Periodical Presumptive Treatment for the Control of Gonococcal Infections Among Sex Workers
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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 |
- 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.
- 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 |
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| Benin | |
| Dispensaire des infections sexuellement transmissibles | |
| Cotonou, Benin | |
| 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 Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013