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Urban community randomised trial for prevention of sexually transmitted diseases
DOI 10.1186/ISRCTN43722548
ClinicalTrials.gov identifier
EudraCT number
Public title Urban community randomised trial for prevention of sexually transmitted diseases
Scientific title An urban community randomised trial of a multicomponent intervention for the prevention of sexually transmitted disease in female sex workers and the general population
Acronym PREVEN
Serial number at source 059131
Study hypothesis We aim to:
1. Determine the impact of a hybrid intervention on:
1.1. Prevalence of gonococcal, chlamydial, and trichomonal infection and syphilis seroreactivity in high-risk Female Sex Workers (FSW), bridging groups of clients of FSW, and the lower-risk young adult general population
1.2. The antimicrobial susceptibility and virulence-associated phenotypes of N. gonorrhoeae
2. Develop and employ mathematical models of gonorrhoea, chlamydial infection, syphilis and trichomoniasis to explain the observed impact of the interventions, and facilitate transfer of the intervention to other locations
Lay summary Not provided at time of registration
Ethics approval Added 03/11/2009:
1. Universidad Peruana Cayetano Heredia approved on the 7th December 1999 (ref: #99084)
2. University of Washington approved on the 25th July 2000 (ref: #99-2288)
3. Naval Medical Research Center Detachment approved on the 19th September 2002 (ref: DOD#31556)
Study design Randomised controlled trial
Countries of recruitment Peru
Disease/condition/study domain Sexually transmitted disease prevention
Participants - inclusion criteria 1. General population survey: one adult per household ages 18 to 29 years, either sex
2. FSW: willing to participate
3.Clients of FSW: sex with a commercial sex worker
Participants - exclusion criteria 1. General population survey: over 29 years old
2. All surveys: under 18 years old
Anticipated start date 24/08/2002
Anticipated end date 31/12/2006
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 20 cities - recruitment ends on the 31st December 2006
Interventions Using data from a baseline survey in 24 Peruvian cities with populations more than 50,000, 20 cities were selected for the trial and placed into matched pairs based on region (coastal, jungle or Andean), size and STD prevalence. The pairs were then randomised into control or intervention groups, with the latter receiving a two-year hybrid intervention of:
1. Strengthened syndromic management through a network of physicians and pharmacists
2. STD screening and treatment of FSW
3. Social marketing of condoms

At the end of the two-year intervention, FSW and the young adult general population in all 20 cities will be surveyed again to evaluate its impact.

The anticipated end date of this trial has been extended to the 31st December 2006. The previous anticipated end date was 31/12/2005.
Primary outcome measure(s) 1. Gonorrhoea, chlamydia, trichomonas, bacterial vaginosis, syphilis and human immunodeficiency virus (HIV) infection
2. Demographic and behavioural information regarding sexual history and risk behaviours
Secondary outcome measure(s) No secondary outcome measures
Sources of funding The Wellcome Trust (UK) (grant ref: 059131)
Trial website http://www.proyectopreven.org/index.php?lang=en
Publications 1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22341824
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22878023
Contact name Prof  King  Holmes
  Address University of Washington
Professor of Medicine, Director, Cen
325 9th Ave., Box 359931
  City/town Seattle, WA
  Zip/Postcode 98104
  Country United States of America
  Tel +1 206 731 3620
  Fax +1 206 731 3693
  Email worthy@u.washington.edu
Sponsor University of Washington (USA)
  Address Center for AIDS and STD
325 9th Avenue, Box
  City/town Seattle, WA
  Zip/Postcode 98104
  Country United States of America
  Sponsor website: http://www.washington.edu/
Date applied 22/07/2005
Last edited 14/03/2013
Date ISRCTN assigned 22/07/2005
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