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.

Study Overview

• Status: Completed
• Conditions: HIV; Chlamydia Trachomatis; Neisseria Gonorrhoeae Infection
• Intervention / Treatment: Drug: Monthly placebo; Drug: Monthly antibiotic

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.

• Study Type: Interventional
• Enrollment (Actual): 636
• Phase: Phase 4

Contacts and Locations

Study Locations

• Benin
  • Cotonou, Benin
    • Dispensaire des infections sexuellement transmissibles

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Zithromax and cipro

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of chlamydia infection	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.	3 months
Presence of chlamydia infection	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.	6 months
Presence of chlamydia infection	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.	9 months

Collaborators and Investigators

• Sponsor: CHU de Quebec-Universite Laval
• Collaborators: Centre de recherche du Centre hospitalier universitaire de Sherbrooke; Maisonneuve-Rosemont Hospital; Ministry of Health, Benin
• Investigators: Principal Investigator: Michel Alary, MD, PhD, Centre de recherche, Centre hospitalier affilié universitaire de Québec

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2001
• Primary Completion (Actual): April 1, 2002
• Study Completion (Actual): April 1, 2002

Study Registration Dates

• First Submitted: February 14, 2011
• First Submitted That Met QC Criteria: April 4, 2011
• First Posted (Estimate): April 6, 2011

Study Record Updates

• Last Update Posted (Estimate): February 13, 2013
• Last Update Submitted That Met QC Criteria: February 12, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: West Africa; Sexually transmitted infections; Female sex workers; Presumptive treatment
• Additional Relevant MeSH Terms: Communicable Diseases; Sexually Transmitted Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Neisseriaceae Infections; Sexually Transmitted Diseases, Bacterial; Infections; Gonorrhea; Anti-Infective Agents; Anti-Bacterial Agents
• Other Study ID Numbers: DR-002-947