Clinical Trials

MainTitle

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

This study has been completed
Sponsor
CHU de Quebec-Universite Laval

Collaborator
Maisonneuve-Rosemont Hospital
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Ministry of Health, Benin

Information provided by (Responsible Party)
CHU de Quebec-Universite Laval
ClinicalTrials.gov Identifier
NCT01329588

First received: February 14, 2011
Last updated: February 12, 2013
Last Verified: February 2013
History of Changes
Purpose

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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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

Further study details as provided by CHU de Quebec-Universite Laval:

Primary Outcome Measures

  • Presence of gonococcal infection [ Time Frame: 3 months ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes 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

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

CHU de Quebec-Universite Laval
Maisonneuve-Rosemont Hospital
Centre de recherche du 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

More Information


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  

Keywords provided by CHU de Quebec-Universite Laval:

Female sex workers
West Africa
Presumptive treatment
Sexually transmitted infections

Additional relevant MeSH terms:
Infection
Communicable Diseases
Gonorrhea
Anti-Bacterial Agents

ClinicalTrials.gov processed this data on December 15, 2017
This information is provided by ClinicalTrials.gov.