samples for CT 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.
Same as current
Not Provided
Not Provided
 
Periodical Presumptive Treatment for the Control of Gonococcal Infections Among Sex Workers
Periodical Presumptive Treatment of Gonorrhoea in Female Sex Workers: Impact on Prevalence of the Disease in Sex Workers and Their Clients

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.

"Seaters" are older, more stable, better organized, and have a much higher prevalence of HIV infection than FSWs who roam the streets or part-time sex workers. These communities (from 3 to 114 FSWs per site) will be aggregated into 18 clusters (one cluster was composed of 1-10 FSW communities) based on geographical proximity. Over a one-year period, FSWs from these clusters presenting to dedicated clinics will be invited to participate. In addition, field workers will visit FSWs at home or at prostitution sites to provide information about the trial and seek participation.

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 using pre-coded envelopes. With an average of 35 FSWs per cluster, the required number of cluster pairs is estimated at 8.7 to detect a 50% reduction in NG prevalence, assuming a baseline prevalence of 25%, 80% power and 5% alpha error.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Neisseria Gonorrhoeae Infection
  • Chlamydia Trachomatis
  • HIV
  • Drug: Monthly antibiotic
    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
    Other Name: Zithromax and cipro
  • Drug: Monthly placebo
    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
  • Placebo Comparator: Sugar pill
    Intervention: Drug: Monthly placebo
  • Experimental: Treatment arm
    Intervention: Drug: Monthly antibiotic
Labbé AC, Pépin J, Khonde N, Dzokoto A, Méda 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
636
April 2002
April 2002   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Female sex worker (seater) from one of the selected clusters

Exclusion Criteria:

  • Allergy to study drugs
  • Pregnancy
  • Intention to leave the city within the next 3 months
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Benin
 
NCT01329588
DR-002-947
No
Michel Alary, Unité de recherche en santé des populations
Centre Hospitalier Universitaire de Québec, CHU de Québec
  • Maisonneuve-Rosemont Hospital
  • Centre Hospitalier Universitaire de Sherbrooke
  • Ministry of Health, Benin
Principal Investigator: Michel Alary, MD, PhD Centre de recherche, Centre hospitalier affilié universitaire de Québec
Centre Hospitalier Universitaire de Québec, CHU de Québec
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP