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
  Purpose

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.


Condition Intervention Phase
Neisseria Gonorrhoeae Infection
Chlamydia Trachomatis
HIV
Drug: Monthly antibiotic
Drug: Monthly placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Periodical Presumptive Treatment of Gonorrhoea in Female Sex Workers: Impact on Prevalence of the Disease in Sex Workers and Their Clients

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Québec, CHU de Québec:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 636
Study Start Date: March 2001
Study Completion Date: April 2002
Primary Completion Date: April 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Sugar pill 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
Experimental: Treatment arm 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

Detailed Description:

"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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01329588

Locations
Benin
Dispensaire des infections sexuellement transmissibles
Cotonou, Benin
Sponsors and Collaborators
Centre Hospitalier Universitaire de Québec, CHU de Québec
Maisonneuve-Rosemont Hospital
Centre Hospitalier Universitaire de Sherbrooke
Ministry of Health, Benin
Investigators
Principal Investigator: Michel Alary, MD, PhD Centre de recherche, Centre hospitalier affilié universitaire de Québec
  More Information

No publications provided by Centre Hospitalier Universitaire de Québec, CHU de Québec

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michel Alary, Unité de recherche en santé des populations
ClinicalTrials.gov Identifier: NCT01329588     History of Changes
Other Study ID Numbers: DR-002-947
Study First Received: February 14, 2011
Last Updated: February 12, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Centre Hospitalier Universitaire de Québec, CHU de Québec:
Female sex workers
West Africa
Presumptive treatment
Sexually transmitted infections

Additional relevant MeSH terms:
Chlamydia Infections
Gonorrhea
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Sexually Transmitted Diseases
Infection
Genital Diseases, Male
Genital Diseases, Female
Neisseriaceae Infections
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on July 10, 2014